[Federal Register Volume 63, Number 111 (Wednesday, June 10, 1998)]
[Rules and Regulations]
[Pages 31633-31640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15173]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300662; FRL 5791-5]
RIN 2070-AB78


Fenbuconazole; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of fenbuconazole and its metabolites in or on blueberries. 
This action is in response to EPA's granting of an emergency exemption 
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act authorizing use of

[[Page 31634]]

the pesticide on blueberries in several States. This regulation 
establishes a maximum permissible level for residues of fenbuconazole 
in this food commodity 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 tolerance will expire and is revoked on December 31, 
1999.

DATES: This regulation is effective June 10, 1998. Objections and 
requests for hearings must be received by EPA on or before August 10, 
1998.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300662], 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-300662], 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, 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: [email protected]. 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-300662]. 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: Daniel Rosenblatt, 
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: Crystal Mall #2, 
1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9375; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 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 
the fungicide fenbuconazole and its metabolites, in or on blueberries 
at 1.0 part per million (ppm). This tolerance will expire and is 
revoked on December 31, 1999. EPA will publish a document in the 
Federal Register to remove the revoked tolerance 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 tolerance 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 Blueberries and FFDCA 
Tolerances

    Mummy berry disease Monilinia vaccinii-corymbosi is a plant disease 
which causes a variety of leaf, flower, and fruit damage. Of special 
concern for blueberry producers are the blighted flower clusters on 
blueberry bushes and mummified fruit that the disease will produce. 
Yield loss projections suggest that mummy berry disease may produce 
losses of 25-50% of the blueberry crop. In addition, the mummified 
fruit will serve as the inoculum for subsequent outbreaks of mummy 
berry disease so it is important to gain control over the pest in order 
to avert future problem outbreaks.
    In past growing seasons, blueberry growers typically used triforine 
to control mummy berry disease. However, triforine was voluntarily 
canceled by its manufacturer. Now that triforine pesticides have been 
canceled, there do not appear to be any registered pesticidal or 
cultural measures that growers can use. Therefore, EPA concurs that the 
pressures presented by mummy berry disease on blueberry growers 
represent an urgent and non-routine situation and has authorized under 
FIFRA section 18 the use of fenbuconazole on blueberries to numerous 
States.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of fenbuconazole in or on 
blueberries. In doing so, EPA considered the new safety standard in 
FFDCA section 408(b)(2), and EPA decided that the necessary

[[Page 31635]]

tolerance under FFDCA section 408(l)(6) would be consistent with the 
new safety standard and with FIFRA section 18. Consistent with the need 
to move quickly on the emergency exemption in order to address an 
urgent non-routine situation and to ensure that the resulting food is 
safe and lawful, EPA is issuing this tolerance without notice and 
opportunity for public comment under section 408(e), as provided in 
section 408(l)(6). Although this tolerance will expire and is revoked 
on December 31, 1999, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on blueberries after that date will not be unlawful, 
provided the pesticide is applied in a manner that was lawful under 
FIFRA, and the residues do not exceed a level that was authorized by 
this tolerance at the time of that application. EPA will take action to 
revoke this tolerance earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.
    Because this tolerance is being approved under emergency conditions 
EPA has not made any decisions about whether fenbuconazole meets EPA's 
registration requirements for use on blueberries or whether a permanent 
tolerance for this use would be appropriate. Under these circumstances, 
EPA does not believe that this tolerance serves as a basis for 
registration of fenbuconazole by a State for special local needs under 
FIFRA section 24(c). Nor does this tolerance serve as the basis for any 
States other than those authorized under section 18 to use this 
pesticide on this crop without following all provisions of 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. Risk Assessment and Statutory Findings

    EPA performs a number of analyses to determine the risks from 
aggregateexposure to pesticide residues. First, EPA determines the 
toxicity of pesticides based primarily on toxicological studies using 
laboratory animals. These studies address many adverse health effects, 
including (but not limited to) reproductive effects, developmental 
toxicity, toxicity to the nervous system, and carcinogenicity. Second, 
EPA examines exposure to the pesticide through the diet (e.g., food and 
drinking water) and through exposures that occur as a result of 
pesticide use in residential settings.

A. Toxicity

    1. Threshold and non-threshold effects. For many animal studies, a 
dose response relationship can be determined, which provides a dose 
that causes adverse effects (threshold effects) and doses causing no 
observed effects (the ``no-observed effect level'' or ``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the Reference Dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 100 is commonly used since it is assumed 
that people may be up to 10 times more sensitive to pesticides than the 
test animals, and that one person or subgroup of the population (such 
as infants and children) could be up to 10 times more sensitive to a 
pesticide than another. In addition, EPA assesses the potential risks 
to infants and children based on the weight of the evidence of the 
toxicology studies and determines whether an additional uncertainty 
factor is warranted. Thus, an aggregate daily exposure to a pesticide 
residue at or below the RfD (expressed as 100% or less of the RfD) is 
generally considered acceptable by EPA. EPA generally uses the RfD to 
evaluate the chronic risks posed by pesticide exposure. For shorter 
term risks, EPA calculates a margin of exposure (MOE) by dividing the 
estimated human exposure into the NOEL from the appropriate animal 
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This 
100-fold MOE is based on the same rationale as the 100-fold uncertainty 
factor.
    Lifetime feeding studies in two species of laboratory animals are 
conducted to screen pesticides for cancer effects. When evidence of 
increased cancer is noted in these studies, the Agency conducts a 
weight of the evidence review of all relevant toxicological data 
including short-term and mutagenicity studies and structure activity 
relationship. Once a pesticide has been classified as a potential human 
carcinogen, different types of risk assessments (e.g., linear low dose 
extrapolations or MOE calculation based on the appropriate NOEL) will 
be carried out based on the nature of the carcinogenic response and the 
Agency's knowledge of its mode of action.
    2. Differences in toxic effect due to exposure duration. The 
toxicological effects of a pesticide can vary with different exposure 
durations. EPA considers the entire toxicity data base, and based on 
the effects seen for different durations and routes of exposure, 
determines which risk assessments should be done to assure that the 
public is adequately protected from any pesticide exposure scenario. 
Both short and long durations of exposure are always considered. 
Typically, risk assessments include ``acute,'' ``short-term,'' 
``intermediate term,'' and ``chronic'' risks. These assessments are 
defined by the Agency as follows.
    Acute risk, by the Agency's definition, results from 1-day 
consumption of food and water, and reflects toxicity which could be 
expressed following a single oral exposure to the pesticide residues. 
High end exposure to food and water residues are typically assumed.
    Short-term risk results from exposure to the pesticide for a period 
of 1-7 days, and therefore overlaps with the acute risk assessment. 
Historically, this risk assessment was intended to address primarily 
dermal and inhalation exposure which could result, for example, from 
residential pesticide applications. However, since enaction of FQPA, 
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from 
food, water, and residential uses when reliable data are available. In 
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 
three sources are not typically added because of the very low 
probability of this occurring in most cases, and because the other 
conservative assumptions built into the assessment assure adequate 
protection of public health. However, for cases in which high-end 
exposure can reasonably be expected from multiple sources (e.g. 
frequent and widespread homeowner use in a specific geographical area), 
multiple high-end risks will be aggregated and presented as part of the 
comprehensive risk assessment/characterization. Since the toxicological 
endpoint considered in this assessment reflects exposure over a period 
of at least 7 days, an additional degree of conservatism is built into 
the assessment; i.e., the risk assessment nominally covers 1-7 days 
exposure, and the toxicological endpoint/NOEL is selected to be 
adequate for at least 7 days of exposure. (Toxicity results at lower 
levels when the dosing duration is increased.)

[[Page 31636]]

    Intermediate-term risk results from exposure for 7 days to several 
months. This assessment is handled in a manner similar to the short-
term risk assessment.
    Chronic risk assessment describes risk which could result from 
several months to a lifetime of exposure. For this assessment, risks 
are aggregated considering average exposure from all sources for 
representative population subgroups including infants and children.

B. Aggregate Exposure

    In examining aggregate exposure, FFDCA section 408 requires that 
EPA take into account available and reliable information concerning 
exposure from the pesticide residue in the food in question, residues 
in other foods for which there are tolerances, residues in groundwater 
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or 
buildings (residential and other indoor uses). Dietary exposure to 
residues of a pesticide in a food commodity are estimated by 
multiplying the average daily consumption of the food forms of that 
commodity by the tolerance level or the anticipated pesticide residue 
level. The Theoretical Maximum Residue Contribution (TMRC) is an 
estimate of the level of residues consumed daily if each food item 
contained pesticide residues equal to the tolerance. In evaluating food 
exposures, EPA takes into account varying consumption patterns of major 
identifiable subgroups of consumers, including infants and children. 
The TMRC is a ``worst case'' estimate since it is based on the 
assumptions that food contains pesticide residues at the tolerance 
level and that 100% of the crop is treated by pesticides that have 
established tolerances. If the TMRC exceeds the RfD or poses a lifetime 
cancer risk that is greater than approximately one in a million, EPA 
attempts to derive a more accurate exposure estimate for the pesticide 
by evaluating additional types of information (anticipated residue data 
and/or percent of crop treated data) which show, generally, that 
pesticide residues in most foods when they are eaten are well below 
established tolerances.
    Percent of crop treated estimates are derived from federal and 
private market survey data. 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 exposure is not 
understated for any significant subpopulation group. Further, regional 
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations 
including several regional groups, to pesticide residues. For this 
pesticide, the most highly exposed population subgroup (females 13 
years and older) was not regionally based.

IV. 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 and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
residues of fenbuconazole and its metabolites on blueberries at 1.0 
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 below.
    1. Acute toxicity. For the purposes of the acute dietary risk 
assessment, EPA assessments are based on an acute RfD of 0.3 
milligrams/kilogram/day (mg/kg/day). This figure is derived from 
developmental toxicity data from laboratory animals where the NOEL was 
determined to be 30 mg/kg/day. The observed effect was a decrease in 
the number of live fetuses at the Lowest Effect Level (LEL) of 75 mg/
kg/day and an uncertainty factor of 100. EPA determined that an 
additional safety factor of 3x for the protection of infants and 
children was appropriate. Therefore, the FQPA acute allowable risk is 
0.1 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 RfD for fenbuconazole 
at 0.03 mg/kg/day. This RfD is based on a chronic toxicity study in the 
rat with a NOEL of 3.03/4.02 in males/females. The NOEL 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. For the population subgroup of 
infants and children an uncertainty factor of 300 was used. The FQPA 
chronic allowable risk is 0.01 mg/kg/day for infants, children, and 
females 13 years and older.
    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 
Q1* approach of 3.59 x 10-3 (mg/kg/
day)-1.

B. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.480) for the use of fenbuconazole and its metabolites, 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. In conducting an acute dietary risk 
assessment for fenbuconazole, EPA has made conservative assumptions 
which result in an overestimate of human dietary exposure. The acute 
dietary (food only) risk assessment used TMRC. The resulting high-end 
exposure estimate is 0.015 mg/kg/day. This exposure level utilizes 15% 
of the dietary (food only) FQPA acute allowable risk for females 13+ 
years. Refinement using anticipated residue values and percent crop-
treated data in conjunction with Monte Carlo analysis would result in 
lower acute dietary exposure estimates.
    ii. Chronic exposure and risk. The chronic dietary risk assessment 
is partially refined. Tolerance level residues were assumed for all 
commodities, including stone fruits. Percent crop treated data were 
used for

[[Page 31637]]

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 blueberries result in an anticipated 
residue contribution (ARC) that is equivalent to 3% of the RfD for non-
nursing infants (<1 year old), the highest exposed subpopulation.
    2. From drinking water. 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.
    Fenbuconazole is moderately persistent and slightly mobile to 
immobile in soil. Because of its adsorption to soil, the potential for 
fenbuconazole to leach to ground water appears to be slight. However, 
the potential to contaminate ground water may be greater at vulnerable 
sites, where soils are low in organic matter and where ground water is 
relatively close to the surface. The long half-lives of aerobic soil 
and terrestrial field dissipation 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.
    For the purposes of EPA's water screening assessments, it is 
assumed that adult males weigh 70 kg, adult females 60 kg, and children 
10 kg. Average consumption is assumed to be 2 liters/day for adults and 
1 liter/day for children.
    EPA performed a ground water assessment with its ground water 
screening tool to establish an estimated environmental concentration 
(EEC). The Tier I estimate projected that the concentration of 
fenbuconazole in drinking water from ground water sources is not likely 
to exceed an acute and chronic EEC of 0.019 g/l for ground and 
aerial applications.
    A Tier I drinking water assessment of fenbuconazole was also 
conducted for surface water. The EECs are generated for high exposure 
agricultural scenarios and correspond to a stagnant pond with no outlet 
that receives pesticide loading from an adjacent 100% cropped, 100% 
treated field. As such, these computer generated EECs represent 
conservative screening levels for ponds and lakes and are thought to 
represent an overestimate of the actual EEC. The peak EEC projection 
for surface water involved aerial applications. The acute peak EEC was 
4.27 g/l. The chronic 56-day EEC was 2.29 g/l. 
Because the surface water EECs appear to be higher, EPA used these 
worst case calculations in its dietary risk assessment.
    i. Acute exposure and risk. EPA calculated the acute risks from 
drinking water for fenbuconazole based on dietary (food) exposure and 
the default assumptions mentioned above. To calculate the acute 
drinking water level of concern (DWLOC), the acute dietary food 
exposure estimate is subtracted from the acute RfD.
    The calculations were based on the following: the acute RfD for 
fenbuconazole is 0.3 mg/kg/day; the FQPA acute allowable risk is 0.1 
mg/kg/day based on an uncertainty factor of 3. If the acute food 
exposure estimate (0.015 mg/kg/day) is subtracted from the FQPA acute 
allowable risk (0.1 mg/kg/day) the result is the maximum acute water 
exposure which is 0.085 mg/kg/day or 2,600 parts per billion (ppb).
    The peak EEC (acute) value is 4.27 ppb, based on aerial application 
of fenbuconazole. This figure is significantly lower that the DWLOC of 
2,600 ppb. Therefore, EPA concludes with reasonable certainty that the 
acute exposure to fenbuconazole in drinking water is less than the 
level of concern.
    ii. Chronic exposure and risk. To calculate the chronic DWLOC, the 
chronic dietary food exposure is subtracted from the RfD. Chronic 
DWLOCs were calculated for various subpopulations ranging from 1,050 
ppb for the U.S. population to 92 ppb for infants and children (non-
nursing < 1 year). The computer model suggested that the chronic EEC 
for fenbuconazole is 2.29 ppb for aerial applications of the pesticide. 
Since the EEC is less than the DWLOC, EPA concludes that there is 
reasonable certainty that chronic exposure is less than the level of 
concern.
    EPA calculated the cancer risk associated with fenbuconazole and 
drinking water. To calculate the DWLOC for cancer, the chronic dietary 
food exposure was subtracted from the negligible risk standard (1 x 
10-6) divided by the Q1* (0.00359 mg/
kg/day). EPA's drinking water level of concern from cancer is 5.4 ppb 
for the U.S. population. This compares to the level of 2.29 ppb from 
the conservative computer model EPA used to estimate exposures. Since 
the DWLOC is higher than the calculated EEC of 2.29 ppb, EPA concludes 
with reasonable certainty that exposure to fenbuconazole in drinking 
water does not pose a level of concern with respect to cancer risks.
    3. From non-dietary exposure. Fenbuconazole is not currently 
registered for any residential or non-food use 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.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will increase the Agency's scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better determining which chemicals 
have a common mechanism of toxicity and evaluating the cumulative 
effects of such chemicals. The Agency anticipates, however, that even 
as its understanding of the science of common mechanisms increases, 
decisions on specific classes of chemicals will be heavily dependent on 
chemical specific data, much of which may not be presently available.
    Although at present the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to which the common mechanism 
issues can be resolved. These pesticides include pesticides that are 
toxicologically dissimilar to existing chemical substances (in which 
case the Agency can conclude that it is unlikely that a pesticide 
shares a common mechanism of activity with other substances) and 
pesticides that produce a common toxic metabolite (in which case common 
mechanism of activity will be assumed).
    EPA does not have, at this time, available data to determine 
whether fenbuconazole has a common mechanism of toxicity with other

[[Page 31638]]

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.

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

    1. Acute risk. For the population subgroup of concern, females 13 
years and older, EPA used the TMRC approach and calculated that 
exposure would utilize 15% of the RfD. 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 
level of concern is 2,600 ppb. The EEC value is 4.27 ppb. This leads 
EPA to conclude that acute exposure to fenbuconazole does not pose a 
level of concern.
    2. Chronic risk. Using ARC exposure assumptions, EPA has concluded 
that aggregate exposure to fenbuconazole from food will utilize less 
than 1% of the RfD for the U.S. population. The major identifiable 
subgroup with the highest aggregate exposure is non-nursing infants 
where 3% of the RfD is utilized. A full discussion of the risks 
associated with exposure to infants and children is presented below. 
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. EPA's level of concern from chronic exposure to drinking 
water is 1,050 ppb for the U.S. population. The EEC for aerial 
application is projected to be 2.29 ppb. Therefore, EPA concludes that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to fenbuconazole residues.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
endpoints were not identified for fenbuconazole. Therefore, an 
aggregate risk assessment was not conducted for these endpoints. 
Furthermore, fenbuconazole has no residential uses.

D. 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). The Q* approach was used for risk assessments 
involving carcinogenic effects. Using partially refined exposure 
estimates, the cancer risk estimate for the U.S. population is 3.25 x 
10-7. For exposures connected with drinking water, EPA's 
level of concern is 5.4 ppb. EPA projects that the EEC for 
fenbuconazole is 2.29 ppb. Therefore, EPA concludes with reasonable 
certainty that exposure to fenbuconazole does not exceed the level of 
concern for cancer risks.

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 and a 2-generation 
reproduction study in the rat. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from maternal pesticide exposure 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 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) NOEL was 30 mg/kg/day, based on 
decreases in body weight and body weight gain at the LOEL of 75 mg/kg/
day. The developmental (fetal) NOEL 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) NOEL 
was 10 mg/kg/day, based on decreased body weight gain at the LOEL of 30 
mg/kg/day. The developmental (pup) NOEL 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 paternal (systemic) NOEL 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) NOEL 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. Based on the 
developmental and reproductive toxicity studies there is not adequate 
evidence to completely remove the FQPA 10x factor. There is some 
evidence suggestive of increased susceptibility in developing 
offspring. An increase in post implantation loss and a significant 
decrease in the number of live fetuses per dam in rats in the presence 
of effects on maternal weight gain may be indicative of increased 
susceptibility in the fetus. However, the increased incidence does not 
appear to be very great at 75 mg/kg/day for either effect. Similarly, 
in rabbits there are reported resorptions at 60 mg/kg/day and effects 
on maternal weight gain at 30 mg/kg/day. Therefore, EPA determined that 
the 10x factor required by FQPA for protection of infants and children 
from exposure to fenbuconazole should be reduced to 3x.
    The retention of the 3x factor for this risk assessment does not 
result in exposure values which exceed EPA's level of concern. This 
action should not pose an unacceptable aggregate risk to infants and 
children.
    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 ARC exposure assumptions, EPA has concluded 
that aggregate exposure to fenbuconazole from food will utilize 3% of 
the RfD for non-nursing infants less than 1 year old to less than 1% 
for children 1-6 years old. EPA generally has no concern for exposures 
below 100% of the RfD

[[Page 31639]]

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. EPA's level of concern for chronic exposure to infants 
and children through drinking water is 92 ppb. EPA's water exposure 
model suggests that aerial application could result in an EEC of 2.29 
ppb. Therefore, EPA concludes that there is a reasonable certainty that 
no harm will result to infants and children from aggregate exposure to 
fenbuconazole residues.

V. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residue of fenbuconazole for this action 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-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, expressed as fenbuconazole as specified in 40 CFR 180.480.
    No livestock feed items are associated with this request. Thus, the 
nature of the residue in livestock is not of concern.

B. Analytical Enforcement Methodology

    Analytical methodology is available to enforce the tolerances 
forfenbuconazole.

C. Magnitude of Residues

    Residues of fenbuconazole and its regulated metabolites are not 
expected to exceed 1.0 ppm in/on blueberries. Secondary residues are 
not expected as no livestock feed items are associated with this use.

D. International Residue Limits

    There are no CODEX, Canadian, or Mexican maximum residue limits 
(MRLs) for fenbuconazole on blueberries.

E. Rotational Crop Restrictions

    Blueberries are not rotated. Rotational crop restrictions are not 
germane to this action.

VI. Conclusion

    Therefore, the tolerance is 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 and trans-5-(4-chlorophenyl)dihydro-3-phenyl-3-(1H 1,2,4-
triazole-1-ylmethyl-2-3H-furanone, expressed as fenbuconazole in 
blueberries at 1.0 ppm.

VII. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) 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 August 10, 1998, 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 above (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). 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.

VIII. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300662] (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.
    Electronic comments may be sent directly to EPA at:
    [email protected].


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above 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 rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.

IX. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does 
it require any prior

[[Page 31640]]

consultation as specified 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 these 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.

X. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in 
today's Federal Register. This 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: May 20, 1998.

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. Section 180.480 is amended by adding a heading to paragraph (a); 
by designating the text in paragraph (a) as paragraph (a)(1); by 
redesignating paragraph (b) as paragraph (a)(2) and amending it to 
revise the phrase ``paragraph (a) of this section'' to read ``paragraph 
(a)(1) of this section''; by adding a new paragraph (b); and by adding 
and reserving with headings paragraphs (c) and (d) to read as follows:


Sec. 180.480  Fenbuconazole; tolerances for residues.

    (a) General. (1) *          *         *        
    (2) *         *          *
    (b) Section 18 emergency exemptions. A time-limited tolerance is 
established for 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 blueberries in connection with use of the pesticide under a 
section 18 exemption granted by EPA. The time-limited tolerance will 
expire on the date specified in the following table.

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    revocation date 
------------------------------------------------------------------------
Blueberries.....................  1.0                 12/31/99          
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 98-15173 Filed 6-9-98; 8:45 am]
BILLING CODE 6560-50-F