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fluvalinate Proposed Pesticide Tolerance 5/96

     

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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; 

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: opp-docket@epamail.epa.gov. 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 60018-3300, 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)-
alpha-cyano-3-phenoxybenzyl N-(2-chloro-
alpha,alpha,alpha-trifluoro-p-tolyl)-D-valinate (formerly 
known as (-alpha-RS,2R)-fluvalinate {RS)-alpha-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 (-alpha-RS,2R)-fluvalinate 
{RS)-alpha-cyano-3-phenoxybenzyl (R)-2{2-chloro-4-
(triflurormethyl)anilino}-3-methyl-butanoate}) to tau-fluvalinate 
{(RS)-alpha-cyano-3-phenoxybenzyl N-(2-chloro-
alpha,alpha,alpha-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)-alpha-cyano-3-phenoxybenzyl N-(2-chloro-
alpha,alpha,alpha-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 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)-alpha-cyano-3-phenoxybenzyl N-
(2-chloro-alpha,alpha,alpha-trifluoro-p-tolyl)-D-valinate; 
Tolerances for residues.

(a) Tolerances are established for residues of the insecticide tau-
fluvalinate {(RS)-alpha-cyano-3-phenoxybenzyl N-(2-chloro-
alpha,alpha,alpha-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)-alpha-cyano-3-phenoxybenzyl N-(2-chloro-
alpha,alpha,alpha-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)-alpha-cyano-3-phenoxybenzyl 
N-(2-chloro-alpha,alpha,alpha-trifluoro-p-tolyl)-D-
valinate.

A regulation is established to permit residues of the insecticide 
taufluvalinate {(RS)-alpha-cyano-3-phenoxybenzyl N-(2-chloro-
alpha,alpha,alpha-trifluoro-p-tolyl)-D-valinate in or on 
the following commodities:

[FR Doc. 96-12350 Filed 5-16-96; 8:45 am]