[Federal Register Volume 62, Number 114 (Friday, June 13, 1997)]
[Rules and Regulations]
[Pages 32230-32236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15564]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300497; FRL-5718-6]
RIN 2070-AC78
Azoxystrobin; 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 the fungicide azoxystrobin in or on the raw agricultural
commodities rice and rice straw and hulls, liver of cattle, hog, goat,
horse, sheep, and poultry; meat and fat of cattle, goat, horse, sheep,
poultry, and swine; kidney and milk of cattle; and eggs in connection
with EPA's granting of emergency exemptions under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of
azoxystrobin on rice in Mississippi. This regulation establishes
maximum permissible levels for residues of azoxystrobin on the
commodities listed above 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 May 30, 1999.
DATES: This regulation becomes effective June 13, 1997. Objections and
requests for hearings must be received by EPA on August 12, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, OPP-300497, 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 document
control number, OPP-300497, should be submitted to: Public Information
and Records Integrity Branch, Information Resources and Services
Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number OPP-300497. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of objections and hearing
requests on this rule may be filed online at many Federal Depository
Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Virginia Dietrich,
Registration Division (7505C), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Office location, telephone number, and
e-mail address: Document Processing Desk, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA, (703) 308-9359, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA, pursuant to section 408(e) and (l)(6)
of
[[Page 32231]]
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) and
(l)(6), is establishing tolerances for residues of the fungicide
azoxystrobin (methyl (E)-2-{2-[6-(2-cyanophenoxy)pyrimidin-4-
yloxy]phenyl}-3-methoxyacrylate) in or on rice grain at 4 ppm, rice
straw at 10 ppm, and rice hulls at 20 ppm. These tolerances will expire
and are revoked on May 30, 1999. After May 30, 1999, EPA will publish a
document in the Federal Register to remove the revoked tolerance from
the Code of Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 CFR 58135, November 13, 1996) (FRL-5572-
9).
New section 408(b)(2)(A)(i) 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, but does not include
occupational exposure. Section 408(b)(2)(C) requires EPA to give
special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) 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. Section 408(l)(6) also requires EPA to promulgate regulations
by August 3, 1997, governing the establishment of tolerances and
exemptions under section 408(l)(6) and requires that the regulations be
consistent with section 408(b)(2) and (c)(2) and FIFRA section 18.
Section 408(l)(6) allows EPA to establish tolerances or exemptions
from the requirement for a tolerance, in connection with EPA's granting
of FIFRA section 18 emergency exemptions, without providing notice or a
period for public comment. Thus, consistent with the need to act
expeditiously on requests for emergency exemptions under FIFRA, EPA can
establish such tolerances or exemptions under the authority of section
408(e) and (l)(6) without notice and comment rulemaking.
In establishing section 18-related tolerances and exemptions during
this interim period before EPA issues the section 408(l)(6) procedural
regulation and before EPA makes its broad policy decisions concerning
the interpretation and implementation of the new section 408, EPA does
not intend to set precedents for the application of section 408 and the
new safety standard to other tolerances and exemptions. Rather, these
early section 18 tolerance and exemption decisions will be made on a
case-by-case basis and will not bind EPA as it proceeds with further
rulemaking and policy development. EPA intends to act on section 18-
related tolerances and exemptions that clearly qualify under the new
law.
II. Emergency Exemptions for Azoxystrobin on Rice and FFDCA
Tolerances
On January 30, 1997, the State of Mississippi, Department of
Agriculture and Commerce requested a specific exemption under FIFRA
section 18 for the use of azoxystrobin to control sheath blight on
rice. Similar requests were received from Arkansas, Louisiana,
Missouri, and Texas. The applicant stated that growers will experience
significant economic loss if the pest is not adequately controlled.
After having reviewed their submission, EPA concurs that an emergency
condition exists.
As part of its assessment of these applications for emergency
exemption, EPA assessed the potential risks presented by residues of
azoxystrobin on rice. In doing so, EPA considered the new safety
standard in FFDCA section 408(b)(2), and EPA decided to grant the
section 18 exemptions only after concluding that the necessary
tolerance under FFDCA section 408(l)(6) would clearly be consistent
with the new safety standard and with FIFRA section 18. These
tolerances for azoxystrobin will permit the marketing of rice treated
in accordance with the provisions of the section 18 emergency
exemptions. Consistent with the need to move quickly on the emergency
exemptions 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
these tolerances will expire and are revoked on May 30, 1999, under
FFDCA section 408(l)(5), residues of azoxystrobin not in excess of the
amount specified in the tolerances remaining in or on rice after that
date will not be unlawful, provided the pesticide is applied during the
term of, and in accordance with all the conditions of, the emergency
exemptions. 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.
EPA has not made any decisions about whether azoxystrobin meets the
requirements for registration under FIFRA section 3 for use on rice or
whether permanent tolerances for azoxystrobin for rice would be
appropriate. This action by EPA does not serve as a basis for
registration of azoxystrobin by a State for special local needs under
FIFRA section 24(c). Nor does this action serve as the basis for any
State other than California to use this product on this rice under
section 18 of FIFRA without following all provisions of section 18 as
identified in 40 CFR 180.166. For additional information regarding the
emergency exemptions for azoxystrobin, contact the Agency's
Registration Division at the address provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many
[[Page 32232]]
adverse health effects, including (but not limited to) reproductive
effects, developmental toxicity, toxicity to the nervous system, and
carcinogenicity. For many of these studies, a dose response
relationship can be determined, which provides a dose that causes
adverse effects (threshold effects) and doses causing no observed
effects (the ``no-observed effect level'' or ``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100 percent or less of the
RfD) is generally considered by EPA to pose a reasonable certainty of
no harm.
EPA generally uses the RfD to evaluate the chronic risks posed by
pesticide exposure. For shorter term risks, EPA calculates a margin of
exposure (MOE) by dividing the estimated human exposure into the NOEL
from the appropriate animal study. Commonly, EPA finds MOEs lower than
100 to be unacceptable. This 100-fold MOE is based on the same
rationale as the 100-fold uncertainty factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, and other non-
occupational exposures, such as where residues leach into groundwater
or surface water that is consumed as drinking water. Dietary exposure
to residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. The TMRC is a
``worst case'' estimate since it is based on the assumptions that food
contains pesticide residues at the tolerance level and that 100 percent
of the rice is treated by pesticides that have established tolerances.
If the TMRC exceeds the RfD or poses a lifetime cancer risk that is
greater than approximately one in a million, EPA attempts to derive a
more accurate exposure estimate for the pesticide by evaluating
additional types of information (anticipated residue data and/or
percent of rice treated data) which show, generally, that pesticide
residues in most foods when they are eaten are well below established
tolerances.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. Azoxystrobin is not registered by EPA for indoor or
outdoor residential use. EPA has sufficient data to assess the hazards
of azoxystrobin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for the time-limited tolerances for
residues of azoxystrobin in or on rice grain at 4 parts per million
(ppm); rice straw at 10 ppm; rice hulls at 20 ppm; liver of cattle,
goat, horse, and sheep at 0.3 ppm, meat and fat of cattle, goat, horse,
sheep, poultry, and swine at 0.01 ppm; cattle kidney at 0.06 ppm; milk
at 0.006 ppm; poultry liver at 0.4 ppm; hog liver at 0.2 ppm; and eggs
at 0.4 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing these tolerances follows.
A. Toxicological Profile
1. Acute risk. The Agency did not identify an acute dietary
endpoint and has determined that this risk assessment is not required.
2. Chronic risk. The RfD, based on a chronic toxicity study in rats
with a NOEL of 18.2 milligrams/kilograms/day (mg/kg/day), was
established at 0.18 mg/kg/day. Reduced body weights and bile duct
lesions were observed at the lowest effect level (LEL) of 34 mg/kg/day.
An Uncertainty Factor (UF) of 100 was used to account for both the
interspecies extra-polation and the intraspecies variability.
3. Short and intermediate term risk. No toxic endpoints for these
durations of exposure were identified in the toxicological data base.
4. Cancer risk. Azoxystrobin has been classified by the Agency's
RfD Committee (November 7, 1996) as ``Not Likely'' to be carcinogenic
to humans via relevant routes of exposure. This decision was made
according to the 1996 proposed guidelines. Therefore, cancer risk was
not assessed.
5. Risk to infants and children--i. Developmental toxicity studies-
-a. Rabbit. In the developmental toxicity study in rabbits, the
developmental NOEL was 500 mg/kg/day, at the highest dose tested (HDT).
Because there were no treatment-related effects, the developmental LEL
was 500 mg/kg/day. The maternal NOEL was 150 mg/kg/day. The
maternal LEL of 500 mg/kg/day was based on decreased body weight gain
during dosing.
b. Rat. In the developmental toxicity study in rats, the maternal
(systemic) NOEL was not established. The maternal LEL of 25 mg/kg/day
at the lowest dose tested (LDT) was based on increased salivation. The
developmental (fetal) NOEL was 100 mg/kg/day (HDT).
(ii) Reproductive toxicity studies--Rat. In the reproductive
toxicity study in rats, the parental (systemic) NOEL was 32.3 mg/kg/
day. The parental LEL of 165.4 mg/kg/day was based on decreased body
weights in males and females, decreased food consumption and increased
adjusted liver weights in females, and cholangitis. The reproductive
NOEL was 32.3 mg/kg/day. The reproductive LEL of 165.4 mg/kg/day was
based on increased weanling liver weights and decreased body weights
for pups of both generations.
B. Aggregate Exposure and Risk
Tolerances for residues of azoxystrobin do not exist. In examining
aggregate exposure, FQPA directs EPA to consider available information
concerning exposures from the pesticide
[[Page 32233]]
residue in food and all other non-occupational exposures. The primary
non-food sources of exposure the Agency looks at include drinking water
(whether from groundwater or surface water), and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses). In evaluating food exposures, EPA takes into account
varying consumption patterns of major identifiable subgroups of
consumers, including infants and children.
At present there are no tolerances for residues of azoxystrobin
because it is currently registered under section 3 of FIFRA only for
use on golf courses and commercial turf farms. Short and intermediate
term aggregate risk assessments were not conducted on azoxystrobin
since no toxic endpoints for these durations of exposure were
identified in the toxicological data base.
The Agency identified chronic exposure as appropriate for aggregate
risk assessment. The Agency determined that an acute exposure analysis
is not required because no acute dietary endpoints for azoxystrobin
were identified.
The Agency identified chronic exposure as appropriate for aggregate
risk assessment. The aggregate chronic risk is equal to the sum of the
chronic risk from exposure from food + water + residential (indoor and
outdoor) uses. Azoxystrobin is not registered for any residential uses
so no exposure from this route is expected. The Agency estimates that
aggregate risk (food plus drinking water) would not exceed the RfD for
azoxystrobin.
The chronic dietary (food only) risk assessment used the TMRC.
Therefore, the resulting exposure estimates should be viewed as
conservative; further refinement using anticipated residues and/or
percent of crop treated would result in lower dietary exposure
estimates. For chronic dietary (food only) risk estimates, the
population subgroup with the largest percentage of the RfD occupied is
non-nursing infants less than 1 year old at 3.9% of the RfD.
Azoxystrobin and its transformation products may potentially
contaminate surface waters through spray drift or surface water run-
off. In addition, transformation products of azoxystrobin exhibit
properties of pesticides found in ground water; some persistence and
mobility in laboratory and field studies. For this reason, exposure to
azoxystrobin through drinking water was considered during the 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 (RfD's
or acute dietary NOEL's) and assumptions about body weight and
consumption, to calculate, for each pesticide, the increment of
aggregate risk contributed by consumption of contaminated water. While
EPA has not yet pinpointed the appropriate bounding figure for
consumption of contaminated water, the ranges the Agency is continuing
to examine are all well below the level that would cause azoxystrobin
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 azoxystrobin 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 tolerances are granted.
Using these conservative estimates, the sum total of the aggregate
chronic risk estimates (food, water, residential indoor, and outdoor)
for azoxystrobin for the population subgroup with the largest
percentage of the RfD occupied, non-nursing infants less than 1 year
old, is 13.9%. In the best scientific judgement of the Agency, the
azoxystrobin aggregate chronic risk does not exceed our level of
concern.
C. Cumulative Exposure to Substances with Common Mechanism of Toxicity
Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' The Agency believes that ``available
information'' in this context might include not only toxicity,
chemistry, and exposure data, but also scientific policies and
methodologies for understanding common mechanisms of toxicity and
conducting cumulative risk assessments. For most pesticides, although
the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances, EPA does not at this
time have the methodologies to resolve the complex scientific issues
concerning common mechanism of toxicity in a meaningful way. EPA has
begun a pilot process to study this issue further through the
examination of particular classes of pesticides. The Agency hopes that
the results of this pilot process will increase the Agency's scientific
understanding of this question such that EPA will be able to develop
and apply scientific principles for better determining which chemicals
have a common mechanism of toxicity and evaluating the cumulative
effects of such chemicals. The Agency anticipates, however, that even
as its understanding of the science of common mechanisms increases,
decisions on specific classes of chemicals will be heavily dependent on
chemical-specific data, much of which may not be presently available.
Although at present the Agency does not know how to apply the
information in its files concerning common mechanism issues to most
risk assessments, there are pesticides as to which the common mechanism
issues can be resolved. These pesticides include pesticides that are
toxicologically dissimilar to existing chemical substances (in which
case the Agency can conclude that it is unlikely that a pesticide
shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case common
mechanism of activity will be assumed).
EPA does not have, at this time, available data to determine
whether azoxystrobin 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,
azoxystrobin 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 azoxystrobin has a common mechanism of
toxicity with other substances.
D. Safety Determinations for U.S. Population
Based on the completeness and reliability of the toxicity data and
the conservative TMRC dietary exposure assumptions, EPA has concluded
that dietary exposure from food to azoxystrobin will occupy 1 percent
of the RfD for the U.S. population. EPA generally has no concern for
exposures below 100 percent of the RfD because
[[Page 32234]]
the RfD represents the level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to human
health. Whatever reasonable bounding figure the Agency eventually
decides upon for the contribution from water, that number is expected
to be well below 99 percent of the RfD. EPA concludes that there is a
reasonable certainty that no harm will result from aggregate exposure
to azoxystrobin residues.
E. Determination of Safety for Infants and Children
FFDCA section 408 provides that EPA shall apply an additional 10-
fold MOE (safety factor) 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
MOE (safety) will be safe for infants and children. MOE (safety) are
often referred to as uncertainty (safety) factors. EPA believes that
reliable data support using the standard MOE (usually 100x for combined
inter- and intra-species variability) and not the additional 10-fold
MOE 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. Based on current
toxicological data requirements, the data base for azoxystrobin
relative to pre (provided by rat and rabbit developmental studies) and
post-natal (provided by the rat reproduction study) toxicity is
complete.
In assessing the adequacy of the standard uncertainty factor for
azoxystrobin, 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 pesticide exposure
during pre-natal development to one or both parents. Reproduction
studies provide information relating to effects from exposure to the
pesticide on the reproductive capability of mating animals and data on
systemic toxicity.
Developmental toxicity from azoxystrobin was not observed in
developmental studies using rats and rabbits. The pre- and post-natal
toxicology data base for azoxystrobin is complete with respect to
current toxicological data requirements. The results of these studies
indicate that infants and children are not more sensitive to exposure,
based on the results of the rat and rabbit developmental toxicity
studies and the 2-generation reproductive toxicity study in rats.
The results of the rabbit developmental toxicity study did not
indicate that an acute dietary risk assessment needed to be performed.
For rabbits, the developmental toxicity NOEL was 500 mg/kg/day, at the
HDT. The maternal NOEL of 150 mg/kg/day was based on decreased body
weight gain at the LEL of 500 mg/kg/day. For rats, the developmental
toxicity NOEL was 100 mg/kg/day at the HDT. The maternal NOEL was not
determined and the maternal LEL of 25 mg/kg/day at the LDT was based on
increased salivation.
In the 2-generation reproductive toxicity study, the reproductive
and parental (systemic) NOEL were both 32.3 mg/kg/day. The reproductive
LEL of 165.4 mg/kg/day was based on increased weanling liver weights
and decreased body weight in pups of both generations. These effects
occurred in the presence of parental (systemic) toxicity. The parental
(systemic) LEL of 165.4 mg/kg/day was based on decreased body weights,
decreased food consumption and increased adjusted liver weights in
females, and cholangitis generations. The Agency notes that the NOEL of
18.2 mg/kg/day used to establish the RfD is approximately 2-fold lower
than the reproductive NOEL; therefore, the Agency concludes that this
section 18 request does not represent any unacceptable pre- or post-
natal risk to infants and children.
Despite the potential for exposure to drinking water, EPA has
concluded that the percentage of the RfD that will be utilized by
dietary exposure (including drinking water exposure) to residues of
azoxystrobin does not exceed 100 percent for any of the population
subgroups. Based on TMRC exposure estimates for food, as described
above, EPA has concluded that the percentage of the RfD that will be
utilized by dietary exposure to residues of azoxystrobin ranges from 11
percent for children 1 to 6 years old, and up to 13.9 percent for non-
nursing infants (the most highly exposed population subgroup).
Therefore, taking into account the completeness and reliability of the
toxicity data and the conservative exposure assessment, EPA concludes
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to azoxystrobin residues.
Therefore, EPA believes that reliable data show that the standard
uncertainty factor will be protective of the safety of infants and
children and an additional uncertainty factor is not needed.
Based on the above, EPA concludes that reliable data support use of
the standard 100-fold MOE/uncertainty factor and that an additional
safety factor is not needed to protect the safety of infants and
children.
V. Other Considerations
The metabolism of azoxystrobin in plants is adequately understood
for the purposes of this tolerance. There is no Codex maximum residue
level established for residues of azoxystrobin on rice. An adequate
enforcement method, GC-NPD or HPLC-UV, is available to enforce the
tolerance expression on plant commodities. An enforcement method (GC-
NPD) has been proposed for animal tissues in association with a
recently submitted petition on wheat. The method has been submitted for
a petition method validation. These methods are available to anyone who
is interested in pesticide residue enforcement from: By mail, Calvin
Furlow, Public Information and Records Integrity Branch, Information
Resources and Services Division (7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., Washington, DC 20460.
Office location and telephone number: Crystal Mall #2, Rm 1128, 1921
Jefferson Davis Hwy., Arlington, VA, 703-305-5805.
VI. Conclusion
Therefore, tolerances in connection with the FIFRA section 18
emergency exemptions are established for residues of azoxystrobin and
its Z-isomer to support this section 18 specific exemption:
eggs: 0.4 ppm.
kidney, cattle: 0.06 ppm,
liver of cattle, goat, horse, and sheep: 0.3 ppm,
liver, hog: 0.2 ppm,
liver, poultry: 0.4 ppm,
meat and fat of cattle, goat, horse, sheep, poultry, and swine:
0.01 ppm,
milk: 0.006 ppm,
rice, grain: 4 ppm,
rice, straw: 10 ppm,
rice, hulls: 20 ppm,
These tolerances will expire and are revoked on May 30, 1999.
VII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing
[[Page 32235]]
requests. These regulations will require some modification to reflect
the new law. However, until those modifications can be made, EPA will
continue to use those procedural regulations with appropriate
adjustments to reflect the new law.
Any person may, by August 12, 1997, file written objections to any
aspect of this regulation (including the automatic revocation
provision) and may also request a hearing on those objections.
Objections and hearing requests must be filed with the Hearing Clerk,
at the address given above (40 CFR 178.20). A copy of the objections
and/or hearing requests filed with the Hearing Clerk should be
submitted to the OPP docket for this rulemaking. The objections
submitted must specify the provisions of the regulation deemed
objectionable and the grounds for the objections (40 CFR 178.25). Each
objection must be accompanied by the fee prescribed by 40 CFR
180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential by marking any part or all of that information as CBI.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. A copy of the information that
does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA without prior notice.
VIII. Public Docket
A record has been established for this rulemaking under docket
number [OPP-300497]. A public version of this record, 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 Rm. 1132 of the Public
Information and Records Integrity Branch, Information Resources and
Services Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway,
Arlington, VA.
The official record for this rulemaking, as well as the public
version, as described above, is kept in paper form. Accordingly, in the
event there are objections and hearing requests, EPA will transfer any
copies of objections and hearing requests received electronically into
printed, paper form as they are received and will place the paper
copies in the official rulemaking record. The official rulemaking
record is the paper record maintained at the address in ADDRESSES at
the beginning of this document.
IX. Regulatory Assessment Requirements
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines ``a significant regulatory action'' as an action that
is likely to result in a rule: (1) Having an annual effect on the
economy of $100 million or more, or adversely and materially affecting
a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local or tribal
governments or communities (also referred to as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlement, grants, user
fees, or loan programs or the rights and obligations thereof; or (4)
raising novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in this Executive
Order. Pursuant to the terms of this Executive Order, EPA has
determined that this rule is not ``significant'' and is therefore not
subject to OMB review.
This action does not impose any enforceable duty, or contain any
``unfunded mandates'' as described in Title II of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as
specified by Executive Order 12875 (58 FR 58093, October 28, 1993),
entitled Enhancing the Intergovernmental Partnership, or special
consideration as required by Executive Order 12898 (59 FR 7629,
February 16, 1994).
Because FFDCA section 408(l)(6) permits establishment of this
regulation without a notice of proposed rulemaking, the regulatory
flexibility analysis requirements of the Regulatory Flexibility Act, 5
U.S.C. 604(a), do not apply.
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted
a report containing this rule and other required information to the
U.S. Senate, the U.S. House of Representatives and the Comptroller
General of the General Accounting Office prior to publication of the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 2, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. By adding Sec. 180.507 to read as follows:
Sec. 180.507 Azoxystrobin; tolerances for residues.
(a) General. [Reserved]
(b) Section 18 emergency exemptions. Time limited tolerances are
established for residues of the fungicide azoxystrobin in connection
with use of the pesticide under section 18 emergency exemptions granted
by EPA. The tolerance is specified in the following table. The
tolerance expires and will be revoked by EPA on the date specified in
the table.
[[Page 32236]]
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Eggs......................... 0.4 5/30/99
Kidney, cattle............... 0.06 5/30/99
Liver of cattle, goat, horse, 0.3 5/30/99
and sheep.
Liver, hog................... 0.2 5/30/99
Liver, poultry............... 0.4 5/30/99
Meat and fat of cattle, goat, 0.01 5/30/99
horse, sheep, poultry, and
swine.
Milk......................... 0.006 5/30/99
Rice, grain.................. 4 5/30/99
Rice, hulls.................. 20 5/30/99
Rice, straw.................. 10 5/30/99
------------------------------------------------------------------------
(c) Tolerances with regional registration. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-15564 Filed 6-12-97; 8:45 am]
BILLING CODE 6560-50-F