[Federal Register Volume 60, Number 239 (Wednesday, December 13, 1995)]
[Rules and Regulations]
[Pages 63953-63954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29990]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 8E3574/R2165; FRL-4973-5]
RIN 2070-AB78
Terbufos; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document extends the time-limited 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 under the Federal Food, Drug and Cosmetic Act
(FFDCA) requesting the regulation to establish a maximum permissible
level for combined residues of the insecticide/nematicide in or on the
commodity.
EFFECTIVE DATE: This regulation becomes effective December 13, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 8E3574/R2165], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. Fees accompanying objections and
hearing requests shall be labeled ``Tolerance Petition Fees'' and
forwarded to: 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 22202.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number [PP
8E3574/R 2165]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of 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: Robert A. Forrest, Product
Manager (PM) 14, Registration Division (7505C), 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: In the Federal Register of August 2, 1995
(60 FR 39299), EPA issued a proposed rule (FRL-4963-5) that gave notice
that the American Cyanamid Co. had submitted data and a request under
the FFDCA that a time-limited tolerance for residues of the
insecticide/nematicide terbufos on coffee beans be changed to permanent
status. The Agency proposed an extension of the time-limited tolerance
to allow it to complete its in-depth reassessment of the current
established tolerances for terbufos.
The following comments were received from the petitioner, American
Cyanamid.
1. American Cyanamid believes that since the acceptance of the new
rat metabolism study fulfills the condition of the time-limited coffee
bean tolerance, it is sufficient to establish the regulation as
permanent, regardless of any on-going analysis of tolerances for
reregistration purposes.
2. Additionally, American Cyanamid believes that ``the
toxicological end-point of a no-observable-effect level (NOEL) based
upon plasma cholinesterase (ChE) inhibition, as mentioned in the
proposed rule, is of equivocal value when used in risk assesments'' and
that ``A NOEL based upon alternative tox endpoints such as red blood
cell ChE inhibition, brain ChE inhibition, or clinical signs would be
more appropriately used to establish reference dose for regulatory
purposes.''
American Cyanamid has requested a reevaluation of plasma
cholinesterase as a suitable endpoint.
The Agency acknowledges that the condition upon which the initial
time-limited tolerance was based, i.e., the lack of an acceptable
guideline rat metabolism study, has now been fulfilled.
However, as described in the proposed rule referenced above, the
Agency currently has concern over the potential acute dietary risk
posed by the current established tolerances based on the estimated
margins of exposure (MOE). In light of this concern, the Agency
believes that it is prudent to limit the period of time in which the
coffee bean tolerance is in effect pending the Agency reassessment of
the tolerances.
The Agency will take American Cyanamid's comments relative to the
toxicological endpoint into consideration in its reassessment of the
established tolerances.
There were no requests for referral to an advisory committee
received in response to the proposed rule.
The data submitted with the proposal and other relevant material
have been evaluated and discussed in the proposed rule. Based on the
data and information considered, the Agency concludes that the time-
limited tolerance will protect the public health. Therefore, the time-
limited tolerance is established as set forth below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections and/or request a hearing 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
[[Page 63954]]
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).
A record has been established for this rulemaking under docket
number [PP 8E3574/R2165] (including any 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/R2165], 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 review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in 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 referred to 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 the rights and obligations of recipients
thereof; 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 the 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: November 28, 1995.
Stephen L. Johnson,
Director, Registration Division, 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. In Sec. 180.352, by revising paragraph (b), to read as follows:
Sec. 180.352 Terbufos; tolerances for residues.
* * * * *
(b) A time-limited tolerance to expire December 15, 1997 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:
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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. 95-29990 Filed 12-12-95; 8:45 am]
BILLING CODE 6560-50-F
