[Federal Register Volume 61, Number 97 (Friday, May 17, 1996)]
[Proposed Rules]
[Pages 24911-24913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12350]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[PP 1E4020 and FAP 2H5619/P655; FRL-5364-2]
RIN 2070-AC18
Tau-fluvalinate; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish tolerances for residues of the
insecticide tau-fluvalinate in or on the raw agriculture commodities
(RAC) apples, oriental pears, and kiwi, to increase the tolerance for
the insecticide tau-fluvalinate in or on the RAC fat of cattle and to
change the chemical nomenclature in the tolerance. The proposed
regulations to establish the maximum permissible levels for residues of
the pesticide were requested pursuant to a petition submitted by Sandoz
Agro, Inc.
DATES: Comments, identified by the docket control number [PP 1E4020/
P655], must be received on or before June 17, 1996.
ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132 CM #2,
1921 Jefferson Davis Highway, Arlington, VA 22202.
Comments and data may also be submitted to OPP by sending
electronic mail (e-mail) to: [email protected]. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by the
docket number [PP 1E4020/P655]. Electronic comments on this proposed
rule may be filed online at many Federal Depository Libraries.
Additional information on electronic submissions can be found below in
this document.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information.'' CBI should not be submitted
through e-mail. Information marked as CBI will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
comment that does not contain CBI must be submitted for inclusion in
the public record. Information not marked confidential may be disclosed
publicly by EPA without prior notice. All written comments will be
available for public inspection in Rm. 1132 at the address given above,
from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
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.
202, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703)
305-6100, e-mail: larocca.george.gov.epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Registers of December 13,
1991 (56 FR 65080) and June 10, 1992 (57 FR 24644), EPA issued rules
that gave notice that Sandoz Agro., Inc. (formerly Sandoz Crop
Protection Corp), 1300 East Touhy Ave., Des Plaines, Illinois 60018-
[[Page 24912]]
3300, had submitted food/feed additive petition (FAP) 2H5619 proposing
to amend 40 CFR parts 185 and 186 by establishing food/feed additive
regulations under section 409 of the Federal, Food, Drug and Cosmetic
Act (21 U.S.C. 348) for the insecticide tau-fluvalinate {(RS)-
-cyano-3-phenoxybenzyl N-(2-chloro-
,,-trifluoro-p-tolyl)-D-valinate (formerly
known as (--RS,2R)-fluvalinate {RS)--cyano-3-
phenoxybenzyl (R)-2{2-chloro-4-(triflurormethyl)anilino}-3-
methylbutanoate}) in or on apple pomace, dry and wet, from imported
apples at 2.0 parts per million (ppm) and hops, dry from imported hops
at 15.0 ppm. At the same time Sandoz Agro., Inc. also submitted a
pesticide petition (PP) 1E4020 proposing to establish tolerances under
408(e) for the insecticide tau-fluvalinate in or on the RACs apples
imported from France, Chile and New Zealand at 0.4 ppm; Nashi imported
from New Zealand at 0.4 ppm, and Kiwi imported from New Zealand at 0.5
ppm.
There were no comments or requests for referral to an advisory
committee received in response to the proposed rule.
On April 22, 1994, Sandoz Agro., Inc. requested voluntary
withdrawal of their petition to establish tolerances in hops without
prejudice to future filing. In the same letter and at the request of
EPA they proposed to increase tolerances for the RACs fat of cattle to
0.1 ppm (previously established at 0.01 ppm), increase the proposed
tolerance for apples to 0.5 ppm, and revise the commodity name
``nashi'' to ``oriental pears'' since it is the term used in the Codex
Classification of Food and Animal Feeds published in the Code of
Federal Regulations. The need for the increased cattle fat tolerance
arises from the feeding of wet apple pomace to cattle raised outside
the U.S. and then importing the cattle fat into the U.S.
With respect to the feed additive proposal for apple pomaces (wet/
dry) the Agency no longer considers dry apple pomace a feed item,
therefore tolerances are not required for this commodity (based on
EPA's latest revision (unpublished) to Table II of the Pesticide
Assessment Guidelines, Subdivision O (Residue Chemistry) titled ``Raw
Agricultural and Processed Commodities and Livestock Feeds Derived from
Field Crops''). With respect to wet apple pomace, the Agency has
concluded that the proposed cattle fat tolerance of 0.10 ppm and
currently established tolerances in the meat, meat by-products and milk
of cattle at 0.01 ppm are adequate to cover the residues expected from
the proposed tolerance on apples. Since economics and perishability
dictate that wet apple pomace will not likely be imported into the U.S.
(either from apples processed overseas or treated apples imported and
processed in the U.S.) the establishment of a tolerance for the animal
feed item wet apple pomace will not be necessary. On July 25, 1995,
Sandoz Agro., Inc. withdrew FAP 2H5619 and their request for a feed
additive tolerance on wet apple pomace. Further, they amended the
tolerance on oriental pears by increasing it to 0.5 ppm to be
consistent with the tolerance level on apples.
Sandoz Agro., Inc. submitted a letter dated October 19, 1994,
requesting a name change of fluvalinate to ``tau-fluvalinate'' and a
change in chemical nomenclature from (--RS,2R)-fluvalinate
{RS)--cyano-3-phenoxybenzyl (R)-2{2-chloro-4-
(triflurormethyl)anilino}-3-methyl-butanoate}) to tau-fluvalinate
{(RS)--cyano-3-phenoxybenzyl N-(2-chloro-
,,-trifluoro-p-tolyl)-D-valinate for all
products registered in the United States (U.S.). This name has appeared
on pesticide registrations in Europe since 1989 and reflects the half
resolved form of fluvalinate. It is an approved American National
Standards Institute (ANSI), British Standards Institute (BSI), and
International Organization for Standardization (ISO) name. EPA
concludes that the name of tau-fluvalinate is a useful means of
distinguishing the half resolved fluvalinate from the completely
racemic mixture, and therefore proposes to revise the current chemical
name under 40 CFR 180.427 and 186.3400 to read as follows: tau-
fluvalinate {(RS)--cyano-3-phenoxybenzyl N-(2-chloro-
,,-trifluoro-p-tolyl)-D-valinate.
The data submitted in support of this tolerance and other relevant
material have been reviewed. 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 August 3, 1989
(54 FR 31972).
A chronic dietary exposure analysis was performed for tau-
fluvalinate using a reference dose (RfD) of 0.01 mg/kg-bwt/day based on
a no-observable effect level (NOEL) of 1.0 mg/kg- bwt/day from a 2-year
rat feeding study with an uncertainty factor of 100. The end point
effect of concern was decreased body weight gain in both sexes. The
Theoretical Maximum Residue Contribution (TMRC) from established
tolerances utilizes 1.6% of the RfD for the U.S. population and 7.0% of
the RfD for the subpopulation most highly exposed, non-nursing infants
(<1 yr). Establishing the new tolerances would utilize 4.9% of the RfD
for the U.S. population and 48.3% for non-nursing infants (<1 yr). If
the new tolerances are approved, the total percentages of the RfD
utilized for the U.S. population and non-nursing infants (< 1yr) are
6.5% and 55.4%, respectively. Generally speaking, EPA has no cause for
concern if total residue contribution for published tolerances is less
than the RfD. EPA concludes that the chronic dietary risk of tau-
fluvalinate, as estimated by the dietary risk assessment, does not
appear to be of concern.
The metabolism of the chemical in animals for this use is
adequately understood. An adequate analytical method, gas-liquid
chromatography, 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 Resources Branch, Field Operations
Divisions (7506C), Office of Pesticide Programs, 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.
There are presently no U.S. registrations for use of the
insecticide tau-fluvalinate on apples, oriental pears, and kiwis.
Based on the above information, the Agency concludes that the
tolerances established by amending 40 CFR part 180 would protect the
public health. Therefore, it is proposed that the tolerances be
established as set forth below.
Interested persons are invited to submit written comments on the
proposed regulation. Comments must bear a notation indicating the
document control number, [PP 1E4020/P655]. All written comments filed
in response to this petition will be available in the Public Response
and Program Resources Branch, at the address given above from 8 a.m. to
4 p.m., Monday through Friday, except legal holidays.
A record has been established for this rulemaking under docket
number [PP 1E4020/P655] (including comments and data submitted
electronically as described below. A public version of this record,
including printed, paper version of electronic comments, which
[[Page 24913]]
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.
Electronic comments 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 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 28, 1993), entitled Enhancing the Intergovernmental
Partnership'' or special consideration 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 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 Parts 180 and 186
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 2, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. In part 180:
a. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 348.
b. Section 180.427 is amended by revising the section heading, the
introductory text of paragraph (a), revising the entry for cattle fat
and by adding and alphabetically inserting the commodities apples,
kiwi, and oriental pears in the table therein paragraph (a), and
revising the introductory text of paragraph (b) to read as follows:
Sec. 180.427 Tau-fluvalinate {(RS)--cyano-3-phenoxybenzyl N-
(2-chloro-,,-trifluoro-p-tolyl)-D-valinate;
Tolerances for residues.
(a) Tolerances are established for residues of the insecticide tau-
fluvalinate {(RS)--cyano-3-phenoxybenzyl N-(2-chloro-
,,-trifluoro-p-tolyl)-D-valinate in or on
the following commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Apples 0.5
Cattle, fat 0.1
* * * * *
Kiwi 0.1
* * * * *
Oriental pears 0.5
* * * * *
------------------------------------------------------------------------
* * * * *
(b) Tolerances with regional registration, as defined in
Sec. 180.1(n) are established for residues of the insecticide tau-
fluvalinate {(RS)--cyano-3-phenoxybenzyl N-(2-chloro-
,,-trifluoro-p-tolyl)-D-valinate in or on
the following commodities:
* * * * *
PART 186--[AMENDED]
2. In part 186:
a. The authority citation for part 186 continues to read as
follows:
Authority: 21 U.S.C. 348.
b. Section 186.3400 is amended by revising the section heading and
introductory paragraph to read as follows:
Sec. 186.3400 Tau-fluvalinate {(RS)--cyano-3-phenoxybenzyl
N-(2-chloro-,,-trifluoro-p-tolyl)-D-
valinate.
A regulation is established to permit residues of the insecticide
taufluvalinate {(RS)--cyano-3-phenoxybenzyl N-(2-chloro-
,,-trifluoro-p-tolyl)-D-valinate in or on
the following commodities:
* * * * *
[FR Doc. 96-12350 Filed 5-16-96; 8:45 am]
BILLING CODE 6560-50-F