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terbufos (Counter) Pesticide Tolerance--Final Rule 12/95

[Federal Register: December 13, 1995 (Volume 60, Number 239)]
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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 
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, green1\.....................................     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.