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cadusafos (Rugby, Apache) Proposed Permanent Tolerance 4/94

40 CFR Part 180



[PP 6E3447/P573; FRL-4744-5]



RIN No. 2070-AC18



Pesticide Tolerance for Cadusafos 



AGENCY: Environmental Protection Agency (EPA). 



ACTION: Proposed rule. permanent tolerance insecticide/nematicide cadusafos

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SUMMARY: This document proposes that a permanent tolerance be 

established for residues of the insecticide/nematicide cadusafos, 

O-ethyl S,S-di-sec-butyl phosphorodithioate, in or on the raw 

agricultural commodity bananas. The proposed regulation to establish 

a maximum permissible level for residues of the insecticide/nematicide 

in or on the commodity was requested in a petition submitted 

by the FMC Corp.



DATES: Comments, identified by the document control number [PP 

6E3447/P573], must be received on or before June 9, 1994. 



ADDRESSES: By mail, submit written comments to: Public Response 

and Program Resources Branch, Field Operations Division (7506C), 

Office of Pesticide Programs, Environmental Protection Agency, 

401 M St., SW., Washington, DC 20460. In person, bring comments 

to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 

22202.



   Information submitted as a comment concerning this document 

may be claimed confidential by marking any part or all of that 

information as ``Confidential Business Information'' (CBI). 

Information so marked will not be disclosed except in accordance 

with procedures set forth in 40 CFR part 2. A copy of the comment 

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. All written 

comments will be available for public inspection in Rm. 1132 

at the address given above, from 8 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays. 



FOR FURTHER INFORMATION CONTACT: By mail: Robert A. Forrest, 

Product Manager (PM) 14, Registration Division (7505C), Office 

of Pesticide Programs, Environmental Protection Agency, 401 

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

number: Rm. 219, CM #2, 1921 Jefferson Davis Hwy., Arlington, 

VA 22202, (703)-305-6600. 



SUPPLEMENTARY INFORMATION: EPA issued a rule in the Federal 

Register of October 23, 1992 (57 FR 48327), which announced 

its decision to establish a time-limited tolerance for residues 

of the pesticide cadusafos on bananas for a period extending 

to October 24, 1994. The Agency limited the period of time that 

the regulation was to be in effect because of the need for confirmatory 

usage data required to ensure that cadusafos was being applied 

on bananas in a manner that would not result in an increase 

in the anticipated residue level.



   The FMC Corp., Agricultural Chemicals Group, 200 Market St., 

Philadelphia, PA 19103, has submitted the confirmatory usage 

data and has requested that EPA, pursuant to section 408(e) 

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(e)), 

propose the establishment of a permanent tolerance for residues 

of the nematicide/insecticide cadusafos in or on the RAC bananas 

at 0.01 part per million (ppm). 

   The data submitted in the petition and other relevant material 

have been evaluated. The pesticide is considered useful for 

the purpose for which the tolerance is sought. The toxicological 

data considered in support of the proposed tolerance include:

   1. A 1-year dog feeding study with a no-observed-effect level 

(NOEL) at 0.001 milligram/kilogram/day (mg/kg/day). The lowest 

effect level (LEL) was 0.005 mg/kg/day for cholinesterase (ChE) 

inhibition. Levels tested were 0.0002, 0.001, 0.005, and 0.02 

mg/kg.

   2. A 2-year rat feeding carcinogenicity study with a NOEL 

of 1.0 ppm for both systemic effects and ChE inhibition. The 

study was negative for carcinogenic effects under the conditions 

of the study at all feeding levels. Systemic effects observed 

at the 5.0 ppm dose level consisted of decreased locomotion 

and elevated clinical chemistry values for serum aspartate aminotransferase 

(SGOT) in females. Levels tested were 0.1, 0.5, 1.0, and 5.0 

ppm.

   3. A 2-year mouse carcinogenic study which was negative for 

carcinogenic effects under the conditions of the study at all 

feeding levels. Levels tested were 0.1, 0.5, 1.0, and 5.0 ppm.

   4. A two-generation reproduction study in rats with a NOEL 

of 0.1 ppm (equivalent to 0.005 mg/kg/day) for reproductive 

effects consisting of a significant decrease in the live birth 

index at the 0.5 ppm (0.025 mg/kg) level. Levels tested were 

0.1, 0.5, and 5.0 ppm. 

   5. A rat teratology study with a NOEL of 6.0 mg/kg/day for 

developmental effects associated with the toxicity of cadusafos. 

Levels tested were 0.2, 6.0, and 18.0 ppm.

   6. A rabbit teratology study with a NOEL greater than 0.9 

mg/kg/day for developmental toxicity. Levels tested were 0.1, 

0.3, and 0.9 mg/kg. 

   7. An acute delayed neurotoxicity study in chickens, which 

was negative for neurotoxic effects under the conditions of 

the study (highest dose tesed was 8.0 mg/kg).

   8. An Ames test was not mutagenic at the highest doses tested, 

600 and 900 micrograms (ug)/plate, with or without metabolic 

activation, respectively.

   9. An unscheduled DNA synthesis test in rat hepatocytes was 

not mutagenic at the highest dose tested, 45 nanoliter (nL)/milliliter 

(mL).

   10. A chromosome aberration assay in Chinese hamster ovary 

cells was not mutagenic at the highest dose tested, 75 nL/mL 

with or without metabolic activation.

   11. In an in vitro cell transformation test, it was concluded 

that cadusafos was capable of inducing morphological transformations 

of mouse embryo cells in the presence of metabolic activation 

at the highest three out of the four dose levels tested, which 

were 0.06, 0.07, 0.08, and 0.09 uL/mL. A positive finding in 

a mutagenicity test such as this one suggests that the test 

substance has the potential for inducing carcinogenic effects. 

Based on the negative findings of the 2-year rat and mouse carcinogenicity 

studies described above, the pesticide is not considered to 

be a carcinogen.

   12. In a metabolism study with rats, 63 to 79 percent of 

the dose was excreted in the urine within 24 hours. The major 

urinary metabolites were methane sulfonic acid; o-ethyl S-(2-

butyl)phosphorothioic acid; the threo and erythro stereoisomers 

of methyl 1-methyl-2-hydroxypropyl-sulfone; and S,S-di(2-butyl) 

phosphorodithioate. 

   The reference dose (RfD) based on the 1-year feeding study 

in dogs with a NOEL for ChE at 0.001 mg/kg/day and using an 

uncertainty factor of 100 is calculated to be 0.00001 mg/kg 

of body weight (bwt)/day. The theoretical maximum residue contribution 

(TMRC) resulting from this action will be 0.000002 mg/kg/bwt/day 

for the overall U.S. population and represents 23 percent of 

the RfD. The TMRC for the highest exposed subgroup, nonnursing 

infants less than 1 year old, is 0.000011 mg/kg/bwt/day, or 

108.38 percent of the RfD, assuming that residue levels are 

at the established tolerances and that 100 percent of the crop 

is treated. 

   However, the Agency believes that actual residues to which 

the public is likely to be exposed are considerably less than 

indicated for the following reasons.

   1. Not all the planted crop for which a tolerance is established 

is normally treated with the pesticide.

   2. Most treated crops have residue levels which are below 

the established tolerance level at the time of consumption.

   To take the second factor into account, the Agency recalculated 

the TMRC using the anticipated residues. The anticipated residue 

value of 0.005 ppm, the limit of detection of the analytical 

method for cadusafos, was used in the recalculation. This value 

was used considering the fact that most bananas are eaten or 

processed with the peel removed. Moreover, the available data 

showed no detectable residues in the pulp even for exaggerated 

application rates. Following this adjustment, the estimate of 

exposure from the proposed tolerance is 0.000001 mg/kg bwt/day, 

or 11.5 percent of the RfD for the overall population, and the 

estimate of exposure to nonursing infants less than 1-year old 

is 0.000005 mg/kg/ bwt/day, or 54.2 percent of the RfD.

   The Agency requested usage data from FMC. That data submitted 

by FMC confirms that cadusafos is being applied on bananas in 

a manner that would not result in an increase in the anticipated 

residue level.

   The nature of the residues in bananas is adequately understood, 

and an adequate analytical method, gas liquid chromatography 

using either a flame photometric detector or an alkali ionization 

detector, is available for enforcement purposes. 

   Because of the long lead time from establishing this tolerance 

to publication of the enforcement methodology in the Pesticide 

Analytical Manual, Vol. II, the analytical methodology is being 

made available in the interim to anyone interested in pesticide 

enforcement when requested from: Calvin Furlow, Public Information 

Branch, Field Operations Division (7506C), Office of Pesticide 

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

DC 20460. Office location and telephone number: Rm. 1128, CM 

#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-

5232. 

   Residue methodology data using the Food and Drug Administration 

pesticide multiresidue method protocol D have been provided. 

   Bananas are not considered to be a livestock feed item. Thus, 

there is no reasonable expectation of secondary residues in 

eggs, milk, and meat byproducts from the use of cadusafos on 

bananas.

   The pesticide is considered useful for the purpose for which 

the tolerance is sought, and it is concluded that the establishment 

of the tolerance will protect the public health. Therefore, 

the tolerance is proposed as set forth below.

   The proposed tolerance of .01 ppm agrees with the tolerance 

proposed by the Codex Alimentarius Commission for residues of 

cadusafos in or on bananas.

   Interested persons are invited to submit written comments 

on the proposed regulation. Comments must bear a notation indicating 

the document control number, [PP 6E3447/P573]. All written comments 

filed in response to this document will be available in the 

Public Information Branch, at the address given above from 8 

a.m. to 4 p.m., Monday through Friday, except legal holidays. 

   Under Executive Order 12866 (58 FR 51735, October 4, 1993), 

the Agency must determine whether the regulatory action is ``significant'' 

and therefore subject to all the requirements of the Executive 

Order (i.e., Regulatory Impact Analysis, review by the Office 

of Management and Budget (OMB)). Under section 3(f), the order 

defines ``significant'' as those actions likely to lead to a 

rule (1) having an annual effect on the economy of $100 million 

or more, or adversely and materially affecting a sector of the 

economy, productivity, competition, jobs, the environment, public 

health or safety, or State, local or tribal governments or communities 

(also known as ``economically significant''); (2) creating serious 

inconsistency or otherwise interfering with an action taken 

or planned by another agency; (3) materially altering the budgetary 

impacts of entitlements, grants, user fees, or loan programs; 

or (4) raising novel legal or policy issues arising out of legal 

mandates, the President's priorities, or the principles set 

forth in this Executive Order. 

   Pursuant to the terms of this Executive Order, EPA has determined 

that this rule is not ``significant'' and is therefore not subject 

to OMB review.

   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 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



   Environmental protection, Administrative practice and procedure, 

Agricultural commodities, Pesticides and pests, Reporting and 

recordkeeping requirements. 



Dated: April 22, 1994.





Stephanie R. Irene,

Acting 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. 346a and 371.



   2. By revising sec 180.461, to read as follows:



sec 180.461   Cadusafos; tolerances for residues.



   A tolerance is established for residues of the nematicide/insecticide 

cadusafos, O-ethyl S,S-di-sec-butyl phosphorodithioate, in or 

on the following raw agricultural commodity: 





                                                                              

                                                                              

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                           Commodity                              Parts per   

                                                                   million    

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Bananas........................................................         0.01  

                                                                              

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There are no U.S. registrations as of May 10, 1994 for the nematicide/insecticide 

cadusafos.



[FR Doc. 94-11196 Filed 5-9-94; 8:45 am]