[Federal Register Volume 63, Number 108 (Friday, June 5, 1998)]
[Rules and Regulations]
[Pages 30636-30642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15020]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300664; FRL-5793-6]
RIN 2070-AB78
Azoxystrobin; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
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 parsley . 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
parsley in Ohio. This regulation establishes maximum permissible levels
for residues of azoxystrobin in this food commodity pursuant to section
408(l)(6) of the Federal Food, Drug, and Cosmetic Act, as amended by
the Food Quality Protection Act of 1996. The tolerance will expire and
is revoked on June 30, 1999.
DATES: This regulation is effective June 5, 1998. Objections and
requests for hearings must be received by EPA on or before August 4,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300664], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300664], 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: [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 5.1/6.1
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-300664]. 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), 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) 308-9359, e-mail:
[email protected].
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 the fungicide azoxystrobin and its Z isomer, in or
on fresh parsley at 0.5 and dried parsley at 1.0 part per million
(ppm). This tolerance will expire and is revoked on June 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 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
[[Page 30637]]
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 Parsley and FFDCA
Tolerances
The Ohio Department of Agriculture requested an emergency exemption
in April of 1998 for the control of septoria leaf blight in parsley. No
foliar fungicides are currently labeled for use on parsley. Seed
treatment (disinfestation) is not practical due to the high seeding
rate used, and seed testing does not appear to be sufficiently
sensitive to identify Septoria contamination in seed lots. Once
Septoria leaf blight occurs in a field, the field should not be planted
to parsley or other umbelliferous crops for 4-5 years. Such long
rotations are impractical for muck crop production areas in Ohio due to
land availability restriction. Crop rotation also cannot assure disease
control since the pathogen may originate on the seed. For these
reasons, EPA has authorized under FIFRA section 18 the use of
azoxystrobin on parsley for control of Septoria leaf blight in parsley
in Ohio.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of azoxystrobin in or on
parsley. 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 is revoked on June
30, 1999, under FFDCA section 408(l)(5), residues of the pesticide not
in excess of the amounts specified in the tolerance remaining in or on
parsley 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 parsley 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 Ohio to use this pesticide on this 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. Toxicity
1. Threshold and non-threshold effects. For many animal 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
[[Page 30638]]
is warranted. Thus, an aggregate daily exposure to a pesticide residue
at or below the RfD (expressed as 100% or less of the RfD) is generally
considered acceptable by EPA. 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.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute,'' ``short-term,''
``intermediate term,'' and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases, and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
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, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). 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. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
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% of the crop 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 crop treated data) which show, generally, that
pesticide residues in most foods when they are eaten are well below
established tolerances.
Percent of crop treated estimates are derived from federal and
private market survey data. Typically, a range of estimates are
supplied and the upper end of this range is assumed for the exposure
assessment. By using this upper end estimate of percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (nonursing
infants (<1year old) was not regionally based.
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, 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 a time-limited tolerance for
combined residues of azoxystrobin and its Z isomer) on fresh parsley at
0.5 and for dried parsley at 1.0 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
[[Page 30639]]
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.
Note: From a 21-day dermal toxicity study the NOEL was 1,000
milligrams/kilogram/day (mg/kg/day)( at the highest dose tested
(HDT) (Acute inhalation toxicity category III).
3. Chronic toxicity. EPA has established the RfD for azoxystrobin
at 0.18 mg/kg/day. This RfD is based on on a chronic toxicity study in
rats with a NOEL 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 HED RfD/Peer Review Committee (November 7,
1996) 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:
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 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.
ii. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, HED 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 -- which result in an overestimation of human dietary
exposure. Thus, in making a safety determination for this tolerance,
HED 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:
------------------------------------------------------------------------
Population Sub-Group TMRC (mg/kg/day) % RFD
------------------------------------------------------------------------
U.S. population (48 States)..... 0.002 1
Nursing infants (<1 year old)... 0.004 2
Non-nursing infants (<1 year 0.009 5
old).
Children (1-6 years old)........ 0.005 3
Children (7-12 years old)....... 0.003 2
Hispanics....................... 0.003 2
Non-Hispanics Others............ 0.005 3
U.S. Population (summer season). 0.003 2
Females (13-19, not pregnant or 0.002 1
nursing).
------------------------------------------------------------------------
The subgroups listed above are: (a) the U.S. population (48 states);
(b) those for infants and children; (c) females (13-19 years old, not
pregnant or nursing); and, (d) the other subgroups for which the
percentage of the RfD occupied is greater than that occupied by the
subgroup U.S. population (48 States).
2. 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.
i. Acute exposure and risk. An assessment was not appropriate since
no toxicological endpoint of concern was identified during review of
the available data.
ii. 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 RAB2s level of
concern.
Drinking Water Levels of Concern
----------------------------------------------------------------------------------------------------------------
TMRC [Food Max Water
RfD (mg/kg/day) Exposure] (mg/kg/ Exposure1 (mg/kg/ DWLOC 2,3,4 ( g/L)
day) day)
----------------------------------------------------------------------------------------------------------------
US Population (48 States)....... 0.18 0.00231 0.178 6,200
Females (13 + years old, not 0.18 0.00176 0.178 5,300
pregnant or nursing).
Non-nursing Infants (< 1 year 0.18 0.00879 0.171 1,700
old).
----------------------------------------------------------------------------------------------------------------
\1\ Maximum Water Exposure (mg/kg/day) = 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.
3. From non-dietary exposure. Azoxystrobin is not currently
registered for use on residential non-food sites.
4. 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.
[[Page 30640]]
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. Acute risk. This is not applicable since no toxicological end-
point of concern was identified during review of the available data.
2. Chronic risk. Using the conservative TMRC exposure assumptions
described above, and taking into account the completeness and
reliability of the toxicity data, HED has estimated the exposure to
azoxystrobin from food will utilize 1% of the RfD for the U.S.
population. HED 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, HED does not expect the aggregate
exposure to exceed 100% of the RfD. Under current HED guidelines, the
registered non-dietary uses of azoxystrobin do not constitute a chronic
exposure scenario. HED 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.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. This risk assessment is not applicable since no
indoor and outdoor residential exposure uses are currently registered
for azoxystrobin.
D. 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 two-
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 NOEL was 500 mg/
kg/day, at the 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).
iii. Reproductive toxicity study-- Rat. In the reproductive
toxicity study (MRID #43678144) 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.
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. The results of these
[[Page 30641]]
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 an ad hoc FQPA Safety Factor
Committee.
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 an ad hoc FQPA Safety Factor Committee.
2. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that aggregate exposure to
azoxystrobin from food will utilize 2 to 5% 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
1. The nature of the residue in grapes is adequately understood.
These data are being translated for watercress for this temporary
tolerance.
2. 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.
B. Analytical Enforcement Methodology
1. 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.
2. 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
Residues of azoxystrobin and its Z isomer are not expected to
exceed 0.5 ppm in/on fresh parsley and 1.0 ppm in/on dried parsley as a
result of this section 18 use. Time-limited tolerances should be
established at this level.
D. International Residue Limits
There are no CODEX, Canadian, or Mexican Maximum Residue Limits
(MRL) for azoxystrobin on parsley. 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, the tolerance is established for combined residues of
azoxystrobin and its Z isomer in parsley at 0.5 and for dried parsley
at 1.0 ppm.
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 August 4, 1998, 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-300664] (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.,
[[Page 30642]]
Monday through Friday, excluding legal holidays. The public record is
located in Room 119 of the Public Information and Records Integrity
Branch, Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA.
Electronic comments may be sent directly to EPA at:
[email protected].
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
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. 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 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.
X. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has 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 this rule in
today's 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: May 20, 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. Section 180.507 is amended in paragraph (b) by alphabetically
adding the following commodities to the table to read as follows:
Sec. 180.507 Azoxystrobin; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
* * * * *
* *
Parsley, dried.................. 1.0 6/30/99
Parsley, fresh.................. 0.5 6/30/99
* * * * *
* *
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-15020 Filed 6-4-98; 8:45 am]
BILLING CODE 6560-50-F