[Federal Register Volume 63, Number 227 (Wednesday, November 25, 1998)]
[Rules and Regulations]
[Pages 65078-65085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31545]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300759; FRL 6045-4]
RIN 2070-AB78
Azoxystrobin; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of azoxystrobin or methyl (E)-2-(2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl)-3-methoxyacrylate) and its Z
isomer in or on sugar beets and soybeans. This action is in response to
EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of
the pesticide on sugar beets and soybeans. This regulation establishes
maximum permissible levels for residues of azoxystrobin in these food
commodities 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 will be revoked on June 30, 2000.
DATES: This regulation is effective November 25, 1998. Objections and
requests for hearings must be received by EPA on or before January 25,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300759], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
[[Page 65079]]
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300759], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, 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: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
or ASCII file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number [OPP-
300759]. 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: Jacqueline Gwaltney,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-6792; e-mail:
gwaltney.jackie@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for
combined residues of fungicide azoxystrobin and its Z isomer, in or on
sugar beets, and soybeans at 0.05 and 1.0 part per million (ppm),
respectively. These tolerances will expire and will be revoked on June
30, 2000. EPA will publish a document in the Federal Register to remove
the revoked tolerance from the Code of Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the 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 FR 58135, November
13, 1996) (FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerance to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Azoxystrobin on Sugar Beets and
Soybeans, and FFDCA Tolerances
The Minnesota Department of Agriculture requested an emergency
exemption in April of 1998 for the control of cercospora leafspots on
sugar beets. The registered alternative fungicides benomyl,
thiabendazole thiophanate methyl, triphenyl tin hydroxide (TPTH), EBDCs
(Mancozeb and Maneb), and copper hydroxide for controlling cercospora
leaf spots do not control the disease effectively because of resistance
and/or tolerance in the pathogen. Moderately resistant cultivars of
sugar beet are available, but their yield potentials are lower than the
susceptible. Cultural practices are not very effective in managing the
disease. During 1998, the disease severity is expected to be higher and
yield losses significant due to mild winter temperature (El Nino
effects).
Minnesota also claims that TPTH is still used in controlling the
disease, but it is significantly less effective than in the past.
In August 1998, the Arkansas Department of Agriculture also
requested an emergency exemption for the control of aerial blight on
soybeans. The disease is particularly aggressive in years of above-
normal night temperatures, high humidity, and frequent rainfall.
Conditions in 1998 have been near perfect for development of sheath
blight of rice, with night temperatures in the 78-82 degree range and
oppressively high relative humidity within crop canopies. Rainfall in
northeast Arkansas has also contributed to the problem. Soybean has
just entered the most susceptible flowering and early pod formation
stages and aerial blight has become exceptionally aggressive as weather
conditions continue to favor its development. Damage to soybean yield
is through destruction of foliage, and to a greater extent-flowers,
pods and seeds. Yield losses in some Arkansas fields in the past have
been estimated as high as 50%, however, this is a very rare occurrence
most years.
For these reasons, EPA has authorized under FIFRA section 18 the
use of azoxystrobin on sugar beets for control of cercospora leafspots
in Minnesota, and the use of azoxystrobin on soybeans for control of
aerial blight in Arkansas.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of azoxystrobin in or on
sugar beets and
[[Page 65080]]
soybeans. In doing so, EPA considered the new safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the new safety
standard and with FIFRA section 18. Consistent with the need to move
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this tolerance without notice and opportunity
for public comment under section 408(e), as provided in section
408(l)(6). Although this tolerance will expire and will be revoked on
June 30, 2000, under FFDCA section 408(l)(5), residues of the pesticide
not in excess of the amounts specified in the tolerance remaining in or
on sugar beets and soybeans after that date will not be unlawful,
provided the pesticide is applied in a manner that was lawful under
FIFRA, and the residues do not exceed a level that was authorized by
this tolerance at the time of that application. EPA will take action to
revoke this tolerance earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because this tolerance is being approved under emergency conditions
EPA has not made any decisions about whether azoxystrobin meets EPA's
registration requirements for use on sugar beets and soybeans or
whether a permanent tolerance for this use would be appropriate. Under
these circumstances, EPA does not believe that this tolerance serves as
a basis for registration of azoxystrobin by a State for special local
needs under FIFRA section 24(c). Nor does this tolerance serve as the
basis for any State other than Minnesota or Arkansas to use this
pesticide on these crop under section 18 of FIFRA without following all
provisions of section 18 as identified in 40 CFR part 166. For
additional information regarding the emergency exemption 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 adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
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 and The Agency's selection of
toxicological endpoints upon which to assess risk caused by
azoxystrobin are discussed below.
1. Acute toxicity. The Agency evaluated the existing toxicology
database for azoxystrobin and did not identify an acute dietary
endpoint. Therefore, a risk assessment is not required.
2. Short - and intermediate - term toxicity. The Agency evaluated
the existing toxicology database for short- and intermediate-term
dermal and inhalation exposure and determined that this risk assessment
is not required.
3. Chronic toxicity. EPA has established the reference dose (RfD)
for azoxystrobin at 0.18 milligrams/kilogram/day (mg/kg/day). This RfD
is based on a chronic toxicity study in rats with a no observed adverse
effect level (NOAEL) of 18.2 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 extrapolation and the intraspecies variability.
4. Carcinogenicity. The Agency determined that azoxystrobin should
be classified as ``Not Likely'' to be a human carcinogen according to
the proposed revised Cancer Guidelines. This classification is based on
the lack of evidence of carcinogenicity in long-term rat and mouse
feeding studies.
B. Exposures and Risks
1. From food and feed uses. Permanent tolerances have been
established (40 CFR 180.507(a)) for the combined residues of
azoxystrobin and its Z isomer, in or on a variety of raw agricultural
commodities at levels ranging from 0.01 ppm in pecans to 1.0 ppm in
grapes. In addition, time-limited tolerances have been established (40
CFR 180.507(b) at levels ranging from 0.006 ppm in milk to 20 ppm in
rice hulls) in conjunction with previous section 18 requests. Risk
assessments were conducted by EPA to assess dietary exposures and risks
from azoxystrobin as follows:
2. 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 one day or single exposure. The Agency did not conduct an acute
risk assessment because no toxicological endpoint of concern was
identified during review of available data.
3. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, EPA has made very conservative assumptions -- 100% of
all commodities having azoxystrobin tolerances will contain
azoxystrobin residues and those residues would be at the level of the
tolerance with the exception of raisins and grape juice -- which result
in an over estimation of human dietary exposure. Thus, in making a
safety determination for this tolerance, The Agency is taking into
account this conservative exposure assessment.
The existing azoxystrobin tolerances published, pending, and
including the necessary section 18 tolerance(s) result in a Theoretical
Maximum Residue Contribution (TMRC) that is equivalent to the following
percentages of the RfD:
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Population Sub-Group TMRC (mg/kg/day) % RFD
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U.S. Population (48 States)..... 0.0026 1.5%
All Infants (<1 year="" old).......="" 0.0079="" 4.4%="" nursing="" infants=""><1 year="" old)...="" 0.0026="" 1.5%="" non-nursing="" infants=""><1 year="" 0.010="" 5.6%="" old).="" children="" (1-6="" years="" old)........="" 0.0065="" 3.6%="" children="" (7-12="" years="" old).......="" 0.0035="" 1.9%="" u.s.="" population="" (summer="" season).="" 0.0030="" 1.7%="" northeast="" region................="" 0.0029="" 1.6%="" western="" region..................="" 0.0029="" 1.6%="" hispanics.......................="" 0.0036="" 2.0%="" non-hispanics="" blacks...........="" 0.0029="" 1.6%="" non-hispanics="" (other="" than="" black="" 0.0045="" 2.5%="" or="" white).="" ------------------------------------------------------------------------="" the="" subgroups="" listed="" above="" are:="" i.="" the="" u.s.="" population="" (48="" states).="" [[page="" 65081]]="" ii.="" those="" for="" infants="" and="" children.="" iii.="" the="" other="" subgroups="" for="" which="" the="" percentage="" of="" the="" rfd="" occupied="" is="" greater="" than="" that="" occupied="" by="" the="" subgroup="" u.s.="" population="" (48="" states).="" 4.="" from="" drinking="" water.="" there="" is="" no="" established="" maximum="" contaminant="" level="" for="" residues="" of="" azoxystrobin="" in="" drinking="" water.="" no="" health="" advisory="" levels="" for="" azoxystrobin="" in="" drinking="" water="" have="" been="" established.="" 5.="" acute="" exposure="" and="" risk.="" an="" assessment="" was="" not="" appropriate="" since="" no="" toxicological="" endpoint="" of="" concern="" was="" identified="" during="" review="" of="" the="" available="" data.="" 6.="" chronic="" exposure="" and="" risk.="" based="" on="" the="" chronic="" dietary="" (food)="" exposure="" estimates,="" chronic="" drinking="" water="" levels="" of="" concern="" (dwloc)="" for="" azoxystrobin="" were="" calculated="" and="" are="" summarized="" in="" the="" following="" table.="" the="" highest="" eec="" for="" azoxystrobin="" in="" surface="" water="" is="" from="" the="" application="" of="" azoxystrobin="" on="" grapes="" (39="">g/L) and is
substantially lower than the DWLOCs calculated. Therefore, chronic
exposure to azoxystrobin residues in drinking water do not exceed EPA
level of concern.
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Chronic RfD (mg/kg/ TMRC Food Exposure Max Water Exposure1 DWLOC 2,3,4 (g/L)
--------------------------------------------------------------------------------------------------------------------------------------------------------
US Population (48 States)....................................... 0.18 0.0026 0.18 6200
Females (13 + years old, not pregnant or nursing)............... 0.18 0.0029 0.18 5300
Non-nursing Infants (< 1="" year="" old)..............................="" 0.18="" 0.010="" 0.17="" 1700="" --------------------------------------------------------------------------------------------------------------------------------------------------------="">1 Maximum Water Exposure (mg/kg/day) = Chronic RfD (mg/kg/day) - TMRC from DRES (mg/kg/day)
2 DWLOC(g/L) = Max water exposure (mg/kg/day) * body wt (kg) /[(10-3 mg/g)*water consumed daily (L/day)]
3 HED Default body wts for males, females, and children are 70 kg, 60 kg, and 10 kg respectively.
4 HED Default Daily Drinking Rates are 2 L/Day for Adults and 1 L/Day for children
7. From non-dietary exposure. Azoxystrobin is not currently
registered for any residential uses.
8. Cumulative exposure to substances with common mechanism of
toxicity. Azoxystrobin is related to the naturally occurring
strobilurins. There are no other members of this class of fungicides
registered with the Agency. 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.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Chronic risk. Using the conservative TMRC exposure assumptions
described above, and taking into account the completeness and
reliability of the toxicity data, EPA has estimated the exposure to
azoxystrobin from food will utilize 1.5% of the RfD for the U.S.
population. 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
azoxystrobin in drinking water, EPA does not expect the aggregate
exposure to exceed 100% of the RfD. Under current EPA guidelines, the
registered non-dietary uses of azoxystrobin do not constitute a chronic
exposure scenario. EPA concludes that there is a reasonable certainty
that no harm will result from chronic aggregate exposure to
azoxystrobin residues. EPA concludes that there is a reasonable
certainty that no harm will result from aggregate exposure to
azoxystrobin residues.
2. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. This risk assessment is not applicable since no
indoor and outdoor residential exposure uses are currently registered
for azoxystrobin.
D. Aggregate Cancer Risk for U.S. Population
The Agency determined that azoxystrobin should be classified as
[[Page 65082]]
``Not Likely'' to be a human carcinogen according to the proposed
revised Cancer Guidelines. The Agency has therefore not conducted a
cancer risk assessment.
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 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 maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a MOE analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. EPA believes that reliable data support using the standard MOE
and uncertainty factor (usually 100 for combined inter- and intra-
species variability) and not the additional tenfold MOE/uncertainty
factor when EPA has a complete data base under existing guidelines and
when the severity of the effect in infants or children or the potency
or unusual toxic properties of a compound do not raise concerns
regarding the adequacy of the standard MOE/safety factor.
ii. Developmental toxicity studies -- a. Rabbit. In the
developmental toxicity study in rabbits, developmental NOAEL 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 NOAEL 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) NOAEL 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) NOAEL was 100 mg/kg/day (HDT).
iii. Reproductive toxicity study -- Rat. In the reproductive
toxicity study in rats, the parental (systemic) NOAEL 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
NOAEL 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.
iv. Pre- and post-natal sensitivity. The pre- and post-natal
toxicology data base for azoxystrobin is complete with respect to
current toxicological data requirements.
v. Conclusion. 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 additional 10x
safety factor to account for sensitivity of infants and children was
removed by the Agency.
2. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to
azoxystrobin from food will utilize 1.9% to 5.6% of the RfD for infants
and children. EPA generally has no concern for exposures below 100% of
the RfD because the RfD represents the level at or below which daily
aggregate dietary exposure over a lifetime will not pose appreciable
risks to human health. Despite the potential for exposure to
azoxystrobin in drinking water and from non-dietary, non-occupational
exposure, EPA does not expect the aggregate exposure to exceed 100% of
the RfD. EPA concludes that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to
azoxystrobin residues.
V. Other Considerations
A. Metabolism In Plants and Animals
The nature of the residue in grapes is adequately understood.
These data are being translated for sugar beets for this section 18
temporary tolerance.
The qualitative nature of the residue in animals is adequately
understood for the purposes of this section 18 request. A ruminant
metabolism study has been submitted, however the animal metabolism data
have not been reviewed by the Office of Pesticide Program's Metabolism
Assessment Review Committee. The residues of concern in ruminants
appears to be different from that of plants. Unidentified metabolite
compounds, designated metabolites 2, 20, and 28, appear to be the major
components of the residue in ruminant tissues. For the purposes of
these time-limited tolerances for emergency exemptions only, the
residues of concern in animal tissues are azoxystrobin and its Z-
isomer.
As sugar beet commodities are not considered to be major poultry
feed items, the nature and the magnitude of residues in poultry and
eggs are not of concern for the this section 18.
B. Analytical Enforcement Methodology
A method (SOP RAM 243/03, GLC/NPD) to determine residues of
azoxystrobin and its Z isomer in banana, peach, peanut, tomato, and
wheat commodities has been submitted. This method has been
independently validated as per PR Notice 88-5. An Agency validation of
this method is pending. The Agency concludes this method is adequate
for enforcement of the requested section 18 tolerances on plant
commodities.
GLC/NPD method RAM 255/01 is adequate for collection of residue
data for azoxystrobin in animal commodities. Adequate independent
method validation and concurrent method recovery data have been
submitted. Method SOP RAM 255/01 has been submitted for Agency method
validation. RAB2 concludes this method is adequate for enforcement of
the necessary section 18 tolerances on livestock commodities.
C. Magnitude of Residues
Residue data for azoxystrobin and its Z-isomer in banana pulp and
in watercress were translated to sugar beet roots and tops,
respectively. Residues are not expected to exceed 0.05 ppm in sugar
beet roots and 0.2 ppm in sugar beet tops as a result of this section
18 use.
According to the OPPTS Test Guidelines (860.1520), a maximum
theoretical concentration factor of 12.5 is noted for the processing of
sugar beet roots to refined sugar. The Agency has applied this factor
to the tolerance level of sugar beet roots to determine the tolerance
level for refined sugar and molasses. Thus, the tolerance level for
azoxystrobin and its Z-isomer in beet, sugar, refined sugar and
molasses will be set at 0.7 ppm. The Agency applied a factor of 20 to
the tolerance level of sugar beet roots to determine the tolerance
level for the dried pulp. Therefore, the tolerance level for
[[Page 65083]]
azoxystrobin and its Z-isomer in beet, sugar, pulp, dried will be set
at 1.0 ppm.
The existing ruminant tolerances established in conjunction with a
previous section 18 request are adequate to cover the proposed uses.
The addition of sugar beet commodities to the diet of ruminants will
not significantly increase the dietary burden for azoxystrobin
residues. The expiration date of livestock commodity tolerances will be
extended to the expiration date of the sugar beet tolerances
established with this section 18 request. In addition, EPA will
establish tolerances for residues of azoxystrobin and its Z-isomer in/
on kidney of goats, hogs, horses, and sheep at 0.06 ppm.
D. International Residue Limits
There are no Codex, Canadian, or Mexican Maximum Residue Limits
(MRL) for azoxystrobin on sugar beet commodities. Thus, harmonization
is not an issue for these section 18 requests.
E. Rotational Crop Restrictions
Rotational crop data were previously submitted. Based on this
information, a 45 day plantback interval is appropriate for all crops.
VI. Conclusion
Therefore, tolerances are established for combined residues of
azoxystrobin and its Z isomer in sugar beets and soybeans at 0.05 ppm,
and 1.0 ppm respectively .
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 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 January 25, 1999, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the 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 Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300759] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under FFDCA section
408(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since these tolerances and exemptions that are
established under FFDCA section 408 (l)(6), such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. Nevertheless, the Agency has previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
entities and concluded, as a generic matter, that there is no adverse
economic impact. The factual basis for the Agency's
[[Page 65084]]
generic certification for tolerance actions published on May 4, 1981
(46 FR 24950), and was provided to the Chief Counsel for Advocacy of
the Small Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local, or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide to OMB, in a separately
identified section of the preamble to the rule, a description of the
extent of EPA's prior consultation with representatives of affected
tribal governments, a summary of the nature of their concerns, and a
statement supporting the need to issue the regulation. In addition,
Executive Order 13084 requires EPA to develop an effective process
permitting elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
X. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submitted 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 rule in the Federal Register. This 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 10, 1998.
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 and 371.
2. In Sec. 180.507, by alphabetically adding the following
commodities to the table in paragraph (b) to read as follows:
Sec. 180.507 Azoxystrobin; tolerances for residues.
* * * * *
(b)* * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Aspirated soybean grain 10. 6/30/00
fractions.
* * * * * * *
Kidney of goats, hogs, and sheep 0.06 6/30/00
grazed on sugar beets.
* * * * * * *
Sugar beet roots................ 0.05 6/30/00
Sugar beet tops................. 0.20 6/30/00
Sugar beet, molasses............ 0.70 6/30/00
Sugar beet, pulp, dried......... 1.0 6/30/00
Sugar beet, refined sugar....... 0.70 6/30/00
Soybean hay..................... 1.0 6/30/00
Soybean forage.................. 0.2 6/30/00
Soybean hulls................... 2.0 6/30/00
Soybean meal.................... 0.3 6/30/00
Soybean oil..................... 2.0 6/30/00
[[Page 65085]]
Soybean seed.................... 0.1 6/30/00
Soybean silage.................. 2.0 6/30/00
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-31545 Filed 11-24-98; 8:45 am]
BILLING CODE 6560-50-F
