FR Doc 03-17730

[Federal Register: July 16, 2003 (Volume 68, Number 136)]
[Proposed Rules]
[Page 41989-41996]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jy03-39]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0092; FRL-7301-5]

Aldicarb, Atrazine, Cacodylic acid, Carbofuran, et al.; Proposed
Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to revoke specific meat, milk, poultry,
and egg tolerances for residues of the insecticides aldicarb,
carbofuran, diazinon, and dimethoate; herbicides atrazine, metolachlor,
and sodium acifluorfen; fungicides fenarimol, propiconazole, and
thiophanate-methyl; and the defoliant cacodylic acid. EPA determined
that there are no reasonable expectations of finite residues in or on
meat, milk, poultry, or eggs for the aforementioned pesticide active
ingredients and that these tolerances are no longer needed. Also, this
document proposes to modify specific fenarimol tolerances. 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. Because all
the tolerances were previously reassessed, no reassessments are counted
here toward the August 2006 review deadline.

DATES: Comments, identified by docket ID number OPP-2003-0092, must be
received on or before September 15, 2003.

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 (NAICS 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

[[Page 41990]]

under docket identification (ID) number OPP-2003-0092. 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 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. 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-2003-0092. 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-2003-0092. 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-2003-0092.
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

[[Page 41991]]

Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP-2003-0092.
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.
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 proposed for
revocation. If EPA receives a comment within the 60-day period to that
effect, EPA will not proceed to revoke the tolerance 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
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 specific meat, milk, poultry, and egg
tolerances for residues of the insecticides aldicarb, carbofuran,
diazinon, and dimethoate; herbicides atrazine, metolachlor, and sodium
acifluorfen; fungicides fenarimol, propiconazole, and thiophanate-
methyl; and the defoliant cacodylic acid because the Agency has
concluded that there is no reasonable expectation of finite residues in
or on the commodities associated with those tolerances, and therefore
these tolerances are no longer needed. Also, EPA is proposing to modify
specific fenarimol tolerances.
The determinations that there are no reasonable expectations of
finite residues for the tolerances listed in this document were made
based on feeding studies submitted since the time that the tolerances
were originally established. These feeding studies used exaggerated
amounts of the compound and did not show measurable residues of the
pesticides tested. The Agency originally made the determination that
there is no reasonable expectation of finite residues for the pesticide
active ingredient/commodity combinations listed in this proposal in
memoranda of March 6, 2002; March 25, 2002; April 21, 2002; July 1,
2002; and July 23, 2002. Because there was no expectation of finite
residues, in subsequent memoranda of May 3, 2002; June 3, 2002; July
11, 2002; and July 23, 2002, the Agency declared these tolerances as
safe and counted these tolerances toward meeting the tolerance
reassessment requirements listed in FFDCA section 408(q). Copies of
these memoranda can be found in the public docket for this proposed
rule. Because EPA determined that there is no reasonable expectation of
finite residues, under 40 CFR 180.6 the tolerances are no longer needed
under the FFDCA and can be proposed for revocation.
1. Aldicarb. Based on available ruminant feeding and storage
stability data, EPA determined that there is no reasonable expectation
of finite residues of aldicarb and its carbamate metabolites in milk
and livestock commodities. The associated tolerances are no longer
needed under 40 CFR 180.6(a)(3). Therefore, EPA is proposing to revoke
the tolerances in 40 CFR 180.269 for the combined residues of the
insecticide and nematocide aldicarb (2-methyl-2-
(methylthio)propionaldehyde O-(methylcarbamoyl) oxime and its
cholinesterase-inhibiting metabolites 2-methyl 2-(methylsulfinyl)
propionaldehyde O-(methylcarbamoyl) oxime and 2-methyl-2-
(methylsulfonyl) propionaldehyde O-(methylcarbamoyl) oxime in or on the
following: cattle, fat; cattle, meat; cattle meat byproducts; goat,
fat; goat, meat; goat, meat byproducts; hog, fat; hog, meat; hog, meat
byproducts; horse, fat; horse, meat; horse, meat byproducts; and sheep,
fat; sheep, meat; sheep, meat byproducts; and milk.
2. Atrazine. Based on available ruminant and poultry feeding data,
EPA determined that there is no reasonable expectation of finite
residues of atrazine in fat, meat, and meat byproducts of hogs and
poultry; and eggs. These tolerances are no longer needed under 40 CFR
180.6(a)(3). Therefore, EPA is proposing to revoke the tolerances in 40
CFR 180.220 for residues of the herbicide atrazine in or on hog, fat;
hog, meat; hog, meat byproducts; poultry, fat; poultry, meat; poultry,
meat byproducts; and egg.
3. Cacodylic acid (dimethylarsinic acid). Arsenic is ubiquitous and
abundant in the environment. Studies show that arsenicals are
methylated in animals to potentially significant levels of dimethyl
arsonate. Also, available

[[Page 41992]]

data show that background levels of dimethyl arsonate (cacodylate)
found in beef tissues and milk may substantially exceed those incurred
from the maximum theoretical dietary burden from ingestion of feed
stuffs derived from raw agricultural commodities treated with cacodylic
acid at the maximum supported use rates. Based on all these data, EPA
determined that tolerances for residues of cacodylic acid in beef
tissues and milk are no longer needed under 40 CFR 180.6(a)(3).
Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.311
for residues of the defoliant cacodylic acid (dimethylarsinic acid),
expressed as As2 O3, in or on cattle, fat; cattle, kidney; cattle,
liver; cattle, meat; and cattle meat byproducts (except kidney and
liver).
Furthermore, in order to conform to current Agency practice, in 40
CFR 180.311, EPA is proposing to revise the tolerance commodity
terminology for ``cottonseed'' to ``cotton, undelinted seed.''
4. Carbofuran. Based on available dairy cattle feeding data, EPA
determined that there is no reasonable expectation of finite residues
of carbofuran and its metabolites in fat, meat, and meat byproducts of
cattle, goats, hogs, horses and sheep. These tolerances are no longer
needed under 40 CFR 180.6(a)(3). Therefore, EPA is proposing to revoke
the tolerances in 40 CFR 180.254 for the combined residues of the
insecticide carbofuran (2,3-dihydro-2,2-dimethyl-7-benzofuranyl-N-
methylcarbamate), its carbamate metabolite 2,3-dihydro-2,2-dimethyl-3-
hydroxy-7-benzofuranyl-N-methylcarbamate, and its phenolic metabolites
2,3-dihydro-2, 2-dimethyl-7-benzofuranol, 2,3-dihydro-2,2-dimethyl-3,-
oxo-7-benzofuranol and 2,3-dihydro-2,2-dimethyl-3,7-benzofurandiol in
or on the following commodities: Cattle, fat; cattle, meat; cattle meat
byproducts; goats, fat; goats, meat; goats, meat byproducts; hogs, fat;
hogs, meat; hogs, meat byproducts; horses, fat; horses, meat; horses,
meat byproducts; sheep, fat; sheep, meat; and sheep, meat byproducts.
5. Diazinon. Based on available cattle dermal treatment and feeding
data, EPA determined that there is no reasonable expectation of finite
residues in or on meat and meat byproducts from the registered uses of
cattle ear tags or from consumption of diazinon-treated feed items by
cattle. These tolerances are no longer needed under 40 CFR 180.6(a)(3).
A tolerance for milk is not required as long as the ear tag labels
maintain that use is for beef cattle and non-lactating dairy cattle,
only. Therefore, EPA is proposing to revoke the tolerances in 40 CFR
180.153 for residues of the insecticide diazinon in or on cattle, meat
(fat basis) (PRE-S appli) and cattle, meat byproducts (fat basis) (PRE-
S appli).
6. Dimethoate. Metabolism and feeding studies in ruminants and
poultry showed no detectable residues of dimethoate in muscle, fat,
kidney, liver, milk, and egg samples. However, residues of omethoate,
its oxygen analog, were found in liver and egg whites samples and
residues of dimethoate carboxylic acid were found in liver, egg whites,
and milk samples. Based on these available ruminant and poultry
metabolism and feeding data, EPA determined that there is no reasonable
expectation of finite residues of concern in meat, fat, and kidney of
livestock (ruminants and poultry) from ingestion of dimethoate treated
crop and feed items. These tolerances are no longer needed under 40 CFR
180.6(a)(3). Therefore, EPA is proposing to revoke the tolerances in 40
CFR 180.204 for total residues of the insecticide dimethoate (O,O-
dimethyl S-(N-methylcarbamoylmethyl) phosphorodithioate) including its
oxygen analog (O,O-dimethyl S-(N-methylcarbamoylmethyl)
phosphorothioate) in or on the following commodities: Cattle, fat;
cattle, meat; goat, fat; goat, meat; hog, fat; hog, meat; horse, fat;
horse, meat; poultry, fat; poultry, meat; sheep, fat; and sheep, meat.
Use of dimethoate on other commodities, including food and feed
commodities, will be addressed in the ``Report on FQPA Tolerance
Reassessment Progress and Interim Risk Management Decision'' (IRED),
which EPA will complete in the near future.
Also, EPA is proposing in 40 CFR 180.204 to remove the ``(N)''
designation from all entries to conform to current Agency
administrative practice (``(N)'' designation means negligible
residues).
7. Fenarimol. Fenarimol tolerances were reassessed according to the
FQPA standard in the August 2002 ``Report of the FQPA Tolerance
Reassessment Progress and Risk Management Decision (TRED) for
Fenarimol.'' The Agency extrapolated data from a 28-day ruminant
feeding study of exaggerated dietary burdens to the 1X feeding rate,
and examined the expected impact of the average theoretical dietary
burden from wet apple pomace (calculated using Food and Drug
Administration monitoring data for apples). Of the currently registered
uses of fenarimol, wet apple pomace is the only commodity considered a
livestock feed item. (Dry apple pomace is no longer considered a
significant feed item). For cattle, goats, horses, and sheep, the
Agency concluded from monitoring, feeding, and metabolism data that
tolerances for liver should be effectively decreased from 0.1 to 0.05
parts per million (ppm) and tolerances for meat byproducts should be
increased from 0.01 to 0.05 ppm based on the highest residue found on
an organ tissue; i.e., liver. Because both liver and meat byproduct
tolerances were reassessed at the same level (0.05 ppm) for cattle,
goats, horses, and sheep, the Agency recommended covering residues in
liver by the reassessed tolerances for meat byproducts, revising each
commodity terminology to ``meat byproducts, except kidney,'' and
revoking existing liver tolerances at 0.1 ppm since they are no longer
needed. EPA issued a finding in this TRED that these revised tolerances
are safe, as required by section 408 of FFDCA.
Therefore, EPA is proposing to revoke the separate tolerances in 40
CFR 180.421 for residues of the fungicide fenarimol in or on cattle,
liver; goat, liver; horse, liver; and sheep, liver. Also, EPA is
proposing in 40 CFR 180.421 to increase the tolerances for the meat
byproducts of cattle, goats, horses, and sheep, each from 0.01 to 0.05
ppm, and to revise their commodity terminologies to cattle, meat
byproducts, except kidney; goat, meat byproducts, except kidney; horse,
meat byproducts, except kidney; and sheep, meat byproducts, except
kidney.
Expected fenarimol residues in muscle, fat and kidney are
calculated from the 28-day data to be less than or near the enforcement
method's limit of detection (0.003 ppm). Therefore, the Agency
concluded that for muscle, fat and kidney of ruminants it is not
possible to establish with certainty whether finite residues will be
incurred, but there is a reasonable expectation of finite residues
under 40 CFR 180.6(a)(2). While EPA reassessed fenarimol tolerances for
cattle, goats, horses, and sheep in the TRED, including meat, kidney,
and fat tolerances at 0.01 ppm, the method limit of quantitation, the
Agency will address them in a Federal Register document to be published
in the near future.
In addition, the fenarimol tolerance for milk (0.003 ppm) should be
revoked because residues in milk for dairy cattle are predicted to be
significantly less than the enforcement method's limit of detection
(0.001 ppm). Based on the available data, EPA determined that there is
no reasonable expectation of finite residues of fenarimol in milk and
that the tolerance is no longer needed under 40 CFR 180.6(a)(3).
Therefore, EPA is proposing to revoke the tolerance

[[Page 41993]]

in 40 CFR 180.421 for residues of the fungicide fenarimol in milk.
Moreover, EPA determined that there is no reasonable expectation of
residue transfer to livestock commodities via consumption of fenarimol-
treated crop and feed items because no feed items for poultry and hogs
are associated with active fenarimol registrations. The tolerances for
eggs, poultry, and hogs are no longer needed and should be revoked.
Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.421
for residues of the fungicide fenarimol in or on the following
commodities: Hog, fat; hog, kidney; hog, liver; hog, meat; hog, meat
byproducts; poultry, fat; poultry, meat; poultry, meat byproducts; and
egg.
Furthermore, in order to conform to current Agency practice, in 40
CFR 180.421, EPA is proposing to revise the tolerance commodity
terminology for ``pecans'' to ``pecan.''
8. Metolachlor. Based on available ruminant feeding data and the
maximum theoretical dietary burden for swine, EPA determined that there
is no reasonable expectation of finite residues of metolachlor and its
metabolites in fat, kidney, liver, meat, and meat byproducts of hogs.
These tolerances are no longer needed under 40 CFR 180.6(a)(3).
Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.368
for the combined residues (free and bound) of the herbicide metolachlor
[2-chloro-N-(2-ethyl-6-methylphenyl)-N-(2-methoxy-1-
methylethyl)acetamide] and its metabolites, determined as the
derivatives, 2-[(2-ethyl-6-methylphenyl)amino]-1-propanol and 4-(2-
ethyl-6-methylphenyl)-2-hydroxy-5- methyl-3-morpholinone, each
expressed as the parent compound, in or on hog, fat; hog, kidney; hog,
liver; hog, meat; and hog, meat byproducts, except kidney and liver.
9. Propiconazole. Based on available poultry metabolism and feeding
data, EPA determined that there is no reasonable expectation of finite
residues of propiconazole and its metabolites (determined as 2,4-
dichlorobenzoic acid) in poultry muscle, liver, fat, and egg samples
from hens fed 10X the maximum theoretical dietary burden for poultry.
These tolerances are no longer needed under 40 CFR 180.6(a)(3).
Therefore, EPA is proposing to revoke tolerances in 40 CFR 180.434 for
the combined residues of the fungicide 1-[[2-(2,4-dichlorophenyl)-4-
propyl-1,3-dioxolan-2-yl] methyl]-1H-1,2,4-triazole and its metabolites
determined as 2,4-dichlorobenzoic acid and expressed as parent compound
in or on poultry, fat; poultry, kidney; poultry, liver; poultry, meat;
poultry, meat byproducts, except kidney and liver; and egg.
10. Sodium acifluorfen. Label restrictions prohibit use of sodium
acifluorfen-treated peanut and soybean forage or hay for feed and
grazing livestock on these treated crops. There is no reasonable
expectation of residues being transferred to livestock commodities via
consumption of feed items derived from crops treated with sodium
acifluorfen according to current use directions. Based on the
registered food/feed use patterns, EPA determined that there is no
reasonable expectation of finite residues of sodium acifluorfen and its
metabolites in kidney and liver of cattle, goats, hogs, horses, and
sheep; fat, meat, and meat byproducts of poultry; eggs, and milk. These
tolerances are no longer needed under 40 CFR 180.6(a)(3). Therefore,
EPA is proposing to revoke the tolerances in 40 CFR 180.383 for
combined residues of the herbicide sodium salt of acifluorfen (sodium
5-[2-chloro-4-trifluoromethyl) phenoxy]-2-nitrobenzoic acid) and its
metabolites (the corresponding acid, methyl ester, and amino analogues)
in or on the following commodities: Cattle, kidney; cattle, liver;
goat, kidney; goat, liver; hog, kidney; hog, liver; horse, kidney;
horse, liver; poultry, fat; poultry, meat; poultry, meat byproducts;
sheep, kidney; sheep, liver; egg; and milk.
11. Thiophanate-methyl. Based on available ruminant and poultry
feeding data, EPA determined that there is no reasonable expectation of
finite residues of thiophanate-methyl, its oxygen analogue, and
benzimidazole metabolites in fat, liver, meat, and meat byproducts of
hogs and poultry. These tolerances are no longer needed under 40 CFR
180.6(a)(3). Therefore, EPA is proposing to revoke the tolerances in 40
CFR 180.371 for residues of the fungicide thiophanate-methyl
(dimethyl[(1,2-phenylene)-bis(iminocarbonothioyl)] bis [carbamate]),
its oxygen analogue dimethyl-4,4-o-phenylene bis(allophonate), and its
benzimidazole-containing metabolites (calculated as thiophanate-methyl)
in or on hog, fat; hog, liver; hog, meat; hog, meat byproducts, except
liver; poultry, fat; poultry, liver; poultry, meat; and poultry, meat
byproducts, except liver.

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.
When EPA establishes tolerances for pesticide residues in or on raw
agricultural commodities, consideration must be given to the possible
residues of those chemicals in meat, milk, poultry, and/or eggs
produced by animals that are fed agricultural products (for example,
grain or hay) containing pesticide residues (40 CFR 180.6). When
considering this possibility, EPA can conclude that:
1. Finite residues will exist in meat, milk, poultry and/or eggs.
2. There is a reasonable expectation that finite residues will
exist.
3. There is a reasonable expectation that finite residues will not
exist. If there is no reasonable expectation of finite pesticide
residues in or on meat, milk, poultry, or eggs, tolerances do not need
to be established for these commodities (40 CFR 180.6(b) and 40 CFR
180.6(c)).
EPA has evaluated the meat, milk, poultry, and egg tolerances
proposed for revocation in this proposed rule and has concluded that
there is no reasonable expectation of finite residues of the listed
pesticide active ingredients in or on those commodities.
Regarding the proposed modification of fenarimol tolerances, EPA is
required to determine wheter each of the amended tolerances meets the
safety standards under the FQPA. A safety finding determination is
found in detail in the August 2002 TRED for fenarimol. An electronic
copy of the TRED for fenarimol is available on EPA's website at http://www.epa.gov/pesticides/reregistration/status.htm
.

[[Page 41994]]

C. When do These Actions Become Effective?

EPA is proposing that these actions become effective on the day of
publication of the final rule in the Federal Register.
The Agency has determined that most of the tolerances herein
proposed for revocation are no longer needed, based on no reasonable
expectation of finite pesticide residues. Therefore, the Agency
believes that this revocation date allows users to continue utilizing
existing pesticide stocks and that commodities treated with these
pesticides in a manner that is lawful under FIFRA will continue to
clear the channels of trade since there is no reasonable expectation of
finite residues. Also, because fenarimol tolerances for liver, when
revised would become duplicates covered by revised ``meat byproduct,
except kidney'' tolerances, they are no longer needed as separate liver
tolerances.
In addition, because the modifications to increase specific
fenarimol tolerances proposed herein are safe, as required by section
408 of FFDCA, the Agency believes that these modifications become
effective on the day of publication of the final rule in the Federal
Register.
If you have comments regarding the effective date, please submit
comments as described under SUPPLEMENTARY INFORMATION.

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 July 2, 2003, EPA has reassessed
over 6,510 tolerances. This document proposes to revoke a total of 105
tolerances, all of which were previously counted as reassessed.
Therefore, none are counted in a final rule 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 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 revoke and modify
specific tolerances 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 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 raising of tolerance levels 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 were published on May 4, 1981 (46 FR 24950)
and on December 17, 1997 (62 FR 66020), respectively, and were provided
to the Chief Counsel for Advocacy of the Small Business Administration.
Taking into account these analyses, and the fact that there is no
reasonable expectation that residues of the pesticides listed in this
proposed rule will be found on the commodities discussed in this
proposed rule (so that the lack of the tolerance could not prevent sale
of the commodity), I certify that this action will not have a
significant economic impact on a substantial number of small entities.
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 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

[[Page 41995]]

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: June 17, 2003.
Martha Monell,
Acting 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.

Sec. 180.153 [Amended]

2. Section 180.153 is amended by removing the entries for cattle,
meat (fat basis) (PRE-S appli) and cattle, meat byproducts (fat basis)
(PRE-S appli) from the table in paragraph (a)(1).

Sec. 180.204 [Amended]

3. Section 180.204 is amended by removing the entries for cattle,
fat; cattle, meat; goat, fat; goat, meat; hog, fat; hog, meat; horse,
fat; horse, meat; poultry, fat; poultry, meat; sheep, fat; and sheep,
meat from the table in paragraph (a), and by also removing from the
table in paragraph (a) the ``(N)'' designation from any entry where it
appears.

Sec. 180.220 [Amended]

4. Section 180.220 is amended by removing the entries for egg; hog,
fat; hog, meat byproducts; hog, meat; poultry, fat; poultry, meat
byproducts; and poultry, meat from the table in paragraph (a)(1).

Sec. 180.254 [Amended]

5. Section 180.254 is amended by removing the entries for cattle,
fat; cattle, meat; cattle, meat byproducts; goat, fat; goat, meat;
goat, meat byproducts; hog, fat; hog, meat; hog, meat byproducts;
horse, fat; horse, meat; horse, meat byproducts; sheep, fat; sheep,
meat; and sheep, meat byproducts from the table in paragraph (a).

Sec. 180.269 [Amended]

6. Section 180.269 is amended by removing the entries for cattle,
fat; cattle, meat byproducts; cattle, meat; goat, fat; goat, meat
byproducts; goat, meat; hog, fat; hog, meat byproducts; hog, meat;
horse, fat; horse, meat byproducts; horse, meat; sheep, fat; sheep,
meat byproducts; sheep, meat; and milk from the table in paragraph (a).
7. Section 180.311 is revised to read as follows:

Sec. 180.311 Cacodylic acid; tolerances for residues.

(a) General. Tolerances are established for residues of the
defoliant cacodylic acid (dimethylarsinic acid), expressed as As2 O3,
in or on the following raw agricultural commodity as follows:

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cotton, undelinted seed.............................. 2.8
------------------------------------------------------------------------

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

Sec. 180.368 [Amended]

8. Section 180.368 is amended by removing the entries for hog, fat;
hog, kidney; hog, liver; hog, meat; and hog, meat byproducts, except
kidney and liver from the table in paragraph (a).

Sec. 180.371 [Amended]

9. Section 180.371 is amended by removing the entries for hog, fat;
hog, liver; hog, meat byproducts, except liver; hog, meat; poultry,
fat; poultry, liver; poultry, meat byproducts, except liver; and
poultry, meat from the table in paragraph (a).
10. Section 180.383 is amended by revising the table in paragraph
(a) to read as follows:

Sec. 180.383 Sodium salt of acifluorfen; tolerances for residues.

(a) * * *

* * * * *
11. Section 180.421 is amended by revising the table in paragraph
(a)(1) to read as follows:

Sec. 180.421 Fenarimol; tolerances for residues.

(a) General. (1) * * *

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Apple................................................ 0.1
Apple, dry pomace.................................... 2.0
Apple, wet pomace.................................... 2.0
Cattle, fat.......................................... 0.1
Cattle, kidney....................................... 0.1
Cattle, meat......................................... 0.01
Cattle, meat byproducts, except kidney............... 0.05
Goat, fat............................................ 0.1
Goat, kidney......................................... 0.1
Goat, meat........................................... 0.01
Goat, meat byproducts, except kidney................. 0.05
Horse, fat........................................... 0.1
Horse, kidney........................................ 0.1
Horse, meat.......................................... 0.01
Horse, meat byproducts, except kidney................ 0.05
Pear................................................. 0.1
Pecan................................................ 0.1
Sheep, fat........................................... 0.1
Sheep, kidney........................................ 0.1
Sheep, meat.......................................... 0.01
Sheep, meat byproducts, except kidney................ 0.05
------------------------------------------------------------------------

* * * * *

[[Page 41996]]

Sec. 180.434 [Amended]

12. Section 180.434 is amended by removing the entries for poultry,
fat; poultry, kidney; poultry, liver; poultry, meat byproducts, except
kidney and liver; poultry, meat; and egg from the table in paragraph
(a).
[FR Doc. 03-17730 Filed 7-15-03; 8:45 am]

BILLING CODE 6560-50-S