[Federal Register Volume 64, Number 139 (Wednesday, July 21, 1999)]
[Rules and Regulations]
[Pages 39041-39049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18190]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300884; FRL-6088-3]
RIN 2070-AB78


Imidacloprid; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for the 
combined residues of imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as parent in or on blueberries 
and cranberries. This action is in response to EPA's granting of 
emergency exemptions under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act authorizing use of the pesticide on 
blueberries and cranberries. This regulation establishes maximum 
permissible levels for residues of imidacloprid in these food 
commodities pursuant to section 408(l)(6) of the Federal Food, Drug, 
and Cosmetic Act, as amended by the Food Quality Protection Act of 
1996. The tolerances will expire and are revoked on June 1, 2001.

DATES: This regulation is effective July 21, 1999. Objections and 
requests for hearings must be received by EPA on or before September 
20, 1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number [OPP-300884], must be submitted to: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
Washington, DC 20460. Fees

[[Page 39042]]

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-300884], 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 also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of electronic 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 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket control number [OPP-300884]. 
No Confidential Business Information (CBI) should be submitted through 
e-mail. Copies of electronic objections and hearing requests on this 
rule may be filed online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, 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. 280, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9367, 
[email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 
21 U.S.C. 346a, is establishing a tolerance for combined residues of 
the insecticide imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as parent, in or on blueberries 
at 1.0 part per million (ppm) and cranberries at 0.5 ppm. This 
tolerance will expire and is revoked on June 1, 2001. EPA will publish 
a document in the Federal Register to remove the revoked tolerance from 
the Code of Federal Regulations.

I. Background and Statutory Findings

    The Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) 
was signed into law August 3, 1996. FQPA amends both the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq. The FQPA amendments went into effect immediately. Among other 
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting 
activities under a new section 408 with a new safety standard and new 
procedures. These activities are described in this preamble and 
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of 
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
    New 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. . . .''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment.
    Because decisions on section 18-related tolerances must proceed 
before EPA reaches closure on several policy issues relating to 
interpretation and implementation of the FQPA, EPA does not intend for 
its actions on such tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemption for Imidacloprid on Blueberries and 
Cranberries and FFDCA Tolerances

    Cranberries. The applicant states that the cranberry rootworm is 
becoming a serious pest of cranberries in New Jersey. The infestations 
of this insect are spreading from few acres in 1995 to several hundreds 
of acres in 1998. Prior to 1995, cranberry rootworm was considered a 
minor pest rarely requiring insecticide interventions. However, in 1997 
and in 1998, severe infestations were seen in approximately 500 acres 
around Chatsworth, Burlington County.
    Most of the cranberry rootworm grubs are found in the top 6-8 
inches from the ground surface area available for absorption of water 
and nutrients. The affected vines become weak, often produce fewer 
berries, and are easily rolled back as a mat. Severe infestations of 
cranberry rootworm can kill the vines and reduce fruit yield. The 
effect of cranberry rootworm feeding on roots is more severe under 
moisture stress during summer months as vines are unable to uptake the 
limited moisture available with reduced root systems. Replanting is 
often necessary to fill dead patches as a result of rootworm injury. 
Newly planted vines may take as long as 5 years to reach full yield 
potential. Adults also skeletonize the foliage and affect the process 
of photosynthesis.
    Currently there are no soil insecticides registered for managing 
cranberry rootworm in New Jersey. Lack of effective materials for use 
against the grub stage has resulted in the present emergency condition 
which left unchecked will cause significant crop losses to growers.
    Blueberries (Oriental Beetle). The applicant states that the 
Oriental beetle has recently become a serious pest of commercial 
highbush blueberries. In surveys undertaken during 1995 and 1996, the 
Oriental beetle was found to be the predominant grub species found in a 
majority of locations surveyed in Atlantic and Burlington Counties. The 
damage to blueberries is caused by grub stages feeding on fine fibrous 
root hairs. Bushes that have sustained damage to the root system by 
grubs show reduced vigor, are twiggy, have smaller leaves, and support 
fewer berries than

[[Page 39043]]

uninfested bushes of the same age. Infested bushes can be easily pulled 
off and growers often replace them with newer, younger bushes. In 
contrast to the grubs feeding on the root system, adults do not feed 
and therefore are not vulnerable to insecticide applications made above 
the ground.
    In blueberry fields in New Jersey, larvae become active and begin 
feeding by late March. The majority of these grubs are found in the top 
8 inches of soil. Pupation occurs during the last week of May to early 
June with adults first appearing in the second week of June.
    The most effective strategy in managing the Oriental beetle is to 
apply insecticides targeting early instar grubs which are closer to the 
soil surface. However, there are currently no soil insecticides 
registered for use against any insect pest in blueberries. Out of 
desperation, some growers have attempted the use of organophosphate and 
carbamate insecticides targeting the adult stage. This strategy is 
generally effective in killing the adults only if the adults come in 
direct contact with the insecticide. Applications of insecticides 
targeting adults have proven to be very ineffective and resulted in 
unwarranted applications of organophosphate and carbamate insecticides.
    Lack of effective materials for use against the grub stage has 
resulted in the present emergency situation. Availability of effective 
insecticides targeting the early instar grubs will alleviate this 
problem and improve the management of Oriental beetle populations in 
blueberries.
    Blueberries (Blueberry Aphid). According to the applicant, 
blueberry aphids, Fimbriaphis fimbriata and Illinoia pepperi are the 
most important pests of highbush blueberries in New Jersey. The green 
peach aphid Myzus persicae also occurs on blueberries on a regular 
basis, but is of less significance. All of these species feed on plant 
sap and reduce the vigor of the bushes. But more importantly, these 
three species of aphids have recently been shown to be the vectors of 
the Blueberry Scorch virus (BBScV), the most important viral disease of 
blueberries in New Jersey. This virus is transmitted in a non-
persistent fashion, and in greenhouse experiments, the applicant has 
shown that as little as 5 minutes of feeding any of the above three 
species is sufficient to transmit the BBScV from an infected plant to a 
non-infected plant.
    The Blueberry Scorch disease (also known as Sheep Pen Hill disease) 
was first detected in the early eighties. For several years this 
disease was restricted to a few areas in Burlington County, but during 
the past 3-4 years, there have been numerous fields that have become 
100% infected with BBScV and showing visible symptoms of the disease. 
This disease is now firmly established in all major blueberry producing 
areas in Atlantic and Burlington counties. Primary symptoms of 
Blueberry Scorch disease are blighting of both flowers and new 
vegetative growth at full bloom and appearance of necrotic line patter 
just prior to leaf drop in autumn. The blighted blossoms are often 
retained throughout the summer but fail to develop into fruit and 
infected plants are less vigorous than healthy plants. The major 
problem in containing this disease is the inability to aggressively 
rogue out infected bushes because disease symptoms may not manifest for 
several years after the transmission of the causal agent (BBScV). This 
allows for the rapid spread of the disease if infected plants (symptom 
free) and aphids are present in a given location. Growers have no 
option but to completely destroy or kill the bushes and replant with 
new, clean bushes. Accurate estimates of total losses due to this 
disease in New Jersey are yet to be determined.
    Effective management of the aphid vectors is the only viable 
strategy to contain the spread of the Blueberry Scorch disease; there 
are no other methods available at the present time. Inadequate control 
of aphids with the existing insecticides has resulted in the present 
emergency situation which could cause severe crop loss to blueberry 
growers if left unchecked. EPA has authorized under FIFRA section 18 
the use of imidacloprid on blueberries for control of blueberry aphids 
and the oriental beetle and cranberries for control of the cranberry 
rootworm in New Jersey. After having reviewed the submission, EPA 
concurs that emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of imidacloprid in or on 
blueberries and cranberries. In doing so, EPA considered the safety 
standard in FFDCA section 408(b)(2), and EPA decided that the necessary 
tolerances under FFDCA section 408(l)(6) would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemptions in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing these tolerances without notice and opportunity 
for public comment under section 408(e), as provided in section 
408(l)(6). Although these tolerances will expire and are revoked on 
June 1, 2001, under FFDCA section 408(l)(5), residues of the pesticide 
not in excess of the amounts specified in the tolerances remaining in 
or on blueberries and cranberries after that date will not be unlawful, 
provided the pesticide is applied in a manner that was lawful under 
FIFRA, and the residues do not exceed a level that was authorized by 
these tolerances at the time of that application. EPA will take action 
to revoke these tolerances earlier if any experience with, scientific 
data on, or other relevant information on this pesticide indicate that 
the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether imidacloprid 
meets EPA's registration requirements for use on blueberries and 
cranberries or whether permanent tolerances for these uses would be 
appropriate. Under these circumstances, EPA does not believe that these 
tolerances serve as a basis for registration of imidacloprid by a State 
for special local needs under FIFRA section 24(c). Nor do these 
tolerances serve as the basis for any State other than New Jersey to 
use this pesticide on this crop under section 18 of FIFRA without 
following all provisions of EPA's regulations implementing section 18 
as identified in 40 CFR part 166. For additional information regarding 
the emergency exemption for imidacloprid, contact the Agency's 
Registration Division at the address provided under the ``ADDRESSES'' 
section.

III. Aggregate Risk Assessment and Determination of Safety

    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).
    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 a time-limited tolerance for 
combined residues of imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as parent on blueberries at 1.0 
ppm and cranberries at 0.5 ppm. EPA's assessment of the dietary 
exposures and

[[Page 39044]]

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 imidacloprid are 
discussed in this unit.

B. Toxicological Endpoint

    Only acute and chronic dietary endpoints were defined. The 10X FQPA 
factor was reduced to 3X for acute and chronic exposure, and applies to 
all population subgroup.
    1. Acute toxicity. The acute Reference Dose (RfD) is 0.42 mg/kg 
bwt/day based on a lowest observed adverse effect level (LOAEL) of 42 
mg/kg body weight/day (bwt/day) based on decreased motor activity in 
female rats. An additional 3X FQPA factor was incorporated for all 
population subgroups to account for neurotoxicity, structure-activity 
concerns, and lack of a no observed adverse effect level (NOAEL). The 
acute Population Adjusted Dose (aPAD), which is the RfD/3 was 
calculated to be 0.14 mg/kg bwt/day. Acceptable acute dietary exposure 
(food plus water) of 100% or less of the aPAD is required for all 
population subgroups.
    2. Short- and intermediate-term toxicity. Dermal and inhalation 
short- and intermediate-term risk assessments are not required for 
imidacloprid as dermal and inhalation exposure endpoints were not 
identified due to the demonstrated absence of toxicity. However, 
because 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. 
According to current OPP policy, 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) will be used to 
incorporate the oral component into aggregate risk.
    3. Chronic toxicity. EPA has established the RfD for imidacloprid 
at 0.057 milligrams/kilograms/day (mg/kg/day). This RfD is based on 
increased number of thyroid lesions at the LOAEL of 16.9/24.9 mg/kg 
bwt/day (males and females, respectively). An additional 3X FQPA factor 
was used for all population subgroups. The chronic Population Adjusted 
Dose (cPAD), which is the RfD/3 was calculated to be 0.019 mg/kg bwt/
day. Acceptable chronic dietary exposure (food plus water) of 100% or 
less of the cPAD is required for all population subgroups.
    4. Carcinogenicity. Imidacloprid has been classified by the Agency 
as a Group E chemical, no evidence of carcinogenicity for humans, thus, 
a cancer risk assessment is not required.

C. Exposures and Risks

    1. From food and feed uses. Tolerances, some time-limited, are 
currently established (40 CFR 180.472) for the combined residues of the 
insecticide imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as parent, in or on a variety of 
raw agricultural and animal commodities at levels ranging from 0.02 ppm 
in eggs to 15 ppm in raisins, waste. 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 1-day or single exposure.
    In conducting the acute dietary (food) risk assessment, EPA used 
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 ranged from 22% for the U.S. population to 44% for 
children 1-6 years old.
    ii. Chronic exposure and risk. In conducting the chronic dietary 
(food only) risk assessment, EPA used tolerance level residues for 
imidacloprid and percent crop-treated (%CT) information for some of 
these crops. 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 percentages of cPAD 
consumed for the general population and subgroups of interest ranged 
from 9.2% for nursing infants <1 year old to 48.5% for children 1-6 
years old.
    Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    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 percent crop treated as required by the section 408(b)(2)(F), EPA 
may require registrants to submit data on PCT.
    As noted above, the Agency used an analysis that evaluated 
individual food consumption as reported by respondents in the USDA 
Continuing Surveys of Food Intake by Individuals conducted in 1989 
through 1992.
    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 that the percentage of the food treated is not likely to 
be underestimated. The regional consumption information and

[[Page 39045]]

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.
    2. From drinking water. There is no established Maximum Contaminant 
Level for residues of imidacloprid in drinking water. No health 
advisory levels for imidacloprid in drinking water have been 
established.
    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, the Agency is requiring the 
submission of the results of two prospective ground water monitoring 
studies. Results from these studies are not yet available.
    i. Acute exposure and risk. Estimated concentrations of 
imidacloprid in surface and ground water used for the acute exposure 
analysis were 4.1 and 1.1 g/L (ppb), respectively. These 
estimated concentrations of imidacloprid in surface and ground water 
were based upon an application rate of 0.5 lbs ai/A/year.
    For purposes of risk assessment, the estimated maximum 
concentration for imidacloprid in surface and ground waters (which is 
4.1 g/L) should be used for comparison to the back-calculated 
human health drinking water levels of concern (DWLOCs) for the acute 
endpoint. The DWLOCs ranged from 780 g/L for children 1-6 
years old to 3,900 g/L for the U.S. population. These figures 
are well above the drinking water estimate concentration (DWEC) of 4.1 
g/L.
    ii. Chronic exposure and risk. Estimated concentrations of 
imidacloprid in surface and ground water for chronic exposure analysis 
were 0.1 and 1.1 g/L (ppb), respectively. These estimated 
concentrations of imidacloprid in surface and ground water were based 
upon an application rate of 0.5 lbs ai/A/year.
    For purposes of chronic risk assessment, the estimated maximum 
concentration for imidacloprid in ground waters (which is 1.1 
g/L) should be used for comparison to the back-calculated 
human health DWLOCs for the chronic (non-cancer) endpoint. The DWLOCs 
ranged from 98 g/L for children 1-6 years old to 490 
g/L for Non-hispanic males (other than black or white). These 
figures are well above the DWEC of 1.1 g/L.
    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, and lawns), tobacco, 
golf courses, walkways, recreational areas, household or domestic 
dwellings (indoor/outdoor), and cats/dogs.
    i. Acute exposure and risk. Occupational/residential exposure risk 
assessments (namely, short-term dermal, intermediate-term dermal, long-
term dermal, and inhalation) are not required owing to the demonstrated 
absence of dermal and inhalation toxicity.
    ii. Chronic exposure and risk. Occupational/residential exposure 
risk assessments (namely, short-term dermal, intermediate-term dermal, 
long-term dermal, and inhalation) are not required owing to the 
demonstrated absence of dermal and inhalation toxicity.
    iii. Short- and intermediate-term exposure and risk. Short- and 
intermediate-term oral exposure are not expected for adult population 
subgroups. However, 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. Thus, a residential short-term 
risk assessment via the oral route is required.
    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 more 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

    1. Acute risk. EPA has determined that the acute exposure to 
imidacloprid from food will utilize 22% of the aPAD (95th percentile) 
for the most highly exposed population subgroup (U.S. population - all 
seasons). Despite the potential for exposure to imidacloprid in 
drinking water, the Agency does not expect the aggregate exposure to 
exceed 100% of the aPAD. The DWLOC calculated for the U.S. population 
was 3,900 g/L, which is well above the DWEC of 4.1 g/
L.
    2. Chronic risk. In conducting the chronic dietary (food only) risk 
assessment, EPA used tolerance level residues for imidacloprid and 
percent crop-treated (%CT) information for some of these crops. 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 percentage of cPAD 
consumed for the U.S. population was 22%. EPA 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. Despite the 
potential for exposure to imidacloprid in drinking water, the Agency 
does not expect the aggregate exposure to exceed 100% of the cPAD. The 
DWLOC calculated for the U.S. population was well above the DWEC of 1.1 
g/L.
    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 risk assessments 
are not required for imidacloprid as dermal and inhalation exposure 
endpoints were not identified due to the demonstrated absence of 
toxicity. Short- and intermediate-term oral exposure are not expected 
for adult population subgroups.
    4. Aggregate cancer risk for U.S. population. Imidacloprid has been

[[Page 39046]]

classified as a Group E chemical, no evidence of carcinogenicity for 
humans, thus, a cancer risk assessment is not required.
    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. 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. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from maternal pesticide exposure during gestation. 
Reproduction studies provide information relating to effects from 
exposure to the pesticide on the 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 postnatal toxicity and the 
completeness of the data base 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 margin of exposure (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 MOE and 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.
    ii. Developmental toxicity studies. 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 bwt/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 bwt/day. No treatment-related 
effects were seen in any of the reproductive parameters (i.e., Cesarean 
section evaluation). At 100 mg/kg bwt/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 LOAEL was 10 
mg/kg bwt/day (LDT) based on decreased body weight gain; a NOAEL was 
not established. For developmental toxicity, the NOAEL was 30 mg/kg 
bwt/day and the LOAEL was 100 mg/kg bwt/day based on increased wavy 
ribs.
    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 bwt/day during gestation days 6 through 18. For 
maternal toxicity, the NOAEL was 24 mg/kg bwt/day and the LOEL was 72 
mg/kg bwt/day based on mortality, decreased body weight gain, increased 
resorptions, and increased abortions. For developmental toxicity, the 
NOAEL was 24 mg/kg bwt/day and the LOEL was 72 mg/kg bwt/day based on 
decreased fetal body weight, increased resorptions, and increased 
skeletal abnormalities.
    iii. Reproductive toxicity study. 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 bwt/day for males and 0, 8.0, 20.5, or 57.4 mg/kg bwt/day 
for females). For parental/systemic/reproductive toxicity, the NOAEL 
was 250 ppm (18.3 mg/kg bwt/day) and the LOEL was 750 ppm (52 mg/kg 
bwt/day), based on decreases in body weight in both sexes in both 
generations. Based on these factors, the Agency determined that the 
review be revised to indicate the parental/systemic/reproductive NOAEL 
and LOEL to be 250 and 700 ppm, respectively, based upon the body 
weight decrements observed in both sexes in both generations.
    iv. Pre- and postnatal sensitivity. 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 NOAELs 
were lower or equivalent to developmental or offspring NOAELs.
    v. Conclusion. There is a need for a developmental neurotoxicity 
study for assessment of potential alterations of functional 
development. However, the Agency has determined that this data gap does 
not preclude the establishment/continuance of tolerances. The 10X 
safety factor to account for enhanced sensitivity of infants and 
children (as required by FQPA) was reduced to 3X and the factor applies 
to all population subgroups.
    2. Acute risk. Using the conservative TMRC exposure assumptions 
described above, 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 children 1-6 years old. The 
maximum concentration of imidacloprid in surface and ground water for 
acute exposure is very small (4.1 g/L) compared to the DWEC of 
780 g/L.
    3. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to imidacloprid from 
food will utilize 48% of the cPAD for infants and children. 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, EPA does not expect the aggregate exposure to exceed 100% of the 
cPAD for children 1-6 years old. The maximum concentration of 
imidacloprid in surface and ground water for acute exposure is very 
small (1.1 g/L) compared to the DWEC of 98 g/L.
    4. Short- or intermediate-term risk. As noted earlier in this 
document, dermal and inhalation short- and intermediate-term risk 
assessments are not required for imidacloprid as dermal and inhalation 
exposure endpoints were not identified due to the demonstrated absence 
of toxicity. Short- and intermediate-term oral exposure are not 
expected for adult population subgroups. However, 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. 
According to current OPP policy, 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) will be

[[Page 39047]]

used to incorporate the oral component into aggregate risk.
    The margin of exposure for chronic dietary exposure (food only) and 
residential exposure (hand-to-mouth from turf, garden, and pet uses) 
for children age 1-6 was calculated to be 302. The safe level for 
imidacloprid is 300.
    Potential short-term exposure from drinking water is at a level 
below the Agency's level of concern with the DWLOC (10 g/L) 
being greater than the DWEC of 1.1 g/L.
    The Agency concludes the short-term aggregate risk to the highest 
exposed population subgroup (children, 1 to 6 years old) from home 
garden, turf, and pet uses of imidacloprid does not exceed EPA's level 
of concern.
    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.

IV. Other Considerations

A. Metabolism in Plants and Animals

    The nature of imidacloprid residues in plants and in 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 methodology (example - gas chromotography) is 
available to enforce the tolerance expression. The method may be 
requested 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.

C. Magnitude of Residues

    Based on data submitted by the Applicant, the Agency is 
establishing time-limited tolerances for residues of imidacloprid and 
its metabolites containing the 6-chloropyridinyl moiety, all expressed 
as parent in or on blueberries at 1.0 ppm and cranberries at 0.5 ppm.

D. International Residue Limits

    There are no CODEX, Canadian, or Mexican Maximum Residue Limits 
(MRL) for imidacloprid on cranberry and blueberries. Thus, 
harmonization is not an issue for these time-limited tolerances.

E. Rotational Crop Restrictions

    The rotational crop restrictions follow the original section 3 
labels. For the use of Provado 1.6 Flowable and Admire 2 Flowable, most 
vegetables can be immediately plantedback while all other crops have a 
12-month plantback interval.

V. Conclusion

    Therefore, the tolerance is established for the combined residues 
of imidacloprid and its metabolites containing the 6-chloropyridinyl 
moiety, all expressed as parent, in or on blueberries at 1.0 ppm and 
cranberries at 0.5 ppm.

VI. 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(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 September 20, 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 
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). 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.

VII. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket 
control number [OPP-300884] (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:

    [email protected]


    E-mailed objections and hearing requests must be submitted as an 
ASCII

[[Page 39048]]

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.

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes tolerances under section 408 of the 
FFDCA. 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 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(l)(6), 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.

IX. 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 1, 1999.

Peter Caulkins,

Acting 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, 321q and 371.

    2. In Sec.  180.472, in paragraph (b), by aphabetically inserting 
the following commodities to the table.

Sec.  180.472   Imidacloprid; tolerance for residues.

     *    *    *    *    *

    (b)*    *    *


------------------------------------------------------------------------
                                                     Parts   Expiration/
                     Commodity                        per     revocation
                                                    million      date
------------------------------------------------------------------------
Blueberries.......................................  1.0           6/1/01
 
                      *      *      *      *      *
Cranberries.......................................  0.5           6/1/01
 

[[Page 39049]]

 
                      *      *      *      *      *
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*    *    *    *    *

[FR Doc. 99-18190 Filed 7-20-99; 8:45 am]
BILLING CODE 6560-50-F