[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:
opp-docket@epamail.epa.gov 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: parker.cynthia@epamail.epa.gov.
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:
opp-docket@epamail.epa.gov
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
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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
