[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