[Federal Register Volume 63, Number 30 (Friday, February 13, 1998)]
[Rules and Regulations]
[Pages 7306-7308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3748]
[[Page 7306]]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300540A; FRL-5769-2]
2070-AB78
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: opp-docket@epamail.epa.gov. 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: wilhite.mark@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
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
certificatio
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
178.32).
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]]
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.
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:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.380 is amended by revising paragraph (a) to read as
follows:
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:
------------------------------------------------------------------------
Expiration/
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]
BILLING CODE 6560-50-F
