[Federal Register Volume 63, Number 57 (Wednesday, March 25, 1998)]
[Rules and Regulations]
[Pages 14363-14371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7647]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300625; FRL-5776-5]
RIN 2070-AB78
Imidacloprid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for residues of the
insecticide 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine and its metabolites in or on pecans. The Bayer
Corporation submitted a petition to EPA
[[Page 14364]]
under the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (Pub. L. 104-170) requesting
this tolerance.
DATES: This regulation is effective March 25, 1998. Objections and
requests for hearings must be received by EPA on or before May 26,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [OPP-300625], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the
document control number, [OPP-300625], must also be submitted to:
Public Information and Records Integrity Branch, Information Resources
and Services Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person, bring a copy of objections and hearing requests to Rm. 119,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the document control
number [OPP-300625]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Elizabeth T. Haeberer,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-2891, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of December 17, 1997
(62 FR 66077)(FRL-5758-3), EPA, issued a notice pursuant to section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e)
announcing the filing of a pesticide petition (PP 5F4480) by the Bayer
Corporation, 8400 Hawthorn Road, P.O. Box 4913, Kansas City, MO 64120-
0013, to establish tolerances for the residues of the insecticide 1-
[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidiinimine in or on
pecan, nut at 0.05 parts per million (ppm). This notice included a
summary of the petition prepared by the Bayer Corporation, the
registrant. There were no comments received in response to the notice
of filing.
The petition requested that 40 CFR 180.472(a) be amended by
establishing a tolerance for the insecticide, 1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2-imidazolidiinimine, in or on pecans at 0.05
ppm.
I. Risk Assessment and Statutory Findings
EPA establishes maximum legal levels (tolerances) for pesticide
residues on food under section 408 of the FFDCA. EPA performs a number
of analyses to determine the risks from aggregate exposure to pesticide
residues. For further discussion of the regulatory requirements of
Section 408 and a complete description of the risk assessment process,
see the Final Rule on Bifenthrin Pesticide Tolerances in the Federal
Register of November 26, 1997, (62 FR 62961-62970)(FRL-5754-7).
II. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action, EPA has sufficient data to assess the hazards of 1-[(6-
chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine and its
metabolites containing the 6-chloropyridinyl moiety, all calculated as
imidacloprid, and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a tolerance for 1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2-imidazolidinimine and its metabolites
containing the 6-chloropyridinyl moiety, all calculated as
imidacloprid, on pecans at 0.05 ppm. EPA's assessment of the dietary
exposures and risks associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by 1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2-imidazolidinimine and its metabolites
containing the 6-chloropyridinyl moiety are discussed below.
1. A battery of acute toxicity studies placing technical
imidacloprid in Toxicity Category II for oral LD50, Category
IV for dermal LD50, inhalation LC50, eye
iritation and dermal irritation. Imidacloprid is a non-sensitizer.
2. In an acute neurotoxicity study, groups of Sprague-Dawley rats
(18/sex/dose) were given a single oral administration of imidacloprid
(97.6%) in 0.5% methylcellulose with 0.4% Tween 80 in deionized water
at 0, 42, 151 or 307 mg/kg. Parameters evaluated included: clinical
pathology (6/sex/dose); Functional Observation Battery (FOB)
measurements (12/sex/dose); and neuropathology (6/sex/dose). FOB
measurements were made approximately 90 minutes post dosing, and on
days 7 and 14. Motor activity measurements were made at approximately
2.5 hours post dosing.
At 307 mg/kg/day, 4/18 males and 10/18 females died and both sexes
of rats at this dose exhibited decreased numbers of rears, grip
strength (forelimb and hindlimb) and response to stimuli (auditory,
touch, or tail pinch) as well as increased gait abnormalities, righting
reflex impairments and body temperatures. These symptoms regressed by
day 5. At 151 milligram/kilograms/day (mg/kg/day), cage side FOB
assessments revealed tremors in one male and one female and red nasal
staining in one male. On the day of dosing, a dose-related decrease in
total session motor activity was observed in males at 151 mg/kg/day
(25% decrease) and 307 mg/kg/day (73%) and in females at all dose
levels with the decreases (25, 48, and 81%, respectively at 42, 151 and
307 mg/kg/day) reaching statistical significance (p <0.05) at 151 and
307 mg/kg/day dose levels. Decreases in motor activity were seen at all
time intervals. Total session locomotor activity was also decreased to
about the same percentage difference but statistical significance was
not reported. On days 7 and 14, decreases (not statistically
significant) were still observed in motor and locomotor activity in
surviving high-dose males. The lowest-observed-effect level (LOEL) was
42 mg/kg based on the decrease in
[[Page 14365]]
motor and locomotor activities observed in females; a no-observed-
effect level (NOEL) was not established.
3. In a subchronic oral toxicity study, groups of Fischer 344 rats
(12/sex/dose) were fed diets containing imidacloprid (98.8%) at 0, 150,
1,000, or 3,000 ppm (0, 9.3, 63.3, or 196 mg/kg/day in males and 0,
10.5, 69.3 or 213 mg/kg/day in females, respectively) for 90 days. No
treatment-related effects were seen at 150 ppm. Treatment-related
effects included decreases in body weight gain during the first 4 weeks
of the study at 1,000 ppm (22% in males and 18% in females) and 3,000
ppm (50% in males and 25% in females) with an associated decrease in
forelimb grip strength especially in males. The NOEL was 150 ppm (9.3
and 10.5 mg/kg/day in males and females, respectively) and the LOEL was
1,000 ppm (63.3 and 69.3 mg/kg/day in males and females, respectively).
4. In a subchronic dermal toxicity study, groups of five male and
five female New Zealand White rabbits received repeated dermal
applications of imidacloprid (95%) at 1,000 mg/kg/day (Limit Dose), 6
hours/day, 5 days/week for 3 weeks. No dermal or systemic toxicity was
seen. For systemic and dermal toxicity, the NOEL was > 1,000 mg/kg/day;
a LOEL was not established.
5. In a rat inhalation study (28-day study in which rats were
exposed 6 hours/day, 5 days a week for 4 weeks), the no observable
effect concentration (NOEC) for imidacloprid was 5.5 mg/m3.
6. In a chronic oral toxicity study, groups of beagle dogs (4/sex/
dose) were fed diets containing imidacloprid (94.9%) at 0, 200 or
1,250/2,500 ppm (0, 6.1, 15 or 41/72 mg/kg/day, respectively) for 52
weeks. The 1,250 ppm dose was increased to 2,500 ppm from week 17
onwards. The threshold NOEL was 1,250 ppm (41 mg/kg/day). The LOEL was
2,500 ppm (72 mg/kg/day) based on increased cytochrome-P-450 levels in
both sexes and was considered to be a threshold dose. Due to the lack
of toxicity at 1,250 ppm, a NOEL was not established in this study;
following the dose increase to the 2,500 ppm level, toxicity was
observed, thus making 1,250 ppm the threshold NOEL and 2,500 ppm the
threshold LOEL.
7. In a combined chronic toxicity/carcinogenicity study, groups of
Bor WISW rats (50/sex/dose) received imidacloprid (95.3%) at 0, 100,
300 or 900 ppm (0, 5.7, 16.9 or 51.3 mg/kg/day in males and 0, 7.6,
24.9, or 73 mg/kg/day in females, respectively) for 104 weeks. In
another study, rats of the same strain (50/sex) received imidacloprid
at 0 or 1,800 ppm (0, 102.6 and 143.7 mg/kg/day in males and females,
respectively) for 104 weeks. For chronic toxicity, the NOEL was 100 ppm
(5.7 mg/kg/day) and the LOEL was 300 ppm (16.9 mg/kg/day) based on
decreased body weight gains in females and increased thyroid lesions in
males. There was no evidence of carcinogenicity in either sex.
8. In a carcinogenicity study groups of B6C3F1 mice (50/sex/dose)
were fed diets containing imidacloprid (95%) at 0, 100, 330 or 1,000
ppm (0, 20, 66 or 208 mg/kg/day in males and 0, 30, 104 or 274 mg/kg/
day in females, respectively) for 2 years. In a supplementary study
conducted to evaluate the adequacy of the high dose tested in the main
study, the same strain of mice (50/sex) received 0 or 2,000 ppm (414
and 424 mg/kg/day in males and females, respectively) for the same time
period. For chronic toxicity, the NOEL was 1,000 ppm (208 mg/kg/day).
The LOEL was 2,000 ppm (414 mg/kg/day) based on decreased body weight
gain, food consumption and water consumption. There was no evidence of
carcinogenicity in either sex.
9. In a developmental toxicity study with Sprague-Dawley rats,
groups of pregnant animals (25/group) received oral administration of
imidacloprid (94.2%) at 0, 10, 30, or 100 mg/kg/day during gestation
days 6 through 16. Maternal toxicity was manifested as decreased body
weight gain at all dose levels and reduced food consumption at 100 mg/
kg/day. No treatment-related effects were seen in any of the
reproductive parameters (i.e., cesarean section evaluation). At 100 mg/
kg/day, developmental toxicity manifested as wavy ribs (fetus =7/149 in
treated vs. 2/158 in controls and litters, 4/25 vs. 1/25). For maternal
toxicity, the LOEL was 10 mg/kg/day lowest dose tested (LDT) based on
decreased body weight gain; a NOEL was not established. For
developmental toxicity, the NOEL was 30 mg/kg/day and the LOEL was 100
mg/kg/day based on increased wavy ribs.
10. In a developmental toxicity study with Chinchilla rabbits,
groups of 16 pregnant does were given oral doses of imidacloprid
(94.2%) at 0, 8, 24 or 72 mg/kg/day during gestation days 6 through 18.
For maternal toxicity, the NOEL was 24 mg/kg/day and the LOEL was 72
mg/kg/day based on mortality, decreased body weight gain, increased
resorptions, and increased abortions. For developmental toxicity, the
NOEL was 24 mg/kg/day and the LOEL was 72 mg/kg/day based on decreased
fetal body weight, increased resorptions, and increased skeletal
abnormalities.
11. In a 2-generation reproductive toxicity study, imidacloprid
(95.3%) was administered to Wistar/Han rats at dietary levels of 0,
100, 250, or 700 ppm (0, 7.3, 18.3, or 52.0 mg/kg/day for males and 0,
8.0, 20.5, or 57.4 mg/kg/day for females). For parental/systemic/
reproductive toxicity, the NOEL was 250 ppm (18.3 mg/kg/day) and the
LOEL was 750 ppm (52 mg/kg/day), based on decreases in body weight in
both sexes in both generations. Based on these factors,the Data
Evaluation Record should be revised to indicate the parental/systemic/
reproductive NOEL and LOEL to be 250 and 700 ppm, respectively, based
upon the body weight decrements observed in both sexes in both
generations.
12. Studies on gene mutation and other genotoxic effects: an Ames
Salmonella Assay which was negative up to 5,500 g/plate
concentration; recombination assay-yeast, negative for cross-over in
yeast up to 10,000 g; In Vivo Chromasomal Aberration, negative
for chromosome breakage up to 2,000 g/ml; In Vitro Chromasomal
Aberrations, positive at 500 g/ml -S9 and 1,300 g/ml
+S9, both toxic doses (acceptable study); In Vivo Sister Chromatid
assay, negative up to 2,000 g/ml; In Vitro Cytogenetics-CHO
cells, negative for producing forward mutation in CHO (mammalian) cells
treated up to 1,222 g/ml; Micronucleus - mouse, negative up to
(toxic) 50 g/ml (ip); DNA repair test, negative for cross-over
in yeast up to 10,000 g; HGPRT assay-CHO, negative up to 2,000
g/ml. Mutagenicity studies have demonstrated that imidacloprid
is non-mutagenic both in vivo and in vitro.
B. Toxicological Endpoints
1. Special sensitivity to infants and children. In assessing the
potential for additional sensitivity of infants and children to
residues of imidacloprid, EPA considered data from developmental
toxicity studies in the rat and rabbit and a 2-generation reproduction
study in the rat. These studies are described in unit II A. of this
document. The developmental toxicity data demonstrated no increased
sensitivity of rats or rabbits to in utero exposure to imidacloprid. In
addition, the multi-generation reproductive toxicity study data did not
identify any increased sensitivity of rats to in utero or postnatal
exposure. Parental NOELs were lower or equivalent to developmental or
offspring NOELs. The developmental toxicity studies are designed to
evaluate adverse effects on the developing organism resulting from
maternal pesticide exposure gestation. Reproduction studies provide
information relating to effects from exposure to the pesticide on the
[[Page 14366]]
reproductive capability of mating animals and data on systemic
toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a MOE analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. EPA believes that reliable data support using the standard
uncertainty factor (usually 100 for combined inter- and intra-species
variability)) and not the additional tenfold MOE/uncertainty factor
when EPA has a complete data base under existing guidelines and when
the severity of the effect in infants or children or the potency or
unusual toxic properties of a compound do not raise concerns regarding
the adequacy of the standard MOE/safety factor.
Although developmental toxicity studies showed no increased
sensitivity in fetuses as compared to maternal animals following in
utero exposures in rats and rabbits, no increased sensitivity in pups
as compared to adults was seen in the two generation reproduction
toxicity study in rats, and the toxicology data base is complete as to
core requirements, the Agency determined that the additional safety
factor for the protection of infants and children will be retained but
reduced to 3x based on the following weight-of-the-evidence
considerations relating to potential sensitivity and completeness of
the data:
(i) There is concern for structure activity relationship.
Imidacloprid, a chloronicotinyl compound, is an analog to nicotine and
studies in the published literature suggests that nicotine, when
administered causes developmental toxicity, including functional
deficits, in animals and/or humans that are exposed in utero.
(ii) There is evidence that imidacloprid administration causes
neurotoxicity following a single oral dose in the acute study and
alterations in brain weight in rats in the 2-year carcinogenicity
study.
(iii) The concern for structure activity relationship along with
the evidence of neurotoxicity dictates the need of a developmental
neurotoxicity study for assessment of potential alterations on
functional development.
Because a developmental neurotoxicity study potentially relates to
both acute and chronic effects in both the mother and the fetus, the
additional UF for FQPA is being applied for all population subgroups,
and both acute and chronic risk.
2. Acute toxicity. Acute dietary risk assessment is required for
all population subgroups. LOEL=42 mg/kg/day based on decreased motor
activity in female rats; MOE=300, as discussed above. Conventionally,
when a LOEL from the critical study is used for risk assessment, an
additional UF will be applied. For acute risk assessment with
imidacloprid, however, the Committee determined that an additional
uncertainty factor is not necessary because: (i) of the low confidence
in the endpoint based on the minimal nature of the effect (decreased
motor activity only in females);(ii) this effect was seen in adult
rats; and (iii) the same effect was not seen in the subchronic toxicity
study following repeated doses.
3. Short - and intermediate - term toxicity. In a dermal toxicity
study, groups of five male and five female New Zealand White rabbits
received repeated dermal applications of imidacloprid (95%) at 1,000
mg/kg/day (Limit Dose), 6 hours/day, 5 days/week for three weeks. No
dermal or systemic toxicity was seen. For systemic and dermal toxicity,
the NOEL was > 1,000 mg/kg/day; a LOEL was not established (MRID No.
42256329).
In an oral toxicity study, groups of Fischer 344 rats (12/sex/dose)
were fed diets containing imidacloprid (98.8%) at 0, 150, 1,000, or
3,000 ppm (0, 9.3, 63.3, or 196 mg/kg/day in males and 0, 10.5, 69.3 or
213 mg/kg/day in females, respectively) for 90 days. No treatment-
related effects were seen at 150 ppm. Treatment-related effects
included decreases in body weight gain during the first 4 weeks of the
study at 1,000 ppm (22% in males and 18% in females) and 3,000 ppm (50%
in males and 25% in females) with an associated decrease in forelimb
grip strength especially in males. The NOEL was 150 ppm (9.3 and 10.5
mg/kg/day in males and females, respectively) and the LOEL was 1,000
ppm (63.3 and 69.3 mg/kg/day in males and females, respectively) (MRID
No. 43286401).
In a rat inhalation study (28-day study in which rats were exposed
6 hours/day, 5 days a week for 4 weeks), the no observable effect
concentration (NOEC) for imidacloprid was 5.5 mg/m3 (MRID No. 422730-
01).
4. Chronic toxicity. EPA has established the RfD for 1-[(6-chloro-
3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine at 0.019 mg/kg/day.
This RfD is based upon increased number of thyroid lesions in male and
decreased body weight gains in female Bor WISW rats, with a NOEL of 5.7
mg/kg/day, and LOEL of 16.9/24.9 mg/kg/day (males and females
respectively); UF=300, as discussed above.
5. Carcinogenicity. This chemical has been classified as a Group E
- no evidence of carcinogenicity for humans. A cancer risk assessment
is not required.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established 40 CFR
180.472(a) for the combined residues of 1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2-imidazolidinimine and its metabolites, in
or on a variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures and risks from
imidacloprid as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a one day or single exposure. An acute dietary risk assessment is
required for all population subgroups.
This acute dietary (food) risk assessment used the Theoretical
Maximum Residue Contribution (TMRC). Resulting exposure values and
Margins of Exposure (MOEs; MOE = Acute Endpoint Exposure) are
shown below.
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High-End\1\ Exposure @ 99th
Population Subgroup Exposure (mg/kg/ MOE\2\ Percentile (mg/kg/ MOE
day) day)
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U.S. population (48 states)......... 0.10 420 0.05\3\ 840
Infants (< 1 yr).................... 0.15 280 0.10 420
Children (1-6 yrs).................. 0.15 280 0.10 420
Females (13+ yrs)................... 0.05 840 0.04 1050
[[Page 14367]]
Males (13+ yrs)..................... 0.10 420 0.05 840
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\1\ > 99.5th Percentile.
\2\ MOE = Margin of Exposure.
\3\ @ 98th Percentile (U.S. Pop. only).
These results should be viewed as a very conservative risk
estimate; refinement using anticipated residue values and percent crop-
treated information in conjunction with Monte Carlo analysis would
result in a lower estimate (i.e., higher MOE) of acute dietary
exposure.
ii. Chronic exposure and risk. The endpoint selected for chronic
risk assessment is decreased body weight gains in females and increased
thyroid lesions observed at 7.6 mg/kg/day in male rats in a combined
chronic toxicity/carcinogenicity study. The NOEL was 5.7 mg/kg/day. A
UF of 300 is required as discussed above. In conducting this chronic
dietary (food) risk assessment, EPA used: (1) tolerance level residues
for pecans, grain sorghum, and all other commodities with published,
permanent or time-limited imidacloprid tolerances, the pending proposed
tolerance for the citrus crop group; and, (2) percent crop-treated
(%CT) information on some of these crops. Thus, this risk assessment
should be viewed as partially refined. Further refinement using
anticipated residue values and additional %CT information would result
in a lower estimate of chronic dietary exposure. The results are
summarized below.
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Exposure(mg/
Population Subgroup kg/day) %RfD
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Nursing Infants (<1 year old) 0.002824 15
Non-Nursing Infants (<1 year old) 0.009983 53
Children (1-6 years old) 0.007514 40
Children (7-12 years old) 0.005305 28
U.S. Population - Fall Season 0.003716 20
Northeast Region 0.003771 20
Western Region 0.003842 20
Hispanics 0.003879 20
Non-Hispanic Others 0.003906 21
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The subgroups listed above are: (1) the U.S. population (48
states); (2) those for infants and children; and, (3) the other
subgroups for which the percentage of the RfD occupied is greater than
that occupied by the subgroup U.S. population (48 states).
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: (1) that the data used
are reliable and provide a valid basis for showing the percentage of
food derived from a crop that is likely to contain residues; (2) that
the exposure estimate does not underestimate the exposure for any
significant subpopulation and; (3) where data on regional pesticide use
and food consumption are available, that the exposure estimate does not
understate exposure for any regional population. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of these estimates of percent crop
treated as required by the section 408(b)(2)(F), EPA may require
registrants to submit data on percent crop treated.
The Agency used percent crop treated (PCT) information as follows.
A routine chronic dietary exposure analysis for imidacloprid was based
on likely maximum percent of crop treated as follows: 6% grapefruits,
3% oranges, 13% other citrus, 19% apples, 2% pears, 11% grapes, 30%
eggplants/peppers, 32% head lettuce, 21% cole crops, 15% melons, 10%
tomatoes, 6% cotton.
The Agency believes that the three conditions listed above have
been met. With respect to (1), EPA finds that the PCT information
described above for imidacloprid is reliable and has a valid basis. The
Agency has utilized the latest statistical data from RFF (Resources For
The Future), DOANE, and USDA, the best available sources for such
information. Concerning (2) and (3), regional consumption information
and consumption information for significant subpopulations is taken
into account through EPA's computer-based model for evaluating the
exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
data available through national food consumption surveys, EPA does not
have available information on the consumption of food bearing
imidacloprid in a particular area.
2. From drinking water. EPA used the estimated environmental
concentration (EEC) data to calculate acute and chronic exposure
estimates for imidacloprid in surface water using the following
formulas:
Adult Male: Exposure (mg/kg/day) = (chemical concentration in g/L
in consumed water) * (10-3 mg/g) (70 kg
body weight) * (2 L water consumed/day)
Adult Female: Exposure (mg/kg/day) = (chemical concentration in g/L
in consumed water) * (10-3 mg/g) (60 kg
body weight) * (2 L water consumed/day)
Child (1-6 years): Exposure (mg/kg/day) = (chemical concentration
in g/L in consumed water) * (10-3 mg/g)
(10 kg body weight) * (1 L water consumed/day)
Acute MOE: Acute Endpoint (42 mg/kg/day) Exposure (mg/kg/
day)
Chronic Risk (%RfD): Exposure (mg/kg/day) RfD (0.019 mg/
kg/day) * 100
The 2 liters (L) of drinking water consumed/day by adults and the 1
L per day consumed by children are default assumptions used by the
Office of Water. The Agency's default body weights for males is 70 kg
and for females, 60 kg. HED's default body weight for children is 10
kg.
The results are summarized below:
[[Page 14368]]
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Acute Scenario Chronic Scenario
-----------------------------------------------------------------------------------------------------------------
Population Subgroup g/L in Exposure (mg/kg/ g/L in Exposure (mg/kg/
Water Consumed day) MOE Water Consumed day) % RfD
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adult male............................ 50.9 0.00145 29,000 19.1 0.00055 2.9
Adult Female.......................... 50.9 0.00170 24,700 19.1 0.00064 3.4
Child (1-6 yrs)....................... 50.9 0.00509 8,250 19.1 0.00191 10.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
These results should be viewed as a very conservative risk
estimate. Refinement by applying factors to account for the percent of
acreage planted in a watershed, the percent of crop-treated, and the
water flow rate would result in a lower estimate of acute and chronic
exposure from consumption of surface waters containing imidacloprid
residues.
3. From non-occupational non-dietary exposure. Imidacloprid is
currently registered for use on the following residential non-food
sites: ornamentals (e.g., flowering and foliage plants, ground covers,
turf, lawns, et al.), tobacco, golf courses, walkways, recreational
areas, bathrooms, household or domestic dwellings (indoor/outdoor),
cats/dogs, and wood protection treatment to buildings. Available data
do not demonstrate that imidacloprid has either dermal or inhalation
toxicity potential, therefore, non-occupational non-dietary risk
assessments are not required. Since data show no toxicity from short
term exposure via the dermal or inhalation route, the Agency feels
there is no contribution to toxicity from these routes of exposure, and
no increase in aggregate risk is anticipated from this exposure.
Therefore residential exposure does not aggregate with dietary exposure
for any risk assessments.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and `` other substances that have a
common mechanism of toxicity.'' An explanation of the current Agency
approach to assessment of pesticides with a common mechanism of
toxicity may be found in the Final Rule on Bifenthrin Pesticide
Tolerances Federal Register of November 26, 1997, (62 FR 62961-
62970)(FRL-5754-7).
EPA does not have, at this time, available data to determine
whether imidacloprid has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
imidacloprid does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that imidacloprid has a common mechanism of
toxicity with other substances. Imidacloprid is the sole member to date
of the new chloronicotinyl class of pesticides.
D. Aggregate Risks and Determination of Safety for U.S. Population,
Infants and Children
1. Acute risk. Acute aggregate dietary risk (combined food and
water) is estimated by adding the acute exposures to food and water
(highest of ground or surface water) and comparing this exposure to the
acute dietary endpoint:
Aggregate MOEACUTE = acute dietary endpoint
aggregate exposure.
The results of the acute aggregate dietary (food and water) risk
assessment are given below.
----------------------------------------------------------------------------------------------------------------
Exposure from Aggregate
Population Subgroup Exposure from Surface Water (mg/ Exposure (mg/kg/ Aggregate Acute
Food (mg/kg/day) kg/day) day) MOE
----------------------------------------------------------------------------------------------------------------
U.S. population (48 states)......... 0.101 0.0023 0.102 412
Infants (<1 yr)..................... 0.102 0.0054 0.105 4005
Children (1-6 yrs).................. 0.102 0.005 0.105 4005
Females (13+ yrs)................... 0.051 0.002 0.052 808
Males (13+ yrs)..................... 0.101 0.002 0.102 412
----------------------------------------------------------------------------------------------------------------
\1\ High-End Exposure (>99.5th Percentile).
\2\ Exposure @ 99th percentile; high-end exposure = 0.15 mg/kg/day.
\3\ 3 Exposure value used was that calculated for females (13+ years) and males (13+ years).
\4\ Exposure value used was that calculated for children (1-6 years).
\5\ Based on exposure @ 99th percentile; MOE is 271 @ high-end exposure (>99.5th percentile).
For imidacloprid, an (aggregate) acute dietary MOE of
300 is needed to protect the safety of all population
subgroups. The aggregate MOEs for the general population, females (13+
years), and males (13+ years) are >400 at the high-end exposure. The
aggregate MOEs for infants and children are calculated to be 400 at the
99th percentile of exposure, and 271 at the high-end exposure (>99.5th
percentile).
In conducting the acute dietary (food) risk assessment the
Theoretical Maximum Residue Contribution (TMRC) was used. There was no
refinement using anticipated residue values and percent crop-treated
information in conjunction with Monte Carlo analysis which would result
in a much lower estimate (i.e., higher MOE) of acute dietary exposure.
Because of the very conservative nature of the assumptions used in
these calculations, and the fact that refinement would lower the risk
estimates (i.e., result in higher MOE values) for both
MOEfood and MOEwater, EPA concludes that there is
a reasonable certainty that no harm will result to infants, children,
or adults from acute agregate (food and water) exposure to imidacloprid
residues.
2. Chronic risk. Dermal and inhalation exposure endpoints were not
selected due to the demonstrated absence of toxicity, thus, there is no
residential component for assessing chronic aggregate exposure and
risk.
In conducting the chronic dietary (food) risk assessment, EPA used:
(i) tolerance level residues for pecans, grain sorghum, and all other
commodities with published, permanent or time-limited imidacloprid
tolerances, the pending proposed
[[Page 14369]]
tolerance for the citrus crop group; and, (ii) percent crop-treated
(%CT) information on some of these crops. Thus, this risk assessment
should be viewed as partially refined. Further refinement using
anticipated residue values and additional %CT information would result
in a lower estimate of chronic dietary exposure.
Chronic aggregate dietary risk (combined food and water) will be
estimated by adding the chronic exposures to food and water (highest of
ground or surface water) and comparing this exposure to the RfD:
Aggregate %RfD Occupied = (aggregate exposure RfD) x 100.
The results of the chronic aggregate dietary (food and water) risk
assessment are given below.
----------------------------------------------------------------------------------------------------------------
Exposure from Aggregate
Population Subgroup Exposure from Surface Water (mg/ Exposure (mg/kg/ % RfD Occupied
Food (mg/kg/day) kg/day) day)
----------------------------------------------------------------------------------------------------------------
U.S. population (48 states)......... 0.0036 0.00061 0.0042 22
Nursing infants (<1 yr old)......... 0.0028 0.00192 0.0047 25
Non-nursing infants (<1 yr old)..... 0.0100 0.00192 0.0119 63
Children (1-6 yrs old).............. 0.0075 0.0019 0.0094 49
Children (7-12 yrs old)............. 0.0053 0.00192 0.0072 38
----------------------------------------------------------------------------------------------------------------
\1\ Used average value based on adult male (0.00055 mg/kg/day) and adult female (0.00064 mg/kg/day).
\2\ Data not available; used the value for children (1-6 years).
This chronic aggregate dietary risk assessment is based on
conservative exposure consumptions. Refinement of the assumptions used
in estimating exposure from food and water sources would result in
lower estimates of chronic aggregate dietary risk.
The calculated results indicate that the aggregate dietary exposure
to imidacloprid utilizes 22% of the RfD for the U.S. general
population.
For infants and children, the percentage of the RfD that is
utilized by aggregate dietary exposure to imidacloprid ranges from 25%
for nursing infants less than 1-year old, up to 63% for non-nursing
infants less than 1-year old.
The Agency generally has no concern for exposures below 100% of the
RfD because the RfD represents the level at or below which daily
aggregate dietary exposure over a lifetime will not pose appreciable
risks to human health.
EPA concludes that there is a reasonable certainty that no harm
will result to infants, children, or adults from chronic aggregate
(food plus water) exposure to imidacloprid residues.
3. Short - intermediate - term risk. Short - and intermediate -
term aggregate exposure take into account chronic dietary food and
water plus indoor and outdoor residential exposure. This risk
assessment is not required for imidacloprid.
E. Aggregate Cancer Risk for U.S. Population
Imidacloprid has been classified as a Group E chemical, no evidence
of carcinogenicity for humans, therefore, a cancer risk assessment is
not required.
III. Other Considerations
A. Metabolism In Plants and Animals
The nature of imidacloprid residues in plants and animals is
adequately understood. The residue of concern is imidacloprid and its
metabolites containing the 6-chloropyridinyl moiety, all expressed as
parent, as specified in 40 CFR 180.472.
B. Analytical Enforcement Methodology
Adequate enforcement methods are available for determination of the
regulated imidacloprid residue in plant (Bayer GC/MS Method 00200 and
Bayer HPLC-UV Confirmatory Method 00357) and animal (Bayer GC/MS Method
00191) commodities. These methods have successfully completed EPA
Tolerance Method Validation, and are awaiting publication in Pesticide
Analytical Manual II (PAM II). In the interim, these methods are
available from Calvin Furlow, EPA, OPP, IRSD, PIRIB.
C. Magnitude of Residues
Residue data have been submitted from 13 field trials, with
adequate geographical representation, and including 8 varieties of
pecans. The pecan trees in 7 field trials were treated with 1 or 2
foliar applications starting at the fill stage for the first
application and at or prior to shuck split for the second application
for a repeat application interval of 10 + or - 2 days. Pecan trees were
treated with imidacloprid at a rate of 0.17 lb ai/acre/application plus
a spray adjuvant using ground airblast sprays, for a total application
of 0.34 lb/ai/acre/season. Pecans were gathered at the earliest harvest
which varied from 4 to 31 days after the last application. Pecan trees
in 6 field trials were treated with imidacloprid in a single soil
application at a rate of 0.5 lb/ai/acre. The pre-harvest interval (PHI)
for pecans from the single soil application ranged from 99 to 150 days.
All treated pecan samples were below the limit of quantitation
(LOQ) of <0.05 ppm regardless of the PHI. Total imidacloprid residues
ranged from approximately 0.001 ppm to 0.005 ppm or <1/2 the limit of
detection (LD).
Crop field trial data are adequate to show that combined residues
of imidacloprid and its metabolites, all calculated as imidacloprid,
will not exceed the tolerance of 0.05 ppm requested and prescribed in
this Federal Register rule for the pesticide chemical residue in the
raw agricultural commodity, pecans. OPPTS Test Guidelines, Series 860,
Residue Chemistry, Table 1, does not list any processed commodities for
pecans, thus no imidacloprid in pecans processing study is required.
Similarly , there are no bovine, porcine, or poultry feedstuffs
associated with pecans; thus there is little likelihood of additional
imidacloprid in meat, milk, poultry, and eggs from the feeding of
pecans. The established imidacloprid secondary tolerances are adequate
for any inadvertent feeding of pecans.
D. Rotational Crop Restrictions.
Field crop rotational studies with three crop groups (small grains,
root crops, and leafy vegetables) support a 12-month plant-back
restriction. Since pecans are not considered to be a rotated crop, this
restriction does not apply to pecans.
E. International Residue Limits
There are no CODEX or Mexican maximum residue limits (MRLs) for
imidacloprid on any crop. There are Canadian MRLs for combined residues
of imidacloprid plus metabolites with the 6-chlorophenyl moiety, but
not on pecans. International compatibility is thus not an issue.
IV. Conclusion
Therefore, the tolerance is established for residues of 1-[(6-
chloro-3-
[[Page 14370]]
pyridinyl)methyl]-N-nitro-2-imidazolidinimine and its metabolites in or
on pecans at 0.05 ppm.
V. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by May 26, 1998, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if the Administrator determines that the material
submitted shows the following: There is genuine and substantial issue
of fact; there is a reasonable possibility that available evidence
identified by the requestor would, if established, resolve one or more
of such issues in favor of the requestor, taking into account
uncontested claims or facts to the contrary; and resolution of the
factual issues in the manner sought by the requestor would be adequate
to justify the action requested (40 CFR 178.32). Information submitted
in connection with an objection or hearing request may be claimed
confidential 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. A copy of the information that
does not contain CBI must be submitted for inclusion in the public
record. Information not marked confidential may be disclosed publicly
by EPA without prior notice.
VI. Public Docket
EPA has established a record for this rulemaking under docket
control number [OPP-300625] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
[email protected].
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
This final rule establishes a tolerance for the residues of
imidacloprid at 0.05 ppm in/on pecans under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408(d), such
as the tolerance for the residues of imidacloprid in/on pecans at 0.05
ppm in this final rule, do not require the issuance of a proposed rule,
the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
et seq.) do not apply. Nevertheless, the Agency has previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
entities and concluded, as a generic matter, that there is no adverse
economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950) and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
VIII. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
[[Page 14371]]
Dated: March 16, 1998
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority : 21 U.S.C. 346a and 371.
2. Section 180.472, paragraph (a) is amended by alphabetically
adding the commodity to read as follows:
Sec. 180.472 Imidacloprid; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * * * *
Pecans.............................. 0.05
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-7647 Filed 3-24-98; 8:45 am]
BILLING CODE 6560-50-F