carbon disulfide Pesticide Tolerance--Final Rule 6/93
Pesticide Tolerances for Carbon Disulfide
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes a tolerance for residues
of the nematicide, insecticide, and fungicide carbon disulfide
in or on the raw agricultural commodities (RACs) grapefruit,
grapes, lemons, and oranges at 0.1 part per million (ppm) from
the application of sodium tetrathiocarbonate. This regulation
to establish the maximum permissible level of residues of the
pesticide in or on these commodities was requested in a petition
submitted by Unocal Corp.
EFFECTIVE DATE: This regulation becomes effective June 21, 1993.
ADDRESSES: Written objections, identified by the document control
number, [PP 8F3580/R2001], may be submitted to: Hearing Clerk
(A-110), Environmental Protection Agency, Rm. 3708, 401 M St.,
St., Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker,
Product Manager (PM) 22, Registration Division, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 229, CM #2, 1921 Jefferson
Davis Hwy., Arlington, VA 22202, (703)-305-5540.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in
the Federal Register of October 12, 1988 (53 FR 39783), which
announced that Unocal Corp., 461 S. Boyston C5, Los Angeles,
CA 90017, had submitted a pesticide petition (PP 8F3580) to
EPA requesting that the Administrator, pursuant to section 408(d)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(d), establish a tolerance for residues of the nematicide,
insecticide, and fungicide carbon disulfide in or on the raw
agricultural commodities (RACs) grapefruit, grapes, lemons,
oranges, potatoes, and tomatoes at 0.1 part per million (ppm)
from the application of sodium tetrathiocarbonate.
Sodium tetrathiocarbonate stoichiometrically converts to
carbon disulfide, sodium hydroxide, hydrogen sulfide, and sulfur
in the soil after application to the RACs. Carbon disulfide
is the pesticide's active compound.
Unocal Corp. subsequently amended PP 8F3580 to delete the
proposed tolerance for potatoes. The Agency is not at this time
establishing a tolerance for tomatoes since this RAC is not
proposed for registration with the concurrent application for
registration under the Federal Insecticide, Fungicide and Rodenticide
Act (FIFRA), as amended. Unocal Corp. will have to petition
the Agency for establishment of a tolerance in tomatoes when
it makes an application for registration under FIFRA for use
on this RAC.
There were no comments received in response to the notice
The data submitted in the petition and all other relevant
material have been evaluated. The toxicology data considered
in support of the tolerances include:
1. A rat acute oral study with an LD50 of 587 milligrams
(mg)/kilogram (kg) for females and 631 mg/kg for combined sexes
for sodium tetrathiocarbonate. The LD50 for carbon disulfide
is 456 mg/kg.
2. A developmental toxicity study in rats for sodium tetrathiocarbonate
with a maternal no-observed-effect level (NOEL) of 150 mg/kg,
and a lowest effect level (LEL) of 400 mg/kg (death), and a
developmental NOEL of 450 mg/kg.
3. A developmental toxicity study in rabbits for sodium tetrathiocarbonate
with a maternal NOEL of 75 mg/kg, and an LEL of 150 mg/kg (convulsions
and prostration), and a developmental NOEL of 150 mg/kg, and
an LEL of 185 mg/kg (increased resorption, post implantation
loss, increase incidence 13th rib).
4. Sodium tetrathiocarbonate was negative in a bacterial
gene mutation study with and without S9 activation, unscheduled
mammalian DNA synthesis, and in vitro chromosomal aberration
without S9 activation, but weakly positive with S9 activation.
5. In a 90-day rat inhalation study with carbon disulfide
there was no NOEL for brain effects.
6. In a 90-day mouse inhalation study with carbon disulfide
the NOEL was 300 ppm and the LEL was 800 ppm (lesions of peripheral
nerves, spinal cord, kidney, and spleen).
The nature of residues is understood. Unocal has documented
that the level of free or bound carbon disulfide or parent sodium
tetrathiocarbonate is extremely low in the treated crops (less
than 50 ppb). Carbon disulfide is a naturally occurring compound
found in grapes and citrus at 5 to 20 parts per billion and
up to 1 to 73 ppm in Shiitake mushrooms. The analytical method
has been validated. A tolerance for carbon disulfide is established
at the analytical level of quantification of 0.1 ppm. Dietary
exposure to carbon disulfide from treatment of the RACs with
sodium tetrathiocarbonate will not be appreciably different
than the natural background levels. Therefore, further toxicity
testing for carbon disulfide was not required, and the standard
risk assessment approach of using the Reference Dose (RfD) based
on systemic toxicity is not relevant to this petition.
The metabolism of carbon disulfide and sodium tetrathiocarbonate
in plants is adequately understood. There is no reasonable expectation
of secondary residues occurring in milk, eggs, and meat of livestock
or poultry. An adequate analytical method, gas chromatography,
is available for enforcement purposes. Because of the long lead
time from establishing these tolerances 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 (H7506C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm. 242, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA 22202, (703-305-4432).
The pesticide is considered useful for the purposes for which
the tolerances are sought. Based on the information and data
considered, the Agency concludes that the establishment of the
tolerances will protect the public health. Therefore, the tolerances
are established as set forth below.
Any person adversely affected by this regulation may, within
30 days after publication of this document in the Federal Register,
file written objections with the Hearing Clerk, at the address
given above (40 CFR 178.20). The objections submitted must specify
the provisions of the regulation deemed objectionable and the
grounds for the objections (40 CFR 178.25). Each objection must
be accompanied by the fees provided by 40 CFR 180.33(i). If
a hearing is requested, the objections must include a statement
of the factual issue(s) on which a hearing is requested, and
the requestor's contentions on each such issue, and a summary
of the evidence relied upon by the objection (40 CFR 178.27).
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following:
there is a genuine and substantial issue of fact; there is a
reasonable possibility that available evidence identified by
the requestor would, if established, resolve on or more of such
issues in favor of the requestor, taking into account uncontested
claims or facts to the contrary; and resolution of the factual
issue(s) in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32).
The Office of Management and Budget has exempted this rule
from the requirements of section 3 of Executive Order 12291.
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
Administrative practice and procedure, Agricultural commodities,
Pesticides and pests, Recording and recordkeeping requirements.
Dated: June 10, 1993.
Douglas D. Campt,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
1. The authority citation for part 180 continues to read
Authority: 21 U.S.C. 346a and 371.
2. In subpart C, by adding new . 180.467, to read as follows:
. 180.467 Carbon disulfide; tolerances for residues.
Tolerances are established for the nematicide, insecticide,
and fungicide carbon disulfide, from the application of sodium
tetrathiocarbonate, in or on the following raw agricultural
Commodity Parts per
[FR Doc. 93-14562 Filed 6-18-93; 8:45 am]