[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: 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. 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:
forrest.robert@epamail.epa.gov. .
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-Docket@epamail.epa.gov
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
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* * * * *
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
