[Federal Register Volume 64, Number 101 (Wednesday, May 26, 1999)]
[Rules and Regulations]
[Pages 28377-28384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12935]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300855; FRL-6079-1]
RIN 2070-AB78


Tebuconazole; Pesticide Tolerance for Emergency Exemption

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 garlic. 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 garlic. 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 June 30, 2000.

DATES: This regulation is effective May 26, 1999. Objections and 
requests for hearings must be received by EPA on or before July 26, 
1999.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300855], 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-300855], 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 electronic objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket control number [OPP-300855]. 
No Confidential Business Information (CBI) should be submitted through 
e-mail. Copies of electronic objections and hearing requests on this 
rule may be filed online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Stephen Schaible, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location, telephone number, and e-mail address: Rm. 271, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-308-9362; e-
mail: [email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
sections 408 and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a and (l)(6), is establishing a tolerance for 
residues of the fungicide tebuconazole, in or on garlic at 0.1 part per 
million (ppm). This tolerance will expire and is revoked on June 30, 
2000. EPA will publish a document in the Federal Register to remove the 
revoked tolerance from the Code of Federal Regulations.

I. Background and Statutory Findings

    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 in this preamble and 
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of 
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
    New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''

[[Page 28378]]

    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 Garlic and FFDCA 
Tolerances

    While garlic rust is usually a disease of minor concern in 
California, it appeared as a serious pest problem in several garlic 
growing areas of the state in the 1997-98 growing season. The mild 
winter that year allowed the pathogen to survive the winter and cause 
infection early in the season. No fungicide is specifically registered 
for control of rust on garlic. The fungicides registered for use on 
garlic are not effective at controlling the disease under high pest 
pressure. Data presented by the state indicate that tebuconazole is 
highly effective at controlling the disease. EPA has authorized under 
FIFRA section 18 the use of tebuconazole on garlic for control of 
garlic rust in California. 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 
garlic. 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 June 30, 2000, 
under FFDCA section 408(l)(5), residues of the pesticide not in excess 
of the amounts specified in the tolerance remaining in or on garlic 
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 garlic 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 California 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 under the ``ADDRESSES'' section.

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 garlic at 0.1 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 in this unit.

B. Toxicological Endpoint

    1. Acute toxicity. The acute reference dose (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 factor of 100 was applied to the 
NOAEL 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), 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), 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

[[Page 28379]]

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 the 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. The developmental effects 
which contributed to the decision to retain the 10x factor for acute 
dietary exposure are considered to be acute effects; maternal effects 
in those same studies were minimal. Additionally, the NOAEL on which 
the RfD is based is the lowest NOAEL in the toxicology data base for 
this chemical. 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:
    1. 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).
    2. 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.

C. 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), as well as infants 
and children.
    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:
    1. Percent crop treated (PCT) data were used for all commodities.
    2. Maximum residue levels from crop field trials for single serving 
commodities such as bananas and peaches were utilized.
    3. Average residue levels from crop field trials were used for 
blended commodities such as fruit juices, grains and oils.
    4. Anticipated residue levels for ruminant commodities were 
calculated using a livestock diet constructed using anticipated residue 
levels for livestock feed items. This analysis is considered to be 
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), 7%; non-
nursing infants (<1 year), 7%; children (1 to 6 years) 9%, children (7 
to 12 years) 3%; all infants (<1 year), 7%; females (13 years plus), 
3%.
    Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of food treated for assessing chronic dietary risk only 
if the Agency can make the following findings: That the data used are 
reliable and provide a valid basis to show what percentage of the food 
derived from such crop is likely to contain such pesticide residue; 
that the exposure estimate does not underestimate exposure for any 
significant subpopulation group; and if data are available on pesticide 
use and food consumption in a particular area, the exposure estimate 
does not understate exposure for the population in such area. In 
addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by section 408(b)(2)(F), EPA may require registrants 
to submit data on PCT.
    The Agency used PCT information as follows:
    PCT refinements were assumed for all commodities evaluated in the 
probablistic risk assessment. For published uses, PCT data were based 
on information obtained from the registrant and were derived from Doane 
Marketing Research and USDA National Agricultural Statistics Service 
(NASS). For those commodities being requested under section 18, total 
U.S. acreage treated under section 18 was aggregated for each crop and 
compared to total acreage grown in the U.S. to derive a national PCT 
estimate.
    The Agency believes that the three conditions, discussed in section 
408 (b)(2)(F) concerning the Agency's responsibilities in assessing 
acute dietary risk findings, have been met. The PCT estimates are 
derived from Federal and private market survey data, which are reliable 
and have a valid basis. Typically, a range of estimates are supplied 
and the upper end of this

[[Page 28380]]

range is assumed for the exposure assessment. By using this upper end 
estimate of the PCT, the Agency is reasonably certain that the 
percentage of the food treated is not likely to be underestimated. The 
regional consumption information and consumption information for 
significant subpopulations is taken into account through EPA's 
computer-based model for evaluating the exposure of significant 
subpopulations including several regional groups. Use of this 
consumption information in EPA's risk assessment process ensures that 
EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which tebuconazole 
may be applied in a particular area.
    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 the very conservative 
assumption that 100% of every commodity evaluated will contain residues 
and those residues will be at tolerance level; this assumption results 
in an overestimation of human dietary exposure. Thus, in making a 
safety determination for this time-limited tolerance, 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 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 available to the 
Agency, 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 
(US EPA, 1992), and it was not an analyte in the National Pesticide 
Survey (US EPA, 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 Generic Estimated 
Environmental Concentration (GENEEC). For surface water, the maximum 
concentrations were used for acute risk calculations, the annual means 
(1-10 years) 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 
comparison (DWLOC), the pesticide is considered to have passed the 
screen. Acute and chronic ground water concentrations were estimated 
using the Screening Concentration in Ground Water (SCI-GROW) 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 SCI-GROW 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 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 do 
not exceed 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 10 kg for children) and drinking water 
consumption figures (2 liters U.S. population females 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

[[Page 28381]]

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).

D. 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), 
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). The maximum 
estimated concentrations of tebuconazole in surface and ground water do 
not exceed 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 in 
this unit, EPA has concluded that aggregate exposure to tebuconazole 
from food will utilize 11% of the RfD for the U.S. population. The 
major identifiable subgroup with the highest aggregate exposure is non-
nursing infants (< 1 yr.), 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. Estimated 
environmental concentrations of tebuconazole in surface water and 
ground water do not exceed chronic DWLOCs calculated by the Agency; 
therefore, EPA does not expect the aggregate exposure to exceed 100% of 
the RfD.
    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 shortand 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 Reference Dose (RfD) 
methodology was used, the discussion for chronic risk (11% of RfD 
utilized) 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.

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 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 data base 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 gram). 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 developmental 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

[[Page 28382]]

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 postnatal 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 
higher--i.e., at doses at least ten-fold 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), 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 are complete or 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), 7%; non-nursing infants (<1 year), 7%; 
children (1 to 6 years) 9%, children (7 to 12 years) 3%; and all 
infants (<1 year), 7%. The maximum estimated concentrations of 
tebuconazole in surface and ground water do not exceed 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 in this 
unit, 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. Estimated environmental 
concentrations of tebuconazole in surface water and ground water do not 
exceed chronic DWLOCs calculated by the Agency; therefore, EPA does not 
expect the aggregate exposure to exceed 100% of the RfD.
    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 and Animals

    The nature of the residue in plants is understood based on 
metabolism studies in grapes, wheat and peanuts. For the purpose of 
this section 18 only, the nature of the residue in garlic is considered 
to be adequately understood. The residue of concern in plants is 
tebuconazole per se.

 B. Analytical Enforcement Methodology

    Method 101341, a GC/NPD method, is adequate to enforce the 
tolerance expression. 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, (703) 305-5229.

C. Magnitude of Residues

    No residue data were provided for garlic. Residue data were 
translated from dry bulb onion data generated in Mexico. Based on these 
data, residues of tebuconazole are not expected to exceed 0.1 ppm on 
garlic as a result of the proposed section 18 use.

 D. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits 
(MRLs) for residues of tebuconazole in/on garlic. International 
harmonization is thus not an issue for this time-limited tolerance.

 E. Rotational Crop Restrictions

    A plant back interval of 120 days after last application for crops 
not listed on the label is required.

 V. Conclusion

    Therefore, the tolerance is established for residues of 
tebuconazole in garlic at 0.1 ppm.

VI. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation as was provided in 
the old section 408 and in section 409. However, the period for filing 
objections is 60 days, rather than 30 days. EPA currently has 
procedural regulations which govern the submission of objections and 
hearing requests. These

[[Page 28383]]

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 July 26, 1999, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40 
CFR 178.20). A copy of the objections and/or hearing requests filed 
with the Hearing Clerk should be submitted to the OPP docket for this 
rulemaking. The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections (40 
CFR 178.25). Each objection must be accompanied by the fee prescribed 
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement 
``when in the judgement of the Administrator such a waiver or refund is 
equitable and not contrary to the purpose of this subsection.'' For 
additional information regarding tolerance objection fee waivers, 
contact James Tompkins, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, (703) 305-5697, [email protected]. Requests for 
waiver of tolerance objection fees should be sent to James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
    If a hearing is requested, the objections must include a statement 
of the factual issues on which a hearing is requested, the requestor's 
contentions on such issues, and a summary of any evidence relied upon 
by the requestor (40 CFR 178.27). A request for a hearing will be 
granted if the Administrator determines that the material submitted 
shows the following: There is genuine and substantial issue of fact; 
there is a reasonable possibility that available evidence identified by 
the requestor would, if established, resolve one or more of such issues 
in favor of the requestor, taking into account uncontested claims or 
facts to the contrary; and resolution of the factual issues in the 
manner sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32). Information submitted in connection with an 
objection or hearing request may be claimed confidential by marking any 
part or all of that information as CBI. Information so marked will not 
be disclosed except in accordance with procedures set forth in 40 CFR 
part 2. A copy of the information that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice.

VII. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket 
control number [OPP-300855] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Objections and hearing requests may be sent by e-mail directly to 
EPA at:
    [email protected].
    E-mailed objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.
    The official record for this regulation, as well as the public 
version, as described in this unit will be kept in paper form. 
Accordingly, EPA will transfer any copies of objections and hearing 
requests received electronically into printed, paper form as they are 
received and will place the paper copies in the official record which 
will also include all comments submitted directly in writing. The 
official record is the paper record maintained at the Virginia address 
in ``ADDRESSES'' at the beginning of this document.

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408 of the 
FFDCA. 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 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or 
special considerations as required by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994), 
or require OMB review in accordance with Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, since tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(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 previously 
assessed whether establishing tolerances, exemptions from tolerances, 
raising tolerance levels or expanding exemptions might adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse economic impact. The factual basis for the Agency's generic 
certification for tolerance actions published on May 4, 1981 (46 FR 
24950), and was provided to the Chief Counsel for Advocacy of the Small 
Business Administration.

B. Executive Order 12875

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

[[Page 28384]]

regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

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

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

List of Subjects in 40 CFR Part 180

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

    Dated: May 12, 1999.

James Jones,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


    2. In Sec. 180.474, by alphabetically adding the following 
commodity ``garlic'' to the table in paragraph (b) to read as follows:


Sec. 180.474  Tebuconazole; tolerances for residues.

*          *          *          *          *
    (b)   *    *    *

------------------------------------------------------------------------
                                                     Parts   Expiration/
                     Commodity                        per     Revocation
                                                    million      Date
------------------------------------------------------------------------
 
                          *    *    *    *    *
Garlic............................................    0.1        6/30/00
 
                          *    *    *    *    *
------------------------------------------------------------------------

*          *          *          *          *

[FR Doc. 99-12935 Filed 5-25-99; 8:45 am]
BILLING CODE 6560-50-F