

[Federal Register: July 14, 2006 (Volume 71, Number 135)]
[Proposed Rules]               
[Page 40051-40057]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jy06-19]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-2006-0056; FRL-8075-4]

 
Bentazon, Carboxin, Dipropyl Isocinchomeronate, and Oil of 
Lemongrass (Oil of Lemon) and Oil of Orange; 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 
fungicide carboxin, the insecticide dipropyl isocinchomeronate, and the 
fungicide/animal repellent oil of lemon (oil of lemongrass) and oil of 
orange. Also, EPA is proposing to modify certain tolerances for the 
herbicide bentazon and the fungicide carboxin. In addition, EPA is 
proposing to establish new tolerances for the herbicide bentazon. The 
regulatory actions proposed in this document are part of the Agency's 
reregistration program under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), and the tolerance reassessment requirements of 
the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(q), as 
amended by the Food Quality Protection Act (FQPA) of 1996. By law, EPA 
is required by August 2006 to reassess the tolerances that were in 
existence on August 2, 1996. No tolerance reassessments will be counted 
at the time of a final rule because tolerances in existence on August 
2, 1996 that are associated with actions proposed herein were 
previously counted as reassessed at the time of the completed 
Reregistration Eligibility Decision (RED), Report of Food Quality 
Protection Act (FQPA) Tolerance Reassessment Progress and Risk 
Management Decision (TRED), or Federal Register.

DATES: Comments must be received on or before September 12, 2006.

[[Page 40052]]


ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2006-0056, 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 
Building); 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-
2006-0056. 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 Building), 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 telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Monisha Dandridge, Special Review and 
Reregistration Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave, NW., 
Washington, DC 20460-0001; telephone number: (703) 308-0410; e-mail 
address: dandridge.monisha@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 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

[[Page 40053]]

submitted as required in the order, EPA will take appropriate action 
under FFDCA.
    EPA issues a final rule after considering comments that are 
submitted in response to this proposed rule. In addition to submitting 
comments in response to this proposal, you may also submit an objection 
at the time of the final rule. If you fail to file an objection to the 
final rule within the time period specified, you will have waived the 
right to raise any issues resolved in the final rule. After the 
specified time, issues resolved in the final rule cannot be raised 
again in any subsequent proceedings.

II. Background

A. What Action is the Agency Taking?

    EPA is proposing to revoke, modify and establish specific 
tolerances for residues of the herbicide bentazon, the fungicide 
carboxin, the insecticide dipropyl isocinchomeronate, and the 
fungicide/animal repellent oil of lemon (oil of lemongrass) and oil of 
orange 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 Reregistration 
Eligibility Decision (RED) and Report of the FQPA Tolerance 
Reassessment Progress and Risk Management Decision (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 for 
bentazon, carboxin, dipropyl isocinchomeronate, and flower and 
vegetable oils (this refers to oil of lemongrass (oil of lemon) and oil 
of orange) at http://www.epa.gov/pesticides/reregistration/status.htm, 

and also for carboxin and dipropyl isocinchomeronate in public dockets 
EPA-HQ-OPP-2004-0233, EPA-HQ-OPP-2004-0124 and, EPA-HQ-OPP-2003-0123, 
respectively. Paper copies for bentazon and flower and vegetable oils, 
which includes oil of lemon (oil of lemongrass) and oil of orange, 
available in the public docket for this rule.
    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. EPA recommends 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 paper copies for carboxin can be found under its respective 
public docket number EPA-HQ-OPP-2004-0124, identified above. Paper 
copies for bentazon are available in the public docket for this rule. 
Because food use registrations have not existed for oil of lemon (oil 
of lemongrass), oil of orange, and dipropyl isocinchomeronate, the 
Agency residue assessment was not needed. Electronic copies are 
available through EPA's electronic public docket and comment system, 
regulations.gov at http://www.regulations.gov. You may search for this 

rule under docket number EPA-HQ-OPP--2006-0056, 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 
pesticide active ingredient bentazon, carboxin, dipropyl 
isocinchomeronate, and oil of lemon (oil of lemongrass) and oil of 
orange 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. Bentazon. The available residue data for bentazon indicate that 
the established tolerances for cowpea, forage; pea, dry, seed; pea, 
field, hay; soybean, forage; and soybean, hay should be increased. 
Therefore, EPA is proposing to increase tolerances in 40 CFR 
180.355(a)(1) for the residues of bentazon in or on cowpea, forage from 
3.0 to 10.0 ppm; pea, dry, seed from 0.05 to 1.0 ppm; pea, field, hay 
from 3.0 to 8.0; soybean, forage from 3.0 to 8.0 ppm and soybean, hay 
from 3.0 to 8.0 ppm. The Agency has determined that

[[Page 40054]]

the increased tolerances are safe; i.e., there is no reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue.
    The Agency determined that the tolerance on pepper, nonbell should 
be decreased to 0.05 ppm, which is the limit of detection for bentazon 
residues of concern. Therefore, the Agency is proposing to decrease the 
tolerances in 40 CFR 180.355(a)(1) for the combined residues of 
bentazon and its metabolites in or on pepper, nonbell to 0.05 ppm.
    The processing data on rice indicate the residues concentrate in 
hulls. Therefore, EPA is proposing to establish a tolerance in 40 CFR 
180.355(a)(1) for the combined residues of bentazon and its metabolites 
in or on rice, hulls at 0.25 ppm.
    In order to conform to current Agency policy on commodity 
terminology, EPA is proposing to modify the tolerance in 40 CFR 
180.355(a)(1), for residues of bentazon in or on mint to peppermint, 
tops and spearmint, tops and maintain the tolerance level at 1.0 ppm.
    2. Carboxin. According to the TRED, the tolerance expression, which 
is currently expressed as ``combined residues of the fungicide carboxin 
(5,6-dihydro-2-methyl-1,4-oxathiin-3-carboxanilide) and its metabolite 
5,6-dihydro-3-carboxanilide-2-meth yl-1,4-oxathiin-4-oxide (calculated 
as carboxin) (from treatment of seed prior to planting) in or on raw 
agricultural commodities as follows'' in 40 CFR 180.301(a) should be 
modified. The residue chemistry data indicates that as crops mature, 
insoluble anilide complexes as well as polar metabolites increased. 
These complexes of carboxin or carboxin derivatives with macromolecules 
such as lignin are insoluble in water and organic solvents and liberate 
aniline upon hydrolysis. Further, analytical methods for detection of 
carboxin regulated residues produce aniline (convert carboxin and 
carboxin derived metabolite to aniline), which is determined either 
spectrophotometrically or by gas-liquid chromatography (GLC). 
Therefore, the residues of concern are carboxin, carboxin sulfoxide, 
and insoluble anilide complexes. Consequently, EPA is proposing that 
the tolerance expression in 40 CFR 180.301(a) read as follows: ``(a) 
General. Tolerances are established for the combined residues of the 
fungicide carboxin (5,6-dihydro-2-methyl-1,4-oxathiin-3-carboxanilide) 
and its metabolites determined as aniline and expressed as parent 
compound, in or on food commodities as follows:''
    Because bean forage, hay, and straw are no longer considered 
significant livestock feed stuffs and have been deleted from Table 
OPPTS 860.1000 (available at http://www.epa.gov/opptsfrs /OPPTS--

Harmonized/ 860-- Residue--Chemistry-- Test--Guidelines/Series); the 
tolerances are no longer needed. Therefore, EPA is proposing to revoke 
the tolerances in 40 CFR 180.301(a) on bean, forage; bean, hay; and 
bean, straw.
    Carboxin has had no active registrations for uses on sorghum over a 
period of many years. Therefore, EPA is proposing to revoke the 
tolerances in 40 CFR 180.301(a) for residues of carboxin in or on 
sorghum are no longer needed, EPA is proposing to revoke the tolerances 
in 40 CFR 180.301(a) for sorghum, forage; sorghum, grain; and sorghum, 
grain, stover.
    Based on the ruminant feeding study, the lack of residues detected 
on the poultry feedstuff produced from treated seeds and the use of 
carboxin only as a fungicide on seeds indicate there is no propensity 
for residues to accumulate in animal tissues, the tolerance should be 
established at the level of quantitation of the analytical method of 
0.05 ppm rather than the current tolerance level of 0.01 ppm. 
Therefore, EPA is proposing to increase the tolerances in 40 CFR 
180.301(a) for combined residues of carboxin and its metabolites in or 
on egg from 0.01 to 0.05 ppm. The Agency has 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 14C-radiolabeled dairy cattle feeding data at 
an exaggerated 1.15x feeding level, milk showed combined carboxin 
residues of concern. The 14C-radiolabeled feeding study had 
a lower limit of quantitation (LOQ) than the enforcement method and 
therefore the tolerance should be established at the LOQ of the 
enforcement analytical method (0.05 ppm). Therefore, EPA is proposing 
to increase the tolerance in 40 CFR 180.301(a) for combined residues of 
carboxin and its metabolites in or on ``milk'' from 0.01 to 0.05 ppm. 
The Agency has 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.
    A dairy cattle feeding study conducted at an exaggerated (1.15x) 
feeding level, shows combined carboxin regulated residues were as low 
as 0.023 and 0.007 ppm in meat and fat. Therefore, EPA is proposing to 
decrease the tolerances in 40 CFR 180.301(a) for residues of carboxin 
in or on the meat and fat of cattle, goats, hogs, horses, and sheep 
from 0.01 to 0.05 ppm, respectively.
    In order to conform to current Agency practice, EPA is proposing to 
revise the commodity terminology in 40 CFR 180.301(a), for residues of 
carboxin in or on corn, stover to read corn, field, stover; corn, pop, 
stover and corn, sweet, stover; corn, forage to corn, field, forage; 
and, corn, sweet, forage; ``corn, fresh, including sweet corn, kernel 
plus cob with husks removed to read corn, sweet, kernel plus cob with 
husks removed; corn, grain to corn, field, grain and corn, pop, grain; 
oat, seed to read oat, grain; rice to rice, grain; and soybean to read 
soybean, seed.
    3. Dipropyl isocinchomeronate (MGK 326). There have been no active 
registrations for uses associated with livestock or milk commodities 
since 1996, such that these tolerances are no longer needed, and 
therefore EPA is proposing to revoke the commodity tolerances in 40 CFR 
180.143(a) for residues of dipropyl isocinchomeronate in or on cattle, 
fat; cattle, meat; cattle, meat byproducts; goat, fat; goat, meat; 
goat, meat byproducts; hog, fat; hog, meat; hog, meat byproducts; 
horse, fat; horse, meat; horse, meat byproducts; milk; sheep, fat; 
sheep, meat; and, sheep, meat byproducts.
    4. Oil of lemongrass (oil of lemon) and oil of orange. Oil of lemon 
is not a registered pesticide active ingredient nor has it ever been an 
active ingredient in any pesticide product. However, the Agency has 
determined that the exemptions from the requirement of a tolerance 
under 40 CFR 180.1238 apply to Oil of lemongrass, which is a registered 
active ingredient included in the 1993 RED entitled Flower and 
Vegetable Oils. There have been no active food-use registrations within 
the past 10 years which contain either oil of lemongrass or oil of 
orange as pesticide active ingredients. Therefore, EPA is proposing to 
revoke the tolerance exemptions on raw agricultural commodities in 40 
CFR 180.1238 and 180.1239 for oil of lemon (oil of lemongrass) and oil 
of orange, respectively, when used as a postharvest fungicide.

B. What is the Agency's Authority for Taking this Action?

    A ``tolerance'' represents the maximum level for residues of 
pesticide chemicals legally allowed in or on raw agricultural 
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, 
as amended by the FQPA of 1996, Public Law 104-170, authorizes the 
establishment of tolerances, exemptions from tolerance requirements,

[[Page 40055]]

modifications in tolerances, and revocation of tolerances for residues 
of pesticide chemicals in or on raw agricultural commodities 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 is 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 a post-FQPA RED for carboxin and dipropyl 
isocinchomeronate (MGK 326), and a pre-FQPA RED for bentazon, whose 
tolerances were reassessed post-FQPA as part of the Agency's 
determination on March 8, 2000 (65 FR 12122) (FRL-6492-7) to establish 
new bentazon uses and therefore a TRED to reassess its tolerances was 
not needed. Also, EPA has issued a TRED for oil of lemongrass (oil of 
lemon) and oil of orange, as these active ingredients were part of the 
Flower and Vegetable Oils pre FQPA RED. 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. EPA has historically been 
concerned that retention of tolerances that are not necessary to cover 
residues in or on legally treated foods may encourage misuse of 
pesticides within the United States. Nonetheless, EPA will establish 
and maintain tolerances even when corresponding domestic uses are 
canceled if the tolerances, which EPA refers to as ``import 
tolerances,'' are necessary to allow importation into the United States 
of food containing such pesticide residues. However, where there are no 
imported commodities that require these import tolerances, the Agency 
believes it is appropriate to revoke tolerances for unregistered 
pesticides in order to prevent potential misuse.
    Furthermore, as a general matter, the Agency believes that 
retention of import tolerances not needed to cover any imported food 
may result in unnecessary restriction on trade of pesticides and foods. 
Under section 408 of the FFDCA, a tolerance may only be established or 
maintained if EPA determines that the tolerance is safe based on a 
number of factors, including an assessment of the aggregate exposure to 
the pesticide and an assessment of the cumulative effects of such 
pesticide and other substances that have a common mechanism of 
toxicity. In doing so, EPA must consider potential contributions to 
such exposure from all tolerances. If the cumulative risk is such that 
the tolerances in aggregate are not safe, then every one of these 
tolerances is potentially vulnerable to revocation. Furthermore, if 
unneeded tolerances are included in the aggregate and cumulative risk 
assessments, the estimated exposure to the pesticide would be inflated. 
Consequently, it may 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 raw 
agricultural commodities, consideration must be given to the possible 
residues of those chemicals in meat, milk, poultry, and/or eggs 
produced by animals that are fed agricultural products (for example, 
grain or hay) containing 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 revocations, modifications, and 
establishments 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

[[Page 40056]]

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, and (2) the residue does not exceed the level that 
was authorized at the time of the application or use to be present on 
the food under a tolerance or exemption from tolerance. Evidence to 
show that food was lawfully treated may include records that verify the 
dates when the pesticide was applied to such food.

D. What Is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August 3, 2006 to reassess the 
tolerances in existence on August 2, 1996. As of May 30, 2006, EPA has 
reassessed over 8,140 tolerances. 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.
    EPA is working to ensure that the U.S. tolerance reassessment 
program under FQPA does not disrupt international trade. EPA considers 
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in 
reassessing them. MRLs are established by the Codex Committee on 
Pesticide Residues, a committee within the Codex Alimentarius 
Commission, an international organization formed to promote the 
coordination of international food standards. It is EPA's policy to 
harmonize U.S. tolerances with Codex MRLs to the extent possible, 
provided that the MRLs achieve the level of protection required under 
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the 
tolerance reassessment section of individual Reregistration Eligibility 
Decision documents. EPA has developed guidance concerning submissions 
for import tolerance support of 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. 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) (Pub. 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), Pub. 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 the EPA's previous 
analysis. Any comments about the Agency's determination should be 
submitted to the EPA along with comments on the proposal, and will be 
addressed prior to issuing a final rule. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various

[[Page 40057]]

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: July 5, 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.


Sec.  180.143  [Removed]

    2. Section 180.143 is removed.
    3. Section 180.301 is amended by revising paragraph (a) to read as 
follows:


Sec. 180.301  Carboxin; tolerances for residues.

    (a) General. Tolerances are established for the combined residues 
of the fungicide carboxin (5,6-dihydro-2-methyl-1,4-oxathiin-3-
carboxanilide) and its metabolites determined as aniline and expressed 
as parent compound, in or on food commodities as follows:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Barley, grain........................................                0.2
Barley, straw........................................                0.2
Bean, dry, seed......................................                0.2
Bean, succulent......................................                0.2
Canola, seed.........................................               0.03
Cattle, fat..........................................               0.05
Cattle, meat.........................................               0.05
Cattle, meat byproducts..............................                0.1
Corn, field, forage..................................                0.2
Corn, field, grain...................................                0.2
Corn, field, stover..................................                0.2
Corn, pop, grain.....................................                0.2
Corn, pop, stover....................................                0.2
Corn, sweet, forage..................................                0.2
Corn, sweet, kernel plus cob with husks removed......                0.2
Corn, sweet, stover..................................                0.2
Cotton, undelinted seed..............................                0.2
Egg..................................................               0.05
Goat, fat............................................               0.05
Goat, meat...........................................               0.05
Goat, meat byproducts................................                0.1
Hog, fat.............................................               0.05
Hog, meat............................................               0.05
Hog, meat byproducts.................................                0.1
Horse, fat...........................................               0.05
Horse, meat..........................................               0.05
Horse, meat byproducts...............................                0.1
Milk.................................................               0.05
Oat, forage..........................................                0.5
Oat, grain...........................................                0.2
Oat, straw...........................................                0.2
Onion, bulb..........................................                0.2
Peanut...............................................                0.2
Peanut, hay..........................................                0.2
Poultry, fat.........................................                0.1
Poultry, meat........................................                0.1
Poultry, meat byproducts.............................                0.1
Rice, grain..........................................                0.2
Rice, straw..........................................                0.2
Safflower, seed......................................                0.2
Sheep, fat...........................................               0.05
Sheep, meat..........................................               0.05
Sheep, meat byproducts...............................                0.1
Soybean, seed........................................                0.2
Wheat, forage........................................                0.5
Wheat, grain.........................................                0.2
Wheat, straw.........................................                0.2
------------------------------------------------------------------------

* * * * *
    4. Section 180.355 is amended by revising the table in paragraph 
(a) to read as follows:


Sec. 180.355  Bentazon; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Bean, dry, seed......................................               0.05
Bean, succulent......................................                0.5
Corn, field, forage..................................                3.0
Corn, field, grain...................................               0.05
Corn, field, stover..................................                3.0
Corn, pop, grain.....................................               0.05
Corn, sweet, kernel plus cob with husks removed......               0.05
Cowpea, forage.......................................               10.0
Cowpea, hay..........................................                3.0
Flax, seed...........................................                1.0
Pea, dry, seed.......................................                1.0
Pea, field, hay......................................                8.0
Pea, field, vines....................................                3.0
Pea, succulent.......................................                3.0
Peanut...............................................               0.05
Peanut, hay..........................................                3.0
Pepper, nonbell......................................               0.05
Peppermint, tops.....................................                1.0
Rice, grain..........................................               0.05
Rice, hulls..........................................               0.25
Rice, straw..........................................                3.0
Sorghum, forage......................................               0.20
Sorghum, grain.......................................               0.05
Sorghum, grain, stover...............................               0.05
Soybean, seed........................................               0.05
Soybean, forage......................................                8.0
Soybean, hay.........................................                8.0
Spearmint, tops......................................                1.0
------------------------------------------------------------------------

* * * * *


Sec.  Sec.  180.1238 and 180.1239  [Removed]

    5. Sections 180.1238 and 180.1239 are removed.
[FR Doc. E6-11016 Filed 7-13-06; 8:45 am]

BILLING CODE 6560-50-S
