[Federal Register Volume 68, Number 237 (Wednesday, December 10, 2003)]
[Proposed Rules]
[Pages 68806-68813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-30272]


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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food uses that are no longer current or registered in the United 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:[email protected].

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://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 [email protected], 
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) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        Date
------------------------------------------------------------------------
Cucumber......................................          2.0      12/4/05
Lettuce.......................................          2.0      12/4/05
Tomato........................................          2.0      12/4/05
------------------------------------------------------------------------

* * * * *
    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:

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        Date
------------------------------------------------------------------------
Apple.........................................          0.1      2/14/04
Grape.........................................          0.1      2/14/04
------------------------------------------------------------------------

    (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]
BILLING CODE 6560-50-S