![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Fenbuconazole; Pesticide Tolerances for Emergency Exemptions
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: January 29, 1999 (Volume 64, Number 19)]
[Rules and Regulations]
[Page 4577-4584]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ja99-16]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300776; FRL-6054-3]
RIN 2070-AB78
Fenbuconazole; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
combined residues of Fenbuconazole and its metabolites RH-9129 and RH-
9130, expressed as the parent fenbuconazole in or on grapefruit and
livestock commodities . This action is in response to EPA's granting of
an emergency exemption under section 18 of the
[[Page 4578]]
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of
the pesticide on grapefruit. This regulation establishes maximum
permissible levels for residues of fenbuconazole in these food and feed
commodities pursuant to section 408(l)(6) of the Federal Food, Drug,
and Cosmetic Act, as amended by the Food Quality Protection Act of
1996. The tolerances will expire and are revoked on June 30, 2000.
DATES: This regulation is effective January 29, 1999. Objections and
requests for hearings must be received by EPA on or before March 30,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300776], 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-300776], 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 (CM #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
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300776]. 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: Andrea Beard, 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: CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA, (703) 308-9356, e-mail:
beard.andrea@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for
combined residues of the fungicide fenbuconazole and its metabolites
RH-9129 and RH-9130, expressed as the parent fenbuconazole, in or on
whole grapefruit at 0.5 part per million (ppm), at 4.0 ppm in/on dried
grapefruit, at 35 ppm in/on grapefruit oil; and at 0.1 ppm in/on meat
and meat by-products of cattle, goats, hogs, horses, and sheep. These
tolerances will expire and are revoked on June 30, 2000. EPA will
publish a document in the Federal Register to remove the revoked
tolerances from the Code of Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
New 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. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Fenbuconazole on Grapefruit and FFDCA
Tolerances
The Florida Department of Agriculture and Consumer Services has
requested an exemption for the use of fenbuconazole on grapefruit for
control of the disease, greasy spot (Mycosphaerella citri). Greasy spot
disease has become a problem in Florida because of high relative
humidity (nearly 100%) and higher temperatures for prolonged periods.
The disease affects all citrus varieties and can be a more serious
problem on grapefruit, due to its low resistance. The applicant asserts
that this pathogen has developed resistance to a registered
alternative, while other alternatives have limited efficacy and can
cause damage to the fruit, causing them to be downgraded to juice
grade. A recent drop in grapefruit prices have exacerbated this
situation, and significant economic losses are predicted without the
requested fungicide. EPA has authorized under FIFRA section 18 the use
of fenbuconazole on grapefruit for control of greasy spot
(Mycosphaerella citri) in Florida. After having reviewed the
submission, EPA concurs that emergency conditions exist for this state.
[[Page 4579]]
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of fenbuconazole in or on
grapefruit and livestock commodities. In doing so, EPA considered the
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerance under FFDCA section 408(l)(6) would be consistent
with the safety standard and with FIFRA section 18. Consistent with the
need to move quickly on the emergency exemption in order to address an
urgent non-routine situation and to ensure that the resulting food is
safe and lawful, EPA is issuing these tolerances without notice and
opportunity for public comment under section 408(e), as provided in
section 408(l)(6). Although these tolerances will expire and are
revoked on June 30, 2000, under FFDCA section 408(l)(5), residues of
the pesticide not in excess of the amounts specified in the tolerance
remaining in or on grapefruit and animal commodities after that date
will not be unlawful, provided the pesticide is applied in a manner
that was lawful under FIFRA, and the residues do not exceed levels that
were authorized by these tolerances at the time of that application.
EPA will take action to revoke these tolerances earlier if any
experience with, scientific data on, or other relevant information on
this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions EPA has not made any decisions about whether fenbuconazole
meets EPA's registration requirements for use on grapefruit or whether
permanent tolerances for this use would be appropriate. Under these
circumstances, EPA does not believe that these tolerances serve as a
basis for registration of fenbuconazole by a State for special local
needs under FIFRA section 24(c). Nor do these tolerances serve as the
basis for any State other than Florida to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
fenbuconazole, contact the Agency's Registration Division at the
address provided above.
III. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the Final Rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997)(FRL-5754-7) .
Consistent with section 408(b)(2)(D), 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 and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
combined residues of fenbuconazole and its metabolites RH-9129 and RH-
9130, expressed as the parent fenbuconazole on whole grapefruit at 0.5
ppm, at 4.0 ppm in/on dried grapefruit, at 35 ppm in/on grapefruit oil;
and at 0.1 ppm in/on meat and meat by-products of cattle, goats, hogs,
horses, and sheep. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerances 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 below.
1. Acute toxicity. For the purposes of the acute dietary risk
assessment, EPA assessments are based on an acute reference dose (RfD)
of 0.3 milligrams/kilogram/day (mg/kg/day). This figure is derived from
the No Observed Adversed Effect Level (NOAEL) of 30 mg/kg/day from the
developmental toxicity study in rats, and an uncertainty factor of 100.
The observed effect was a decrease in the number of live fetuses at the
Lowest Effect Level (LEL) of 75 mg/kg/day.
2. Short- and intermediate-term toxicity. No dermal or systemic
toxicity endpoints were identified for this exposure duration.
Therefore, a risk assessment is not needed.
3. Chronic toxicity. EPA has established the chronic RfD for
fenbuconazole at 0.03 mg/kg/day. This RfD is based on a chronic
toxicity study in the rat with a NOAEL of 3.03/4.02 mg/kg/day in males/
females, and an uncertainty factor of 100. The NOAEL is based on
decreased body weight gains (females), hepatocellular enlargement and
vaculation (females), increases in thyroid weight (both sexes) and
histopathological lesions in the thyroid glands (males), at the LEL of
30.62/43.04 mg/kg/day in males/females.
4. Carcinogenicity. Using its Guidelines for Carcinogen Risk
Assessment, EPA has classified fenbuconazole as a Group C (possible
human carcinogen) chemical. EPA believes it is appropriate to use the
Q<INF>1</INF>* approach for determination of risk, and has calculated a
Q<SUP>1</SUP>* of 3.59 x 10<SUP>-3</SUP> (mg/kg/day)<SUP>-1</SUP>.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.480) for the combined residues or residues of fenbuconazole and
its metabolites RH-9129 and RH-9130, expressed as the parent
fenbuconazole, in or on a variety of raw agricultural commodities.
Time-limited tolerances have been established for residues of
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, expressed as fenbuconazole in or on commodities ranging from
0.1 ppm in pecans to 2.0 ppm in the stone fruit crop group. Risk
assessments were conducted by EPA to assess dietary exposures and risks
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 one day or single exposure. An acute dietary risk assessment for
fenbuconazole is only needed for the population subgroup, females 13+
years (yrs.) old, as the effect was increased resorptions and decreased
live fetuses. The acute dietary risk assessment used the Theoretical
Maximum Residue Contribution (TMRC, tolerance level residues and 100%
crop treated); the tolerances used for grapefruit and animal
commodities are the levels given above. The Novigen Dietary Exposure
Evaluation Model (DEEM) analysis was used and this 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.
Resulting exposure values (at the 99th percentile) and percentage of
the acute RfD are shown below. Values for the 99th percentile are
considered to be conservative as OPP policy dictates exposure estimates
from as low as the 95th percentile may be utilized for risk estimates
from acute DEEM runs. Thus,
[[Page 4580]]
these results are viewed as conservative estimates, and refinement
using anticipated residue values and percent crop treated information,
in conjunction with a Monte Carlo analysis, would result in lower
estimates of acute dietary exposure and risk. The resulting high-end
exposure estimates (food only, 99.9 percentiles) ranges from 0.0072 to
0.015 mg/kg/day for the population subgroups females 13+ yrs. old
(nursing), and females 13 - 19 yrs. old (not pregnant or nursing),
respectively. The percentages of the acute RfD utilized by these
exposure levels, for these two subgroups are 2.3 and 5.0%,
respectively.
ii. Chronic exposure and risk. The chronic dietary risk assessment
is partially refined. Additional refinement would incorporate percent
crop treated and anticipated residues for all commodities, and would
result in lower exposure estimates. Again, the Novigen DEEM analysis
was used, as described above. Tolerance level residues were assumed for
all commodities, including stone fruits. Percent crop treated data were
used for stone fruits only and 100% crop-treated data were used for all
other commodities. The existing tolerances for fenbuconazole plus
exposures connected with the section 18 on grapefruit result in an
anticipated residue contribution (ARC) that is equivalent to 3.1% of
the RfD for non-nursing infants <1 yr. old, the highest exposed
subpopulation. Exposure for all other population subgroups was at a
level below this. iii. Cancer Risk. Fenbuconazole is classified as a
Group C Carcinogen, with a Q<INF>1</INF>* of 3.59 x 10<SUP>-3</SUP>
(mg/kg/day)<SUP>-1</SUP>. Using the partially refined exposure
estimates described above under Chronic exposure and risk, the cancer
risk estimate for the U.S. Population is calculated to be 8.3 x
10<SUP>-7</SUP>.
2. From drinking water. There is no established Maximum Contaminant
Level or Health Advisory Levels for imidacloprid in drinking water. To
date, there are no validated modeling approaches for reliably
predicting pesticide levels in drinking water. The Agency uses models
designed for use for ecological assessment, which are not ideal tools
for use in drinking water risk assessment, as they could overestimate
actual drinking water concentrations.
Thus, these models are considered a coarse screening tool for
sorting out pesticides for which it is highly unlikely that drinking
water concentrations would ever exceed human health levels of concern.
For surface water, the Agency used PRZM1 (Pesticide Root Zone Model -
simulates the transport of a pesticide off the agricultural field) and
EXAMS (EXposure Analysis Modeling System - simulates fate and transport
of a pesticide in surface water) models which are used to produce
estimates of pesticide concentrations in a farm pond. For ground water
the Agency used SCI-GROW (Screening Concentration In GROund Water)
model to estimate the concentration of imidacloprid residues in ground
water. SCI-GROW is a prototype model for estimating ``worst case'
ground water concentrations of pesticides. This model assumes that the
pesticide is applied at its maximum rate in areas where the ground
water is particularly vulnerable to contamination. SCI-GROW is biased
in that studies where the pesticide is not detected in ground water are
not included in the data set. Thus, it is not expected that SCI-GROW
estimates would be exceeded. In the absence of monitoring data for
pesticides, drinking water levels of comparison (DWLOCs) are calculated
and used as a point of comparison against the model estimated
environmental concentrations (EECs) 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. A DWLOC will
vary depending on the toxic endpoint, with drinking water consumption,
and body weights. Different populations will have different DWLOCs.
DWLOCs are used in the risk assessment process as a surrogate measure
of potential exposure associated with pesticide exposure through
drinking water. DWLOC values are not regulatory standards for drinking
water. Since DWLOCs address total aggregate exposure to imidacloprid
they are further discussed in the aggregate risk sections below.
i. Acute exposure and risk. EPA used estimated concentrations of
imidacloprid in surface and ground water for acute exposure analysis of
6.7 and 0.03 g/L parts per billion (ppb), respectively. Since the
ground water estimate is much less than that for surface water, only
the surface water estimated maximum concentration of 6.7 ppb was used
for comparison to the DWLOCs. The acute DWLOC was calculated for the
segment of the population subgroup of concern with the highest food
exposure, females 13 - 19 yrs. old (not pregnant or nursing). This
DWLOC was calculated to be 8,600 ppb.
ii. Chronic exposure and risk. Since the estimated concentration
for chronic exposure to ground water (0.03 ppb) was much less than that
for surface water (3.6 ppb), EPA used the surface water estimate for
chronic exposure analysis as a worst case estimation. The chronic
DWLOCs were calculated for the population subgroup with the highest
food exposure, Non-Hispanic (other than black or white). These DWLOCs
were calculated to be 1,000 ppb for males and 890 ppb for females.
3. From non-dietary exposure. Fenbuconazole is not currently
registered for use on any residential non-food sites: Therefore, a
discussion of the toxicity endpoints for non-dietary exposure and a
risk assessment for these uses is not germane to this review.
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
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 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 more 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).
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. For the population subgroups of concern, females 13+
yrs. old (nursing), and females 13 - 19 yrs. old (not pregnant or
nursing), the percentages of the acute RfD utilized by these exposure
levels, for these two subgroups are 2.3 and 5.0%, respectively. EPA
generally has no concerns for exposures below 100% of the acute RfD. In
addition, for acute exposures associated with drinking water, EPA has
concluded that the DWLOC is 8,600 ppb. The EEC value is 6.7 ppb. This
leads EPA to conclude that acute exposure to fenbuconazole is within
acceptable limits, and there is reasonable certainty of no harm.
2. Chronic risk. Using the ARC exposure assumptions described
above,
[[Page 4581]]
EPA has concluded that aggregate exposure to fenbuconazole from food
will utilize <1% of the RfD for the U.S. population. The major
identifiable subgroup with the highest aggregate exposure is 3.1% of
the chronic RfD for non-nursing infants <1 yr. old, which is further
discussed below. For the rest of the population subgroups, the RfD
utilized is <1 - 2.5%. Based upon dietary (food only) exposure, the
chronic DWLOCs were calculated for the population subgroup with the
highest food exposure, Non-Hispanic (other than black or white). These
DWLOCs were calculated to be 1,000 ppb for males and 890 ppb for
females. Using the rough screening models described above for ground
and surface water, the EEC was estimated at 3.6 ppb, significantly less
than the calculated DWLOCs. 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 fenbuconazole in drinking water and from non-dietary, non-
occupational exposure, EPA does not expect the aggregate exposure to
exceed 100% of the RfD.
3. Short- and intermediate-term risk. Short- and intermediate-term
endpoints were not identified; additionally, fenbuconazole has no
residential uses. Thus short- and intermediate-term aggregate risk
assessments are not required.
4. Aggregate cancer risk for U.S. population. The existing
tolerance plus this proposed tolerance for this exemption result in a
cancer risk estimate of 8.3 x 10<SUP>-7</SUP> for the overall U.S.
population. The risk from the time-limited tolerances with section 18s
(blueberries, grapefruit, meat, and meat by-products) was not
amortized. This is sometimes done to account for the temporary nature
of the section 18 use. Based on this level, and the level considered to
be acceptable for cancer risk, and incorporating the usual default
values for body weight and drinking water consumption, a DWLOC was
calculated of 1.6 ppb for the U.S. Population. This is compared to the
EEC, as derived from the rough screening models (described above) of
3.6 ppb. EPA policy is that a factor of 3 will be applied to these
model values to determine whether a DWLOC has been exceeded. If the
model value is <3 times the DWLOC, the pesticide is considered to have
passed the screen and no further assessment is needed. In this case,
the model value of 3.6 ppb is less than three times the DWLOC (3 x 1.6
= 4.8 ppb), and thus EPA concludes with reasonable certainty that
residues of fenbuconazole in drinking water, considered along with
other sources of chronic exposure, will not result in unacceptable
levels of aggregate cancer risk estimates. EPA also notes that the
chronic food exposure estimate is only partially refined, and further
refinement of this exposure would result in lower risk estimates.
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 fenbuconazole residues.
D. 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 and a two-
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 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 MOE and 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 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 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 lowest observed
effectlevel (LOEL) 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 LOEL
of 75 mg/kg/day. In the developmental toxicity study in rabbits, the
maternal (systemic) NOAEL was 10 mg/kg/day, based on decreased body
weight gain at the LOEL of 30 mg/kg/day. The developmental (pup) NOAEL
was 30 mg/kg/day, based on increased resorptions at the LOEL of 60 mg/
kg/day.
iii. Reproductive toxicity study. In the 2-generation reproductive
study in rats, the maternal (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 LOEL of 40 mg/kg/day. The
reproductive (pup) NOAEL was 40 mg/kg/day, the highest dose tested
(HDT).
iv. Pre- and post-natal sensitivity. The toxicological data base
for evaluating pre-and post-natal toxicity for fenbuconazole is
complete with respect to EPA's current data requirements. EPA has
determined that the studies indicated no increased susceptibility of
rats or rabbits to in utero and/or postnatal exposure to fenbuconazole.
In the prenatal developmental toxicity studies in rats and rabbits, and
the 2-generation reproduction study in rats, toxicity to the fetuses
and offspring, when observed, occurred at equivalent or higher doses
and was not judged to be more severe than toxic effects on the maternal
and parental animals. Based on the developmental and reproductive
toxicity studies, EPA scientists concluded that the FQPA 10x
uncertainty factor may be removed.
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.
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, an aggregate risk assessment is not required for this
subpopulation.
3. Chronic risk. Using the exposure assumptions described above,
EPA has concluded that aggregate exposure to fenbuconazole from food
will utilize 3.1% of the RfD for the most highly exposed subgroup for
infants and children, non-nursing infants <1 yr. old. EPA generally has
no concern for
[[Page 4582]]
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 fenbuconazole 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. Short- and intermediate-term
endpoints were not identified; additionally, fenbuconazole has no
residential uses. Thus short- and intermediate-term aggregate risk
assessments are not required.
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.
IV. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue of fenbuconazole in plants and livestock
is adequately understood, for this action. 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-5-(4-
chlorophenyl)dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3H-
furanoneandtrans-5-(4-chlorophenyl)dihydro-3-phenyl-3-(1H-1,2,4-
triazole-1-ylmethyl)-2-3H-furanone (also known as RH-9129 and RH-
9130,respectively), expressed as fenbuconazole as specified in 40 CFR
180.480.
B. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography with a
nitrogen phosphorus detector) is available to enforce the tolerance
expression. The method has not yet appeared in the Pesticide Analytical
Manual II, but 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, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA,
(703) 305-5229.
C. Magnitude of Residues
Residues of fenbuconazole and its regulated metabolites are not
expected to exceed 0.5 ppm in/on whole grapefruit, 4.0 ppm in dried
citrus pulp, and 35 ppm in citrus oil. Grapefruit pulp is not a poultry
feed, but may be fed to other livestock. Therefore, residues are not
expected to exceed 0.01 ppm in or on meat and meat by-products of
cattle, goats, hogs, horses, and sheep.
D. International Residue Limits
There are no CODEX, Canadian, or Mexican maximum residue limits
(MRLs) for fenbuconazole on grapefruit or livestock commodities. Thus,
harmonization is not an issue for this use.
E. Rotational Crop Restrictions
Grapefruit is not rotated to other crops, and therefore, rotational
crop restrictions are not germane to this action.
V. Conclusion
Therefore, the tolerance is established for combined residues of
fenbuconazole and its metabolites RH-9129 and RH-9130, expressed as the
parent fenbuconazole in grapefruit at 0.5 ppm, in grapefruit pulp,
dried, at 4.0 ppm, in grapefruit oil at 35 ppm, and in meat and meat
by-products of cattle, goats, hogs, horses, and sheep at 0.01 ppm.
VI. 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 March 30, 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 un der 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
rulemaking. 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 wave 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, CM #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.
VII. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300776] (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,
[[Page 4583]]
Environmental Protection Agency, CM #2, 1921 Jefferson Davis Highway,
Arlington, VA.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.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.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes time-limited tolerances under FFDCA
section 408(l)(6). 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
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
under FFDCA section 408 (l)(6), 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. Nevertheless, the Agency has 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 to 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.
IX. 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 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: January 20, 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, paragraph (b) by alphabetically inserting the
following commodities to the table to read as follows:
Sec. 180.480 Fenbuconazole; tolerances for residues.
* * * * *
(b) * * *
[[Page 4584]]
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
* * * * * * *
Cattle, fat..................... 0.01 6/30/00
Cattle, mbyp.................... 0.01 6/30/00
Cattle, meat.................... 0.01 6/30/00
Goats, fat...................... 0.01 6/30/00
Goats, mbyp..................... 0.01 6/30/00
Goats, meat..................... 0.01 6/30/00
Grapefruit...................... 0.5 6/30/00
Grapefruit pulp, dried.......... 4.0 6/30/00
Grapefruit oil.................. 35 6/30/00
Hogs, fat....................... 0.01 6/30/00
Hogs, mbyp...................... 0.01 6/30/00
Hogs, meat...................... 0.01 6/30/00
Horses, fat..................... 0.01 6/30/00
Horses, mbyp.................... 0.01 6/30/00
Horses, meat.................... 0.01 6/30/00
* * * * * * *
Sheep, fat...................... 0.01 6/30/00
Sheep, mbyp..................... 0.01 6/30/00
Sheep, meat..................... 0.01 6/30/00
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-2207 Filed 1-28-99; 8:45 am]
BILLING CODE 6560-50-F