[Federal Register Volume 64, Number 31 (Wednesday, February 17, 1999)]
[Rules and Regulations]
[Pages 7794-7801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3519]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300789; FRL 6059-7]
RIN 2070-AB78
Fenbuconazole; Reestablishment of Time-Limited Pesticide
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation extends time-limited tolerances for combined
residues of fenbuconazole [alpha-(2-(4-chlorophenyl)-ethyl)-alpha-
phenyl-3-(1H-1,2,4-triazole)-1-propanenitrile] and its metabolites
[cis-and trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-
1-ylmethyl)-2-3H-furanone] of fenbuconazole in or on stone fruits
(except plums and prunes) at 2.0 ppm, pecans at 0.1 ppm and bananas at
0.3 ppm. The Rohm and Haas Company requested these tolerance under the
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food
Quality Protection Act of 1996 (Pub. L. 104-170). The tolerances will
expire on December 31, 2001.
DATES: This regulation is effective February 17, 1999. Objections and
requests for hearings must be received by EPA on or before April 19,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300789], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300789], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
or ASCII file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number [OPP-
300789]. No Confidential Business Information (CBI) should be submitted
through e-mail. Electronic copies of objections and hearing requests on
this rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker,
Registration Division 7505C, Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Rm. 247, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-7740; e-
mail: cynthia giles-parker@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 7, 1998;
(63 FR 67476) (FRL 6047-2), EPA, issued a notice pursuant to section
408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(e) announcing the filing of a pesticide petition (PP) for
tolerance by The Rohm and Haas Company, 100 Independence Mall West,
Philadelphia, PA 19106-2399. This notice included a summary of the
petition prepared by The Rohm and Haas Company, the registrant. There
were no comments received in response to the notice of filing. The
petition requested that 40 CFR 180.480 be amended by establishing time-
limited tolerances for combined residues of the fungicide
fenbuconazole, [alpha-(2-(4-chlorophenyl)-ethyl)-alpha-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile] and its metabolites [cis-and trans-5-
(4-chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3H-
furanone]] expressed as fenbuconazole, in or on stone fruits (except
plums and prunes), 2.0 ppm; pecans, 0.1 ppm; bananas, 0.3 ppm part per
million (ppm). The existing time-limited tolerances expired December
31, 1998. The reestablishment of these time-limited tolerances will
expire on December 31, 2001. Time-limited tolerances are being
reestablished due to a chemistry data gap for storage stability in
other raw agricultural commodities. However, based on apparent storage
stability, EPA believes that the existing data support reestablishment
of time-limited tolerances to December 31, 2001.
I. Background and Statutory Findings
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
[[Page 7795]]
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).
II. 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
Fenbuconazole, [alpha-(2-(4-chlorophenyl)-ethyl)-alpha-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile] and its metabolites [cis-and trans-5-
(4-chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3H-
furanone]] and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for reestablishment of time-limited
tolerances for combined residues of Fenbuconazole, [alpha-(2-(4-
chlorophenyl)-ethyl)-alpha-phenyl-3-(1H-1,2,4-triazole)-1-
propanenitrile] and its metabolites [cis-and trans-5-(4-chlorophenyl)-
dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3H-furanone]] on
stone fruit (except plums and prunes), 2.0 ppm; pecans, 0.1 ppm; and
bananas, 0.3 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 Fenbuconazole are
discussed in this unit.
1. A rat acute oral study with an LD50 greater than 2
grams (g)/kilogram (kg).
2. A 13-week rat feeding study with a no-observed-adverse-effect-
level (NOAEL) of 20 ppm (1.3 milligrams(mg)/kg/day males and 1.5 mg/kg/
day females) and a lowest-observed-adverse-effect-level (LOAEL) of 80
ppm (5.1 mg/ kg/day males and 6.3 mg/kg/day females), based on
hepatotoxicity.
3. A 3-month mouse feeding study with a NOAEL of 20 ppm (3.8 mg/kg/
day males and 5.7 mg/kg/day females) and a LOAEL of 60 ppm (11.1 mg/kg/
day males and 17.6 mg/kg/day females) based on hepatotoxicity.
4. A 3-month dog feeding study with a NOAEL of 100 ppm (3.3 mg/kg/
day males and 3.5 mg/kg/day females) and LOAEL of 400 ppm (13.3 mg/kg/
day males and 14.0 mg/kg/day females), based on hepatocellular
hypertrophy.
5. A 21-day rabbit dermal study with a NOAEL greater than 1,000 mg/
kg/day (limit dose).
6. A 78-week dietary carcinogenicity study in mice with a NOAEL of
1.43 mg/kg/day and a LOAEL of 28.6 mg/kg/day (males) and 92.9 mg/kg/day
(females) based on hepatocellular enlargement and a greater incidence
and severity of hepatocellular vacuolation. There was evidence of
carcinogenicity based on the occurrence of increased trend for
malignant liver tumors in males and an increase in benign and malignant
liver tumors in females.
7. A 24-month rat chronic feeding/carcinogenicity study with a
NOAEL of 40 ppm (3.03 mg/kg/day for females and 4.02 mg/kg/day for
males) for systemic effects and a LOAEL of 800 ppm (30.62 mg/kg/day for
males and 43.07 mg/kg/day for females) based on decreases in body
weight gains and hepatocellular enlargement and vacuolization in
females, and thyroid weight and histopathological changes in both
sexes. There was evidence of carcinogenicity based on the increased
occurrence of thyroid follicular cell benign and malignant tumors in
males.
8. A 24-month male rat chronic feeding/carcinogenicity study with a
NOAEL of 800 ppm (30.41 mg/kg/day) and a LOAEL of 1,600 ppm (63.94 mg/
kg/ day) based on increased liver and thyroid weights and lesions.
There was evidence of carcinogenicity based on the increased occurrence
of thyroid follicular cell benign and malignant tumors.
9. A 1-year dog chronic feeding study with a NOAEL of 150 ppm (3.75
mg/kg/day). The LOAEL is based on decreases in body weight gain and
increased liver weight, at 1,200 ppm (30 mg/kg/day).
10. A 2-generation reproduction study in rats with a parental
(systemic) and reproductive NOAEL of 4 mg/kg/day (80 ppm) and a LOAEL
of 40 mg/kg/day (800 ppm), based on decreased body weight and food
consumption, increased number of dams not delivering viable or
delivering nonviable offspring, and increases in adrenal and thyroid/
parathyroid weights.
11. A developmental toxicity study in rabbits with a maternal NOAEL
of 10 mg/kg/day, and a developmental NOAEL of 30 mg/kg/day, and a
maternal LOAEL of 60 mg/kg/day due to only 1/19 (5) of the pregnant
does producing a viable fetus and no developmental LOAEL (greater than
30 mg/kg/day).
12. A developmental toxicity study in rats with a maternal NOAEL
and developmental NOAEL of 30 mg/kg/day and an LOAEL of 75 mg/kg/day
due to decrease in maternal body weight compared to controls and
increase in early and late resorption with a decrease in number of live
fetuses per dam.
13. No evidence of gene mutation was observed in a test for
induction of gene mutation at the HGPRT locus in Chinese hamster ovary
cells. No increase in the number of cells with aberrations or
observations per cell were noted in an in vivo cytogenetics assay using
bone marrow from treated rats. No increase in unscheduled DNA synthesis
in rat primary hepatocyte study was observed.
14. A rat metabolism study showed that radiolabeled fenbuconazole
is rapidly absorbed, distributed, and excreted following oral
administration in rats. Biliary excretion data indicated that systemic
absorption of fenbuconazole was high for all dosing groups. The feces
was the major route of excretion. Tissue distribution and
bioaccumulation of fenbuconazole appeared to be minimal.
B. Toxicological Endpoints
1. Acute toxicity. For an acute dietary risk assessment a Reference
Dose (acute RfD) of 0.3 mg/kg/day was established for females 13+
years, the population subgroup of concern, based on the developmental
toxicity study in the rat with a NOAEL of 30 mg/kg/day based on an
increase in post implantation loss with a significant decrease in the
number of live fetuses per dam at the LOAEL of 75 mg/kg/day and an
uncertainty factor of 100. EPA determined that the 10X factor required
by FQPA for protection of infants and children from exposure to
fenbuconazole should be removed since:
i. The toxicology data base is complete.
ii. There is no indication of increased susceptibility of rats or
rabbit fetuses to in utero and/or postnatal exposure in the
developmental and reproductive toxicity studies.
iii. Dietary (food) exposure estimates are slightly refined (using
limited %CT data for stone fruit) but likely result in
[[Page 7796]]
an overestimate of the actual dietary exposure.
iv. Models are used for ground and surface source drinking water
exposure assessments resulting in estimates that are upper-bound
concentrations.
v. There are currently no registered residential uses for
fenbuconazole and therefore, this type of exposure to infants and
children is not expected.
2. Short - and intermediate - term toxicity. Short- and
intermediate-term endpoints were not identified; therefore, an
aggregate risk assessment was not done for these endpoints.
Furthermore, fenbuconazole has no residential uses.
3. Chronic toxicity. The Reference Dose (chronic RfD) of 0.03 mg/
kg/day was re-affirmed by the Hazard Identification Assessment Review
Committee (HIARC) based on the chronic toxicity study in the rat with a
NOAEL of 3.03/4.02 mg/kg/day in males/females based on decreased body
weight gains (females), hepatocellular enlargement and vacuolation
(females), increases in thyroid weight (both sexes) and
histopathological lesions in the thyroid glands (males), at the LOAEL
of 30.62/43.04 mg/kg/day in males/females and an uncertainty factor of
100.
4. Carcinogenicity. The Health Effects Division Carcinogenicity
Peer Review Committee has concluded that the available data provide
limited evidence of the carcinogenicity of fenbuconazole in mice and
rats and has classified fenbuconazole as a Group C (possible human
carcinogen with limited evidence of carcinogenicity in animals) in
accordance with Agency guidelines, published in the Federal Register in
1986 (51 FR 33992, Sept. 24, 1986) and recommended that for the purpose
of risk characterization a low-dose extrapolation model applied to the
experimental animal tumor data should be used for quantification for
human risk (Q1*). This decision was based on the induction of thyroid
follicular cell adenomas and/or combined adenomas-carcinomas in male
rats in two studies, both by pair-wise comparison with controls and by
trend analysis. The studies were combined for the purpose of deriving
the Q1*. The Q1* for fenbuconazole is 3.59 x 10-3 (mg/kg/
day)-1 in human equivalents.
C. Exposures and Risks
1. From food and feed uses. Time-limited tolerances have been
established (40 CFR 180.480) for the combined residues of
fenbuconazole, [alpha-(2-(4-chlorophenyl)-ethyl)-alpha-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile] and its metabolites [cis-and trans-5-
(4-chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-ylmethyl)-2-3H-
furanone]] in/on stone fruits (except plums prunes), bananas (banana
pulp), pecans, and blueberries. Risk assessments were conducted by EPA
assessing dietary exposures from fenbuconazole 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. In conducting this acute dietary risk
assessment, very conservative assumptions were used which resulted in
an overestimate of human dietary exposure. The following assumptions
have been made: 100% of the crops are treated and residues will be at
the tolerance levels. These assumptions result in a conservative risk
estimate; refinement using anticipated residue values and percent crop-
treated data in conjunction with Monte Carlo analysis would result in a
lower acute dietary exposure estimate. Thus, in making a safety
determination for these tolerances, the Agency is taking into account
this conservative exposure assessment.
The Novigen Dietary Exposure Evaluation Model (DEEM) system was
used for this acute dietary exposure analysis. The analysis evaluates
individual food consumption as reported by respondents in the USDA
Continuing Surveys of Food Intake by Individuals conducted in 1989
through 1992. The model accumulates exposure to the chemical for each
commodity and expresses risk as a function of dietary exposure.
The acute dietary (food only) risk assessment used Theoretical
Maximum Residue Contribution (TMRC). The resulting high-end exposure
estimate for females, 13 years old ranges from 0.0072 to
0.015 mg/kg/day for the population subgroup females, 13
years old (nursing), and females, 13 to 19 years old (not pregnant or
nursing), respectively . These exposure levels utilize 2.3% to 5.0% of
the Acute RfD, respectively.
ii. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, the Agency has made a partially refined exposure
estimate. Tolerance level residues were assumed for all commodities,
including stone fruits. Percent crop treated data were used for stone
fruits and 100% crop treated data were assumed for all other
commodities. The percent crop treated data for stone fruits were based
upon a production cap. For additional refinement, incorporation of
percent crop treated and anticipated residues for all commodities would
result in lower exposure estimates. The Novigen DEEM system was used
for this chronic dietary exposure analysis. The analysis evaluates
individual food consumption as reported by respondents in the USDA
Continuing Surveys of Food Intake by Individuals conducted in 1989
through 1992. The model accumulates exposure to the chemical for each
commodity and expresses risk as a function dietary exposure.
The existing fenbuconazole tolerances (published, pending, and
including the necessary section 18 tolerance(s)) result in an
anticipated residue contribution (ARC) that is equivalent to the
following percentages of the chronic RfD: U.S. population (48 States),
< 1%; all infants (< 1 year old), 2.5%; nursing Infants (< 1 year old),
1.1%; non-nursing infants, 3.1%; children (1-6 years old), 1.5%;
children (7-12 years old) < 1.0%; non-hispanic (other than black or
white), 1.0%; seniors 1.0%.
The subgroups listed above are: (1) the U.S. population (48
states); (2) those for infants and children; and, (3) the other
subgroups for which the percentage of the RfD occupied is greater than
that occupied by the subgroup U.S. population (48 states).
Fenbuconazole is classified as a group C carcinogen (Q1*=.00359
(mg/kg/day). Using the partially refined exposure estimates described
above, the cancer risk estimate for the U.S. population (48 states) is
8.3 x 10-7.
2. From drinking water. In the absence of reliable, available
monitoring data, EPA uses models to estimate concentrations of
pesticides in ground and surface water. For fenbuconazole, modeling was
used to estimate surface water concentrations because of very limited
surface water monitoring data. However, EPA does not use these model
estimates to quantify risk. Currently, EPA uses drinking water levels
of comparison (DWLOC's) as a surrogate to capture risk associated with
exposure to pesticides in drinking water. A DWLOC is the concentration
of a pesticide in drinking water that would be acceptable as an upper
limit in light of total aggregate exposure to that pesticide from food,
water and residential uses. A DWLOC will vary depending on the residue
level in foods, the toxicity endpoint and with drinking water
consumption patterns and body weights for specific subpopulations. EPA
believes model estimates to be overestimates of concentrations of
fenbuconazole expected in drinking water.
Fenbuconazole is moderately persistent to persistent and slightly
mobile to immobile in soil. Because of its adsorption to soil, the
potential for
[[Page 7797]]
fenbuconazole to leach to ground water appears to be slight. However,
the potential to contaminate ground water may be greater at vulnerable
sites (i.e. where soils are low in organic matter and where ground
water is relatively close to the surface). The long half-lives of the
aerobic soil and terrestrial field dissipation studies indicate that
when fenbuconazole is applied over multiple growing seasons, soil
residue accumulation may result. These residues may be available for
rotational crop uptake or may be transported with sediments during
runoff events. There are no established Maximum Contaminant Level for
residues of fenbuconazole in drinking water, and no health advisory
levels for fenbuconazole in drinking water have been established.
i. Acute exposure and risk. Acute DWLOC for drinking water were
calculated using the default body weights and drinking water
consumption figures. Based on an adult female body weight of 60 kg and
2L consumption of water per day, level of comparison from acute
exposure estimates for females 13 years and older, is 8,600 ppb. The
peak EEC (acute) value of 6.7 ppb for aerial application is lower than,
the acute DWLOCs for females 13 years and older (8,600 ppb).
ii. Chronic exposure and risk. Based on the chronic dietary (food)
exposure and using default body weights and water consumption figures,
chronic drinking water levels of comparison (DWLOC) for drinking water
were calculated. The level of comparison from chronic exposure
estimates for males is 1,000 ppb, 890 ppb for females and 290 ppb for
infants and children. The chronic EEC, GENEEC 56-day, value of 3.6 ppb
for aerial application is lower than, the chronic DWLOCs for males
1,000 ppb, females 890 ppb, and infants and children 290 ppb.
Section 408(b)(2)(F) 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: 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;
that the exposure estimate does not underestimate exposure for any
significant subpopulation group; and 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 percent of crop treated as required by the section 408(b)(2)(F), EPA
may require registrants to submit data on percent of crop treated.
The Agency used percent crop treated (PCT) information as follows:
Percent crop treated data were used only for stone fruits, in
conducting the chronic risk assessment. For all other commodities it
was assumed that 100% of the crop would be treated. The Agency believes
that the three conditions listed in Units II, C1 i-iii of this preamble
have been met. With respect to Unit II, C1 i of this preamble, percent
of crop treated estimates are derived from federal and private market
survey data, which are reliable and have a valid basis. The assumption
is that stone fruit residues (except plums and prunes) are at the
tolerance level and the limitation of production of the only
fenbuconazole product registered under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) for use on stone fruit to 28,500
pounds of active ingredient per year (calculated to be equivalent to
treating 12.812f the total U.S. acreage of apricots, cherries,
nectarines, and peaches per year). Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that the percentage of the
food treated is not likely to be an underestimated. As to Units II,
C1ii, and iii of this preamble, 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 fenbuconazole
may be applied in a particular area.
3. From non-dietary exposure. Currently fenbuconazole has no
registered residential non-food sites uses. No dermal or systemic
toxicity was observed in the short- or intermediate term studies.
Therefore, no endpoints were established and a risk assessment for
residential non-dietary exposure was not needed.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
considers ``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 fenbuconazole 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,
fenbuconazole 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 fenbuconazole 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. Toxicological effects applicable to population
subgroups other than females 13 years old or older that could be
attributed to a single exposure (dose) were not observed in oral
toxicity studies in rats and rabbits. Therefore, a dose and endpoint
was not identified for acute dietary risk assessment for these
population groups.
The population subgroup of concern for acute risk is females, 13
years and older. The acute dietary (food only) risk assessment used
TMRC. The resulting high-end exposure estimates (food only) for
females, 13 years old, ranges from 0.0072 to 0.015 mg/kg/
day for the population subgroups females, 13 years old
(nursing), and females, 13 to 19 years old (not pregnant or nursing),
respectively. These exposure levels utilize 2.3% to 5.0% of the Acute
RfD, respectively. Based on the acute dietary (food only) exposure,
acute DWLOCs were calculated. To calculate the acute DWLOCs, the acute
dietary food exposure (from the DEEM analysis) was subtracted from the
Acute RfD to give the maximum allowable exposure level for drinking
water. DWLOCs were then calculated using default body weights
[[Page 7798]]
and drinking water consumption figures. The estimated peak
concentration of fenbuconazole in surface water (6.7 g/L) is
less than the level of comparison for fenbuconazole in drinking water
as a contribution to acute aggregate exposure (8.6 x 103
g/L). Therefore, taking into account the registered uses and
uses proposed, it is concluded with reasonable certainty that residues
of fenbuconazole in drinking water (when considered along with other
sources of acute exposure for which the Agency has reliable data) would
not result in unacceptable levels of acute aggregate human health risk
estimates for females, 13 years old and older, at this time.
The Agency generally has no concern for exposures below 100% of the
acute RfD (when the FQPA Safety Factor has been removed, as is the case
for fenbuconazole) because the acute RfD represents the level at or
below which a single daily exposure will not pose appreciable risks to
human health. The acute aggregate exposure is not expected to exceed
100% of the acute RfD for the subpopulation of concern (females 13
years and older). It is concluded that there is a reasonable certainty
that no harm will result to females (13 years and older) from acute
aggregate exposure to fenbuconazole residues.
2. Chronic risk. Using the conservative ARC exposure assumptions
described above, and taking into account the completeness and
reliability of the toxicity data, it was determined that chronic
dietary exposure to fenbuconazole from food will utilize from <1.0% to
1.0% of the chronic RfD for the population subgroups which include
adults (U.S. population (48 States) and non-hispanics (other than black
or white), respectively). Based on the chronic dietary (food only)
exposure, chronic (non-cancer) DWLOCs were calculated. To calculate the
chronic DWLOCs, the chronic dietary food exposure (from the DEEM
analysis) was subtracted from the chronic RfD to give the maximum
allowable exposure level for drinking water. DWLOCs were then
calculated using the default body weights and drinking water
consumption figures. The estimated 56-day concentration of
fenbuconazole in surface water (3.6 g/L) is less than the
levels of comparison for fenbuconazole in drinking water as a
contribution to chronic aggregate exposure (1.0 x 103
g/L and 8.9 x 102 g/L for males and
females, respectively). Therefore, taking into account the registered
uses and uses proposed, it is concluded with reasonable certainty that
residues of fenbuconazole in drinking water (when considered along with
other sources of chronic exposure for which there is reliable data)
would not result in unacceptable levels of chronic aggregate human
health risk estimates for adult population subgroups.
The Agency generally has no concern for exposures below 100% of the
chronic RfD (when the FQPA Safety Factor has been removed, as is the
case for fenbuconazole) because the chronic RfD represents the level at
or below which average daily life-time exposure will not pose
appreciable risks to human health. Despite the potential for exposure
to fenbuconazole in drinking water, the chronic aggregate exposure is
not expected to exceed 100% of the chronic RfD for population subgroups
which include adults.
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. Short- and intermediate-term endpoints were not
identified; therefore, an aggregate risk assessment was not done for
these endpoints. Furthermore, fenbuconazole has no residential uses.
4. Aggregate cancer risk for U.S. population. Fenbuconazole has
been classified as a Group C Carcinogen with a Q1* of 3.59 x
10-3 (0.00359 (mg/kg/day)-1.
The existing fenbuconazole tolerances (published, pending, and
including the necessary section 18 tolerance(s)) result in a cancer
risk estimate of 8.3 x 10-7 for the U.S. population (48
States). Based on the cancer dietary (food only) exposure and using
default body weights and water consumption figures, a cancer DWLOC was
calculated. To calculate the cancer DWLOC, the negligible risk level (1
x 10-6) is divided by the Q1* to give the maximum
allowable exposure (food plus water). The chronic food exposure was
subtracted from the maximum allowable exposure (from the DEEM analysis)
to give the maximum allowable exposure level for drinking water. The
DWLOC was then calculated using the default body weight and drinking
water consumption figure. The estimated 56-day concentration of
fenbuconazole in surface water (3.6 g/L) is less than three
times the level of comparison (3 x 1.6 = 4.8 g/L) for
fenbuconazole in drinking water as a contribution to chronic (cancer)
aggregate exposure. Therefore, taking into account the registered uses
and uses proposed, it is concluded with reasonable certainty that
residues of fenbuconazole in drinking water (when considered along with
other sources of chronic (cancer) exposure for which there is reliable
data) would not result in unacceptable levels of cancer aggregate human
health risk estimates for the U.S. population (48 States). The chronic
food exposure estimate is partially refined. Further refinement of the
food exposure would result in a lower exposure estimate and result in a
higher DWLOC.
The Agency generally has no concern for exposures that result in a
cancer risk estimate below 1 x 10-6. Despite the potential
for exposure to fenbuconazole in drinking water, the Agency does not
expect the chronic (cancer) aggregate exposure to exceed 1 x
10-6 for the U.S. population (48 States). It is concluded
that there is a reasonable certainty that no harm will result to the
U.S. population (48 States) from chronic aggregate exposure to
fenbuconazole residues.
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 residues of fenbuconazole.
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 fenbuconazole, EPA considered data from
developmental toxicity studies in the rat and rabbit as well as a 2-
generation reproduction study in the rat. The developmental toxicity
studies are designed to evaluate adverse effects on the developing
fetus resulting from maternal pesticide exposure during 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 pre-and post-natal toxicity and the
completeness of the database 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 inter-
and intra-species variability)) and not the additional tenfold MOE/
uncertainty factor when EPA has a complete data base under existing
guidelines and
[[Page 7799]]
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.
The Agency has determined that the FQPA Safety Factor (for enhanced
sensitivity of infants and children as required by the Food Quality
Protection Act of 1996) should be removed for this active ingredient.
ii. Developmental toxicity studies--a. Rats. In the developmental
toxicity study in rats, the maternal (systemic) NOAEL was 30 mg/kg/day,
based on decreases in body weight and body weight gain at the LOAEL of
75 mg/kg/day. The developmental (fetal) NOAEL was 30 mg/kg/day, based
on an increase in post implantation loss and a significant decrease in
the number of live fetuses per dam at the LOAEL of 75 mg/kg/day.
b. Rabbits. In the developmental toxicity study in rabbits, the
maternal (systemic) NOAEL was 10 mg/kg/day, based on decreased body
weight gain at the LOAEL of 30 mg/kg/day. The developmental (pup) NOAEL
was 30 mg/kg/day, based on increased resorptions at the LOAEL of 60 mg/
kg/day.
iii. Reproductive toxicity study--Rats. In the 2-generation
reproductive toxicity study in rats, the parental (systemic) NOAEL was
4 mg/kg/day, based on decreased body weight and food consumption,
increased number of dams not delivering viable or delivering nonviable
offspring, and increases in adrenal and thyroid weights at the LOAEL of
40 mg/kg/day. The reproductive (pup) NOAEL was 40 mg/kg/day, the
highest dose tested.
iv. Pre- and post-natal sensitivity. The toxicological data base
for evaluating pre- and post-natal toxicity for fenbuconazole is
complete with respect to current data requirements. Based on the
developmental and reproductive toxicity studies there is no increased
susceptibility of rats or rabbits to in utero and/or postnatal exposure
to fenbuconazole. In the developmental toxicity studies in rats and
rabbits as well as the 2-generation reproduction study in rats,
toxicity to the fetuses/offspring, when observed, occurred at
equivalent or higher doses and was not judged to be more severe than in
the maternal/parental animals.
v. Conclusion. There is a complete toxicity database for
fenbuconazole and exposure data is complete or is estimated based on
data that reasonably accounts for potential exposures. EPA determined
that it was safe for infants and children to remove the FQPA safety
factor sine:
i. The toxicology data base is complete.
ii. There is not indication of increased susceptibility of rats or
rabbit fetuses to in utero and/or postnatal exposure in the
developmental and reproductive toxicity studies.
iii. Dietary (food) exposure estimates are slightly refined (using
limited %CT data for stone fruit) but likely result in an overestimate
of the actual dietary exposure.
iv. EFED models are used for ground and surface source drinking
water exposure assessments resulting in estimates that are upper-bound
concentrations.
v. There are currently no registered residential uses for
fenbuconazole and therefore, this type of exposure to infants and
children is not expected.
2. Acute risk. Toxicological effects relevant to infants and
children that could be attributed to a single exposure (dose) were not
observed in oral toxicity studies including the developmental toxicity
studies in rats and rabbits. A dose and endpoint was not identified;
therefore, this subpopulation is not expected to face any appreciable
acute risk.
3. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that chronic exposure to
fenbuconazole from food will utilize 3.1% for non-nursing infants less
than 1 year old, 2.5% for all infants (<1 year old), 1.5% for children
(1-6 years old), 1.1% for nursing infants (<1 year old), 1% for non-
hispanic (other than black or white), 1% for seniors (>55 years old)
and <1% for children (7-12 years old) of the chronic RfD. 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. Base
on chronic dietary exposure, a chronic (non-cancer) drinking water
level of comparison (DWLOC) was calculated to be 2.9 x 10 for non-
nursing infants (<1 year old). The estimated 56-day concentration of
fenbuconazole in surface water (3.6 g/L) is less than the
Agency's levels of comparison for fenbuconazole in drinking water as a
contribution to chronic aggregate exposure (1.0 x 103
g/L and 8.9 x 102 g/L for males and
females, respectively). It is concluded with reasonable certainty that
residues of fenbuconazole in drinking water (when considered along with
other sources of chronic exposure data) would not result in
unacceptable levels of chronic aggregate human health risk estimates
for the population subgroups.
4. Short- or intermediate-term risk. There are no residential uses.
No short and intermediate term aggregate exposure end points were
identified, therefore EPA concluded that fenbuconazole did not pose a
short or intermediate term risk.
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 fenbuconazole
residues.
III. Other Considerations
A. Metabolism In Plants and Animals
1. The nature of the residue in plants is adequately understood.
The residue of concern is fenbuconazole, [alpha-(2-(4-chlorophenyl)-
ethyl)-alpha-phenyl-3-(1H-1,2,4-triazole)-1-propanenitrile] and its
metabolites [cis-and trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-
(1H1,2,4-triazole-1-ylmethyl)-2-3H-furanone], as specified in 40 CFR
180.480.
2. As no livestock feed items are associated with this request, the
nature of the residue in livestock is not of concern.
B. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. This method involves extraction of parent and
metabolites into solvent followed by concentration, clean up,
separation by GC, and detection with a nitrogen phosphorus detector.
This method was submitted for inclusion in PAM II. The method may be
requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm 101FF, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703-305-5229).
C. Magnitude of Residues
Fenbuconazole, [alpha-(2-(4-chlorophenyl)-ethyl)-alpha-phenyl-3-
(1H-1,2,4-triazole)-1-propanenitrile] and its metabolites [cis-and
trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H1,2,4-triazole-1-
ylmethyl)-2-3H-furanone] expressed as fenbuconazole are not expected to
exceed the tolerance levels. Tolerances levels in/on bananas are based
on the highest residues resulting from applications to both bagged and
unbagged bananas. Additional crop field trial data submitted as a
condition of registration support reestablishment of time-limited
tolerance for whole bananas. These data showed that level for residues
in banana
[[Page 7800]]
pulp was exceeded in these field trials. Based on field data, EPA is
not reestablishing a separate tolerance on banana pulp.
D. International Residue Limits
There are no CODEX, Canadian, or Mexican Maximum Residue Limits
(MRL) for fenbuconazole on pecans, bananas and the crop group stone
fruit (except prunes and plums).
E. Rotational Crop Restrictions
Rotational crop restrictions are not applicable since pecans,
bananas and stone fruit (except prunes and plums), are not routinely
rotated.
IV. Conclusion
Therefore the time-limited tolerances are reestablished and amended
for combined residues of fenbuconazole, [alpha-(2-(4-chlorophenyl)-
ethyl)-alpha-phenyl-3-(1H-1,2,4-triazole)-1-propanenitrile] and its
metabolites [cis-and trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-
(1H1,2,4-triazole-1-ylmethyl)-2-3H-furanone] in or on [stone fruits
(except plums and prunes) at 2.0 ppm, pecans at 0.1 ppm and bananas at
0.3] ppm.
V. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation as was provided in
the old section 408 and in section 409. However, the period for filing
objections is 60 days, rather than 30 days. EPA currently has
procedural regulations which govern the submission of objections and
hearing requests. These regulations will require some modification to
reflect the new law. However, until those modifications can be made,
EPA will continue to use those procedural regulations with appropriate
adjustments to reflect the new law.
Any person may, by April 19, 1999, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the Hearing Clerk should be submitted to the OPP docket for this
regulation. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection.'' For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington,
VA, (703) 305-5697, tompkins.jim@epa.gov. Requests for waiver of
tolerance objection fees should be sent to James Hollins, Information
Resources and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is genuine and substantial issue of fact;
there is a reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of such issues
in favor of the requestor, taking into account uncontested claims or
facts to the contrary; and resolution of the factual issues in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). 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.
VI. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300789] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. Objections and
hearing requests may be sent by e-mail directly to EPA at: opp-
docket@epa.gov. e-mailed objections and hearing requests must be
submitted as an ASCII file avoiding the use of special characters and
any form of encryption. The official record for this regulation, as
well as the public version, as described in this unit will be kept in
paper form. Accordingly, EPA will transfer any copies of objections and
hearing requests received electronically into printed, paper form as
they are received and will place the paper copies in the official
record which will also include all comments submitted directly in
writing. The official record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408(d) of the
FFDCA 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) (Pub. L. 104-4). Nor does
it require any prior consultation as specficed by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or 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 in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), such as the
tolerance/exemption in this final rule, do not require the issuance of
a proposed rule, the
[[Page 7801]]
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. Nevertheless, the Agency previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
entities and concluded, as a generic matter, that there is no adverse
economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule. VIII. Submission to Congress and the Comptroller General.
VIII. Submission of Report to Congress and 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 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 the rule in the Federal Register. This 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: February 2, 1999.
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. 346a and 371
2. In Sec. 180.480, by revising paragraph (a)(1) to read as
follows:
Sec. 180.480 Fenbuconazole; tolerances for residues.
(a) General. (1) Time-limited tolerances, to expire on December 31,
2001, are reestablished for combined residues of the fungicide
fenbuconazole [alpha-[2-(4-chlorophenyl)-ethyl]-alpha-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile] and its metabolites, cis-5-(4-
chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-
furanone and trans-5-(4-chlorophenyl)dihydro-3-phenyl-3-(1H-1,2,4-
triazole-1-ylmethyl-2-3H-furanone, expressed as fenbuconazole, in or on
the following raw agricultural commodities:
------------------------------------------------------------------------
Parts Expiration/
Commodity per revocation
million date
------------------------------------------------------------------------
Bananas (whole fruit)............................. 0.3 12/31/01
Pecans............................................ 0.1 12/31/01
Stone fruit crop group (except plums and prunes).. 2.0 12/31/01
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-3519 Filed 2-16-99; 8:45 am]
BILLING CODE 6560-50-F