Chlorpropham, Linuron, Pebulate, Asulam, and Thiophanate-methyl; Proposed Tolerance Actions, 54953-54965 [E6-15471]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 182 (Wednesday, September 20, 2006)]
[Proposed Rules]
[Pages 54953-54965]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15471]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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:https://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 
https://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 https://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 
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 https://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 https://www.ntis.gov. Electronic copies of REDs and TREDs 
are available on the internet at https://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 https://
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 https://www.epa.gov/opptsfrs/
publications/OPPTS_Harmonized/860_Residue_Chemistry_
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 
https://www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/860_
Residue_Chemistry_Test_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 https://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 https://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