[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