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carbon disulfide Pesticide Tolerance--Final Rule 6/93

Pesticide Tolerances for Carbon Disulfide

AGENCY: Environmental Protection Agency (EPA). 

ACTION: Final rule.
.
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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 
of filing.
   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:

PART 180-[AMENDED]

   1. The authority citation for part 180 continues to read 
as follows:

   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 
commodities: 


                                                                              
                                                                              
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                           Commodity                              Parts per   
                                                                   million    
------------------------------------------------------------------------------
                                                                              
Grapefruit.....................................................          0.1  
Grapes.........................................................          0.1  
Lemons.........................................................          0.1  
Oranges........................................................          0.1  
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[FR Doc. 93-14562 Filed 6-18-93; 8:45 am]