[Federal Register Volume 60, Number 148 (Wednesday, August 2, 1995)]
[Proposed Rules]
[Pages 39299-39302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19004]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 8E3574/P620; FRL-4963-5]
RIN 2070-AC18


Terbufos; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to extend the time-limited import tolerance for 
combined residues of the insecticide/nematicide terbufos and its 
cholinesterase-inhibiting metabolites in or on the raw agricultural 
commodity (RAC) green coffee beans for an additional 2 years. American 
Cyanamid Co. submitted a petition pursuant to the Federal Food, Drug 
and Cosmetic Act (FFDCA) requesting the proposed regulation to 
establish a maximum permissible level for combined residues of the 
insecticide/nematicide in or on the commodity.

DATES: Comments, identified by the document control number [PP 8E3574/
P620], must be received on or before September 1, 1995.

ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132 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. 1132 at the address given above, 
from 8 a.m. to 4:30 p.m., 

[[Page 39300]]
Monday through Friday, excluding legal holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number [PP 8E3574/P620]. No Confidential Business 
Information (CBI) should be submitted through e-mail. Electronic 
comments on this proposed 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: Robert A. Forrest, Product 
Manager (PM) 14, Registration Division (7505C), 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 Hwy., Arlington, VA 22202, (703)-305-6600; e-mail: 
[email protected]. .

SUPPLEMENTARY INFORMATION: EPA issued rules, published in the Federal 
Register of May 19, 1993 (58 FR 29118), and May 26, 1993 (58 FR 30220), 
which announced its decision to establish a time-limited tolerance for 
residues of the insecticide/nematicide terbufos on coffee beans for a 
period extending to May 19, 1995. The Agency limited the period of time 
that the regulation was to be in effect because the available rat 
metabolism study was found to only partially satisfy current guideline 
requirements of 85-1.
    The American Cyanamid Co. has submitted a new rat metabolism study 
and has requested that the Administrator, pursuant to section 408(e) of 
the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), 
amend 40 CFR 180.352 by converting the 2-year time-limited import 
tolerance for 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) to 
permanent status.
    The designation, coffee beans, is corrected to read ``green coffee 
beans'' to reflect the current definition of this raw agricultural 
commodity.
    The scientific data submitted in the petition and other relevant 
material have been evaluated. 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) (the lowest dose 
tested) based on the inhibition of plasma cholinesterase activity.
    2. A 4-week dog plasma cholinesterase study with a no-observable-
effect level (NOEL) of 0.005 mg/kg/day in which inhibition of plasma 
cholinesterase activity was observed at the 0.015-dose level, the 
highest dose tested. This represents an increase in the NOEL value for 
plasma cholinesterase activity from 0.0013 (which was previously 
considered as the NOEL for this study), and is consistent with the LOEL 
observed for this activity in the 1-year dog study referenced in item 
one above where effects were also observed at the 0.015- dose level. 
Doses of 0.00125, 0.0025, 0.005, and 0.015 were administered in the 4-
week dog study.
    3. A 1-year rat feeding study with an NOEL of 0.5 ppm (0.025 mg/kg) 
for inhibition of plasma and brain cholinesterase activity.
    4. An 18-month mouse carcinogenicity study with no carcinogenic 
effect observed at dosages 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 mutagenic tests which were all negative. These include 
a dominant-lethal study in rats; an acute in vivo cytogenic 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.
    11. In a metabolism study with rats, 69.3 to 86.3% of the dose was 
excreted in the urine within 168 hours. The total recovery of the dose 
ranged from 89.1 to 98.7%. There was no evidence of terbufos or its 
metabolites bioaccumulating in tissues. The percentage of 
phosphorylated and nonphosphorylated metabolites recovered in the urine 
ranged from nondetectable to 0.68% and from 5.6 to 18.4 percent, 
respectively. The predominant compound recovered in the feces was the 
parent.
    The reference dose(RfD), based on the plasma cholinesterase 
inhibition (ChE) NOEL as defined in a 4-week dog study (0.005 mg/kg/
day) and using a safety factor of 100 to account for the inter-species 
extrapolation and intra-species variability, is calculated to be 
0.00005 mg/kg of body weight (bwt)/day. The co-critical study is a 1-
year dog feeding study in which an NOEL was not established. The LOEL 
was 0.015 mg/kg based on chloinesterase inhibition. The theoretical 
maximum residue contribution (TMRC) for existing tolerances and the 
current action is 0.000052 mg/kg/bwt/day for the overall U.S. 
population. The current action will increase the TMRC by 0.000003 mg/
kg/bwt/day (6 percent of the RfD).
    This tolerance and previously established tolerances utilize a 
total of 110 percent of the RfD for the overall U.S. population and 
represent an increase in the previously calculated value of 42.1%.
    Available information on anticipated residues and/or percent of 
crop treated was incorporated into the analysis to estimate the 
Anticipated Residue Contribution (ARC). The ARC is generally considered 
a more realistic estimate than an estimate based on tolerance-level 
residues and 100 percent crop treated. The ACR from established 
tolerances and the current action is estimated at 0.000016 mg/kg/day 
and utilizes 32.7 percent of the RfD for the U.S. population.
    The ARC for children, aged 1 to 6 years old, and nonnursing infants 
(the group most highly exposed) for the established tolerances utilize 
77.3 and 81.0 percent of the RfD, respectively. This action will not 
increase exposure to these subgroups because there is no information on 
coffee consumption for these subgroups.
    Utilizing the NOEL from the 4-week dog plasma cholinesterase study 
(0.005 mg/kg/day), the estimated margins of exposure (MOEs) calculated 
as the acute dietary risk for coffee alone is 125 for four of the five 
subgroups indicating that coffee per se does not present an 
unacceptable acute risk and does not appear to substantially increase 
the acute dietary risk from terbufos. For the remaining subgroup, 
nonnursing infants, there is no exposure resulting from the green 
coffee bean tolerance.

[[Page 39301]]

    The Agency is currently conducting a reassessment of all the 
established tolerances for terbufos and, if warranted, will refine the 
estimated MOEs based on results of that reassessment. The current 
estimated acute dietary risk for all the established terbufos 
tolerances indicates that an unacceptable risk exists assuming that 
residue levels are at the established tolerance and that 100 percent of 
the crop is treated. The Agency believes that actual residues to which 
the public is likely to be exposed are considerably less than indicated 
for the following reasons.
    1. Most treated crops have residue levels which are below the 
established tolerance level at the time of consumption.
    2. Not all the planted crop for which a tolerance is established is 
normally treated with the pesticide.
    The nature of the residue in plants is adequately understood for 
the use of terbufos on coffee beans imported from Central America. 
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.
    There are currently no regulatory actions pending against the 
continued registration of this chemical.
    The Agency is limiting the period of time that the proposed 
regulation is to be in effect to allow the Agency to complete its in-
depth reassessment of the current established tolerances for terbufos. 
Upon completion of this reassessment, and, if warranted, the Agency 
will consider the establishment of a permanent tolerance for green 
coffee beans.
    Residues not in excess of 0.05 part per million in or on green 
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 information and data considered, the Agency has 
determined that the tolerance established by amending 40 CFR part 180 
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 FFDCA.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
document control number, [PP 8E3574/P620]. All written comments filed 
in response to this petition will be available in the Public Response 
and Program Resources Branch, at the address given above from 8 a.m. to 
4:30 p.m., Monday through Friday, except legal holidays.
     A record has been established for this rulemaking under docket 
number [PP 8E3574/P620] (including objections and hearing requests 
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 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The public record is located in Room 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Written objections and hearing requests, identified by the document 
control number [PP 8E3574/P620], may be submitted to the Hearing Clerk 
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW., 
Washington, DC 20460.
    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk can be sent directly to EPA at:
    opp-D[email protected]


    A copy of electronic objections and hearing requests filed with the 
Hearing Clerk must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any objections and hearing requests received 
electronically into printed, paper form as they are received and will 
place the paper copies in the official rulemaking record which will 
also include all objections and hearing requests submitted directly in 
writing. The official rulemaking record is the paper record maintained 
at the address in ``ADDRESSES'' at the beginning of this document.
    Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency 
must determine whether the regulatory action is ``significant'' and 
therefore subject to all the requirements of the Executive Order (i.e., 
Regulatory Impact Analysis, review by the Office of Management and 
Budget (OMB)). Under section 3(f), the order defines ``significant'' as 
those actions likely to lead to a rule (1) having an annual effect on 
the economy of $100 million or more, or adversely and materially 
affecting a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local or tribal 
governments or communities (also known as ``economically 
significant''); (2) creating serious inconsistency or otherwise 
interfering with an action taken or planned by another agency; (3) 
materially altering the budgetary impacts of entitlement, grants, user 
fees, or loan programs; or (4) raising novel legal or policy issues 
arising out of legal mandates, the President's priorities, or the 
principles set forth in this Executive Order.
    Pursuant to the terms of this Executive Order, EPA has determined 
that this rule is not ``significant'' and is therefore not subject to 
OMB review.
    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

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

    Dated: July 18, 1995.

Peter Caulkins,
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 Sec. 180.352, by revising paragraph (b), to read as follows.

[[Page 39302]]



Sec. 180.352   Terbufos; tolerances for residues.

*        *        *        *        *
    (b) A time-limited tolerance to expire (date 2 years after date of 
publication of final rule based on this proposal) is established for 
combined residues of the insecticide/nematicide terbufos (S-[[1,1-
dimethyl)thio] methyl] O,O-diethyl phosphorodithioate) and its 
cholinesterase-inhibiting metabolites in or on the following raw 
agricultural commodity:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Coffee beans, green\1\.....................................         0.05
                                                                        
                 *        *        *        *        *                  
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\1\There are no U.S. registrations as of August 2, 1995 for the use of  
  terbufos on the growing crop, coffee.                                 


[FR Doc. 95-19004 Filed 8-1-95; 8:45 am]
BILLING CODE 6560-50-F