[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: [email protected].
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:
    [email protected]

    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