[Federal Register Volume 62, Number 209 (Wednesday, October 29, 1997)]
[Rules and Regulations]
[Pages 56089-56095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28656]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300570; FRL-5752-4]
RIN 2070-AB78


Tebuconazole; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of tebuconazole in or on sunflower seed and sunflower oil. 
This action is in response to an emergency exemption under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
use of the pesticide on sunflowers. This regulation establishes a 
maximum permissible level for residues of tebuconazole in these food 
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 September 30, 1998.

DATES: This regulation is effective October 29, 1997. Objections and 
requests for hearings must be received by EPA on or before December 29, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300570], 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-300570], 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. 1132, 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 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-300570]. 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 tolerances for 
residues of the fungicide tebuconazole, in or on sunflower seed and 
sunflower oil at 0.2 and 0.4 parts per million (ppm). These tolerances 
will expire and are revoked on September 30, 1998. 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

[[Page 56090]]

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 Tebuconazole on Sunflower Seeds and 
Sunflower Oil and FFDCA Tolerances

    Agriculture officials in states where the sunflower is produced 
commercially have identified sunflower rust, caused by the pathogen 
Puccinia helianthi, as a severe threat to crop yields. Information on 
the anticipated yield loss if tebuconazole were not used indicates that 
losses would be quite significant. One state suggested that losses 
could be as high as 80% for specific locations. Earlier this year, the 
States of Kansas, Colorado, and North Dakota determined that conditions 
may be favorable for a sunflower rust outbreak. Consequently, these 
states invoked their authorities pursuant to 40 CFR 166.40 to declare a 
crisis situation. EPA considered the health and safety implications of 
these actions and permitted the crisis actions to go forward. 
Therefore, EPA has authorized under FIFRA section 18 the use of 
tebuconazole on sunflower seed and sunflower oil for control of rust 
(Puccinia helianthi) in Colorado, North Dakota, and Kansas.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of tebuconazole in or on 
sunflower seed and sunflower oil. In doing so, EPA considered the new 
safety standard in FFDCA section 408(b)(2), and EPA decided that the 
necessary tolerances 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 emergency exemptions 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 September 30, 1998, under FFDCA section 408(l)(5), residues 
of the pesticide not in excess of the amounts specified in the 
tolerances remaining in or on sunflower seed and sunflower oil after 
that date will not be unlawful, provided the pesticide is applied in a 
manner that was lawful under FIFRA. 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 tebuconazole 
meets EPA's registration requirements for use on sunflower 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 tebuconazole 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 Colorado, North Dakota and Kansas to use 
this pesticide on this crop under section 18 of FIFRA without following 
all provisions of section 18 as identified in 40 CFR part 166. For 
additional information regarding the emergency exemption for 
tebuconazole, 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 
aggregate exposure 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.

[[Page 56091]]

    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 3 
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.)
    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 (non-nursing 
infants less than a year old) 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 
tebuconazole and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
residues of tebuconazole on sunflower seed and sunflower oil at 0.2 and 
0.4 ppm. 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 tebuconazole are 
discussed below.
    1. Acute toxicity. For acute dietary risk assessment, OPP 
recommended use of the developmental NOEL of 10 mg/kg/day from the 
developmental toxicity study in mice. Effects observed at the lowest 
observed effect level (LOEL) of 30 mg/kg/day are an increased number of 
runts and fetuses with malformations of the skull, brain, and spinal 
cord. The

[[Page 56092]]

population subgroup of concern for this acute dietary risk assessment 
is females (13+ years old).
     2. Short - and intermediate - term toxicity. [OPP has determined 
that short- and intermediate-term inhalation risk assessments and 
short-term dermal risk assessments are appropriate for non-
occupational, non-dietary routes of exposure. OPP recommends that the 
NOEL of 1,000 mg/kg/day, taken from the dermal developmental toxicity 
study in mice, be used for the short-term dermal MOE calculations. This 
NOEL was the highest dose tested in the study. For short- and 
intermediate-term inhalation MOE calculations, OPP recommends using the 
NOEL of 0.0106 mg/L/day (1.75 mg/kg/day), based on liver toxicity and 
piloerection at the LOEL of 0.1558 mg/L/day (25.7 mg/kg/day) in the 3-
week inhalation rat toxicity study.
    3. Chronic toxicity. EPA has established the RfD for tebuconazole 
at 0.03 milligrams/kilogram/day (mg/kg/day). This RfD is based on the 
NOEL of 2.96 mg/kg/day from a 1-year dog feeding study. Adrenal effects 
(fatty change and hypertrophy) were observed at the LOEL of 4.39 mg/kg/
day. An uncertainty factor (UF) of 100 was applied to account for both 
interspecies and intra species variability.
    4. Carcinogenicity. OPP's Cancer Peer Review Committee (CPRC) has 
determined that tebuconazole is a Group C (possible human carcinogen) 
chemical, based on mouse liver tumors in both sexes (adenomas and 
carcinomas in males and carcinomas in females) at 280 mg/kg/day, the 
highest dose tested. OPP recommends using the RfD approach for 
quantification of human risk. Therefore, the RfD is deemed protective 
of all chronic human health effects, including cancer.

B. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.474) for parent tebuconazole (alpha-[2-(4-chlorophenyl)-ethyl]-
alpha-1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol), in or on a 
variety of raw agricultural commodities The established levels range 
from 0.05 ppm in barley, oat and wheat grain to 4.0 ppm in cherries and 
peanut hulls. Risk assessments were conducted by EPA to assess dietary 
exposures and risks from tebuconazole 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. For the purpose of assessing potential 
acute dietary risks, tolerance level residues and 100% of crop treated 
to estimate the TMRC for major identifiable subgroups of consumers. An 
MOE of 889 was calculated for females 13+ years, the populations 
subgroup of concern. The high end exposure value was 0.01125 mg/kg/day.
    ii. Chronic exposure and risk. For the purpose of assessing 
potential chronic dietary exposure from tebuconazole, EPA assumed 
tolerance level residues and 100% of crop treated to estimate the TMRC 
for major identifiable subgroups of consumers. The tolerances for 
tebuconazole result in a TMRC that is equivalent to the following range 
of RfD percentages: U.S. populations (48 states) 6% to non-nursing 
infants (<1 year old) 32%.
    2. From drinking water. There are no groundwater data for 
tebuconazole. In addition, no maximum concentration levels or Health 
Advisories have been established for the pesticide.
    Because the Agency lacks sufficient water-related exposure data to 
complete a comprehensive drinking water risk assessment for many 
pesticides, EPA has commenced and nearly completed a process to 
identify a reasonable yet conservative bounding figure for the 
potential contribution of water-related exposure to the aggregate risk 
posed by a pesticide. In developing the bounding figure, EPA estimated 
residue levels in water for a number of specific pesticides using 
various data sources. The Agency then applied the estimated residue 
levels, in conjunction with appropriate toxicological endpoints (RfD's 
or acute dietary NOEL's) and assumptions about body weight and 
consumption, to calculate, for each pesticide, the increment of 
aggregate risk contributed by consumption of contaminated water. While 
EPA has not yet pinpointed the appropriate bounding figure for exposure 
from contaminated water, the ranges the Agency is continuing to examine 
are all below the level that would cause tebuconazole to exceed the RfD 
even with the inclusion of the tolerances being granted in this 
document. The Agency has therefore concluded that the potential 
exposures associated with tebuconazole in water, even at the higher 
levels the Agency is considering as a conservative upper bound, would 
not prevent the Agency from determining that there is a reasonable 
certainty of no harm if the tolerance is granted.
    3. From non-dietary exposure. Tebuconazole is not currently 
registered for indoor or outdoor residential uses. Thus, no non-
dietary, non-occupational exposure is expected.
    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 tebuconazole has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides

[[Page 56093]]

for which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, tebuconazole 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 tebuconazole has 
a common mechanism of toxicity with other substances.

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

    1. Acute risk. EPA has concluded that for the population subgroup 
of concern, females 13+ years), acute aggregate exposure to 
tebuconazole from existing and proposed food uses will result in an MOE 
of 889. Despite the potential for exposure to tebuconazole in drinking 
water, EPA does not expect the aggregate exposure to exceed the level 
of concern for acute dietary exposure. EPA concludes that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to tebuconazole residues.
    2. Chronic risk. Using the TMRC exposure assumptions described 
above, EPA has concluded that aggregate exposure to tebuconazole from 
food will utilize 6% of the RfD for the U.S. population. The major 
identifiable subgroup with the highest aggregate exposure is non-
nursing infants less than 1 year old (discussed 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. 
Despite the potential for exposure to tebuconazole in drinking water 
and from non-dietary, non-occupational exposure, EPA does not expect 
the aggregate exposure to exceed 100% of the RfD. EPA concludes that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to tebuconazole residues.

D. Aggregate Cancer Risk for U.S. Population

    Tebuconazole has been classified as a Group C (possible human 
carcinogen) chemical by EPA, with the recommendation that the RfD 
approach be used to assess cancer risk. A quantitative cancer risk was 
not performed because human health risk concerns due to long-term 
exposure to tebuconazole residues are adequately addressed by the 
aggregate chronic exposure analysis using the RfD.

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 tebuconazole, 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 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 100-
fold safety factor (usually 100 for combined inter- and intra-species 
variability) and not the additional tenfold 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 safety factor.
    ii. Developmental toxicity studies. From the rat developmental 
study, the maternal NOEL was 30 mg/kg/day, based on increased liver 
weight at the LOEL of 60 mg/kg/day. The developmental NOEL was 30 mg/
kg/day, based on delayed ossification and supernumerary ribs at the 
developmental LOEL of 60 mg/kg/day. In the rabbit developmental study, 
the maternal NOEL was 30 mg/kg/day, based on decreased weight gain and 
food consumption at the maternal LOEL of 100 mg/kg/day. The 
developmental NOEL was 30 mg/kg/day, based on increased resorptions due 
to post-implantation loss at the developmental LOEL of 100 mg/kg/day. 
The maternal NOEL in the mouse study was 10 mg/kg/day, with reduced 
hematocrit occurring at the maternal LOEL of 30 mg/kg/day in the oral 
development toxicity study. The developmental NOEL was 10 mg/kg/day, 
with effects at the LOEL of 30 mg/kg/day being an increased number of 
runts, and fetuses with malformations of the skull, brain and spinal 
cord.
    iii. Reproductive toxicity study. In the 2-generation rat 
reproduction study, the parental NOEL was 15 mg/kg/day, based on 
decreased body weight and increased spleen weight at the LOEL of 50 mg/
kg/day. The reproductive NOEL was 15 mg/kg/day, with decreased body 
weight of neonates being the effect at the LOEL of 50 mg/kg/day.
    iv. Pre- and post-natal sensitivity. The pre- and post-natal 
toxicology data base for tebuconazole is complete with respect to 
current toxicological data requirements. The developmental toxicity 
studies in rats, rabbits, and mice had developmental findings occurring 
at the same dose levels (NOELs and LOELs) as maternal effects, 
indicating no extra pre-natal sensitivity.
    The reproductive toxicity study in rats did not demonstrate any 
extra pre- or post-natal sensitivity to infants and children since the 
NOEL and LOEL of 15 and 50 mg/kg/day, respectively, were the same for 
both parental and pup toxicity. Additionally, the decreased body weight 
gain in parental animals was also observed in pups.
    v. Conclusion. Based on the above, EPA concludes that reliable data 
support use of the standard 100-fold uncertainty factor and that an 
additional safety factor is not needed to protect infants and children.
    2. Acute risk. The acute dietary (food only) MOE for females 13+ 
years (accounts for both maternal and fetal exposure) was calculated to 
be 889. This MOE calculation was based on the developmental NOEL in 
mice of 10 mg/kg/day. Maternal effects observed at the LOEL of 30 mg/
kg/day included a reduced hematocrit. This assessment assumed 100% 
crop-treated with tolerance level residues on all treated crops 
consumed, resulting in a significant over-estimate of dietary exposure. 
No data were available for potential exposures of tebuconazole in 
drinking water. However, EPA does not expect that aggregate exposure 
(food plus water) would result in an unacceptable acute dietary MOE. 
EPA concludes that the large acute dietary MOE provides assurance that 
there is a reasonable certainty of no harm for both females 13+ years 
and the pre-natal development of infants.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
tebuconazole from food will utilize between 9% for children (7-12 years 
old) to 32% for non-nursing infants (less that 1 year old). 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

[[Page 56094]]

exposure over a lifetime will not pose appreciable risks to human 
health. Despite the potential for exposure to tebuconazole in drinking 
water and from non-dietary, non-occupational exposure, EPA does not 
expect the aggregate exposure to exceed 100% of the RfD. EPA concludes 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to tebuconazole residues.

V. Other Considerations

A. Metabolism In Plants and Animals

    The nature of tebuconazole residues in plants and animals is 
adequately understood. The residue of concern in plants is tebuconazole 
per se. In ruminants and poultry, the residue of concern is the parent 
compound and its 1-(4-chlorophenyl)-4,4-dimethyl-3-(1H-1,2,4-triazole-
1-yl-methyl)-pentane-3,5-diol metabolite (HGW 2061).

B. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expressions. The gas chromatographic method entitled ``Gas 
Chromatographic Method for Determination of Residues of Tebuconazole in 
Crops, Processed Products, Soil and Water'' is adequate to enforce 
time-limited tolerances for tebuconazole per se residues in/on 
sunflower seed and oil to support compliance efforts. The gas 
chromatographic method entitled ``An Analytical Residue Method for the 
Determination of Tebuconazole and HWG 2061 Residues in Bovine and 
Poultry Tissues, Milk and Eggs'' is adequate to enforce the time-
limited tolerances presently established for the combined residues of 
tebuconazole and HWG 2061 in animal commodities.

C. Magnitude of Residues

    Residues of tebuconazole per se are not expected to exceed 0.2 ppm 
in sunflower seed as a result of this use. Sunflower hulls and forage 
do not require regulation as they are not considered livestock feed 
items.

D. International Residue Limits

    There are no Canadian, Mexican, or Codex maximum residue limits for 
tebuconazole on sunflowers.

E. Rotational Crop Restrictions

    Product labels for tebuconazole are to carry a plant back interval 
of 120 days after the last application for crops which are not on the 
label.

VI. Conclusion

    Therefore, tolerances are established for residues of tebuconazole 
in sunflower seed and sunflower oil at 0.2 ppm and 0.4 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 December 29, 1997, 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 Docket

    EPA has established a record for this rulemaking under docket 
control number [OPP-300570] (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 1132 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 time-limited tolerances under FFDCA 
section 408(1)(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 
prior consultation as specified by Executive Order 12875, entitled 
Enhancing the

[[Page 56095]]

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 (1)(6), such as the tolerances 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: October 17, 1997.

James Jones,
Acting 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. 180.474, paragraph (b)(1) is amended by alphabetically 
adding the following commodities to the table to read as follows:


Sec. 180.474 Tebuconazole; tolerances for residues.

*        *        *        *        *
    (b) Section 18 emergency exemptions. (1) *        *        *

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
                                                                        
*                *                *                *                *   
                                  *                *                    
Sunflower oil...................  0.4                 9/30/98           
Sunflower seed..................  0.2                 9/30/98           
                                                                        
*                *                *                *                *   
                                  *                *                    
------------------------------------------------------------------------

*        *        *        *        *

[FR Doc. 97-28656 Filed 10-28-97; 8:45 am]
BILLING CODE 6560-50-F