[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: deegan.dave@epa.gov.
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
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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%
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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:="">furlow.calvin@epa.gov.
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 tompkins.jim@epa.gov,
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: docket@epa.gov. 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
