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Bifenthrin; Pesticide Tolerance
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: June 12, 1996 (Volume 61, Number 114)]
[Rules and Regulations]
[Page 29676-29678]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jn96-25]
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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