Pesticide Tolerance for Cadusafos

ENVIRONMENTAL PROTECTION AGENCY

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.

-----------------------------------------------------------------------

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:

------------------------------------------------------------------------

Parts per

Commodity million

------------------------------------------------------------------------

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

------------------------------------------------------------------------

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]

BILLING CODE 6560-50-F