FLUORIDE ACTION NETWORK PESTICIDE PROJECT
Return to FAN's Pesticide Homepage
Return to Tau-fluvalinate Index Page
Tau-fluvalinate (Sandoz). May 17, 1996. Proposed Pesticide Tolerance. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/1996/May/Day-17/pr-707.html
Tau-fluvalinate; Pesticide Tolerance
[Federal Register: May 17, 1996 (Volume 61, Number 97)] [Proposed Rules]
[Page 24911-24913]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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.
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-
[[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)- <greek-a>-cyano-3-phenoxybenzyl
N-(2-chloro- <greek-a>,<greek-a>,<greek-a>-trifluoro-p-tolyl)-D-valinate
(formerly known as (-<greek-a>-RS,2R)-fluvalinate {RS)-<greek-a>-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 (-<greek-a>-RS,2R)-fluvalinate
{RS)-<greek-a>-cyano-3-phenoxybenzyl (R)-2{2-chloro-4- (triflurormethyl)anilino}-3-methyl-butanoate})
to tau-fluvalinate {(RS)-<greek-a>-cyano-3-phenoxybenzyl N-(2-chloro-
<greek-a>,<greek-a>,<greek-a>-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: taufluvalinate {(RS)-<greek-a>-cyano-3-phenoxybenzyl
N-(2-chloro- <greek-a>,<greek-a>,<greek-a>-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 taufluvalinate 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 1.612f the RfD for the U.S. population and 7.0267f the RfD
for the subpopulation most highly exposed, non-nursing infants (<1 yr). Establishing
the new tolerances would utilize 4.912f the RfD for the U.S. population and
48.3 0.000000or 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 6.5and 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 taufluvalinate,
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]
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)-<greek-a>-cyano-3-phenoxybenzyl N- (2-chloro-<greek-a>,<greek-a>,<greek-a>-trifluoro-p-tolyl)-D-valinate; Tolerances for residues.
(a) Tolerances are established for residues of the insecticide taufluvalinate {(RS)-<greek-a>-cyano-3-phenoxybenzyl N-(2-chloro- <greek-a>,<greek-a>,<greek-a>-trifluoro-p-tolyl)-D-valinate in or on the following commodities:
Commodity Parts per million
Apples 0.5
Cattle, fat 0.1
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)-<greek-a>-cyano-3-phenoxybenzyl N-(2-chloro-<greek-a>,<greek-a>,<greek-a>-trifluoro-p-tolyl)-Dvalinate.
A regulation is established to permit residues of the insecticide taufluvalinate
{(RS)-<greek-a>-cyano-3-phenoxybenzyl N-(2-chloro- <greek-a>,<greek-a>,<greek-a>-trifluoro-p-tolyl)-D-valinate
in or on the following commodities: