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vinclozolin (Ronilan) Revocation of Certain Tolerances 2/98


[Federal Register: February 13, 1998 (Volume 63, Number 30)]
[Rules and Regulations]               
[Page 7306-7308]
>From the Federal Register Online via GPO Access []

[[Page 7306]]



40 CFR Part 180

[OPP-300540A; FRL-5769-2]

Vinclozolin; Revocation of Certain Tolerances

AGENCY: Environmental Protection Agency (EPA)

ACTION: Final rule.


SUMMARY: EPA is revoking the tolerances for residues of the pesticide 
vinclozolin in or on the raw agricultural commodities tomatoes, plums, 
prunes, grapes (other than wine grapes), and the food additive 
tolerances for prunes and raisins. EPA is revoking these tolerances 
because the uses associated with them have been voluntarily deleted 
from vinclozolin labels.
DATES: This regulation becomes effective February 13, 1998. Written 
objections and requests for hearings must be received on or before 
April 14, 1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300540A], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests 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 any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300540A], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: 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 5.1/6.1 or ASCII file format. All copies of 
electronic objections and hearing requests must be identified by the 
docket number [OPP-300540A]. 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.

FOR FURTHER INFORMATION CONTACT: By mail: Mark Wilhite, Special Review 
and Reregistration Division (7508W), Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. Office location, telephone number 
and e-mail address: Special Review Branch, Crystal Station #1, 3rd 
floor, 2800 Crystal Drive, Arlington, VA 22202, telephone: (703) 308-
8029; e-mail:

I. Introduction

    Vinclozolin (trade names Ronilan, Curalan, and Ornilan) is a 
fungicide first registered in 1981 to control various types of rot 
caused by Botrytis spp., Sclerotinia spp, and other types of mold and 
blight causing organisms, on strawberries, lettuce (all types), 
stonefruit, grapes, raspberries, onions, succulent beans, and turf in 
golf courses, commercial and industrial sites. Vinclozolin is also 
registered for use on ornamentals in green houses and nurseries.

II. Legal Authority

    The Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 301 et 
seq., as amended by the Food Quality Protection Act of 1996 (FQPA), 
Pub. L. 104-170) authorizes the establishment of tolerances (maximum 
residue levels), exemptions from the requirement of a tolerance, 
modifications in tolerances, and revocation of tolerances for residues 
of pesticide chemicals in or on raw agricultural commodities and 
processed foods pursuant to section 408 (21 U.S.C. 346(a), as amended). 
Without a tolerance or exemption, food containing pesticide residues is 
considered to be unsafe and therefore ``adulterated'' under section 
402(a) of the FFDCA, and hence may not legally be moved in interstate 
commerce (21 U.S.C. 342). For a food-use pesticide to be sold and 
distributed, the pesticide must not only have appropriate tolerances 
under the FFDCA, but also must be registered under section 3 of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. 
136 et seq.).

III. Regulatory Background

    In May 1997, when BASF requested amendment of its labels to include 
a use for succulent beans, BASF also requested deletion of several food 
and non-food uses from its vinclozolin registrations. These deletions 
were announced in the Federal Register Notice of August 13, 1997 (62 FR 
43327)(FRL-5736-2). Since no comments were received they became 
effective on September 13, 1997. The proposal to revoke the tolerances 
for the pesticide vinclozolin on the raw agricultural commodities 
tomatoes, plums, prunes, grapes (other than wine grapes), the food 
additive tolerances for prunes and raisins, and the animal feed 
tolerance for dry grape pomace was published on August 27, 1997 (62 FR 
45377)(FRL-5739-6). EPA proposed these revocations because it is EPA's 
general practice to revoke tolerances where the associated pesticide 
use has been deleted from all FIFRA labels. See 40 CFR 180.32(b).
    In response to the proposal to revoke these tolerances, EPA 
received one comment from the California Environmental Protection 
Agency on behalf of the States FIFRA Issues Research and Evaluation 
Group (SFIREG). These comments are located in the OPP Docket under 
docket number OPP-300540. The
commenter pointed out that EPA had not established a deadline for use 
of existing stocks of product labeled for the deleted uses, other than 
exhaustion of supplies, but had indicated that it intends to publish 
its final revocation notice relatively soon after the proposal was 
published. The commenter noted that this short time frame for final 
revocation would not allow for exhaustion of existing stocks, since the 
residues on these commodities which were treated with existing stocks 
after the revocation date would not be legal, but would be considered 
adulterated by FDA or states which have residue monitoring programs. In 
an earlier inquiry about this discrepancy, the commenter had been told 
by the Agency that it was using section 408(l)(5) to allow product in 
the channels of trade to be used legally, under the existing stocks 
provision, even if the use was after the tolerance has been revoked. 
Further, the commenter pointed out, these upcoming actions should be 
better communicated to the states and other interested parties so that 
they can prepare their laboratories and authorities for their 
implementation. The commenter suggested that the Agency's home page on 
the internet present up to date information.
    In response to these comments, the Agency agrees that it should 
have, in this case, established a formal date for exhaustion of 
existing stocks in the original use deletion notice (62 FR

[[Page 7307]]

43327). After conferring again with BASF about the status of the 
products with these deleted uses for which tolerances are being revoked 
and examining its registration records, the Agency believes that there 
is no product in the channels of trade which bears labeling allowing 
its use on either tomatoes, plums, prunes or table grapes, since 
tomatoes and grapes were never registered in the United States, and 
plums and prunes were removed from the product labels by BASF in 1991. 
Accordingly, the tolerances may be revoked with little chance that 
legal use of existing stocks will occur, since these uses have not been 
in the channels of trade for many years and it is therefore unlikely 
that it is still in the hands of end-users. Therefore, EPA believes it 
should proceed with the revocation of tolerances, but in future, a more 
concentrated effort to alert states, through its home page on the 
internet or other means, will be made as well as by providing a precise 
date for exhaustion of existing stocks before proceeding with final 
revocation of tolerances. In addition, EPA would like to clarify its 
interpretation of section 408(l)(5) of the FFDCA.That section states:
    Notwithstanding any other provision of this Act, if a tolerance 
or exemption for a pesticide chemical residue is revoked, suspended 
or modified under this section, an article of food shall not be 
deemed unsafe solely because of the presence of such pesticide 
chemical residue in or on such food if it is shown...(A) the residue 
is present as the result of an application or use of a pesticide at 
a time and in manner that was lawful under the Federal Insecticide, 
Fungicide, and Rodenticide Act; and (B) the residue does not exceed 
a level that was authorized at the time of that application or use 
to be present on the food under a tolerance ***

    This provision legalizes pesticide residues of cancelled pesticides 
if both the use under FIFRA was legal (e.g. because applied in 
accordance with an existing stocks provision) and the treatment occured 
before revocation of the tolerance. If use occurs after revocation of 
the tolerance, this provision does not apply.

IV. Regulatory Assessment Requirements

    This is a final revocation of a tolerance established under FFDCA 
section 408. The Office of Management and Budget (OMB) has exempted 
this type of action from review under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993). In 
addition, this rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., or impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does it require any 
prior consultation as specified by Executive Order 12875, entitled 
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 
1993), special considerations as required by Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994), 
or require special OMB review in accordance with Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, pursuant to the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.), the Agency previously assessed whether revocations 
of tolerances might significantly impact a substantial number of small 
entities and concluded that, as a general matter, these actions do not 
impose a significant economic impact on a substantial number of small 
entities. The factual basis and the Agency's certification under 
section 605(b) for tolerance revocations published on December 17, 1997 
(62 FR 66020)(FRL-5753-1), and was provided to the Chief Counsel for 
Advocacy of the Small Business Administration. Since no extraordinary 
circumstances exist as to the present revocation that would change 
EPA's previous analysis, the Agency is able to reference the general 

V. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a 
report containing this rule and other required information to the U.S. 
Senate, the U.S. House of Representatives, and the Comptroller General 
of the General Accounting Office prior to publication of this rule in 
today's Federal Register. This is not a ``major rule'' as defined by 5 
U.S.C. 804(2).''

VI. Objections and Hearing Request

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person adversely affected by this regulation may, by April 14, 
1998, 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 

VII. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control [OPP-300540A] (including any comments and data submitted 
electronically). 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 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Recoreds 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments may be sent directly to EPA at:

[[Page 7308]]

    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 any copies of 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 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.

 List of Subjects 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 3, 1998.

Lois Rossi,

Director, Special Review and Reregistration Division, Office of 
Pesticide Programs.
    Therefore, 40 CFR part 180 is amended as follows:


    1. The authority citation for part 180 continues to read as 
    Authority: 21 U.S.C. 346a and 371.

    2. Section 180.380 is amended by revising paragraph (a) to read as 

Sec. 180.380  Vinclozolin; tolerances for residues.

    (a) General. Tolerances are established for the combined residues 
of the fungicide vinclozolin (3-(3,5-dichlorophenyl)-5-ethenyl-5-
methyl-2,4-oxazolidinedione) and its metabolites containing the 3,5-
dichloroaniline moiety in or on the food commodities in the table 
below. There are no U.S. registrations for Belgian endive, tops, 
cucumbers, grapes (wine), kiwi, pepper (bell) as of July 30, 1997. The 
tolerances will expire and are revoked on the date(s) listed in the 
following table:

                 Commodity                    Parts per     Revocation  
                                               million         Date     
Beans, succulent...........................          2.0         10/1/99
Belgian endive, tops.......................          5.0            None
Cucumbers..................................          1.0            None
Grapes, (wine).............................          6.0            None
Kiwifruit..................................         10.0            None
Lettuce, head..............................         10.0            None
Lettuce (leaf).............................         10.0            None
Onions (dry bulb)..........................          1.0            None
Peppers (bell).............................          3.0            None
Raspberries................................         10.0            None
Stonefruits, except plums/fresh prunes.....         25.0            None
Strawberries...............................         10.0            None

*      *      *      *      *

[FR Doc. 98-3748 Filed 2-12-98; 8:45 am]