[Federal Register Volume 69, Number 28 (Wednesday, February 11, 2004)]
[Rules and Regulations]
[Pages 6561-6567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2956]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0344; FRL-7338-3]


Aldicarb, Atrazine, Cacodylic Acid, Carbofuran, et al.; Tolerance 
Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This final rule revokes specific meat, milk, poultry, and egg 
(MMPE) 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 modifies specific fenarimol tolerances. The regulatory actions 
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: This regulation is effective February 11, 2004. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0344, 
must be received on or before April 12, 2004.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit IV. 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:
     Crop production (NAICS 111)
     Animal production (NAICS 112)
     Food manufacturing (NAICS 311)
     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-2003-0344. 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. 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. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.

II. Background

A. What Action Is the Agency Taking?

    In this final rule, EPA is revoking 105 specific MMPE 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 modifying other 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 these determinations 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, respectively, the Agency declared these 
tolerances as safe and counted

[[Page 6562]]

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 the proposed rule which published in the 
Federal Register of July 16, 2003 (68 FR 41989) (FRL-7301-5), under 
docket number OPP-2003-0092. 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 they can therefore 
be revoked.
    Generally, EPA will proceed with the revocation of these tolerances 
on the grounds discussed in Unit II.A., if one of these conditions 
applies, as follows:
    1. Prior to EPA's issuance of a FFDCA section 408(f) order 
requesting additional data or issuance of a FFDCA section 408(d) or (e) 
order revoking the tolerances on other grounds, commenters retract the 
comment identifying a need for the tolerance to be retained.
    2. EPA independently verifies that the tolerance is no longer 
needed.
    3. The tolerance is not supported by data that demonstrate that the 
tolerance meets the requirements under FQPA.
    This final rule does not revoke those tolerances for which EPA 
received comments stating a need for the tolerance to be retained. In 
the Federal Register of July 16, 2003 (68 FR 41989), EPA issued a 
proposed rule to revoke specific MMPE 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; and to modify specific fenarimol tolerances. Also, the July 16, 
2003, proposal provided a 60-day comment period which invited public 
comment for consideration and for support of tolerance retention under 
the FFDCA standards. In response to the proposal published in the 
Federal Register of July 16, 2003 (68 FR 41989), EPA received two 
comments as follows:
     Comments. An individual from Michigan requested 
that the MMPE tolerances proposed for revocation not be revoked. 
Another individual from New Jersey requested that the aldicarb, 
cacodylic acid, and fenarimol MMPE tolerances proposed for revocation 
not be revoked. Both individuals expressed concern with pesticide use 
in general.
    In addition, Syngenta Crop Protection objected to the revocation of 
poultry and egg tolerances for propiconazole. The Syngenta comment 
expressed a concern that the reregistration process for propiconazole 
might result in a requirement that new studies be conducted and that if 
new studies happen to show propiconazole residues of concern in/on 
these poultry and egg commodities, then tolerances might be needed.
     Agency response. None of the comments addressed 
any of the available feeding studies that EPA reviewed in making its 
determinations that there are no reasonable expectations of finite 
residues for the MMPE tolerances in question. Nor did the comments take 
issue with the Agency's conclusion that the tolerances were no longer 
needed under 40 CFR 180.6. When EPA establishes tolerances for 
pesticide residues in or on raw agricultural commodities, consideration 
must be given to the possible residues of those active ingredients in 
MMPE commodities 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 there 
is a reasonable expectation that finite residues will not exist. Based 
on the available data, EPA made such a determination and believes that 
the tolerances revoked in this final rule are no longer needed.
    Should future data be made available to EPA that shows pesticide 
residues of concern in or on the specific MMPE commodities associated 
with the tolerances revoked herein, then the Agency will evaluate all 
the available data, including the availability of a practicable 
analytical method to determine the pesticide residue. The Agency may 
conclude from such new data that finite residues will actually be 
incurred, or that it is not possible to establish with certainty 
whether finite residues will be incurred, but that there is a 
reasonable expectation of finite residues or no reasonable expectation 
of finite residues (40 CFR 180.6). Should EPA determine that a 
tolerance is needed, the Agency will take appropriate action to 
establish the tolerance.
    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 revoking 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; 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 revoking 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 (cacodylate). Also, available data show that background levels 
of 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 revoking the tolerances in 40 CFR 
180.311 for residues of the defoliant cacodylic acid (dimethylarsinic 
acid), expressed as As2O3, in or on cattle, fat; cattle, kidney; 
cattle, liver; cattle, meat; cattle meat byproducts, except kidney; and 
cattle meat byproducts, except liver.
    In the Federal Register of July 16, 2003 (68 FR 41989), EPA issued 
a rule which proposed the tolerance revocations made in this final 
rule. The July 16, 2003 document proposed to revoke 105 tolerances. The 
proposal was signed on June 17, 2003. Later, in the Federal Register of 
July 1, 2003 (68 FR 39435) (FRL-7316-9), EPA made terminology revisions 
in 40 CFR 180.311 for cacodylic acid which created two tolerances for 
meat byproducts of cattle (cattle, meat byproducts, except kidney and 
cattle, meat byproducts, except liver, both at 0.7 ppm). This specific 
terminology revision was in error. The Agency

[[Page 6563]]

considers the preferred terminology to be one tolerance; i.e. cattle, 
meat byproducts, except kidney and liver. While EPA is revoking both 
tolerances, the Agency will count them as one revocation in a total of 
105 revocations in this final rule.
    In the Federal Register of July 1, 2003 (68 FR 39435), EPA issued a 
final rule that revised specific tolerance nomenclatures, including the 
terminology for ``cottonseed'' to ``cotton, undelinted seed'' in 40 CFR 
180.311, making the proposal in the Federal Register of July 16, 2003 
(68 FR 41989) to revise cottonseed in 40 CFR 180.311 no longer needed.
    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, goat, hog, horse, and sheep. These tolerances are no longer 
needed under 40 CFR 180.6(a)(3). Therefore, EPA is revoking 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 (of which no more than 
0.02 parts per million (ppm) is carbamates); cattle, meat (of which no 
more than 0.02 ppm is carbamates); cattle, meat byproducts (of which no 
more than 0.02 ppm is carbamates); goat, fat (of which no more than 
0.02 ppm is carbamates); goat, meat (of which no more than 0.02 ppm is 
carbamates); goat, meat byproducts (of which no more than 0.02 ppm is 
carbamates); hog, fat (of which no more than 0.02 ppm is carbamates); 
hog, meat (of which no more than 0.02 ppm is carbamates); hog, meat 
byproducts (of which no more than 0.02 ppm is carbamates); horse, fat 
(of which no more than 0.02 ppm is carbamates); horse, meat (of which 
no more than 0.02 ppm is carbamates); horse, meat byproducts (of which 
no more than 0.02 ppm is carbamates); sheep, fat (of which no more than 
0.02 ppm is carbamates); sheep, meat (of which no more than 0.02 ppm is 
carbamates); and sheep, meat byproducts (of which no more than 0.02 ppm 
is carbamates).
    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 revoking the tolerances in 40 CFR 180.153 for 
residues of the insecticide diazinon in or on cattle, meat (fat basis) 
and cattle, meat byproducts (fat basis).
    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 revoking 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, in 40 CFR 180.204, EPA is removing 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 
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 revoking 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 in 40 CFR 180.421, 
EPA is increasing the tolerances for the meat byproducts of cattle, 
goats, horses, and sheep, each from 0.01 to 0.05 ppm, respectively, and 
revising 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, 
respectively.
    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

[[Page 6564]]

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 revoking the tolerance 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 revoking the tolerances in 40 CFR 180.421 for 
residues of the fungicide fenarimol in or on the following commodities: 
Egg; hog, fat; hog, kidney; hog, liver; hog, meat; hog, meat 
byproducts; poultry, fat; poultry, meat; and poultry, meat byproducts.
    Furthermore, in order to conform to current Agency practice, in 40 
CFR 180.421, EPA is revising 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 revoking 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 revoking 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 egg; poultry, fat; poultry, kidney; poultry, liver; poultry, 
meat; and poultry, meat byproducts, except kidney and liver.
    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. As noted in a memorandum 
dated April 21, 2002, available under docket ID number OPP-2003-0092, 
EPA evaluated available ruminant and poultry metabolism data and 
determined that 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 and 
metabolism data, EPA determined that there is no reasonable expectation 
of finite residues of sodium acifluorfen and its metabolites in eggs; 
kidney and liver of cattle, goats, hogs, horses, and sheep; fat, meat, 
and meat byproducts of poultry; and milk. These tolerances are no 
longer needed under 40 CFR 180.6(a)(3). Therefore, EPA is revoking 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; egg; goat, kidney; goat, 
liver; hog, kidney; hog, liver; horse, kidney; horse, liver; milk; 
poultry, fat; poultry, meat; poultry, meat byproducts; sheep, kidney; 
and sheep, liver.
    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 revoking 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?

    When EPA establishes tolerances for pesticide residues in or on raw 
agricultural commodities, the Agency gives consideration to possible 
pesticide residues 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, 
or
    2. There is a reasonable expectation that finite residues will 
exist, or
    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, then tolerances do not need to 
be established for these commodities (40 CFR 180.6(b) and 40 CFR 
180.6(c)). EPA has evaluated specific meat, milk, poultry, and egg 
tolerances in this final rule, concluded that there is no reasonable 
expectation of finite residues of the listed pesticide active 
ingredients in or on those commodities, and is revoking them.
    Regarding the modification of specific fenarimol tolerances, EPA is 
required to determine whether 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.

C. When Do These Actions Become Effective?

    These actions become effective on February 11, 2004. The Agency has 
determined 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, while certain individual liver tolerances for 
fenarimol are revoked, residues in/on liver of cattle, goat, horse, and 
sheep are covered by revised ``meat byproduct, except kidney'' 
tolerances.
    In addition, because the modifications to specific fenarimol 
tolerances increased herein are safe, as required by section 408 of 
FFDCA, the Agency has

[[Page 6565]]

determined that these modifications are effective on February 11, 2004.

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 January 27, 2004, EPA has 
reassessed 6,628 tolerances. In this final rule, EPA is revoking 105 
tolerances. These tolerances were previously reassessed and counted as 
described in Unit II.A.
    In the July 1, 2003 version of 40 CFR 180.311, there are two cattle 
meat byproducts tolerances in the table in paragraph (a). However, when 
converting the text in 40 CFR 180.311 to tabular form, the tolerance 
for meat, fat, and meat byproducts, except kidney and liver, of cattle 
was erroneously published as two seperate entries. Therefore, for 
tolerance reassessment counting purposes, the meat byproducts tolerance 
for cattle was previously counted as one reassessment; i.e., cattle, 
meat byproducts, except kidney and liver.

III. Are There Any International Trade Issues Raised by This Final 
Action?

    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. When possible, EPA seeks 
to harmonize U.S. tolerances with Codex MRLs. EPA may establish a 
tolerance that is different from a Codex MRL; however, FFDCA section 
408(b)(4) requires that EPA explain in a Federal Register document the 
reasons for departing from the Codex level. EPA's effort to harmonize 
with Codex MRLs is summarized in the tolerance reassessment section of 
individual REDs. The 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. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
FFDCA by FQPA, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a regulation for an exemption from 
the requirement of a tolerance issued by EPA under new section 408(d) 
of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need To Do To File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0344 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before April 12, 
2004.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit IV.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2003-0344, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and

[[Page 6566]]

hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 
or ASCII file format. Do not include any CBI in your electronic copy. 
You may also submit an electronic copy of your request at many Federal 
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

V. Statutory and Executive Order Reviews

    This final rule revokes and modifies tolerances established under 
section 408 of FFDCA. 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 rule 
has been exempted from review under Executive Order 12866 due to its 
lack of significance, this 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 final 
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 
final rule will be found on the commodities discussed in this final 
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, 
the Agency knows of no extraordinary circumstances that exist as to the 
present revocations that would change EPA's previous analysis. 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 final 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 FFDCA. For these same reasons, the Agency has 
determined that this 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 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 rule.

VI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: January 21, 2004.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR Chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

[[Page 6567]]

Sec. 180.153  [Amended]

0
2. Section 180.153 is amended by removing the entries for cattle, meat 
(fat basis) and cattle, meat byproducts (fat basis) from the table in 
paragraph (a)(1).


Sec. 180.204  [Amended]

0
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]

0
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]

0
5. Section 180.254 is amended by removing the entries for cattle, fat 
(of which no more than 0.02 ppm is carbamates); cattle, meat (of which 
no more than 0.02 ppm is carbamates); cattle, meat byproducts (of which 
no more than 0.02 ppm is carbamates); goat, fat (of which no more than 
0.02 ppm is carbamates); goat, meat (of which no more than 0.02 ppm is 
carbamates); goat, meat byproducts (of which no more than 0.02 ppm is 
carbamates); hog, fat (of which no more than 0.02 ppm is carbamates); 
hog, meat (of which no more than 0.02 ppm is carbamates); hog, meat 
byproducts (of which no more than 0.02 ppm is carbamates); horse, fat 
(of which no more than 0.02 ppm is carbamates); horse, meat (of which 
no more than 0.02 ppm is carbamates); horse, meat byproducts (of which 
no more than 0.02 ppm is carbamates); sheep, fat (of which no more than 
0.02 ppm is carbamates); sheep, meat (of which no more than 0.02 ppm is 
carbamates); and sheep, meat byproducts (of which no more than 0.02 ppm 
is carbamates) from the table in paragraph (a).


Sec. 180.269  [Amended]

0
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; milk; sheep, fat; 
sheep, meat byproducts; and sheep, meat from the table in paragraph 
(a).
0
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 As2O3, 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]

0
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)(1).


Sec. 180.371  [Amended]

0
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).
0
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) * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Peanut...............................................                0.1
Rice, grain..........................................                0.1
Rice, straw..........................................                0.1
Soybean..............................................                0.1
Strawberry...........................................               0.05
------------------------------------------------------------------------

* * * * *
0
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) * * * (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
------------------------------------------------------------------------

* * * * *


Sec. 180.434  [Amended]

0
12. Section 180.434 is amended by removing the entries for egg; 
poultry, fat; poultry, kidney; poultry, liver; poultry, meat 
byproducts, except kidney and liver; and poultry, meat; from the table 
in paragraph (a).
[FR Doc. 04-2956 Filed 2-10-04; 8:45 am]
BILLING CODE 6560-50-S