[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]


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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.

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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: [email protected]. 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: [email protected].

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\ DWLOC(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, [email protected]. 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:
     [email protected].

    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