[Federal Register Volume 63, Number 231 (Wednesday, December 2, 1998)]
[Rules and Regulations]
[Pages 66449-66456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31684]


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 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300745; FRL-6036-3]
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 a time-limited tolerance for 
residues of tebuconazole in or on hops. 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 
the pesticide on hops. This regulation establishes a maximum 
permissible level for residues of tebuconazole 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, 2,000.

DATES: This regulation is effective December 2, 1998. Objections and 
requests for hearings must be received by EPA on or before February 1, 
1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300745], 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-300745], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 119, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [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-300745]. 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: Barbara A. Madden, 
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) 305-6463, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
sections 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for 
residues of the fungicide tebuconazole in or on hops at 4.0 part per 
million (ppm). This tolerance will expire and is revoked on December 
31, 2,000. 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

[[Page 66450]]

safety standard and new procedures. These activities are described 
below and discussed in greater detail in the final rule establishing 
the time-limited tolerance associatedwith the emergency exemption for 
use of propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-
5572-9).
    New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment.
    Because decisions on section 18-related tolerances must proceed 
before EPA reaches closure on several policy issues relating to 
interpretation and implementation of the FQPA, EPA does not intend for 
its actions on such tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemption for tebuconazole on hops and FFDCA 
Tolerances

    The States of Idaho, Oregon, and Washington availed themselves of 
the authority to declare a crisis exemption to use tebuconazole for 
control of Powdery mildew (Sphaerotheca macularis) on hops. Powdery 
mildew is a serious hop disease in many hop growing areas in the world. 
The elimination of commercial hop production in New York during the 
early part of this century is largely blamed on this disease. Since 
this disease has not been observed in the Pacific Northwest until very 
recently, no effective fungicides are registered for use on hops to 
control it. Sulfur is the only pesticide available, but does not 
provide effective control. The pathogen is airborne and spreads 
quickly, primarily during the months of July and August, which are 
critical to hop production. EPA has authorized under FIFRA section 18 
the use of tebuconazole on hops for control of Powdery mildew 
(Sphaerotheca macularis) in Idaho, Oregon, and Washington. After having 
reviewed the submission, EPA concurs that emergency conditions exist 
for this state.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of tebuconazole in or on 
hops. In doing so, EPA considered the safety standard in FFDCA section 
408(b)(2), and EPA decided that the necessary tolerance under FFDCA 
section 408(l)(6) would be consistent with the safety standard and with 
FIFRA section 18. Consistent with the need to move quickly on the 
emergency exemption in order to address an urgent non-routine situation 
and to ensure that the resulting food is safe and lawful, EPA is 
issuing 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, 
2,000, under FFDCA section 408(l)(5), residues of the pesticide not in 
excess of the amounts specified in the tolerance remaining in or on 
hops 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 tebuconazole meets EPA's 
registration requirements for use on hops 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 tebuconazole by a State for special local needs under 
FIFRA section 24(c). Nor does this tolerance serve as the basis for any 
State other than Idaho, Oregon, and Washington to use this pesticide on 
this crop under section 18 of FIFRA without following all provisions of 
EPA's regulations implementing section 18 as identified in 40 CFR part 
166. For additional information regarding the emergency exemption for 
tebuconazole, contact the Agency's Registration Division at the address 
provided above.

III. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the Final Rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997)(FRL-5754-7) .
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action EPA has sufficient data to assess the hazards of 
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 hops at 4.0 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 tebuconazole are 
discussed below.
    1. Acute toxicity. The acute reference dose (acute RfD) of 0.1 
milligrams/kilogram/day (mg/kg/day) for tebuconazole was established 
based on a developmental toxicity study in mice with a No-Observed-
Adverse-Effect-Level (NOAEL) of 10 mg/kg/day for developmental 
toxicity. At the Lowest-Observed-Adverse-Effect-Level (LOAEL) of 30 mg/
kg/day, an increased incidence of runts (fetuses weighing less than 1.3 
gram) were observed. An uncertainty

[[Page 66451]]

factor of 100 (10X for inter-species extrapolation and 10X for intra-
species variability) was applied to the NOAEL of 10 mg/kg/day to 
calculate the acute RfD of 0.1 mg/kg/day. EPA has determined that the 
10X factor to account for enhanced susceptibility of infants and 
children (as required by FQPA) should be retained. This determination 
is based on the results of the developmental toxicity study in mice 
used to establish the acute RfD, other developmental toxicity studies 
in mice, rats and rabbits and the structural relationship of 
tebuconazole to several other triazole pesticides which also have been 
shown to induce developmental toxicity in rats and/or rabbits. For 
acute dietary exposure, EPA determined that the 10X safety factor is 
applicable to the subpopulations females (13+ years old), as well as 
infants and children because the effects seen were developmental and 
are presumed to occur following ``acute'' exposures. For subpopulations 
other than females (13+ years old), infants and children, a 
toxicological endpoint was not identified. Application of the 10X 
safety factor for enhanced susceptibility of infants and children to 
the acute RfD of 0.1 mg/kg/day results in an acceptable acute dietary 
exposure (food plus water) of 10% or less of the acute RfD.
    2. Short- and intermediate-term toxicity. Toxicological endpoints 
for short- or intermediate-term dermal toxicity were not identified. 
Adverse systemic effects were not observed in dermal developmental 
toxicity studies in mice or rats at the limit dose of 1,000 mg/kg/day 
or in a 21-day dermal toxicity study in rabbits at the limit dose of 
1,000 mg/kg/day. Therefore, risk assessments for short- or 
intermediate-term dermal exposure were not conducted.
    A NOAEL of 0.0106 mg/liter/day (equivalent to 2.9 mg/kg/day) was 
identified as the toxicological endpoint for short- and intermediate-
term (and chronic) inhalation toxicity based on a 21-day inhalation 
toxicity study in rats. At the LOAEL of 0.1558 mg/liter/day, 
piloerection and increased liver O-demethylase and N-demethylase 
activity were observed in both males and females. EPA determined that 
the 10X safety factor to account for enhanced susceptibility of infants 
and children (as required by FQPA) is not applicable for inhalation 
toxicity for the currently registered residential exposures to 
tebuconazole. A Margin of Exposure (MOE) of 100 or more for short- or 
intermediate-term non-dietary risk is acceptable for all 
subpopulations.
    3. Chronic toxicity. EPA has established a chronic RfD for 
tebuconazole at 0.03 mg/kg/day. This RfD is based on a 1-year chronic 
feeding study in dogs in which the NOAEL was 100 ppm (2.96 mg/kg/day in 
males and 2.94 mg/kg/day in females) and the LOAEL was 150 ppm (4.39 
mg/kg/day in males and 4.45 mg/kg/day in females), based on 
histopathological changes in the adrenal gland (hypertrophy of the zona 
fasciculata and fatty changes in the zona glomerulosa in both sexes and 
lipid hyperplasia in the cortex in males). An uncertainty factor of 100 
was used to account for inter-species extrapolation and intra-species 
variability. EPA determined that the 10X factor for enhanced 
susceptibility of infants and children (as required by FQPA) is not 
applicable for chronic dietary exposure. A chronic dietary exposure 
(food plus water) of 100% or less of the Chronic RfD is acceptable for 
all subpopulations.
    4. Carcinogenicity. Tebuconazole is classified as a Group C 
(possible human) carcinogen. This decision was primarily based on 
results in a 91-week carcinogenicity study in mice in which the 
following effects were observed:
    i. A statistically significant increase in the incidence of 
hepatocellular adenomas, carcinomas and combined adenomas/carcinomas in 
male mice at the highest dose tested (279 mg/kg/day).
    ii. A statistically significant increase in the incidence of 
hepatocellular carcinomas and combined adenomas/carcinomas in female 
mice at the highest dose tested (366 mg/kg/day).
In addition, tebuconazole is structurally related to several other 
triazole pesticides that produce similar liver tumors in mice. For the 
purpose of carcinogenic risk assessment, the RfD methodology is used to 
estimate human risk.

B. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.474) for the residues of tebuconazole, in or on a variety of 
raw agricultural commodities. Tolerances have been established for milk 
and meat byproducts in connection with use of tebuconazole under a 
previous section 18. 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 1 day or single exposure. An acute dietary endpoint of concern was 
identified for subpopulations females (13+ years old), as well as 
infants and children. For acute dietary exposure, EPA determined that 
the 10X safety factor for enhanced susceptibility of infants and 
children (as required by FQPA) is applicable to all of these 
subpopulations. Application of the 10X safety factor for enhanced 
susceptibility of infants and children to the acute RfD of 0.1 mg/kg/
day results in an acceptable acute dietary exposure (food plus water) 
of 10% or less of the acute RfD.
    An acute dietary (food only) probablistic risk analysis submitted 
in conjunction with another action was used to estimate acute dietary 
risk. The following assumptions were utilized in the Monte Carlo 
analysis: (a) Percent crop treated data were used for all commodities; 
(b) maximum residue levels from crop field trials for single serving 
commodities such as bananas and peaches were utilized; (c) average 
residue levels from crop field trials were used for blended commodities 
such as fruit juices, grains and oils; (d) anticipated residue levels 
for ruminant commodities were calculated using a livestock diet 
constructed using anticipated residue levels for livestock feed items. 
This analysis should be considered highly refined. This analysis was 
run with 2,000 iterations. The results of the Monte Carlo analysis 
indicate that the percent of acute RfD for all children and infants 
subgroups as well as females 13+ years old are all below 10% of the 
RfD: nursing infants (< 1 year old), 7%; non-nursing infants (< 1 year 
old), 7%; children (1 to 6 years old) 9%, children (7 to 12 years old) 
3%; all infants (< 1 year old), 7%; females (13 years plus old), 3%.
    ii. Chronic exposure and risk. The Agency conducted a chronic 
dietary exposure analysis and risk assessment. The analysis evaluated 
individual food consumption as reported by respondents in the USDA 
1977-78 Nationwide Food Consumption Survey (NFCS) and accumulates 
exposure to the chemical for each commodity. In conducting the chronic 
dietary risk assessment, the Agency made very conservative assumptions 
(100% of hops, pistachios and wheat and all other commodities having 
tebuconazole tolerances will contain residues and those residues will 
be at tolerance level) which results in an overestimation of human 
dietary exposure. Thus, in making a safety determination for these 
tolerances, the Agency is taking into account this conservative 
exposure assessment.
    The existing tebuconazole tolerances (published, pending, and 
including the necessary section 18 tolerance(s)) result

[[Page 66452]]

in a Theoretical Maximum Residue Contribution (TMRC) that is equivalent 
to percentages of the RfD below 100% for all subgroups (i.e., U.S. 
population, 11% and non-nursing infants (< 1 year old), the most highly 
exposed subgroup, 37%).
    2. From drinking water. Based on present data in the Agency files, 
tebuconazole is persistent and relatively immobile. There are no 
established Maximum Contaminant Level or health advisory levels for 
residues of tebuconazole in drinking water. Monitoring data for 
residues of tebuconazole in surface and ground water are not available. 
Tebuconazole is not included in the Pesticides in Ground Water Database 
(USEPA, 1992), and it was not an analyte in the National Pesticide 
Survey (USEPA, 1990).
    EPA estimated exposure for tebuconazole for both surface and ground 
water based on available modeling. Environmental concentrations for 
surface water were estimated using modeling from GENEEC (Generic 
Estimated Environmental Concentration). For surface water, the maximum 
concentrations were used for acute risk calculations, the annual means 
(1-10 years old) for chronic risk calculations. Current Agency policy 
allows that a factor of 3 be applied to GENEEC model values when 
determining whether or not a level of concern has been exceeded. If the 
GENEEC model value is  3 times the drinking water level of 
concern (DWLOC), the pesticide is considered to have passed the screen. 
Acute and chronic ground water concentrations were estimated using the 
SCI-GROW (Screening Concentration in Ground Water) model. For the 
purposes of the screening level assessment, the maximum and average 
annual concentrations in ground water are not believed to vary 
significantly. DWLOCs will be compared directly to values.
    i. Acute exposure and risk. DWLOCs were calculated for acute 
exposures to tebuconazole in surface and ground water for females 13+ 
years old and children (1-6 years old). Relative to an acute toxicity 
endpoint, the acute dietary food exposure (from the probablistic 
analysis) was subtracted from the ratio of the acute NOAEL to the 
appropriate percentage acute RfD to obtain the acceptable acute 
exposure to tebuconazole in drinking water. DWLOCs were then calculated 
from this acceptable exposure using default body weights (60 kg for 
females and 10 kg for children) and drinking water consumption figures 
(2 liters for females and 1 liter for children). Based on these 
calculations EPA's DWLOC for acute dietary risk is 14 parts per billion 
(ppb) for children (1-6 years old) and 200 ppb for females 13+ years 
old.
    Maximum concentrations of tebuconazole in surface and ground water 
are estimated to be 14 ppb and 0.3 ppb, respectively. The maximum 
estimated concentrations of tebuconazole in surface and ground water 
are less than EPA's levels of concern for acute exposure in drinking 
water for the females 13+ and children.
    ii. Chronic exposure and risk. EPA has calculated DWLOCs for 
chronic exposures to tebuconazole in surface and ground water. To 
calculate the DWLOC for chronic exposures relative to a chronic 
toxicity endpoint, the chronic dietary food exposure was subtracted 
from the chronic RfD (0.03 mg/kg/day) to obtain the acceptable chronic 
exposure to tebuconazole in drinking water. DWLOCs were then calculated 
from this exposure using default body weights (70 kg for U.S. 
population, 60 kg for females and 10 kg for children) and drinking 
water consumption figures (2 liters U.S. population and females and 1 
liter children). Based on these calculations EPA's DWLOCs for chronic 
risk are 950 ppb for the U.S. population, 780 ppb for females and 190 
ppb for non-nursing infants (< 1 year old).
     Estimated annual average concentrations of tebuconazole in surface 
water and ground water are 10 ppb and 0.3 ppb, respectively. The 
estimated annual average concentrations of tebuconazole in surface and 
ground water are less than EPA's levels of concern for chronic exposure 
in drinking water. 
    3. From non-dietary exposure. No short- or intermediate-term dermal 
toxicological endpoints were identified. Tebuconazole's registered 
residential uses are for the formulation of wood-based composite 
products, wood products for in-ground contact, plastics, exterior 
paints, glues and adhesives. Currently, the only residential end-use 
products on the market are for exterior treated wood use. Exposure via 
incidental ingestion (by children) and inhalation are not a concern for 
these products which are used outdoors. No paints or other end-use 
products containing tebuconazole are available for interior use. 
Accordingly, residential exposure is not expected at this time.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether tebuconazole has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
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. For more information regarding EPA's 
efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the Final Rule for Bifenthrin Pesticide Tolerances (62 FR 62961, 
November 26, 1997).

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

    1. Acute risk. A toxicological endpoint was identified for acute 
dietary risk assessments for subpopulations females (13+ years old), 
infants and children. The 10X safety factor for enhanced susceptibility 
of infants and children as required by FQPA is applicable for all of 
these subgroups. Therefore, 10% or less of the acute RfD of 0.1 mg/kg/
day results in an acceptable acute dietary exposure (food plus water).
    An acute dietary (food only) probablistic risk analysis resulted in 
3% of the acute RfD utilized for females (13+ years old). The maximum 
estimated concentrations of tebuconazole in surface and ground water 
are less than EPA's levels of concern for acute exposure in drinking 
water for the females 13+. Currently the only residential end-use 
products on the market are for exterior treated wood use. Exposure via 
incidental ingestion (by children) and inhalation are not a concern for 
these products which are used outdoors. No paints or other end-use 
products containing tebuconazole are available for interior use. 
Accordingly residential exposure is not expected with these uses. 
Therefore, EPA concludes with reasonable certainty that residues of 
tebuconazole do not contribute significantly to the aggregate acute 
risk at the present time.
    2. Chronic risk. Using the TMRC exposure assumptions described 
above, EPA has concluded that aggregate exposure to tebuconazole from 
food will utilize 11% of the RfD for the U.S. population. The major 
identifiable

[[Page 66453]]

subgroup with the highest aggregate exposure from food is Non-Nursing 
Infants (< 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. As stated 
above, residential exposure to tebuconazole is not expected for the 
currently registered uses. Despite the potential for exposure to 
tebuconazole in drinking water, EPA does not expect the aggregate 
exposure to exceed 100% of the RfD. Therefore, EPA concludes with 
reasonable certainty that residues of tebuconazole do not contribute 
significantly to the aggregate chronic risk at the present time.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure. No short- or intermediate-term dermal 
toxicological endpoints were identified. Also, no residential exposure 
is expected from the current residential uses. Thus, no risk 
assessments were conducted for residential exposure. Therefore, EPA 
concludes with reasonable certainty that tebuconazole does not 
contribute significantly to the aggregate short- and intermediate-term 
risk at the present time.
    4. Aggregate cancer risk for U.S. population. Tebuconazole is 
classified as a Group C (possible human) carcinogen. Since, for the 
purpose of carcinogenic risk assessment the RfD methodology was used, 
the discussion for Chronic risk (11% of RfD utilized) in Unit III.D.2 
above applies to cancer risk as well. Therefore, EPA concludes with 
reasonable certainty that tebuconazole does not contribute 
significantly to the aggregate cancer risk at the present time.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to tebuconazole residues.

D. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children-- i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of tebuconazole, 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 margin of exposure (MOE) analysis or through using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans. EPA believes that reliable data support 
using the standard MOE and uncertainty factor (usually 100 for combined 
inter- and intra-species variability)) and not the additional tenfold 
MOE/uncertainty factor when EPA has a complete data base under existing 
guidelines and when the severity of the effect in infants or children 
or the potency or unusual toxic properties of a compound do not raise 
concerns regarding the adequacy of the standard MOE/safety factor.
     ii. Developmental toxicity studies.  In two associated oral 
developmental toxicity studies in mice, the maternal NOAEL was 10 mg/
kg/day and the LOAEL was 20 mg/kg/day, based on decreased hematocrit 
and effects in the liver. The developmental toxicity NOAEL was 10 mg/
kg/day and the LOAEL was 30 mg/kg/day, based on increased numbers of 
runts (fetuses weighing less than 1.3 grams). In addition, at 100 mg/
kg/day, frank malformations in the skull, brain and spinal column and a 
reduced rate of ossification in the cranium were observed. In a dermal 
developmental toxicity study in mice, no toxicologically significant 
maternal toxicity or developmental toxicity was observed at the limit 
dose of 1,000 mg/kg/day.
     In an oral developmental toxicity study in rats, the maternal 
NOAEL was 30 mg/kg/day and the LOAEL was 60 mg/kg/day, based on 
increased liver weight. The developmental toxicity NOAEL was 30 mg/kg/
day and the LOAEL was 60 mg/kg/day, based on delayed ossification of 
several bones and increased numbers of fetuses with supernumerary ribs. 
In addition, at 120 mg/kg/day, increased resorptions, decreased fetal 
body weights and frank malformations in two fetuses (missing tail, 
agnatha, microtomia and anophthalmia) were observed. In a dermal 
developmental toxicity study in rats, no toxicologically significant 
maternal toxicity or developmental toxicity was observed at the limit 
dose of 1,000 mg/kg/day.
     In an oral developmental toxicity study in rabbits, the maternal 
NOAEL was 30 mg/kg/day and the LOAEL was 100 mg/kg/day, based on 
decreased body weight gain and decreased food consumption during the 
dosing period. The de velopmental toxicity NOAEL was 30 mg/kg/day and 
the LOAEL was 100 mg/kg/day, based on increased postimplantation loss, 
increased frank malformations, hydrocephalus and delayed ossification 
of bones. In another oral developmental toxicity study in rabbits, the 
maternal NOAEL was < 10 mg/kg/day and the LOAEL was 10 mg/kg/day, based 
on increased incidences of single cell necrosis (minimal severity) in 
liver cells. The maternal NOAEL from this study was not used to 
determine the acute RfD because single cell necrosis was not considered 
to result from a single exposure. The developmental toxicity NOAEL was 
30 mg/kg/day and the LOAEL was 100 mg/kg/day, based on increased 
postimplantation loss, decreased fetal body weights, increased 
percentage of fetuses with abnormalities (including runts, 
hemidiaphragm, limb abnormalities and neural tube defects characterized 
as meningocoele and spina bifida) and delayed ossification of bones.
    iii. Reproductive toxicity study. In a 2-generation reproduction 
study in rats, the parental (systemic) toxicity NOAEL was 15 mg/kg/day 
and the LOAEL was 50 mg/kg/day, based on loss of hair, decreased body 
weights, decreased food consumption, increased severity of spleen 
hemosiderosis and decreased liver and kidney weights. For offspring 
toxicity, the NOAEL was 15 mg/kg/day and the LOAEL was 50 mg/kg/day, 
based on decreased pup body weights from birth through weeks 3-4 in all 
litter groups.
    iv. Pre- and post-natal sensitivity. The above studies meet the 
standard toxicology data requirements, as required for a food-use 
chemical, in 40 CFR part 158. However, after evaluation of the findings 
in these studies, particularly with respect to effects on the fetal 
nervous system, together with a consideration of neurotoxic effects 
observed in several other developmental toxicity studies on 
structurally related triazole pesticides, the Agency requested a 
postnatal developmental neurotoxicity study in rats (Guideline 83-6) be 
conducted. The EPA notes effects on the nervous system of fetuses in 
studies on tebuconazole occurred only at doses of 100 mg/kg/day or

[[Page 66454]]

higher--i.e. at doses at least tenfold higher than the developmental 
toxicity NOAEL (10 mg/kg/day) to be used for the assessment of acute 
dietary risk.
     On the basis of comparative NOAELs and LOAELs, it was determined 
there was no indication of increased susceptibility of the offspring of 
mice, rats or rabbits resulting from prenatal and/or postnatal exposure 
to tebuconazole. However, the maternal effects observed in the 
developmental toxicity studies at the LOAEL were of minimal concern and 
did not increase substantially in severity at higher doses, whereas the 
developmental effects at the LOAEL were pronounced and at higher doses 
were quite severe (including frank malformations) in mice (at 100 mg/
kg/day), rats (at 120 mg/kg/day) and rabbits (at 100 mg/kg/day). Based 
on a consideration of all the above findings, the Agency retained the 
10X factor for enhanced susceptibility to infants and children. The 10X 
factor is applicable to acute dietary exposures for the subpopulations 
females (13+ years old), infants and children. The 10x factor for 
enhanced sensitivity of infants and children is not applicable to 
chronic exposure analysis.
    v. Conclusion. There is a complete toxicity data base for 
tebuconazole and exposure data is complete or is estimated based on 
data that reasonably accounts for potential exposures.
    2. Acute risk. An acute dietary (food only) probablistic risk 
analysis resulted in the following percentages for the acute RfD: 
nursing infants (< 1 year old), 7%; non-nursing infants (< 1 year old), 
7%; children (1 to 6 years old) 9%, children (7 to 12 years old) 3%; 
and all infants (< 1 year old), 7%. The maximum estimated 
concentrations of tebuconazole in surface and ground water are less 
than EPA's levels of concern for acute exposure in drinking water for 
children. Currently the only residential end-use products on the market 
are for exterior treated wood use. Exposure via incidental ingestion 
(by children) and inhalation are not a concern for these products which 
are used outdoors. No paints or other end-use products containing 
tebuconazole are available for interior use. Accordingly residential 
exposure is not expected with these uses. Therefore, EPA concludes with 
reasonable certainty that residues of tebuconazole do not contribute 
significantly to the aggregate acute risk at the present.
    3. Chronic risk. Using the exposure assumptions described above, 
EPA has concluded that aggregate exposure to tebuconazole from food 
will utilize up to 37% of the RfD for infants and children. EPA 
generally has no concern for exposures below 100% of the RfD because 
the RfD represents the level at or below which daily aggregate dietary 
exposure over a lifetime will not pose appreciable risks to human 
health. As stated above, residential exposure to tebuconazole is not 
expected for the currently registered uses. Despite the potential for 
exposure to tebuconazole in drinking water, EPA does not expect the 
aggregate exposure to exceed 100% of the RfD. Therefore, EPA concludes 
with reasonable certainty that residues of tebuconazole do not 
contribute significantly to the aggregate chronic risk at the present 
time.
    4. Short- or intermediate-term risk. As stated above, residential 
exposure to tebuconazole is not expected for the currently registered 
uses.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to tebuconazole 
residues.

IV. Other Considerations

A. Metabolism In Plants

     The metabolism of tebuconazole in or on grapes, wheat, and peanuts 
have been reviewed. The nature of the residue in wheat is adequately 
understood. For the purposes of this section 18, the nature of the 
residue in hops is considered to be adequately understood (by 
translation from grapes, wheat and peanuts). The residue of concern in 
plants is tebuconazole per se.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. The method entitled ``Gas Chromatographic Method 
[GLC/TSD] for Determination of Residues of Tebuconazole in Crops, 
Processed Products, Soil and Water'' ( PP #9F3724) is adequate to 
enforce time-limited tolerances for residues of tebuconazole in or on 
hops. The method may be requested from: Calvin Furlow, PRRIB, IRSD 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. Office location and telephone 
number: Rm 101FF, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA 22202, (703-305-5229).

C. Magnitude of Residues

     Residues of tebuconazole per se are not expected to exceed 4.0 ppm 
in or on dried hops cones as a result of this section 18 use.

D. International Residue Limits

     There are no Codex, Canadian, or Mexican maximum residue limits 
for residues of tebuconazole in or on dried hops cones. International 
harmonization is thus not an issue for this time-limited tolerance.

E. Rotational Crop Restrictions

     A plantback interval of 120 days after last application for crops 
not listed on the label is required. However, rotation restrictions are 
not applicable to hops as these crops are not normally rotated.

V. Conclusion

    Therefore, the tolerance is established for residues of 
tebuconazole in hops at 4.0 ppm.

VI. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation 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 February 1, 1999, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given 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

[[Page 66455]]

contrary; and resolution of the factual issues in the manner sought by 
the requestor would be adequate to justify the action requested (40 CFR 
178.32). Information submitted in connection with an objection or 
hearing request may be claimed confidential by marking any part or all 
of that information as CBI. Information so marked will not be disclosed 
except in accordance with procedures set forth in 40 CFR part 2. A copy 
of the information that does not contain CBI must be submitted for 
inclusion in the public record. Information not marked confidential may 
be disclosed publicly by EPA without prior notice.

VII. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300745] (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 Highway, 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.

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under FFDCA section 408 
(l)(6). The Office of Management and Budget (OMB) has exempted these 
types of actions from review under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This 
final rule does not contain any information collections subject to OMB 
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., or impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4). Nor does it require any special considerations 
as required by Executive Order 12898, entitled Federal Actions to 
Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    In addition, since tolerances and exemptions that are established 
under FFDCA section 408 (l)(6), such as the tolerance in this final 
rule, do not require the issuance of a proposed rule, the requirements 
of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not 
apply. Nevertheless, the Agency has previously assessed whether 
establishing tolerances, exemptions from tolerances, raising tolerance 
levels or expanding exemptions might adversely impact small entities 
and concluded, as a generic matter, that there is no adverse economic 
impact. The factual basis for the Agency's generic certification for 
tolerance acations published on May 4, 1981 (46 FR 24950), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local, or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide to OMB, in a separately 
identified section of the preamble to the rule, a description of the 
extent of EPA's prior consultation with representatives of affected 
tribal governments, a summary of the nature of their concerns, and a 
statement supporting the need to issue the regulation. In addition, 
Executive Order 13084 requires EPA to develop an effective process 
permitting elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a

[[Page 66456]]

report containing this rule and other required information to the U.S. 
Senate, the U.S. House of Representatives, and the Comptroller General 
of the United States prior to publication of the rule in the Federal 
Register. This rule is not a ``major rule'' as defined by 5 U.S.C. 
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: October 6, 1998.

Arnold E. Layne,

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, in the table to paragraph (b)(1) by adding an 
entry for ``Hops'' to read as follows:


Sec. 180.474  Tebuconazole; tolerances for residues.

*      *      *      *      *
    (b) *   *   *

 
------------------------------------------------------------------------
                                                     Parts   Expiration/
                     Commodity                        per     Revocation
                                                    million      Date
------------------------------------------------------------------------
Hops..............................................    4.0       12/31/00
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 98-31684 Filed 12-1-98; 8:45 am]
BILLING CODE 6560-50-F