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imazalil (Fecundal,Fungaflor) Pesticide Tolerances 5/93

40 CFR Part 180



[PP 5F3250/R1199; FRL-4586-8]



RIN No. 2070-AB78



Pesticide Tolerances for Imazalil



AGENCY: Environmental Protection Agency (EPA). 



ACTION: Final rule.

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SUMMARY: This rule amends existing tolerances and establishes 

new tolerances for residues of the fungicide imazalil and its 

metabolite in or on various raw agricultural commodities. The 

regulation was requested by Janssen Pharmaceutica and establishes 

the maximum permissible level for residues of the fungicide 

in or on the raw agricultural commodities.



EFFECTIVE DATE: Effective on May 17, 1993. 



ADDRESSES: Written objections, identified by the document control 

number, [PP 5F3250/R1199], may be submitted to: Hearing Clerk 

(A-110), Environmental Protection Agency, Rm. 3708, 401 M St., 

SW., Washington, DC 20460. In person, bring comments to: Rm. 

1128, CM .2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. 



FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker, 

Product Manager (PM 22), Registration Division (H7505C), Office 

of Pesticide Programs, Environmental Protection Agency, 401 

M St., SW., Washington, DC 20460. Office location and telephone 

number: Rm. 229, CM .2, 1921 Jefferson Davis Hwy., Arlington, 

VA 22202, (703)-305-5540.



SUPPLEMENTARY INFORMATION: EPA issued a notice, published in 

the Federal Register of April 30, 1986 (51 FR 16106), which 

announced that Janssen Pharmaceutica had submitted pesticide 

petition (PP) 5F3250 to EPA proposing to amend 40 CFR part 180 

by establishing tolerances under section 408 of the Federal 

Food, Drug, and Cosmetic Act, 21 U.S.C. 346a, for residues of 

the herbicide imazalil, 1-[2-(2,4-dichlorophenyl)-2-(2-propenyloxy)ethyl]-

1H-imidazole, and its metabolite 1-(2,4-dichlorophenyl)-2-(1H-

imidazole-1-yl)-1-ethanol in or on the raw agricultural commodities 

barley forage and wheat forage at 2.0 parts per million (ppm). 



   The petitioner subsequently amended the petition by submitting 

a revised Section F proposing the establishment of tolerances 

for residues of imazalil and its metabolite on wheat and barley 

forage and hay at 0.5 ppm and proposing the amendment of the 

existing tolerances for straw of wheat and barley from 2.0 ppm 

to 0.5 ppm. The Tolerance Support, Chemistry Branch has recommended 

in favor of amending the tolerances on straw of wheat and barley 

and establishing the tolerances for forage of wheat and barley. 

Residues of imazalil in wheat and barley hay will be covered 

by the straw tolerances, and thus tolerances will not be established 

for hay of wheat and barley. This notice establishes tolerances 

for residues of imazalil and its metabolite at 0.5 ppm in straw 

(decreasing the established tolerance of 2.0 ppm), and 0.5 ppm 

in forage (establishing a new tolerance).

   The data submitted in the petition and other relevant material 

have been evaluated. The toxicological data considered in support 

of these tolerances are listed below:

   1. A 2-year feeding/carcinogenic study in rats fed dosages 

of 2, 5, 10, and 40 milligrams/kilogram of body weight/day (mg/kg/day) 

with no carcinogenic effects observed under the conditions of 

the study at dose levels up to and including 40 mg/kg/day and 

a systemic no-observed-effect level (NOEL) of 10 mg/kg/day.

   2. A 2-year mouse feeding/carcinogenic study with mice fed 

dosages of 2, 5, 10, and 40 mg/kg/day with no carcinogenic effects 

observed under the conditions of the study at dose levels up 

to and including 40 mg/kg/day (HDT) and a systemic NOEL of 10 

mg/kg/day.

   3. A 2-year feeding study in dogs fed dosage levels of 1.25 

mg/kg/day, and 5.0 mg/kg/day with a NOEL of 1.25 mg/kg, and 

an LEL of 5 mg/kg (decreased body weight).

   4. A developmental toxicity study in rats fed dosage levels 

of 40, 80, and 120 mg/kg/day, with no developmental effects 

at 40 mg/kg/day, and maternal toxicity NOEL of less than 40 

mg/kg/day, and a developmental toxicity NOEL equal to 40 mg/kg. 

An acceptable developmental toxicity study in rabbits fed dosage 

levels of 1.25, 2.5, and 5.0 mg/kg/day, with no developmental 

toxicity reported in fetuses at the dose levels tested.

   5. A three-generation reproduction study in rats fed dosage 

levels of 2.5, 10, and 40 mg/kg/day with a NOEL for reproductive 

effects of 40 mg/kg/day.

   6. A mutagenicity study with Salmonella typhimurium (negative), 

an in vitro cytogenetics study on human lymphocytes (unacceptable), 

and a micronucleus test in mice (negative).

   An acceptable Reference Dose (RfD) was calculated to be 0.0125 

mg/kg/day based on the 2-year dog feeding study (NOEL of 1.25 

mg/kg/day) and a hundred-fold uncertainty factor. There are 

published tolerances for this chemical on bananas, barley grain 

and straw, citrus fruit, citrus oil, citrus pulp, cottonseed, 

wheat grain and straw, meat, and milk. Established tolerances 

utilize 16.32 percent of the RfD. Since the established tolerances 

for meat and milk will cover secondary residues from the tolerances 

established with this document, this action does not change 

percentage of the RfD utilized. 

   The pesticide is useful for the purposes of this tolerance 

rule. The nature of the residue is adequately understood, and 

adequate analytical methods (gas-liquid chromatography with 

a nitrogen-sensitive detector) are available for enforcement 

purposes. The method is not yet published in the Pesticide Analytical 

Manual, Vol. II (PAM-II), but can be obtained in the interim 

period as follows: By Mail: Calvin Furlow, Public Information 

Branch, Field Operations Division (H7506C), Office of Pesticide 

Programs, Environmental Protection Agency, 401 M St., SW., Washington, 

DC 20460. Office location and telephone number: CM .2, Rm. 1126, 

1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-5937.

   There are currently no actions pending against the registration 

of this chemical. Established tolerances under 40 CFR 180.413(b) 

will cover any secondary residues that occur in meat, milk, 

poultry, or eggs from this use. Based on the information cited 

above, the Agency has determined that the establishment of the 

tolerances by amending 40 CFR part 180 will protect the public 

health. Therefore, the tolerances are established as set forth 

below. 

   Any person adversely affected by this regulation may, within 

30 days after the date of this document in the Federal Register, 

file written objections with the Hearing Clerk, at the address 

given above. 40 CFR 178.20. 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). If 

a hearing is requested, the objections must include a statement 

of the factual issue(s) on which a hearing is requested, the 

requestor's contentions on each such issue, and a summary of 

anyevidence relied upon by the objector. 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 a 

genuine and substantial issue of fact; there is a reasonable 

possibility that available evidence identified by the requestor 

would, if established, resolve one or more of such issues in 

favor of the requestor, taking into account uncontested claims 

or facts to the contrary; and resolution of the factual issue(s) 

in the manner sought by the requestor would be adequate to justify 

the action requested. 40 CFR 178.32.

   The Office of Management and Budget has exempted this rule 

from the requirements of section 3 of Executive Order 12291. 

   Pursuant to the requirements of the Regulatory Flexibility 

Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator 

has determined that the regulations establishing new tolerances 

or raising tolerance levels or establishing exemptions from 

tolerance requirements do not have a significant economic impact 

on a substantial number of small entities. A certification statement 

to this effect was published in the Federal Register of May 

4, 1981 (46 FR 24950).



List of Subjects in 40 CFR Part 180



   Administrative practice and procedure, Agricultural commodities, 

Pesticides and pests, Reporting and recordkeeping requirements.



   Dated: May 17, 1993.





Douglas D. Campt,

Director, Office of Pesticide Programs.

   Therefore, 40 CFR part 180 is amended as follows:



PART 180-[AMENDED]



   1. The authority citation for part 180 continues to read 

as follows: 



   Authority: 21 U.S.C. 346a and 371.



   2. In . 180.413, paragraph (a) is amended by revising the 

table therein, to read as follows:



. 180.413   Imazalil; tolerances for residues.



   (a) *  *  * 





                                                                              

                                                                              

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                           Commodity                              Parts per   

                                                                   million    

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Bananas (Whole)................................................         3.00  

Bananas (Pulp).................................................         0.20  

Barley, forage.................................................          0.5  

Barley, grain..................................................         0.05  

Barley, straw..................................................          0.5  

Citrus fruit (Postharvest).....................................         10.0  

Cottonseed.....................................................         0.05  

Wheat, forage..................................................          0.5  

Wheat, grain...................................................         0.05  

Wheat, straw...................................................          0.5  

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[FR Doc. 93-12479 Filed 5-25-93; 8:45 am]

BILLING CODE 6560-50-F