[Federal Register Volume 65, Number 29 (Friday, February 11, 2000)]
[Notices]
[Pages 7008-7012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3220]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-915; FRL-6487-9]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for Certain Pesticide Chemicals 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 
certain pesticide chemicals in or on various food commodities.

DATES: Comments, identified by docket control number PF-915, must be 
received on or before March 13, 2000.

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-915 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Peg Perreault, Registration 
Support Branch, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 
305-5417; 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

[[Page 7009]]

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'' 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-915. 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 Mall2, 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-915 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 (OPP), Environmental Protection 
Agency, Ariel Rios Bldg., 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 Mall2, 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-915. 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 Comestic 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 supports 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: January 27, 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. EPA is publishing the petition summary verbatim without 
editing it in any way. 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.

BAYER Corporation

PP 8F4940

    EPA has received a pesticide petition (PP 8F4940) from BAYER 
Corporation, 8400 Hawthorn Road, P.O. Box 4913, Kansas City, MO 64120-
0013 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 in or on the 
raw agricultural commodities (RAC): citrus fruit, citrus pulp, dried 
and the leafy petiole subgroup (4-B) at 0.7, 5.0, and 6.0 parts per 
million (ppm), respectively. EPA has determined that the petition 
contains data or information regarding the elements set forth in

[[Page 7010]]

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 nature of the imidacloprid residue in 
plants is adequately understood. The residues of concern are combined 
residues of imidacloprid and it metabolites containing the 6-
chloropyridinyl moiety, all calculated as imidacloprid.
    2. Analytical method. The analytical method is a common moiety 
method for imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety using a permanganate oxidation, silyl 
derivatization, and capillary gas chromatography mass spectrometry (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 high performance liquid chromotography using ultra-violet detection 
(HPLC-UV) which has been validated by EPA as well. Imidacloprid and its 
metabolites are stable for at least 24 months in the commodities when 
frozen.
    3. Magnitude of residues--i. Citrus. Forty-three residue crop field 
trials (23 foliar applications and 20 soil applications) were conducted 
to evaluate the quantity of imidacloprid expected in citrus from Admire 
2, Flowable and Provado 1.6 applications. These trials were conducted 
in EPA Regions III, VI, and X. Imidacloprid residues in citrus whole 
fruit (oranges, grapefruit, and lemons) were quantitated by GC using a 
MS detector. The limit of quantitation (LOQ) was 0.05 ppm. The highest 
average field trial (HAFT) was 0.61 ppm in oranges. A processing study 
at 5 times the maximum recommended label use rate was conducted to 
evaluate the quantity of imidacloprid and metabolite residue in orange 
processed commodities following treatment of orange trees with Admire 
2F. Harvested whole oranges were processed into dried pulp, oil, 
molasses, and juice using procedures which simulated commercial orange 
processing practices. Imidacloprid and metabolite residues in orange 
whole fruit and orange processed commodities were quantitated by GC 
using a MS detector. Total residue of imidacloprid and metabolites in 
orange whole fruit was 0.19 ppm. EPA's Table 1 - RAC and processed 
commodities and feedstuffs derived from crops lists dried pulp, oil, 
and juice as processed commodities. The processing study showed a total 
residue for imidacloprid and metabolites of 1.42 ppm (7.5x 
concentration) in dried pulp and no concentration of total residue of 
imidacloprid and metabolites in both orange juice and oil (0.05 ppm).
    ii. Leaf petioles subgroup vegetables. Twelve residue crop field 
trials on celery were conducted to evaluate the quantity of 
imidacloprid expected in members of the leaf petiole vegetable subgroup 
from Admire 2 Flowable applications. These trials, which compared plant 
drench, soil sidedress and in-furrow at transplant applications, were 
conducted in EPA Regions III, V, VI, X, and XI. Imidacloprid residues 
in untrimmed celery stalks were quantitated by using a GC/MC. The LOQ 
was 0.05 ppm. Total residue values ranged from 0.13 to 5.62 ppm.

B. Toxicological Profile

    1. Acute toxicity. The acute oral LD50 values for 
imidacloprid technical ranged from 424 - 475 milligrams/kilograms/body 
weight (mg/kg/bwt) in the rat. The acute dermal LD50 was 
greater than 5,000 mg/kg in rats. The 4-hour rat inhalation 
LC50 was 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 male and 7.6 mg/kg/bwt female) 
for noncarcinogenic effects that included decreased bwt 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 that 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.
    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% of 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 data base 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.

[[Page 7011]]

C. Aggregate Exposure

    1. Dietary exposure--i. Food. For purposes of assessing the 
potential acute and chronic dietary exposure, Bayer has estimated 
exposure based on the theoretical maximum residue contribution (TMRC). 
The TMRC is obtained by using a model which multiplies the tolerance 
level residue for each commodity by consumption data. The consumption 
data, based on the NFCS 1989-92 data base, estimates the amount of each 
commodity and products derived from the commodities that are eaten by 
the U.S. population and various population subgroups.
    a. Acute. For acute dietary exposure the model calculates a margin 
of exposure (MOE) by dividing the estimated human exposure into the 
NOAEL from the appropriate animal study. Commonly, EPA finds MOEs lower 
than 100 to be unacceptable. EPA has determined that a NOAEL of 24 mg/
kg/day from a developmental toxicity study in rabbits should be used to 
assess acute toxicity.
    The MOE for imidacloprid derived from previously established 
tolerances, pending tolerances, plus the proposed use on citrus and the 
leaf petiole subgroup would be 366 for the U.S. population (48 
contiguous States), 323 for non-nursing infants, 101 for children (ages 
1-6 years), 420 for children (ages 7-12 years), 622 for males 13+ 
years, and 554 for females 13+ years at the 99.9 percentile. These MOEs 
do not exceed EPA's level of concern for acute dietary exposure.
    b. Chronic. For purposes of assessing the potential chronic dietary 
exposure, the model uses the RfD which EPA has determined to be 0.057 
mg/kg/day. This is based on the 2-year rat feeding/carcinogenic study 
with a NOAEL of 5.7 mg/kg/bwt and 100-fold uncertainty factor. In 
conducting this exposure assessment, very conservative assumptions 
(100% of all commodities contain imidacloprid residues and those 
residues are at the level of the tolerance) result in a large 
overestimate of human exposure.
    Using these conservative assumptions, the TMRC for imidacloprid 
derived from previously established tolerances, pending tolerances, 
plus the proposed use on citrus and leaf petiole subgroup would be 
0.008149 mg/kg bwt/day (14.3% of the RfD) for the U.S. population (48 
contiguous States) and 0.018367 mg/kg bwt/day (32.2% of the RfD) for 
the most highly exposed population subgroup, children (1-6 years old). 
Therefore, chronic dietary exposure from the existing and proposed uses 
will not exceed the RfD for any subpopulation, including infants and 
children.
    ii. Drinking water. EPA has determined that imidacloprid is 
persistent and could potentially leach into groundwater. However, there 
is no established maximum contamination level (MCL) or health advisory 
levels established for imidacloprid in drinking water. EPA's 
``Pesticides in Groundwater Database'' has no entry for imidacloprid. 
In addition, Bayer is not aware of imidacloprid being detected in any 
ponds, lakes, streams, etc. from its use in the United States. 
Groundwater monitoring studies conducted in California, Michigan, and 
Long Island over the past 2 years have found maximum concentrations to 
be only 0.0001, 0.0002, and 0.0019 milligrams/liter (mg/L), 
respectively. Therefore, contributions to the dietary burden from 
residues of imidacloprid in water would be inconsequential.
    2. Non-dietary exposure--i. Residential turf. Bayer 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 - 33.5 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. Data indicate that the 
MOS 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; 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 2% 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 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 under aggregate exposure 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 14.3% of the RfD 
for the U.S. population from food, water, and non-occupational sources. 
EPA generally has no concern 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. In addition, the MOEs for all population groups does not exceed 
EPA's level of concern for acute dietary exposure. 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

[[Page 7012]]

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 two generations, as well as any observed systemic 
toxicity.
    FFDCA section 408 provides that 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 data base. 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 old 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 under 
aggregate exposure, Bayer has determined from a chronic dietary 
analysis that the percent of the RfD utilized by aggregate exposure to 
residues of imidacloprid ranges from 9.3% for nursing infants up to 
32.2% for children (1-6 years old). EPA generally has no concern for 
exposure below 100% of the RfD. In addition, the MOEs for all infant 
and children population groups do not exceed EPA's level of concern for 
acute dietary exposure. Therefore, based on the completeness and 
reliability of the toxicity data and the conservative exposure 
assessment, there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the residues of 
imidacloprid, including all anticipated dietary exposure and all other 
non-occupational exposures

F. International Tolerances

    No CODEX maximum residue levels have been established for residues 
of Imidacloprid on any crops at this time.
[FR Doc. 00-3220 Filed 2-10-00; 8:45 am]
BILLING CODE 6560-50-F