[Federal Register Volume 60, Number 187 (Wednesday, September 27, 1995)]
[Rules and Regulations]
[Pages 49793-49795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24004]



-----------------------------------------------------------------------


ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 3F4186/R2174; FRL-4979-1]
RIN 2070-AB78


Fenpropathrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This rule establishes time-limited tolerances with an 
expiration date of November 15, 1997, for residues of the pyrethroid 
fenpropathrin in or on the raw agricultural commodities (RACs) 
strawberries and tomatoes. Valent U.S.A. submitted petitions under the 
Federal Food, Drug and Cosmetic Act (FFDCA) that requested a regulation 
to establish these maximum permissible levels for residues of the 
insecticide.

EFFECTIVE DATE: This regulation becomes effective September 27, 1995.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number [PP 3F4186/R2174], 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 
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. 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.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. 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 
3F4186/R2174]. 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: 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 and telephone number: Second Floor, Crystal 
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703)-305-
6100; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: EPA issued notices, published in the Federal 
Register of October 21, 1993 (58 FR 54354), which announced that Valent 
U.S.A. Corp., 1333 N. California Blvd., Suite 600, Walnut Creek, CA 
94596, had submitted pesticide petition (PP) 3F4186 and food/feed 
additive petition (FAP) 3H5661 to EPA requesting that the 
Administrator, pursuant to sections 408(d) and 409(b) of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d) and 348(b), 
establish tolerances for residues of the insecticide fenpropathrin 
(alpha-cyano-3-phenoxybenzyl 2,2,3,3-
tetramethylcyclopropanecarboxylate) in or on the raw agricultural 
commodities (RACs) strawberries at 2 parts per million (PPM); tomatoes 
(fresh market, Florida only) at 0.5 ppm; and tomato cannery waste at 5 
ppm. EPA issued a revised notice, published in the Federal Register of 
November 2, 1994 (59 FR 54911), in which Valent U.S.A. proposed to 
amend PP 3F4186 by increasing the tolerances for fenpropathrin in or on 
the RAC tomatoes from 0.5 to 0.6 ppm and removing the fresh marketing 
regional restrictions for tomatoes; establish tolerances for 
fenpropathrin in or on strawberries (caps removed) at 2.0 ppm; meat and 
meat byproducts of cattle, goats, hogs, horses, and sheep at 0.1 ppm; 
fat of cattle, goats, hogs, horses, and sheep at 1.0 ppm; milk fat 
(reflecting 0.11 ppm in whole milk) at 2.75 ppm; poultry meat, fat, and 
meat byproducts and eggs at 0.02 ppm; and amending the FAP 3H5661 by 
replacing the proposed tomato cannery waste tolerance with proposals 
for tolerances in or on tomato pomaces (wet) at 6.00 ppm and tomato 
pomaces (dry) at 3.00 ppm.
    In a letter dated August 30, 1995, Valent U.S.A. requested 
withdrawal of the feed additive petition (3H5661) in or on tomato 
pomaces and deletion of the proposed tolerances in meat, milk, poultry, 
and eggs. Valent U.S.A.'s withdrawal and deletion of certain tolerances 
were submitted in response to EPA's latest revision (unpublished) to 
Table II of the Pesticide Assessment Guidelines, Subdivision O (Residue 
Chemistry) Raw Agricultural and Processed Commodities and Livestock 
Feeds Derived from Field Crops. With respect to tomatoes, EPA concluded 
that tomato pomaces (wet and dry) are no longer considered significant 
animal feedstuffs. Although the latest revisions to the Livestock Feed 
Table for Subdivision O of the Pesticide Assessment Guidelines have not 
yet been published, pending petitions will continue to be processed 
based upon previous regulations, except they will be given the benefit 
of any appropriate revised or reduced residue data requirements if 
needed.
    No comments were received in response to the notices of filing.
    The scientific data submitted in the petitions and other relevant 
material have been evaluated. The toxicological and metabolism data and 
analytical methods for enforcement purposes considered in support of 
these tolerances are discussed in detail in related documents published 
in the Federal Register of April 14, 1993 (58 FR 19357).
    A dietary exposure/risk assessment was performed for fenpropathrin 
using a Reference Dose (RfD) of 0.025 mg/kg/day. The RfD is based on a 
no-observable- effect level (NOEL) of 2.5 mg/kg/body weight/day (100 
ppm) and a uncertainty factor of 100 from a 1-year dog-feeding study 
that demonstrated tremors in test animals at the lowest effect level. 
The current estimated dietary exposure for the overall U.S. population 
and nonnursing infants (less than 1 year old), the subgroup population 
exposed to the highest risk, is 0.4% and 0.5% of the RfD, respectively. 
The current action will increase exposure to 4.1% and 3%, respectively. 
Generally speaking, the Agency has no cause for concern if total 
residue contribution for published and proposed tolerances is less than 
the RfD.
    The metabolism of the chemical in plants and livestock is 
adequately understood for this use. Any secondary residues occurring in 
meat, fat, meat by products of cattle, goats, hogs, horses, poultry, 
sheep and eggs will be covered by the existing tolerances. An adequate 

[[Page 49794]]
analytical method (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 and 
published in the Pesticide Analytical Manual Vol. II (PAM II).
    The Agency issued a conditional registration for fenpropathrin for 
use on cotton with an expiration date of November 15, 1993 (see the 
Federal Register of April 14, 1993 (58 FR 19357)). The conditional 
registration was subsequently amended and extended to November 15, 1996 
(see the Federal Register dated February 22, 1995 (60 FR 9783)). The 
registrations were amended and extended to allow time for submission 
and evaluation of additional environmental effects data. In order to 
evaluate the effects of the pyrethroids on fish and aquatic organisms 
and its fate in the environment, additional data were required to be 
collected and submitted during the period of conditional registration. 
Such requirements included a sediment bioavailability and toxicity 
study and a small-plot runoff study that must be submitted to the 
Agency by July 1, 1996. Due to the conditional status of the 
registration, tolerances have been established for fenpropathrin on a 
temporary basis, (until November 15, 1997) on cottonseed, meat, fat and 
meat-byproducts of hogs, horses, cattle, goats, sheep, poultry, eggs, 
and milk to cover residues expected to be present from use during the 
period of conditional registration. To be consistent with the 
conditional registration status of fenpropathrin on cotton the Agency 
is establishing these tolerances with an expiration date of November 
15, 1997.
    Residues remaining in or on the above commodities after expiration 
of these tolerances will not be considered actionable if the pesticide 
is legally applied during the term of and in accordance with provisions 
of the conditional registration.
    There are currently no actions pending against the continued 
registration of this chemical. The pesticide is considered useful for 
the purposes which it is sought and capable of achieving the intended 
physical or technical effect. Based on the information and data 
considered, the Agency has determined that the tolerances established 
by amending 40 CFR part 180 will protect the public health. Therefore, 
the tolerances are 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 to the regulation and may also request a hearing on 
those objections. Objections and hearing requests must be filed 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 3F4186/R2174] (including 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 3F4186/R2174], 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-D[email protected]


    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, 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.
    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 

[[Page 49795]]
and pests, Reporting and recordkeeping requirements.

    Dated: September 15, 1995.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

PART 180--[AMENDED]

    Therefore, 40 CFR part 180 is amended as follows:
    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 371.

    2. By amending Sec. 180.466 in the table therein by adding and 
alphabetically inserting entries for the commodities tomatoes and 
strawberries, to read as follows:


Sec. 180.466   Fenpropathrin; tolerances for residues.

* * * * *

------------------------------------------------------------------------
                                                 Parts per    Expiration
                   Commodity                      million        date   
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Strawberries..................................          2.0          Do.
Tomatoes......................................          0.6          Do.
                                                                        
------------------------------------------------------------------------


[FR Doc. 95-24004 Filed 9-26-95; 8:45 am]
BILLING CODE 6560-50-F