[Federal Register: December 16, 2005 (Volume 70, Number 241)]
[Rules and Regulations]
[Page 74688-74696]
[DOCID:fr16de05-15]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0276; FRL-7746-5]

Bifenazate; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes time-limited tolerances for
combined residues of bifenazate in or on tart cherries and soybeans.
This action is in response to EPA's granting of emergency exemptions
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizing use of the pesticide on tart cherries and
soybeans. This regulation establishes maximum permissible levels for
residues of bifenazate in these food commodities. The tolerance will
expire and is revoked on December 31, 2009.

DATES: This regulation is effective December 16, 2005. Objections and
requests for hearings must be received on or before February 14, 2006.

ADDRESSES:  To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2005-0276. All documents in the
docket are listed on the http://www.regulations.gov web site. (EDOCKET, EPA's

electronic public docket and comment system was replaced on November
25, 2005, by an enhanced federal-wide electronic docket management and
comment system located at http://www.regulations.gov/. Follow the on-

line instructions.) Although listed in the index, some information is
not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., 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.

FOR FURTHER INFORMATION CONTACT:  Marcel Howard, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to

certain entities. If you have any questions regarding the applicability
of this action to a particular entity, consult the person listed under
FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/), 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 on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

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
miticide bifenazate, 1-methylethyl-2-(4-methoxy[1,1'-biphenyl]-3-yl
hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy-[1,1'-
biphenyl]-3-yl), 1-methylethyl ester, expressed as bifenazate, in or on
tart cherries at 5.0 parts per million (ppm); soybean seed at 1.5 ppm;
soybean hulls at 20 ppm; soybean meal at 3.5 ppm; and soybean refined
oil at 20 ppm. These tolerances will expire and are revoked on December
31, 2009. 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 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.

III. Emergency Exemption for Bifenazate on Tart Cherries and Soybeans
and FFDCA Tolerances

    The state of Utah petitioned EPA to allow use of bifenazate on tart
cherries to control phytophagous spider mites. EPA has determined that
Utah tart cherry growers are likely to suffer significant economic
losses due to pest infestation without use of bifenazate. Data
submitted indicate that effective control has not been achieved using
current registered products. In addition, the primary pesticide used
for mite control in the past, propargite, has been relabeled for post-
harvest use only. Bifenazate is necessary to prevent crop losses in the
current year and to ensure tree vitality in the next year.
    In a separate action, the state of Delaware petitioned EPA to allow
use of bifenazate on soybeans to control two spotted spider mites.
According to the applicant, there are two registered products,
dimethoate and chlorpyrifos, which have some miticidal activity and are
recommended for spider mite control in Delaware soybeans. EPA has
determined that, in the event of hot, dry weather, mite populations
could cause significant economic losses to soybean growers in Delaware,
even in light of these alternatives.
    EPA determined that bifenazate can be used with a reasonable
certainty of no harm to humans or to the environment. Thus, EPA has
authorized under FIFRA section 18 the use of bifenazate on tart
cherries for control of phytophagous spider mites in Utah, and on
soybeans for control of two spotted spider mites in Delaware. After
having reviewed the submission, EPA concurs that emergency conditions
exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of bifenazate in or on tart
cherries and soybeans. 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 these tolerances will expire and are revoked on
December 31, 2009, under section 408(l)(5) of the FFDCA, residues of
the pesticide not in excess of the amounts specified in the tolerance
remaining in or on tart cherries and soybeans after that date will not
be unlawful, provided the pesticide is applied in a manner that was
lawful under FIFRA, and the residues do not exceed a level that was
authorized by these tolerances at the time of that application. 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 are not safe.
    Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether bifenazate
meets EPA's registration requirements for use on tart cherries and
soybeans or whether a permanent tolerance for these uses would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of bifenazate by a State
for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for any State other than Utah and
Delaware to use this pesticide on these crops 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 bifenazate, 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 (62 FR 62961, November 26, 1997) (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
bifenazate and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for a time-limited
tolerance for combined residues of bifenazate in or on tart cherries at
5.0 ppm; soybean seed at 1.5 ppm; soybean hulls at 20 ppm; soybean meal
at 3.5 ppm; and soybean refined oil at 20 ppm. EPA's assessment of the
dietary exposures and risks associated with establishing the tolerance
follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA safety factor
(SF).
    For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 106 or one in a million).
Under certain specific circumstances, MOE calculations will be used for
the carcinogenic risk assessment. In this non-linear approach, a
``point of departure'' is identified below which carcinogenic effects
are not expected. The point of departure is typically a NOAEL based on
an endpoint related to cancer effects though it may be a different
value derived from the dose response curve. To estimate risk, a ratio
of the point of departure to exposure (MOEcancer = point of
departure/exposures) is calculated. A summary of the toxicological
endpoints for bifenazate used for human risk assessment is shown in the
following Table 1:

      Table 1.--Summary of Toxicological Dose and Endpoints for Bifenazate for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population        An acute dietary endpoint was not selected based on the absence of an
 including infants, children, and                    endpoint of concern attributed to a single dose
 females 13-50 years old)
--------------------------------------
Chronic Dietary (All populations)      NOAEL = 1.0 mg/kg/day    FQPA SF = 1X             1-Year Dog Feeding
                                       UF = 100...............  cPAD = chronic RfD/FQPA   Study
                                       Chronic RfD = 0.01 mg/    SF = 0.01 mg/kg/day.    LOAEL = 8.9/10.4 mg/kg/
                                        kg/day.                                           day
                                                                                [M/F] based on changes
                                                                                in hematological and
                                                                                clinical chemistry
                                                                                parameters, and
                                                                                histopathology in bone
                                                                                marrow, liver, and
                                                                                kidney
--------------------------------------
Incidental Oral, Short-Term (1 to 30   Oral study               LOC for MOE < = 100       Rat Developmental Study
 days)                                 NOAEL = 10 mg/kg/day...   (Residential)           maternal LOAEL = 100 mg/
(Residential)........................                                                     kg/day based on
                                                                                clinical signs,
                                                                                decreased body weight
                                                                                and food consumption
                                                                                during the dosing
                                                                                period
--------------------------------------
Incidental Oral, Intermediate-Term     Oral study               LOC for MOE < = 100       90-Day Subchronic Dog
 (30 days to 6 months)                 NOAEL = 0.9 mg/kg/day..   (Residential)            Study
(Residential)........................                                                    LOAEL = 10.4/10.7 mg/kg/
                                                                                day
                                                                                [M/F] based on changes
                                                                                in hematologic
                                                                                parameters
--------------------------------------
Short-, Intermediate-, and Long-Term   Dermal study             LOC for MOE < = 100       21-Day Dermal Toxicity
 Dermal (1 to 30 days, 30 days to 6    NOAEL = 80 mg/kg/day...   (Residential)            Study in Rats
 months, and 6 months to lifetime)                                                       LOAEL = 400 mg/kg/day
(Residential)........................                                                     based on decreased
                                                                                body weight and food
                                                                                consumption,
                                                                                hematologic effects,
                                                                                increased spleen
                                                                                weight, and
                                                                                extramedullary
                                                                                hemapoiesis in the
                                                                                spleen
--------------------------------------

Short-Term Inhalation (1 to 30 days)   Oral study               LOC for MOE < = 100       Rat Developmental Study
(Residential)........................  NOAEL = 10 mg/kg/         (Residential)           LOAEL = 100 mg/kg/day
                                        day(inhalation                                    based on decreased
                                        absorption rate =                                 body weight andfood
                                        100%).                                            consumption
--------------------------------------
Intermediate-Term Inhalation (30 days  Oral study               LOC for MOE < = 100       90 Day Dog Feeding
 to 6 months)                          NOAEL = 0.9 mg/kg/day     (Residential)            Study
(Residential)........................   (inhalationabsorption                            LOAEL = 10.4/10.7 mg/kg/
                                        rate = 100%).                                     day
                                                                                [M/F] based on changes
                                                                                in hematologic
                                                                                parameters
--------------------------------------
Long-Term Inhalation (6 months         Oral study               LOC for MOE < = 100       1-Year Dog Feeding
 tolifetime)                           NOAEL = 1.0 mg/kg/day     (Residential)            Study
(Residential)........................   (inhalation absorption                           LOAEL = 8.9/10.4 mg/kg/
                                        rate = 100%).                                     day
                                                                                [M/F] based on changes
                                                                                in hematological and
                                                                                clinical chemistry
                                                                                parameters, and
                                                                                histopathology in bone
                                                                                marrow, liver, and
                                                                                kidney
--------------------------------------
Cancer (oral, dermal, inhalation)         Bifenazate is classified as ``not likely'' to be a human carcinogen
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA SF refers to any additional SF retained due to concerns of FQPA.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.572) for the combined residues of bifenazate,
in or on a variety of raw agricultural commodities. Tolerances on
primary crops range from 0.1 ppm to 35 ppm on pome fruit, fruiting
vegetable, cucurbit vegetable, tree nut, nectarine, peach, plum, grape,
strawberry, cotton, hops, okra, peppermint, and spearmint. Tolerances
have also been established in milk, ruminant meat, and ruminant meat
byproducts at 0.02 ppm. Bifenazate is a selective miticide which
controls the motile stage of mites either by direct contact or through
contact with foliar residues. Risk assessments were conducted by EPA to
assess dietary exposures from bifenazate in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure. As indicated in Table 1 above, toxicological data for
bifenazate do not identify any dose to the chemical which triggers a
toxic effect based on an acute dose. As there were no toxic effects
attributable to a single dose, an endpoint of concern was not
identified to quantitate acute-dietary risk to the general population,
to infants, to children or to the subpopulation females 13-50 years
old. Therefore, there is no acute reference dose (aRfD) or acute
population-adjusted dose (aPAD) for the general population or females
13-50 years old. An acute aggregate risk assessment was not performed
because no acute risk is expected.
    ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM\TM\) analysis
evaluated the individual food consumption as reported by respondents in
the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity.
    The chronic dietary exposure analysis was based on tolerance level
residues excluding tomato and soybean (average field trial residues was
assumed for these crops) and average percent crop treated information.
DEEM\TM\ (Version 7.76) default processing factors were used for some
commodities. The analyses also included the chronic surface water point
estimate generated using the Tier 1 model First Index Reservoir
Screening Tool (FIRST) which assumed that 87% of the basin is cropped
and 100% of the cropped area treated at the maximum rate (surface water
chronic point estimate was greater than the ground water point
estimate).
    iii. Cancer. Bifenazate has been classified as ``not likely'' to be
a human carcinogen.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must pursuant
to section 408(f)(1) require that data be provided 5 years after the
tolerance is established, modified, or left in effect, demonstrating
that the levels in food are not above the levels anticipated. Following
the initial data submission, EPA is authorized to require similar data
on a time frame it deems appropriate. For the present action, EPA will
issue such Data Call-Ins for information relating to anticipated
residues as is required by FFDCA section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Such Data Call-Ins will be required to
be submitted no later than 5 years from the date of issuance of this
tolerance.
    Section 408(b)(2)(F) of the FFDCA states that the Agency may use
data on the actual percent of food treated for assessing chronic
dietary risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid basis
to show what percentage of the food derived from such crop is likely to
contain such pesticide residue; Condition 2, that the exposure estimate
does not underestimate exposure for any significant subpopulation
group; and Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by

section 408(b)(2)(F) of the FFDCA, EPA may require registrants to
submit data on PCT.
    The Agency used average PCT information for several commodities.
    The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which bifenazate may
be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for bifenazate in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of bifenazate.
    The Agency uses the FIRST or the Pesticide Root Zone/Exposure
Analysis Modeling System (PRZM/EXAMS) to produce estimates of pesticide
concentrations in an index reservoir. The Screening Concentrations in
Groundwater (SCI-GROW) model is used to predict pesticide
concentrations in shallow ground water. For a screening-level
assessment for surface water EPA will generally use FIRST (a Tier 1
model) before using PRZM/EXAMS (a Tier 2 model). The FIRST model is a
subset of the PRZM/EXAMS model that uses a specific high-end runoff
scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an
index reservoir environment, the PRZM/EXAMS model includes a percent
crop area factor as an adjustment to account for the maximum percent
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead, drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to bifenazate they are further
discussed in the aggregate risk sections below.
    Based on the FIRST and SCI-GROW models the EECs of bifenazate for
chronic exposures are estimated to be 6.4 parts per billion (ppb) for
surface water and < 0.001 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Bifenazate is currently registered for use on the following
residential non-dietary sites: Ornamentals and non-bearing fruit trees.
The risk assessment was conducted using the following exposure
assumptions: Only short-term dermal and short-term inhalation exposure
are expected for homeowner applicators. Post-application exposure is
anticipated to be negligible and was not assessed.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to bifenazate and any other
substances and bifenazate does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that bifenazate has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative/.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.

    2. Prenatal and postnatal sensitivity. Developmental toxicity and
reproductive toxicity studies performed with bifenazate yield no
qualitative or quantitative toxicity evidence of increased
susceptibility among rats and rabbits during in utero exposure or
during postnatal exposure.
    3. Conclusion. There is a complete toxicity data base for
bifenazate and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. Based on the
lack of increased susceptibility and the completeness of the toxicity
and exposure databases, EPA has concluded that the additional 10X
safety factor for childrens' health can be reduced to 1X.

D. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water EECs. DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water (e.g., allowable chronic water exposure (mg/kg/day) =
cPAD - (average food + chronic non-dietary, non-occupational
exposure)). This allowable exposure through drinking water is used to
calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and
1L/10 kg (child). Default body weights and drinking water consumption
values vary on an individual basis. This variation will be taken into
account in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to bifenazate in drinking water (when considered along with
other sources of exposure for which EPA has reliable data) would not
result in unacceptable levels of aggregate human health risk at this
time. Because EPA considers the aggregate risk resulting from multiple
exposure pathways associated with a pesticide's uses, levels of
comparison in drinking water may vary as those uses change. If new uses
are added in the future, EPA will reassess the potential impacts of
bifenazate on drinking water as a part of the aggregate risk assessment
process.
    1. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
bifenazate from food will utilize 36% of the cPAD for the U.S.
population, 72% of the cPAD for all infants (<  1 year old) and 84% of
the cPAD for children 1-2 years old. Based on the use pattern, chronic
residential exposure to residues of bifenazate is not expected. In
addition, despite the potential for chronic dietary exposure to
bifenazate in drinking water, after calculating DWLOCs and comparing
them to conservative model EECs of bifenazate in surface water and
ground water, EPA does not expect the aggregate exposure to exceed 100%
of the cPAD, as shown in Table 2 of this unit:

              Table 2.--Aggregate Risk Assessment for Chronic (Non- Cancer) Exposure to Bifenazate
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     %cPAD      Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                         0.01           36          6.4       < 0.001          230
------------------------------------------------
All infants (< 1 year old)                               0.01           72          6.4       < 0.001           26
------------------------------------------------
Children (1-2 years old)                                0.01           84          6.4       < 0.001           21
------------------------------------------------
Children (3-5 years old)                                0.01           78          6.4       < 0.001           25
------------------------------------------------
Children (6-12 years old)                               0.01           52          6.4       < 0.001           47
------------------------------------------------
Youth (13-19 years old)                                 0.01           33          6.4       < 0.001          200
------------------------------------------------
Adults (20-49 years old)                                0.01           31          6.4       < 0.001          250
------------------------------------------------
Adults (50 + years old)                                 0.01           30          6.4       < 0.001          270
------------------------------------------------
Females (13-49)                                         0.01           35          6.4       < 0.001          260
----------------------------------------------------------------------------------------------------------------

    2. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Bifenazate is currently registered for use(s) that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for bifenazate.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food and residential exposures
aggregated result in aggregate MOEs of 1,672 for U.S. population, 1,741
for youth 13-19 years old, 1,820 for adults 20-49 years old, 1,849 for
adults 50+ years old, and 1,684 for females 13-49 years old. These
aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic
exposure of bifenazate in ground water and surface water. After
calculating DWLOCs and comparing them to the EECs for surface water and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in Table 3 of this unit:

                    Table 3.--Aggregate Risk Assessment for Short-Term Exposure to Bifenazate
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population                                        1,672          100          6.4       < 0.001        3,200
-----------------------------------------------
Youth (13-19 years old)                                1,741          100          6.4       < 0.001        3,000
-----------------------------------------------
Adults (20-49 years old)                               1,820          100          6.4       < 0.001        3,300
-----------------------------------------------
Adults (50 + years old)                                1,849          100          6.4       < 0.001        3,500
-----------------------------------------------
Females (13-49 years old)                              1,684          100          6.4       < 0.001        2,700
----------------------------------------------------------------------------------------------------------------

    3. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Though residential exposure could occur with the use of
bifenazate, only short-term exposures are expected for homeowner
applicators. Therefore, the aggregate risk is the sum of the risk from
food and water, which were previously addressed.
    4. Aggregate cancer risk for U.S. population. Bifenazate is
classified as ``not likely'' to be a human carcinogen. Thus, a
quantification of human cancer risk has not been performed.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to bifenazate residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example--gas chromatography) is
available to enforce the tolerance expression. The method may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    Canada, Codex, and Mexico do not have maximum residue limits for
residues of bifenazate in or on the proposed crops. Therefore,
harmonization is not an issue.

VI. Conclusion

    Therefore, time-limited tolerances are established for combined
residues of bifenazate, 1-methylethyl-2-(4-methoxy[1,1'-biphenyl]-3-yl
hydrazinecarboxylate and diazinecarboxylic acid, 2-(4-methoxy-[1,1'-
biphenyl]-3-yl), 1-methylethyl ester, expressed as bifenazate, in or on
tart cherries at 5.0 ppm; soybean seed at 1.5 ppm; soybean hulls at 20
ppm; soybean meal at 3.5 ppm; and soybean refined oil at 20 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 EPA-HQ-OPP-2005-0276 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 February
14, 2006.
    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 issue(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 (1900L),
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 Suite 350, 1099 14\th\ St., NW.,
Washington, DC 20005. 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<PHONE_NUMBER>.
    2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A.1.,
you should also send a copy of your request to the PIRIB for its
inclusion in the official record that is described in ADDRESSES. Mail
your copies, identified by the docket ID number EPA-HQ-OPP-2005-0276,
to: Public Information and Records Integrity Branch, Information
Technology and Resource Management 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 ADDRESSES. You may also
send an

electronic copy of your request via e-mail to<EMAIL_ADDRESS>
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 issue(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 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: December 1, 2005.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.572 is amended by alphabetically adding commodities in
the table in paragraph (b) to read as follows:

Sec.  180.572  Bifenazate; tolerance for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Cherry, tart..................................          5.0     12/31/09
                                * * * * *
Soybean, hulls................................           20     12/31/09
Soybean, meal.................................          3.5     12/31/09

Soybean, refined oil..........................           20     12/31/09
Soybean, seed.................................          1.5     12/31/09
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 05-24137 Filed 12-15-05; 8:45 am]

BILLING CODE 6560-50-S


[ Federal Register: May 17, 2002 ( Volume 67, Number 96)] [ Rules and Regulations] [ Page 35045 35050] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr17my02 9]

===================================================================== ==

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP 2002  0037; FRL 6835 7] RIN 2070 AB78 Pesticides; Removal of Duplicative or Expired Time limited Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: EPA is amending 40 CFR part 180 to remove time limited tolerances for several pesticides that were originally established to support emergency exemptions issued under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). These time limited tolerances are being removed from 40 CFR part 180 because they have since expired or because permanent tolerances have been established for the pesticide and commodity covered by the time limited tolerance. The expired time limited tolerance is obsolete, while the unexpired time limited tolerance covered by a permanent tolerance is duplicative. In either case, the time limited tolerance is unnecessary and is being removed with this final rule to ensure that the regulatory listings of tolerances is properly updated.

DATES: This rule is effective May 17, 2002. Objections and requests for hearings, identified by docket control number OPP 2002 0037, must be received by EPA on or before July 16, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit I. C. of the " SUPPLEMENTARY INFORMATION" section. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP 2002 0037 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: Robert Forrest, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308 9376; and e mail address: forrest. robert@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

 Examples of Potentially Categories NAICS Affected Entities  Industry 111 Crop production 112 Animal production 311 Food manufacturing 32532 Pesticide manufacturing

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 the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have 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 Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select " Laws and Regulations," " Regulations and Proposed Rules," and then look up the entry for this document under the " Federal Register& mdash; Environmental Documents." You can also go directly to 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. 2. In person. The Agency has established an official record for this action under docket control number OPP 2002 0037. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805.

C. How Can I Submit an Objection or Request a Hearing Under FFDCA?

Although section 408( g) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act ( FQPA), allows any person to file an objection or request a hearing when the Agency issues a final tolerance action under section 408, EPA does not expect that anyone will file an objection or request a hearing for this particular rule because the tolerances being revoked here are unnecessary duplicates of a permanent tolerance that remains in place or are obsolete by their own terms. If, for some reason, anyone wishes to file an objection or request for a hearing under section 408( g), please follow the EPA procedural regulations which govern the submission of objections and requests for hearings that appear in 40 CFR part 178. Note that the period for filing objections is now 60 days, rather than 30 days.

II. Authority A. What is EPA's Authority for Revoking these Tolerances?

This final rule is issued pursuant to section 408( e) of FFDCA, as amended by the FQPA ( 21 U. S. C. 346a( e)). Section 408 of FFDCA authorizes the establishment of tolerances, exemptions from the requirement of a tolerance, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or tolerance exemption, food containing pesticide residues is considered to be unsafe and therefore " adulterated" under section 402( a) of the FFDCA. If food containing pesticide residues is found to be adulterated, the food may not be [[ Page 35046]]

distributed in interstate commerce ( 21 U. S. C. 331( a) and 342( a)).

B. Why is EPA Issuing this as a Final Rule?

Section 553 of the Administrative Procedure Act, 5 U. S. C. 553( b)( B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's rule final without prior proposal and opportunity for comment because the actions taken in this final rule represent technical corrections to the regulations and do not involve substantive Agency action. The removal of an expired time limited tolerance from 40 CFR part 180 represents a simple correction of the regulations, and does not involve any substantive Agency action. The expiration date for the time limited tolerance is set when the Agency issues the final rule that originally establishes, or a subsequent final rule that amends, the specific time limited tolerance. Once that time limited tolerance expires, the associated listing in 40 CFR part 180 is obsolete and must be removed to reflect that expiration. The revocation of an unexpired time limited tolerance from 40 CFR part 180, however, represents a substantive Agency action. In this case, that action is appropriate because the Agency's subsequent establishment of a permanent tolerance for the same pesticide chemical and commodity that was covered by the time limited tolerance, causes the time limited tolerance to become obsolete. Although the time limited tolerance would expire by its own terms and become obsolete, the Agency is removing these tolerances today to eliminate an unnecessary duplication in the regulations. For these reasons, notice and public procedure are unnecessary. EPA finds that this constitutes good cause under 5 U. S. C. 553( b)( B).

III. Overview of Today's Action A. What Action is EPA Taking?

For each pesticide chemical and commodity combination listed below, EPA previously established a time limited tolerance, under section 408 of the FFDCA, 21 U. S. C. 346a, as amended by the FQPA of 1996 ( Public Law 104 170). EPA established the tolerances because 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. These time limited tolerances are being removed from 40 CFR part 180 today because they have since expired or because permanent tolerances have since been established making these time limited tolerances obsolete or unnecessary.

B. Which Time Limited Tolerances are Obsolete?

The time limited tolerances for the following pesticide chemicals on specific commodities are being removed from 40 CFR part 180 because the time limited tolerances have expired, or are duplicative of a permanent tolerance that the Agency subsequently established for the pesticide and commodity covered by the time limited tolerance. In either case, the time limited tolerance is obsolete and no longer necessary: 1. Avermectin. The time limited tolerance for celeriac is being removed from 40 CFR 180.449 because a permanent tolerance for the same pesticide chemical and commodity has been established. 2. Azoxystrobin. Time limited tolerances for aspirated soybean grain fractions; cucurbits; eggs; kidney of cattle; kidney of goats, hogs, and sheep grazed on sugar beets; leaf and head lettuce; liver of cattle, goat, horse, sheep, hog, and poultry; meat and fat of cattle, goat, horse, sheep, poultry and swine; milk; dried and fresh parsley; rice grain; rice hulls; rice straw; soybean meal; soybean oil; soybean silage; spinach; sugar beet roots; sugar beet tops; sugar beet molasses; dried sugar beet pulp; refined sugar of sugar beet; and strawberries; are being removed from 40 CFR 180.507 because they expired on or before December 30, 2001. The time limited tolerance for watercress is being removed from 40 CFR part 180 because a permanent tolerance for the same pesticide chemical and commodity has been established. 3. Bentazon. The time limited tolerance for succulent peas is being removed from 40 CFR 180.355 because it expired on December 31, 2000. 4. Bifenthrin. Time limited tolerances for broccoli; cabbage; canola seed; cauliflower; grapes; raspberries; and cucurbit vegetables are being removed from 40 CFR 180.442 because they expired on or before December 31, 2001. 5. Carfentrazone ethyl. Time limited tolerances for rice grain and rice straw are being removed from 40 CFR 180.515 because they expired on December 31, 2000. 6. Chlorfenapyr. Time limited tolerances for fat; meat byproducts and meat of cattle, goats, hogs, horses and sheep; cottonseed; cotton gin byproducts; milk; and milk fat are being removed from 40 CFR 180.513 because they expired on January 31, 2001. 7. Clomazone. Time limited tolerances for rice grain, rice straw, sugarcane and watermelons are being removed from 40 CFR 180.425 because permanent tolerances for the same pesticide chemical and commodities have been established. 8. Cymoxanil. The time limited tolerance for tomatoes is being removed from 40 CFR 180.503 because it expired on May 15, 1999. 9. Cyprodinil. The time limited tolerance for strawberries is being removed from 40 CFR 180.532 because it expired on May 31, 2001. 10. Dicloran. Time limited tolerances for peanut oil and peanuts are being removed from 40 CFR 180.200 because they expired on October 31, 2001. 11. Diflubenzuron. The time limited tolerance for pears is being removed from 40 CFR 180.377 because it expired on March 31, 2001. 12. Dimethomorph. Time limited tolerances for potatoes, tomatoes, tomato paste, and tomato puree are being removed from 40 CFR 180.493 because they expired on or before September 15, 2000. 13. Endothall. The time limited tolerance for canola seed is being removed from 40 CFR 180.293 because it expired on February 29, 2000. 14. Ethametsulfuron methyl. The time limited tolerance for canola is being removed from 40 CFR 180.563 because a permanent tolerance for the same pesticide chemical and commodity has been established. 15. Fenarimol. Time limited tolerances for filberts and hops are being removed from 40 CFR 180.421 because they expired on December 31, 1998. 16. Fenoxycarb. The time limited tolerance for pears is being removed from 40 CFR 180.504 because it expired on April 30, 1998. 17. Fenpropathrin. Time limited tolerances for soybean forage, soybean hay, soybean hulls, soybean meal, refined soybean oil, and soybean seed are being removed from 40 CFR 180.466 because they expired on December 31, 2001. 18. Fludioxonil. The time limited tolerance for strawberry is being removed from 40 CFR 180.516 because it expired on May 31, 2001. 19. Glyphosate. Time limited tolerances for kidney of cattle, goats,

[[ Page 35047]]

horses, and sheep; chickpeas; lentils; pea hay; pea vines; dry peas and silage hay are being removed from 40 CFR 180.364 because they expired on February 29, 2000. 20. Imidacloprid. Time limited tolerances for citrus fruits crop group; dried citrus pulp; field corn forage; field corn stover ( fodder); field corn grain; sweet corn fodder; sweet corn forage; sweet corn grain and cucurbits vegetable are being removed from 40 CFR 180.472 because permanent tolerances for the same pesticide chemical and commodities have been established. 21. Lambda cyhalothrin. Time limited tolerances for canola seed and flax seed are being removed from 40 CFR 180.438 because they expired on December 31, 2000. 22. Maleic hydrazide. Time limited tolerances for fat, liver, kidney, and meat of cattle, goats, hogs, horses, poultry, and sheep; eggs; milk; rice bran; rice grain; rice hulls; and rice straw are being removed from 40 CFR 180.175 because they expired on September 30, 2000. 23. Mefenoxam. The time limited tolerance for canola is being removed from 40 CFR 180.546 because it expired on December 31, 2001. 24. Myclobutanil. Time limited tolerances for asparagus; caneberries; cucurbit vegetables; peppermint; spearmint; strawberries; tomato fruit; tomato paste; and tomato puree are being removed from 40 CFR 180.443 because they expired on or before December 31, 2000. 25. Oxyfluorfen. The time limited tolerance for strawberries is being removed from 40 CFR 180.381 because it expired on April 15, 2001. 26. Paraquat. The time limited tolerance for artichokes is being removed from 40 CFR 180.205 because a permanent tolerance for the same pesticide chemical and commodity has been established. Time limited tolerances for mustard seed; poultry meat by products; aspirated grain fractions of sorghum; sorghum forage; sorghum grain; and sorghum stover are being removed from 40 CFR 180.205 because they expired on or before November 15, 1998. 27. Primisulfuron methyl. The time limited tolerance for bluegrass hay is being removed from 40 CFR 180.452 because it expired on April 30, 2000. 28. Propamocarb hydrochloride. Time limited tolerances for potatoes; fat, meat, meat by product of cattle, goats, hogs, horse and sheep; milk are being removed from 40 CFR 180.499 because they expired on September 15, 2000. 29. Propiconazole. Time limited tolerances for almond hull and almond nut meat are being removed from 40 CFR 180.434 because they expired on July 31, 2000. 30. Propyzamide. Time limited tolerances for grass forage and grass hay are being removed from 40 CFR 180.317 because they expired on December 31, 2001. 31. Pyridate. Time limited tolerances for peppermint tops ( leaves and stems) and spearmint tops ( leaves and stems) are being removed from 40 CFR 180.462 because they expired on December 31, 2001. 32. Pyriproxyfen. Time limited tolerances for almond hulls, almond nutmeats, citrus fruit, citrus juice, citrus oil, dried citrus pulp, pears, and tomatoes are being removed from 40 CFR 180.510 because permanent tolerances for the same pesticide chemical and commodities have been established. 33. Quinclorac. Time limited tolerances for fat and meat byproducts of cattle, goats, hogs, horses, and sheep; poultry fat; sorghum grain fodder ( stover); sorghum grain forage; sorghum grain; aspirated grain fractions of wheat; wheat forage; wheat grain; milled wheat fractions; and wheat straw are being removed from 40 CFR 180.463 because they expired on May 30, 2000. 34. Sethoxydim. Time limited tolerances for buckwheat and horseradish are being removed from 40 CFR 180.412 because they expired on or before December 31, 2001. 35. Sodium Salt of Acifluorfen. Time limited tolerances for cowpeas, lima beans, and Southern peas are being removed from 40 CFR 180.383 because they expired on December 31, 1998. 36. Sodium Salt of Fomesafen. Time limited tolerances for snap beans and dry beans are being removed from 40 CFR 180.433 because they expired on or before October 31, 1998. 37. Tebuconazole. Time limited tolerances for pistachios; milk and meat byproducts of cattle, goats, hogs, horses, poultry and sheep are being removed from 40 CFR 180.474 because they expired on December 30, 2000. 38. Tebufenozide. Time limited tolerances for apple pomace; apples; fat, kidney, liver, meat byproducts and meat of cattle, goats, hogs, and sheep; horse meat; cotton gin byproducts; cottonseed hulls; cottonseed meal; cottonseed oil; undelinted cottonseed; cranberries; leafy vegetable ( Cole brassica); leafy vegetables ( non brassica); milk; pears; pecans; peppers; rice bran; rice grain; rice hulls; rice straw; soybeans; sugar beet tops; sugar beet roots; dried sugar beet pulp; sugar beet molasses; sugar beet refined sugar; sugarcane; sugarcane molasses; and turnip tops are being removed from 40 CFR 180.482 because they expired on or before December 31, 2001. 39. Thiamethoxam. Time limited tolerances for meat and meat byproducts of cattle, goat, horse, and sheep; undelinted cotton seed; cotton gin byproducts; and milk are being removed from 40 CFR 180.565 because permanent tolerances for the same pesticide chemical and commodities have been established. 40. Triadimefon. Time limited tolerances for artichokes, asparagus, and chili peppers are being removed from 40 CFR 180.410 because they expired on or before September 1, 1999. 41. Triclopyr. Time limited tolerances for fish and shellfish are being removed from 40 CFR 180.417 because they expired on or before June 30, 2000.

IV. Regulatory Assessment Requirements This final rule removes obsolete or unnecessary time limited tolerances that were previously established under FFDCA section 408. The Office of Management and Budget ( OMB) has exempted tolerance actions like this revocation from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866, this rule is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997), or Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). Because the agency has made a good cause finding that this action is not subject to notice and comment requirements under the Administrative Procedure Act or any other statute ( see discussion in Unit II. B. of this preamble), it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act ( RFA)( 5 U. S. C. 601 et seq.), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 ( UMRA)( Public Law 104 4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). This action will not have substantial direct effects [[ Page 35048]]

on State or tribal governments, on the relationship between the Federal government and States or Indian tribes, or on the distribution of power and responsibilities between the Federal government and States or Indian tribes. As a result, this action does not require any action under Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999), or under Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Nor does it require 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 Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights ( 53 FR 8859, March 15, 1988). 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). This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act ( PRA)( 44 U. S. C. 3501 et seq.). In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988 ( 61 FR 4729, February 7, 1996).

V. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U. S. C. 808( 2). As stated in Unit II. B. of this preamble, EPA has made such a good cause finding for this rule, including the reasons therefor, and established an effective date of May 17, 2002. 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: April 26, 2002. Donald R. Stubbs, Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180& mdash;[ AMENDED]

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

Authority: 21 U. S. C. 321( q), 346( a) and 374.

Sec. 180.175 [ Amended]

2. In Sec. 180.175, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.200 [ Amended]

3. In Sec. 180.200, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.205 [ Amended]

4. In Sec. 180.205, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.293 [ Amended]

5. In Sec. 180.293, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.317 [ Amended]

6. In Sec. 180.317, in the table in paragraph ( b), remove the entries grass, forage and grass, hay.

Sec. 180.355 [ Amended]

7. In Sec. 180.355, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.364 [ Amended] 8. In Sec. 180.364, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.377 [ Amended]

9. In Sec. 180.377, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.381 [ Amended]

10. In Sec. 180.381, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.383 [ Amended]

11. In Sec. 180.383, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.410 [ Amended]

12. In Sec. 180.410, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.412 [ Amended]

13. In Sec. 180.412, in the table in paragraph ( b), remove the entries buckwheat and horseradish.

Sec. 180.417 [ Amended]

14. In Sec. 180.417, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.421 [ Amended]

15. In Sec. 180.421, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.425 [ Amended]

16. In Sec. 180.425, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.433 [ Amended] 17. In Sec. 180.433, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.434 [ Amended]

18. In Sec. 180.434, in the table in paragraph ( b), remove the entries for " Almond hull" and " Almond nut meat".

Sec. 180.438 [ Amended]

19. In Sec. 180.438, in the table in paragraph ( b), remove the entries for " Canola, seed" and " Flax, seed". 20. In Sec. 180.442, the table in paragraph ( b) is revised to read as follows:

Sec. 180.442 Bifenthrin; tolerances for residues.

* * * * * ( b) * * *

 Expiration/ Commodity Parts per revocation million date  Citrus..................................... 0.05 12/ 31/ 02 Citrus, dried pulp......................... 0.3 12/ 31/ 02 Citrus, oil................................ 0.3 12/ 31/ 02 Peanut..................................... 0.05 12/ 31/ 03 Potato..................................... 0.05 12/ 31/ 02

* * * * *

[[ Page 35049]]

21. In Sec. 180.443, the table in paragraph ( b) is revised to read as follows:

Sec. 180.443 Myclobutanil; tolerances for residues.

* * * * * ( b) * * *  Expiration/ Commodity Parts per revocation million date  Artichoke, globe........................... 1.0 6/ 30/ 03 Beet, sugar, dried pulp.................... 1.0 12/ 31/ 02 Beet, sugar, molasses...................... 1.0 12/ 31/ 02 Beet, sugar, refined sugar................. 0.70 12/ 31/ 02 Beet, sugar, roots......................... 0.05 12/ 31/ 02 Beet, sugar, tops.......................... 1.0 12/ 31/ 02 Hop, dried cones........................... 5.0 12/ 31/ 03 Pepper..................................... 1.0 6/ 30/ 03

* * * * *

Sec. 180.449 [ Amended]

22. In Sec. 180.449, in the table in paragraph ( b), remove the entry for " Celeriac".

Sec. 180.452 [ Amended]

23. In Sec. 180.452, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.462 [ Amended]

24. In Sec. 180.462, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.463 [ Amended]

25. In Sec. 180.463, the text of paragraph ( b) following the paragraph heading is removed and reserved. 26. In Sec. 180.466, the table in paragraph ( b) is revised to read as follows:

Sec. 180.466 Fenpropathrin; tolerances for residues.

* * * * * ( b) * * *

 Expiration/ Commodity Parts per revocation million date  Currant....................................... 15 12/ 31/ 03

* * * * * 27. In Sec. 180.472, the table in paragraph ( b) is revised to read as follows:

Sec. 180.472 Imidacloprid; tolerances for residues.

* * * * * ( b) * * *

 Expiration/ Commodity Parts per revocation million date  Almond..................................... 0.05 12/ 31/ 03 Almond, hulls.............................. 4.0 12/ 31/ 03 Blueberry.................................. 1.0 12/ 31/ 03 Cranberry.................................. 0.5 12/ 31/ 03 Plum, prune................................ 10.0 12/ 31/ 03 Stone fruit................................ 3.0 12/ 31/ 03 Strawberry................................. 0.1 6/ 30/ 02 Vegetable, legume.......................... 1.0 6/ 30/ 02

* * * * *

Sec. 180.474 [ Amended]

28. In Sec. 180.474, in the table in paragraph ( b)( 1), remove the entry for " Pistachios", remove paragraph ( b)( 1) paragraph heading, redesignate paragraph ( b)( 1) as paragraph ( b), and remove paragraph ( b)( 2). 29. In Sec. 180.482, the table in paragraph ( b) is revised to read as follows:

Sec. 180.482 Tebufenozide; tolerances for residues.

* * * * * ( b) * * *

 Expiration/ Commodity Parts per revocation million date  Beet, garden, roots........................ 0.3 12/ 31/ 02 Beet, garden, tops......................... 9.0 12/ 31/ 02 Egg........................................ 0.01 6/ 30/ 03 Grape...................................... 3.0 12/ 31/ 03 Grass, forage.............................. 5 6/ 30/ 03 Grass, hay................................. 18 6/ 30/ 03 Longan..................................... 1.0 12/ 31/ 03 Lychee..................................... 1.0 12/ 31/ 03 Peanut..................................... 0.05 6/ 30/ 03 Peanut, hay................................ 5 6/ 30/ 03 Peanut, meal............................... 0.15 6/ 30/ 03 Peanut, refined oil........................ 0.15 6/ 30/ 03 Poultry, fat............................... 0.1 6/ 30/ 03 Poultry, meat.............................. 0.01 6/ 30/ 03 Poultry, meat byproducts................... 0.05 6/ 30/ 03 Sunflower, seed............................ 1.5 12/ 31/ 02 Sweet potato, roots........................ 0.25 12/ 31/ 02 Vegetable, foliage of legume, group........ 7.0 12/ 31/ 02 Vegetable, legume, group................... 2.0 12/ 31/ 02

* * * * *

Sec. 180.493 [ Amended]

30. In Sec. 180.493, in the table to paragraph ( b), remove the entries for " Potatoes", " Tomatoes", " Tomato paste", and " Tomato puree". 31. In Sec. 180.499, the table in paragraph ( b) is revised to read as follows:

Sec. 180.499 Propamocarb hydrochloride; tolerances for residues.

* * * * * ( b) * * *

 Parts per Expiration/ Commodity million revocation date  Tomato.................................. 2.0 12/ 31/ 03 Tomato, paste........................... 5.0 12/ 31/ 03

* * * * *

Sec. 180.503 [ Amended]

32. In Sec. 180.503, in the table in paragraph ( b), remove the entry for " Tomatoes."

Sec. 180.504 [ Removed and Reserved]

33. Section 180.504, is removed and reserved. 34. In Sec. 180.507, the table in paragraph ( b) is revised to read as follows:

Sec. 180.507 Azoxystrobin; tolerances for residues.

* * * * * ( b) * * *

 Expiration/ Commodity Parts per revocation million date  Brassica, head and Stem, subgroup.......... 30 12/ 31/ 03 Chickpea, seed............................. 0.5 12/ 31/ 03 Lychee..................................... 3.0 12/ 31/ 03 Pepper..................................... 2.0 12/ 31/ 03

* * * * * 35. In Sec. 180.510, the table in paragraph ( b) is revised to read as follows:

Sec. 180.510 Pyriproxyfen; tolerances for residues.

* * * * * ( b)* * *  Expiration/ Commodity Parts per revocation million date  Bean, succulent............................ 0.10 6/ 30/ 03 Stone fruits ( Crop Group 12)............... 0.1 12/ 31/ 02

* * * * *

Sec. 180.513 [ Removed and Reserved]

36. Section 180.513, is removed and reserved.

[[ Page 35050]]

Sec. 180.515 [ Amended]

37. In Sec. 180.515, in the table in paragraph ( b), remove the entries for " Rice, grain" and " Rice, straw".

Sec. 180.516 [ Amended]

38. In Sec. 180.516, in the table in paragraph ( b), remove the entry " Strawberry".

Sec. 180.532 [ Amended]

39. In Sec. 180.532, in the table to paragraph ( b), remove the entry " Strawberries".

Sec. 180.546 [ Amended]

40. In Sec. 180.546, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.563 [ Amended]

41. In Sec. 180.563, the text of paragraph ( b) following the paragraph heading is removed and reserved.

Sec. 180.565 [ Amended] 42. In Sec. 180.565, the text of paragraph ( b) following the paragraph heading is removed and reserved. [ FR Doc. 02 11742 Filed 5 16 02; 8: 45 am] BILLING CODE 6560 50 S