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
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
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
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
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
9. An unscheduled DNA synthesis test in rat hepatocytes was
not mutagenic at the highest dose tested, 45 nanoliter (nL)/milliliter
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)
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
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
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-
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
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
Dated: April 22, 1994.
Stephanie R. Irene,
Acting Director, Registration Division, Office of Pesticide
Therefore, it is proposed that 40 CFR part 180 be amended
1. The authority citation for part 180 continues to read
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:
Commodity Parts per
There are no U.S. registrations as of May 10, 1994 for the nematicide/insecticide
[FR Doc. 94-11196 Filed 5-9-94; 8:45 am]