[Federal Register Volume 64, Number 147 (Monday, August 2, 1999)]
[Rules and Regulations]
[Pages 41804-41810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19595]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300894; FRL-6090-2]
RIN 2070-AB78
Imidacloprid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of imidacloprid and its metabolites containing the 6-chloropyridinyl
moiety in or on cucurbit vegetables (Crop Group 9) at 0.5 parts per
million (ppm), tuberous and corm vegetable subgroup at 0.3 ppm, dasheen
leaves at 3.5 ppm, and watercress (upland) at 3.5 ppm. The
Interregional Research Project Number 4 (IR-4) New Jersey Agricultural
Experiment Station requested these tolerances under the Federal Food,
Drug, and Cosmetic Act, as amended by the Food Quality Protection Act
of 1996.
DATES: This regulation is effective August 2, 1999. Objections and
requests for hearings must be received by EPA on or before October 1,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300894], 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 docket
control number, [OPP-300894], 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, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may 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 docket control
number [OPP-300894]. 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: Peg Perreault, 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: Rm. 209, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5417,
Perreault.P[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of April 8, 1999 (64
FR 17171) (FRL-6071-2), EPA issued a notice pursuant to section 408 of
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as
amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law
104-170) announcing the filing of three pesticide petitions (PP 6E4766,
7E4898, and 7E4899) for tolerances by the Interregional Research
Project Number 4 (IR-4) New Jersey Agricultural Experiment Station,
P.O. Box 231, Rutgers University, New Brunswick, NJ 08903. This notice
included a summary of the petitions prepared by IR-4. There were no
comments received in response to the notice of filing.
The petitions requested that 40 CFR 180.472(a) be amended by
establishing tolerances for combined residues of the insecticide
imidacloprid (1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as (1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine, in or on cucurbit vegetables (Crop Group 9) at 0.5
parts per million (ppm), tuberous and corm vegetable subgroup at 0.3
ppm, dasheen leaves at 3.5 ppm, and watercress (upland) at 3.5 ppm.
I. Background and Statutory Findings
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
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 (62 FR 62961, November 26, 1997) (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
imidacloprid and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for tolerances for combined residues
of imidacloprid and its metabolites containing the 6-chloropyridinyl
moiety on cucurbit vegetables (Crop Group 9) at 0.5 ppm, tuberous and
corm vegetable subgroup at 0.3 ppm, dasheen leaves at 3.5 ppm, and
watercress (upland) at 3.5 ppm. EPA's assessment of the dietary
exposures and risks associated with establishing the tolerances
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
[[Page 41805]]
infants and children. The nature of the toxic effects caused by
imidacloprid are discussed in Unit II.A. of the Final rule on
Imidacloprid Pesticide Tolerances published in the Federal Register on
September 18, 1998 (63 FR 49837) (FRL-6027-1).
B. Toxicological Endpoints
The toxicological endpoints for imidacloprid are discussed in Unit
II.B. of the Final rule on Imidacloprid Pesticide Tolerances published
in the Federal Register on September 18, 1998.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.472) for the combined residues of imidacloprid and its
metabolites containing the 6-chloropyridinyl moiety, in or on a variety
of raw agricultural commodities and meat at 0.3 ppm, milk at 0.1 ppm,
poultry at 0.05 ppm, and eggs at 0.02 ppm. Risk assessments were
conducted by EPA to assess dietary exposures from imidacloprid as
follows.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of crop treated (PCT) for assessing chronic dietary risk
only if the Agency can make the following findings: That the data used
are reliable and provide a valid basis to show what percentage of the
food derived from such crop is likely to contain such pesticide
residue; that the exposure estimate does not underestimate exposure for
any significant subpopulation group; and if data are available on
pesticide use and food consumption in a particular area, the exposure
estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by section 408(b)(2)(F), EPA may require registrants
to submit data on PCT.
The Agency used PCT information to conduct a chronic dietary
exposure analysis for imidacloprid 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, discussed in section
408 (b)(2)(F) concerning the Agency's responsibilities in assessing
chronic dietary risk findings, have been met. The PCT estimates are
derived from Federal and private market survey data, which are reliable
and have a valid basis. Typically, a range of estimates are supplied
and the upper end of this range is assumed for the exposure assessment.
By using this upper end estimate of the PCT, the Agency is reasonably
certain that the percentage of the food treated is not likely to be
underestimated. The 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 the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which imidacloprid
may be applied in a particular area.
i. Acute exposure and risk. Acute 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 1-day or
single exposure. The acute population adjusted dose (aPAD) for
imidacloprid is 0.14 mg/kg bwt/day (aPAD = acute RfD/FQPA UF = 0.42 mg/
kg bwt/day/3 = 0.14 mg/kg bwt/day). EPA conducted a DEEM (Dietary
Exposure Evaluation Model) analysis for acute dietary (food) risk
assessment using the Theoretical Maximum Residue Contribution (TMRC),
which assumes tolerance level residues and 100% crop-treated (Tier 1).
The analysis evaluates individual food consumption as reported by
respondents in the USDA Continuing Surveys of Food Intake by
Individuals conducted in 1989 through 1992. The model accumulates
exposure to the chemical for each commodity and expresses risk as a
function of dietary exposure. Resulting exposure values (at the 95th
percentile) and percentage of aPAD utilized were below EPA's level of
concern for the U.S. population and all subgroups, with the highest
exposure in the subgroup children, 1-6 yrs (0.062 mg/kg bwt/day, 44% of
the aPAD). The results of this analysis indicate that the acute risk
from residues of imidacloprid on food is below EPA's level of concern.
ii. Chronic exposure and risk. The chronic population adjusted
dose (cPAD) for imidacloprid is 0.019 mg/kg bwt/day (cPAD = chronic
RfD/FQPA UF = 0.057 mg/kg bwt/day/3 = 0.019 mg/kg bwt/day). EPA
conducted a DEEM analysis for chronic dietary (food only) risk
assessment using tolerance level residues for imidacloprid and PCT
information for some crops. The resulting of cPAD utilized is below
EPA's level of concern for the U.S. population and all subgroups, with
the highest exposure in the subgroup children, 1-6 yrs. (0.0092 mg/kg/
day, 48% of the cPAD). The results of this analysis indicate that the
chronic risk from residues of imidacloprid on food is below EPA's level
of concern. The chronic risk assessment should be considered partially
refined. Further refinement using anticipated residue values and PCT
information would result in a lower estimate of chronic exposure.
2. From drinking water. There are no Maximum Contaminant Levels
(MCLs) or Health Advisory (HA) levels established for residues of
imidacloprid in drinking water.
EPA's Drinking Water Assessment for Imidacloprid indicates that
imidacloprid is persistent, water soluble, and fairly mobile. Thus,
residues of imidacloprid may be transported to both surface and ground
waters. As a condition of registration, EPA has required the submission
of the results of two prospective ground water monitoring studies;
however, results from these studies are not yet available. Therefore,
EPA has calculated estimated concentrations of imidacloprid in surface
and ground waters.
i. Acute exposure and risk. For acute exposure analysis, the
estimated concentrations of imidacloprid in surface and ground water
were calculated based on an application rate of 0.5 lbs ai/acre/year.
The estimated concentrations in surface and ground water are 4.1 and
1.1 g/L (ppb), respectively. Estimated acute drinking water
levels of comparison (DWLOCs) for imidaloprid range from 780
g/L for children (1-6 years old) to 3,900 g/L for the
U.S. population (male). The estimated acute concentrations of
imidacloprid in surface and ground water are less than the acute DWLOCs
for imidacloprid. Therefore, taking into account the currently
registered uses and the uses proposed in this action, EPA concludes
with reasonable certainty that residues of imidacloprid in drinking
water (when considered along with other sources of exposure for which
EPA has reliable data) would not result in unacceptable levels of acute
aggregate human health risk at this time.
ii. Chronic exposure and risk. For chronic exposure analysis, the
estimated concentrations of imidacloprid in surface and ground water
were calculated based on an application rate
[[Page 41806]]
of 0.5 lbs ai/acre/year. The estimated concentrations in surface and
ground water are 0.1 and 1.1 g/L parts per billion (ppb),
respectively. Estimated chronic drinking water levels of comparison
(DWLOCs) for imidacloprid range from 98 g/L for children (1-6
years old) to 490 g/L for the population subgroup males. The
estimated chronic concentrations of imidacloprid in surface and ground
water are less than the chronic DWLOCs for imidacloprid. Therefore,
taking into account the currently registered uses and the uses proposed
in this action, EPA concludes with reasonable certainty that residues
of imidacloprid in drinking water (when considered along with other
sources of exposure for which EPA has reliable data) would not result
in unacceptable levels of chronic aggregate human health risk at this
time.
iii. Short-term exposure and risk. For purposes of risk assessment,
the estimated maximum chronic exposure of imidacloprid from surface and
ground waters (1.1 g/L), were used for comparison to the
DWLOCs for the short-term endpoint.
The DWLOC for short-term exposure to imidacloprid was calculated
relative to the aPAD which was utilized for estimating risk for short-
term oral exposure to imidacloprid. To calculate the DWLOC for short-
term exposure relative to an acute toxicity endpoint, the sum of
chronic dietary food exposure and oral exposure to imidacloprid from
home garden, turf, and pet uses was subtracted from the aPAD to obtain
the acceptable short-term exposure to imidacloprid in drinking water
(highest chronic food exposure = 0.0092 mg/kg/day, oral exposure from
home garden and turf uses = 0.072 mg/kg bwt/day and, oral exposure from
pet uses = 0.058 mg/kg bwt/day). DWLOCs were then calculated using
default body weights and drinking water consumption figures. The
estimated chronic concentrations of imidacloprid in surface and ground
water are less than the short-term DWLOCs for imidacloprid. Therefore,
taking into account the currently registered uses and the uses proposed
in this action, EPA concludes with reasonable certainty that residues
of imidacloprid in drinking water (when considered along with other
sources of exposure for which EPA has reliable data) would not result
in unacceptable levels of short-term aggregate human health risk at
this time.
3. From 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), tobacco,
golf courses, walkways, recreational areas, household or domestic
dwellings (indoor/outdoor), and pets (cats and dogs). Available data do
not demonstrate that imidacloprid has either dermal or inhalation
toxicity potential; therefore, non-dietary dermal and inhalation
exposure assessments are not required. Since available 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. However, there is the potential for residential exposure via
incidental non-dietary ingestion from treated lawns and gardens and
incidental non-dietary ingestion by toddlers of pesticide residues on
pets from hand-to-mouth transfer. Therefore, an increase in short-term
aggregate risk is anticipated from residential exposure via incidental
non-dietary ingestion and residential exposure.
The product Premise, a termiticide, is also registered for
residential use. Premise may be applied only by PCOs and only to
inaccessible areas of homes or other buildings; therefore, oral
exposure to children is not expected. There is potential for inhalation
exposure. However, an inhalation endpoint has not been established, and
data from EPA's environmental fate one-liner data base indicates that
imidacloprid has a low vapor pressure (6.9 x 10-9 torr).
Therefore, inhalation exposure due to residential use is not expected
to pose a risk.
Short-term exposure and risk from residential uses of imidacloprid
are discussed in detail in Unit II.C.3. of the Final rule on
Imidacloprid Pesticide Tolerances published in the Federal Register on
September 18, 1998. In summary, the residential exposure scenarios
examined include the following postapplication short-term oral exposure
scenarios for toddlers:
Incidental non-dietary ingestion of residues on lawns from
hand-to-mouth transfer.
Ingestion of pesticide-treated turfgrass.
Incidental ingestion of soil from treated gardens.
Incidental ingestion of pesticide residues on pets from
hand-to-mouth transfer.
For children (1 - 6 years), the residential exposure from the home
garden and turf uses was estimated to be 0.072 mg/kg bwt/day and the
residential exposure from the pet use was estimated to be 0.058 mg/kg
bwt/day. It should be noted that these exposures are very conservative
estimates since EPA utilized the Draft Standard Operating Procedures
for Residential Exposure Assessments (dated December 18, 1997) to
estimate these exposures. In the absence of data, it was estimated that
20% of the application rate is retained on pets and that 1% of the
available residues are transferred to the skin of individuals who have
contact with treated animals. The actual values may be different. A
study to quantify dislodgeable residue for toddler's hand from pets
treated with these types of products is required. The submission of
this study is a condition of the registration of imidacloprid.
4. Cumulative exposure to substances with a 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.''
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. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Aggregate Risks and Determination of Safety for U.S. Population
In examining aggregate exposure, FQPA directs EPA to consider
available information concerning exposures from the pesticide residue
in food and all other non-occupational exposures. The primary non-food
sources of exposure the Agency looks at include drinking water (whether
from ground or surface water), and exposure through pesticide use in
gardens, lawns, or buildings (residential and other indoor and/or
outdoor uses). In evaluating food exposures, EPA takes into account
varying consumption patterns of major identifiable subgroups of
consumers, including infants and children.
[[Page 41807]]
1. Acute risk. Using the conservative TMRC exposure assumptions
and taking into account the completeness and reliability of the
toxicity data, EPA has estimated the acute exposure to imidacloprid
from food for the most highly exposed population subgroup (children 1 -
6 yrs) will utilize 44% of the aPAD. It was determined that an
acceptable acute dietary exposure (food plus water) of 100% or less of
the aPAD is needed to protect the safety of all population subgroups.
Despite the potential for exposure to imidacloprid in drinking
water, EPA does not expect the aggregate exposure to exceed 100% of the
aPAD for adults. The maximum estimated concentration of Imidacloprid in
surface and ground water for acute exposure is very small compared to
the DWLOC. Under current EPA guidelines, non-dietary uses of
imidacloprid do not constitute an acute exposure scenario.
2. Chronic risk. Using the partially refined exposure assumptions
described in this unit and taking into account the completeness and
reliability of the toxicity data, EPA has estimated the chronic
exposure to imidacloprid from food for the most highly exposed
population subgroup (children, 1-6 years old) will utilize 48% of the
cPAD. It was determined that an acceptable chronic dietary exposure
(food plus water) of 100% or less of the cPAD is needed to protect the
safety of all population subgroups.
Despite the potential for exposure to imidacloprid in drinking
water, EPA does not expect the aggregate exposure to exceed 100% of the
cPAD. The maximum estimated concentration of Imidacloprid in surface
and ground water for chronic exposure is very small compared to the
DWLOC. The registered non-dietary uses of imidacloprid do not
constitute a chronic exposure scenario.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. Dermal and inhalation short- and intermediate-
term risks are not expected for imidacloprid as dermal and inhalation
exposure endpoints were not identified due to the demonstrated absence
of toxicity. Short- and intermediate-term oral exposures are not
expected for adult population subgroups.
Since imidacloprid is registered for use on turf, home gardens and
pets, EPA has identified potential short-term oral exposures to
children for these uses. A short-term oral endpoint was not identified
for imidacloprid. If an oral endpoint is needed for short-term risk
assessment (for incorporation of food, water, or oral hand-to-mouth
type exposures into an aggregate risk assessment), the acute oral
endpoint (LOAEL = 42 mg/kg bwt/day) is used to incorporate the oral
component into aggregate risk. The short-term aggregate exposure and
risk were calculated (chronic dietary exposure (food only) plus
residential exposure (hand-to-mouth from turf, garden, and pet uses)
for children age 1-6, resulting in a total MOE of 302 (the acceptable
MOE for imidacloprid is 300). Potential short-term exposure from
drinking water is at a level below EPA's level of concern. It should
also be pointed out that this short-term aggregate risk assessment is a
very conservative assessment due to the fact that all exposures are
conservative estimates, with the chronic food exposure derived from
assuming all residues at the tolerance level and some PCT, and the
residential exposures from lawn, garden, and pet uses derived from the
Draft Standard Operating Procedures for Residential Exposure Assessment
(December 18, 1997) where several conservative assumptions were made
including assuming 100% of residue on hands of toddlers is ingested. In
addition, the aggregation routes are conservative by assuming children
eat treated grass, soil, and have hand-to-mouth transfer from treated
pets all on the same day.
4. Aggregate cancer risk for U.S. population. Imidacloprid has
been classified as a Group E chemical, no evidence of carcinogenicity
for humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to imidacloprid residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children-- i. In general. The
determination of the 3X safety factor to account for the potential for
increased sensitivity of infants and children to residues of
imidacloprid is discussed in Unit II.E.1.i. of the Final rule on
Imidacloprid Pesticide Tolerances published in the Federal Register on
September 18, 1998.
ii. Developmental toxicity studies. Developmental toxicity is
discussed in Units II.A.4. and II.E.1. of the Federal Register document
published on September 18, 1998.
iii. Reproductive toxicity study. Reproductive toxicity is
discussed in Units II.A.5. and II.E.1. of the Federal Register document
published on September 18, 1998.
iv. Prenatal and postnatal sensitivity. Prenatal and postnatal
sensitivity is discussed in Unit II.E.1. of the Federal Register
document published on September 18, 1998.
v. Conclusion. The toxicology data base for imidacloprid is
complete with respect to core requirements; however, a developmental
neurotoxicity study (Guideline No. 83-6) is required. Exposure data are
estimated based on data that reasonably accounts for potential
exposures; however, a study to quantify dislodgeable residues on
toddler's hands from pets treated with imidacloprid is required.
2. Acute risk. Aggregate acute risks for the entire U.S. population
and for population subgroups, including infants and children, are
discussed in Unit II.D.1. of this preamble.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to imidacloprid from
food will utilize 31% of the cPAD for all infants (< 1 year old), 9.2%
of the cPAD for nursing infants (<1 year old), 40% of the cPAD for non-
nursing infants (<1 year old), 48% of the cPAD for children 1-6 years
old, and 10% of the cPAD for children 7-12 years old. EPA generally has
no concern for exposures below 100% of the cPAD because the cPAD
represents the level at or below which daily aggregate dietary exposure
over a lifetime will not pose appreciable risks to human health.
Despite the potential for exposure to imidacloprid in drinking water
and from non-dietary, non-occupational exposure, EPA does not expect
the aggregate exposure to exceed 100% of the cPAD.
4. Short- or intermediate-term risk. Aggregate short- and
intermediate-term risks for the entire U.S. population and for
population subgroups, including infants and children are discussed in
Unit II.D.3. of this preamble.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to imidacloprid
residues.
III. Other Considerations
A. Metabolism in Plants and Animals.
Data concerning the metabolism of imidacloprid in apples, potatoes,
tomatoes, eggplant, cottonseed, field corn, ruminants and poultry have
previously been submitted. The nature of imidacloprid residues in
plants and animals is adequately understood. The residue of concern is
imidacloprid and its metabolites containing the 6-
[[Page 41808]]
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 PAM II. In
the interim, these methods are available from: Calvin Furlow, PRRIB,
IRSD (7502C), Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location and
telephone number: Rm 101FF, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703-305-5229).
Bayer Corporation has previously submitted adequate multiresidue
method (MRM) recovery data for imidacloprid and its olefin, hydroxy,
guanidine, and 6-chloronicotininc acid metabolites through FDA's
Protocols A through E. imidacloprid and its metabolites were not
recoverable by these methods. These data have been forwarded to FDA and
we expect them to be published in the Pesticide Analytical Manual
(PAM), Vol I, Appendix I in a future update. Additional MRM recovery
data are not required.
C. Magnitude of Residues
The crop field trial data support the proposed tolerances for
combined residues of imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety.
D. International Residue Limits
There are no established CODEX, Canadian or Mexican residue limits
for imidacloprid in/on the cucurbit vegetable crop group, tuberous and
corm vegetable subgroup, dasheen leaves, and upland watercress. Thus,
harmonization of the proposed tolerances with CODEX, Canada and Mexico
is not an issue for these petitions.
E. Rotational Crop Restrictions
Data concerning the metabolism of imidacloprid in confined
rotational crops was previously submitted. The nature of the residue in
rotational crops is adequately understood and is nearly identical to
that identified in the primary crops. The residue of concern in
rotational crops is imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as parent. Treated areas may be
replanted with any crop specified on an imidacloprid label, or any crop
for which a tolerance exists for imidacloprid, as soon as practical
following the last application, with the exception of cereals, legumes,
and safflower, which have a 30-day plant-back restriction. A 12-month
plant-back restriction must be observed for crops not listed on an
imidacloprid label and for crops for which no tolerances for
imidacloprid have been established.
IV. Conclusion
Therefore, tolerances are established for combined residues of
Imidacloprid and its metabolites containing the 6-chloropyridinyl
moiety in cucurbit vegetables (Crop Group 9) at 0.5 ppm, tuberous and
corm vegetable subgroup at 0.3 ppm, dasheen leaves at 3.5 ppm, and
upland watercress at 3.5 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 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 October 1, 1999, 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 under the ``ADDRESSES'' section (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
regulation. 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). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection.'' For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, 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: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697, [email protected]. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
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 Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300894] (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 Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
[[Page 41809]]
[email protected]
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit 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 record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes tolerances under section 408(d) of the
FFDCA 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) (Public Law
104-4). Nor does it require any 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 tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(d), such as the
tolerances 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
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.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
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 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.
Dated: July 19, 1999.
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. 321(q), (346a) and 371.
2. In Sec. 180.472(a), by alphabetically adding the following
commodities to the table to read as follows:
Sec. 180.472 Imidacloprid; tolerances for residues.
(a) * * *
[[Page 41810]]
------------------------------------------------------------------------
Parts
Commodity per Expiration/
million RevocationDate
------------------------------------------------------------------------
* * * * *
Dasheen, leaves................................ 3.5 None
* * * * *
Vegetable, cucurbit, group..................... 0.5 None
Vegetable, tuberous and corm, subgroup......... 0.3 None
Watercress, upland............................ 3.5 None
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-19595 Filed 7-30-99; 8:45 am]
BILLING CODE 6560-50-F