[Federal Register Volume 64, Number 149 (Wednesday, August 4, 1999)]
[Rules and Regulations]
[Pages 42280-42286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19910]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300880; FRL-6086-9]
RIN 2070-AB78


Azoxystrobin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
combined residues of azoxystrobin or methyl (E)-2-[2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-methoxyacrylate) and its Z 
isomer in or on parsley. This action is in response to EPA's granting 
of an emergency exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act authorizing use of the pesticide on 
parsley in 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 December 30, 2000.

DATES: This regulation is effective August 4, 1999. Objections and 
requests for hearings must be received by EPA on or before October 4, 
1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300880], 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-300880], 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-300880]. 
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, 
[email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 
21 U.S.C. 346a, is establishing a tolerance for combined residues or 
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 parsley at 20 parts per million (ppm) for fresh and at 
100 ppm for dry. This tolerance will expire and is revoked on December 
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) (Public Law 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 preamble 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.

[[Page 42281]]

II. Emergency Exemption for Azoxystrobin on Parsley and FFDCA 
Tolerances

    The State of California requested an exemption for the use of 
azoxystrobin (Quadris flowable fungicide) on 3,000 acres of parsley to 
control Septoria leaf blight disease caused by Septoria petroselini. 
After crop harvest the pathogen does not survive in the fields during 
the winter months and must therefore be reintroduced into parsley 
fields each season if disease is to reoccur. This is a seed borne-
disease. When contaminated seeds are planted, the pathogen is 
reintroduced. The reintroduced pathogen spreads in the field through 
rain splash or sprinkler irrigation. During spring, the parsley growing 
areas have mild temperatures and high humidity favoring disease 
development. Disease severity is weather dependent and can vary from 
season to season. The most logical way of controlling this would be to 
eradicate this pathogen from the seeds. The spring seasons of 1995 and 
1998 were wet and humid favoring disease development. In spite of using 
registered alternatives (copper fungicides and neem oil), California 
growers experienced significant losses due to high disease pressure. It 
is clearly documented that the registered alternatives are not 
effective in controlling the disease under high disease pressure. 
During 1999, the spring season was wet and conditions were favorable 
for the development of disease. It is expected that parsley growers in 
California will suffer significant losses during the 3rd and 4th 
parsley cutting without the use of azoxystrobin. EPA has authorized 
under FIFRA section 18 the use of azoxystrobin on parsley for control 
of septoria blight/septoria leaf spot in California. 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 
parsley. 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 December 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 
parsley after that date will not be unlawful, provided the pesticide is 
applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by this tolerance at the time of 
that application. EPA will take action to revoke this tolerance earlier 
if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether azoxystrobin 
meets EPA's registration requirements for use on parsley or whether a 
permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of azoxystrobin by a State for special local 
needs under FIFRA section 24(c). Nor does this tolerance serve as the 
basis for any State other than 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 or methyl (E)-2-[2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-methoxyacrylate) and its Z 
isomer on parsley at fresh parsley at 20 ppm and dried parsley at 100 
ppm 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 and the Agency's selection of 
toxicological endpoints upon which to assess risk caused by 
azoxystrobin are discussed below.
    1. Acute toxicity. The Agency evaluated the existing toxicology 
data base for azoxystrobin and did not identify an acute dietary 
endpoint. Therefore, a risk assessment is not required.
    2. Short- and intermediate-term toxicity. The Agency evaluated the 
existing toxicology data base for short- and intermediate-term dermal 
and inhalation exposure and determined that this risk assessment is not 
required. Note: From a 21-day dermal toxicity study the no observed 
adverse effect level (NOAEL) was 1,000 milligrams/kilograms/day (mg/kg/
day) at the highest dose tested (HDT) (Acute inhalation toxicity 
category III).
    3. Chronic toxicity. EPA has established the Reference Dose (RfD) 
for azoxystrobin at 0.18 mg/kg/day. This RfD is based on on a chronic 
toxicity study in rats with a NOAEL of 18.2 mg/kg/day. Reduced body 
weights and bile duct lesions were observed at the lowest effect level 
(LEL) of 34 mg/kg/day. An Uncertainty Factor (UF) of 100 was used to 
account for both the interspecies extrapolation and the intraspecies 
variability.
    4. Carcinogenicity. The EPA has determined that azoxystrobin should 
be classified as ``Not Likely'' to be a human carcinogen according to 
the proposed revised Cancer Guidelines. This classification is based on 
the lack of evidence of carcinogenicity in long-term rat and mouse 
feeding studies.

B. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.507(a)) for the combined residues of azoxystrobin and R230310 
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

[[Page 42282]]

commodities. Time-limited tolerances range from 0.1 ppm in soybeans to 
30 ppm in spinach.
    2. 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. Therefore, no acute 
endpoint has been assigned.
    3. Chronic risk. In conducting this chronic dietary risk 
assessment, EPA has made very conservative assumptions: 100% of parsley 
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 default ratio between grape juice and juice 
concentrate was retained. (Chronic RfD = 0.18 mg/kg/day)
    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 tolerances 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.

     Table 1.--Summary: Chronic Exposure Analysis by the DEEM System
------------------------------------------------------------------------
                                                       Percent Reference
        Population Subgroup          Exposure (mg/kg/  Dose\1\ (%Chronic
                                           day)             PAD/RfD)
------------------------------------------------------------------------
U.S. Population (total)...........            .012246               6.8%
All Infants (<1 year old).........           0.014830               8.2%
Nursing Infants (<1 year old).....           0.003917               2.2%
Non-Nursing Infants (<1 year old).           0.019422              10.8%
Children (1-6 years old)..........           0.022035              12.2%
Children (7-12 years old).........           0.012990               7.2%
Non-Hispanic Blacks...............           0.016444               9.1%
Non-Hispanic/non-white/non-black..           0.021015              11.7%
Females 20+ (not pregnant or                 0.012325               6.8%
 nursing).........................
Females 13+ (nursing).............           0.014238               7.9%
Seniors 55+.......................           0.013489               7.5%
------------------------------------------------------------------------
\1\ Percentage reference dose (% Chronic PAD) = Exposure x 100% (as
  RfD=PAD in this case) Chronic PAD

    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).
    Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    4. 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 has estimated 
the concentration of azoxystrobin in surface water based on GENEEC 
(Generic Estimated Environmental Concentration) modeling and in ground 
water based on Screening Concentration in Ground Water (SCI-GROW) 
modeling.
    5. 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 (June 6, 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.

                      Table 2.--Drinking Water Levels of Comparison for Chronic Exposure\1\
----------------------------------------------------------------------------------------------------------------
                                                                           Max. Water
     Population Category\2\       Chronic RfD (mg/  Food Exposure (mg/  Exposure\3\ (mg/  DWLOC4,5,6(g/
                                      kg/day)            kg/day)            kg/day)                 L)
----------------------------------------------------------------------------------------------------------------
U.S. Population (total)........               0.18           0.012246              0.168                 5,900
Females 13+ (nursing)..........               0.18           0.014238              0.166                 5,000

[[Page 42283]]


Non-nursing Infants............               0.18           0.019422              0.161                 1,600
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\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 of the 
chronic (non-cancer) aggregate risk assessment process.
    6. From non-dietary uses. 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 (November 12, 1996) 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.
    7. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure. This risk assessment is not applicable since no 
indoor and outdoor residential exposure uses are currently registered 
for azoxystrobin.

C. Aggregate Cancer Risk for U.S. Population

    1. Short- and intermediate-term aggregate risk. There are no 
applicable endpoints for short-term exposure (TES Committee, November 
12, 1996); 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.
    2. Chronic aggregate risk. Using the conservative TMRC exposure 
assumptions described above, and taking into account the completeness 
and reliability of the toxicity data, EPA has estimated the exposure to 
azoxystrobin from food will utilize 11.7% of the chronic PAD for the 
most highly exposed adult population subgroup (Non-Hispanic/non-white/
non-black). The exposure to azoxystrobin from food for infants and 
children will utilize from 2.2% to 12.2% of the chronic PAD. EPA 
generally has no concern for exposures below 100% of the chronic PAD 
because the chronic PAD 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 PAD. 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.

D. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children-- i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of azoxystrobin, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a 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 prenatal and postnatal 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 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.

[[Page 42284]]

    ii. Developmental toxicity studies-- a. Rabbit. In the 
developmental toxicity study in rabbits, developmental NOEL was 500 mg/
kg/day, at the HDT. Because there were no treatment-related effects, 
the developmental LEL was 500 mg/kg/day. The maternal NOEL 
was 150 mg/kg/day. The maternal LEL of 500 mg/kg/day was based on 
decreased body weight gain during dosing.
    b. Rat. In the developmental toxicity study in rats, the maternal 
(systemic) NOAEL was not established. The maternal LEL of 25 mg/kg/day 
at the lowest dose tested (LDT) was based on increased salivation. The 
developmental (fetal) NOAEL was 100 mg/kg/day (HDT).
    iii. Reproductive toxicity study. In the reproductive toxicity 
study in rats, the parental (systemic) NOAEL was 32.3 mg/kg/day. The 
parental LEL of 165.4 mg/kg/day was based on decreased body weights in 
males and females, decreased food consumption and increased adjusted 
liver weights in females, and cholangitis. The reproductive NOAEL was 
32.3 mg/kg/day. The reproductive LEL of 165.4 mg/kg/day was based on 
increased weanling liver weights and decreased body weights for pups of 
both generations.
    iv. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology data base for azoxystrobin is complete with respect to 
current toxicological data requirements. The results of these studies 
indicate that infants and children are not more sensitive to exposure, 
based on the results of the rat and rabbit developmental toxicity 
studies and the 2-generation reproductive toxicity study in rats. The 
additional 10X safety factor to account for sensitivity of infants and 
children was removed by an ad hoc FQPA Safety Factor Committee.
    v. Conclusion. Therefore, the tolerance is established for combined 
residues or residues of azoxystrobin or methyl (E)-2-[2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-methoxyacrylate) and its Z 
isomer in parsley at fresh parsley at 20 ppm and dried parsley at 100 
ppm ppm. The results of these studies indicate that infants and 
children are not more sensitive to exposure, based on the results of 
the rat and rabbit developmental toxicity studies and the 2-generation 
reproductive toxicity study in rats. The additional 10X safety factor 
to account for sensitivity of infants and children was removed by an ad 
hoc FQPA Safety Factor Committee.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
azoxystrobin from food will utilize 2 to 5% of the RfD for infants and 
children. EPA generally has no concern for exposures below 100% of the 
RfD because the RfD represents the level at or below which daily 
aggregate dietary exposure over a lifetime will not pose appreciable 
risks to human health. Despite the potential for exposure to 
azoxystrobin in drinking water and from non-dietary, non-occupational 
exposure, EPA does not expect the aggregate exposure to exceed 100% of 
the RfD. EPA concludes that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to 
azoxystrobin residues.

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. EPA will translate these data to parsley for 
this section 18.
    2.  Animals. As there are no animal feed items associated with this 
section 18, the nature of the residue in animals is not of concern.

B. Analytical Enforcement Methodology

    An adequate analytical method is available for enforcement of the 
proposed tolerances. Method RAM 243 (GC/NPD) can be used for parsley. 
The limit of quantitation for spinach was 0.01 ppm. This method has 
been validated by the Agency's Analytical Chemistry Laboratory and will 
be submitted to the Food and Drug Administration for inclusion in the 
Pesticide Analytical Manual II.

C. Magnitude of the Residues

    1.  Plants. IR-4 performed five field trials on spinach. In each 
trial, six applications were made at an application rate of 0.25 lb ai/
A. The PHI was either 6 or 7 days. This use pattern is the same as that 
proposed for parsley.
    2.  Animals. There are no animal feed items associated with 
parsley; therefore, the magnitude of the residue in animals is not 
relevant to this petition.

D. Rotational Crop Restrictions

    Rotational crop data were submitted in pesticide petition #6F4762. 
Based on this information, a 45-day plantback interval is appropriate 
for all crops other than those with azoxystrobin tolerances.

E. International Residue Limits

    There are no CODEX, Canadian, or Mexican Maximum Residue Limits 
(MRL) for azoxystrobin on parsley. Thus, harmonization is not an issue 
for this section 18 request.

V. Conclusion

    Therefore, the tolerance is established for combined residues or 
residues of azoxystrobin or methyl (E)-2-[2-[6-(2-
cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-methoxyacrylate) and its Z 
isomer in fresh parsley at 20 ppm and dried parsley at 100 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 issued by EPA under 
new section 408(l)(6) as was provided in the old section 408 and in 
section 409. However, the period for filing objections is 60 days, 
rather than 30 days. EPA currently has procedural regulations which 
govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by October 4, 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,

[[Page 42285]]

[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-300880] (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 
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) (Public Law 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

[[Page 42286]]

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: July 22, 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. 346a, 321q and 371.

    2. In Sec.  180.507 (b), by revising two commodities in the table 
to read as follows:


Sec.  180.507   Azoxystrobin; tolerances for residues.

    *    *    *    *    *
    (b)*    *    *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                      Parts per   revocation
                                                   million       date
------------------------------------------------------------------------

                   *        *        *      *        *
Parsley, dried.................................    20.0         12/30/00
Parsley, fresh.................................   100.0         12/30/00

                   *        *        *      *        *
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 99-19910 Filed 8-3-99; 8:45 am]
BILLING CODE 6560-50-F