[Federal Register Volume 62, Number 166 (Wednesday, August 27, 1997)]
[Proposed Rules]
[Pages 45377-45380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22808]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300540; FRL-5739-6]
RIN 2070-AB18
Vinclozolin; Proposed Revocation of Tolerances for Deleted Uses
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Revocation of Tolerances.
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SUMMARY: EPA is proposing the revocation of tolerances for uses of the
fungicide vinclozolin which were recently deleted from the vinclozolin
labels.
DATES: Public comments, identified by the docket control number [OPP-
300540] must be received on or before October 27, 1997.
ADDRESSES: By mail, submit comments to Public Information and Records
Integrity Branch, Information Resources and Services Division (7506C),
Office of Pesticide Programs, 401 M St., SW., Washington, DC 20460. In
person deliver comments to Room 1132, Crystal Mall #2, 1921 Jefferson
Davis Highway, Arlington VA.
Comments and data may also be submitted electronically by following
the instructions under Unit VII. of this document. No Confidential
Business Information (CBI) should be submitted through e-mail.
FOR FURTHER INFORMATION CONTACT: By mail: Mark Wilhite, Special Review
Branch (7508W), Special Review and Reregistration Division, Office of
Pesticide Programs, U.S. Environmental Protection Agency, 401 M St.,
SW., Washington, DC 20046. Office location, telephone number, and e-
mail: Special Review Branch, 3rd floor, 2800 Crystal Drive, Arlington,
VA, (703) 308-8586; e-mail: wilhite.mark@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. Background Information
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, raspberries, onions, succulent beans, and turf in
recreational areas, golf courses, commercial and industrial sites.
Vinclozolin is also registered for use on ornamentals in green houses
and nurseries. 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).
II. Proposed Revocation of Tolerances
This notice proposes to revoke the tolerances for the food uses
deleted from the vinclozolin registrations. EPA is proposing to revoke
these tolerances because there are no active registrations associated
with them. These revocations include the tolerances for the raw
agricultural commodities tomatoes, plums, prunes, and grapes other than
wine grapes, the food additive tolerances for raisins and prunes, and
the animal feed tolerance for grape pomace. Revocation of the
tolerances for fresh plums and prunes requires that the tolerance for
stonefruits be changed to stonefruits, except plums and prunes. To
revoke tolerances for grapes other than wine grapes, the tolerance will
be revised to wine grapes.
III. 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). 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. 331(a) and 342(a)).
Under FFDCA section 408(e)(A), the Administrator may issue a
regulation revoking a tolerance for a pesticide
[[Page 45378]]
chemical residue. Before such a regulation may become final the
Administrator must issue a notice of proposed rulemaking and provide a
period of not less than 60 days for public comment. Abandonment of uses
constitutes reasonable grounds for revoking a tolerance. [40 CFR
180.32(b)]
IV. Regulatory Background
It is EPA's general practice to propose revocation of tolerances
for residues of pesticide active ingredients for which FIFRA
registrations no longer exist. In accordance with FFDCA section 408,
however, EPA will not revoke any tolerance or exemption proposed for
revocation if any person will commit to support its retention, and if
retention of the tolerance will meet the tolerance standard established
under FQPA. Generally, interested parties commit to support the
retention of such tolerances in order to permit treated commodities to
be legally imported into the United States, since raw agricultural
commodities or processed food or feed commodities containing pesticide
residues not covered by a tolerance or exemption are considered to be
adulterated and subject to seizure.
Tolerances and exemptions established for pesticide chemicals with
FIFRA registrations cover residues in or on both domestic and imported
commodities. To retain these tolerances and exemptions for import
purposes only, EPA must make a finding that the tolerances and
exemptions are safe. To make this safety finding, EPA needs data and
information indicating that there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide residues
covered by the tolerances and exemptions.
EPA determines on a case-by-case basis the data required to
determine that a tolerance or exemption is safe, and in general
requires the same technical chemistry and toxicology data for
tolerances without related U.S. registrations as are required to
support U.S. food-use registrations and any resulting tolerances or
exemptions. (See 40 CFR part 158 for EPA's data requirements to support
domestic use of a pesticide and the establishment and maintenance of a
tolerance. At a future date, EPA will announce its import tolerance
policy.) In most cases, EPA also requires residue chemistry data (crop
field trials) that are representative of growing conditions in
exporting countries in the same manner that EPA requires representative
residue chemistry data from different U.S. regions to support domestic
use of a pesticide and any resulting tolerance(s) or exemption(s). Good
Laboratory Practice (GLP) requirements for studies submitted in support
of tolerances and exemptions for import purposes only are the same as
for domestic purposes; i.e., the studies are required to either fully
meet GLP standards, or have sufficient justification presented to show
that deviations from GLP requirements do not significantly affect the
results of the studies.
Under FFDCA section 408(f), if EPA determines that additional data
are needed to support continuation of a tolerance, EPA may require that
those data be submitted by registrants under FIFRA section 3(c)(2)(B),
or by other persons by order after opportunity for hearing.
Section 408(f) of the FFDCA states that if EPA determines that
additional data are needed to support the continuation of an existing
tolerance or exemption, EPA shall issue a notice that:
1. Requests that any parties identify their interest in supporting
the tolerance or exemption.
2. Solicits the submission of data and information from interested
parties.
3. Describes the data and information needed to retain the
tolerance or exemption.
4. Outlines how EPA will respond to the submission of supporting
data.
5. Provides time frames and deadlines for the submission of such
data and information.
Monitoring and enforcement of pesticide tolerances and exemptions
are carried out by the U.S. Food and Drug Administration (FDA) and the
U.S. Department of Agriculture (USDA). This includes monitoring for
pesticide residues in or on commodities imported into the United
States. It is generally FDA's enforcement policy to not consider
imported foods with residues adulterated until three years after the
effective date of the revocation.
V. Proposed Actions
This notice proposes to revoke the tolerances listed below. EPA is
proposing these revocations because EPA has deleted their uses from the
registrations for the pesticide chemical associated with the
tolerances, and it is EPA's general practice to propose revocation of
those tolerances for residues of pesticide chemicals for which there
are no active registrations.
VI. Effective Dates
These proposed revocations will become effective 30 days following
the publication in the Federal Register of a final rule revoking the
tolerances. FDA's enforcement policy is, in most cases, to not consider
imported foods with residues adulterated until 3 years after the
effective date of the revocation. Prior to the August 1996 amendment of
the FFDCA, it was generally the practice of EPA in similar instances to
establish an effective date for each tolerance revocation that took
into consideration the time needed for legally treated food to pass
entirely through the channels of trade. That is no longer necessary
because under section 408(l)(5), food lawfully treated will not be
rendered adulterated despite the lack of a tolerance, so long as the
residue on the food complies with the tolerance in place at the time of
treatment.
VII. Public Comment Procedures
EPA invites interested persons to submit written comments,
information, or data in response to this proposed rule. Comments must
be submitted by October 27, 1997. Comments must bear a docket control
number. Three copies of the comments should be submitted to either
location listed under ``ADDRESSES'' at the beginning of this notice.
In formation submitted as a comment concerning this notice may be
claimed confidential by marking any or all that information as
Confidential Business Information (CBI). EPA will not disclose
information so marked, except in accordance with procedures set forth
in 40 CFR part 2. A second copy of such comments, with CBI deleted,
also must be submitted for inclusion in the public record. EPA may
publicly disclose without prior notice information not marked
confidential.
After consideration of comments, EPA will issue a final rule. Such
rule will be subject to objections. Failure to file an objection within
the appointed period will constitute waiver of the right to raise in
future proceedings issues resolved in the final rule.
This proposal provides 60 days for any interested person to request
that a tolerance be retained. If EPA receives a comment to that effect,
EPA will not revoke the tolerance, but will take steps to ensure the
submission of supporting data and will issue an order in the Federal
Register under FFDCA section 408(f). The order would specify the data
needed, the time frames for its submission, and would require that
within 90 days some person or persons notify EPA that they will submit
the data. Thereafter, if the data are not submitted as required, EPA
will take appropriate action under FIFRA or FFDCA.
[[Page 45379]]
VIII. Rulemaking Record
The official record for this proposed revocation, as well as the
public version, has been established for this document under docket
control number [OPP-300540] (including comments and data submitted
electronically as described below). 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 official record is located at the address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at:
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. Comment 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 OPP-300540. Electronic comments on this
document may be filed at many Federal Depository Libraries.
IX. Regulatory Assessment Requirements
Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA
must determine whether the regulatory action is ``significant'' and
therefore subject to review by the Office of Management and Budget and
the requirements of the Executive Order. Under section 3(f), E.O. 12866
defines a ``significant regulatory action'' as an action that is likely
to result in 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; (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 the rights and obligations of recipients
thereof; or (4) raising novel legal or policy issues arising out of
legal mandates, the President's priorities, or principles set forth in
this Executive Order.
Pursuant to the terms of E.O. 12866, EPA has determined that this
proposed rule is not a significant regulatory action and, since this
action does not impose any information collection requirements subject
to approval under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.),
it is not subject to review by the Office of Management and Budget. 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 considerations as required by Executive Order
12898 (59 FR 7629, February 16, 1994).
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) generally requires an agency
to conduct a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements unless the agency certifies
that the rule will not have a significant economic impact on a
substantial number of small entities. Small entities include small
businesses, small not-for-profit enterprises, and small governmental
jurisdictions. Absent extraordinary circumstances, EPA believes that
revocation of a tolerance after use of the pesticide becomes illegal in
this country will not have a significant impact on a substantial number
of small entities.
In the case of domestically grown food, the tolerance revocations
proposed today will have no economic impact. The associated pesticide
registered uses have already been canceled. Since U.S. growers may no
longer use the pesticide in those ways, revoking the tolerance should
have no effect on food grown in the United States after cancellation of
the registered uses of the pesticide. As for food grown before the
cancellation occurred, it will not be considered adulterated if it was
treated in a way that complied with the tolerance in effect at the time
of treatment.
Revocation has a greater potential to affect foreign-grown food,
since the uses of the pesticide prohibited in the United States may
still be lawful in other countries. If foreign growers use the
pesticide in the ways prohibited in the United States, the food they
grow will be considered adulterated once the tolerance is revoked.
However, while revocation may have an economic effect on foreign
growers that import food to the United States, the RFA is concerned
only with the effect of U.S. regulations on domestic small entities.
Revocation may also have an effect on domestic importers of
foreign-grown food to the extent their suppliers use pesticides in ways
that result in residues no longer allowed in the United States.
However, EPA believes that the effect on U.S. importers will be
minimal. Theoretically, U.S. importers could face higher food prices
and transactions costs. The revocation of a particular tolerance,
though, is unlikely to have a significant impact on the price of a
commodity on the international market. Transaction costs may occur as a
result of having to find alternative suppliers of food untreated with
pesticides for which tolerances were revoked. Affected importers would
have the options of finding other suppliers in the same country or in
other countries, or inducing the same supplier to switch to alternative
pest controls. Given the existence of these options, EPA expects any
price increases or transaction costs resulting from revocations will be
minor. Any such impacts will be further reduced by the FDA's
enforcement policy of not considering imported foods with residues
adulterated until, in most cases, three years after the effective date
of the revocation. EPA has reviewed its available data on imports and
foreign pesticide usage and concludes that there is a reasonable
international supply of food not treated with the revoked pesticide,
generally within the same countries from which the relevant commodities
are currently imported.
Moreover, whatever the effect on U.S. importers of foreign-grown
food, EPA believes that it would be inappropriate and inconsistent with
the purpose of the RFA to ameliorate that effect. To the extent any
adverse effect occurs, it will be the result of foreign growers using
pesticides in ways not allowed in the U.S. Domestic growers have no
choice but to refrain from using pesticides in ways prohibited by U.S.
law. U.S. growers and those who follow them in the chain of commerce--
distributors and consumers--will bear the cost of complying with U.S.
law. For EPA to somehow address the economic effect of the revocation
on U.S. distributors of foreign-grown food would potentially give those
distributors a competitive advantage over distributors of U.S.-grown
food, and that advantage could potentially translate to a competitive
advantage for foreign growers over domestic growers. The RFA was
enacted in part to preserve competition in the marketplace, and it
would be perverse to implement it in a way that creates competitive
inequities, particularly between United States and foreign products.
Finally, EPA notes that potential increased costs to importers
would not be cognizable as grounds for not revoking the tolerance.
Because no
[[Page 45380]]
extraordinary circumstances exist as to the present revocation that
would change EPA's above analysis, I certify that this action will not
have a significant economic impact on a substantial number of small
entities.
List of Subjects 40 CFR Part 180
Environmental protection, Vinclozolin, Administrative practice and
procedure, Agricultural commodities, Pesticides and pests, Reporting
and record keeping requirements.
Dated: August 18, 1997.
Lois Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended to read
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 371.
b. 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:
------------------------------------------------------------------------
Parts per Expiration/Revocation
Commodity 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
------------------------------------------------------------------------
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[FR Doc. 97-22808 Filed 8-26-97; 8:45 am]
BILLING CODE 6560-50-P
