[Federal Register Volume 66, Number 4 (Friday, January 5, 2001)]
[Notices]
[Pages 1126-1129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-370]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-991; FRL-6761-9]


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 control number PF-991, must be 
received on or before February 5, 2001.

ADDRESSES:  Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-991 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Kerry Leifer, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-8811; 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:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                      affected  entities
------------------------------------------------------------------------
Industry                          111...............  Crop production
  ..............................  112...............  Animal production
                                  311                 Food manufacturing
  ..............................  32532.............  Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-991. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-991 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs

[[Page 1127]]

(OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to:``[email protected]'', or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-991. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. 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 version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified 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 
control 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 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.


    Dated: December 22, 2000.

James Jones,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. 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.

 Gustafson LLC,

PP 6F4682

    EPA has received a pesticide petition PP6F4682 from Gustafson LLC, 
1400 Preston Road, Suite 400, Plano, TX 75093 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 by establishing a tolerance 
for residues of imidacloprid: 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-
2-imidazolidinimine in or on the raw agricultural commodities: corn, 
field fodder at 0.20 parts per million (ppm); corn, field forage at 
0.10 ppm; and corn, field grain at 0.05 ppm. 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 supports granting of the petition. Additional data may be 
needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of imidacloprid in plants is 
adequately understood for the purposes of these tolerances. The 
residues of concern are combined residues of imidacloprid and its 
metabolites containing the 6-chloro-pyridinyl moiety, all calculated as 
imidacloprid.
    2. Analytical method. The analytical method is a common moiety 
method for imidacloprid and its metabolites containing the 6-chloro-
pyridinyl moiety using a permanganate oxidation, silyl derivatization, 
and capillary GC-MS selective ion monitoring. This method has 
successfully passed a petition method validation in EPA labs. There is 
a confirmatory method specifically for imidacloprid and several 
metabolites utilizing GC/MS and HPLC-UV which has been validated by the 
EPA as well. Imidacloprid and its metabolites are stable for at least 
24 months in the commodities when frozen.
    3. Magnitude of residues. Corn seed was treated with imidacloprid, 
formulated as Gaucho 480 FS at a rate of 8.0 oz.ai/cwt seed. Field 
trials were conducted at twenty locations, one in Region 1, one in 
Region 2, seventeen in Region 5, and one in Region 6. The corn seed was 
planted and the RACs were harvested at the appropriate growth stages. 
The highest average residue level found in field corn forage was 0.064 
ppm. The highest average residue level found in the field corn grain 
was less than the Limit of Quantitation, which was 0.05 ppm. The 
highest average residue level found in the field corn fodder was 0.150 
ppm. The proposed tolerance for field corn forage is 0.10 ppm. The 
proposed tolerance for the field corn fodder is 0.20 ppm. The

[[Page 1128]]

proposed tolerance for the field corn grain is 0.05 ppm.
    Since there were no quantifiable residues in the field corn grain 
RAC samples analyzed in the processing study or in the RAC study, 
neither a Section 409 food/feed additive tolerance or a Section 701 
maximum residue level is required for the processed commodities.

B. Toxicological Profile

    1. Acute toxicity. The acute oral LD50 values for 
imidacloprid technical ranged from 424 - 475 milligrams/kilograms (mg/
kg) body weight (bwt) in the rat. The acute dermal LD50 was 
greater than 5,000 mg/kg in rats. The 4-hour inhalation LC50 
was less than 69 mg/m3 air (aerosol). Imidacloprid was not 
irritating to rabbit skin or eyes. Imidacloprid did not cause skin 
sensitization in guinea pigs.
    2. Genotoxicity. Extensive mutagenicity studies conducted to 
investigate point and gene mutations, DNA damage and chromosomal 
aberration, both using in vitro and in vivo test systems show 
imidacloprid to be non-genotoxic.
    3. Reproductive and developmental toxicity. A 2-generation rat 
reproduction study gave a no observed adverse effect level (NOAEL) of 
100 ppm (8 mg/kg/bwt). Rat and rabbit developmental toxicity studies 
were negative at doses up to 30 mg/kg/bwt and 24 mg/kg/bwt, 
respectively.
    4. Subchronic toxicity. Ninety-day feeding studies were conducted 
in rats and dogs. The NOAELs for these tests were 14 mg/kg/bwt/day (150 
ppm) and 5 mg/kg/bwt/day (200 ppm), for the rat and dog studies, 
respectively.
     5. Chronic toxicity. A 2-year rat feeding/carcinogenicity study 
was negative for carcinogenic effects under the conditions of the study 
and had a NOAEL of 100 ppm (5.7 mg/kg/bwt in males and 7.6 mg/kg/bwt in 
females for non-carcinogenic effects that included decreased body 
weight gain in females at 300 ppm and increased thyroid lesions in 
males at 300 ppm and females at 900 ppm. A 1-year dog feeding study 
indicated a NOAEL of 1,250 ppm (41 mg/kg/bwt). A 2-year mouse 
carcinogenicity study was negative for carcinogenic effects under 
conditions of the study and had a NOAEL of 1,000 ppm (208 mg/kg/day).
    Imidacloprid has been classified under ``Group E'' (no evidence of 
carcinogenicity) by EPA's OPP/HED's Reference Dose (RfD) Committee. 
There is no cancer risk associated with exposure to this chemical. The 
RfD based on the 2-year rat feeding/carcinogenic study with a NOAEL of 
5.7 mg/kg/bwt and 100-fold uncertainty factor, is calculated to be 
0.057 mg/kg/bwt. The theoretical maximum residue contribution (TMRC) 
from published uses is 0.008358 mg/kg/bwt/day utilizing 14.7% of the 
RfD.
    6. Animal metabolism. The metabolism of imidacloprid in rats was 
reported in seven studies. Data in these studies show that imidacloprid 
was rapidly absorbed and eliminated in the excreta (90% of the dose 
within 24 hours), demonstrating no biologically significant differences 
between sexes, dose levels, or route of administration. Elimination was 
mainly renal (70-80% o f the dose) and fecal (17-25%). The major part 
of the fecal activity originated in the bile. Total body accumulation 
after 48 hours consisted of 0.5% of the radioactivity with the liver, 
kidney, lung, skin and plasma being the major sites of accumulation. 
Therefore, bioaccumulation of imidacloprid is low in rats. Maximum 
plasma concentration was reached between 1.1 and 2.5 hours. Two major 
routes of biotransformation were proposed for imidacloprid. The first 
route included an oxidative cleavage of the parent compound rendering 
6-chloronicotinic acid and its glycine conjugate. Dechlorination of 
this metabolite formed the 6-hydroxynicotinic acid and its mercapturic 
acid derivative. The second route included the hydroxylation followed 
by elimination of water from the parent compound.
    7. Metabolite toxicology. Several metabolites of imidacloprid have 
been investigated for acute toxicity and genotoxicity. No evidence for 
genotoxicity was found, and acute toxicity values for all metabolites 
studied ranged from slightly more toxic to significantly less toxic 
than parent imidacloprid.
    8. Endocrine disruption. The toxicology data base for imidacloprid 
is current and complete. Studies in this database include evaluation of 
the potential effects on reproduction and development, and an 
evaluation of the pathology of the endocrine organs following short-
term or long-term exposure. These studies revealed no primary endocrine 
effects due to imidacloprid.

C. Aggregate Exposure

    1. Dietary exposure. Imidacloprid is a broad-spectrum insecticide 
with excellent systemic and contact toxicity characteristics with both 
food and non-food uses. Imidacloprid is currently registered for use on 
various food crops including seed treatments, tobacco, turf, 
ornamentals, buildings for termite control, and cats and dogs for flea 
control. Those potential exposures are addressed below:
    i. Food. The EPA has determined that the reference dose (RfD) based 
on the 2 year rat feeding/carcinogenicity study with a NOAEL of 5.7 mg/
kg/bwt and 100-fold uncertainty factor, is calculated to be 0.057 mg/
kg/bwt. As published in the Federal Register June 12, 1996 (61 FR 
29674) (FRL-5367-8) (petition to establish tolerances on leafy green 
vegetables (PP 5F4522/R2237)), the theoretical maximum residue 
contribution (TMRC) from published uses is 0.008358 mg/kg/bwt utilizing 
14.7% of the RfD for the general population. For the most highly 
exposed subgroup in the population, non-nursing infants (less than 1 
year old), the TMRC for the published tolerances is 0.01547 mg/kg/day. 
This is equal to 27.1% of the RfD.
    The TMRC for corn is calculated to be 0.000055 mg/kg/bwt/day for 
the general population, which represents 0.1% of the RfD. The TMRC for 
the most highly exposed subgroup in the population, non-nursing infants 
is 0.000131 mg/kg/bwt/day, which represents 0.2% of the RfD. The TMRC 
for children ages 1 to 6 years is 0.000130 mg/kg/bwt/day, which 
represents 0.2% of the RfD, and for nursing infants is 0.000032 mg/kg/
bwt/day, which represents 0.1% of the RfD. For children 7 to 12 years 
of age, the TMRC is 0.000098 mg/kg/bwt/day, which represents 0.2% of 
the RfD. Therefore, dietary exposure from field corn will not exceed 
the reference dose for any subpopulation (including infants and 
children).
    ii. Drinking water. Although the various imidacloprid labels 
contain a statement that this chemical demonstrates the properties 
associated with chemicals detected in ground water, the Registrant is 
not aware of imidacloprid being detected in any wells, ponds, lakes, 
streams, etc. from its use in the United States. Imidacloprid is 
hydrolytically stable at pH 5 and 7 with photolytic degradation in 
water having a half-life of 4.2 hours. Under aerobic soil conditions in 
laboratory studies, imidacloprid has a half-life of 188 to >366 days. 
Under laboratory anaerobic aquatic conditions, the half-life was 27 
days. Adsorption/desorption studies indicate that aged imidacloprid 
residues do not leach into the soil. Imidacloprid dissipates under 
actual field conditions with a half-life of 7 to 196 days. Imidacloprid 
remained in the top six inches of the soil in U.S. tests for the 
duration of nine of ten field dissipation studies. The presence of 
growing vegetation significantly increased the rate of degradation of 
imidacloprid. In studies conducted in

[[Page 1129]]

1995, imidacloprid was not detected in seventeen wells on potato farms 
in Quebec, Canada. In addition, ground water monitoring studies are 
currently underway in California and Michigan. Therefore, contributions 
to the dietary burden from residues of imidacloprid in water would be 
inconsequential.
    2. Non-dietary exposure-- i. Residential turf. Bayer Corporation 
has conducted an exposure study to address the potential exposures of 
adults and children from contact with imidacloprid treated turf. The 
population considered to have the greatest potential exposure from 
contact with pesticide treated turf soon after pesticides are applied 
are young children. Margins of safety (MOS) of 7,587 - 41,546 for 10 
year old children and 6,859 - 45,249 for 5 year old children were 
estimated by comparing dermal exposure doses to the imidacloprid NOAEL 
of 1,000 mg/kg/day established in a 15 day dermal toxicity study in 
rabbits. The estimated safe residue levels of imidacloprid on treated 
turf for 10 year old children ranged from 5.6 - 38.2 g/cm2 
and for 5 year old children from 5.1 - 33.3 g/cm2. This 
compares with the average imidacloprid transferable residue level of 
0.080 g/cm2 present immediately after the sprays have dried. 
These data indicate that children can safely contact imidacloprid-
treated turf as soon after application as the spray has dried.
    ii. Termiticide. Imidacloprid is registered as a termiticide. Due 
to the nature of the treatment for termites, exposure would be limited 
to that from inhalation and was evaluated by EPA's Occupational and 
Residential Exposure Branch (OREB) and Bayer Corporation. Data indicate 
that the Margins of Safety for the worst case exposures for adults and 
infants occupying a treated building who are exposed continuously (24 
hours/day) are 8.0 x 107 and 2.4 x 108, 
respectively, and exposure can thus be considered negligible.
    iii. Tobacco smoke. Studies have been conducted to determine 
residues in tobacco and the resulting smoke following treatment. 
Residues of imidacloprid in cured tobacco following treatment were a 
maximum of 31 ppm (7 ppm in fresh leaves). When this tobacco was burned 
in a pyrolysis study only two percent of the initial residue was 
recovered in the resulting smoke (main stream plus side stream). This 
would result in an inhalation exposure to imidacloprid from smoking of 
approximately 0.0005 mg per cigarette. Using the measured subacute rat 
inhalation NOAEL of 5.5 mg/m3, it is apparent that exposure 
to imidacloprid from smoking (direct and/or indirect exposure) would 
not be significant.
    iv. Pet treatment. Human exposure from the use of imidacloprid to 
treat dogs and cats for fleas has been addressed by EPA's Occupational 
and Residential Exposure Branch (OREB) who have concluded that due to 
the fact that imidacloprid is not an inhalation or dermal toxicant and 
that while dermal absorption data are not available, imidacloprid is 
not considered to present a hazard via the dermal route.

D. Cumulative Effects

    No other chemicals having the same mechanism of toxicity are 
currently registered, therefore, there is no risk from cumulative 
effects from other substances with a common mechanism of toxicity.

E. Safety Determination

    1. U.S. population. Using the conservative exposure assumptions 
described above and based on the completeness and reliability of the 
toxicity data, it can be concluded that total aggregate exposure to 
imidacloprid from all current uses including those currently proposed 
will utilize little more than 15% of the RfD for the U.S. population. 
EPA generally has no concerns for exposures below 100% of the RfD, 
because the RfD represents the level at or below which daily aggregate 
exposure over a lifetime will not pose appreciable risks to human 
health. The TMRC from exposure to field corn for the general 
population, is 0.000055 mg/kg/bwt/day, which represents 0.1% of the 
RfD. Thus, it can be concluded that there is a reasonable certainty 
that no harm will result from aggregate exposure to imidacloprid 
residues.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of imidacloprid, the 
data from developmental studies in both rat and rabbit and a 2-
generation reproduction study in the rat have been considered. The 
developmental toxicity studies evaluate potential adverse effects on 
the developing animal resulting from pesticide exposure of the mother 
during prenatal development. The reproduction study evaluates effects 
from exposure to the pesticide on the reproductive capability of mating 
animals through 2 generations, as well as any observed systemic 
toxicity.
    FFDCA Section 408 provides that the EPA may apply an additional 
safety factor for infants and children in the case of threshold effects 
to account for prenatal and postnatal effects and the completeness of 
the toxicity database. Based on current toxicological data 
requirements, the toxicology database for imidacloprid relative to 
prenatal and postnatal effects is complete. Further for imidacloprid, 
the NOAEL of 5.7 mg/kg/bwt from the 2-year rat feeding/carcinogenic 
study, which was used to calculate the RfD (discussed above), is 
already lower than the NOAELs from the developmental studies in rats 
and rabbits by a factor of 4.2 to 17.5 times. Since a 100-fold 
uncertainty factor is already used to calculate the RfD, it is surmised 
that an additional uncertainty factor is not warranted and that the RfD 
at 0.057 mg/kg/bwt/day is appropriate for assessing aggregate risk to 
infants and children. Using the conservative exposure assumptions 
described above, EPA has concluded that the TMRC from use of 
imidacloprid from published uses is 0.008358 mg/kg/bwt/day utilizing 
14.7% of the RfD for the general population. For the most highly 
exposed subgroup in the population, non-nursing infants (less than 1 
year old), the TMRC for the published tolerances is 0.01547 mg/kg/day. 
This is equal to 27.1% of the RfD. The TMRC from exposure to field corn 
to non-nursing infants is 0.000131 mg/kg/bwt/day, which represents 0.2% 
of the RfD. The TMRC for children ages 1 to 6 years is 0.000130 mg/kg/
bwt/day, which represents 0.2% of the RfD. For nursing infants, the 
TMRC is 0.000032 mg/kg/bwt/day, which is 0.1% of the RfD. For children 
ages 7 to 12 years, the TMRC is 0.000098 mg/kg/bwt/day, which is 0.2% 
of the RfD. Thus, it can be concluded that there is a reasonable 
certainty that no harm will result from additional exposure of infants 
and children.

F. International Tolerances

    No CODEX Maximum Residue Levels (MRLs) have been established for 
residues of imidacloprid on any crops at this time.

[FR Doc. 01-370 Filed 1-4-01; 8:45 am]
BILLING CODE 6560-50-S