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Fenpropathrin - Pesticide Tolerance 4/00

[Federal Register: April 26, 2000 (Volume 65, Number 81)]
[Rules and Regulations]
[Page 24392-24398]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ap00-7]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300992; FRL-6554-4]
RIN 2070-AB78
Fenpropathrin; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of
fenpropathrin in or on the cucumber/squash crop subgroup. The
Interregional Research Project Number 4 (IR-4) requested this tolerance
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective April 26, 2000. Objections and
requests for hearings, identified by docket control number OPP-300992,
must be received by EPA on or before June 26, 2000.

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 VI. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-300992 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania
Ave., NW.,Washington, DC 20460; telephone number: (703) 308-3194; and
e-mail address: brothers.shaja@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:

------------------------------------------------------------------------
                                  NAICS       Examples of potentially
           Categories             codes         affected  entities
------------------------------------------------------------------------
Industry                             111  Crop production.
                                     112  Animal production.

[[Page 24393]]

                                     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" and then look up the entry for this document under the
"Federal Register--Environmental Documents." You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-300992. 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 (CM #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.

II. Background and Statutory Findings

    In the Federal Register of December 3, 1999 (64 FR 679054) (FRL-
6392-6), EPA issued a notice pursuant to section 408 of the FFDCA, 21
U.S.C. 346a as amended by the FQPA (Public Law 104-170) announcing the
filing of a pesticide petition (PP 9E6042) for tolerance by IR-4,
Rutgers State University, North Brunswick, NJ 08902-3390. This notice
included a summary of the petition prepared by Valent USA Company, 1333
North California Boulevard, Suite 600, Walnut Creek, CA 94596-8025, the
registrant. There were no comments received in response to the notice
of filing.
    The petition requested that 40 CFR 180.466 be amended by
establishing a tolerance for residues of the insecticide fenpropathrin,
(alpha-cyano-3-phenoxy-benzyl 2,2,3,3- tetra-
methylcyclopropanecarboxylate), in or on the cucurbit vegetable group
at 0.5 part per million (ppm). The petition was subsequently amended by
IR-4 to propose a tolerance for the squash/cucumber subgroup at 0.5
ppm.
    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) 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)
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.* * *"
    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 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).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for a tolerance for residues of fenpropathrin on the
cucumber/squash crop subgroup at 0.5 ppm. EPA's assessment of the
dietary exposures and risks associated with establishing the tolerance
follows.

A. Toxicological Profile

    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. The nature of the toxic effects caused by fenpropathrin are
discussed in this unit.

B. Toxicological Endpoints

    1. Acute toxicity. An acute reference dose (RfD) of 0.06 mg/kg/day
was established based on clinical signs of neurotoxicity on the day of
dosing in dams during a developmental toxicity study in rats. The no
observed adverse effect level (NOAEL) was 6.0 milligrams/kilograms/day
(mg/kg/day). An uncertainty factor of 100 (10X for interspecies
extrapolation and 10X for intraspecies variations) was used to
determine the acute RfD. The acute Population Adjusted Dose (PAD) is
equal to the acute RfD divided by the FQPA Safety Factor. Since the
FQPA Safety Factor was reduced to 1X, the acute PAD is equal to the
acute RfD.
    2.Chronic toxicity. EPA has established the RfD for fenpropathrin
at 0.025 mg/kg/day. This RfD is based on the observance of tremors in
dogs in the 1-year oral feeding study. The NOAEL was 2.5 mg/kg/day. An
uncertainty factor of 100 (10X for interspecies extrapolation and 10X
for intraspecies variation) was used to determine the chronic RfD. The
chronic PAD is equal to the chronic RfD divided by the FQPA Safety
Factor. Since the FQPA Safety Factor was reduced to 1X, the chronic PAD
is equal to the chronic RfD.
    3. Carcinogenicity. As no indication of carcinogenicity was seen in
rats or mice, no carcinogenic endpoint was selected.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40

[[Page 24394]]

CFR 180.466) for the residues of fenpropathrin, in or on a variety of
raw agricultural commodities. Permanent tolerances are established for
the residues of fenpropathrin in/on pome fruit crop group at 5.0 ppm;
grapes at 5.0 ppm and the processed product raisins at 10 ppm; citrus
fruit crop group at 2.0 ppm and the processed product citrus oil at
75.0 ppm and dried citrus pulp at 4.0 ppm; head and stem brassica crop
group at 3.0 ppm and the melons crop group at 0.5 ppm. Risk assessments
were conducted by EPA to assess dietary exposures from fenpropathrin as
follows:
    i. Acute exposure and risk. 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. Tier 3 acute dietary exposure analyses
for fenpropathrin were performed with the Dietary Exposure Evaluation
Model (DEEM™) using field trial values and percent crop
treated estimates. The acute risk was analyzed at the 99.9th percentile
using the 1989-1992 food consumption survey. The U.S. population and
population subgroups (with the exception of nursing infants, all
infants, and children) acute dietary risk estimates are below EPA's
level of concern. The acute dietary risk estimates for subgroups of
nursing infants, all infants, and children were above EPA's level of
concern. In the 1989-1992 survey, there is a consumption value
associated with grapes which can be considered to be aberrant. There
were only 4 nursing infants in the 1989-1992 survey who reportedly ate
grapes. A single 10-month old nursing infant consumed 2/3 of a pound of
grapes in 1 day. This is an unusually high quantity of grapes for an
infant to consume in 1 day. Because of the aberrant data point, the
acute dietary exposure analysis was conducted using the 1994-1996 food
consumption survey.
    ii. Chronic exposure and risk. A DEEM™ chronic dietary
exposure analysis was performed using anticipated residues (field trial
data) and percent crop treated data. The FQPA 10X safety factor was
removed. As a result, the chronic PAD is equivalent to the chronic RfD:
0.025 mg/kg/day. Based on the 1989-1992 data base, the most highly
exposed subgroup (children 1-6 years) utilized 9% of the chronic PAD.
As a result, exposure to fenpropathrin of the U.S. population and all
population subgroups is below EPA's level of concern.
    2. From drinking water. Fenpropathrin is persistent and immobile.
There are no established maximum contaminant level for residues of
fenpropathrin in drinking water. Neither has any health advisory levels
for fenpropathrin in drinking water been established.
    The Agency lacks sufficient water-related exposure data to complete
a comprehensive dietary exposure analysis and risk assessment for
fenpropathrin in drinking water. Because the Agency does not have
comprehensive monitoring data, drinking water concentration estimates
must be made by reliance on some sort of simulation or modeling. The
Agency is currently relying on GENEEC (Generic Estimated Environmental
Concentration) and PRZM/EXAMS for surface water, which are used to
produce estimates of pesticide concentrations in a farm pond and SCI-
GROW (Screening Concentration in Ground Water), which predicts
pesticide concentrations in ground water. None of these models include
consideration of the impact processing 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 estimates
are used as screening tools in the risk assessment process, the Agency
does not use the estimates from GENEEC, PRZM/EXAMS and SCI-GROW to
quantify drinking water exposure and risk as a %RfD or %PAD. Instead
drinking water levels of comparison (DWLOC) 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, drinking water, and residential uses.
Different populations have different DWLOCs. EPA uses DWLOCs internally
in the risk assessment process as a surrogate measure of potential
exposure associated with pesticide exposure through drinking water. In
the absence of monitoring data for pesticides, it is used as a point of
comparison against conservative model estimates of a pesticide's
concentration in water. DWLOC values are not regulatory standards for
drinking water. They do have an indirect regulatory impact through
aggregate exposure and risk assessments.
    The Agency used its SCI-GROW and GENEEC screening models and
environmental fate data to determine the estimated environmental
concentration (EEC) for fenpropathrin in ground water and surface water
respectively. EPA reported ground water EEC of 0.006 parts per billion
(ppb) and surface water EECs of 2.72 ppb (acute) and 0.34 ppb (chronic)
for fenpropathrin.
    EPA has calculated DWLOCs for both acute and chronic risks. To
calculate the DWLOC for acute exposure relative to an acute toxicity
endpoint, the acute dietary food exposure (from DEEM) was subtracted
from the acute PAD to obtain the acceptable acute exposure to
fenpropathrin in drinking water. To calculate the DWLOC for chronic
(non-cancer) exposure relative to a chronic toxicity endpoint, the
chronic dietary food exposure (from DEEM) was subtracted from the
chronic PAD to obtain the acceptable chronic (non-cancer) exposure to
fenpropathrin in drinking water. DWLOCs were then calculated using
default body weights and drinking water consumption figures.
    i. Acute exposure and risk. The drinking water EEC for dietary
exposures at the 99.9th percentile exceeds the DWLOC for the population
subgroups all infants, nursing infants, and children 1-6 years. The
DWLOCs, which were calculated based on the exposure values at the
99.5th percentile of exposure for nursing infants and at the 99.75th
percentile of exposure for all infants and for children 1-6 years, were
above the drinking water EEC. The same is true for the DWLOCs
calculated based on the 99.9th percentile exposure values from the
1994-1996 food consumption survey. For the reasons discussed in Unit
C.1.i. EPA has chosen to use data from the 1994-1996 food consumption
survey for these three population subgroups (and for this risk
assessment only). Although the dietary exposure estimates are highly
refined, EPA notes that 100% crop treated was used for the following
crops: cucurbit group, grapes, pome fruit group, citrus group, and head
and stem Brassica vegetable subgroup. Based on percent crop treated
values for registered uses, the percent crop treated for these uses
will probably be significantly less than 100%.
    ii.Chronic exposure and risk. EPA generally reduces GENEEC model
values by a factor of 3 when determining whether or not a chronic level
of comparison has been exceeded. If the GENEEC model value is
≤ 3 times the DWLOC, the pesticide is considered to have
passed the screen and no further assessment is needed.
    Based on the chronic dietary (food) exposure estimates, chronic
DWLOC for

[[Page 24395]]

fenpropathrin have been calculated. The lowest DWLOC is 230 ppb for
both nursing infants and children 1-6 years. The highest EEC for
fenpropathrin in surface water is from the application of fenpropathrin
to pears and citrus fruits (0.34 ppb) and is substantially lower than
the DWLOCs calculated. Therefore, chronic exposure to fenpropathrin
residues in drinking water are not expected to exceed EPA's level of
concern.
    3. From non-dietary exposure. There are no residential or non-
occupational uses for fenpropathrin; therefore residential exposures
are not expected.
    4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider "available information" concerning the cumulative effects of
a particular pesticide's residues and "other substances that have a
common mechanism of toxicity."
    EPA does not have, at this time, available data to determine
whether fenpropathrin has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
fenpropathrin 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 fenpropathrin 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 final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. For this risk assessment, the acute aggregate risk
is equivalent to the risk from (food + water). Using the 1994-96 food
consumption survey, it is estimated that acute exposure to
fenpropathrin from food for the most highly exposed population
subgroup, children (1-6 years), will utilize 76% of the acute PAD at
the 99.9 percentile of exposure (see discussion in Unit III.C.). An
acute dietary exposure (food + water) of 100% or less of the acute PAD
is needed to protect the safety of all population subgroups. The EECs
of fenpropathrin in surface and ground water for acute exposure are
below the DWLOCs. Thus, the acute aggregate risk of exposure to
fenpropathrin from food and drinking water is below EPA's level of
concern for the U.S. population and all population subgroups.
    2. Chronic risk. For this risk assessment, the chronic aggregate
risk is equivalent to the risk from (food + water). Chronic residential
exposure to fenpropathrin residues is not expected. In addition, no
chronic dermal or inhalation endpoints were identified. As discussed
above, EPA has concluded that exposure to fenpropathrin from food for
the most highly exposed subgroup (children 1-6 years) will utilize 9%
of the chronic PAD. EPA generally has no concern for exposure below
100% of the chronic PAD because the chronic PAD represents the level at
or below which daily aggregate dietary exposure over a lifetime will
not pose appreciable risks to human health. The highest EEC for
fenpropathrin in drinking water (0.34 ppb) is substantially lower than
the lowest DWLOC (230 ppb). Therefore, chronic aggregate risk does not
exceed EPA's level of concern.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. Since there is no expected residential exposure
to residues of fenpropathrin, the short- and intermediate-term
aggregate risk does not exceed EPA's level of concern.
    4. Aggregate cancer risk for U.S. population. The Agency has
determined that there is no evidence of carcinogenicity in studies in
either the mouse or rat.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to fenpropathrin residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children--i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of fenpropathrin, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure gestation. Reproduction
studies provide information relating to effects from exposure to the
pesticide on the reproductive capability of mating animals and data on
systemic toxicity.
    FFDCA section 408 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 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 margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans. EPA believes that reliable data
support using the standard uncertainty factor (usually 100 for combined
interspecies and intraspecies variability) and not the additional
tenfold MOE/uncertainty factor when EPA has a complete data base under
existing guidelines and when the severity of the effect in infants or
children or the potency or unusual toxic properties of a compound do
not raise concerns regarding the adequacy of the standard MOE/safety
factor.
    ii. Developmental toxicity studies. In a developmental toxicity
study in rats, pregnant female rats were dosed by gavage on gestation
days 6-15 at 0 (corn oil control), 0.4, 1.5, 2.0, 3.0, 6.0, or 10.0 mg/
kg/day. The maternal NOAEL is 6 mg/kg/day; maternal LOAEL is 10 mg/kg/
day based on death, moribundity, ataxia, sensitivity to external
stimuli, spastic jumping, tremors, prostration, convulsions, hunched
posture, squinted eyes, chromodacryorrhea, and lacrimation;
developmental NOAEL is > 10 mg/kg/day. There were no developmental
effects observed under the conditions of the study.
    In a developmental toxicity study in rabbits, pregnant female New
Zealand rabbits were dosed by gavage on gestation days 7 through 19 at
0, 4, 12, or 36 mg/kg/day. Maternal NOAEL is 4 mg/kg/day; maternal
LOAEL is 12 mg/kg/day based on grooming, anorexia, flicking of the
forepaws; developmental NOAEL is > 36 mg/kg/day highest dose tested.
There were no developmental effects observed under the conditions of
the study.
    iii. Reproductive toxicity study. A 3-generation reproduction study
was performed in rats. Rats were dosed with fenpropathrin at
concentrations of 0, 40, 120, or 360 ppm (0, 3.0, 8.9, or 26.9 mg/kg/
day in males; 0, 3.4, 10.1, or 32.0 mg/kg/day in females,
respectively). Parents (male/female): Systemic NOAEL = 40 ppm (3.0/3.4
mg/kg/day). Systemic LOAEL = 120 ppm (8.9/10.1 mg/kg/day) based on body
tremors with spasmodic muscle twitches, increased sensitivity

[[Page 24396]]

and maternal lethality; reproductive NOAEL = 120 ppm (8.9/10.1 mg/kg/
day). Reproductive LOAEL = 360 ppm (26.9/32.0 mg/kg/day) based on
decrease mean F1B pup weight, increased F2B loss.
Pups (male/female): Developmental NOAEL = 40 ppm (3.0/3.4 mg/kg/day).
Developmental LOAEL = 120 ppm (8.9/10.1 mg/kg/day) based on body
tremors, and increased mortality.
    iv. Prenatal and postnatal sensitivity. There is no evidence of
sensitivity to young rats or rabbits following prenatal or postnatal
exposure to fenpropathrin.
    v. Conclusion. There is a complete toxicity data base for
fenpropathrin, and exposure data are complete or are estimated based on
data that reasonably accounts for potential exposures. Based on the
above, EPA concludes that reliable data support use of the 100-fold
uncertainty factor and that an additional uncertainty factor is not
needed to protect the safety of infants and children.
    2. Acute risk. (food + water) The percentages of the acute PAD
utilized (by food alone) at the 99.9 percentile exposure are 56% for
infants and 77% for children (1-6 years), the most highly exposed
population subgroup. The EEC for fenpropathrin in drinking water is
below the DWLOC. The Agency has no cause for concern if total acute
exposure is 100% or less of the acute PAD. Therefore, the Agency has no
acute aggregate concern due to exposure to fenpropathrin through food
and drinking water.
    3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to fenpropathrin from
food will utilize 5% of the RfD for infants and 9% of the RfD for
children. EPA generally has no concern for exposures below 100% of the
RfD because the RfD represents the level at or below which daily
aggregate dietary exposure over a lifetime will not pose appreciable
risks to human health. Despite the potential for exposure to
fenpropathrin in drinking water and from non-dietary, non-occupational
exposure, EPA does not expect the aggregate exposure to exceed 100% of
the RfD.
    4. Short- or intermediate-term risk. No uses of fenpropathrin have
been identified for residential exposures, therefore, fenpropathin need
not be evaluated for short- or intermediate-term risk resulting from
residential exposure.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to fenpropathrin
residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

    The nature of the residue in plants and animals is adequately
understood.

B. Analytical Enforcement Methodology

    EPA concludes that adequate methodology is available for
enforcement of the proposed tolerances. Method RM-22-4 can be used for
the analysis of fenpropathrin in cucurbits. Residues are extracted with
acetone/hexane, cleaned up with silica gel and C18 Sep Pak
chromatography and detection is by gas chromatography. The limit of
detection is 0.01 ppm.
    The method may be requested from: Calvin Furlow, PRRIB, IRSD
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

C. Magnitude of Residues

    Adequate residue field trials reflecting the prosed use rate were
submitted to EPA to demonstrate that tolerances for cucumber/squash
crop subgroup will not be exceeded when fenpropathrin products labeled
for these uses are used as directed.

V. Conclusion

    Therefore, the tolerance is established for residues of
fenpropathrin, (alpha-cyano-3-phenoxy-benzyl 2,2,3,3-tetra-
methylcyclopropanecarboxylate), in or on the cucumber/squash crop
subgroup at 0.5 ppm.

VI. 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 of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409.
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 control number OPP-300992 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 June 26,
2000.
    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 (1900),
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania
Ave., NW., Washington, DC 20460. You may also deliver your request to
the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St.,
SW., Washington, DC 20460. 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 (202) 260-4865.
    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

[[Page 24397]]

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, Ariel Rios Bldg., 1200
Pennsylvania Ave., NW., Washington, DC 20460.
    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, Ariel Rios Bldg.,
1200 Pennsylvania Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.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.2. Mail your
copies, identified by docket control number OPP-300992, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.2. 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 file
format 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).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). 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 prior consultation as specified by Executive Order
13084, entitled Consultation and Coordination with Indian Tribal
Governments (63 FR 27655, May 19, 1998); special considerations as
required by Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or require 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 petition under FFDCA section 408(d), such
as the tolerance in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. 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 FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

    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: April 11, 2000.
James Jones,
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), (346a) and 371.
    2. In Sec. 180.466, amend paragraph (a) by alphabetically adding
the following entry to the table to read as follows:

Sec. 180.466  Fenpropathrin; tolerances for residues.

    (a) General.  * * *

[[Page 24398]]

------------------------------------------------------------------------
                 Commodity                       Parts  per million
------------------------------------------------------------------------
                      *      *      *      *      *
Squash/cucumber subgroup..................  0.5
                      *      *      *      *      *
------------------------------------------------------------------------
    *      *      *      *      *
[FR Doc. 00-10042 Filed 4-25-00; 8:45 am]
BILLING CODE 6560-50-F