[Federal Register Volume 64, Number 178 (Wednesday, September 15, 1999)]
[Proposed Rules]
[Pages 50043-50050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24047]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300913; FRL-6098-7]
RIN 2070-AB78


Cyromazine; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to establish tolerances for residues of 
cyromazine (CAS No. 66215-27-8) in or on mango at 0.3 parts per million 
(ppm); onion, green at 2.0 ppm; onion, dry bulb at 0.1 ppm; potato at 
0.8 ppm; corn, sweet, (kernels plus cob with husks removed) at 0.5 ppm; 
corn, sweet, forage at 0.5 ppm; corn, sweet, stover at 0.5 ppm; radish, 
roots at 0.5 ppm; radish, tops at 0.5 ppm; lima beans at 1.0 ppm; 
cotton, undelinted seed at 0.1 ppm; milk at 0.05 ppm; and meat, fat and 
meat byproducts (of cattle, goats, hogs, horses and sheep) at 0.05 ppm. 
EPA also proposes to remove melamine, a metabolite of cyromazine from 
the tolerance expression since it is no longer considered a residue of 
concern. The Interregional Research Project (IR-4) and Novartis Crop 
Protection, Inc., requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act 
of 1996.

DATES: Comments, identified by the docket control number ``OPP-
300913,'' must be received by EPA on or before November 15, 1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300913], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. In person, bring comments to Rm. 100, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA 22202.
    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 or ASCII 
file format. All copies of objections and hearing requests in 
electronic form must be identified by the docket control number [OPP-
300913]. 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: Linda DeLuise, 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. 202, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-305-5428; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of July 11, 1997 (62 
FR 37246) (FRL-5723-1), EPA issued a notice 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) (Public Law 
104-170) announcing the filing of pesticide petitions (PP) for 
tolerances by Novartis Crop Protection, Inc., 410 Swing Road, 
Greensboro, NC 27419. The notice included summaries of the petitions 
prepared by Novartis Crop Protection, Inc., the registrant. There were 
no comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.414 be amended by 
establishing tolerances for residues of the insecticide cyromazine and 
its metabolite melamine, in or on various food commodities as follows:
    1. Novartis Corporation PP5E4450 proposes the establishment of a 
tolerance for mangoes at 0.3 ppm.
    2. Norvartis Corporation PP5F4576 proposes the establishment of a 
tolerance for onion, green at 3.0 ppm and onion, dry bulb at 0.3 ppm.
    3. Novartis Corporation PP6F4613 proposes the establishment of a 
tolerance for potato at 1.5 ppm.
    4. Novartis Corporation PP5F4546 proposes establishment of a 
tolerance for cotton, undelinted seed at 0.2 ppm.
    5. Novartis Corporation PP6F3332 proposes establishment of 
tolerances for sweet corn, (kernels plus cob with husks removed), 
forage and stover at 0.5 ppm; radish roots, and tops at 0.5 ppm; and 
milk at 0.04 ppm for cyromazine and 0.02 ppm melamine.
    6. Novartis Corporation PP6F3332 proposes establishment of a 
tolerance for meat, fat and meat byproducts (of cattle, goats, hogs, 
horses and sheep) at 0.05 ppm.

[[Page 50044]]

    7. IR-4 PP7E4905 proposes the establishment of a tolerance for lima 
beans at 3.0 ppm.
    The tolerance requests for cotton, corn and radish are for indirect 
or inadvertent residues when these commodities are planted as 
rotational crops. The tolerance request for mangoes is for a tolerance 
to enable the importation of mangoes treated in Mexico with cyromazine. 
There are no U.S. registrations for use of cyromazine on mangoes as of 
the date of this publication.
    There currently exists separate tolerances in 40 CFR 180.414(a) for 
cyromazine on celery at 10.0 ppm and lettuce, head at 5.0 ppm. Since 
the crop group leafy vegetables (except Brassica) includes celery and 
lettuce, (head) these individual tolerances under 40 CFR 180.414(a) are 
being removed.
    EPA has concluded that only residues of the parent compound 
cyromazine need to be regulated and used for risk assessment and is 
proposing that melamine, a metabolite of cyromazine, be removed from 
the tolerance expression as a residue of toxicological concern.
    Melamine was initially included in the tolerance expression for 
cyromazine because of limited evidence of its carcinogenic potential in 
laboratory animals. At that time EPA agreed with FDA's Cancer 
Assessment Committee that melamine was not a carcinogen, per se, but 
was indirectly responsible for the induction of urinary bladder 
neoplasia through production of stones in the bladder. A detailed 
discussion of the initial risk of melamine can be found in the Federal 
Register of April 27, 1984 (49 FR 18120). Since then EPA has reassessed 
the weight-of-the evidence for both cyromazine and melamine with 
particular reference to their carcinogenic potential. Cyromazine is 
classified as a group ``E'' carcinogen (no evidence of carcinogenicity) 
with an chronic RfD of 0.0075 milligram/kilogram/day (mg/kg/day) with 
an uncertainty factor (UF) of 100 using a no observed adverse effect 
level (NOAEL) of 0.75 mg/kg/day and a lowest observed adverse effect 
level (LOAEL) of 7.5 mg/kg/day.
    Melamine is a chemical intermediate in the manufacture of amino 
resins and plastics as well as a contaminate and/or a metabolite of 
several pesticides including cyromazine. Melamine produced bladder 
tumors only in the male rat urinary bladder at very high doses i.e., at 
a threshold effect > 10,000 ppm in the diet. These tumors were due to 
the accumulation of stones (hard crystalline solids) which caused 
irritation and secondarily resulted in the formation of tumors; 
therefore melamine is not considered to be a direct carcinogen by the 
Agency.
    In addition, only about 10% of cyromazine is converted to melamine 
in vivo. Anticipated human dietary and occupational exposure to the 
parent compound cyromazine from its current pesticide usage is 
estimated to result in melamine concentrations far below the NOAEL in 
rats (500 mg/kg/day) that led to formation of stones in rats. Thus, EPA 
does not have any toxicological concerns for the minimal amount of 
melamine residues that could result from the use of the pesticide 
cyromazine. Also, melamine has been removed from the World Health 
Organization as a residue of concern for cyromazine, and Codex limits 
are established for the parent cyromazine only.
    EPA determined that the requested tolerances for potatoes at 0.8 
ppm, green onions at 2.0 ppm, onion, dry bulb at 0.1 ppm, cotton, 
undelinted seed at 0.1 ppm, and lima beans at 1.0 ppm are too high 
based upon the magnitude of the residue studies and removal of the 
metabolite melamine from consideration. Therefore, EPA is proposing 
that the tolerance be set at 0.8 ppm, 2.0 ppm, 0.1 ppm, 0.1 ppm, and 
1.0 ppm respectively. As a result of the animal feed items, processed 
potato waste, potato culls and sweet corn forage and stover being added 
to the animal diet at this time, EPA concluded that the requested milk 
tolerance of 0.04 ppm was too low and is proposing it be increased to 
0.05 ppm. Likewise, as a result of the animal feed items, EPA is 
proposing establishment of tolerances in meat, fat and meat byproducts 
of cattle, goats, hogs, horses and sheep at 0.05 ppm.
    EPA has reassessed the established cyromazine tolerances in order 
to determine the tolerance levels without melamine residues. As a 
result, EPA is proposing the tolerances be adjusted as follows: 
cucurbit vegetables from 2.0 to 1.0 ppm; leafy vegetables (except 
Brassica) from 10.0 to 7.0 ppm; mushrooms from 10.0 to 1.0 ppm; pepper 
from 4.0 to 1.0 ppm and tomato from 1.0 to 0.5 ppm. The tolerances for 
Chinese cabbage and Chinese mustard should remain at 3.0 ppm since the 
available field trial data do not support a lowering of the established 
tolerances. Since melamine is being removed from the tolerance 
expression EPA is proposing to remove 40 CFR 180.414(a)(2) because it 
is for melamine only on chicken byproducts.
    Cyromazine is an insect growth regulator currently proposed for 
control of leafminers on lima beans, Colorado potato beetle and 
leafminers on potatoes and seed treatment for control of onion maggots 
on onions.
    EPA is issuing this action as a proposal (rather than a final) 
because after review of the initial petitions and Notices of Filing the 
Agency has determined that:
    1. The metabolite melamine should be removed from the tolerance 
expression.
    2. The proposed tolerance in milk needs to be raised.
    3. Additional tolerances on animal commodities (meat, fat and milk 
byproducts of cattle, goats, hogs, horses and sheep) are needed.
    4. A notice of filing was not initially published after receipt of 
the petition for lima beans.
    Interested persons are invited to submit comments on the proposed 
regulation. Comments must bear a notation indicating the docket control 
number ``OPP-300913.''

I. Background and Statutory Findings

    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....''
    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), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action, EPA has sufficient data to assess the

[[Page 50045]]

hazards of cyromazine and to make a determination on aggregate 
exposure, consistent with section 408(b)(2), for tolerances for 
residues of cyromazine in or on mangoes at 0.3 ppm; onion, green at 2.0 
ppm; onion, dry bulb at 0.1 ppm; potato at 0.8 ppm; corn, sweet 
(kernels plus cob with husks removed) at 0.5 ppm; corn, sweet, forage 
at 0.5 ppm; corn, sweet, stover at 0.05 ppm; radish, root at 0.5 ppm; 
radish, tops at 0.05 ppm; lima beans at 1.0 ppm; cotton, undelinated 
seed at 0.1 ppm; milk at 0.05 ppm; and meat, fat and meat byproducts 
(of beef, goat, hogs, horses and sheep) at 0.05 ppm. EPA's assessment 
of the dietary exposures and risks associated with establishing the 
tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by technical 
cyromazine are discussed in this unit.
    A rat acute oral toxicity study with a LD50 of 
approximately 3,387 milligrams/kilogram (mg/kg). Toxicity Category III 
(Moderately Toxic).
    A rat acute dermal toxicity study with an LD50 greater 
than 3,100 mg/kg. Toxicity Category III (Moderately Toxic).
    A rat acute inhalation study with an LC50 greater than 
2.9 mg/kg. Toxicity Category IV (Slightly Toxic).
    A primary eye irritation study in the rabbit that showed no eye 
irritation.
    A primary dermal irritation study in the rabbit that showed mild 
irritation. Toxicity Category IV.
    A dermal sensitization study in the guinea pig that showed no 
sensitization.
    In a 6-month feeding study in dogs the NOAEL was 30 ppm (0.75 mg/
kg). The LOAEL was 300.0 ppm (7.5 mg/kg) based upon decreased 
hematocrit and decreased hemoglobin. Groups of male and female beagle 
dogs (4/sex/dose) were fed diets containing cyromazine at 0, 30, 300, 
or 3,000 ppm (0, 0.75, 7.5, or 75 mg/kg/day, respectively) for 6-
months. No treatment related effects were observed in survival, 
clinical signs or body weight parameters. Pronounced effects on 
hematologic parameters, were manifested as decreases in hematocrit and 
hemoglobin levels at 300 and 3,000 ppm.
    In a 24-month feeding study in rats the NOAEL for the study was 30 
ppm (1.5 mg/kg/day). The LOAEL was 300.0 ppm (15.0 mg/kg) based on 
decreased body weight.
    In a 24-month mouse chronic feeding carcinogenicity study the NOAEL 
was 50 ppm (7.5 mg/kg/day). The LOAEL was 1,000.0 ppm (150.0 mg/kg) 
based upon decreased body weight. There was no evidence of 
carcinogenicity at 3,000.0 ppm (450.0 mg/kg).
    In a 24-month rat chronic feeding carcinogenicity study the NOAEL 
was greater than 3,000.0 ppm (150.0 mg/kg), highest dose tested. There 
was no evidence of carcinogenicity at 3,000 ppm.
    In a rat developmental toxicity study the maternal NOAEL was 100 
mg/kg/day. The maternal LOAEL was 300.0 mg/kg based on decreased body 
weight gain and clinical observations. The developmental NOAEL was 
300.0 ppm. The developmental LOAEL was 600.0 mg/kg based upon an 
increase of minor skeletal variations.
    In a rabbit developmental toxicity study the maternal NOAEL was 
10.0 mg/kg. The maternal LOAEL was 30.0 mg/kg based upon decreased body 
weight gain and food consumption. The developmental NOAEL/LOAEL was 
greater than or equal to 60.0 mg/kg.
    In a multi-generation study in rats the systemic NOAEL was 30.0 ppm 
(1.5 mg/kg). The systemic LOAEL was 1,000.0 ppm (50.0 mg/kg) based upon 
decreased body weights associated with decreased food consumption. The 
developmental/offspring systemic NOAEL was 1,000.0 ppm. The 
developmental/offspring systemic LOAEL was 3,000.0 ppm (150.0 mg/kg) 
based upon decreased body weight at birth thru weaning. There were no 
effects on reproductive parameters at the highest dose tested (3,000 
ppm).
    Studies on gene mutation and other genotoxic effects showed no 
evidence of point mutation in an Ames test; no indication of mutagenic 
effects in a dominant lethal test; and no evidence of mutagenic effects 
in a nucleus anomaly test in Chinese hamsters.
    In a dermal absorption study, rats received dermal application of 
14C cyromazine (75W, formulation) in an aqueous solution at 
0.10, 1.0 or 10 mg/rat. Absorption was measured at 10 and 24 hours post 
treatment. Cyromazine was rapidly absorbed into the skin (no peak 
discernible) in an inverse dose-related manner. The absorption into the 
skin was followed by a slower release into the body. There was no 
evidence that the compound was sequestered in the skin permanently. The 
main route of excretion was via the urine. At 10 hours post treatment, 
the absorption was 7.57, 5.06 and 1.84% for the low, mid and high 
doses, respectively. At 24 hours post exposure, the absorption was 
6.87, 2.78 and 2.63% for the low, mid and high doses, respectively. For 
the 24-hour animals with 48-hour depletion period, the absorption was 
16.07, 12.45 and 9.10% for the low, mid and high doses, respectively.

B. Toxicological Endpoints

    1. Acute toxicity. (1-day) There was no toxicological effects 
attributable to a single exposure (dose) observed in oral toxicity 
studies including the developmental toxicity studies in rats or 
rabbits. Therefore, a dose and an endpoint was not selected for this 
acute dietary risk assessment.
    2. Short- and intermediate-term toxicity. The Agency selected 
short- and intermediate-term dermal and inhalation endpoints from the 
6-month oral toxicity study in dogs, in which pronounced effects on 
hematological parameters were manifested as decreases in hematocrit and 
hemoglin levels at 7.5 (LOAEL) and 75 mg/kg/day. The hematological 
effects began during the first week of the study and continued 
throughout the study. The NOAEL is 0.75 mg/kg/day. A margin of exposure 
(MOE) of 100 or greater is adequate. For dermal inhalation exposure 
adsorption rates of 8% for dermal and 100% for inhalation are 
appropriate.
    3. Chronic toxicity. The Agency selected a chronic RfD for 
cyromazine of 0.0075 mg/kg/day (NOAEL = 0.75 mg/kg/day; UF = 100). This 
RfD is based on a 6-month oral toxicity in dogs, in which pronounced 
effects on hematological parameters were manifested as decreases in 
hematocrit and hemoglobin levels at 7.5 (LOAEL) and 75 mg/kg/day.
    4. Carcinogenicity. Cyromazine has been classified a Group E 
(evidence of non-carcinogenicity for humans) chemical by the Cancer 
Peer Review Committee.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.414) for the residues of cyromazine, in or on a variety of raw 
agricultural commodities at levels ranging from 1.0 ppm in tomatoes to 
10 ppm in leafy vegetables and including poultry feed. In addition, EPA 
proposes to establish tolerances for mangoes at 0.3 ppm; onion, green 
at 2.0 ppm; onion, dry bulb at 0.1 ppm; potato at 0.8 ppm; cotton, 
undelinted seed at 0.1 ppm; corn, sweet, (kernels plus cob with husks 
removed) at 0.5 ppm; corn, sweet, forage at 0.5 ppm; corn, sweet, 
stover at 0.5 ppm; radish, root at 0.5 ppm; radish,

[[Page 50046]]

tops at 0.5 ppm; lima beans at 1.0 ppm; milk at 0.05 ppm and meat, fat 
and meat byproducts (of cattle, goat, hogs, horses and sheep) at 0.05 
ppm. Risk assessments were conducted by EPA to assess dietary exposures 
from cyromazine as follows:
    The Agency used Dietary Exposure Evaluation Model 
(DEEM) software for conducting a Tier 3 chronic (non-
cancer) dietary (food only) exposure analysis. The following 
assumptions were used in the assessment: (i) Percent crop-treated (PCT) 
estimates were utilized for cucurbit vegetables, leafy vegetables 
(except Brassica), onions, peppers and tomatoes; (ii) all other crops 
100% crop-treated was assumed; (iii) anticipated residue estimates were 
used for milk, meat, fat, and meat byproducts of cattle, goats, hogs, 
horses, and sheep; and (iv) all other commodities tolerance level 
residues were assumed. This assessment is considered to be somewhat 
refined. The chronic DEEM analysis indicates that the 
most highly exposed population subgroup is children (1 to 6 years old), 
which occupies 34% of the chronic RfD or chronic population adjusted 
dose (PAD)
    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.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual PCT for assessing chronic dietary risk only if the Agency can 
make the following findings: That the data used are reliable and 
provide a valid basis to show what percentage of the food derived from 
such crop is likely to contain such pesticide residue; that the 
exposure estimate does not underestimate exposure for any significant 
subpopulation group; and if data are available on pesticide use and 
food consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F), EPA may require registrants to submit data on 
PCT.
    The Agency believes that the three conditions, discussed in section 
408(b)(2)(F) in this unit concerning the Agency's responsibilities in 
assessing chronic dietary risk findings, have been met. With respect to 
PCT, estimates are derived from Federal and private market survey data, 
which are reliable and have a valid basis. Typically, a range of 
estimates are supplied and the upper end of this range is assumed for 
the exposure assessment. By using this upper end estimate of the crop 
treated, the Agency is reasonably certain that the percentage of the 
food treated is not likely to be underestimated. As to regional 
consumption information and consumption information for significant 
subpopulations is taken into account through EPA's computer-based model 
for evaluating the exposure of significant subpopulations including 
several regional groups. Use of this consumption information in EPA's 
risk assessment process ensure's that EPA's exposure estimate does not 
understate exposure for any significant subpopulation group and allows 
the Agency to be reasonably certain that no regional population is 
exposed to residue levels higher than those estimated by the Agency. 
Other than the data available through national food consumption 
surveys, EPA does not have available information on the regional 
consumption of food to which cyromazine may be applied in a particular 
area.
    a. Acute exposure and risk. A food-use pesticide is presumed to 
pose an acute risk if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. There were no toxicological effects attributed to a 
single exposure (dose) observed in oral toxicity studies including the 
developmental toxicity studies in rats and rabbits. Therefore, the 
Agency concludes that there is a reasonable certainty of no harm from 
acute dietary exposure.
    b. Chronic exposure and risk. The chronic and/or chronic PAD RfD 
used for the chronic dietary analysis is 0.0075 milligram/kilogram/body 
weight/day (mg/kg/bwt/day). The following assumptions were used in the 
dietary risk assessment: (i) PCT estimates were utilized for cucurbit 
vegetables, leafy vegetables (except Brassica), onions, peppers and 
tomatoes. All other crops 100% crop-treated was assumed; (ii) 
anticipated residue estimates were used for milk, meat, fat, and meat 
byproducts of cattle, goats, hogs, horses, and sheep; and (iii) all 
other commodities tolerance level residues were assumed. The proposed 
and established cyromazine tolerances result in an exposure estimate 
that is equivalent to the following percents of the RfD: U.S. 
population (17% of RfD), non-nursing infants, (1 year old) (13% of 
RfD), children (1-6 years old) (34%), and children (7-12 years old) 
26%. EPA is generally concerned with chronic exposures that exceed 100% 
of the RfD or PAD.
    This chronic analysis for cyromazine is an over-estimate of dietary 
exposure from food due to the use of tolerance level residues for some 
commodities and the assumption that 100% of the crop would be treated 
for some of the commodities in this dietary exposure analysis. Thus in 
making a safety determination for these tolerances, EPA is taking into 
account this conservative exposure assessment.
    2. From drinking water. The Agency has calculated drinking water 
levels of comparison (DWLOCs) for chronic (non-cancer exposure) to 
cyromazine in surface and ground water.
    i. Acute exposure and risk. Because no acute dietary endpoint was 
determined, EPA does not expect exposure to cyromazine through drinking 
water to pose an acute risk.
    ii. Chronic exposure and risk. EPA has calculated DWLOCs for 
chronic (non-cancer) exposure to cyromazine in surface and ground 
water. A human health DWLOC is the concentration of a pesticide in 
drinking water which would result in an acceptable aggregate risk after 
having factored in all food exposures and other non-occupational 
exposures for which EPA has reliable data. The DWLOCs are 220, 190, 50, 
and 210 parts per billion (ppb) for the U.S. population, females 13+, 
children, and others respectively. To calculate the DWLOCs for chronic 
(non-cancer) exposure relative to a chronic toxicity endpoint, the 
chronic dietary food exposure from DEEM was 
subtracted from the RfD to obtain the acceptable chronic (non-cancer) 
exposure to cyromazine in drinking water. DWLOCs were then calculated 
using default body weights and drinking water consumption figures. 
Although cyromazine may be commercially applied to landscape 
ornamentals and around residences, EPA believes these uses will not 
result in any exposure through the oral route; therefore, aggregate 
exposure is limited only to food plus water.
    Estimated maximum concentrations of cyromazine in surface and 
ground

[[Page 50047]]

water are 28.9 and 1.6 ppb, respectively. The modeling conducted was 
based on the environmental profile and the maximum seasonal application 
rate proposed for cyromazine (6 applications at 0.125 lbs/A). The 
estimated average concentrations of cyromazine in surface and ground 
water are less than the Agency's levels of comparison for cyromazine in 
drinking water as a contribution to chronic aggregate exposure. Thus, 
the Agency concludes that there is reasonable certainity of no harm 
from chronic exposure from drinking water.
    The Agency bases this determination on a comparison of estimated 
concentrations of cyromazine in surface waters and ground waters to 
back-calculated ``levels of comparison'' for cyromazine in drinking 
water. These levels of comparison in drinking water were determined 
after the Agency has considered all other non-occupational human 
exposures for which it has reliable data, including all current uses, 
and uses considered in this action. The estimates of cyromazine in 
surface and ground waters are derived from water quality models that 
use conservative assumptions (health-protective) regarding the 
pesticide transport from the point of application to surface and ground 
water. Because the Agency 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 (including crop or residential) are added in the future, the 
Agency will reassess the potential impacts of cyromazine on drinking 
water as a part of the aggregate risk assessment process.
    3. From non-dietary exposure. Cyromazine is currently registered 
for commercial outdoor use on landscape ornamentals and commercial 
interiorscapes. There are no lawn or indoor residential uses. Although 
cyromazine could be commercially applied to ornamentals around 
residences based upon the large MOE's calculated for occupational use 
(i.e. > 1,900) and minimal contact anticipated with the active 
ingredient after application, significant residential exposure is not 
expected.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Cyromazine is a member of the triazine class of pesticides. 
Other members of this class include atrazine, simizine, cyanazine, 
prometin, propazine, metribuzin, prometryn, and ametryn.
    EPA does not have, at this time, available data to determine 
whether cyromazine 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, 
cyromazine 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 cyromazine has a common mechanism of toxicity 
with other substances.

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

    1. Acute risk. There were no toxicological effects attributable to 
a single exposure (dose) observed in oral toxicity studies including 
the developmental toxicity studies in rats or rabbits.
    2. Chronic risk (food + water). Using the exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
cyromazine from food will utilize 17% of the chronic RfD for the U.S. 
population. The major identifiable subgroup with the highest aggregate 
exposure is 34% for children (1-6 years 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 dietary (food only) exposures and using default body weights 
and water consumption figures, chronic DWLOCs for drinking water were 
calculated. For chronic exposure, based on an adult body weight of 70 
kg and 2L consumption of water per day, EPA's level of comparison from 
chronic dietary exposure in drinking water is 220 g/L. For 
children (10 kg and consuming 1 liter water/day) the level of 
comparison for drinking water is 50 g/L. The estimated chronic 
drinking water exposure for cyromazine is 28.9 g/L. Thus the 
potential residues in drinking water are not greater the EPA's level of 
comparison. Therefore, the combined exposure of chronic dietary food 
and drinking water exposure to cyromazine would be no greater than 100% 
of the RfD for children or the general U.S. population. Due to the 
nature of the non- dietary use, EPA believes that the commercial use of 
cyromazine on landscape ornamentals will not result in any significant 
residential exposure. Therefore the chronic risk is the sum of food and 
water. The Agency concludes that there is reasonable certainty that no 
harm will result from aggregate exposure to cyromazine residues.
    3. Short- and intermediate-term risk. These aggregate risk 
assessments take into account chronic dietary exposure from food and 
water (considered to be a background exposure level) plus (acute, 
intermediate, or chronic, as applicable) indoor and outdoor residential 
exposure. The Agency selected a dose and toxicological endpoint for 
assessments of short- and intermediate-term dermal and inhalation risk. 
However, since there are no significant residential uses for cyromazine 
(either established or pending) at this time, these risk assessments 
are not currently required.
    4. Aggregate cancer risk for U.S. population. The Cancer Peer 
Review Committee determined that there is no evidence of 
carcinogenicity in studies in either the mouse or rat. Based upon this 
determination it can be concluded that cyromazine 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 cyromazine residues.

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

    1. Safety factor for infants and children-- i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of cyromazine, 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 pesticide exposure during prenatal development to one or 
both parents. 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 
interspecies and intraspecies 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

[[Page 50048]]

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. In the rabbit developmental 
study, the maternal (systemic) NOAEL was 10 mg/kg/day, the highest dose 
tested. In the rat developmental study, the developmental NOAEL was 
identified at 300 mg/kg/day, while the maternal NOAEL was 100 mg/kg/
day. Although there were developmental findings at 600 mg/kg/day in rat 
fetuses, these findings were not severe effects and only occurred in 
the presence of maternal toxicity.
    iii. Reproductive toxicity study. In the multi-generation study in 
rats the systemic NOAEL was 30.0 ppm (1.5 mg/kg). The systemic LOAEL 
was 1,000.0 ppm (50.0 mg/kg) based upon decreased body weights 
associated with deceased food consumption. The developmental/offspring 
systemic NOAEL was 1,000.0 ppm. The developmental/offspring systemic 
LOAEL was 3,000.0 ppm (150.0 mg/kg) based upon decreased body weight at 
birth thru weaning. There were no effect on reproductive parameters at 
the highest dose tested (3,000 ppm).
    iv. Prenatal and postnatal sensitivity. The results of the rat and 
rabbit developmental studies did not demonstrate any potential for 
additional prenatal sensitivity. In the rat reproduction study, the 
parental and reproductive/developmental NOAELs were established at 1.5 
and 50 mg/kg/day respectively which suggests that there is no special 
postnatal sensitivity to cyromazine.
    v. Conclusion. Based on the completeness and reliability of the 
toxicity data and the conservative exposure assessment, the Agency 
concludes that an additional safety factor of 10 is not necessary to be 
protective of infants and children.
    2. Acute risk. There were no toxicological effects attributable to 
a single exposure (dose) observed in oral toxicity studies including 
the developmental toxicity studies in rats or rabbits.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
cyromazine from food will utilize a maximum 34% of the RfD for children 
1-6 years 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. As noted above potential exposure from drinking 
water is at a level below EPA's level of comparisons. EPA concludes 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to cyromazine residues.
    4. Short- and intermediate-term risk. These aggregate risk 
assessments take into account chronic dietary exposure from food and 
water (considered to be a background exposure level) plus (acute, 
intermediate, or chronic, as applicable) indoor and outdoor residential 
exposure. The Agency selected a dose and toxicological endpoint for 
assessments of short- and intermediate-term dermal and inhalation risk. 
However, since there are no significant residential uses for cyromazine 
(either established or pending) at this time, these risk assessments 
are not currently required.
    5. 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 cyromazine residues.

III. Other Considerations

A. Metabolism in Plants and Animals

    EPA has reviewed the results of plant metabolism studies (celery, 
lettuce and tomato) and livestock metabolism studies (goat and hen). 
The metabolism of cyromazine in plants and animals is adequately 
understood for the purposes of these tolerances. The major residues in 
plants, milk, meat and meat byproducts (except liver and kidney) are 
cyromazine and melamine. The major residues in liver and kidney are 
cyromazine, melamine and 1-methylcyromazine. EPA concluded (see 
background) that the metabolite melamine was no longer a residue of 
concern and the metabolite 1-methhylcyromazine was only found in 
ruminants. Provided the dietary burden to animals remains low only the 
parent compound cyromazine needs to be included in the tolerance 
expression and used for dietary risk assessment.

B. Analytical Enforcement Methodology

    Methods AG-408 and AG-417A are the tolerance enforcement methods as 
published in PAM, Vol II. These methods combined, and with minor 
modifications is Method AG-621. The residue data on the treated crops 
was analyzed by these methods. The limit of quantitation is 0.05 ppm 
for cyromazine and 0.05 ppm for melamine expressed as cyromazine 
equivalents. These extraction and cleanup procedures are similar to the 
Methods AG-408 and AG-417, but AG-621 uses a gas chromatography for 
analysis, while the other methods use high pressure liquid 
chromatography for determination of cyromazine and melamine levels in 
the crop matrix.
    Methods AG-408 and AG-417 as listed in FDA's Pesticide Analytical 
Manual (PAM), Vol-II are adequate to enforce the proposed tolerance. 
AG-621 is acceptable to support the crop field trial residue data for 
cyromazine on RAC's.
    The PAM II enforcement method for the determination of cyromazine 
residues limit of quantitation (LOQ) is 0.05 ppm in meat, fat, and meat 
byproducts.

C. Magnitude of Residues

    Adequate residue data were provided to support permament tolerances 
of mangoes at 0.3 ppm; onion, green at 2.0 ppm; onion, dry blub at 0.1 
ppm; potato at 0.8 ppm; corn, sweet (kernels plus cob with husks 
removed) at 0.5 ppm; corn, sweet, forage at 0.5 ppm; corn, sweet, 
stover at 0.5 ppm; radish, root at 0.5 ppm; radish, tops at 0.5 ppm; 
lima beans at 1.0 ppm; milk at 0.05 ppm; meat, fat and meat byproducts 
(of beef, goat, hogs, horses and sheep) at 0.05 ppm and in cotton, 
undelinted seed at 0.1 ppm. There were no data available for cotton gin 
products (commonly called cotton gin trash). The petitioner has 
committed to conduct the additional residue trials and obtain data for 
cotton gin byproducts. Although residue data for lima beans were 
conducted per the EPA guidance that was in effect at the time of the 
field trials, EPA now requires residue data for the succulent beans 
without the pods. EPA will issue a conditional registration for these 
uses while the petitioner generates the additional data.
    Processing data provided for potatoes did not show any 
concentration of residues for potato chips above the tolerance level. 
For potato granules the concentration factor is below 1.5x value that 
is generally used for setting tolerances for processed commodities. 
Thus no tolerances are required for processed potato commodities.
    The only significant animal feed items from either published or 
proposed tolerances are potato culls, processed potato waste and sweet 
corn forage and stover. Since none of these items are fed to poultry 
the established poultry tolerances are adequate.
    A ruminant feeding study was submitted. Based upon the results of 
this study the data support permanent tolerances in milk at 0.05 ppm 
and meat, fat and meat byproducts (of cattle, goat, hogs, horses and 
sheep) at 0.05

[[Page 50049]]

ppm resulting from the feeding of animal commodities indicated above.

D. International Residue Limits

    With deletion of the metabolite melamine there are no longer any 
compatibility problems between Codex limits, Mexican limits and 
proposed U.S. tolerances. There are currently no Codex, Canadian or 
Mexican limits for residues of cyromazine on potatoes and lima beans. 
There is a Codex limit of 0.01 ppm in milk which is less than the 
proposed tolerance of 0.05 ppm. Although residues in milk would most 
likely be below 0.05 ppm, this level is the limit of quatitation (LOQ) 
used for enforcement purposes for determination of cyromazine residues.

E. Rotational Crop Restrictions

    Rotational crop tolerances are being requested for cotton, 
undelinated seed, sweet corn (kernels plus cob with husks removed), 
sweet corn forage and stover as well as radish, roots and tops 
(leaves). When these crops are planted as rotational crops, cyromazine 
is persistent in soils and residues can be present in crops that are 
rotated to treated crops. For those crops with no tolerances 
established, a 1 year plant back interval is specified on the label.

IV. Conclusion

    Tolerances are being proposed for residues of cyromazine in mangos 
at 0.3 ppm; onion, green at 2.0 ppm; onion, dry bulb at 0.1 ppm; potato 
at 0.8 ppm; corn, sweet, (kernels plus cob with husks removed) at 0.5 
ppm; corn, sweet, forage at 0.5 ppm; corn, sweet, stover at 0.5 ppm; 
radish, root at 0.5 ppm; radish, tops at 0.5 ppm; lima beans at 1.0 
ppm; cotton, undelinted seed at 0.1 ppm; milk at 0.05 ppm; and meat, 
fat and meat byproducts (of cattle, goat, hogs, horses and sheep) at 
0.05 ppm. Conditional Registration for use of cyromazine on succulent 
lima beans and cotton are being proposed to allow for development and 
review of additional residue field studies. The analysis for cyromazine 
using tolerance level residues shows that the proposed uses will not 
cause exposure to exceed levels at which EPA believes there is an 
appreciable risk. All population subgroups examined by EPA are exposed 
to cyromazine residues at levels below 100% of the RfD for chronic 
effects. Based on the information and data considered, EPA concludes 
that the proposed tolerances will be safe. Therefore, these tolerances 
are being proposed as set forth below.

V. Public Comment Procedures

    EPA invites interested persons to submit written comments, 
information, or data in response to this proposed rule. After 
consideration of comments, EPA will issue a final rule. Such rule will 
be subject to objections. Failure to file an objection within the 
appointed period will constitute waiver of the right to raise in future 
proceedings issues resolved in the final.

VI. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket 
control number [OPP-300913] (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.
    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 comments received 
electronically into printed, paper form as they are received and will 
place the paper copies in the official record. The official record is 
the paper record maintained at the Virginia address in ``ADDRESSES'' at 
the beginning of this document.

VII. Regulatory Assessment Requirements

    This action proposes to establish tolerance under FFDCA section 
408(e). 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). In 
addition this proposed 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, under the Regulatory Flexibility Act (RFA) (5 U.S.C. 
601 et seq.), 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.

List of Subjects in 40 CFR Part 180

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

    Dated: August 26, 1999.

James Jones,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR part 180 be amended as 
follows:

PART 180 [AMENDED]

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

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


    2. Section 180.414, is revised to read as follows:


Sec.   180.414  Cyromazine; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide cyromazine (N-cyclopropyl-1,3,5-triazine-2,4,6 triamine) in 
or on the following raw agricultural commodities:

 
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cattle, fat..................................................   0.05
 
Cattle, meat.................................................   0.05
 
Cattle, meat byproduct.......................................   0.05
 
Cucurbit vegetables..........................................   1.0
 
Eggs.........................................................   0.25
 

[[Page 50050]]

 
Goats, fat...................................................   0.05
 
Goats, meat..................................................   0.05
 
Goats, meat byproduct........................................   0.05
 
Hogs, fat....................................................   0.05
 
Hogs, meat...................................................   0.05
 
Hogs, meat byproduct.........................................   0.05
 
Horses, fat..................................................   0.05
 
Horses, meat.................................................   0.05
 
Horses, meat byproduct.......................................   0.05
 
Leafy vegetables (except Brassica)...........................   7.0
 
Lima beans...................................................   1.0
 
Mango1.......................................................   0.3
 
Milk.........................................................   0.05
 
Mushrooms....................................................   1.0
 
Onion, dry bulb..............................................   2.0
 
Onion, green.................................................   0.1
 
Peppers......................................................   1.0
 
Potato.......................................................   0.8
 
Poultry, fat (from chicken layer hens and chicken breeder       0.05
 hens only)..................................................
 
Poultry, meat byproduct (from chicken layer hens and chicken    0.05
 breeder hens only)..........................................
 
Poultry, meat (from chicken layer hens and chicken breeder      0.05
 hens only)..................................................
 
Sheep, fat...................................................   0.05
 
Sheep, meat..................................................   0.05
 
Sheep, meat byproduct........................................   0.05
 
Tomato.......................................................   0.5
------------------------------------------------------------------------
1There are no U.S. registrations on mango as of (inset date of
  publication).

    (2) The additive cyromazine (N-cyclopropyl-1,3,5-triazine-2,4,6-
triamine) may be safely used in accordance with the following 
prescribed conditions:
    (i) It is used as a feed additive only in the feed for chicken 
layer hens and chicken breeder hens at the rate of not more than 0.01 
pound of cyromazine per ton of poultry feed.
    (ii) It is used for control of flies in manure of treated chicken 
layer hens and chicken breeder hens.
    (iii) Feeding of cyromazine-treated feed must stop at least 3 days 
(72 hours) before slaughter. If the feed is formulated by any person 
other than the end user, the formulator must inform the end user, in 
writing, of the 3-day (72 hours) preslaughter interval.
    (iv) To ensure safe use of the additive, the labeling of the 
pesticide formulation containing the feed additive shall conform to the 
labeling which is registered by the U.S. Environmental Protection 
Agency, and the additive shall be used in accordance with this 
registered labeling.
    (v) Residues of cyromazine are not to exceed 5.0 parts per million 
(ppm) in poultry feed.
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for the combined residues of the insecticide cyromazine (N-
cyclopropyl-1,3,5-triazine-2,4,6-triamine) and its metabolite, melamine 
(1,3,5-triazine-2,4,6-triamine), in connection with use of the 
pestiicde under section 18 emergency exemption granted by EPA. The 
tolerances are specified in the following table. These tolerances 
expire and are revoked on the date specified in the table.

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
Turkey, fat...................................         0.05       4/1/00
Turkey, meat..................................         0.05       4/1/00
Turkey, meat byproduct........................         0.05       4/1/00
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. As defined in 180.1(n), 
are established for the residues of cyromazine (N-cyclopropyl-1,3,5-
triazine-2,4,6-triamine) in or on the following raw agricultural 
commodities:

 
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cabbage, Chinese.............................................   3.0
 
Mustard, Chinese.............................................   3.0
------------------------------------------------------------------------

    (d) Indirect or inadvertent residues. Tolerances are established 
for the indirect or inadvertent residues of cyromazine (N-cyclopropyl- 
1,3,5-triazine-2,4,6-triamine), in or on the raw agricultural 
commodities when present therein as a result of the application of 
cyromazine to growing crops listed in paragraphs (a)(1) of this 
section.

 
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Cotton, undelinted seed......................................   0.1
 
Corn, sweet, (kernels plus cob with husks removed)...........   0.5
 
Corn, sweet, forage..........................................   0.5
 
Corn, sweet, stover..........................................   0.5
 
Radish, root.................................................   0.5
 
Radish, tops (leaves)........................................   0.5
------------------------------------------------------------------------


[FR Doc. 99-24047 Filed 9-14-99; 8:45 am]
BILLING CODE 6560-50-F