[Federal Register Volume 65, Number 201 (Tuesday, October 17, 2000)]
[Rules and Regulations]
[Pages 61270-61278]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26638]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301049; FRL-6742-9]
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 
residues of azoxystrobin or methyl (E)-2-2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl-3-methoxyacrylate) and its Z 
isomer in or on brassica leafy vegetable. This action is in response to 
EPA's granting of an emergency exemption under section 18 of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing 
use of the pesticide on brassica leafy vegetable. This regulation 
establishes a maximum permissible level for residues of azoxystrobin in 
this food commodity. The tolerance will expire and is revoked on 
December 31, 2001.

DATES:  This regulation is effective October 17, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301049, 
must be received by EPA on or before December 18, 2000.

ADDRESSES:  Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301049 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Jacqueline E. Gwaltney, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: 703 305-6792; and e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:   

[[Page 61271]]

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected categories and entities may include, but are not 
limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                      affected  entities
------------------------------------------------------------------------
Industry                          111...............  Crop production
  ..............................  112...............  Animal production
                                  311                 Food manufacturing
  ..............................  32532.............  Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of This 
Document and Other Related Documents?

    1. Electronically.You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301049. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408 (l)(6) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is 
establishing a tolerance for residues of the fungicide azoxystrobin or 
methyl (E)-2-2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl-3-
methoxyacrylate) and its Z isomer, in or on brassica leafy vegetable at 
25.0 parts per million (ppm). This tolerance will expire and is revoked 
on December 31, 2001. EPA will publish a document in the Federal 
Register to remove the revoked tolerances from the Code of Federal 
Regulations.
    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. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.
    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 the Federal Insecticide, Fungicide, and Rodenticide 
Act (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 
the Food Quality Protection Act (FQPA). EPA has established regulations 
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Azoxystrobin on Brassica Leafy 
Vegetable and FFDCA Tolerances

    Georgia has also requested the use of azoxystrobin to control leaf 
spots of leafy greens caused by Cercospora brassicicola and 
cercosporella brassica. Losses due to these fungal pathogens have 
increased in recent year and, in some cases, entire fields are 
destroyed because leaves of greens are unmarketable due to spotting.
    EPA has authorized under FIFRA section 18 the use of azoxystrobin 
on brassica leafy vegetable. After having reviewed the submission, EPA 
concurs 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 
brassica leafy vegetable. 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 as provided in section 408(l)(6). Although these 
tolerances will expire and are revoked on December 31, 2001, under 
FFDCA section 408(l)(5), residues of the pesticide not in excess of the 
amounts specified in the tolerance remaining in or on brassica leafy 
vegetable 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

[[Page 61272]]

pesticide indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether azoxystrobin 
meets EPA's registration requirements for use on brassica leafy 
vegetable 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 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 FOR FURTHER INFORMATION CONTACT.

IV. 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 tolerances for 
residues of azoxystrobin in or on brassica leafy vegetable at 25.0 ppm. 
EPA's assessment of the dietary exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect uncertainties inherent in the extrapolation from laboratory 
animal data to humans and in the variations in sensitivity among 
members of the human population as well as other unknowns. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intra species differences. Discuss any additional uncertainty 
factors (other than the FQPA SF) used in the assessment.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD=NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE)=NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10\-6 \or one in a million). Under 
certain specific circumstances, MOE calculations will be used for the 
carcinogenic risk assessment. In this non-linear approach, a ``point of 
departure'' is identified below which carcinogenic effects are not 
expected. The point of departure is typically a NOAEL based on an 
endpoint related to cancer effects though it may be a different value 
derived from the dose response curve. To estimate risk, a ratio of the 
point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for azoxystrobin used for human risk assessment is shown in 
the following Table 1:

    Table 1.--Summary of Toxicological Doses and Endpoints for Azoxystrobin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 TES/RfD/FQPA Committee
               Endpoint                    Dose (mg/kg/day)          Determinations             Conclusion
----------------------------------------------------------------------------------------------------------------
Acute Dietary                                                   No appropriate endpoint  This risk assessment is
                                                                 was identified for       not required.
                                                                 this exposure
                                                                 scenario. No
                                                                 developmental toxicity
                                                                 was observed in the
                                                                 rabbit and rat studies
                                                                 reviewed. Effects seen
                                                                 in the acute
                                                                 neurotoxicity study
                                                                 were due to abdominal
                                                                 discomfort, not
                                                                 primary neurotoxicity
                                                                 (TES Committee, 12/10/
                                                                 96).
----------------------------------------------------------------------------------------------------------------
 
Chronic Dietary                        NOAEL = 18.2 UF = 100    The RfD was established  This risk assessment is
                                                                 based on a chronic       required. Chronic RfD
                                                                 toxicity study           =0.18 mg/kg/day.
                                                                 (MRID43678139
                                                                 ) in rats with a NOAEL
                                                                 of 18.2 mg/kg/day.
                                                                 Reduced body weights
                                                                 and bile duct lesions
                                                                 were observed at the
                                                                 LOAEL of 34 mg/kg/day.
                                                                 An uncertainty factor
                                                                 of 100 was used to
                                                                 account for both the
                                                                 inter-species
                                                                 extrapolation and the
                                                                 intra-species
                                                                 variability (see Memo,
                                                                 RfD Committee, 11/7/
                                                                 96).
----------------------------------------------------------------------------------------------------------------
 

[[Page 61273]]

 
FQPA Safety Factor                                              The FQPA Safety Factor   10x Safety Factor was
                                                                 Committee recommended    removed. The chronic
                                                                 that the10x Safety       population adjusted
                                                                 Factor be removed for    dose is equivalent to
                                                                 the following reasons:   the chronic RfD (cPAD
                                                                 1) the toxicology data   = cRfD).
                                                                 base is complete; 2)
                                                                 the developmental and
                                                                 reproductive toxicity
                                                                 data did not indicate
                                                                 increased
                                                                 susceptibility of rats
                                                                 or rabbits to in utero
                                                                 and/or postnatal
                                                                 exposure; 3) unrefined
                                                                 chronic dietary
                                                                 exposure estimates
                                                                 (assuming all
                                                                 commodities contain
                                                                 tolerance level
                                                                 residues) will
                                                                 overestimate dietary
                                                                 exposure; 4) modeling
                                                                 data are used for
                                                                 ground and surface
                                                                 source drinking water
                                                                 exposure assessments
                                                                 resulting in estimates
                                                                 considered to be upper-
                                                                 bound concentrations;
                                                                 and 5) there are
                                                                 currently no
                                                                 registered residential
                                                                 uses for Azoxystrobin
                                                                 (FQPA document, 9/3/
                                                                 98).
----------------------------------------------------------------------------------------------------------------
 
Carcinogenicity                                                 The HED RfD/Peer Review  A cancer risk assess-
                                                                 Committee determined     ment is not required.
                                                                 that azoxystrobin
                                                                 should be classified
                                                                 as ``Not Likely'' to
                                                                 be a human carcinogen
                                                                 according to the
                                                                 proposed revised
                                                                 Cancer Guidelines (See
                                                                 TES Document, 12/10/
                                                                 96).
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------

B. Residue Information

    Tolerances for azoxystrobin (including time-limited tolerances) are 
published in 40 CFR 180.507. The tree nuts tolerance of 0.01 ppm which 
is listed in the 40 CFR was amended to 0.02 ppm.
     For this analysis, tolerance level residues and 100 percent crop 
treated assumptions were made for all commodities. Processing studies 
show that residues do not concentrate in the following foods: citrus 
juice, grapes-raisins, plums-prunes (dried), potatoes-white (dry), 
grape juice, tomato juice, and tomatoes-puree. As a result, DEEM 
default processing factors (adjustment factors #1) were set to 1.0 for 
these commodities. The concentration factors for the following juice 
concentrates were changed to preserve the concentration ratio from 
juice to concentrate: grapes (3.6 to 3.0), grapefruit (8.3 to 3.9), 
lemons (11.4 to 5.7), limes (6 to 3), oranges (6.7 to 3.7), and 
tangerines (7.4 to 3.2).* The reference to the FQPA Safety Factor 
refers to any additional safety factor retained due to concerns unique 
to the FQPA.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.507) for the residues of azoxystrobin, in or on 
a variety of raw agricultural commodities at levels ranging from 0.010 
ppm in tree nuts to 20 ppm in rice hulls. Included in these tolerances 
are numerous ones for animal commodities which were established in 
conjunction with tolerances for rice and wheat commodities. Risk 
assessments were conducted by EPA to assess dietary exposures from 
azoxystrobin in food as follows:
     i. Acute risk. No toxicological effects which could be attributed 
to a single dietary exposure were observed, including developmental and 
neurotoxic effects in the appropriate studies. The Dietary Exposure 
Evaluation Model (DEEM\ \) analysis evaluated the individual food 
consumption as reported by respondents in the USDA nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII) and 
accumulated exposure to the chemical for each commodity. The following 
assumptions were made for the acute exposure assessments:
    ii. Chronic risk. (Chronic RfD = 0.18 mg/kg/day) In conducting this 
chronic dietary risk assessment, HED has made very conservative 
assumptions: 100% of Brassica vegetables and turnip tops 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, tomato juice and puree or 
potatoes. The default ratio between grape juice and juice concentrate 
was retained.
     The Novigen DEEM (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. As the 10x safety factor 
was removed, the chronic RfD is equal to the PAD (population-adjusted 
dose). As a result, the exposure given as a percentage of the total 
allowable exposure is reported as %PAD, as shown in the following Table 
2:

[[Page 61274]]



    Table 2.--Summary: Chronic Exposure Analysis by the DEEM Systems
------------------------------------------------------------------------
                                                       Percent Reference
       Population Subgroup         Exposure (mg/kg/    Dose 1 (%Chronic
                                         day)              PAD/RfD)
------------------------------------------------------------------------
U.S. Population (total)           0.012207            7.4%
------------------------------------------------------------------------
 
All Infants (less than 1 year     0.014855            11.5%
 old)
------------------------------------------------------------------------
 
Nursing Infants (less than 1      0.003915            3.1%
 year old)
------------------------------------------------------------------------
 
Non-Nursing Infants (less than 1  0.019460            14.0%
 year old)
------------------------------------------------------------------------
 
Children (1-6 years old)          0.021949            12.1%
------------------------------------------------------------------------
 
Children (7-12 years old)         0.012950            7.7%
------------------------------------------------------------------------
 
Non-Hispanic Blacks               0.016431            9.1%
------------------------------------------------------------------------
 
Non-Hispanic/non- white/non-      0.020967            14.8%
 black
------------------------------------------------------------------------
 
Females (13+/nursing)             0.014210            8.8%
------------------------------------------------------------------------
 
Seniors 55+                       0.013462            7.5%
------------------------------------------------------------------------
1 Percentage reference dose (% Chronic PAD) = Exposure/Chronic PAD x
  100% (as RfD=PAD in this case)

     The subgroups listed above are: (1) the U.S. Population (total); 
(2) those for infants and children; and, (3) the other subgroups 
(except regions and seasons) for which the percentage of the Chronic 
PAD occupied is greater than that occupied by the subgroup U.S. 
Population (total).
    iii. Anticipated residue and percent crop treated information. The 
Agency used percent crop treated (PCT) information as follows:
    A routine chronic dietary exposure analysis for the wheat 
hybridizing agent X was based on 0.1% of wheat crop treated, and 0.1% 
of the cereal grains group (except rice, wild rice, sweet corn, and 
wheat) and soybeans as rotated crops in fields previously containing 
wheat treated with chemical X. PCT of 0.1% was based on the 
petitioner's expectations that up to 35,000 acres of wheat grown for 
seed will be treated annually, which amounts to 0.05% of the 70,000,000 
acres of wheat grown in the United States. The reason for using 0.1% 
instead of 0.05% is to allow expansion of use if other conditions of 
registration are satisfied. Before expansion beyond 0.1% is allowed, 
reevaluation of the dietary exposure may be performed using all 
available information.
    The Agency believes that the three conditions previously discussed 
have been met. With respect to Condition 1, EPA finds that the PCT 
information described above for chemical X used on wheat grown for seed 
is reliable and has a valid basis. Chemical X is a hybridizing agent 
specific for sterilizing the male organ of the wheat plant in seed 
production. The majority of seed will be used planting purposes, and 
not directly as food or feed. Before the petitioner can increase 
production of product for treatment of greater than 35,000 acres per 
year, permission from the Agency must be obtained. As to Conditions 2 
and 3, regional consumption information and consumption information for 
significant subpopulations is taken into account through EPA's 
computer-based model for evaluating the exposure of significant 
subpopulations including several regional groups. Use of this 
consumption information in EPA's risk assessment process ensures that 
EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which pesticide X 
may be applied in a particular area.
    2. Dietary exposure 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, 4/15/99). EFED has supplied 
RAB2 with estimates for the concentration of azoxystrobin in surface 
water based on GENEEC (Generic Estimated Environmental Concentration) 
modeling and in ground water based on SCI-GROW modeling.
     Chronic 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 
(6/20/97).
     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 3:

                       Table 3.--Drinking Water Levels of Comparison for Chronic Exposure1
----------------------------------------------------------------------------------------------------------------
                                                                Chronic       Food      Max. Water   DWLOC 4,5,6
                    Population Category2                     RfD  (mg/kg/   Exposure    Exposure3   (g/
                                                                 day)     (mg/kg/day)  (mg/kg/day)       L)
----------------------------------------------------------------------------------------------------------------
U.S. Population (total)                                             0.18    0.0122 07        0.168         5,900
----------------------------------------------------------------------------------------------------------------
Females (13+ years, nursing)                                        0.18    0.0142 10        0.166         5,000
----------------------------------------------------------------------------------------------------------------
Non-nursing Infants (less than 1 year old)                          0.18    0.0194 60        0.161        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 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 Default daily drinking rates are 2 L/day for adults and 1 L/day for children.


[[Page 61275]]

     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 HED 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 of the 
chronic (non-cancer) aggregate risk assessment process.
    The Agency lacks sufficient monitoring exposure data to complete a 
comprehensive dietary exposure analysis and risk assessment for 
azoxystrobin in drinking water. Because the Agency does not have 
comprehensive monitoring data, drinking water concentration estimates 
are made by reliance on simulation or modeling taking into account data 
on the physical characteristics of azoxystrobin.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in groundwater. In 
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS 
(a tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes a percent crop area factor as an adjustment to account 
for the maximum percent crop coverage within a watershed or drainage 
basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a %RfD or %PAD. Instead drinking 
water levels of comparison (DWLOCs) are calculated and used as a point 
of comparison against the model estimates of a pesticide's 
concentration in water. DWLOCs are theoretical upper limits on a 
pesticide's concentration in drinking water in light of total aggregate 
exposure to a pesticide in food, and from residential uses. Since 
DWLOCs address total aggregate exposure to azoxystrobin they are 
further discussed in the aggregate risk sections below.
    3.  From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Azoxystrobin is currently registered for use on the following 
residential non-dietary sites: ornamental turf. The risk assessment was 
conducted using the following exposure assumptions: Short-term exposure 
may occur for residential handlers and for postapplication activities. 
Because the TES Committee (11/12/96) 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 a 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 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. Safety Factor for Infants and Children

    Safety factor for infants and children--In general. 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 prenatal and postnatal toxicity and the completeness of the 
data base on toxicity and exposure 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.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water.

[[Page 61276]]

DWLOCs are theoretical upper limits on a pesticide's concentration in 
drinking water in light of total aggregate exposure to a pesticide in 
food and residential uses. In calculating a DWLOC, the Agency 
determines how much of the acceptable exposure (i.e., the PAD) is 
available for exposure through drinking water e.g., allowable chronic 
water exposure (mg/kg/day)= cPAD - (average food+ chronic non-dietary, 
non-occupational exposure). This allowable exposure through drinking 
water is used to calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the USEPA Office of Water are used to calculate 
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg 
(child). Default body weights and drinking water consumption values 
vary on an individual basis. This variation will be taken into account 
in more refined screening-level and quantitative drinking water 
exposure assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to azoxystrobin in drinking water (when considered along with 
other sources of exposure for which EPA has reliable data) would not 
result in unacceptable levels of aggregate human health risk at this 
time. 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 on drinking water as a part of the aggregate risk 
assessment process.
     1. Chronic risk. Using the conservative TMRC exposure assumptions 
described in this unit for chronic exposure, EPA has concluded that 
exposure to azoxystrobin from food will utilize 11.6% of the cPAD for 
the U.S. population, 2.2% of the cPAD for infant subpopulations at 
greatest exposure and 12.2% of the cPAD for children subpopulation at 
greatest exposure. Based the use pattern, chronic residential exposure 
to residues of the azoxystrobin is not expected. In addition, despite 
the potential for chronic dietary exposure to azoxystrobin in drinking 
water, after calculating the DWLOCs and comparing them to conservative 
model estimated environmental concentrations of azoxystrobin in surface 
and ground water. EPA does not expect the aggregate exposure to exceed 
100% of the cPAD.
    2. Short-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.
    Short-term aggregate exposure takes into account residential 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    Though residential exposure could occur with the use of 
azoxystrobin, the potential short-term exposures were not aggregated 
with chronic dietary food and water exposures because the toxic effects 
are different. Therefore, based on the best available data and current 
policies, potential risks do not exceed the Agency's level of concern.
    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. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to azoxystrobin residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method is available for enforcement of the 
proposed tolerances. Method RAM 243 (GC/NPD) can be used for the 
commodities in crop groups 2 and 5. The limit of quantitation for 
spinach and leaf lettuce was 0.01 ppm and the LOQ for head lettuce was 
either 0.02 ppm or 0.05 ppm (depending on laboratory). This method has 
been validated by the Agency's Analytical Chemistry Laboratory and will 
be submitted to FDA for inclusion in PAM II.
     The method may be requested from: Calvin Furlow, PIRIB, IRSD 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW, Washington, DC 20460; telephone number: 
(703) 305-5229; e-mail address: [email protected].

B. International Residue Limits

    There are no CODEX, Canadian, or Mexican Maximum Residue Limits 
(MRL) for azoxystrobin.

C. Conditions

    No special conditions, other than this tolerance are in conjunction 
with a Section 18 specific exemption.

VI. Conclusion

    Therefore, the tolerance is established for residues of 
azoxystrobin in or on brassica leafy vegetable at 25.0 ppm ppm.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301049 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before December 
18, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by

[[Page 61277]]

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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    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 the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by the docket control number OPP-301049, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
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(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408. 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) (Public Law 104-4). Nor does it require any prior consultation 
as specified by Executive Order 13084, entitled Consultation and 
Coordination with Indian Tribal Governments (63 FR 27655, May 19, 
1998); 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 or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 petition under FFDCA section 408, such as the tolerance/
exemption 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. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of FFDCA section 408(n)(4).

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 to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final

[[Page 61278]]

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: September 28, 2000.

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. Section 180.507 is amended by alphabetically adding commodities 
to the table in paragraph (b) to read as follows:


Sec. 180.507   Azoxystrobin; tolerances for residues.

* * * * *
    (b)* * *

 
----------------------------------------------------------------------------------------------------------------
                           Commodity                             Parts per million   Expiration/Revocation Date
----------------------------------------------------------------------------------------------------------------
                                  *        *        *        *        *
Brassica leafy vegetable.......................................               25.0                      12/31/01
                                  *        *        *        *        *
----------------------------------------------------------------------------------------------------------------

* * * * *

[FR Doc. 00-26638 Filed 10-16-00; 8:45 am]
BILLING CODE 6560-50-S