[Federal Register Volume 64, Number 56 (Wednesday, March 24, 1999)]
[Rules and Regulations]
[Pages 14106-14113]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7175]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300805; FRL-6066-4]
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 in or on lettuce and spinach. 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 lettuce grown in California. This
regulation establishes a maximum permissible level 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 September 30, 2000.
DATES: This regulation is effective March 24, 1999. Objections and
requests for hearings must be received by EPA on or before May 24,
1999.
[[Page 14107]]
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300805], 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-300805], 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, Crystal Mall #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@epa.gov. Copies of electronic 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 electronic objections and hearing
requests must be identified by the docket control number [OPP-300805].
No Confidential Business Information (CBI) should be submitted through
e-mail. Copies of electronic objections and hearing requests on this
rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Jacqueline E. 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: Rm. 278, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-6792, e-
mail: gwaltney.jackie@epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408 and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a and (l)(6), is establishing a tolerance for
combined residues of the fungicide, in or on lettuce, leaf at 20.0 part
per million (ppm); lettuce, head at 6.0 ppm and spinach at 25 ppm.
These tolerances will expire and be revoked on September 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 Findings
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 in this preeamble 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 tolerances 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 Lettuce and FFDCA
Tolerances
The California Department of Pesticide Regulation requested on
December 30, 1998 a specific exemption for the use of azoxystrobin on
lettuce to control anthracnose. This is the first year this use has
been requested under section 18 of FIFRA. Anthracnose became a serious
economic problem during the late winter-spring 1998, the lettuce
growing season in California. This disease has not been reported in
previous years, and it has never reached the infestation levels
experienced in 1998. Under moderate to severe infestation conditions,
anthracnose will cause reduction in yield and crop quality, with
resultant economic losses to growers. The growers in the Salinas Valley
estimate losses ranging from 20-60%, to a complete loss in some fields.
EPA has authorized under FIFRA section 18 the use of azoxystrobin on
lettuce for control of Anthracnose in California. After having reviewed
the submission, EPA concurs that emergency conditions exist for this
state.
The Maryland Department of Agriculture requested on February 19,
1999 a specific exemption for the use of azoxystrobin on spinach to
control white rust. This is the first year this use has been requested
under section 18 of FIFRA. White rust is one of the most serious
constraints to increased spinach production, and disease control
represents a large production investment in the mid-atlantic. The most
severe disease of spinach whithin the region is white rust caused by
Albugo occidentalis. When this disease is not controlled, losses in
yield can be severe. White rust can cause dramatic quality reductions
to the crop and can render a processing spinach crop unmarketable. EPA
has authorized under FIFRA section 18 the use of azoxystrobin on
spinach for control of white rust in Maryland. After having reviewed
the submission, EPA concurs
[[Page 14108]]
that emergency conditions exist for this state.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of azoxystrobin in or on
lettuce. In doing so, EPA considered the 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 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 September 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
lettuce 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 lettuce 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 California to use this pesticide on this crop under
section 18 of FIFRA without following all provisions of EPA's
regulations implementing section 18 as identified in 40 CFR part 166.
For additional information regarding the emergency exemption for
azoxystrobin, contact the Agency's Registration Division at the address
provided under the ``ADDRESSES'' section.
III. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7) .
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
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 on lettuce, leaf at 20.0 ppm;
lettuce, head at 6.0 ppm and spinach at 25.0 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 studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by azoxystrobin are
discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. The Agency did not identify an acute dietary
endpoint and has determined that this risk assessment is not required.
2. Short- and intermediate-term toxicity. No toxic endpoints for
these durations of exposure were identified in the toxicological data
base.
3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for azoxystrobin at 0.18 milligrams/kilogram/day (mg/kg/day). The RfD,
based on a chronic toxicity study in rats with a no observed adverse
effect level of 18.2 mg/kg/day, was established at 0.18 mg/kg/day.
Reduced body weights and bile duct lesions were observed at the lowest
obseved adverse effect level 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. Azoxystrobin has been classified by the
Agency's RfD Committee 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.
C. Exposures and Risks
In examining aggregate exposure, FQPA directs EPA to consider
available information concerning exposures to the pesticide 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 and/or
outdoor uses). In evaluating food exposures, EPA takes into account
varying consumption patterns of major identifiable subgroups of
consumers, including infants and children.
1. From food and feed uses. Tolerances have been established (40
CFR 180.507) for the combined residues of azoxystrobin, in or on a
variety of raw agricultural commodities. 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 peanuts and 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. No toxicological effects which could
be attributed to a single dietary exposure were observed, including
developmental and neurotoxic effects in the appropriate studies. Acute
dietary risk assessments are performed for a food-use pesticide if a
toxicological study has indicated the possibility of an effect of
concern occurring as a result of a 1-day or single exposure.
ii. Chronic exposure and risk-- (Chronic RfD = 0.18 mg/kg/day). In
conducting this chronic dietary risk assessment, EPA has made very
conservative assumptions: 100% of lettuce commodities and all other
commodities having azoxystrobin tolerances will contain azoxystrobin
residues and those residues will be at the level of the tolerance.
Default concentration factors have been removed (i.e., set to 1) for
the following commodities: grapes-juice, grapes-raisins, tomatoes-
juice, tomatoes-puree, and potatoes-white (dry). Concentration factors
were removed because data which were previously submitted show no
concentration of residues into raisins, grape juice, tomato juice and
puree or potatoes. The Novigen DEEM
[[Page 14109]]
(Dietary Exposure Evaluation Model) system was used for this chronic
dietary exposure analysis. The analysis evaluates individual food
consumption as reported by respondents in the USDA Continuing Surveys
of Food Intake by Individuals conducted in 1989 through 1991. The model
accumulates exposure to the chemical for each commodity and expresses
risk as a function of dietary exposure. 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 Chronic
RfD:
------------------------------------------------------------------------
Percent
Exposure Reference
Population Subgroup (mg/kg/ Dose \1\
day) (%Chronic
RfD)
------------------------------------------------------------------------
U.S. Population (48 States)........................ 0.0052 2.9
All Infants (<1 year="" old)..........................="" 0.012="" 6.7="" nursing="" infants=""><1 year="" old)......................="" 0.0036="" 2.0="" non-nursing="" infants=""><1 year="" old)..................="" 0.016="" 8.6="" children="" (1-6="" years="" old)...........................="" 0.010="" 5.6="" children="" (7-12="" years="" old)..........................="" 0.0068="" 3.8="" u.s.="" population="" (spring="" season)....................="" 0.0060="" 3.3="" u.s.="" population="" (summer="" season)....................="" 0.0056="" 3.1="" northeast="" region...................................="" 0.0058="" 3.2="" western="" region.....................................="" 0.0055="" 3.0="" pacific="" region.....................................="" 0.0057="" 3.2="" hispanics..........................................="" 0.0060="" 3.3="" non-hispanic="" (other="" than="" black="" or="" white)...........="" 0.0086="" 4.8="" females="" (13+/nursing)..............................="" 0.0064="" 3.6="" ------------------------------------------------------------------------="" \1\percentage="" reference="" dose="" (%="" chronic="" rfd)="Exposure/Chronic" rfd="" x="" 100%="" the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (48="" states);="" (2)="" those="" for="" infants="" and="" children;="" and,="" (3)="" the="" other="" subgroups="" for="" which="" the="" percentage="" of="" the="" chronic="" rfd="" occupied="" is="" greater="" than="" that="" occupied="" by="" the="" subgroup="" u.s.="" population="" (48="" states).="" 2.="" from="" drinking="" water.="" azoxystrobin="" is="" persistent="" and="" mobile.="" 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="" (epa="" safe="" drinking="" water="" hotline,="" 1(800)426-4791,="" january="" 27,="" 1999).="" epa="" has="" estimates="" for="" the="" concentration="" of="" azoxystrobin="" in="" surface="" water="" based="" on="" geneec="" (generic="" estimated="" environmental="" concentration)="" modeling.="" chronic="" exposure="" and="" risk.="" estimated="" environmental="" concentrations="" (eecs)="" using="" geneec="" for="" azoxystrobin="" on="" bananas,="" grapes,="" peaches,="" peanuts,="" pecans,="" tomatoes,="" and="" wheat="" are="" listed="" in="" the="" swat="" team="" second="" interim="" report="" (june="" 20,="" 1997).="" the="" highest="" eec="" for="" azoxystrobin="" in="" surface="" water="" (39="">g/L) is
from the application of azoxystrobin to grapes. The EEC for ground
water is 0.064 g/L resulting from use on turf. For purposes of
risk assessment, the maximum EEC for azoxystrobin in drinking water (39
g/L) should be used for comparison to the back-calculated
human health drinking water levels of comparison (DWLOC) for the
chronic (non-cancer) endpoint. These DWLOCs for various population
categories are summarized in the following table.
Drinking Water Levels of Comparison for Chronic Exposure \1\
----------------------------------------------------------------------------------------------------------------
Food Maximum
Chronic Exposure Water DWLOC 4,5,6
Population Category \2\ RfD (mg/ (mg/kg/ Exposure (g/
kg/day) day) \3\ (mg/kg/ L)
-------------------------------------------------------------------------------------------day)-----------------
U.S. Population (48 states)....................................... 0.18 0.0052 0.17 6,100
Females (13+ years, nursing)...................................... 0.18 0.0064 0.17 5,200
Non-nursing Infants (<1 year="" old).................................="" 0.18="" 0.016="" 0.16="" 1,600="" ----------------------------------------------------------------------------------------------------------------="" \1\="" values="" are="" expressed="" to="" 2="" significant="" figures.="" \2\="" within="" each="" of="" these="" categories,="" the="" subgroup="" with="" the="" highest="" food="" exposure="" was="" selected.="" \3\="" maximum="" water="" exposure="" (chronic)="" (mg/kg/day)="Chronic" rfd="" (mg/kg/day)="" -="" food="" exposure="" (mg/kg/day).="" \4\="">g/L) = Max. water exposure (mg/kg/day) x body wt (kg) [(10-3 mg/g) * water
consumed daily (L/day)].
\5\ HED Default body weights are: General U.S. Population, 70 kg; Males (13+ years old), 70 kg; Females (13+
years old), 60 kg; Other Adult Populations, 70 kg; and, All Infants/Children, 10 kg.
\6\ HED Default daily drinking rates are 2 L/day for adults and 1 L/day for children.
The estimated maximum concentrations of azoxystrobin in surface water
and ground water are less than EPA's levels of comparison for
azoxystrobin in drinking water as a contribution to chronic aggregate
exposure. Therefore, taking into account the present uses and uses
proposed in this Section 18 and the fact that GENEEC can substantially
overestimate (by up to 3x) true pesticide concentrations in drinking
water, EPA concludes with reasonable certainty that residues of
azoxystrobin in drinking water (when considered along with other
sources of chronic exposure for which EPA has reliable data) would not
result in an unacceptable estimate of chronic (non-cancer) aggregate
human health risk at this time.
EPA bases this determination on a comparison of estimated average
concentrations of azoxystrobin in surface and ground water to back-
calculated DWLOCs for azoxystrobin in drinking water. These levels of
comparison in drinking water were determined after EPA considered all
other non-occupational human exposures for which it has reliable data,
including all current uses, and the use considered in this action. The
estimate of azoxystrobin in surface water is derived from a water
quality model that uses conservative assumptions (health-protective)
regarding the pesticide transport from the point of application to
surface and ground water. Because EPA considers the aggregate risk
resulting from multiple exposure pathways associated with a pesticide's
uses, levels of comparison in drinking water may vary as those uses
change. If new uses are added in the future, EPA will reassess the
potential impacts of azoxystrobin in drinking water as a part
[[Page 14110]]
of the chronic (non-cancer) aggregate risk assessment process.
3. From non-dietary exposure. Azoxystrobin is currently registered
for use on the following residential non-food sites: A search of
References indicated that azoxystrobin (Heritage formulation) is
registered for residential use on ornamental turf. Short-term exposure
may occur for residential handlers and for postapplication activities.
Because the TES Committee did not select applicable acute dietary or
short-term dermal or inhalation endpoints, a short-term risk assessment
is not required. No toxicity was observed at the limit dose (1,000 mg/
kg body wt/day) in a 21-day dermal study and an acute inhalation study
indicated low toxicity. Intermediate-term and chronic exposures are not
expected for residential use.
4. 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.''
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. For more information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961,
November 26, 1997).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Chronic risk. Using the conservative Theoretical Maximum Residue
Contribution 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 4.8% of
the Chronic RfD for the most highly exposed adult population subgroup
(Non-Hispanic (other than black or white)). The exposure to
azoxystrobin from food for infants and children will utilize from 2.0%
to 8.6% of the chronic RfD. EPA generally has no concern for exposures
below 100% of the Chronic RfD (when the FQPA 10x safety factor is
removed, as is the case with azoxystrobin) because the Chronic RfD
represents the level at which daily aggregate oral 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 Chronic RfD.
Chronic exposures are not expected for residential uses. EPA concludes
that there is a reasonable certainty that no harm will result to
adults, infants, or children from chronic aggregate exposure to
azoxystrobin residues.
2. Short- and intermediate-term risk. There are no applicable
endpoints for short-term exposure, therefore, a short-term aggregate
risk assessment is not required. Intermediate-term exposure is not
expected for registered residential uses, therefore, an intermediate-
term risk assessment is not required.
3. Aggregate cancer risk for U.S. population. The EPA 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. Therefore, a cancer risk
assessment is not required.
4. Endocrine disrupter effects. EPA is required to develop a
screening program to determine whether certain substances (including
all pesticides and inerts) ``may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect....'' The Agency is currently working with
interested stakeholders, including other government agencies, public
interest groups, industry, and research scientists in developing a
screening and testing program and a priority setting scheme to
implement this program. Congress has allowed 3 years from the passage
of FQPA (August 3, 1999) to implement this program. At that time, EPA
may require further testing of this active ingredient and end use
products for endocrine disrupter effects.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to azoxystrobin residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children--i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of 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 data base unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a margin of exposure (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. Conclusion. There is a complete toxicity data base for
azoxystrobin and exposure data is complete or is estimated based on
data that reasonably accounts for potential exposures.
2. Acute risk. This is not applicable since no toxicological
endpoints of concern were identified during review of the data.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to azoxystrobin from
food will utilize 2-8.6% 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.
4. Determination of safety. Based on these risk assessments, EPA
concludes
[[Page 14111]]
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to azoxystrobin residues.
IV. Other Considerations
A. Metabolism In Plants and Animals
1. Plants. The nature of the residue in plants is adequately
understood. The HED Metabolism Assessment Review Committee (MARC) met
on November 10, 1998 and determined that the residue of concern in
plants is azoxystrobin and its Z isomer, R230310. The committee based
this determination on the results of metabolism studies done on grapes,
peanuts, and wheat. In all three studies the major residues were
azoxystrobin and R230310. RAB2 will translate these data to lettuce for
this Section 18.
2. Animals. As there are no animal feed items associated with
lettuce, the nature of the residue in animal commodities is not of
concern for this Section 18.
B. Analytical Enforcement Methodology
Adequate methodology (RAM 243, GC/NPD, MRID No. 445951-05) is
available for enforcement of the proposed tolerance in/on lettuce. This
method will be submitted to FDA for inclusion in PAM. The method may be
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm 101FF, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5229.
C. Magnitude of Residues
Zeneca Ag Products has submitted field trial data for a variety of
crops. The data from cherries were translated to lettuce for the
purposes of this Section 18 only. The data were submitted in
conjunction with a request for the establishment of a permanent
tolerance on the stone fruit crop group. In choosing a crop to
translate data from, the following criteria were considered:
azoxystrobin application rate, PHI, and plant morphology. Several crops
had similar application rates, but cherries had the most similar PHI.
D. International Residue Limits
There are no CODEX, Canadian, or Mexican maximum residue limits
for azoxystrobin on lettuce commodities. Thus, harmonization is not an
issue for this Section 18 request.
E. Rotational Crop Restrictions
Rotational crop data were previously submitted. Based on this
information, a 45-day plantback interval is appropriate for all crops
other than those with azoxystrobin tolerances.
V. Conclusion
Therefore, the tolerance is established for combined residues of
azoxystrobin in lettuce, leaf at 20.0 ppm; lettuce, head at 6.0 ppm;
and spinach at 25.0 ppm.
VI. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation 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 May 24, 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 under the ``ADDRESSES'' section (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). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection.'' For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, 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: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697, tompkins.jim@epa.gov. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
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.
VII. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300805] (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 Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov.
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit 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
[[Page 14112]]
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408 of the
FFDCA. 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
specficed 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 tolerances and exemptions that are established
on the basis of a petition 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 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.
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 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.
IX. 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 submit a rule report, which includes a copy of the rule,
to each House of the Congress and 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 the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 16, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.507, paragraph (b), by adding an entry for
``lettuce, leaf'', ``lettuce, head'', and ``spinach'', to the table to
read as follows:
Sec. 180.507 Azoxystrobin; tolerance for residues.
* * * * *
(b) Section 18 emergency exemptions.* * *
------------------------------------------------------------------------
Parts Expiration/
Commodity per Revocation
million date
------------------------------------------------------------------------
* * * * *
Lettuce, head..................................... 6.0 9/30/00
Lettuce, leaf..................................... 20.0 9/30/00
* * * * *
Spinach........................................... 25.0 9/30/00
[[Page 14113]]
* * * * *
------------------------------------------------------------------------
[FR Doc. 99-7175 Filed 3-23-99; 8:45 am]
BILLING CODE 6560-50-F
