[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
