[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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