[Federal Register Volume 59, Number 89 (Tuesday, May 10, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11196]


[[Page Unknown]]

[Federal Register: May 10, 1994]


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


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