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Bifenthrin (FMC). June 12, 1996. Pesticide Tolerance. Final Rule. Federal Register.
http://www.epa.gov/docs/fedrgstr/EPA-PEST/1996/June/Day-12/pr-733DIR/pr-733.html
[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]
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.
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]
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:
Commodity Parts per million
Strawberries.............................. 3.00
[FR Doc. 96-14630 Filed 6-11-96; 8:45 am] BILLING CODE 6560-50-F