FR Doc E6-15471

[Federal Register: September 20, 2006 (Volume 71, Number 182)]
[Proposed Rules]
[Page 54953-54965]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se06-30]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0483; FRL-8078-2]

Chlorpropham, Linuron, Pebulate, Asulam, and Thiophanate-methyl;
Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke certain tolerances for the
herbicides linuron and pebulate and the fungicide thiophanate-methyl.
Also, EPA is proposing to modify certain tolerances for the herbicides
chlorpropham, linuron, asulam and the fungicide thiophanate-methyl. In
addition, EPA is proposing to establish new tolerances for the
herbicides chlorpropham, linuron, asulam, and the fungicide
thiophanate-methyl. The regulatory actions proposed in this document
are part of the Agency's reregistration program under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA).

DATES: Comments must be received on or before November 20, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0483, by one of the following methods:
Federal eRulemaking Portal:http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.); 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0483. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information -unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. 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. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Drive,
Arlington, VA. The hours of operation for this docket facility are from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The docket facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Jane Smith, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave, NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0048; e-mail
address:smith.jane-scott@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:
Crop production (NAICS code 111)
Animal production (NAICS code 112)
Food manufacturing (NAICS code 311)
Pesticide manufacturing (NAICS code 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

[[Page 54954]]

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

1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the

information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, 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 claimed as CBI. In addition to one
complete version of the comment that includes 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.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.

C. 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 will issue 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, modify, and establish specific
tolerances for residues of the herbicides chlorpropham, linuron,
pebulate, and asulam and the fungicide thiophanate-methyl in or on
commodities listed in the regulatory text.
EPA is proposing these tolerance actions to implement the tolerance
recommendations made during the reregistration and tolerance
reassessment processes (including follow-up on canceled or additional
uses of pesticides). As part of these processes, EPA is required to
determine whether each of the amended tolerances meets the safety
standard of the FQPA. The safety finding determination of ``reasonable
certainty of no harm'' is discussed in detail in each RED and Report of
the FQPA TRED for the active ingredient. REDs and TREDs recommend the
implementation of certain tolerance actions, including modifications to
reflect current use patterns, meet safety findings, and change
commodity names and groupings in accordance with new EPA policy.
Printed copies of many REDs and TREDs may be obtained from EPA's
National Service Center for Environmental Publications (EPA/NSCEP),
P.O. Box 42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198;
fax 1-513-489-8695; internet at http://www.epa.gov/ncepihom/ and from

the National Technical Information Service (NTIS), 5285 Port Royal
Road, Springfield, VA 22161, telephone 1-800-553-6847 or 703-605-6000,
internet at http://www.ntis.gov Electronic copies of REDs and TREDs are available on the internet at http://www.epa.gov/pesticides/.

reregistration/status.htm and chlorpropham in docket number EPA-HQ-OPP-
2002-0180, asulam in docket number EPA-HQ-OPP-2002-0329, linuron in
docket number EPA-HQ-OPP-2002-0079, and thiophanate-methyl in dockets
EPA-HQ-OPP-2002-0140, and EPA-HQ-OPP-2002-0265.
The selection of an individual tolerance level is based on crop
field residue studies designed to produce the maximum residues under
the existing or proposed product label. Generally, the level selected
for a tolerance is a value slightly above the maximum residue found in
such studies. The evaluation of whether a tolerance is safe is a
separate inquiry. EPArecommends the raising of a tolerance when data
show that: 1. Lawful use (sometimes through a label change) may result
in a higher residue level on the commodity; and 2. the tolerance
remains safe, notwithstanding increased residue level allowed under the
tolerance.
In REDs, Chapter IV on ``Risk management, Reregistration, and
Tolerance Reassessment'' typically describes the regulatory position,
FQPA assessment, cumulative safety determination, determination of
safety for U.S. general population, and safety for infants and
children. In particular, the human health risk assessment document
which supports the RED describes risk exposure estimates and whether
the Agency has concerns. In TREDs, the Agency discusses its evaluation
of the dietary risk associated with the active ingredient and whether
it can determine that there is a reasonable certainty (with appropriate
mitigation) that no harm to any population subgroup will result from
aggregate exposure.
Explanations for proposed modifications in tolerances can be found
in the RED and TRED document and in more detail in the Residue
Chemistry Chapter document which supports the RED and TRED. Copies of
the Residue Chemistry Chapter documents are found in the Administrative
Record and are available electronically through EPA's electronic public
docket and comment system, regulations.gov at http://www.regulations.gov.
You may search

[[Page 54955]]

for this proposed rule and for pebulate under docket number EPA-HQ-OPP-
2006-0483, or for an individual chemical under its respective docket
number, then click on that docket number to view its contents.
The aggregate exposures and risks are not of concern for the above-
mentioned pesticide active ingredients based upon the data identified
in the RED or TRED which lists the submitted studies that the Agency
found acceptable.
EPA has found that the tolerances that are proposed in this
document to be established or modified, are safe, i.e., that there is a
reasonable certainty that no harm will result to infants and children
from aggregate exposure to the pesticide chemical residues, in
accordance with section 408(b)(2)(C). (Note that changes to tolerance
nomenclature do not constitute modifications of tolerances). These
findings are discussed in detail in each RED or TRED. The references
are available for inspection as described in this document under
SUPPLEMENTARY INFORMATION.
In addition, EPA is proposing to revoke certain specific tolerances
because either they are no longer needed or are associated with food
uses that are no longer registered under FIFRA. Those instances where
registrations were canceled were because the registrant failed to pay
the required maintenance fee and/or the registrant voluntarily canceled
one or more registered uses of the pesticide. It is EPA's general
practice to propose revocation of those tolerances for residues of
pesticide active ingredients on crop uses for which there are no active
registrations under FIFRA, unless any person in comments on the
proposal indicates a need for the tolerance to cover residues in or on
imported commodities or domestic commodities legally treated.
1. Chlorpropham. A plant commodity tolerance on postharvest potato
for chlorpropham is currently regulated for residues of CIPC (isopropyl
m-chlorocarbanilate) and its metabolite 1-hydroxy-2-propyl 3'-
chlorocarbanilate (calculated as CIPC) in 40 CFR 180.181. Because the
regulated metabolite was not detected in potato following treatment
with radiolabelled ¹⁴C-chlorpropham, EPA determined that the
tolerance expression for plants should be expressed in terms of
chlorpropham per se. Meanwhile, the current interim milk and livestock
tolerances in 40 CFR 180.319 are regulated for isopropyl m-
chlorocarbanilate (CIPC) residues. However, based on available ruminant
data that show residues of chlorpropham and its metabolite 4-
hydroxychlorpropham-O-sulfonic acid (4-HSA) in milk and edible tissues,
EPA determined that the tolerance expression should be expressed in
terms of the combined residues of chlorpropham and 4-
hydroxychlorpropham-O-sulfonic acid (4-HSA) and recodified under 40 CFR
180.181 as permanent tolerances. Therefore, EPA is proposing to
recodify plant tolerances for chlorpropham from 40 CFR 180.181(a) to
(a)(1), and regulate tolerances there for residues of the plant
regulator and herbicide chlorpropham (isopropyl m-chlorocarbanilate).
Also, EPA is proposing to remove the interim milk and livestock
tolerances (meat, fat, and meat byproducts of cattle, hog, horse, and
sheep) for chlorpropham (isopropyl m-chlorocarbanilate) in 40 CFR
180.319, recodify them as permanent tolerances in 40 CFR 180.181(a)(2),
and regulate tolerances there for the combined residues of the plant
regulator and herbicide chlorpropham (isopropyl m-chlorocarbaniliate
(CIPC)) and its metabolite 4-hydroxychlorpropham-O-sulfonic acid (4-
HSA).
In addition, based on ruminant feeding data and the calculated
maximum theoretical dietary burden (MTDB) estimates, EPA determined
that tolerances on the meat of cattle, hog, horse and sheep should be
increased in 40 CFR 180.181(a)(2) from 0.05 to 0.06 ppm, the limit of
quantitation (LOQ), and a tolerance for goat meat should be established
at 0.06 ppm. Also, based on exaggerated feeding study data that showed
combined residues of concern in kidney at about 0.3 ppm, the Agency
determined that tolerances for kidney of cattle, hog, horse, and sheep
should be separated from their existing meat byproduct tolerances at
0.05 ppm and in 40 CFR 180.181(a)(2) increased to 0.30 ppm, and a
tolerance for goat kidney should be established at 0.30 ppm. However,
because combined residues of concern in liver were shown to be near the
LOQ (0.06 ppm), the Agency determined that tolerances for meat
byproduct, except kidney of cattle, hog, horse, and sheep should be
increased in 40 CFR 180.181(a)(2) from 0.05 to 0.06 pm, and a tolerance
for goat, meat byproducts, except kidney should be established at 0.06
ppm. In addition, based on ruminant feeding data that showed combined
residues of concern in fat at 0.17 ppm, the Agency determined that
tolerances for the fat of cattle, hog, horse, and sheep should be
increased from 0.05 to 0.20 ppm, and a tolerance for goat fat should be
established at 0.20 ppm. Moreover, based on ruminant feeding data and
the MTDB estimates that showed combined residues of concern to be 0.25
ppm, the Agency determined that the tolerance for milk should be
increased from 0.05 to 0.30 ppm. Therefore, EPA is proposing to
increase tolerances in newly recodified 40 CFR 180.181(a)(2) for the
combined residues of chlorpropham and 4-hydroxychlorpropham-O-sulfonic
acid (4-HSA) as follows: Milk from 0.05 to 0.30 ppm; cattle, fat; hog,
fat; horse, fat; and sheep, fat from 0.05 to 0.20 ppm; cattle, meat;
hog, meat; horse, meat; and sheep, meat from 0.05 to 0.06 ppm; cattle,
meat byproducts, except kidney; hog, meat byproducts, except kidney;
horse, meat byproducts, except kidney; and sheep, meat byproducts,
except kidney from 0.05 to 0.06 ppm, and cattle, kidney; hog, kidney;
horse, kidney; and sheep, kidney from 0.05 to 0.30 ppm. The Agency
determined that the increased tolerances are safe; i.e., there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue.
Also, EPA is proposing to establish tolerances in newly recodified
40 CFR 180.181(a)(2) for the combined residues of chlorpropham and 4-
hydroxychlorpropham-O-sulfonic acid (4-HSA) as follows: Goat, fat at
0.20 ppm; goat, kidney at 0.30 ppm; goat, meat at 0.06 ppm; and goat,
meat byproducts,except kidney at 0.06 ppm.
Based on available potato field trial data that show residues of
chlorpropham as high as 24.0 ppm, the Agency determined that the
tolerance in newly recodified 40 CFR 180.181(a)(1) should be decreased
from 50.0 to 30.0 ppm. Therefore, EPA is proposing to decrease the
tolerance in newly recodified 40 CFR 180.181(a)(1) on potato,
postharvest from 50.0 to 30.0 ppm.
Based on an available potato processing data that show an average
concentration factor of chlorpropham residues at 3x and a highest
average field trial (HAFT) whole potato residue of 12.0 ppm, the Agency
determined that residues would be 36 ppm and a tolerance should be
established on potato, wet peel at 40 ppm. (Residues did not
concentrate in potato granules, flakes, or chips). Therefore, EPA is
proposing to establish a tolerance in newly recodified 40 CFR
180.181(a)(1) on potato, wet peel at 40.0 ppm.
Since the chlorpropham TRED, the spinach tolerance in 40 CFR
180.319 was revoked by final rule published in the Federal Register on
July 23, 2004 (69 FR 43918) (FRL-7358-6), which included tolerance
actions on a number

[[Page 54956]]

of pesticide active ingredients including chlorpropham.
2. Linuron. According to the TRED, the tolerance expression, which
is currently expressed as ``residues of the herbicide linuron (3-(3,4-
dichlorophenyl)-1-methoxy-1-methylurea)'' in 40 CFR 180.184(a) and (c),
should be modified to include metabolites that can be converted to 3,4-
dichloroaniline that are of toxicological concern. Consequently, EPA is
proposing the tolerance expression in 40 CFR 180.184(a) and (c) read as
follows:
(a) General. Tolerances are established for the combined residues
of the herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-
methylurea) and its metabolites convertible to 3,4-dichloroaniline,
calculated as linuron, in or on the following food commodities:
* * * * *
(c) Tolerances with regional registrations. Tolerances with
regional registrations, as defined in Sec. 180.1(n), are established
for the combined residues of the herbicide linuron (3-(3,4-
dichlorophenyl)-1-methoxy-1-methylurea) and its metabolites convertible
to 3,4-dichloroaniline, calculated as linuron, in or on the following
food commodities:
The feeding of treated soybean forage or hay to livestock is
prohibited as stated on registration labels and therefore the
tolerances are no longer needed. Consequently, EPA is proposing to
revoke the tolerances in 40 CFR 180.184(a) for residues of the
herbicide linuron and its metabolites convertible to 3,4-
dichloroaniline, calculated as linuron, in or on soybean, forage and
soybean, hay.
Based on field trial data that indicate linuron residues of concern
in or on field corn stover are as high as 5.5 ppm, the Agency
determined that a tolerance of 6.0 ppm is appropriate. Therefore, EPA
is proposing to increase the tolerance in 40 CFR 180.184(a) for
residues of the herbicide linuron and its metabolites convertible to
3,4-dichloroaniline, calculated as linuron, in or on corn, field,
stover from 1.0 to 6.0 ppm. The Agency determined that the increased
tolerance is safe; i.e., there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue.
In order to conform to current Agency practice, EPA is proposing to
revise the commodity terminology in 40 CFR 180.184 for corn, grain
(inc. pop) at 0.25 ppm into corn, field, grain and corn, pop, grain.
However, because there are no active U.S. registrations for linuron
residues of concern on popcorn, and therefore a tolerance is no longer
needed, EPA is proposing to revoke the newly revised tolerance in 40
CFR 180.184(a) on corn, pop, grain. In addition, based on field trial
data that indicate linuron residues of concern in or on corn grain as
high as 0.06 ppm, the Agency determined that the corn, field, grain
tolerance should be decreased from 0.25 to 0.1 ppm. Therefore, EPA is
proposing to decrease the newly revised tolerance in 40 CFR 180.184(a)
for the combined residues of the linuron and its metabolites
convertible to 3,4-dichloroaniline, calculated as linuron, in or on
corn, field, grain from 0.25 to 0.1 ppm.
Ruminant feeding data at an exaggerated level (6.9x) show that
linuron residues of concern expected at a 1x feeding level are 0.16 ppm
in fat, 0.07 ppm in meat, 1.9 ppm in liver and kidney, and 0.05 ppm
(LOQ) in milk. Based on these expected residue levels, the Agency
determined that the fat tolerances of cattle, goat, horse and sheep
should be decreased from 1.0 to 0.2 ppm; meat tolerances of cattle,
goat, horse and sheep should be decreased from 1.0 to 0.1 ppm; meat
byproduct tolerances of cattle, goat, horse, and sheep should be
separated into tolerances for meat byproducts, except kidney and liver,
and decreased from 1.0 to 0.1 ppm, kidney of cattle, goat, horse, and
sheep, which should be established separately and increased from 1.0 to
2.0 ppm, and liver of cattle, goat, horse, and sheep, which should be
established separately and increased from 1.0 to 2.0 ppm; and a
tolerance for milk should be established at 0.05 ppm. Therefore, EPA is
proposing to decrease tolerances from 1.0 ppm in 40 CFR 180.184(a) to
the following: Cattle, fat; goat, fat; horse, fat; and sheep, fat; each
at 0.2 ppm; cattle, meat; cattle, meat byproducts, except kidney and
liver; goat, meat; goat, meat byproducts, except kidney and liver;
horse, meat; horse, meat byproducts, except, kidney and liver; sheep,
meat and sheep, meat byproducts, except kidney and liver; each at 0.1
ppm. Also, EPA is proposing to established separate tolerances and
increase them from 1.0 in 40 CFR 180.184(a) as follows: Cattle, kidney;
cattle, liver; goat, kidney; goat, liver; horse, kidney; horse, liver;
sheep, kidney; and sheep, liver; each at 2.0 ppm. In addition, EPA is
proposing to establish a tolerance in 40 CFR 180.184(a) on milk at 0.05
ppm. The Agency determined that the increased tolerances are safe;
i.e., there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue.
Based on ruminant feeding data and an estimated dietary burden in
swine that is much less than that for beef and dairy cattle, the Agency
calculated likely linuron residues of concern to be 0.007 ppm in hog
fat, 0.003 ppm in hog meat, and 0.08 ppm in hog liver and kidney, and
therefore tolerances should be decreased from 1.0 ppm to 0.05 ppm, 0.05
ppm, and 0.1 ppm for hog fat, meat, and meat byproducts, respectively.
Therefore, EPA is proposing to decrease tolerances in 40 CFR 180.184(a)
for the combined residues of linuron and its metabolites convertible to
3,4-dichloroaniline, calculated as linuron, in or on hog, fat and hog,
meat from 1.0 to 0.05 ppm; and hog, meat byproducts from 1.0 to 0.1
ppm.
Based on field trial data, the Agency determined that linuron
residues of concern were non-detectable (< 0.05 ppm) in or on parsnips.
Therefore, EPA is proposing to decrease the tolerance in 40 CFR
180.184(a) for the combined residues of linuron and its metabolites
convertible to 3,4-dichloroaniline, calculated as linuron, in or on
parsnip (with or without tops) from 0.5 to 0.05 ppm and revise the
commodity terminology into parsnip, roots and parsnip, tops.
The Linuron TRED reassessed the tolerance on cottonseed and
recommended that it should be decreased from 0.25 to 0.05 ppm and be
recodified from 40 CFR 80.184(a) to (c) as a regional tolerance, with
use restricted to east of the Rocky Mountains. Since completion of the
Linuron TRED, EPA has reviewed additional cotton field trial data from
all cotton growing regions of the U.S. that indicate linuron residues
of concern ranged from < 0.05 to 0.244 ppm in or on undelinted
cottonseed and that linuron did not concentrate in the processed
fractions of cottonseed (meal, refined oil, and hulls). The Agency
determined that the number of cottonseed field trials met geographical
representation guidelines in accordance with OPPTS Harmonized Guideline
860.1500 (which is available at http://www.epa.gov/opptsfrs/publications/
[fxsp0]OPPTS--Harmonized/860--Residue--Chemistry--

[fxsp0]Test--Guidelines/Series/) for use of linuron on cotton both east
and west of the Rocky Mountains. Based on these data, the Agency
determined that the current tolerance for cotton, undelinted seed at
0.25 ppm is appropriate and should be maintained in 40 CFR 180.184(a),
and separate tolerances are not needed on cotton meal, refined oil and
hulls.
Since completion of the Linuron TRED, the registrant has adequately

[[Page 54957]]

responded to the deficiencies for cotton gin byproducts and has
provided sufficient information with regard to the type of equipment
used for harvesting the cotton commodities as well as justification for
hand harvesting some cotton gin byproduct samples. Based on more recent
cotton storage stability and field trial data reflecting all cotton
growing regions of the U.S. submitted in response to the TRED that show
linuron residues of concern in or on stripper cotton gin byproducts as
high as 3.32 ppm, the Agency determined that a tolerance should be
established for cotton gin byproducts in 40 CFR 180.184(a) at 5.0 ppm.
Therefore, EPA is proposing to establish a tolerance in 40 CFR
180.184(a) for the combined residues of linuron and its metabolites
convertible to 3,4-dichloroaniline, calculated as linuron, in or on
cotton, gin byproducts at 5.0 ppm.
Because use of linuron on potatoes and celery is restricted to east
of the Rocky Mountains, and use on wheat is restricted to the states of
Idaho, Oregon, and Washington, the Agency determined that tolerances on
celery, potato, and the forage, grain, hay, and straw of wheat should
be recodified as regional registrations. Also, based on field trial
data that indicate linuron residues of concern were as high as 0.42 ppm
in or on celery, nondetectable (< 0.05 ppm) in or on all but one sample
(0.07 ppm) of potato, < 0.03 ppm in or on wheat grain, and as high as
2.0 ppm in or on wheat straw, the Agency determined that the tolerance
should remain at 0.5 ppm on celery, be decreased from 1.0 to 0.2 ppm on
potato and 0.25 to 0.05 ppm on wheat, grain, and increased from 0.5 to
2.0 ppm on wheat straw. However, while tolerances for wheat forage and
hay have been reassessed, additional data are anticipated in 2007 in
response to the 2002 Linuron TRED. Therefore, EPA is proposing to
recodify tolerances on celery, potato, and the forage, grain, hay, and
straw of wheat from 40 CFR 180.184(a) to (c) and maintain or modify
their tolerance levels for combined residues of linuron and its
metabolites convertible to 3,4-dichloroaniline, calculated as linuron,
as follows: Celery; wheat, forage; and wheat, hay; each maintained at
0.5 ppm; potato decreased from 1.0 to 0.2 ppm; wheat, grain decreased
from 0.25 to 0.05 ppm; and wheat, straw increased from 0.5 to 2.0 ppm.
The Agency determined that the increased tolerance is safe; i.e. there
is a reasonable certainty that no harm will result from aggregate
exposure to the pesticide chemical residue.
Interregional Research Project number 4 (IR-4) has submitted
petitions (PP 8E5027 and PP 8E5028) requesting the establishment of
tolerances on celeriac and rhubarb based on use directions and data
translated from carrots and celery, respectively. Based on field trial
data that show linuron residues of concern for carrot samples treated
at 0.75x were as high as 0.56 ppm and celery samples treated at 1x were
as high as 0.42 ppm, the Agency determined that tolerances should be
established at 1.0 ppm on celeriac and 0.5 ppm on rhubarb. Therefore,
EPA is proposing to establish tolerances in 40 CFR 180.184(a) for the
combined residues of linuron and its metabolites convertible to 3,4-
dichloroaniline, calculated as linuron, in or on celeriac at 1.0 ppm
and rhubarb at 0.5 ppm.
Although additional data are anticipated in 2007 in response to the
TRED, tolerances associated with sorghum and sweet corn have been
reassessed at the current tolerance levels. The Agency determined that
the tolerances are safe; i.e. there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue. EPA is proposing to maintain the tolerance and revise
commodity terminology in 40 CFR 180.184(a) to conform to current Agency
practice as follows: ``Sorghum, forage'' to ``sorghum, grain, forage''
at 1.0 ppm; ``corn, fresh (inc. kernel plus cob with husks removed)''
to ``corn, sweet, kernel plus cob with husks removed'' at 0.25 ppm; and
``soybean, (dry or succulent)'' to ``soybean, seed'' at 1.0 ppm and
``soybean, vegetable'' at 1.0 ppm.
3. Pebulate. The last U.S. registration for the pesticide active
ingredient pebulate (S-propyl butylethylthiocarbamate) was canceled on
October 24, 2003, due to non-payment of registration fees and a notice
was published in the Federal Register on November 6, 2003 (68 FR 62785)
(FRL-7331-3). Therefore, the tolerances are no longer needed and EPA is
proposing to revoke the tolerances in 40 CFR 180.238 for residues of S-
propyl butylethylthiocarbamate in or on beet, sugar, roots; beet,
sugar, tops; and tomato.
4. Asulam. The tolerance expression in 40 CFR 180.360 currently
regulates asulam (methyl sulfanilylcarbamate) per se. Because an
adequate enforcement method is available for the determination of
combined residues of asulam and all metabolites containing the
sulfanilamide moiety, the Agency recommended in the asulam TRED that
the tolerance expression be revised to include metabolites containing
the sulfanilamide moiety. Therefore, EPA is proposing the tolerance
expression in 40 CFR 180.360 read as follows:
``(a) General. Tolerances are established for the combined residues
of asulam (methyl sulfanilylcarbamate) and its metabolites containing
the sulfanilamide moiety in or on the following food commodities:''
Based on sugarcane field trial data that showed asulam residues of
concern as high as 0.213 ppm and a correction for a 70% loss of
residues during storage, the Agency calculated that maximum residues
should be 0.71 ppm and determined that the tolerance on sugarcane
should be increased from 0.1 to 1.0 ppm. Therefore, EPA is proposing to
increase the tolerance in 40 CFR 180.360(a) for the combined residues
of asulam and its metabolites containing the sulfanilamide moiety in or
on sugarcane, cane from 0.1 to 1.0 ppm. The Agency determined that the
increased tolerance is safe; i.e. there is a reasonable certainty that
no harm will result from aggregate exposure to the pesticide chemical
residue.
Based on an available sugarcane processing data that show an
average concentration factor of asulam residues at 48x and a HAFT
residue value that when corrected for a 70% loss in storage is expected
to be 0.557 ppm (0.167 ppm/0.3), the Agency calculated that residues
would be about 26.7 ppm and determined that a tolerance should be
established on sugarcane, molasses at 30.0 ppm. Therefore, EPA is
proposing to establish a tolerance in 40 CFR 180.360(a) for the
combined residues of asulam and its metabolites containing the
sulfanilamide moiety in or on sugarcane, molasses at 30 ppm.
Based on a 1.2x exaggerated feeding data, animal metabolism data,
and a ruminant diet of containing 10% molasses, a livestock feed item,
the Agency determined that because the anticipated residues of asulam
and sulfanilamide containing metabolites in milk are < 0.025 ppm, in or
on fat, liver, and muscle are < 0.05 ppm, and kidney is 0.12 ppm, that
tolerances should be established in milk, and on the fat and meat of
cattle, goats, hogs, horses, and sheep at 0.05 ppm, and meat byproducts
of cattle, goats, hogs, horses, and sheep at 0.2 ppm. Therefore, EPA is
proposing to establish tolerances in 40 CFR 180.360(a) for the combined
residues of asulam and its metabolites containing the sulfanilamide
moiety in or on commodities, as follows: Cattle, fat; cattle, meat;
goat, fat; goat, meat; hog, fat; hog, meat; horse, fat; horse, meat;
sheep, fat; and sheep, meat at 0.05 ppm; and cattle, meat byproducts;
goat, meat byproducts; hog, meat byproducts; horse, meat byproducts;
and sheep meat

[[Page 54958]]

byproducts at 0.2 ppm; and milk at 0.05 ppm.
5. Thiophanate-methyl. Currently, the tolerances for thiophanate-
methyl are expressed in 40 CFR 180.371(a) in terms of 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); and in 180.371(b) and (c) in terms
of thiophanate-methyl and its metabolite methyl 2-benzimidazoyl
carbamate (MBC). However, the Agency no longer considers the metabolite
allophanate to be a residue of concern and has determined that residues
of concern for plant and animal commodities for tolerance enforcement
consists of the parent and its metabolite methyl 2-benzimidazoyl
carbamate. Therefore, EPA is proposing to amend the tolerance
expression in 40 CFR 180.371(a), (b) and (c) so as to regulate
tolerances for the combined residues of thiophanate-methyl (dimethyl
[(1,2-phenylene) bis(iminocarbonothioyl)] bis(carbamate)) and its
metabolite methyl 2-benzimidazoyl carbamate, calculated as thiophanate-
methyl, in or on food commodities.
CODEX alimentarius commission maximum residues limits (MRLs) for
thiophanate-methyl are currently expressed as methyl 2-benzimidazoyl
carbamate (carbendazim), which is incompatible with the revised U.S.
tolerance definition that will include both thiophanate-methyl and
methyl 2-benzimidazoyl carbamate. EPA has determined that residues of
concern for plant and animal commodities for tolerance enforcement
consists of the parent and its metabolite methyl 2-benzimidazoyl
carbamate based on the metabolism of thiophanate-methyl in/on apples,
sugar beets, wheat, lima beans, and in ruminants and poultry.
EPA no longer considers dry apple pomace, banana pulp, bean forage
and hay, and peanut forage to be significant animal feed items, and
therefore, tolerances are no longer needed. (A listing of significant
food and feed commodities is found in Table 1. - Raw Agricultural and
Processed Commodities and Feedstuffs Derived from Crops of the Residue
Chemistry Test Guideline OPPTS 860.1000 dated August 1996, available at
http://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/860_Residue_
[fxsp0]Chemistry--Test--[fxsp0]Guidelines/Series/). Currently,

there is a tolerance in 40 CFR 180.371 on peanut (forage and hay).
Based on field trial data that show thiophanate-methyl residues of
concern as high as 3.76 ppm, the Agency determined that the tolerance
on peanut hay should be decreased from 15.0 to 5.0 ppm. In addition,
thiophanate-methyl registrations were approved by EPA to be amended to
delete use on celery by request of the registrant in 1997. Therefore,
EPA is proposing to revoke the tolerances in 40 CFR 180.371(a) on
apple, dry pomace; banana, pulp; bean (forage and hay), and celery, and
revise the commodity terminology from peanut (forage and hay) into
separate tolerances for peanut, forage and peanut, hay, and revoke
peanut forage, and decrease peanut, hay from 15.0 to 5.0 ppm.
Based on available exaggerated (10x) poultry feeding data, EPA
determined that there is no reasonable expectation of finite
thiophanate-methyl residues of concern in poultry commodities and
therefore, the tolerance for egg (the only existing poultry commodity
tolerance) is no longer needed under 40 CFR 180.6(a)(3). Therefore, EPA
is proposing to revoke the tolerance in 40 CFR 180.371 for egg.
Based on the available ruminant feeding study, the Agency
determined that thiophanate-methyl residues of concern in milk and
animal tissues were at the combined Limit of Quantitions (LOQs) and
therefore the tolerances for the fat and meat of cattle, goat, horse,
and sheep should be increased from 0.10 (N) to 0.15 ppm, meat
byproducts, except kidney and liver of cattle, goat, and sheep should
be increased from 0.10 (N) to 0.15 ppm, meat byproducts, except liver
of horse should be increased from 0.10 (N) to 0.15 ppm, and kidney of
cattle, goat, and sheep should be decreased from 0.2 to 0.15 ppm, and
therefore the separate meat byproduct tolerances should be combined at
0.15 ppm for cattle, goat, horse, and sheep, and milk from 1.0 to 0.15
ppm, and milk decreased from 1.0 to 0.15 ppm. Consequently, EPA is
proposing to remove the ``(N)'' designation from all entries in 40 CFR
180.371 to conform to current Agency administrative practice (``(N)''
designation means negligible residues), and to increase the tolerances
in 40 CFR 180.371 for the combined residues of thophanate-methyl and
methyl 2-benzimidazoyl carbamate in or on cattle, fat; cattle, meat;
goat, fat; goat, meat; horse, fat; horse, meat; sheep, fat; and sheep,
meat from 0.1(N) to 0.15 ppm, and remove individual meat byproduct
commodity tolerances of a given animal and combine them into a single
tolerance for meat byproducts for that animal in 40 CFR 180.371 for the
combined residues of thiophanate-methyl and methyl 2-benzimidazoyl
carbamate in or on the cattle, meat byproducts; goat, meat byproducts;
horse, meat byproducts; and sheep, meat byproducts at 0.15 ppm, and
decrease milk from from 1.0 to 0.15 ppm. The Agency determined that the
increased tolerances are safe; i.e. there is a reasonable certainty
that no harm will result from aggregate exposure to the pesticide
chemical residue.
Based on field trial data that show thiophanate-methyl residues of
concern as high as 16.25 ppm in or on tart and sweet cherries, 6.22 ppm
on strawberries, less than the LOQ (< 0.1 ppm) on wheat, the Agency
determined that the tolerances should be increased on cherries from
15.0 to 20.0 ppm, on strawberries from 5.0 to 7.0 ppm, and on wheat
grain from 0.05 to 0.1 ppm. Therefore, EPA is proposing to increase the
tolerances in 40 CFR 180.371(a) for the combined residues of
thiophanate-methyl and methyl 2-benzimidazoyl carbamate in or on
cherry, postharvest from 15.0 to 20.0 ppm, strawberry from 5.0 to 7.0
ppm, and on wheat, grain from 0.05 to 0.1 ppm. The Agency determined
that the increased tolerances are safe; i.e. there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue.
Crop field trials conducted in North Dakota on canola seed samples
in 2001 demonstrate the combined residues thiophanate-methyl and methyl
2-benzimidazoyl carbamate were below the LOQ (< 0.14 ppm) at the 1x rate
of application (1.4 lb ai/acre) after 38 days. These data indicate the
tolerance on canola seeds should be increased from 0.1 to 0.2 ppm with
a regional registration restricted to Minnesota, North Dakota, and
Montana (East of Interstate 15). Therefore, EPA is proposing to
increase a tolerance in 40 CFR 180.371(c) for the combined residues of
thiophanate-methyl and methyl 2-benzimidazoyl carbamate in or on
canola, seed from 0.1 to 0.2 ppm. The Agency determined that the
increased tolerance is safe; i.e. there is a reasonable certainty that
no harm will result from aggregate exposure to the pesticide chemical
residue.
Based on available field trial data that indicates that
thiophanate-methyl residues of concern were less than 2.0 ppm in or on
apples, less than the combined LOQs (< 0.1 ppm each) in or on almond
nutmeat and as high as 0.49 ppm in or on almond hulls, < 0.1 ppm in or
on pecans and peanut nutmeat, as high as 0.19 ppm in or on dry beans
(as high as 1.43 on snap beans), as high as 2.55 ppm in or on peaches,
and less than 0.5 ppm in or on plums, the Agency determined that
established

[[Page 54959]]

tolerances for thiophanate-methyl and methyl 2-benzimidazoyl carbamate
should be decreased for apples; almonds; almond, hulls; dry beans,
peaches, peanuts, pecans, and plums. Therefore, EPA is proposing to
decrease the tolerances in 40 CFR 180.371(a) for the combined residues
of thiophanate-methyl and methyl 2-benzimidazoyl carbamate in or on
apple, postharvest from 7.0 to 2.0 ppm; almond from 0.2(N) to 0.1 ppm;
almond, hulls from 1.0 to 0.5 ppm; dry beans from 2.0 to 0.2 ppm, and
revise the commodity terminology from bean (snap and dry) to bean, dry,
seed at 0.2 ppm and bean, snap, succulent (which will be maintained at
2.0 ppm); peach, postharvest from 15.0 to 3.0 ppm; peanut from 0.2(N)
to 0.1 ppm; pecans from 0.2 to 0.1 ppm, and revise the commodity
terminology from pecans to pecan; and plum, postharvest from 15.0 to
0.5 ppm.
In accordance with 40 CFR 180.1(h), residues in or on nectarines
are covered by the reassessed tolerance on peaches, and therefore the
tolerance on postharvest nectarines is no longer needed. Therefore, EPA
is proposing to remove the tolerance in 40 CFR 180.371(a) on nectarine,
postharvest.
Based on plum processing data from plums treated at 10x that show
thiophanate-methyl residues of concern do not concentrate in prunes,
the Agency determined that the tolerance on plum, prune, postharvest is
no longer needed since residues in or on prunes would be covered by the
reassessed tolerance on plum, postharvest at 0.5 ppm. Therefore, EPA is
proposing to remove the tolerance in 40 CFR 180.371(a) on plum, prune,
postharvest.
Based on field trial data that show thiophanate-methyl residues of
concern in or on dry bulb onions as high as 0.30 ppm, the Agency
determined that the tolerance for onion, dry should be decreased from
3.00 to 0.5 ppm and residues on garlic are covered by the bulb onion
tolerance in accordance with 40 CFR 180.1(h). EPA is proposing to
decrease the tolerance in 40 CFR 180.371 for the combined residues of
thiophanate-methyl and methyl 2-benzimidazoyl carbamate in or on onion,
dry from 3.00 to 0.5 ppm, and revise the term to onion, bulb.
Based upon a HAFT residue level of 0.2 ppm in or on soybeans and
the observed 6.5x concentration factor for hulls, the Agency determined
that a separate tolerance should be established on soybean hulls at 1.5
ppm. Therefore, EPA is proposing to establish a tolerance in 40 CFR
180.371(a) for the combined residues of thiophanate-methyl and methyl
2-benzimidazoyl carbamate in or on soybean, hulls at 1.5 ppm.
The available field trial residue data in or on cucumbers, melons,
pumpkins, and squash are adequate to support a cucurbit vegetable group
tolerance at 1.0 ppm. Because a crop group tolerance covers all of the
cucurbit vegetables, individual tolerances are no longer needed.
Therefore, EPA is proposing in 40 CFR 180.371(a) to remove the
individual tolerances on cucumber, melon, pumpkin, and squash at 1.0
ppm and combine them into a crop group tolerance on vegetable,
cucurbit, group 9 at 1.0 ppm.
EPA is proposing to revise commodity terminology in 40 CFR
180.371(a) to conform to current Agency practice as follows: ``Sugar
beet, roots'' to ``beet, sugar, roots;'' ``sugar beet, tops'' to
``beet, sugar, tops;'' ``soybean'' to ``soybean, seed;'' and
``sugarcane, seed piece treatment PRE-H'' to ``sugarcane, seed piece
treatment'' and in 40 CFR 180.371(b) from ``cotton'' to ``cotton,
undelinted seed.''
The Agency will address the tolerance in Sec. 180.371 on
sugarcane, seed piece treatment in a future Federal Register notice.

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 (RACs) and processed foods. Section 408 of FFDCA, 21 U.S.C.
346a, 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 RACs and processed foods.
Without a tolerance or exemption, food containing pesticide residues is
considered to be unsafe and therefore ``adulterated'' under section
402(a) of the FFDCA, 21 U.S.C. 342(a). Such food may not be distributed
in interstate commerce (21 U.S.C. 331(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. 136 et seq.). Food-use pesticides not registered in the United
States must have tolerances in order for commodities treated with those
pesticides to be imported into the United States.
EPA is proposing these tolerance actions to implement the tolerance
recommendations made during the reregistration and tolerance
reassessment processes (including follow-up on canceled or additional
uses of pesticides). As part of these processes, EPA was required to
determine whether each of the amended tolerances meets the safety
standard of the FQPA. The safety finding determination is discussed in
detail in each Post-FQPA RED and TRED for the active ingredient. REDs
and TREDs recommend the implementation of certain tolerance actions,
including modifications to reflect current use patterns, to meet safety
findings, and change commodity names and groupings in accordance with
new EPA policy. Printed and electronic copies of the REDs and TREDs are
available as provided in Unit II.A.
EPA has issued post-FQPA REDs for pebulate and thiophanate-methyl
and TREDs for chlorpropham, linuron, and asulam, which had REDs
completed prior to FQPA. REDs and TREDs contain the Agency's evaluation
of the data base for these pesticides, including requirements for
additional data on the active ingredients to confirm the potential
human health and environmental risk assessments associated with current
product uses, and in REDs state conditions under which these uses and
products will be eligible for reregistration. The REDs and TREDs
recommended the establishment, modification, and/or revocation of
specific tolerances. RED and TRED recommendations such as establishing
or modifying tolerances, and in some cases revoking tolerances, are the
result of assessment under the FQPA standard of ``reasonable certainty
of no harm.'' However, tolerance revocations recommended in REDs and
TREDs that are proposed in this document do not need such assessment
when the tolerances are no longer necessary.
EPA's general practice is to propose revocation of tolerances for
residues of pesticide active ingredients on crops for which FIFRA
registrations no longer exist and on which the pesticide may therefore
no longer be used in the United States. Nonetheless, EPA will establish
and maintain tolerances even when corresponding domestic uses are
canceled if the tolerances, which EPA refers to as ``import
tolerances,'' are necessary to allow importation into the United States
of food containing such pesticide residues. However, where there are no
imported commodities that require these import tolerances, the Agency
believes it is appropriate to revoke tolerances for unregistered
pesticides in order to prevent potential misuse.
Furthermore, as a general matter, the Agency believes that
retention of import tolerances not needed to cover any

[[Page 54960]]

imported food may result in unnecessary restriction on trade of
pesticides and foods. Under section 408 of the FFDCA, a tolerance may
only be established or maintained if EPA determines that the tolerance
is safe based on a number of factors, including an assessment of the
aggregate exposure to the pesticide and an assessment of the cumulative
effects of such pesticide and other substances that have a common
mechanism of toxicity. In doing so, EPA must consider potential
contributions to such exposure from all tolerances. If the cumulative
risk is such that the tolerances in aggregate are not safe, then every
one of these tolerances is potentially vulnerable to revocation.
Furthermore, if unneeded tolerances are included in the aggregate and
cumulative risk assessments, the estimated exposure to the pesticide
would be inflated. Consequently, it may be more difficult for others to
obtain needed tolerances or to register needed new uses. To avoid
potential trade restrictions, the Agency is proposing to revoke
tolerances for residues on crops uses for which FIFRA registrations no
longer exist, unless someone expresses a need for such tolerances.
Through this proposed rule, the Agency is inviting individuals who need
these import tolerances to identify themselves and the tolerances that
are needed to cover imported commodities.
Parties interested in retention of the tolerances should be aware
that additional data may be needed to support retention. These parties
should be aware that, under FFDCA section 408(f), if the Agency
determines that additional information is reasonably required to
support the continuation of a tolerance, EPA may require that parties
interested in maintaining the tolerances provide the necessary
information. If the requisite information is not submitted, EPA may
issue an order revoking the tolerance at issue.
When EPA establishes tolerances for pesticide residues in or on
RACs, 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
pesticides 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 (c)).
EPA has evaluated certain specific meat, milk, poultry, and egg
tolerances proposed for revocation in this rule and has concluded that
there is no reasonable expectation of finite pesticide residues of
concern in or on those commodities.

C. When do These Actions Become Effective?

EPA is proposing that these revocations, modifications,
establishment of tolerances, and commodity terminology revisions become
effective on the date of publication of the final rule in the Federal
Register. For this rule, proposed revocations will affect tolerances
for uses which have been canceled for many years or are no longer
needed. The Agency believes that treated commodities have had
sufficient time for passage through the channels of trade. However, if
EPA is presented with information that existing stocks would still be
available and that information is verified, the Agency will consider
extending the expiration date of the tolerance. If you have comments
regarding existing stocks and whether the effective date allows
sufficient time for treated commodities to clear the channels of trade,
please submit comments as described under SUPPLEMENTARY INFORMATION.
Any commodities listed in this proposal treated with the pesticides
subject to this proposal, and in the channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(1)(5), as
established by FQPA. Under this section, any residues of these
pesticides in or on such food shall not render the food adulterated so
long as it is shown to the satisfaction of the Food and Drug
Administration that:
1. The residue is present as the result of an application or use of
the pesticide at a time and in a manner that was lawful under FIFRA.
2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates when the
pesticide was applied to such food.

D. What is the Contribution to Tolerance Reassessment?

By law, EPA was required by August 3, 2006, to reassess the
tolerances in existence on August 2, 1996. Regarding tolerances
mentioned in this proposed rule, tolerances in existence as of August
2, 1996, were previously counted as reassessed at the time of the
signature completion of a Post-FQPA RED or TRED for each active
ingredient. Therefore, no further tolerance reassessments would be
counted toward the August 2006 review deadline.

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 standard established by the FFDCA. The same
food safety standards apply to domestically produced and imported
foods.
The tolerance action in the proposal apply equally to domestically-
produced and import foods. In making its tolerance decisions, the
Agency seeks to harmonize with international standards whenever
possible, consistent with U.S.food safety standards and agricultural
practices. EPA considers the international Maximum Residue Limits
(MRLs) established by the Codex Alimentarium Comission, as required by
section 408(b)(4) of the Federal Food, Drug, and Cosmetic Act. The
Codex Alimentarium is a joint UN food and Agriculture Organization/
World Health Organization food standards program, and it is recognized
as an international food safty standards-setting organization in trade
agreements to which the United States is a party. EPA also considers
MRLs established in Canada and Mexico.
EPA's effort to harmonize MRLs is summarized in the tolerance
reassessment section of individual RED documents. EPA has developed
guidance concerning submissions for import tolerance support (June 1,
2000, 65 FR 35069) (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 establish tolerances
under FFDCA section 408(e), and also modify and revoke specific
tolerances established under FFDCA section 408.

[[Page 54961]]

The Office of Management and Budget (OMB) has exempted these types of
actions (i.e., establishment and 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 establishment of
tolerances, exemptions from tolerances, raising of tolerance levels,
expansion of exemptions, or revocations might significantly impact a
substantial number of small entities and concluded that, as a general
matter, these actions do not impose a significant economic impact on a
substantial number of small entities. These analyses for tolerance
establishments and modifications, and for tolerance revocations were
published on May 4, 1981 (46 FR 24950) and 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 this
analysis, and available information concerning the pesticides listed in
this proposed rule, the Agency hereby certifies that this proposed
action will not have a significant negative economic impact on a
substantial number of small entities. In a memorandum dated May 25,
2001, EPA determined that eight conditions must all be satisfied in
order for an import tolerance or tolerance exemption revocation to
adversely affect a significant number of small entity importers, and
that there is a negligible joint probability of all eight conditions
holding simultaneously with respect to any particular revocation. (This
Agency document is available in the docket of this proposed rule).
Furthermore, for the pesticide named in this proposed rule, the Agency
knows of no extraordinary circumstances that exist as to the present
proposal that would change EPA's previous analysis. Any comments about
the Agency's determination should be submitted to EPA along with
comments on the proposal, and will be addressed prior to issuing a
final rule. In addition, the Agency has determined that this action
will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

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

Dated: August 29, 2006.
James Jones,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I 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), 346a and 371.

2. In Sec. 180.181 the section heading and paragraph (a) are
revised to read as follows:

Sec. 180.181 Chlorpropham; tolerances for residues.

(a)(1) General. Tolerances are established for residues of the
plant regulator and herbicide chlorpropham (isopropyl m-
chlorocarbaniliate (CIPC)) in or on the following food commodities:

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Potato, postharvest............................ 30
------------------------------------------------------------------------

[[Page 54962]]

Potato, wet peel............................... 40
------------------------------------------------------------------------

(2) Tolerances are established for the combined residues of the
plant regulator and herbicide chlorpropham (isopropyl m-
chlorocarbaniliate (CIPC)) and its metabolite 4-hydroxychlorpropham-O-
sulfonic acid (4-HSA) in or on the following food commodities:

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat.................................... 0.20
Cattle, kidney................................. 0.30
Cattle. meat................................... 0.06
Cattle, meat byproducts, except kidney......... 0.06
Goat, fat...................................... 0.20
Goat, kidney................................... 0.30
Goat, meat..................................... 0.06
Goat, meat byproducts, except kidney........... 0.06
Hog, fat....................................... 0.20
Hog, kidney.................................... 0.30
Hog, meat...................................... 0.06
Hog, meat byproducts, except kidney............ 0.06
Horse, fat..................................... 0.20
Horse, kidney.................................. 0.30
Horse, meat.................................... 0.06
Horse, meat byproducts, except kidney.......... 0.06
Milk........................................... 0.3
Sheep, fat..................................... 0.20
Sheep, kidney.................................. 0.30
Sheep, meat.................................... 0.06
Sheep, meat byproducts, except kidney.......... 0.06
------------------------------------------------------------------------

* * * * *
3. In Sec. 180.184 paragraphs (a) and (c) are revised to read as
follows:

Sec. 180.184 Linuron; tolerances for residues.

(a) General. Tolerances are established for the combined residues
of the herbicide linuron (3-(3,4-dichlorophenyl)-1-methoxy-1-
methylurea) and its metabolites convertible to 3,4-dichloroaniline,
calculated as linuron, in or on the following food commodities:

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Asparagus...................................... 7.0
Carrot, roots.................................. 1.0
Cattle, fat.................................... 0.2
Cattle, kidney................................. 2.0
Cattle, liver.................................. 2.0
Cattle, meat................................... 0.1
Cattle, meat byproducts, except kidney and 0.1
liver.........................................
Celeriac....................................... 1.0
Corn, field, forage............................ 1.0
Corn, field, grain............................. 0.1
Corn, field, stover............................ 6.0
Corn, sweet, forage............................ 1.0
Corn, sweet, kernel plus cob with husks removed 0.25
Corn, sweet, stover............................ 1.0
Cotton, gin byproducts......................... 5.0
Cotton, undelinted seed........................ 0.25
Goat, fat...................................... 0.2
Goat, kidney................................... 2.0
Goat, liver.................................... 2.0
Goat, meat..................................... 0.1
Goat, meat byproducts, except kidney and liver. 0.1
Hog, fat....................................... 0.05
Hog, meat...................................... 0.05
Hog, meat byproducts........................... 0.1
Horse, fat..................................... 0.2
Horse, kidney.................................. 2.0
Horse, liver................................... 2.0
Horse, meat.................................... 0.1
Horse, meat byproducts, except kidney and liver 0.1
Milk........................................... 0.05
Parsnip, roots................................. 0.05
Parsnip, tops 0.05

[[Page 54963]]

Rhubarb........................................ 0.5
Sheep, fat..................................... 0.2
Sheep, kidney.................................. 2.0
Sheep, liver................................... 2.0
Sheep, meat.................................... 0.1
Sheep, meat byproducts, except kidney and liver 0.1
Sorghum, grain, forage......................... 1.0
Sorghum, grain, grain 0.25
Sorghum, grain, stover......................... 1.0
Soybean, seed.................................. 1.0
Soybean, vegetable............................. 1.0
------------------------------------------------------------------------

* * * * *
(c) Tolerances with regional registrations. Tolerances with
regional registrations, as defined in Sec. 180.1(n), are established
for the combined residues of the herbicide linuron (3-(3,4-
dichlorophenyl)-1-methoxy-1-methylurea) and its metabolites convertible
to 3,4-dichloroaniline, calculated as linuron, in or on the following
food commodities:

----------------------------------------------------------------------------------------------------------------
Commodity Parts per million
----------------------------------------------------------------------------------------------------------------
Celery................................................ 0.5
Parsley, leaves....................................... 0.25
Potato................................................ 0.2
Wheat, forage......................................... 0.5
Wheat, grain.......................................... 0.05
Wheat, hay............................................ 0.5
Wheat, straw.......................................... 2.0
----------------------------------------------------------------------------------------------------------------

* * * * *

Sec. 180.238 [Amended]

4. Section 180.238 is removed.

Sec. 180.319 [Amended]

5. Section 180.319 is amended by removing from the table the entry
for isopropyl m-chlorocarbanilate (CIPC).
6 In Sec. 180.360 paragraph (a) is revised to read as follows:

Sec. 180.360 Asulam; tolerances for residues.

(a) General. Tolerances are established for the combined residues
of asulam (methyl sulfanilylcarbamate) and its metabolites containing
the sulfanilamide moiety in or on the following food commodities:

* * * * *
7 In Sec. 180.371 paragraphs (a), (b), and (c) are revised to read
as follows:

Sec. 180.371 Thiophanate-methyl; tolerances for residues.

(a) General. Tolerances are established for the combined residues
of thiophanate-methyl (dimethyl [(1,2-phenylene) bis
(iminocarbonothioyl)] bis(carbamate)) and its metabolite methyl 2-
benzimidazoyl carbamate, calculated as thiophanate-methyl in or on the
following commodities:

[[Page 54964]]

Apple, postharvest............................. 2.0
Apricot, postharvest........................... 15.0
Banana......................................... 2.0
Bean, dry, seed................................ 0.2
Bean, snap, succulent.......................... 2.0
Beet, sugar, roots............................. 0.2
Beet, sugar, tops.............................. 15.0
Cattle, fat.................................... 0.15
Cattle, meat................................... 0.15
Cattle, meat byproducts........................ 0.15
Cherry, postharvest............................ 20.0
Goat, fat...................................... 0.15
Goat, meat..................................... 0.15
Goat, meat byproducts.......................... 0.15
Grape.......................................... 5.0
Horse, fat..................................... 0.15
Horse, meat.................................... 0.15
Horse, meat byproducts......................... 0.15
Milk........................................... 1.5
Onion, bulb.................................... 0.5
Onion, green................................... 3.0
Peach, postharvest............................. 3.0
Peanut......................................... 0.1
Peanut, hay.................................... 5.0
Pecan.......................................... 0.1
Pistachio...................................... 0.1
Pear........................................... 3.0
Plum, postharvest.............................. 0.5
Potato......................................... 0.1
Sheep, fat..................................... 0.15
Sheep, meat.................................... 0.15
Sheep, meat byproducts......................... 0.15
Soybean, seed.................................. 0.2
Soybean, hulls................................. 1.5
Strawberry..................................... 7.0
Sugarcane, seed piece treatment................ 0.1
Vegetable, cucurbit, group 9................... 1.0
Wheat, grain................................... 0.1
Wheat, hay..................................... 0.1
Wheat, straw................................... 0.1
------------------------------------------------------------------------

(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the combined residues of thiophanate-methyl (dimethyl
[(1,2-phenylene) bis (iminocarbonothioyl)] bis(carbamate)) and its
metabolite methyl 2-benzimidazoyl carbamate, calculated as thiophanate-
methyl, in or on the following commodities:

----------------------------------------------------------------------------------------------------------------
Commodity Parts per million Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
Blueberry.......................................... 1.5 6/30/07
Citrus............................................. 0.5 6/30/07
Cotton, gin byproducts............................. 5.0 12/31/07
Cotton, undelinted seed............................ 0.05 12/31/07
Mushroom........................................... 0.01 12/31/07
Vegetable, fruiting, group 8....................... 0.5 12/31/08
----------------------------------------------------------------------------------------------------------------

(c) Tolerances with regional registrations. Tolerances with
regional registration, as defined in 180.1(n), are established for the
combined residues of thiophanate-methyl (dimethyl [(1,2-phenylene) bis
(iminocarbonothioyl)] bis(carbamate)) and its metabolite methyl 2-
benzimidazoyl carbamate, calculated as thiophanate-methyl, in or on the
following commodities:

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Canola, seed........................ 0.2
------------------------------------------------------------------------

[[Page 54965]]

* * * * *
[FR Doc. E6-15471 Filed 9-19-06; 8:45 am]

BILLING CODE 6560-50-S