[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Rules and Regulations]
[Pages 26946-26949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12915]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300487; FRL-5716-8]


Carbon Disulfide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of the 
nematicide, insecticide, and fungicide, carbon disulfide (Chemical Code 
Number 16401 and CAS Number 75-15-0), in or on the food commodities 
almond nutmeat, almond hulls, peaches, and plums (fresh prunes) from 
the application of sodium tetrathiocarbonate (Chemical Code Number 
128904 and CAS Number 7345-69-9). Entek Corporation submitted a 
petition to EPA under the

[[Page 26947]]

Federal Food, Drug, and Cosmetic Act (FFDCA) as amended by the Food 
Quality Protection Act of 1996 (Pub. L. 104-170) requesting the 
tolerances.
DATES: This regulation becomes effective May 16, 1997. Objections and 
hearing requests must be received on or before July 15, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [OPP-300487], may be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections shall be 
labeled ``Tolerance Petition Fees'' and forwarded: EPA Headquarters 
Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, 
Pittsburgh, PA 15251. A copy of any objections and hearing requests 
filed with the Hearing Clerk should be identified by the document 
control number and submitted 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 copy of objections and hearing requests to 
Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may be submitted to OPP by sending electronic mail (e-mail) to: 
[email protected] Copies of electronic objections and hearing 
requests must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Copies of electronic objections 
and hearing requests will also be accepted on disks in WordPerfect 5.1 
file format or ASCII file format. All copies of electronic objections 
and hearing requests must be identified by the docket number [OPP-
300487]. No Confidential Business Information (CBI) should be submitted 
through e-mail. Copies of electronic objections and hearing requests on 
this rule may be filed online at many Federal Depository Libraries. 
Additional information on electronic submissions can be found below in 
this document.

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, 
telephone number and e-mail address: Rm. 229, CM #2, 1921 Jefferson 
Davis Highway, Arlington, VA (703-305-7740), e-mail: giles-
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of February 12, 1997 
(62 FR 6526)(FRL-5586-5), EPA issued a notice pursuant to section 
408(d)of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 
346a(d), announcing the filing of a pesticide tolerance petition (PP 
5F4482) by Entek Corporation, P.O. Box 458, Brea, CA 92622-0458 to EPA 
requesting that the Administrator amend 40 CFR part 180 by establishing 
a tolerance for residues of the nematicide, insecticide, and fungicide, 
carbon disulfide, in or on the food commodities almond nutmeat, almond 
hulls, peaches, and plums (fresh prunes) at 0.1 parts per million (ppm) 
from the application of sodium tetrathiocarbonate. There were no 
comments received in response to the notice of filing.
    Sodium tetrathiocarbonate stoichiometrically converts to carbon 
disulfide, sodium hydroxide, hydrogen sulfide and sulfur in the soil 
after application to the crops. Carbon disulfide is the pesticide's 
active compound.
    The data submitted in the petition and all other relevant material 
have been evaluated. The data listed below were considered in support 
of these tolerances.

I. Toxicological Profile

    1. The toxicology data for sodium tetrathiocarbonate include:
    a. 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.
    b. 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.
    c. A developmental toxicity study in rabbits for sodium 
tetrathiocarbonate with a maternal NOEL of 75 mg/kg and a LEL of 150 
mg/kg (convulsions, prostration) and a developmental NOEL of 150 mg/kg 
and a LEL of 185 mg/kg (increased resorption, post implantation loss, 
increase incidence 13th rib).
    d. 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.
    2. The toxicology data for carbon disulfide include:
    a. In a 90-day rat inhalation study with carbon disulfide the NOEL 
for neuropathology was 50 ppm, the LOEL was 300 ppm based on axonal 
swelling in the spinal cord and peripheral nerves. No NOEL was 
determined for brain-weight effects.
    b. In a 90-day rat inhalation study with carbon disulfide the NOEL 
was 50 ppm and the LEL was 300 ppm (axonal swelling in the spinal cord 
and peripheral nerves.
    c. 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).
    d. A developmental toxicity study in rats with carbon disulfide 
with a maternal no-observed effect level (NOEL) of 100 mg/kg/day and a 
LEL of 200 mg/kg/day based on clinical signs and decreased body-weight 
gains and a developmental NOEL of 100 mg/kg/day and developmental LEL 
of 200 mg/kg/day, based on decreased fetal body weight in both sexes.
    e. A developmental toxicity study in rabbits with carbon disulfide 
with no NOEL for maternal effects (the number and percentage of does 
with 100% intrauterine deaths and the percentage of resorptions/litter 
[mean litter percentage] were increased in a dose-related manner with 
statistical significance at all dose levels for mean litter 
percentage). The NOEL for developmental toxicity was 75 mg/kg/day with 
a LEL of 150 mg/kg/day based on increased malformations.

II. Aggregate Exposures

    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from the pesticide residue 
in food and all other non-occupational exposures. The primary non-food 
sources of exposure the Agency looks at include drinking water (whether 
from groundwater or surface water), and exposure through pesticide use 
in gardens, lawns, or buildings (residential and other indoor uses).
    1. From food and feed uses. The nature of residues is understood. 
Entek Corporation has documented that the level of free or bound carbon 
disulfide is extremely low in the treated crops (less than 50 parts per 
billion (ppb)). Carbon disulfide is a naturally occurring compound 
found in grapes and citrus at 5 to 20 ppb 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 almonds, peaches and plums with sodium 
tetrathiocarbonate will not be appreciably different from the natural 
background levels of carbon disulfide in

[[Page 26948]]

these crops. 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 are not relevant to 
this petition.
    2. From potable water. Two prospective ground water monitoring 
studies were conducted for sodium tetrathiocarbonate. In both studies, 
sodium tetrathiocarbonate was applied above very shallow aquifers (3 to 
7 ft. below the surface) and the ground water was analyzed for carbon 
disulfide. Transient groundwater contamination with carbon disulfide 
was detected. Carbon disulfide, however, which is very volatile rapidly 
moves upward through the soil profile and diffuses to the atmosphere. 
With the proposed and registered uses of sodium tetrathiocarbonate only 
in the Western United States with its deeper aquifers and a label 
restriction prohibiting application within 100 feet of a potable water 
well, carbon disulfide is not likely to be a residual ground water 
contaminant.
    3. From non-dietary uses. There are no non-food uses of sodium 
tetrathiocarbonate registered under the Federal Insecticide, Fungicide 
and Rodenticide Act, as amended. No non-dietary exposures are expected 
for the general population.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will increase the Agency's scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better determining which chemicals 
have a common mechanism of toxicity and evaluating the cumulative 
effects of such chemicals. The Agency anticipates, however, that even 
as its understanding of the science of common mechanisms increases, 
decisions on specific classes of chemicals will be heavily dependent on 
chemical specific data, much of which may not be presently available.
    EPA does not have, at this time, available data to determine 
whether carbon disulfide has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. There is the possibility that other pesticides such as 
metam sodium or the EDBC's (such as zineb or maneb) may degrade to 
carbon disulfide. However, we do not have information to indicate that 
use of the other pesticides would raise the level of carbon disulfide 
in treated crops above the background level. For the purposes of this 
tolerance action, therefore, EPA has not assumed that carbon disulfide 
has a common mechanism of toxicity with other substances. The general 
populations dietary exposure to carbon disulfide from treatment of the 
crops with sodium tetrathiocarbonate will not be appreciably different 
from the natural background levels of carbon disulfide the untreated 
crops.

III. Determination Of Safety For Infants And Children

    FFDCA section 408 provides that EPA shall apply an additional 
safety factor for infants and children in the case of threshold effects 
to account for pre- and post-natal toxicity and the completeness of the 
data base, unless EPA determines that such an additional factor is not 
necessary to protect the safety of infants and children. 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 
ppb and up to 1 to 73 ppm in Shiitake mushrooms. A tolerance for carbon 
disulfide is established at the analytical level of quantification of 
0.1 ppm. Children's dietary exposure to carbon disulfide resulting from 
treatment of the almonds, peaches and plums with sodium 
tetrathiocarbonate will not be appreciably different from the natural 
background levels of carbon disulfide in the untreated crops.

IV. Other Considerations

    1. Endocrine effects. An evaluation of the potential effects on the 
endocrine systems of mammals has not been determined; however, no 
evidence of such effects were reported in the toxicology studies 
described above. There was no observed pathology of the endocrine 
organs in these studies. There is no evidence at this time that carbon 
disulfide causes endocrine effects.
    2. Metabolism in plants and animals. 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.
    3. Analytical method. 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 (7506C), 
Office of Pesticide Programs, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460. Office location and telephone number: 
Room 1130A, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA (703-305-
5937).
    4. International tolerances. There are no Codex Alimentarius 
Commission (Codex) Maximum Residue Levels (MRLs) for carbon disulfide.

V. Summary of Findings

    The analysis for carbon disulfide shows the proposed uses on 
almonds, peaches and plums will not cause exposure at which the Agency 
believes there is an appreciable risk.
    Based on the information cited above, the Agency has determined 
that the establishment of the tolerances by amending 40 CFR part 180 
will be safe; therefore, the tolerances are established as set forth 
below.

VI. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (1)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which governs the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use

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those procedural regulations with appropriate adjustments to reflect 
the new law.
    Any person may, by July 15, 1997, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. 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 fee prescribed 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, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the objector (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 one 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). Information 
submitted in connection with an objection or hearing request may be 
claimed confidential by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. A copy of the information 
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.

VII. Public Docket

    The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket number 
[OPP-300487] (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The 
official rulemaking record is located at the Virginia address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    [email protected]

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on disks in Wordperfect 5.1 file format or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket number [OPP-300487]. Electronic comments on 
this proposed rule may be filed online at many Federal Depository 
Libraries.

VIII. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), this 
action is not a ``significant regulatory action'' and since this action 
does not impose any information collection requirements subject to 
approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it 
is not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty, or contain 
any ``unfunded mandates'' as described in Title II of the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior 
consultation as specified by Executive Order 12875 (58 FR 58093, 
October 28, 1993), or special considerations as required by Executive 
Order 12898 (59 FR 7629, February 16, 1994).
    Because tolerances established on the basis of a petition under 
section 408(d) of FFDCA do not require issuance of a proposed rule, the 
regulatory flexibility analysis requirements of the Regulatory 
Flexibility Act (RFA), 5 U.S.C. 604(a), do not apply. Prior to the 
recent amendment of the FFDCA, EPA had treated such rulemakings as 
subject to the RFA; however, the amendments to the FFDCA clarify that 
no proposal is required for such rulemakings and hence that the RFA is 
inapplicable.
    Pursuant to 5 U.S.C. 801(a)(1)(A), EPA submitted a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives and the Comptroller General of the 
General Accounting Office prior to publication of the rule in today's 
Federal Register. This rule is not a major rule as defined by 5 U.S.C. 
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements

    Dated: May 6, 1997

Daniel M. Barolo,

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. By amending Sec. 180.467 to alphabetically add the food 
commodities: almond hulls; almond nutmeat; peaches; and plums (fresh 
prunes) to the table as follows:


Sec. 180.467   Carbon disulfide; tolerances for residues.

*     *     *     *     *

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
Almond hulls...............................................          0.1
Almond nutmeat.............................................          0.1
                  *        *        *        *        *                 
Peaches....................................................          0.1
Plums (fresh prunes).......................................          0.1
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[FR Doc. 97-12915 Filed 5-15-97; 8:45 am]
BILLING CODE 6560-50-F