[Federal Register Volume 64, Number 51 (Wednesday, March 17, 1999)]
[Rules and Regulations]
[Pages 13106-13112]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6387]



[[Page 13106]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300801; FRL-6064-6]
RIN 2070-AB78


Azoxystrobin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of azoxystrobin (methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate and its Z isomer (methyl(Z)-2-(2-(6-(2-
cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) in or on 
almond hulls, aspirated grain fractions, bananas (postharvest), canola, 
cucurbits, peanut hay, pistachios, potatoes, rice, stone fruits, and 
wheat; and residues of azoxystrobin (only) on fat of cattle, goats, 
hogs, horses, and sheep; meat of cattle, goats, hogs, horses, and 
sheep; meat byproducts of cattle, goats, hogs, horses, and sheep; and 
milk. Zeneca Ag Products requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection 
Act of 1996.

DATES: This regulation is effective March 17, 1999. Objections and 
requests for hearings must be received by EPA on or before May 17, 
1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300801], 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-300801], 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 be submitted electronically by sending electronic mail (e-
mail) to: [email protected]. Copies of objections and hearing requests 
must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Copies of objections and hearing 
requests will also be accepted on disks in WordPerfect 5.1/6.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300801]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker, 
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. 249, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-305-7740, giles-
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of October 8, 1997 
(62 FR 52544)(FRL-5746-9) and December 11, 1998 (63 FR 68458)(FRL-6043-
3), EPA issued notices pursuant to section 408 of the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) announcing the 
filing of two pesticide petitions (PP) 8F4995 and 7F4864, for 
tolerances by Zeneca Ag Products, 1800 Concord Pike, P.O. Box 15458, 
Wilmington, DE 19850-5458. This notice included a summary of the 
petition prepared by Zeneca Ag Products, the registrant. There were no 
comments received in response to the notices of filing.
    The petitions requested that 40 CFR part 180 be amended by 
establishing tolerances for combined residues of the fungicide 
azoxystrobin (methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate) and its Z isomer (methyl(Z)-2-(2-(6-
(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) in or on 
almond hulls at 4.0 parts per million (ppm), bananas (postharvest) at 
2.0 ppm, canola at 1.0 ppm, cucurbits at 0.3 ppm, peanut hay at 1.5 
ppm, pistachios at 0.01 ppm, potatoes at 0.03 ppm, rice grain at 4.0 
ppm, rice straw at 11 ppm, rice hulls at 20 ppm, stone fruits at 1.5 
ppm, tree nuts at 0.01 ppm; wheat grain at 0.04 ppm, wheat bran at 0.12 
ppm, wheat hay at 13.0 ppm, wheat straw at 4.0 ppm; wheat aspirated 
grain fractions at 15.0 ppm, and for the residues of azoxystrobin 
(only) in eggs at 0.4 ppm; fat of cattle, goats, hogs, horses, poultry, 
and sheep at 0.01 ppm; kidney of cattle at 0.06 ppm; liver of cattle, 
goats, horses, and sheep at 0.3 ppm; liver of hogs at 0.2 ppm; liver of 
poultry at 0.4 ppm; meat of cattle, goats, hogs, horses, poultry, and 
sheep at 0.01 ppm; and milk at 0.006 ppm.

I. Background and Statutory Findings

    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal upper 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....''
    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).

II. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, 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 establishment of permanent 
tolerances for combined residues of azoxystrobin (methyl(E)-2-(2-(6-(2-
cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) and its Z 
isomer (methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-
methoxyacrylate) in or on almond hulls at 4.0 ppm, aspirated grain 
fractions at 10 ppm, bananas (pre-harvest and postharvest) at 2.0 ppm 
(of which not more than 0.1 ppm is

[[Page 13107]]

contained in the pulp), canola at 1.0 ppm, cucurbits at 0.3 ppm, peanut 
hay at 2.0 ppm, pistachios at 0.01 ppm, potatoes at 0.03 ppm, rice 
grain at 5.0 ppm, rice straw at 12 ppm, rice hulls at 20 ppm, stone 
fruits at 1.5 ppm, tree nuts at 0.010 ppm, wheat grain at 0.10 ppm, 
wheat bran at 0.20 ppm, wheat hay at 15 ppm, wheat straw at 4.0 ppm, 
and for the residues of azoxystrobin (only) in fat of cattle, goats, 
hogs, horses, and sheep at 0.010 ppm; meat of cattle, goats, hogs, 
horses, and sheep at 0.01 ppm; meat byproducts of cattle, goats, hogs, 
horses, and sheep at 0.010 ppm; and milk at 0.006 ppm. A permanent 
domestic tolerance of 0.5 ppm already exists for bananas and will be 
amended by this rule. Temporary tolerances already exist for fat of 
cattle, goats, hogs, horses, and sheep at 0.01 ppm; kidney of cattle, 
goats, hogs, and sheep at 0.06 ppm; liver of cattle, goats, horses, and 
sheep at 0.3 ppm; liver of hogs at 0.2 ppm; meat of cattle, goats, 
hogs, horses, and sheep at 0.01 ppm; cucurbits at 1.0 ppm; milk at 
0.006 ppm; potatoes at 0.03 ppm; rice grain at 4 ppm; rice hulls at 20 
ppm; and rice straw at 10 ppm. A tolerance of 0.8 ppm already exists 
for peaches; this will be superseded by the stone fruits tolerance of 
1.5 ppm that is being established in this rule. Several of the 
tolerances that are being established by this rule are different from 
(often higher than) those proposed by Zeneca Ag Products. EPA review of 
the data submitted by the company lead to an Agency decision to modify 
the proposed tolerances. During these reviews it was also determined 
that azoxystrobin uses that have been registered so far do not lead to 
a need to establish tolerances for poultry commodities (including 
eggs). EPA's assessment of the exposures and risks associated with 
establishment of the above tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by azoxystrobin is 
discussed in this unit.
    1. Acute toxicity. The acute oral toxicity study in rats of 
technical azoxystrobin resulted in an LD50 of > 5,000 
milligrams/kilogram (mg/kg) (limit test) for both males and females. 
The acute dermal toxicity study in rats of technical azoxystrobin 
resulted in an LD50 of > 2,000 mg/kg (limit dose). The acute 
inhalation study of technical azoxystrobin in rats resulted in an 
LC50 of 0.962 mg/liter (mg/L) in males and 0.698 mg/L in 
females. In an acute oral neurotoxicity study in rats dosed once by 
gavage with 0, 200, 600, or 2,000 mg/kg azoxystrobin, the systemic 
toxicity no observable adverse effect level (NOAEL) was < 200 mg/kg and 
the systemic toxicity lowest observed adverse effect level (LOAEL) was 
200 mg/kg, based on the occurrence of transient diarrhea in both sexes. 
There was no indication of neurotoxicity at the doses tested.
    2. Mutagenicity. Azoxystrobin was negative for mutagenicity in the 
salmonella/mammalian activation gene mutation assay, the mouse 
micronucleus test, and the unscheduled DNA synthesis in rat 
hepatocytes/mammalian cells (in vivo/in vitro procedure study). In the 
forward mutation study using L5178 mouse lymphoma cells in culture, 
azoxystrobin tested positive for forward gene mutation at the TK locus. 
In the in vitro human lymphocytes cytogenetics assay of azoxystrobin, 
there was evidence of a concentration related induction of chromosomal 
aberrations over background in the presence of moderate to severe 
cytotoxicity.
    3. Rat metabolism. In this study, azoxystrobin--unlabeled or with a 
pyrimidinyl, phenylacrylate, or cyanophenyl label--was administered to 
rats by gavage as a single dose or as 14-day repeated doses. Less than 
0.5% of the administered dose was detected in the tissues and carcass 
up to 7 days post-dosing and most of it was in excretion-related 
organs. There was no evidence of potential for bioaccumulation. The 
primary route of excretion was via the feces, though 9- to 18% was 
detected in the urine of the various dose groups. Absorbed azoxystrobin 
appeared to be extensively metabolized. A metabolic pathway was 
proposed showing hydrolysis and subsequent glucuronide conjugation as 
the major biotransformation process. This study was classified as 
supplementary but upgradeable; the company has submitted data intended 
to upgrade the study to acceptable and these data have been scheduled 
for review.
    4. Sub-chronic toxicity. i. In a 90-day rat feeding study the NOAEL 
was 20.4 mg/kg/day for males and females. The LOAEL was 211.0 mg/kg/day 
based on decreased weight gain in both sexes, clinical observations of 
distended abdomens and reduced body size, and clinical pathology 
findings attributable to reduced nutritional status.
     ii. In a subchronic toxicity study in which azoxystrobin was 
administered to dogs by capsule for 92 or 93 days, the NOAEL for both 
males and females was 50 mg/kg/day. The LOAEL was 250 mg/kg/day, based 
on treatment-related clinical observations and clinical chemistry 
alterations at this dose.
    iii. In a 21-day repeated-dose dermal rat study using azoxystrobin, 
the NOAEL for both males and females was greater than or equal to 1,000 
mg/kg/day (the highest dosing regimen); a LOAEL was therefore not 
determined.
    5. Chronic feeding toxicity and carcinogenicity. i. In a 2-year 
feeding study in rats fed diets containing 0, 60, 300, and 750/1,500 
ppm (males/females), the systemic toxicity NOAEL was 18.2 mg/kg/day for 
males and 22.3 mg/kg/day for females. The systemic toxicity LOAEL for 
males was 34 mg/kg/day, based on reduced body weights, food 
consumption, and food efficiency; and bile duct lesions. The systemic 
toxicity LOAEL for females was 117.1 mg/kg/day, based on reduced body 
weights. There was no evidence of carcinogenic activity in this study.
    ii. In a 1-year feeding study in dogs to which azoxystrobin was fed 
by capsule at doses of 0, 3, 25, or 200 mg/kg/day, the NOAEL for both 
males and females was 25 mg/kg/day and the LOAEL was 200 mg/kg/day for 
both sexes, based on clinical observations, clinical chemistry changes, 
and liver weight increases that were observed in both sexes.
    iii. In a 2-year carcinogenicity feeding study in mice using dosing 
concentrations of 0, 50, 300, or 2,000 ppm, the systemic toxicity NOAEL 
was 37.5 mg/kg/day for both males and females. The systemic toxicity 
LOAEL was 272.4 mg/kg/day for both sexes, based on reduced body weights 
in both sexes at this dose. There was no evidence of carcinogenicity at 
the dose levels tested.
    According to the new proposed guidelines for Carcinogen Risk 
Assessment (April, 1996), the appropriate descriptor for human 
carcinogenic potential of azoxystrobin is ``Not Likely.'' The 
appropriate subdescriptor is ``has been evaluated in at least two well 
conducted studies in two appropriate species without demonstrating 
carcinogenic effects.''
    6. Developmental and reproductive toxicity. i. In a prenatal 
development study in rats gavaged with azoxystrobin at dose levels of 
0, 25, 100, or 300 mg/kg/day during days 7 through 16 of gestation, 
lethality at the highest dose caused the discontinuation of dosing at 
that level. The developmental NOAEL was greater than or equal to 100 
mg/kg/

[[Page 13108]]

day and the developmental LOAEL was > 100 mg/kg/day because no 
significant adverse developmental effects were observed. In this same 
study, the maternal NOAEL was not established; the maternal LOAEL was 
25 mg/kg/day, based on increased salivation.
    ii. In a prenatal developmental study in rabbits gavaged with 0, 
50, 150, or 500 mg/kg/day during days 8 through 20 of gestation, the 
developmental NOAEL was 500 mg/kg/day and the developmental LOAEL was > 
500 mg/kg/day because no treatment-related adverse effects on 
development were seen. The maternal NOAEL was 150 mg/kg/day and the 
maternal LOAEL was 500 mg/kg/day, based on decreased body weight gain.
    iii. In a two-generation reproduction study, rats were fed 0, 60, 
300, or 1,500 ppm of azoxystrobin. The reproductive NOAEL was 32.2 mg/
kg/day. The reproductive LOAEL was 165.4 mg/kg/day; reproductive 
toxicity was demonstrated as treatment-related reductions in adjusted 
pup body weights as observed in the F1a and F2a pups dosed at 1,500 ppm 
(165.4 mg/kg/day).

B. Toxicological Endpoints

    1. Acute toxicity. The Agency evaluated the existing toxicology 
database for azoxystrobin and did not identify any acute dietary 
endpoint because there were no effects of concern attributable to a 
single dose (exposure) in oral toxicology studies including 
developmental toxicity studies in the rat and rabbit and acute 
neurotoxicity study in the rat. Therefore, this risk assessment is not 
required.
     2. Short- and intermediate-term toxicity. The Agency evaluated the 
existing toxicology database for short-term and intermediate-term 
dermal and inhalation exposure and determined that this risk assessment 
is not required because no dermal or systemic effects were seen in the 
repeated dose dermal study at the limit dose. The only registered 
residential use for azoxystrobin is residential turf.
     3. Chronic toxicity. EPA has established the Reference Dose (RfD) 
for azoxystrobin at 0.18 mg/kg/day. This RfD is based on a NOAEL of 
18.2 mg/kg/day from the rat chronic toxicity/carcinogenicity feeding 
study. Effects observed at the LOAEL's (34 mg/kg/day for males, 117.1 
mg/kg/day for females) included reduced body weights, food consumption 
and efficiency. Males also had bile duct lesions. An uncertainty factor 
of 100 was used to allow for interspecies sensitivity and intraspecies 
variability. There was no evidence of increased susceptibility of 
infants or children to azoxystrobin. Therefore, no additional 
uncertainty factor to protect infants and children is needed at this 
time.
    4. Carcinogenicity. The Agency 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.

C. Exposures and Risks

    1. From food and feed uses. Permanent tolerances have been 
established (40 CFR 180. 507(a)) for the combined residues of 
azoxystrobin (methyl(E)-2(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate) and its Z isomer (methyl (Z)-2-(2-(6-
(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate)), in or on 
the following raw agricultural commodities: pecans at 0.01 ppm, peanuts 
at 0.01 ppm, peanut oil at 0.03 ppm, grapes at 1.0 ppm, bananas at 0.5 
ppm, peaches at 0.80 ppm, tomatoes at 0.2 ppm, and tomato paste at 0.6 
ppm. In addition, time-limited tolerances have been established for 
crops, processed foods and animal commodities (40 CFR 180.507(b)) at 
levels ranging from 0.006 ppm in milk to 20 ppm in rice hulls and 
including cucurbits at 1.0 ppm, rice grain at 4 ppm, rice hulls at 20 
ppm, rice straw at 10 ppm, and potatoes at 0.03 ppm. Risk assessments 
were conducted by EPA to assess dietary exposures from azoxystrobin as 
follows:
     i.  Acute exposure and risk. The Agency did not conduct an acute 
risk assessment because no toxicological endpoint of concern was 
identified during review of available data.
    ii. Chronic exposure and risk. The Dietary Exposure Evaluation 
Model (DEEM), a chronic exposure analysis, was used in conducting this 
chronic dietary risk assessment. EPA has made very conservative 
assumptions -- 100% of all commodities having azoxystrobin residues at 
the level of the tolerance with the exception of raisins and grape 
juice which are expected to result in an over estimation of human 
dietary exposure. Thus, in making a safety determination for this 
tolerance, the Agency is taking into account these conservative 
exposure assessments. The following percentages of the RfD from dietary 
exposure were calculated: U.S. population (48 states, all seasons), 2%; 
all infants (< 1 year old), 7%; nursing infants (< 1 year old), 2%; 
non-nursing infants (< 1 year old), 9%; children (1-6 years old), 5%; 
children (7-12 years old), 3% and non-Hispanic (other than black or 
white), 4%. The subgroups listed are infants/children and other 
subgroups for which the percentage of the RfD occupied is greater than 
the group U.S. population (48 states).
    2. From drinking water. In the absence of reliable, available 
monitoring data, EPA uses models to estimate concentrations of 
pesticides in ground and surface water. For azoxystrobin, modeling was 
used to estimate surface water concentrations because of very limited 
surface water monitoring data. However, EPA does not use these model 
estimates to quantify risk. Currently, EPA uses drinking water levels 
of comparison (DWLOC's) as a surrogate to capture risk associated with 
exposure to pesticides in drinking water. A DWLOC is the concentration 
of a pesticide in drinking water that would be acceptable as an upper 
limit in light of total aggregate exposure to that pesticide from food, 
water, and residential uses. A DWLOC will vary depending on the residue 
level in foods, the toxicity endpoint and with drinking water 
consumption patterns and body weight for specific subpopulations. EPA 
believes model estimates to be overestimations of concentrations of 
azoxystrobin expected in drinking water. Azoxystrobin is moderately 
persistent in soil in the absence of light and one of its metabolites 
is potentially moderately mobile in coarse textured soils. The 
potential mobility and persistence of some degradates based on batch 
equilibrium studies, aerobic soil metabolism and some field dissipation 
studies are similar to pesticides with a potential to leach into ground 
water under some conditions. There is no established Maximum 
Contaminant Level for residues of azoxystrobin in drinking water. No 
health advisory levels for azoxystrobin in drinking water have been 
established.
    i. Acute exposure and risk. An assessment was not conducted because 
no toxicological end-point of concern was identified.
    ii. Chronic exposure and risk. Based on the chronic dietary (food) 
exposure estimates, chronic DWLOC's for azoxystrobin were calculated 
and are summarized as follows: U. S. Population (48 states) 6,200 
g/L; females (13+) (using the highest TMRC for the 5 subgroups 
of females), 5,200 g/L; infants/children (using the highest 
TMRC for the 5 subgroups of infants/children) 1,600 g/L and 
non-Hispanic (other than black or white), 6,100 g/L. The 
highest EEC for azoxystrobin in surface water is from the application 
of azoxystrobin on grapes (39 g/L) and is substantially lower 
than the DWLOCs

[[Page 13109]]

calculated. Therefore, chronic exposure to azoxystrobin residues in 
drinking water does not exceed EPA's level of concern.
    3. From non-dietary exposure. The only registered indoor/outdoor 
residential use for azoxystrobin is residential turf. The Agency 
evaluated the existing toxicology database and determined that there 
are no toxicological end points of concern.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether azoxystrobin has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
azoxystrobin does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that azoxystrobin has a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. There were no effects of concern attributable to a 
single dose (exposure) in oral toxicological studies including 
developmental toxicity studies in rat and rabbit and an acute 
neurotoxicity study in rats. Accordingly, EPA concludes that 
azoxystrobin does not pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to azoxystrobin from 
food will utilize from 2% to 9% of the RfD for the U.S. population. The 
major identifiable subgroup with the highest aggregate exposure is non-
nursing infants (<1 year old). 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. Based on the chronic (food 
only) exposure, chronic DWLOC's were calculated. The lowest DWLOC of 
1,600 g/L was for infants/children (using the highest TMRC for 
the five subgroups of infants/children listed in the DEEM analysis). 
The highest Estimated Environmental Concentration (EEC) in surface 
water is from application to grapes (39 g/L) and is 
substantially lower than the calculated DWLOC. The EEC's as a result of 
application to the proposed uses are no higher than those calculated 
for grapes. Therefore chronic exposure in drinking water does not 
exceed the Agency's level of concern.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
risk. No dermal or systemic effects were seen in the repeated dose 
dermal study at the limit dose. The only indoor or outdoor residential 
use currently registered for azoxystrobin is residential turf. EPA 
concluded that azoxystrobin does not pose a short- or intermediate-term 
risk.
    4. Aggregate cancer risk for U.S. population. The Agency determined 
that azoxystrobin should be classified as ``Not Likely'' to be a human 
carcinogen according to the proposed revised Cancer Guidelines because 
there was no evidence of carcinogenicity in valid chronic toxicity 
studies using two species of mammals. The Agency has therefore 
concluded that azoxystrobin does not pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to azoxystrobin residues as a result of current 
use patterns.

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

    1. Safety factor for infants and children--i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of azoxystrobin, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a 2-generation 
reproduction study in the rat. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from maternal pesticide exposure during gestation. 
Reproduction studies provide information relating to effects from 
exposure to the pesticide on the reproductive capability of mating 
animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre- and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a margin of exposure (MOE) analysis or through using 
uncertainty (safety) factors in calculating a dose level that poses no 
appreciable risk to humans. EPA believes that reliable data support 
using the standard MOE and uncertainty factor (usually 100 for combined 
inter- and intra species variability) and not the additional tenfold 
MOE/uncertainty factor when EPA has a complete data base under existing 
guidelines and when the severity of the effect in infants or children 
or the potency or unusual toxic properties of a compound do not raise 
concerns regarding the adequacy of the standard MOE/safety factor.
    ii. Developmental toxicity studies-- a. Rabbit. In the 
developmental toxicity study in rabbits, developmental NOAEL was 500 
mg/kg/day, at the highest dose tested (HDT). Because there were no 
treatment-related effects, the developmental LOAEL was greater than 500 
mg/kg/day. The maternal NOAEL was 150 mg/kg/day. The maternal LOAEL 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 LOAEL 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. Rat. In the 2-generation 
reproductive toxicity study in rats, the parental (systemic) NOAEL was 
32.3 mg/kg/day. The parental LOAEL 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 LOAEL of 165.4 
mg/kg/day was based on increased weanling liver weights and decreased 
body weights for pups of both generations.
     iv. Pre- and post-natal sensitivity. The pre- and post-natal 
toxicology data base for azoxystrobin is complete with respect to 
current toxicological data requirements. The results of these studies 
indicate that infants and children are no more sensitive to exposure 
than adults, based on the results of the rat and rabbit developmental 
toxicity studies and the 2-generation reproductive toxicity study in 
rats. There are no developmental effects in the rat and rabbit 
developmental studies and the effects

[[Page 13110]]

observed in the offspring in the reproduction study occur at the same 
dose levels in which toxicity was observed in the parents. The effects 
in the young are not more severe than those observed with the parents 
(decreased body weights in both parents and pups).
    v. Conclusion. There is a complete toxicity database for 
azoxystrobin and exposure data are complete or are estimated based on 
data that reasonably account for potential exposures. Accordingly, EPA 
has determined that the standard margin of safety of infants and 
children and the additional tenfold safety factor can be removed.
    2. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to azoxystrobin from 
food will utilize from 2% to 9% 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.
    3. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to azoxystrobin 
residues.

III. Other Considerations

A. Metabolism In Plants and Animals

     The qualitative nature of the residue in plants is adequately 
understood. A grape metabolism study was evaluated by the Agency in 
December, 1995 and it was determined that the residues of concern in 
grapes were the parent and its Z isomer. In peanut and wheat metabolism 
studies the major residues were also azoxystrobin and its Z isomer. 
Azoxystrobin does not accumulate in crop seeds or fruits. Metabolism of 
azoxystrobin in plants is complex, with more than 15 metabolites 
identified. However, these metabolites are present at low levels, 
typically much less than 5% of the total radioactive residue level. 
Based on parent being the predominant residue in the grape, wheat and 
peanut metabolism studies, the Agency concludes that the residues of 
concern in all directly treated crops are the parent and its Z isomer.
    The nature of the residue in animals is adequately understood. The 
Agency has determined that the residue of concern in livestock is 
parent azoxystrobin only. This determination was based on the results 
of metabolism studies performed on goats and poultry. The goat 
metabolism study was reviewed in conjunction with PP 5F4541. The 
poultry metabolism study was reviewed in conjunction with PP 6F4762. 
Azoxystrobin and one metabolite (compound 28) were identified in egg 
yolk and compound 28 alone was found in liver. Residues in extracts of 
egg whites, muscle, and skin with underlying peritoneal fat were less 
than 0.01 ppm. Residues of azoxystrobin were less than 0.01 ppm at a 
feeding level of 1.4x in the radiolabeled study and also less than 0.01 
ppm in a feeding study at 60 ppm (about 7x). As a result, there is no 
reasonable expectation of finite residues of azoxystrobin in poultry 
commodities.
    The registrant submitted three analytical methods for the analysis 
of the subject commodities.
    1. The first method, RAM 243, is a gas chromatography with 
nitrogen-phosphorus detection (GC/NPD) method which can be used for the 
analysis of cereals, processed cereals, dried beans, peas, leafy crops, 
bananas, soft fruits, processed soft fruits, citrus, fruiting 
vegetables, root crops, stone fruits, wine, and citrus juice. This 
method has been reviewed and validated by the Agency, and will be 
submitted to the Food and Drug Administration (FDA) for inclusion in 
PAM II.
    2. The second method, RAM 260, is a GC/NPD method for the analysis 
of azoxystrobin and its Z isomer in crops of high lipid content. The 
registrant has used it for analysis of peanut kernel and hull, 
processed peanut, pecan kernel, coffee bean, citrus skin, and canola 
oil. This method has been validated by the Agency and will be submitted 
to the FDA for inclusion in PAM II.
    3. The third method, RAM 255, uses gas chromatography with 
thermionic detection, nitrogen mode, for analysis of animal 
commodities. It has been validated by the Agency for analysis of milk 
and animal tissues. The laboratory will issue a written report shortly 
and the method will be submitted to FDA for inclusion in PAM II.
    Therefore, adequate analytical methodology is available to enforce 
the tolerance expression. The method may be requested from: Calvin 
Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office and telephone number: Rm. 101FF, Crystal Mall #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, (703) 305-5229.

B. Magnitude of Residues

    Azoxystrobin has been subjected to FDA's multiresidue protocols. It 
could not be recovered through application of any protocol. Residues of 
azoxystrobin and its Z isomer are not expected to exceed the proposed 
tolerance levels and the submitted data support tolerance levels for 
combined residues of azoxystrobin (methyl(E)-2-(2-(6-(2-
cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) and its Z 
isomer (methyl(Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-
methoxyacrylate) in or on almond hulls at 4.0 ppm, aspirated grain 
fractions at 10 ppm, bananas (pre-harvest and postharvest) at 2.0 ppm 
(of which not more than 0.1 ppm is contained in the pulp), canola at 
1.0 ppm, cucurbits at 0.3 ppm, peanut hay at 2.0 ppm, pistachios at 
0.01 ppm, potatoes at 0.03 ppm, rice grain at 5.0 ppm, rice straw at 12 
ppm, rice hulls at 20 ppm, stone fruits at 1.5 ppm, tree nuts at 0.010 
ppm, wheat grain at 0.10 ppm, wheat bran at 0.20 ppm, wheat hay at 15 
ppm, wheat straw at 4.0 ppm, and for the residues of azoxystrobin 
(only) in fat of cattle, goats, hogs, horses, and sheep at 0.010 ppm; 
meat of cattle, goats, hogs, horses, and sheep at 0.01 ppm; meat 
byproducts of cattle, goats, hogs, horses, and sheep at 0.010 ppm; and 
milk at 0.006 ppm. The submitted residue data support a tolerance level 
of 2.0 ppm for residues of azoxystrobin in or on whole bananas and a 
tolerance level of 0.1 ppm in or on banana pulp. The tolerance for 
bananas must be listed as 2.0 ppm for the combined residues of 
azoxystrobin and its Z isomer in/on bananas (whole fruit) and residues 
in banana pulp must not exceed 0.1 ppm.

C. International Residue Limits

     There are no Codex, Canadian or Mexican Maximum Residue Limits 
(MRL) established for azoxystrobin for bananas, curcurbits, potatoes, 
or stone fruits.

D. Rotational Crop Restrictions

    Rotational crop data were previously submitted. Based on this 
information, a 45-day plantback interval is appropriate for all crops 
other than those having tolerances for azoxystrobin and its Z isomer.

IV. Conclusion

    Therefore, tolerances are established for combined residues of 
azoxystrobin (methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate) and its Z isomer (methyl(Z)-2-(2-(6-
(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) in or

[[Page 13111]]

on almond hulls at 4.0 ppm, aspirated grain fractions at 10 ppm, 
bananas (pre-harvest and postharvest) at 2.0 ppm (of which not more 
than 0.1 ppm is contained in the pulp), canola at 1.0 ppm, cucurbits at 
0.3 ppm, peanut hay at 2.0 ppm, pistachios at 0.01 ppm, potatoes at 
0.03 ppm, rice grain at 5.0 ppm, rice straw at 12 ppm, rice hulls at 20 
ppm, stone fruits at 1.5 ppm, tree nuts at 0.010 ppm, wheat grain at 
0.10 ppm, wheat bran at 0.20 ppm, wheat hay at 15 ppm, wheat straw at 
4.0 ppm, and for the residues of azoxystrobin (only) in fat of cattle, 
goats, hogs, horses, and sheep at 0.010 ppm; meat of cattle, goats, 
hogs, horses, and sheep at 0.01 ppm; meat byproducts of cattle, goats, 
hogs, horses, and sheep at 0.010 ppm; and milk at 0.006 ppm.

V. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation as was provided in 
the old section 408 and in section 409. However, the period for filing 
objections is 60 days, rather than 30 days. EPA currently has 
procedural regulations which govern the submission of objections and 
hearing requests. These regulations will require some modification to 
reflect the new law. However, until those modifications can be made, 
EPA will continue to use those procedural regulations with appropriate 
adjustments to reflect the new law.
    Any person may, by May 17, 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 
regulation. The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections (40 
CFR 178.25). Each objection must be accompanied by the fee prescribed 
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement 
``when in the judgement of the Administrator such a waiver or refund is 
equitable and not contrary to the purpose of this subsection.'' For 
additional information regarding tolerance objection fee waivers, 
contact James Tompkins, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, (703) 305-5697, [email protected]. Requests for 
waiver of tolerance objection fees should be sent to James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
     If a hearing is requested, the objections must include a statement 
of the factual issues on which a hearing is requested, the requestor's 
contentions on such issues, and a summary of any evidence relied upon 
by the requestor (40 CFR 178.27). A request for a hearing will be 
granted if the Administrator determines that the material submitted 
shows the following: There is genuine and substantial issue of fact; 
there is a reasonable possibility that available evidence identified by 
the requestor would, if established, resolve one or more of such issues 
in favor of the requestor, taking into account uncontested claims or 
facts to the contrary; and resolution of the factual issues in the 
manner sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32). Information submitted in connection with an 
objection or hearing request may be claimed confidential by marking any 
part or all of that information as CBI. Information so marked will not 
be disclosed except in accordance with procedures set forth in 40 CFR 
part 2. A copy of the information that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice.

VI. Public Record and Electronic Submissions

     EPA has established a record for this regulation under docket 
control number [OPP-300801] (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.

VII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does 
it require any prior consultation as specified by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or special considerations as required by 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    In addition, since tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(d), such as the 
tolerances 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

[[Page 13112]]

the Agency's generic certification for tolerance actions published on 
May 4, 1981 (46 FR 24950), and was provided to the Chief Counsel for 
Advocacy of the Small Business Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and the Comptroller General of the United 
States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 5, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

Sec. 180.507 [Amended]

    2. In Sec. 180.507, paragraph (a)(1), by removing from the table 
the commodities ``Bananas'', and ``Peaches''.
    3. Section 180.507 is further amended in paragraph (a)(1) by 
changing the words ``raw agricultural commodities'' to read ``food 
commodities'', by alphabetically adding the following commodities to 
the table in paragraph (a)(1), by redesignating paragraph (a)(2) as 
paragraph (a)(3), and by adding a new paragraph (a)(2) to read as 
follows:


Sec. 180.507   Azoxystrobin; tolerances for residues General.

    (a) General. (1) * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Almond hulls..............................  4.0
Aspirated grain fractions.................  10
Bananas (pre-harvest and post harvest)....  2.0 (of which not more than
                                             0.1 is contained in the
                                             pulp)
Canola....................................  1.0
Cucurbits.................................  0.3
 
                  *        *        *        *        *
Peanut hay................................  2.0
Pistachios................................  0.010
Potatoes..................................   0.03
Rice grain................................  5.0
Rice hulls................................  20
Rice straw................................  12
Stone fruits..............................  1.5
 
                  *        *        *        *        *
Tree nuts.................................   0.010
Wheat bran................................  0.20
Wheat grain...............................  0.10
Wheat hay.................................  15
Wheat straw...............................  4.0
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the fungicide, 
azoxystrobin [methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate] in or on the following food 
commodities.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................        0.010
Cattle, meat...............................................         0.01
Cattle, meat byproducts....................................        0.010
Goats, fat.................................................        0.010
Goats, meat................................................         0.01
Goats, meat byproducts.....................................        0.010
Hogs, fat..................................................        0.010
Hogs, meat.................................................         0.01
Hogs, meat byproducts......................................        0.010
Horses, fat................................................        0.010
Horses, meat...............................................         0.01
Horses, meat byproducts....................................        0.010
Milk.......................................................        0.006
Sheep, fat.................................................        0.010
Sheep, meat................................................         0.01
Sheep, meat byproducts.....................................        0.010
------------------------------------------------------------------------

*    *    *    *    *
[FR Doc. 99-6387 Filed 3-16-99; 8:45 am]
BILLING CODE 6560-50-F