FR Doc 03-30272

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[Federal Register: December 10, 2003 (Volume 68, Number 237)]
[Proposed Rules]
[Page 68806-68813]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10de03-23]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0265; FRL-7330-8]

Bitertanol, Chlorpropham, Cloprop, Combustion Product Gas,
Cyanazine, et al.; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to revoke certain tolerances and
tolerance exemptions for residues of the fungicide and insecticide
dinocap; insecticides combustion product gas, ethion, formetanate
hydrochloride, nicotine-containing compounds, polyoxyethylene, and
tartar emetic; herbicides chlorpropham, cyanazine, and tridiphane;
fungicides bitertanol, 1,1,1-trichloroethane, and triforine; and the
plant regulators cloprop and 4,6-dinitro-o-cresol because these
specific tolerances are either no longer needed or are associated with
food uses that are no longer current or registered in the United
States. Also, EPA is proposing to modify certain ethion tolerances
before they expire. The regulatory actions proposed in this document
contribute toward the Agency's tolerance reassessment requirements of
the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as
amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA
is required by August 2006 to reassess the tolerances in existence on
August 2, 1996. The regulatory actions in this document pertain to the
proposed revocation of 61 tolerances and tolerance exemptions. Because
three tolerances were previously reassessed, 58 tolerances/exemptions
would be counted as reassessed toward the August, 2006 review deadline.

DATES: Comments, identified by docket ID number OPP-2003-0265, must be
received on or before February 9, 2004.

ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave, NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8037; e-mail address:nevola.joseph@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
[sbull] Crop production (NAI CS 111)
[sbull] Animal production (NAICS 112)
[sbull] Food manufacturing (NAICS 311)
[sbull] Pesticide manufacturing (NAICS 32532)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II.A. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0265. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/ A frequently updated electronic version of 40 CFR part 180 is available at http://.

http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a
beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will

[[Page 68807]]

not be placed in EPA's electronic public docket but will be available
only in printed, paper form in the official public docket. To the
extent feasible, publicly available docket materials will be made
available in EPA's electronic public docket. When a document is
selected from the index list in EPA Dockets, the system will identify
whether the document is available for viewing in EPA's electronic
public docket. Although not all docket materials may be available
electronically, you may still access any of the publicly available
docket materials through the docket facility identified in Unit I.B.1.
EPA intends to work towards providing electronic access to all of the
publicly available docket materials through EPA's electronic public
docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the Docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.

C. How and To Whom Do I Submit Comments?

You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPP-2003-0265. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment. ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID Number OPP-2003-0265. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0265.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID Number OPP-2003-0265. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.

[[Page 68808]]

4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the proposed rule or
collection activity.
7. Make sure to submit your comments by the deadline in this
document.
8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

F. What Can I do if I Wish the Agency to Maintain a Tolerance that the
Agency Proposes to Revoke?

This proposed rule provides a comment period of 60 days for any
person to state an interest in retaining a tolerance or tolerance
exemption proposed for revocation. If EPA receives a comment within the
60-day period to that effect, EPA will not proceed to revoke the
tolerance/exemption immediately. However, EPA will take steps to ensure
the submission of any needed supporting data and will issue an order in
the Federal Register under the Federal Food, Drug, and Cosmetic Act
(FFDCA) section 408(f) if needed. The order would specify data needed
and 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. If the data are not submitted as required in the order, EPA will
take appropriate action under FFDCA.
EPA issues a final rule after considering comments that are
submitted in response to this proposed rule. In addition to submitting
comments in response to this proposal, you may also submit an objection
at the time of the final rule. If you fail to file an objection to the
final rule within the time period specified, you will have waived the
right to raise any issues resolved in the final rule. After the
specified time, issues resolved in the final rule cannot be raised
again in any subsequent proceedings.

II. Background

A. What Action is the Agency Taking?

EPA is proposing to revoke certain tolerances and tolerance
exemptions for residues of the fungicide and insecticide dinocap;
insecticides combustion product gas, ethion, formetanate hydrochloride,
nicotine-containing compounds, polyoxyethylene, and tartar emetic;
herbicides chlorpropham, cyanazine, and tridiphane; fungicides
bitertanol, 1,1,1-trichloroethane, and triforine; and the plant
regulators cloprop and 4,6-dinitro-o-cresol because these specific
tolerances and exemptions correspond to uses no longer current or
registered under FIFRA in the United States. It is EPA's general
practice to propose revocation of those tolerances and tolerance
exemptions for residues of pesticide active ingredients on crop uses
for which there are no active registrations under FIFRA, unless any
person in comments on the proposal indicates a need for the tolerance
or tolerance exemption to cover residues in or on imported commodities
or domestic commodities legally treated.
Concerning the Reregistration Eligibility Decisions (REDs) for
chlorpropham and ethion and the Report on FQPA Tolerance Reassessment
Progress and Interim Risk Management Decision (TRED) for chlorpropham
mentioned in this rule, printed copies of the REDs and TREDs may be
obtained from EPA's National Service Center for Environmental
Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419,
telephone 1-800-490-9198; fax 1-513-489-8695; internet at http://www.epa.gov/ncepihom/
and from the National Technical Information
Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone
1-800-553-6847 or 703-605-6000; internet at http://www.ntis.gov/.
Electronic copies of REDs and TREDs are available on the internet at
http://www.epa.gov/pesticides/reregistration/status.htm.
1. Bitertanol. EPA is proposing to revoke the tolerance in 40 CFR
180.457 for residues of beta-([1,1'-biphenyl]-4-yloxy)-alpha-(1,1-
dimethylethyl)-1H-1,2,4-triazole-1-ethanol, also called bitertanol, in
or on banana (whole) because no active U.S. registrations have existed
for its associated commodity use since 1992 and the tolerance is no
longer needed.
2. Chlorpropham. In the 1996 RED for chlorpropham, EPA required
environmental fate and ecological effects data to maintain the spinach
registration, which was registered as a Special Local Need under FIFRA
24(c) and was not being supported by the primary registrants of
technical chlorpropham. In February 2002, EPA canceled the last Special
Local Need registration, but allowed use until December 31, 2002. On
July 19, 2002, EPA reassessed the spinach tolerance in a TRED for
chlorpropham. That reassessment decision was a recommendation to revoke
the spinach tolerance because there are no active registrations and the
tolerance is no longer needed. The Agency believes that there has been
sufficient time for chlorpropham-treated spinach to clear the channels
of trade. Therefore, EPA is proposing to revoke the interim tolerance
in 40 CFR 180.319 regarding isopropyl m-chlorocarbanilate (CIPC),
called chlorpropham, for residues in or on spinach.
3. Cloprop. On January 21, 1998 (63 FR 3057)(FRL-5743-8), EPA
published a Notice of Proposed Rulemaking in the Federal Register in
which the Agency proposed to revoke all cloprop tolerances. On January
26, 1998, the Pineapple Growers Association of Hawaii commented and
requested that the pineapple tolerance for cloprop not be revoked for 5
years. On October 26, 1998 (63 FR 57062)(FRL-6035-8), EPA published a
final rule in the Federal Register in which the Agency responded and
stated that it would not revoke the cloprop tolerance on pineapple at
that time. On September 21, 2001, EPA amended its authorization of a
specific emergency exemption under Section 18 of FIFRA for application
of cloprop on pineapple in Hawaii (which was to expire on August 3,
2001) until August 2, 2002. The Agency believes that there has been
sufficient time for cloprop-treated pineapple to clear the channels of
trade. Therefore, EPA is now proposing to revoke the tolerance in 40
CFR 180.325 for residues of 2-(m-chlorophenoxy) propionic acid, called
cloprop, from application of the acid or of 2-(m-chlorophenoxy)
propionamide in or on pineapple because no active registration exists
and the tolerance is no longer needed.
4. Combustion product gas. EPA is proposing to revoke the tolerance
exemption in 40 CFR 180.1051 for residues of the gas produced by the
controlled combustion in air of butane, propane, or natural gas in or
on all food commodities (except fresh meat) when used after harvest in
modified atmospheres for stored product with prescribed conditions. The
Agency is proposing this revocation because no active U.S.
registrations have existed since 1993.
5. Cyanazine. In November 1994, EPA initiated a Special Review of
cyanazine based on concerns that cyanazine may pose a risk of inducing
cancer in humans from dietary, occupational, and residential exposure.
In the Federal Register of July 25, 1996 (61 FR 39023) (FRL-5385-7),
EPA announced a final determination to terminate the cyanazine Special
Review. In the same notice, EPA accepted requests for the voluntary
cancellation of cyanazine

[[Page 68809]]

registrations effective December 31, 1999 and ordered the cancellations
to take effect on January 1, 2000, authorized sale and distribution of
such products in the channels of trade in accordance with their labels
through September 30, 2002, and prohibited the use of cyanazine
products after December 31, 2002. EPA issued an order confirming the
cyanazine cancellation on January 6, 2000 (65 FR 771) (FRL-6486-7).
EPA proposed to revoke the tolerances for cyanazine on April 23,
1999 (64 FR 19961) (FRL-6076-4). Only one significant comment was
received in response to that document. Griffin L.L.C. requested that
EPA not revoke the tolerances for cyanazine and due to Griffin's
interest in maintaining those tolerances as import tolerances, the
Agency did not take action on cyanazine at that time (64 FR 39078, July
21, 1999) (FRL-6093-9). However, in a letter to the Agency dated August
24, 1999, Griffin L.L.C. stated that it no longer needs EPA to maintain
import tolerances for cyanazine. The Agency believes that there has
been sufficient time for cyanazine-treated commodities to clear the
channels of trade. Therefore, EPA is proposing to revoke the tolerances
in 40 CFR 180.307 for residues of the herbicide 2-[[4-Chloro-6-
(ethylamino)-s-triazin-2-yl]amino]-2-methylpropionitrile, called
cyanazine, in or on corn, forage; corn, fresh, kernal plus cob with
husks removed; corn, grain; corn, stover; cotton, undelinted seed;
sorghum, forage; sorghum, grain; sorghum, grain, stover; wheat, forage;
wheat, grain; and wheat, straw.
6. 4,6-Dinitro-o-cresol. EPA is proposing to revoke the tolerance
in 40 CFR 180.344 for residues of 4,6-dinitro-o-cresol (DNOC) and its
sodium salt in or on apple from application to apple trees at the
blossom stage because no active U.S. registrations have existed for its
associated commodity use since 1993.
7. Dinocap. On April 26, 2002 (67 FR 20767)(FRL-6833-8), EPA
published a notice in the Federal Register under section 6(f)(1) of
FIFRA announcing its receipt of a request from the registrant for
cancellation of the last active dinocap product registrations. EPA
approved the registrants' requests for voluntary cancellation and
issued cancellation orders with an effective date of October 24, 2002
which allowed the registrants to sell and distribute existing stocks of
the canceled products until February 14, 2003. The Agency believes that
there is sufficient time for end users to exhaust those existing stocks
and treated commodities to clear the channels of trade by February 14,
2004. Therefore, EPA is proposing to revoke the tolerances in 40 CFR
180.341 for combined residues that is a mixture of 2,4-dinitro-6-
octylphenyl crotonate and 2,6-dinitro-4-octylphenyl crotonate, called
dinocap, in or on apple and grape with a expiration/revocation date of
February 14, 2004.
8. Ethion. On July 31, 2002 (67 FR 49606)(FRL-7191-4), EPA
published a final rule in the Federal Register which revoked ethion
tolerances on citrus fruit; dried citrus pulp, and certain animal
commodities with expiration/revocation dates of October 1, 2008. The
Agency acknowledged that citrus and animal feed (citrus, dried pulp)
with legal residues of ethion can take several years to clear channels
of trade from ethion's last legal use date of December 31, 2004.
In the July 2002 final rule, EPA did not act on the cattle and milk
fat tolerances for ethion because of an existing cattle ear tag
product. On October 16, 2002 (67 FR 63909)(FRL-7276-6), EPA published a
notice in the Federal Register under section 6(f)(1) of FIFRA
announcing its receipt of a request from the registrant for
cancellation of the last cattle ear tag product for ethion. EPA
approved the registrant's request for voluntary cancellation and on
June 4, 2003 issued a cancellation order with an effective date of May
31, 2003, i.e., the order allowed the basic registrant to distribute
and sell existing stocks of the canceled product until May 31, 2003.
Therefore, EPA is now proposing to revoke tolerances in 40 CFR 180.173
for residues of the insecticide ethion (O,O,O',O'-tetraethyl S,S'-
methylene bisphosphorodithioate) including its oxygen analog (S-
[[(diethoxyphos phinothioyl) thio]methyl] O,O-diethyl phosphorothioate)
in or on cattle, fat; cattle, meat byproducts; cattle, meat (fat
basis); and milk fat (reflecting (n) residues in milk), each with an
expiration/revocation date of October 1, 2008. These proposed dates are
consistent with the expiration/revocation date concerning the ethion
tolerance on dried citrus pulp, an animal feed. In addition and in
accordance with the 2001 RED for ethion, EPA is proposing not only to
revoke the cattle tolerances, but also to decrease them based on an
available ruminant feeding study to 0.2 ppm during the period before
they expire on October 1, 2008. In the RED, EPA found that these
revised tolerances are safe in accordance with section 408 of the
FFDCA. (A copy of the ethion RED will be made available in the docket
for this proposed rule. See the ethion RED Part IV(C)(1)(b): Tolerance
Summary).
Also, in the 2001 RED for ethion, EPA recommended that the citrus
tolerances should be revoked, but also be raised during the period
before they expire (from 10.0 to 25.0 ppm for dehydrated pulp and from
2.0 to 5.0 ppm for citrus fruits) based on the available citrus field
trial and processing data. In the RED, EPA found that these revised
tolerances are safe in accordance with section 408 of the FFDCA. (See
the ethion RED Part IV(C)(1)(b): Tolerance Summary). Therefore, in 40
CFR 180.173, while the citrus, dried pulp and fruit, citrus tolerances
will continue to expire on October 1, 2008, the Agency is proposing to
increase the tolerances for citrus, dried pulp (10 ppm) and fruit,
citrus (2.0 ppm) during the period before they expire to 25.0 and 5.0
ppm, respectively.
In addition, to conform to current Agency practice, EPA is
proposing in 40 CFR 180.173 to revise the commodity terminologies for
``fruit, citrus'' to ``fruit, citrus, group 10;'' and ``milk fat
(reflecting (N) residues in milk)'' to ``milk, fat, reflecting
negligible residues in milk.''
9. Formetanate hydrochloride. EPA had initiated negotiations with
the registrant for formetanate hydrochloride due to Agency concerns. As
one measure to reduce concerns, the registrant agreed to delete the
product use on plums and prunes, which appear to benefit little from
use of the product. Pursuant to section 6(f) of FIFRA, EPA received the
request for voluntary amendments to delete the aforementioned uses from
the registrations. On February 8, 2000, a 6(f)(1) notice of receipt of
the request by the registrant was published in the Federal Register (65
FR 6208) (FRL-6489-6). EPA granted the registrant's request to waive
the 180-day comment period, but the Agency provided a 30-day public
comment period, and granted the requested amendments to delete those
uses from registration labels on May 31, 2000. Except for the purpose
of relabeling, the Agency had prohibited sale and distribution by the
registrant after December 1, 1999 and by persons other than the
registrant, including existing stocks, after June 1, 2000, of products
labeled for use on plums and prunes.
Because there are no active registrations for use of formetanate
hydrochloride on plums and prunes, the tolerances are no longer needed.
Therefore, EPA is proposing to revoke the tolerances in 40 CFR
180.276(a)(1) for residues of the insecticide formetanate hydrochloride
in or on plum, prune, fresh and in 40 CFR 180.276(a)(2) for residues of
the

[[Page 68810]]

insecticide formetanate hydrochloride in or on dried prunes.
10. Nicotine-containing compounds. On December 6, 2002 (67 FR
72673)(FRL-7281-5), EPA published a notice in the Federal Register
under section 6(f)(1) of FIFRA announcing its receipt of a request from
the registrant to amend a registration for a product whose active
ingredient is a nicotine-containing compound and delete greenhouse food
crop uses, including cucumber, lettuce, and tomato. (These were the
last active food use registrations for nicotine-containing compounds).
EPA approved the registrants' requests for voluntary deletion of these
uses and allowed a period of 18 months for the registrant to sell and
distribute existing stocks until December 4, 2004. The Agency believes
that there is sufficient time for end users to exhaust those existing
stocks and treated commodities to clear the channels of trade by
December 4, 2005. Therefore, EPA is proposing to revoke the tolerances
in 40 CFR 180.167 for residues of nicotine-containing compounds in or
on cucumber, lettuce, and tomato with expiration/revocation dates of
December 4, 2005.
11. Polyoxyethylene. EPA is proposing to revoke the tolerance
exemptions in 40 CFR 180.1078 for residues of poly(oxy-1,2-ethanediyl),
alpha-isooctadyl-omega-hydroxy, also called polyoxyethylene, in or on
fish, shellfish, irrigated crops, meat, milk, poultry, and eggs because
no active U.S. registrations have existed since 1990.
12. Tartar emetic. EPA is proposing to revoke the tolerances in 40
CFR 180.179 for residues, calculated as combined antimony trioxide, in
or on fruit, citrus; grape, and onion because no active U.S.
registrations have existed for their associated commodity uses since
1992.
13. 1,1,1-Trichloroethane. EPA is proposing to revoke the tolerance
exemption in 40 CFR 180.1012 for residues of 1,1,1-trichloroethane when
used in the postharvest fumigation of citrus fruits because no active
U.S. registrations have existed since 1989.
14. Tridiphane. On September 26, 2001 (66 FR 49184)(FRL-6802-1),
EPA published a notice in the Federal Register under section 6(f)(1) of
FIFRA announcing its receipt of a request from the registrant for
cancellation of the last active tridiphane product registration. EPA
approved the registrants' request for voluntary cancellation and issued
a cancellation order with an effective date of April 5, 2002 which
allowed the registrant to sell and distribute existing stocks of the
canceled product until July 17, 2002. The Agency believes that there
has been sufficient time for end users to exhaust those existing stocks
and for treated commodities to clear the channels of trade. Therefore,
EPA is proposing to revoke the tolerances in 40 CFR 180.424 for
residues of 2-(3,5-dichlorophenyl)-2-(2,2,2-trichloroethyl)-oxirane,
called tridiphane, in or on corn, grain, field; corn, forage; and corn,
stover.
15. Triforine. On December 24, 1997 (62 FR 67365)(FRL-5761-8), EPA
published a notice in the Federal Register under section 6(f)(1) of
FIFRA announcing its receipt of a request from the registrant to amend
a triforine product registration and delete certain triforine uses,
including almonds, apples, apricots, asparagus, blueberries, cherries,
cranberries, nectarines, plums, and prunes. EPA approved the
registrants' requests for voluntary deletion of these uses and allowed
a period of 18 months for the registrant to sell and distribute
existing stocks (until approximately the end of 1999). Also, on July
31, 1998 (63 FR 41145)(FRL-6015-8), EPA published a notice in the
Federal Register which announced cancellation of a triforine
registration for non-payment of 1998 maintenance fee and issuance of a
cancellation order which permitted the registrant to sell and
distribute existing stocks of the canceled product until January 15,
1999.
The Agency believes that end users had sufficient time (at least
3[frac12] years beyond the endpoint for sale and distribution by
registrants) to exhaust those existing stocks and for treated
commodities to have cleared the channels of trade. Therefore, EPA is
proposing to revoke the tolerances in 40 CFR 180.382(a) for residues of
triforine in or on almond, hulls; almond; apple; apricot; bell pepper;
blueberry; cantaloupe; cherry; cranberry; cucumber; eggplant; hop,
dried cone; hop, spent; nectarine; peach; plum; plum, prune, fresh;
strawberry; and watermelon; and in Sec. 180.382(c) for residues of
triforine in or on asparagus because no active U.S. registrations exist
which cover those commodities.

B. What is the Agency's Authority for Taking this Action?

A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 301 et
seq., as amended by the FQPA of 1996, Public Law 104-170, authorizes
the establishment of tolerances, exemptions from tolerance
requirements, modifications in tolerances, and revocation of tolerances
for residues of pesticide chemicals in or on raw agricultural
commodities and processed foods (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.
Such food may not be distributed in interstate commerce (21 U.S.C.
331(a) and 342(a)). 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 FIFRA (7 U.S.C. et
seq.). Food-use pesticides not registered in the United States must
have tolerances in order for commodities treated with those pesticides
to be imported into the United States.
EPA's general practice is to propose revocation of tolerances for
residues of pesticide active ingredients on crops for which FIFRA
registrations no longer exist and on which the pesticide may therefore
no longer be used in the United States. EPA has historically been
concerned that retention of tolerances that are not necessary to cover
residues in or on legally treated foods may encourage misuse of
pesticides within the United States. Nonetheless, EPA will establish
and maintain tolerances even when corresponding domestic uses are
canceled if the tolerances, which EPA refers to as ``import
tolerances,'' are necessary to allow importation into the United States
of food containing such pesticide residues. However, where there are no
imported commodities that require these import tolerances, the Agency
believes it is appropriate to revoke tolerances for unregistered
pesticides in order to prevent potential misuse.
Furthermore, as a general matter, the Agency believes that
retention of import tolerances not needed to cover any imported food
may result in unnecessary restriction on trade of pesticides and foods.
Under section 408 of the FFDCA, a tolerance may only be established or
maintained if EPA determines that the tolerance is safe based on a
number of factors, including an assessment of the aggregate exposure to
the pesticide and an assessment of the cumulative effects of such
pesticide and other substances that have a common mechanism of
toxicity. In doing so, EPA must consider potential contributions to
such exposure from all tolerances. If the cumulative risk is such that
the tolerances in aggregate are not safe, then every one of these
tolerances is potentially vulnerable to revocation. Furthermore, if
unneeded tolerances are included in the aggregate and cumulative risk
assessments, the estimated exposure to the pesticide would be inflated.
Consequently, it may

[[Page 68811]]

be more difficult for others to obtain needed tolerances or to register
needed new uses. To avoid potential trade restrictions, the Agency is
proposing to revoke tolerances for residues on crops for which FIFRA
registrations no longer exist, unless someone expresses a need for such
tolerances. Through this proposed rule, the Agency is inviting
individuals who need these import tolerances to identify themselves and
the tolerances that are needed to cover imported commodities.
Parties interested in retention of the tolerances or tolerance
exemptions should be aware that additional data may be needed to
support retention. These parties should be aware that, under FFDCA
section 408(f), if the Agency determines that additional information is
reasonably required to support the continuation of a tolerance, EPA may
require that parties interested in maintaining the tolerances provide
the necessary information. If the requisite information is not
submitted, EPA may issue an order revoking the tolerance at issue.

C. When do These Actions Become Effective?

For this rule, the proposed actions will affect tolerances and
tolerance exemptions for uses which have been canceled, in some cases,
for many years. With the exception of certain tolerances for dinocap,
ethion, and nicotine-containing compounds for which EPA is proposing
specific expiration/revocation dates, the Agency is proposing that
these revocations, modifications, and commodity terminology revisions
become effective 90 days following publication of a final rule in the
Federal Register. EPA is proposing to delay the effectiveness of those
revocations for 90 days following publication of a final rule to ensure
that all affected parties receive notice of EPA's actions. With the
exception of dinocap, ethion, and nicotine-containing compounds, the
Agency believes that existing stocks of pesticide products labeled for
the uses associated with the tolerances and tolerance exemptions
proposed for revocation have been completely exhausted and that treated
commodities have cleared the channels of trade.
EPA is proposing expiration/revocation dates of February 14, 2004
for the dinocap tolerances on apple and grape. Also, EPA is proposing
expiration/revocation dates of October 1, 2008 for the ethion
tolerances on milk fat and the fat, meat, and meat byproducts of
cattle. In addition, EPA is proposing expiration/revocation dates of
December 4, 2005 for the nicotine-containing compounds tolerances on
cucumber, lettuce, and tomato. The Agency believes that these
revocation dates allow users time to exhaust stocks and allow
sufficient time for passage of treated commodities through the channels
of trade. However, if EPA is presented with information that existing
stocks would still be available and that information is verified, the
Agency will consider extending the expiration date of the tolerance. If
you have comments regarding existing stocks and whether the effective
date allows sufficient time for treated commodities to clear the
channels of trade, please submit comments as described under Unit I.C.
of the SUPPLEMENTARY INFORMATION.
Any commodities listed in this proposal treated with the pesticides
subject to this proposal, and in the channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(l)(5), as
established by FQPA. Under this section, any residues of these
pesticides in or on such food shall not render the food adulterated so
long as it is shown to the satisfaction of the Food and Drug
Administration that: (1) The residue is present as the result of an
application or use of the pesticide at a time and in a manner that was
lawful under FIFRA, and (2) the residue does not exceed the level that
was authorized at the time of the application or use to be present on
the food under a tolerance or exemption from tolerance. Evidence to
show that food was lawfully treated may include records that verify the
dates that the pesticide was applied to such food.

D. What Is the Contribution to Tolerance Reassessment?

By law, EPA is required by August 2006 to reassess the tolerances
in existence on August 2, 1996. As of November 20, 2003, EPA has
reassessed 6,628 tolerances. This document proposes to revoke a total
of 61 tolerances and tolerance exemptions, 3 of which were previously
counted as reassessed (1 via the chlorpropham TRED and 2 via the
dinocap RED). Therefore, 58 tolerances/exemptions would be counted as
reassessed toward the August, 2006 review deadline of FFDCA section
408(q), as amended by FQPA in 1996.

III. Are the Proposed Actions Consistent with International
Obligations?

The tolerance and tolerance exemption revocations in this proposal
are not discriminatory and are designed to ensure that both
domestically-produced and imported foods meet the food safety standards
established by the FFDCA. The same food safety standards apply to
domestically produced and imported foods.
EPA is working to ensure that the U.S. tolerance reassessment
program under FQPA does not disrupt international trade. EPA considers
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in
reassessing them. MRLs are established by the Codex Committee on
Pesticide Residues, a committee within the Codex Alimentarius
Commission, an international organization formed to promote the
coordination of international food standards. It is EPA's policy to
harmonize U.S. tolerances with Codex MRLs to the extent possible,
provided that the MRLs achieve the level of protection required under
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the
tolerance reassessment section of individual Reregistration Eligibility
Decision documents. EPA has developed guidance concerning submissions
for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3).
This guidance will be made available to interested persons. Electronic
copies are available on the internet at http://www.epa.gov/. On the
Home Page select ``Laws, Regulations, and Dockets,'' then select
``Regulations and Proposed Rules'' and then look up the entry for this
document under ``Federal Register--Environmental Documents.'' You can
also go directly to the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/
.

IV. Statutory and Executive Order Reviews

In this proposed rule EPA is proposing to modify and revoke
specific tolerances and tolerance exemptions established under FFDCA
section 408. The Office of Management and Budget (OMB) has exempted
these types of actions (i.e., modification of a tolerance and tolerance
revocation for which extraordinary circumstances do not exist) from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this proposed rule has
been exempted from review under Executive Order 12866 due to its lack
of significance, this proposed rule is not subject to Executive Order
13211, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed
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

[[Page 68812]]

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any 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 OMB review or any other
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency previously assessed whether
establishment of tolerances, exemptions from tolerances, raising of
tolerance levels, expansion of exemptions, or 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.
These analyses for tolerance establishments and modifications, and for
tolerance revocations were published on May 4, 1981 (46 FR 24950) and
December 17, 1997 (62 FR 66020), respectively, and were provided to the
Chief Counsel for Advocacy of the Small Business Administration. Taking
into account this analysis, and available information concerning the
pesticides listed in this rule, I certify that this action will not
have a significant economic impact on a substantial number of small
entities. Specifically, as per the 1997 notice, 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 canceled pesticides. Furthermore, for the pesticides named in this
proposed rule, the Agency knows of no extraordinary circumstances that
exist as to the present proposed revocations that would change the
EPA's previous analysis. Any comments about the Agency's determination
should be submitted to the EPA along with comments on the proposal, and
will be addressed prior to issuing a final rule. In addition, the
Agency has determined that this action will not have a substantial
direct effect on States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

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

Dated: November 20, 2003.
James Jones,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:

PART 180--[AMENDED]

1. The authority citation for part 180 continues to read as
follows:

Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. Section 180.167 is amended by revising the table in paragraph
(a) to read as follows:

Sec. 180.167 Nicotine-containing compounds; tolerances for residues.

(a) * * *

* * * * *
3. Section 180.173 is amended by revising the table in paragraph
(a) to read as follows:

Sec. 180.173 Ethion; tolerances for residues.

(a) * * *

------------------------------------------------------------------------
Expiration/
Commodity Parts per Revocation
million Date
------------------------------------------------------------------------
Cattle, fat................................... 0.2 10/1/08
Cattle, meat (fat basis)...................... 0.2 10/1/08
Cattle, meat byproducts....................... 0.2 10/1/08
Citrus, dried pulp............................ 25.0 10/1/08
Fruit, citrus, group 10....................... 5.0 10/1/08
Goat, fat..................................... 0.2 10/1/08
Goat, meat.................................... 0.2 10/1/08
Goat, meat byproducts......................... 0.2 10/1/08
Hog, fat...................................... 0.2 10/1/08
Hog, meat..................................... 0.2 10/1/08
Hog, meat byproducts.......................... 0.2 10/1/08
Horse, fat.................................... 0.2 10/1/08
Horse, meat................................... 0.2 10/1/08
Horse, meat byproducts........................ 0.2 10/1/08
Milk, fat, reflecting negligible residues in 0.5 10/1/08
milk.........................................
Sheep, fat.................................... 0.2 10/1/08
Sheep, meat................................... 0.2 10/1/08
Sheep, meat byproducts........................ 0.2 10/1/08
------------------------------------------------------------------------

* * * * *

Sec. 180.179 [Removed]

4. Section 180.179 is removed.

[[Page 68813]]

5. Section 180.276 is revised to read as follows:

Sec. 180.276 Formetanate hydrochloride; tolerances for residues.

(a) General. Tolerances are established for residues of the
insecticide formetanate hydrochloride (m-[[(dimethylamino)
methylene]amino]phenyl methylcarbamate hydrochloride) in or on raw
agricultural commodities as follows:

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Apple................................................ 3.0
Grapefruit........................................... 4.0
Lemon................................................ 4.0
Lime................................................. 4.0
Nectarine............................................ 4.0
Orange, sweet........................................ 4.0
Peach................................................ 5.0
Pear................................................. 3.0
Tangerine............................................ 4.0
------------------------------------------------------------------------

(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]

Sec. 180.307 [Removed]

6. Section 180.307 is removed.

Sec. 180.319 [Amended]

7. Section 180.319 is amended by removing the Isopropyl m-
chlorocarbanilate (CIPC) entry for spinach.

Sec. 180.325 [Removed]

8. Section 180.325 is removed.
9. Section 180.341 is revised to read as follows:

Sec. 180.341 2,4-Dinitro-6-octylphenyl crotonate and 2,6-dinitro-4-
octylphenyl crotonate; tolerances for residues.

(a) General. Tolerances are established for combined negligible
residues of a fungicide and insecticide that is a mixture of 2,4-
dinitro-6-octylphenyl crotonate and 2,6-dinitro-4-octylphenyl crotonate
in or on a raw agricultural commodoties as follows:

(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]

Sec. Sec. 180.344, 180.382, 180.424, 180.457,180.1012, 180.1051, and
180.1078 [Removed]

10. Sections 180.344, 180.382, 180.424, 180.457, 180.1012,
180.1051, and 180.1078 are removed.
[FR Doc. 03-30272 Filed 12-9-03; 8:45 am]

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