[Federal Register Volume 62, Number 30 (Thursday, February 13, 1997)]
[Proposed Rules]
[Pages 6750-6753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3518]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180, 185, and 186

[OPP-300432; FRL-5381-9]
RIN 2070-AC18


Propargite; Proposed Revocation of Certain Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed Rule.

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SUMMARY: EPA is proposing to revoke tolerances for residues of the 
pesticide Propargite in or on the following commodities: apples, dried 
apple pomace, apricots, cranberries, figs, dried figs, peaches, pears, 
plums (fresh prunes), strawberries, and succulent beans. EPA is 
proposing these revocations because the uses associated with the 
tolerances have been voluntarily deleted from propargite labels by 
Uniroyal Chemical Company. Uniroyal deleted the uses to address risk 
concerns raised by EPA.
DATES: Written comments should be submitted to EPA by April 14, 1997.

ADDRESSES: By mail, submit comments to Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, 401 M St., SW., Washington, DC 20460. In person, 
bring comments to Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis 
Highway, Arlington, VA.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. 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 in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number [OPP-300432]. No Confidential Business Information 
(CBI) should be submitted through e-mail. Electronic comments on this 
proposed rule may be filed online at many Federal Depository Libraries. 
Additional information on electronic submissions can be found in Unit 
VII. of this document.

FOR FURTHER INFORMATION CONTACT: By mail: Jeff Morris, Special Review 
and Reregistration Division (7508W), Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460.

[[Page 6751]]

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: 
[email protected].
SUPPLEMENTARY INFORMATION:

I. Introduction

    Propargite (trade names Omite and Comite) is a pesticide that was 
registered in 1969 for the control of mites on a number of agricultural 
commodities and ornamental plants. EPA classifies propargite as a 
B2 (probable) human carcinogen.

II. Legal Authorization

    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 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

    EPA published a Registration Standard for propargite in 1986, and 
FIFRA reregistration is ongoing. Through the reregistration process, in 
1992 EPA received from Uniroyal Chemical Company, the sole propargite 
registrant in the United States, a voluntarily submitted market basket 
survey examining residue levels in selected commodities in a nation-
wide cross section of grocery stores. The survey attempted to better 
reflect propargite residues in these commodities as purchased by 
consumers. Uniroyal's market basket survey, as well as other sampling 
data used by EPA, indicated propargite residues on certain foods such 
as apples and peaches that were far below tolerance levels but 
nevertheless resulted in dietary risks of concern for those foods. 
Based on this and other information, EPA conducted an intensive dietary 
risk assessment and concluded that long-term exposure to propargite 
posed an unreasonable dietary cancer risk to persons who consume 
propargite-treated foods.

A. Use Deletions

    EPA discussed its risk findings with Uniroyal, and Uniroyal 
responded in an April 5, 1996 letter by requesting, among other things, 
voluntary deletion of the following uses from all applicable propargite 
labels: apples, apricots, cranberries, figs, green beans, lima beans, 
peaches, pears, plums (including plums grown for prune production), and 
strawberries. EPA agreed to this request, and the deletions were 
announced in a Federal Register notice dated May 3, 1996 (61 FR 19936) 
(FRL-5367-4). EPA received comments both supporting and opposing the 
use deletions; those comments were considered prior to the requested 
use deletions taking effect on August 1, 1996. The comments are 
available in the public record under docket number OPP-64029. As part 
of its use-deletion agreement with EPA, Uniroyal also agreed not to 
challenge revocation of tolerances for any of the deleted uses.

B. Previous Actions

    EPA previously proposed to revoke the apple and fig tolerances 
listed under 40 CFR 180.259, because apples and figs had or needed food 
additive regulations (FAR) that were prohibited by the Delaney clause. 
Under EPA's coordination policy, EPA proposed to revoke the tolerances 
for apples and figs (61 FR 8174, March 1, 1996) (FRL-5351-6). On March 
22, 1996, EPA issued a final rule, subject to objections, revoking the 
FARs for dried figs and tea, also on grounds that the FARs violated the 
Delaney clause (61 FR 11994)(FRL-5357-7). The propargite registrant 
filed objections to the ``induces cancer'' ground for the final 
revocation and requested a hearing. Those revocations were stayed. In 
the same notice, EPA revoked the FAR for raisins because it was not 
needed. However, the August 3, 1996 enactment of the FQPA removed 
pesticides from coverage under FFDCA section 409 and the Delaney 
clause. Therefore, the proposed and final revocations based on Delaney 
clause grounds have no basis in law. Accordingly, EPA published a 
notice in the Federal Register (61 FR 50684, September 26, 1996)(FRL-
5397-4) withdrawing the proposed and final revocations for apples and 
figs that were premised on the Delaney clause.
    The dried apple pomace tolerance listed under 40 CFR 186.5000 was 
proposed for revocation on September 21, 1995 (60 FR 49142)(FRL-4977-3) 
on the ground that dried apple pomace is no longer listed on Table 1 of 
Series 860--Residue Chemistry Test Guidelines (formerly Table II of 
Subdivision O of EPA's Pesticide Assessment Guidelines), and therefore 
a tolerance is not needed.

IV. Current Proposal

    This notice proposes to revoke the following tolerances established 
under sections 408 and 409 of FFDCA (as a matter of law, these 
tolerances are now all considered to be under section 408) for residues 
of the pesticide propargite (2-(p-tert-butylphenoxy) cyclohexyl 2-
propynyl sulfite) in or on the following commodities listed under 40 
CFR 180.259, 185.5000, and 186.5000:
    Under Sec. 180.259: apples, 3 parts per million (ppm); apricots, 7 
ppm; beans, succulent, 20 ppm; cranberries, 10 ppm; figs, 3 ppm; 
peaches, 7 ppm; pears, 3 ppm; plums (fresh prunes), 7 ppm; 
strawberries, 7 ppm.
    Under Sec. 185.5000: figs, dried, 9 ppm.
    Under Sec. 186.5000: apple pomace, dried, 80 ppm.
    EPA is proposing these revocations because the registrant requested 
that the uses associated with the above tolerances be formally deleted 
from all of its propargite registrations, and those uses have been 
deleted. End-use propargite labels no longer list as registered uses 
the commodities associated with these tolerances. 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).
    An additional ground for revoking the dried apple pomace tolerance 
is that dried apple pomace is no longer listed on Table 1 of Series 
860--Residue Chemistry Test Guidelines, because it is no longer 
considered to be a significant livestock feed item and therefore does 
not require a feed additive regulation. Documentation explaining EPA's 
conclusions on what animal feeds are significant has been included in 
the public record.
    Propargite degrades in soil with a half-life of less than 60 days. 
Based on this lack of persistence, there is no expectation of 
unavoidable residues.
    Codex maximum residue limits exist for propargite. Propargite is a 
candidate for Codex re-evaluation, but review has not yet been 
scheduled. EPA requests comments on whether residues are present in or 
on imported commodities.

V. Effective Dates of Proposed Tolerance Revocations

    Prior to the amendment of the FFDCA, it was generally the practice 
of

[[Page 6752]]

EPA in similar instances to establish an effective date for each 
tolerance revocation that takes 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.
    At this time, EPA estimates that legally treated commodities should 
clear the channels of trade within 3 years of issuance of a final order 
revoking these tolerances. This is based on a preliminary EPA estimate 
that food processors attempt to deliver their products to grocery 
stores within 2 years of production, and that the products in general 
remain on store shelves for less than 1 year. EPA also estimates that 
no fresh market commodities are expected to be in the channels of trade 
3 years after treatment with propargite. However, because it is 
important to FDA as the agency that monitors residues in food to have 
accurate information regarding the length of time required for each 
affected commodity to move through commerce, EPA specifically requests 
comment from growers, processors, and other interested parties on this 
matter. The procedure for filing comments is described below in unit VI 
of this preamble.

VI. Public Comment Procedures

    EPA invites interested persons to submit written comments, 
information, or data in response to this proposed rule. 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.
    Comments must be submitted by April 14, 1997, and must bear a 
notation indicating the docket number [OPP-300432]. Three copies of the 
comments should be submitted to either location listed under ADDRESSES 
at the beginning of this notice.
    Information submitted as a comment concerning this notice may be 
claimed confidential by marking any or all of that information as 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 the CBI deleted, also must be submitted for inclusion in the 
public record. EPA may publicly disclose without prior notice 
information not marked confidential.

VII. Public Record

    A record has been established for this notice under docket number 
[OPP-300432] (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of electronic comments, that 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 Rm. 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 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.
    The official record for this notice, 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 
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 notice.

VIII. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action 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).
    Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the 
Administrator has determined that there will be no economic impacts 
from revocation of the tolerances in this notice, because the 
registrant has cancelled the uses. Despite the revocation, commodities 
legally treated under FIFRA and consistent with the tolerance in place 
at time of treatment are allowed by the statute to clear the channels 
of trade. Therefore, EPA certifies that this action will not have a 
significant impact on a substantial number of small entities.

List of Subjects

40 CFR Part 180

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

40 CFR Part 185

    Food additives, Pesticide and pest.

40 CFR Part 186

    Animal feeds, Pesticide and pest.

    Dated: January 31, 1997.

Daniel M. Barolo,

Director, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR parts 180, 185, and 186 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.

Sec. 180.259 [Amended]

    b. In Sec. 180.259, the table in paragraph (a) is amended by 
removing the entries for apples; apricots; beans, succulent; 
cranberries; figs; peaches; pears; plums (fresh prunes); and 
strawberries.

PART 185--[AMENDED]

    2. In part 185:
    a. The authority citation for part 185 continues to read as 
follows:
    Authority: 21 U.S.C. 348.

Sec. 185.5000 [Amended]

    b. Section 185.5000 is amended by removing the entry for ``Figs, 
dried.''

PART 186--[AMENDED]

    3. In part 186:
    a. The authority citation for part 186 continues to read as 
follows:
    Authority: 21 U.S.C. 348.


[[Page 6753]]



Sec. 186.5000 [Amended]

    b. Section 186.5000 is amended by removing the entry for ``Apple 
pomace, dried.''

[FR Doc. 97-3518 Filed 2-12-97; 8:45 am]
BILLING CODE 6560-50-F