[Federal Register Volume 65, Number 81 (Wednesday, April 26, 2000)]
[Rules and Regulations]
[Pages 24392-24398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10042]


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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: <a href="/cdn-cgi/l/email-protection#fd9f8f928995988f8ed38e959c979cbd988d9cd39a928b"><span class="__cf_email__" data-cfemail="1072627f64787562633e6378717a71507560713e777f66">[email protected]</span></a>.

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:

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

[[Page 24393]]

 
                                     311  Food manufacturing.
                                   32532  Pesticide manufacturing.
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    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<SUP>TM</SUP>) 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<SUP>TM</SUP> 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 
<ls-thn-eq> 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 F<INF>1B</INF> pup weight, increased F<INF>2B</INF> 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: 
<a href="/cdn-cgi/l/email-protection#e88e9d9a84879fc68b89849e8186a88d9889c68f879e"><span class="__cf_email__" data-cfemail="187e6d6a74776f367b79746e7176587d6879367f776e">[email protected]</span></a>.

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 
<a href="/cdn-cgi/l/email-protection#1b6f74766b70727568357172765b7e6b7a357c746d"><span class="__cf_email__" data-cfemail="2b5f44465b40424558054142466b4e5b4a054c445d">[email protected]</span></a>, 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: <a href="/cdn-cgi/l/email-protection#a9c6d9d984cdc6cac2ccdde9ccd9c887cec6df"><span class="__cf_email__" data-cfemail="076877772a6368646c62734762776629606871">[email protected]</span></a>. 
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


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