terbufos (Counter) Proposed Pesticide Tolerance 3/93
40 CFR Part 180
[PP 8E3574/P552; FRL-4175-2]
Pesticide Tolerance for Terbufos
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: This document proposes to establish a 2-year time-limited
import tolerance for the combined residues of the insecticide/nematicide
terbufos and its cholinesterase-inhibiting metabolites in or
on the raw agricultural commodity (RAC) coffee beans. This proposal
to establish a maximum permissible level for residues of the
insecticide/nematicide was requested by the American Cyanamid
DATES: Comments, identified by the document control number [PP
8E3574/P552], must be received on or before April 9, 1993.
ADDRESSES: By mail, submit written comments to: Public Response
and Program Resources Branch, Field Operations Division (H7506C),
Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring comments
to: Rm. 1128, CM#2, 1921 Jefferson Davis Hwy., Arlington, VA
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. 1128 at the address
given above, from 8 a.m. to 4 p.m., Monday through Friday, excluding
FOR FURTHER INFORMATION CONTACT: By mail: Robert A. Forrest,
Product Manager (PM) 14, Registration Division (H7505C), 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 Highway, Arlington,
VA 22202, 703-305-6600.
SUPPLEMENTARY INFORMATION: The American Cyanamid Co., P.O. Box
400, Princeton, NJ 08540, has submitted pesticide petition (PP)
8E3574 to EPA requesting that the Administrator, pursuant to
section 408(e) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 346a(e)) propose the establishment of a tolerance for
the combined residues of the insecticide/nematicide terbufos
and its cholinesterase-inhibiting metabolites in or on the raw
agricultural commodity coffee beans at 0.05 part per million
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 lowest-observable-effect
level (LOEL) of 0.015 milligram/kilogram/day (mg/kg/day) based
on the inhibition of plasma cholinesterase activity.
2. A 4-week dog plasma cholinesterase study with a no-observable-
effect level (NOEL) of 0.0013 mg/kg/day based on the inhibition
of plasma cholinesterase activity.
3. A 1-year rat feeding study with a no-observable-effect
level (NOEL) of 0.5 ppm (0.025 mg/kg) based on the inhibition
of plasma and brain cholinesterase activity.
4. An 18-month mouse carcinogenicity study with no carcinogenic
effects observed at dosage levels up to and including 12.0 ppm
(1.7 mg/kg/day), which was the highest level tested.
5. A 2-year rat carcinogenicity study with no carcinogenic
effects observed at doses up to and including 2.0 ppm (0.10
6. A three-generation rat reproduction study with a NOEL
of 0.25 ppm (0.0125 mg/kg) for reproductive effects.
7. A rat teratology study with a NOEL of 0.1 mg/kg/day for
8. A rabbit teratology study with a NOEL of 0.25 mg/kg/day
for developmental toxicity.
9. An acute delayed
neurotoxicity study in chickens, which
was negative for neurotoxic effects under the conditions of
the study (highest dose tested was 40 mg/kg).
10. Several mutagenicity tests which were all negative. These
include a dominant lethal study in rats; an acute in vivo cytogenetic
assay in rats; an Ames test including metabolic activation;
a DNA repair chromosomal aberration (CHO cells); CHO/HGPRT mutation
assay; and a rat hepatocyte primary culture/DNA repair test.
The reference dose (RfD), based on the plasma cholinesterase
inhibition (ChE) NOEL as defined in a 4-week dog study (0.0013
mg/kg/day) and using a safety factor of 10, is calculated to
be 0.00013 mg/kg of body weight (bwt)/day. The theoretical maximum
residue contribution (TMRC) is 0.000052 mg/kg/bwt/day for existing
tolerances for the overall U.S. population. The current action
will increase the TMRC by 0.000003 mg/kg/bwt/day (2 percent
of the RfD). These tolerances and previously established tolerances
utilize a total of 42.1 percent of the RfD for the overall U.S.
The nature of the residues is adequately understood for the
use of terbufos on coffee beans imported from Central America.
The nature of the residues in plants is adequately defined,
and there are no animal feed items involved with this use. Therefore,
it is expected that no
secondary residues in meat, milk, poultry,
and eggs will result from the use of the pesticide on coffee
An adequate analytical method, gas chromatography with a
flame photometric detector, is available in the Pesticide Analytical
Manual, Vol. II, for enforcement purposes.
The available rat metabolism study was found to only partially
satisfy current guideline requirements (85-1). Because of the
lack of an acceptable guideline rat metabolism study, the Agency
is limiting the period of time that the proposed regulation
is to be in effect. A new rat metabolism study has been received
and is currently under evaluation. Should the Agency find that
the new metabolism study is acceptable, it will reassess the
tolerance for coffee beans and, if appropriate, will establish
a permanent tolerance for this commodity. There are currently
no actions pending against the continued registration of this
Residues not in excess of 0.05 part per million in or on
coffee beans after expiration of the tolerance will not be considered
actionable if the insecticide-nematicide is legally applied
during the term of, and in accordance with, provisions of the
Based on the above
information considered by the Agency,
the tolerance established by amending 40 CFR 180.352 would protect
the public health. Therefore, it is proposed that the tolerance
be established as set forth below.
Any person who has registered or submitted an application
for registration of a pesticide, under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) as amended, which contains
any of the ingredients listed herein, may request within 30
days after publication of this document in the Federal Register
that this rulemaking proposal be referred to an Advisory Committee
in accordance with section 408(e) of the Federal Food, Drug,
and Cosmetic Act.
Interested persons are invited to submit written comments
on the proposed regulation. Comments must bear a notation indicating
the document control number, [PP 8E3574/P552]. All written comments
filed in response to this petition 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.
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, Reporting and recordkeeping requirements.
Dated: February 24, 1993.
Acting Director, Registration Division, Office of Pesticide
Therefore, it is proposed that 40 CFR part 180 be amended
1. The authority citation for part 180 continues to read
Authority: 21 U.S.C. 346a and 371.
2. In 180.352, by adding new paragraph (b), to read as follows:
180.352 Terbufos; tolerances for residues.
* * * * *
(b) A time-limited tolerance to expire (insert date 24 months
after effective date of final rule) is established for combined
residues of the insecticide/nematicide terbufos (S-[[1,1-dimethyl)thio]methyl]
0,0-diethyl phosphorodithioate and its cholinesterase-inhibiting
metabolites in or on the following raw agricultural commodity:
Commodity Parts per
Coffee beans................................................... 0.05
There are no U.S. registrations as of March 10, 1993 for coffee
[FR Doc. 93-5103 Filed 3-9-93; 8:45 am]
BILLING CODE 6560-50-F