[Federal Register Volume 64, Number 233 (Monday, December 6, 1999)]
[Rules and Regulations]
[Pages 68046-68052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31546]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300931; FRL-6384-1]
RIN 2070-AB78


Tetraconazole [(+/-)-2-(2,4-dichlorophenyl)-3-(1H-1,2,4-triazol-
1-yl) propyl 1, 1,2,2-tetrafluoroethyl ether]; Pesticide Tolerances for 
Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of tetraconazole in or on sugar beets, and sugar beet-related 
commodities, and for secondary residues of triazole on animal 
commodities from livestock fed sugar beet by-products. This action is 
in response to EPA's granting of an emergency exemption under 
provisions of section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act, authorizing use of the pesticide on sugar beets. This 
regulation establishes maximum permissible levels for residues of 
tetraconazole [(+/-)-2-(2,4-dichlorophenyl)-3-(1H-1,2,4-triazol-1-yl) 
propyl 1, 1,2,2-tetrafluoroethyl ether] in the effected food 
commodities. The tolerances will expire and will be revoked on December 
31, 2001.

DATES: This regulation is effective December 6, 1999. Objections and 
requests for hearings, identified by docket control number OPP-300931, 
must be received by EPA on or before February 4, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the ``SUPPLEMENTARY 
INFORMATION'' section. To ensure proper receipt by EPA, your objections 
and hearing requests must identify docket control number OPP-300931 in 
the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: David Deegan, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
number: 703-308-9358; and e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected categories and entities may include, but are not 
limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            Potentially
                                                       Affected Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

B. How Can I Get Additional Information, Including Copies of This 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental

[[Page 68047]]

Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-300931. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408 (l)(6) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is 
establishing tolerances for residues of the fungicide tetraconazole, in 
or on sugar beet at 0.10 part per million (ppm), 6.0 ppm in sugar beet 
top, 0.20 ppm in sugar beet dried pulp, 0.30 ppm in sugar beet 
molasses, 0.050 ppm in milk, 0.030 ppm in cattle, meat and meat 
byproducts except kidney and liver, 0.20 ppm in kidney, 6.0 ppm in 
liver, and 0.60 ppm in fat. These tolerances will expire and are 
revoked on December 31, 2001. EPA will publish a document in the 
Federal Register to remove the revoked tolerance from the Code of 
Federal Regulations.
    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. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.
    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 the Federal Insecticide, Fungicide, and Rodenticide 
Act (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 
the Food Quality Protection Act (FQPA). EPA has established regulations 
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Tetraconazole on Sugar beets and FFDCA 
Tolerances

    The Red River Valley, shared by North Dakota and Minnesota, is the 
leader in U.S. sugar beet production, representing approximately 45% of 
planted acreage and 50% of tonnage produced annually. Cercospora 
leafspot began to present a problem to sugarbeet growers in the early 
1980's. Growers at that time preferred benzimidazole fungicides 
(benomyl and thiophanate methyl) which were registered. Within a few 
years, resistance was shown to have developed toward these compounds 
(also, since then sugar beets was dropped from the thiabendazole 
label). During approximately the following 17 years, growers have 
employed a variety of chemical classes in the control of C. beticola. 
Triphenyltin hydroxide (Fentin Hydroxide, TPTH) provided reliable 
control of cercospora between about 1983 and 1994. In 1994, resistance 
was documented and use very quickly dropped off as use was no longer 
recommended as a sound control practice. There continues to be some 
limited use of the benzimidazole fungicides, but they are no longer 
recommended for stand-alone use, nor for more than one application per 
year. There are currently ethylenebisdithiocarbamate (EBDC) fungicides 
registered for this use (Mancozeb, maneb) that do work effectively when 
applied at full label rates. However, label restrictions preclude 
mancozeb being used for season-long control, leaving significant 
acreage unprotected during the final month of growth. A final 
alternative, copper hydroxide, is less effective than mancozeb and is 
not preferred or recommended. The applicants stated that without 
approval of the use of tetraconazole to control cercospora on sugar 
beets, losses to growers could approach and exceed 17% of net revenue. 
After having reviewed the submission, EPA concurs that emergency 
conditions exist for these states. EPA has authorized under FIFRA 
section 18 the use of tetraconazole on sugar beets for control of 
Cercospora leafspot in North Dakota and Minnesota.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of tetraconazole in or on 
sugar beets. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerances under 
FFDCA section 408(l)(6) would be consistent with the safety standard 
and with FIFRA section 18. Consistent with the need to move quickly on 
the emergency exemption in order to address an urgent non-routine 
situation and to ensure that the resulting food is safe and lawful, EPA 
is issuing these tolerances without notice and opportunity for public 
comment as provided in section 408(l)(6). Although these tolerances 
will expire and be revoked on December 31, 2001, under FFDCA section 
408(l)(5), residues of the pesticide not in excess of the amounts 
specified in the tolerances remaining in or on sugar beets 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-setting action at the time 
of that application. EPA will take action to revoke these tolerances 
earlier if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether tetraconazole 
meets EPA's registration requirements for use on sugar beets, or 
whether permanent tolerances for this use would be appropriate. Under 
these circumstances, EPA does not believe that these tolerances serve 
as a basis for

[[Page 68048]]

registration of tetraconazole by a State for special local needs under 
FIFRA section 24(c). Nor do these tolerances serve as the basis for any 
State other than North Dakota and Minnesota 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 
tetraconazole, contact the Agency's Registration Division at the 
address provided under the ``ADDRESSES'' section.

IV. 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 
tetraconazole and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for a time-limited tolerance for 
residues of tetraconazole on sugar beets at 0.10 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 tetraconazole are 
discussed in this unit.

B. Toxicological Endpoint

    1. Acute toxicity. Acute Reference Dose (RfD) = 0.05 milligrams/
kilogram/day (mg/kg/day). For acute dietary risk assessment, EPA used 
the no observed adverse effect level (NOAEL) of 5 mg/kg/day, based on 
decreased maternal body weight and food consumption at the lowest 
observed adverse effect level (LOAEL) of 22.5 mg/kg/day, from the 
developmental study in rats. Due to the severity of pup effects in rat 
reproduction study, an additional FQPA safety factor of three has been 
applied to the acute and chronic RfD calculations. The percent of acute 
and chronic RfD utilized should not exceed 33%. This risk assessment 
will evaluate acute dietary risk to all population subgroups.
    2. Short- and intermediate-term toxicity. For short-term Margin of 
Exposure (MOE) calculations, EPA used the NOAEL of 5 mg/kg/day, based 
on decreased maternal body weight and food consumption at the LOAEL of 
22.5 mg/kg/day, from the developmental study in rats.
    For intermediate-term MOE calculations, EPA used the NOAEL of 0.8 
mg/kg/day 10 ppm from the 90-day oral feeding study in rats. At the 
LOAEL of 4.1 mg/kg/day 60 ppm, there were increased liver weights and 
associated changes in liver pathology observed as minimal centrilobular 
hepatocyte enlargement.
    3. Chronic toxicity. EPA has established the RfD for tetraconazole 
at 0.005 mg/kg/day. This RfD is based on a 2-year chronic toxicity/
carcinogenicity study in rats with a NOAEL of 0.5 mg/kg/day 10 ppm and 
an uncertainty factor of 100 based on osseous hypertrophy of skull 
bones at the LOAEL of 3.9 mg/kg/day 80 ppm. Due to the severity of pup 
effects in the rat reproduction study, an additional FQPA safety factor 
of three has been applied to the acute and chronic RfD calculations. 
The percent of acute and chronic RfD utilized should not exceed 33%.
    4. Carcinogenicity. Tetraconazole has not been classified with 
respect to carcinogenic potential by EPA. However, based on the 
tumorigenic results in the mouse carcinogenicity study, EPA has made an 
initial determination that a Q1* should be determined based on the male 
mouse benign liver tumors, excluding the highest dose. The Q1* is 0.037 
(mg/kg/day)-1.

C. Exposures and Risks

    1. From food and feed uses. Because EPA has never registered any 
other uses of tetraconazole, there are no other tolerances for food or 
feed items that have been established prior to this action. The current 
action being taken to establish time-limited tolerances to support an 
authorized emergency exemption use of tetraconazole represent the total 
potential exposure to this chemical. Risk assessments were conducted by 
EPA to assess dietary exposures and risks from tetraconazole 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. The acute dietary (food only) risk 
assessment used the Anticipated Residue Contribution (ARC). The high-
end exposure estimate (food only) of 0.002231 mg/kg/day, represents 13% 
of the Population Adjusted Dose (PAD) for children 1-6 years of age. 
This should be viewed as a partially refined risk estimate; refinement 
using anticipated residue values and percent crop-treated (PCT) data in 
conjunction with Monte Carlo analysis would result in a lower acute 
dietary exposure estimate.
    ii. Chronic exposure and risk. In conducting this chronic dietary 
risk assessment, EPA incorporated anticipated residue values.The 
emergency exemption tetraconazole time-limited tolerances result in an 
ARC that is equivalent to the following percentages of the RfD:

------------------------------------------------------------------------
                                                Exposure mg/
                                                   kg/day       % PAD
------------------------------------------------------------------------
U.S. Population (48 Contiguous States)........     0.000068         4.0%
Hispanics.....................................     0.000097         5.7%
Non-Hispanic Blacks...........................     0.000082         4.8%
Children (1-6 years old)......................     0.000153         9.0%
------------------------------------------------------------------------

    The subgroups listed above are: (1) The U.S. population (48 
contiguous states); (2) those for children; and, (3) the other 
subgroups for which the percentage of the RfD occupied is greater than 
that occupied by the subgroup U.S. population (48 contiguous states).
    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.
    2. From drinking water. Because tetraconazole is a new and 
unregistered chemical, EPA does not currently have adequate data with 
which to model

[[Page 68049]]

upper-level screening concentrations due to consumption of drinking 
water. Therefore, EPA is not able to determine if concentrations of 
residues of tetraconazole in drinking water would exceed the drinking 
water level of concern (DWLOC) estimates. However, because both the 
cancer risk and the non-cancer risk dietary estimates determined by EPA 
are sufficiently low that it is EPA's best scientific judgement that, 
for this pesticide tolerance setting action, a conclusion can be made 
that there is ``a reasonable certainty of no harm'' that will result 
from possible water-borne residues of tetraconazole. Additionally, 
there are no residential uses, nor any other type of currently 
registered use, of tetraconazole. Due to the limited amounts of 
exposure to residues of tetraconazole anticipated to result from this 
emergency exemption use, and because of the conservative nature of this 
risk assessment, EPA believes that any potential exposure to residues 
of tetraconazole from drinking water will not result in levels of 
exposure that exceed margins of safety identified in this risk 
assessment.
    Because the Agency lacks sufficient water-related exposure data to 
complete a comprehensive drinking water risk assessment for many 
pesticides, EPA has commenced and nearly completed a process to 
identify a reasonable yet conservative bounding figure for the 
potential contribution of water-related exposure to the aggregate risk 
posed by a pesticide. In developing the bounding figure, EPA estimated 
residue levels in water for a number of specific pesticides using 
various data sources. The Agency then applied the estimated residue 
levels, in conjunction with appropriate toxicological endpoints (RfDs 
or acute dietary NOAELs) and assumptions about body weight and 
consumption, to calculate, for each pesticide, the increment of 
aggregate risk contributed by consumption of contaminated water. While 
EPA has not yet pinpointed the appropriate bounding figure for exposure 
from contaminated water, the ranges the Agency is continuing to examine 
are all below the level that would cause tetraconazole to exceed the 
RfD if the tolerances being considered in this document were granted. 
The Agency has therefore concluded that the potential exposures 
associated with tetraconazole in water, even at the higher levels the 
Agency is considering as a conservative upper bound, would not prevent 
the Agency from determining that there is a reasonable certainty of no 
harm if the tolerance is granted.
    3. From non-dietary exposure. There are currently no other 
registered uses of tetraconazole. The only exposure to residues of 
tetraconazole would result from the subject emergency exemptions, and 
are described in detail throughout this document.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Tetraconazole is a member of the conazole class of 
pesticides. Other members of this class include hexaconazole, and 
propiconazole. All of the conazoles demonstrate carcinogenicity in 
animal studies. 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 tetraconazole 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, 
tetraconazole 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 tetraconazole 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).

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

    1. Chronic risk. Using the ARC exposure assumptions described in 
this unit, EPA has concluded that aggregate exposure to tetraconazole 
from food will utilize 4% of the cPAD for the U.S. population. The 
major identifiable subgroup with the highest aggregate exposure is 
children up to 6 years of age. EPA generally has no concern for 
exposures below 100% of the RfD because the RfD represents the level at 
or below which daily aggregate dietary exposure over a lifetime will 
not pose appreciable risks to human health. Despite the potential for 
exposure to tetraconazole in drinking water, EPA does not expect the 
aggregate exposure to exceed 100% of the RfD.
    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.
    2. Aggregate cancer risk for U.S. population. Tetraconazole 
produced statistically significant increases in male and female mouse 
liver adenomas and carcinomas. Based on a determination of the Q1* for 
this tolerance setting action only, the Q1* was determined to be 3.7 x 
10-2 based on benign tumors in males with the exclusion of 
the high dose group.
    The cancer risk for the U.S. population is, without adjustment, 2.5 
x 10-6. Because this is an emergency exemption use of 
tetraconazole, it is considered appropriate to divide the cancer risk 
by a factor of 14 [5 years for potential emergency exemption use/70 
years lifetime = 1/14].
    The adjusted cancer risk for the U.S. population is 1.8 x 
10-7 and this adjusted cancer risk is below EPA's level of 
concern.
    3. 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 tetraconazole 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 tetraconazole, 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 prenatal and postnatal 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 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 
interspecies and intraspecies variability) and not the additional 
tenfold MOE/uncertainty factor when

[[Page 68050]]

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-- a. Rats. In the developmental 
study in rats, the maternal (systemic) NOAEL was 5 mg/kg/day, based on 
decreased body weight and decreased food consumption at the LOAEL of 
22.5 mg/kg/day. The developmental (fetal) NOAEL was 22.5 mg/kg/day, 
based on visceral changes, supernumerary ribs, and delayed ossification 
at the LOAEL of 100 mg/kg/day.
    b. Rabbits. In the developmental toxicity study in rabbits, the 
maternal (systemic) NOAEL was 15 mg/kg/day, based on decreased weight 
gain and decreased food consumption at the LOAEL of 30 mg/kg/day. The 
developmental (fetal) NOAEL was 30 mg/kg/day highest dose tested (HDT).
    iii. Reproductive toxicity study-- Rats. In the 2-generation 
reproductive toxicity study in rats, the maternal (systemic) NOAEL was 
0.7 mg/kg/day, based on dystocia, delayed vaginal opening, and 
increased liver weight at the LOAEL of 5.9 mg/kg/day. The developmental 
(pup) NOAEL was 0.7 mg/kg/day, based on increased time to observation 
of balanopreputial skin fold and liver weight at the LOAEL of 5.9 mg/
kg/day. At the high dose of 35.5 mg/kg/day, there was a decrease in the 
mean number of live pups per litter on lactation days 0 and 4 (precull) 
in the presence of significant maternal toxicity.
    iv. Prenatal and postnatal sensitivity. The toxicological data base 
for evaluating prenatal and postnatal toxicity for tetraconazole is 
complete with respect to current data requirements. Based on the 
developmental and reproductive toxicity studies discussed above, for 
tetraconazole there does appear to be an extra sensitivity for prenatal 
or postnatal effects. EPA has therefore concluded that, for purposes of 
this tolerance-setting action, the FQPA safety factor of 10 be reduced 
to three for both the acute and chronic dietary estimates, and be 
applied to all population subgroups.
    v. Conclusion. There is a complete toxicity data base for 
tetraconazole and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures.
    2. Acute risk. The acute dietary (food only) risk assessment used 
the ARC. The high-end exposure estimate (food only) of 0.002231 mg/kg/
day, represents 13% of the PAD for children ages 1-6 years. As stated 
earlier, this should be viewed as a partially refined risk estimate; 
refinement using anticipated residue values and PCT data in conjunction 
with Monte Carlo analysis would result in a lower acute dietary 
exposure estimate.
    3. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to tetraconazole from 
food will utilize 9% of the RfD for children ages 1-6 years. EPA 
generally has no concern for exposures below 100% of the RfD because 
the RfD represents the level at or below which daily aggregate dietary 
exposure over a lifetime will not pose appreciable risks to human 
health. Despite the potential for exposure to tetraconazole in drinking 
water exposure, EPA does not expect the aggregate exposure to exceed 
100% of the RfD.
    4. 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 tetraconazole 
residues.

V. Other Considerations

A. Metabolism in Plants and Animals

    The nature of the residue in sugar beet is adequately understood 
for the purpose of this tolerance action only. Ten-week old potted 
sugar beet plants in an outdoor field were treated with tetraconazole 
labeled with carbon-14 in the triazole ring at 100g/ha, and were then 
re-treated twice more at 21-day intervals. Samples of root and leaf 
were collected 0, 20, 41, and 76 days after the first treatment. The 
total radioactive residue (TRR) found in the root was always <0.01 ppm. 
TRRs in the leaf were 1.6, 1.9, 3.1, and 1.3 ppm, respectively. Over 
90% of the TRR in beet leaf was extractable. The main residue was 
identified as tetraconazole, declining from 94-95% TRR (day 0 and 20) 
to 81% on day 41 and 54% on day 76. The TRR in the root was not 
characterized. The residue of concern is the parent compound, 
tetraconazole, in beet root and leaf.
    The nature of the residue in the goat is adequately understood for 
the purpose of this tolerance action only. Upon dosing a lactating goat 
for 5 consecutive days with radiolabled tetraconazole (in phenyl and 
triazole rings), liver retained the highest radioactivity and muscle 
contained the lowest radioactivity. Tetraconazole was found to be the 
major residue in the liver and fat, and triazole was the major residue 
in milk, muscle and kidney.

B. Analytical Enforcement Methodology

    An enforcement method for sugar beet and livestock commodities is 
not available. However, a method for measuring tetraconazole in beet 
root and top is available (MRID 44751314), and for measuring 
tetraconazole in livestock commodities is available (MRID 44751316). 
The registrant needs to conduct independent laboratory validation 
before these methods can be tested in EPA laboratories as enforcement 
methods.
    To request information on the above referenced measuring methods, 
please contact: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

C. Magnitude of Residues

    Residues of tetraconazole are not expected to exceed 6.0 ppm in 
sugar beet top, 0.10 ppm in roots, 0.20 ppm in dry pulp, 0.30 ppm in 
molasses, and 0.012 ppm in refined sugar as a result of the authorized 
emergency exemption use. Time-limited tolerances should be established 
on sugar beet top, root, pulp, and molasses.
    Sugar beet tops, dry pulp, and molasses may be fed to cattle as a 
result of the authorized use. Secondary residues in animal commodities 
are not expected to exceed 0.050 ppm in milk, 6.0 ppm in liver, 0.60 
ppm in fat, 0.20 ppm in kidney, and 0.030 ppm in muscle of cattle as a 
result of use authorized under these emergency exemptions. Time-limited 
tolerances should be established at these levels on milk, meat, meat 
byproducts, kidney, liver, and fat of cattle.

D. International Residue Limits

    There are no CODEX MRLs, Canadian or Mexican tolerances 
established.

E. Rotational Crop Restrictions

    Crops other than sugar beet should not be grown within 120 days 
following the last application of tetraconazole.

VI. Conclusion

    Therefore, the tolerances are established for residues of 
tetraconazole in sugar beet roots at 0.10 ppm, 6.0 ppm in sugar beet 
top, 0.20 ppm in sugar beet dried pulp, 0.30 ppm in sugar beet 
molasses, 0.050 ppm in milk, 0.030 ppm in cattle meat and meat 
byproducts except kidney and liver, 0.20 ppm in cattle kidney, 6.0 ppm 
in cattle liver, and 0.60 ppm in cattle fat.

[[Page 68051]]

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-300931 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before February 
4, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
You may also deliver your request to the Office of the Hearing Clerk in 
Room M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The 
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    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 the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
    3.  Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A. of 
this preamble, you should also send a copy of your request to the PIRIB 
for its inclusion in the official record that is described in Unit 
I.B.2. of this preamble. Mail your copies, identified by the docket 
number OPP-300931, 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 or by courier, bring a copy to the 
location of the PIRIB described in Unit I.B.2. of this preamble. You 
may also send an electronic copy of your request via e-mail to: opp-
[email protected]. Please use an ASCII file format and avoid the use of 
special characters and any form of encryption. Copies of electronic 
objections and hearing requests will also be accepted on disks in 
WordPerfect 5.1/6.1 file format or ASCII file format. Do not include 
any CBI in your electronic copy. You may also submit an electronic copy 
of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
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(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408. 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) (Public Law 104-4). Nor does it require any prior consultation 
as specified by Executive Order 13084, entitled Consultation and 
Coordination with Indian Tribal Governments (63 FR 27655, May 19, 
1998); 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 or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 petition under FFDCA section 408, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the

[[Page 68052]]

Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. 
In addition, the Agency has determined that this action will not have a 
substantial direct effect on States, on the relationship between the 
national government and the States, or on the distribution of power and 
responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4).

IX. Submission to Congress and the General Accounting Office

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
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: November 4, 1999.

James Jones,

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

PART 180-AMENDED

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

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

    2. Section 180.557 is added to read as follows:

Sec. 180.557   Tetraconazole; tolerances for residues.

    (a) General. [Reserved]
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the fungicide tetraconazole [(+/-)-2-(2,4-
dichlorophenyl)-3-(1H-1,2,4-triazol-1-yl) propyl 1, 1,2,2-
tetrafluoroethyl ether] in connection with the use of the pesticide 
under section 18 emergency exemptions granted by EPA. The tolerances 
will expire and be revoked on the date specified in the following 
table.

 
------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    revocation date
------------------------------------------------------------------------
Beet, sugar, dried pulp.........  0.20                12/31/01
Beet, sugar, molasses...........  0.30                12/31/01
Beet, sugar, roots..............  0.10                12/31/01
Beet, sugar, tops...............  6.0                 12/31/01
Cattle, fat.....................  0.60                12/31/01
Cattle, kidney..................  0.20                12/31/01
Cattle, liver...................  6.0                 12/31/01
Cattle, meat....................  0.030               12/31/01
Cattle, meat byproducts; except   0.030               12/31/01
 kidney and liver.
Milk............................  0.050               12/31/01
------------------------------------------------------------------------

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

[FR Doc. 99-31546 Filed 12-3-99; 8:45 am]
BILLING CODE 6560-50-F