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terbufos (Counter) Proposed Pesticide Tolerance 3/93

40 CFR Part 180

[PP 8E3574/P552; FRL-4175-2]

RIN 2070-AC18

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 
Co. 

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 
22202.

   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 
legal holidays.

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 
(ppm).

   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 
mg/kg/day). 
   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 
developmental toxicity.
   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. 
population. 
   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 
beans. 
   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 
chemical. 
   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 
time-limited tolerance. 
   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.


Frank Sanders,
Acting Director, Registration Division, Office of Pesticide 
Programs.
   Therefore, it is proposed that 40 CFR part 180 be 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 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   
                                                                   million    
------------------------------------------------------------------------------
                                                                              
Coffee beans...................................................         0.05  
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There are no U.S. registrations as of March 10, 1993 for coffee 
beans.

[FR Doc. 93-5103 Filed 3-9-93; 8:45 am]
BILLING CODE 6560-50-F


 

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