[Federal Register Volume 61, Number 114 (Wednesday, June 12, 1996)]
[Rules and Regulations]
[Pages 29676-29678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14630]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 5F4485/R2232; FRL-5364-3]
RIN 2070-AB78


Bifenthrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes a tolerance for residues of the 
pesticide bifenthrin in or on the raw agricultural commodity 
strawberries. The regulation to establish a maximum permissible level 
for residues of the pesticide was requested in a petition submitted by 
FMC Corporation.

Effective Date: This regulation becomes effective June 12, 1996.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number [PP 5F4485/R2232], may be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. A copy of any objections and hearing 
requests filed with the Hearing Clerk should be identified by the 
docket 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 Highway, Arlington, 
VA 22202. Fees accompanying objections shall be labeled ``Tolerance 
Petition Fees'' and forwarded to: EPA Headquarters Accounting 
Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, 
PA 15251.
    An electronic copy of objections and hearing requests filed with 
the Hearing Clerk may be submitted to OPP by sending electronic mail 
(e-mail) to:

    opp-docket epamail.epa.gov.

    Copies of electronic objections and hearing requests must be 
submitted as an ASCII file avoiding the use of special characters and 
any form of encryption. Copies of electronic 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 
5F4485/R2232]. No Confidential Business Information (CBI) should be 
submitted through e-mail. Copies of electronic 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: George T. LaRocca, Product 
Manager (PM) 13, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location, telephone number, and e-mail address: Rm. 
204, CM #2, 1921 Jefferson Davis Highway, Arlington, VA, (703) 305-
6100; e-mail: larocca.george.@epamail. epa.gov.

SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the 
Federal Register of June 15, 1995 (60 FR 31466), which announced that 
FMC Corporation, 1735 Market Street, Philadelphia, PA 19103, had 
submitted a pesticide petition (PP 5F4485) to EPA requesting that the 
Administrator, pursuant to section 408(d) of the Federal Food, Drug, 
and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establish a tolerance for 
the residues of the pyrethroid bifenthrin (2-methyl(1,1-biphenyl)-3-
yl)methyl-3-(2-chloro-3,3,3-trifluoro-1-propenyl-2,2-
dimethylcyclopropanecarboxylate) in or on the raw agricultural 
commodity strawberries at 3.0 parts per million (ppm).
    No comments were received in response to the notice of filing.
    The scientific data submitted in support of this petition and other 
relevant material have been evaluated. The toxicological and metabolism 
data considered in support of this tolerance are discussed in detail in 
a related document published in the Federal Register of June 22, 1994 
(59 FR 32167).
    A chronic dietary exposure/risk assessment has been performed for 
bifenthrin using a Reference Dose (RfD) of 0.015 mg/kg of bwt/day. The 
RfD was based on a No Observed Effect Level (NOEL) of 1.5 mg/kg/day 
from the 1-year study in dogs and a safety factor of 100. The endpoint 
effect of concern was intermittent tremors in test animals at the 
lowest effect level. The chronic exposure analysis was performed using 
tolerance level residues and 100 percent crop treated information. The 
current estimated dietary exposure for the

[[Page 29677]]

overall U.S. population resulting from established tolerances is 
0.002641 mg/kg of bwt/day, which represents 17.6 percent of the RfD, 
and for non-nursing infants (< 1 yr old) the subgroup population 
exposed to the highest risk the estimated dietary exposure is 0.008183, 
which represents 54.6 percent of the RfD. The current action will 
increase the exposure for the overall U.S. population to 0.002745 mg/kg 
of bwt/day or 18.3 percent of the RfD and for non-nursing infants (< 1 
yr old) to 0.008265 mg/kg of bwt/day or 55.1 percent of the RfD. 
Generally speaking, the Agency has no concern if for all published and 
proposed tolerances dietary exposure is less than the RfD.
    Because there was a sign of developmental effects seen in animal 
studies, the Agency used the rat developmental toxicity study with a 
maternal NOEL of 1 mg/kg/day to assess acute dietary exposure and 
determine a margin of exposure (MOE) for the overall U.S. population 
and certain subgroups. Since the toxicological end-point pertains to 
developmental toxicity, the population group of concern for this 
analysis is women age 13 and above, the subgroup which most closely 
approximates women of child-bearing age. The MOE is calculated as the 
ratio of the NOEL to the exposure. For this analysis the Agency 
calculated the MOE for women age 13 and above to be 200. Generally 
speaking, MOE's greater than 100 for data derived from animal studies 
are regarded as showing no appreciable risk.
    The metabolism of the chemical in plants and animals for the use is 
adequately understood. Secondary residues occurring in livestock and 
their by-products are not expected since there are no known animal feed 
stock uses for strawberries. Adequate analytical methodology (Gas 
liquid chromatography with an electron capture detector) is available 
for enforcement purposes. The enforcement methodology has been 
submitted to the Food and Drug Administration for publication in the 
Pesticide Analytical Manual, Vol. II (PAM II). Because of the long lead 
time for publication of the method in PAM II, the analytical 
methodology is being made available in the interim to anyone interested 
in pesticide enforcement when requested from Calvin Furlow, Public 
Response and Program Resource Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, U.S. Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Office location and 
telephone number: Rm. 1132, CM #2, 1921 Jefferson-Davis Hwy., 
Arlington, VA 22202, (703) 305-5232.
    The tolerances established by amending 40 CFR part 180 will be 
adequate to cover residues in or on strawberries. The pesticide is 
considered useful for the purposes which it is sought and capable of 
achieving the intended physical or technical effect. There are 
presently no actions pending against the continued registration of this 
chemical. 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, the 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 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 5F4485/R2232] (including comments and data submitted 
electronically). A public version of this record, including printed, 
paper version 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, Crystall Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    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 all comments 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 comments 
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, October 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. In addition, this action does not impose any enforceable 
duty or contain any ``unfunded mandates'' as described in Title II of 
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require 
prior consultation as specified by Executive Order 12875 (58 FR 58093, 
October 1993), entitled Enhancing the Intergovernmental Partnership, or 
special considerations as required by Executive Order 12898 (59 FR 
7629, February 16, 1994).
    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

[[Page 29678]]

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: May 28, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR part 180 is amended to read as follows:

PART 180--[AMENDED]

    1. The authority citation of part 180 continues to read as follows:

    Authority: 21 U.S.C. 346a.

    2. Section 180.442 is amended by redesignating and revising the 
current introductory text and commodity table as paragraph (a) and 
adding a new paragraph (b) to read as follows:


Sec. 180.442   Bifenthrin; tolerances for residues.

    (a) Tolerances, to expire November 15, 1997, are established for 
residues of the pyrethroid bifenthrin, (2-methyl(1,1-biphenyl)-3-
yl)methyl-3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on the following commodities:
    *    *    *    *    *
    (b) Tolerances, are established for residue of the pyrethroid 
bifenthrin, (2-methyl(1,1-biphenyl)-3-yl)methyl-3-(2-chloro-3,3,3-
trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate, in or on the 
following commodity:

                                                                        
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                 Commodity                        Parts per million     
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Strawberries..............................  3.00                        
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[FR Doc. 96-14630 Filed 6-11-96; 8:45 am]
BILLING CODE 6560-50-F