[Federal Register Volume 67, Number 246 (Monday, December 23, 2002)]
[Notices]
[Pages 78229-78232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32260]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0342; FRL-7284-5]


Imazamox; Notice of Filing a Pesticide Petition to Establish a 
Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2002-0342, must be 
received on or before January 22, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:
    [sbull] Crop production (NAICS code 111)
    [sbull] Animal production (NAICS code 112)
    [sbull] Food manufacturing (NAICS code 311)
    [sbull] 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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2002-0342. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
Although not all docket materials may be available electronically, you 
may still access any of the publicly available docket materials through 
the docket facility identified in Unit I.B. EPA intends to work towards 
roviding electronic access to all of the publicly available docket 
materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical

[[Page 78230]]

objects will be photographed, and the photograph will be placed in 
EPA's electronic public docket along with a brief description written 
by the docket staff.

C. How and To Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
I.D. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/
edocket, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2002-0342 The system is an ``anonymous access'' system, which means 
EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to [email protected], 
Attention: Docket ID Number OPP-2002-0342. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2002-0342.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket 
ID Number OPP-2002-0342. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI To the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

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

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.


[[Page 78231]]


    Dated: December 12, 2002.
 Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by FFDCA section 408(d)(3). The summary of the petition was 
prepared by the petitioner and represents the view of the petitioner. 
The petition summary announces the availability of a description of the 
analytical methods available to EPA for the detection and measurement 
of the pesticide chemical residues or an explanation of why no such 
method is needed.

Interregional Research Project Number 4 and BASF Corporation

PP 2E6472

    EPA has received a pesticide petition (2E6472) from Interregional 
Research Project Number 4 (IR-4), 681 U.S. Highway 1 South, 
North Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of 
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to 
amend 40 CFR part 180. Subpart D by establishing an exemption from the 
requirement of a tolerance for imazamox,([sim])-2-4,5-dihydro-4-methyl-
4-(1-methylethyl)-5-oxo-1H-imidazol-2-yl-5-(methoxymethyl)-3-
pyridinecarboxylic acid in or on all raw and processed agricultural 
commodities. EPA has determined that the petition contains data or 
information regarding the elements set forth in section 408(d)(2) of 
the FFDCA; however, EPA has not fully evaluated the sufficiency of the 
submitted data at this time or whether the data support granting of the 
petition. Additional data may be needed before EPA rules on the 
petition. This notice includes a summary of the petition prepared by 
BASF Corporation, Research Triangle Park, 27709.

A. Residue Chemistry

    1. Plant metabolism. EPA has concluded that the nature of the 
residue is adequately understood and the residues of concern are the 
parent imazamox only.
    2. Analytical method. Since imazamox and its metabolic degradates 
are not of toxicological concern, analytical methods are not 
applicable.
    3. Magnitude of residues. Since imazamox and its metabolic 
degradates are not of toxicological concern, and this petition is a 
request for an exemption from a tolerance, the magnitude of residues is 
not applicable.

B. Toxicological Profile

    1. Acute toxicity. Imazamox technical is considered to be nontoxic 
(toxicity category IV) to the rat by the oral route of exposure. In the 
acute oral toxicity study in rats, the lethal dose LD50 
value of imazamox technical was greater than 5,000 milligram/kilogram 
body weight (mg/kg bwt) for males and females. The results from the 
acute dermal toxicity study in rabbits indicate that imazamox is 
slightly toxic (toxicity category III) to rabbits by the dermal 
exposure. The dermal LD50 value of imazamox technical was 
greater than 4,000 mg/kg bwt for both male and female rabbits. Imazamox 
technical is considered to be nontoxic (toxicity category IV) to the 
rat by the respiratory route of exposure. The 4-hour lethal 
concentration LC50 value was greater than 6.3 milligrams/
Liter (mg/L) (analytical) for both males and females. Imazamox 
technical was shown to be non-irritating to slightly irritating to 
rabbit skin (toxicity category IV). Based on the results of a dermal 
sensitization study (Buehler), imazamox technical is not considered a 
sensitizer in guinea pigs.
    2. Genotoxicity. Imazamox technical was tested in the following 
four assays measuring several different endpoints of potential 
genotoxicity. Collective results from these studies indicate that 
imazamox does not pose a mutagenic or genotoxic risk.
    i. Bacterial mutagenicity assay - negative.
    ii. In vitro structural chromosomal aberration assay - negative.
    iii. In vitro chinese hampster ovary/hypoxanthine guanine 
phophoribosyl transferase (CHO/HGPRT) assay - negative.
    iv. In vivo micronucleus aberration assay - negative.
    3. Reproductive and developmental toxicity. The development 
toxicity study in rats conducted with imazamox technical showed no 
evidence of teratogenic effects in fetuses and no evidence of 
developmental toxicity. Thus, imazamox is neither a developmental 
toxicant nor a teratogen in the rat. The results from this study 
supported a no observed adverse effect level (NOAEL) for developmental 
toxicity of 1,000 mg/kg bwt/day, the highest dose tested (HDT) and 
limit dose. The NOAEL for maternal toxicity was 500 mg/kg bwt/day, 
based on reduced mean body weights, weight gains and food consumption 
at 1,000 mg/kg bwt/day. Results from a developmental toxicity study in 
rabbits conducted with imazamox technical also indicated no evidence of 
teratogenicity or developmental toxicity. Thus, imazamox technical is 
neither a developmental toxicant nor a teratogen in the rabbit. In the 
rabbit developmental toxicity study, the NOAEL for maternal toxicity 
was 300 mg/kg bwt/day, based on decreased food consumption at 600 mg/kg 
bwt/day, the next HDT. The NOAEL for developmental toxicity was 900 mg/
kg bwt/day, the HDT. The results from the 2-generation reproduction 
toxicity study in rats with imazamox technical support a NOAEL for 
parental and reproductive toxicity of 20,000 parts per million (ppm) 
(or approximately 1,639 mg/kg bwt/day, calculated from the food 
consumption data), the highest concentration tested (HCT). The NOAEL 
for growth and development of offspring is also 20,000 ppm (or 
approximately 1,639 mg/kg bwt/day).
    Results from the reproduction study and the developmental toxicity 
studies conducted with imazamox technical show no increased sensitivity 
to developing offspring as compared to parental animals, because the 
NOAELs for growth and development of offspring were equal to or greater 
than the NOAELs for parental or maternal toxicity.
    4. Subchronic toxicity. No treatment-related adverse effects were 
noted in subchronic toxicity studies at the HDT. A short-term (28-day) 
dermal study in rabbits was conducted with imazamox technical. No 
dermal irritation or systemic toxicity was observed at dose levels up 
to and including 1,000 mg/kg bwt/day HDT, supporting a NOAEL of 1,000 
mg/kg bwt/day. In a subchronic (13-week) dietary toxicity study in rats 
with imazamox technical, no signs of systemic toxicity were noted, 
supporting a NOAEL of 20,000 ppm (or approximately 1,661 mg/kg bwt/day, 
calculated from food consumption data), the HCT. In a subchronic (90-
day) dietary toxicity study in dogs with imazamox technical, no signs 
of systemic toxicity were noted, supporting a NOAEL of 40,000 ppm (or 
approximately 1,368 mg/kg bwt/day, calculated from the food consumption 
data), the HCT.
    5. Chronic toxicity. The low order of mammalian toxicity of 
imazamox technical is also evident from the chronic dietary toxicity 
studies. These studies showed no increased mortalities or clinical 
signs of toxicity attributed to imazamox treatment. Moreover, there 
were no treatment-related effects on food consumption, body weights, 
organ weights, or hematology, clinical chemistry, urinalysis or 
ophthalmologic parameters. There was no gross or microscopic evidence 
of treatment-related lesions or carcinogenicity in the

[[Page 78232]]

three chronic studies conducted in dogs, mice or rats. A 1-year dietary 
study was conducted with imazamox technical in dogs at dietary 
concentrations of 0, 1,000, 10,000, and 40,000 ppm. The NOAEL for this 
study was 40,000 ppm (or approximately 1,165 mg/kg bwt/day, based on 
food consumption), the HCT.
    A chronic feeding/carcinogenicity study was conducted with imazamox 
technical in male and female rats at dietary concentrations of 0, 
1,000, 10,000, and 20,000 ppm. The NOAEL for systemic toxicity and 
carcinogenicity was 20,000 ppm (or approximately 1,167 mg/kg bwt/day, 
based on food consumption) the HCT. A chronic feeding/ carcinogenicity 
study was conducted with imazamox technical in male and female mice at 
dietary concentration of 500, 3,500, and 7,000 ppm. The NOAEL for 
systemic toxicity and carcinogenicity was 7,000 ppm (or approximately 
1,201 mg/kg bwt/day, based on food consumption), the HCT.
    6. Animal metabolism. The qualitative nature of the residues of 
imazamox and its metabolites CL 263284 and CL 263284's carboxylate AC 
312622 in animals is adequately understood. Based on metabolism studies 
with goats, hens and rats, there is no reasonable expectation that 
measurable imazamox-related residues will occur in meat, milk, poultry 
or eggs from the proposed use.
    7. Metabolite toxicology. No toxicologically significant 
metabolites were detected in plant or animal metabolism studies for 
soybeans or the rest of the crops in the legume vegetable crop grouping 
(6) or canola. Therefore, no metabolites need to be regulated in these 
crops. The plant metabolism study in wheat indicated very low residues 
of concern. A very small amount of the metabolite CL 263284 was found 
in the wheat grain. The plant metabolism in alfalfa indicated very low 
residues in the alfalfa seed. However, the parent imazamox underwent 
metabolism to the metabolite CL 263284 (the same metabolite seen in 
wheat). This metabolite was captured by a glucose molecule to form the 
glucose conjugate CL 189215 and the hydroxymethyl AC 263284 was also 
further oxidized to the carboxylate metabolite CL 312622. Both 
metabolites, CL 263284 and CL 312622 were present in the rat metabolism 
study. No additional toxicologically significant metabolites were 
detected in any plant or animal studies.
    8. Endocrine disruption. Collective organ weight data and 
histopathological findings from the 2-generation rat reproductive 
study, as well as from the sub-chronic and chronic toxicity studies 
conducted in two or more animal species, demonstrate no apparent 
estrogenic effects or effects on the endocrine system. There is no 
information available that suggests that imazamox would be associated 
with endocrine effects.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. Residues of imazamox and its 
metabolic degradates are not of toxicological concern. Therefore, 
dietary exposure through he food is not a concern.
    ii. Drinking water. Residues of imazamox and its metabolic 
degradates are not of toxicological concern. Therefore, dietary 
exposure through water is not a concern.
    2. Non-dietary exposure. There is no available information 
quantifying non-dietary exposure to imazamox. However, based on the 
physical and chemical characteristics of the compound, the proposed use 
pattern and available information concerning its environmental fate, 
non-dietary exposure is not expected.

D. Cumulative Effects

    Because of the low toxicity of imazamox and its metabolic 
degradates, there is no concern regarding the potential for cumulative 
effects of imazamox and its degradates with other substances with a 
common mode of action. Imazamox belongs to the imidazolinone class of 
chemistry. The herbicidal activity of the imidazolinones is due to the 
inhibition of acetohydroxy acid synthase (AHAS), an enzyme only found 
in plants. AHAS is part of the biosynthetic pathway leading to the 
formation of branched-chain amino acids. Animals lack AHAS and this 
biosynthetic pathway. This lack of AHAS contributes to the low toxicity 
of imazamox in mammals. We are aware of no information to indicate or 
suggest that imazamox has any toxic effects on mammals that would be 
cumulative with those of any other chemical. Since imazamox is 
relatively non-toxic, cumulative effects of residues of imazamox and 
other chemicals are not anticipated. Therefore, for the purposes of 
this tolerance petition, no assumption has been made with regard to 
cumulative exposure with other chemicals having a common mode of 
herbicidal action.

E. Safety Determination

    1. U.S. population. Because imazamox and its degradates are not of 
toxicological concern and there is low exposure to imazamox and its 
degradates, this exemption from the requirement of a tolerance in or on 
all raw agricultural commodities will not pose a dietary risk under 
reasonably foreseeable circumstances.
    2. Infants and children. Likewise, because imazamox and its 
degradates are not of toxicological concern and there is low exposure 
to imazamox and its degradates, this exemption from the requirement of 
a tolerance in or on all raw agricultural commodities will not pose a 
dietary risk under reasonably foreseeable circumstances to the U.S. 
population sub-group of infants and children.

F. International Tolerances

    There is no Codex maximum residue level established for residues of 
imazamox on any crops.
FR Doc. 02-32260 Filed 12-20-02; 8:45 a.m.]
BILLING CODE 6560-50-S