Imidacloprid; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: December 2, 1998 (Volume 63, Number 231)]
[Rules and Regulations]
[Page 66438-66447]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02de98-16]

[[Page 66438]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300758; FRL-6045-3]
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 field corn
forage at 0.1 parts per million (ppm), field corn stover (fodder) at
0.2 ppm, and field corn grain at 0.05 ppm. This action is in response
to EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of
the pesticide on field corn. 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 May 1, 2000.

DATES: This regulation is effective December 2, 1998. Objections and
requests for hearings must be received by EPA on or before February 1,
1999.

ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300758], 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-300758], 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: opp-docket@epamail.epa.gov. 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-300758]. 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: 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: Crystal Mall #2, 1921 Jefferson
Davis Hwy., Arlington, VA, (703) 308-9367, e-mail:
ertman.andrew@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for
the combined residues of the insecticide imidacloprid, in or on field
corn forage at 0.1 ppm, field corn stover (fodder) at 0.2 ppm, and
field corn grain at 0.05 ppm. These tolerances will expire and are
revoked on May 1, 2000. EPA will publish a document in the Federal
Register to remove the revoked tolerance from the Code of Federal
Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 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 below 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 Field Corn and FFDCA
Tolerances

The states of Illinois and Iowa requested the use of imidacloprid
on field corn to control the flea beetle because the flea beetle has
been shown to be a vector of a bacteria that causes Stewart's Wilt in
corn. Stewart's wilt can cause serious yield loss when infection occurs
early in the growing

[[Page 66439]]

season. Also, many countries require seed fields to be inspected for
Stewart's wilt infected plants, and will not allow seed from these
fields to be sent to their country. The United States is a major
producter of seed corn for the world. EPA has authorized under FIFRA
section 18 the use of imidacloprid on field corn for control of corn
flea beetles (a vector of Stewart's wilt) in Illinois and Iowa. After
having reviewed the submission, EPA concurs that emergency conditions
exist for these states.
As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of imidacloprid in
or on field corn. In doing so, EPA considered the safety standard in
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance
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 exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this tolerance without notice and opportunity
for public comment under section 408(e), as provided in section
408(l)(6). Although this tolerance will expire and is revoked on May 1,
2000, under FFDCA section 408(l)(5), residues of the pesticide not in
excess of the amounts specified in the tolerance remaining in or on
field corn 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 this tolerance at the time of
that application. EPA will take action to revoke this tolerance 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 field corn or whether
permanent tolerances for this use 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 States other than Illinois and Iowa 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 above.

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 time-limited tolerances for the
combined residues of imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as parent on field corn forage at
0.1 ppm, field corn stover (fodder) at 0.2 ppm, and field corn grain at
0.05 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 infants and
children. The nature of the toxic effects caused by imidacloprid are
discussed below.
1. Acute toxicity. Acute Reference dose (RfD): 0.42 milligrams per
kilogram of bodyweight per day (mg/kg bwt/day). The endpoint selected
for assessment of acute dietary risk is 42 mg/kg bwt/day (Lowest
Observed Effect Level (LOEL)) from an acute neurotoxicity study in
rats. A NOAEL was not established in this study. The uncertainty
factors (UF) are 10X for inter-, 10X for intra-species variations, and
3X for FQPA.
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. A short-term
aggregate risk assessment (oral exposure) is required for hand-to-mouth
residential exposure. The Agency utilized the acute toxicological
endpoint for this risk assessment. The acute dietary endpoint is based
upon dose-related decreases in motor activity in female rats from an
acute neurotoxicity study.
3. Chronic toxicity. EPA has established the RfD for imidacloprid
at 0.057 milligrams/kilogram/day (mg/kg/day). This RfD is based on
decreased body weight gains in female rats and increased number of
thyroid lesions in male rats from a combined chronic toxicity/
carcinogenicity study at 16.9 mg/kg bwt/day LOEL. The No Observed
Adverse Effect Level (NOAEL) in this study was established at 5.7 mg/kg
bwt/day. An uncertainty factor of 100 is required for all population
subgroups (10X for inter-species variation and 10X for intra-species
variation). For chronic dietary risk assessment, the Agency determined
that the FQPA safety factor could be reduced to 3X and should be
applied to 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.

B. 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. Application of the 3X safety factor to
the Acute RfD results in an acceptable acute dietary exposure (food
plus water) of 33.3% or less of the Acute RfD for all population
subgroups
This acute dietary (food) risk assessment used the Theoretical
Maximum Residue Contribution (TMRC) which assumes tolerance level
residues and 100% crop-treated. The Novigen DEEM (Dietary Exposure
Evaluation Model) system was used for this acute dietary exposure
analysis. The analysis evaluates individual food consumption as
reported by respondents in the USDA Continuing

[[Page 66440]]

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 99th percentile) and percentage of the Acute RfD
utilized are shown in the following Table 1.

Table 1.--Acute Dietary (Food Only) Exposure Analysis by DEEM for
Imidacloprid
------------------------------------------------------------------------
Exposure @
99th Percent
Population Subgroup Percentile Acute
(mg/kg bwt/ RfD\1\
day)
------------------------------------------------------------------------
U.S. Population (48 states)...................... 0.051 12
All infants (< 1 yr)............................. 0.067 16
Nursing infants (< 1 yr)......................... 0.096 23
Non-nursing infants (< 1 yr)..................... 0.059 14
Children (1-6 yrs)............................... 0.086 20
Children (7-12 yr)............................... 0.058 14
------------------------------------------------------------------------
\1\ Percentage reference dose (% Acute RfD) = Exposure/Acute RfD X 100%

The subgroups listed above are: (1) the U.S. population (48
states) and (2) those for infants and children. There are no other
subgroups for which the percentage of the Acute RfD occupied is
greater than that occupied by the subgroup U.S. Population (48
states).

ii. Chronic exposure and risk. The chronic dietary exposure
analysis from food sources was conducted using the reference dose
(chronic RfD) of 0.057 mg/kg bwt/day. This RfD (RfD = NOAEL/UF) is
based on the NOAEL of 5.7 mg/kg bwt/day in male rats from the chronic
toxicity/carcinogenicity study in rats, and an uncertainty factor (UF)
of 100. The FQPA Safety Factor for enhanced sensitivity of infants and
children was reduced to 3X. For this risk assessment, the FQPA factor
applies to all population subgroups. Application of the 3X safety
factor to the chronic RfD results in an acceptable chronic dietary
exposure (food plus water) of 33.3% or less of the chronic RfD for all
population subgroups.
In conducting this chronic dietary (food only) risk assessment, EPA
used: (1) tolerance level residues for field corn and all other
commodities with published, pending, permanent or time-limited,
imidacloprid tolerances; and, (2) percent crop-treated (%CT)
information for some of these crops. Thus, this risk assessment should
be viewed as partially refined. Further refinement using anticipated
residue values and additional %CT information would result in a lower
estimate of chronic dietary exposure. The Novigen DEEM (Dietary
Exposure Evaluation Model) system was used for this chronic dietary
exposure analysis. 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.
The existing imidacloprid tolerances (published, pending, and
including the necessary section 18 tolerance(s)) result in a TMRC that
is equivalent to the percentages of the Chronic RfD in the following
Table 2:

Table 2.--Chronic Exposure Analysis by the DEEM System for Imidacloprid
------------------------------------------------------------------------
Percent
Exposure Reference
Population Subgroup (mg/kg/ Dose\1\
day) (%Chronic
RfD)
------------------------------------------------------------------------
U.S. Population (48 States)........................ 0.0032 5.6
All Infants (<1 year old).......................... 0.0039 6.9
Nursing Infants (<1 year old)...................... 0.0014 2.4
Non-Nursing Infants (<1 year old).................. 0.0050 8.7
Children (1-6 years old)........................... 0.0074 13
Children (7-12 years old).......................... 0.0046 8.2
U.S. Population (Autumn Season).................... 0.0032 5.7
Northeast Region................................... 0.0032 5.7
Western Region..................................... 0.0033 5.7
Non-hispanic (Other Than Black or White)........... 0.0036 6.2
------------------------------------------------------------------------
\1\ Percentage reference dose (% Chronic RfD) = Exposure/Chronic RfD X
100%

The subgroups listed above are: (1) the U.S. population (48
states); (2) those for infants and children; and (3) the other
subgroups for which the percentage of the Chronic RfD occupied is
greater than that occupied by the subgroup U.S. Population (48
states).

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. EPA used
estimates for the concentration of imidacloprid in surface and ground
waters.
The Agency used PRZM1 (Pesticide Root Zone Model - simulates the
transport of a pesticide off the agricultural field) and EXAMS
(EXposure Analysis Modeling System - simulates fate and transport of a
pesticide in surface water) models to estimate concentrations of
imidacloprid residues in surface water.
The Agency used the SCI-GROW (Screening Concentration In GROund
Water) model to estimate the concentration of imidacloprid residues in
ground water. SCI-GROW is a prototype model for estimating ``worst
case'' ground water concentrations of pesticides. SCI-GROW is biased in
that studies where the pesticide is not detected in ground water are
not included in the data set. Thus, it is not expected that SCI-GROW
estimates would be exceeded.
i. Acute exposure and risk. Estimated concentrations of
imidacloprid in surface and ground water for acute exposure analysis
are 4.1 and 1.1 grams per liter (parts per million) (<greek-m>g/L parts
per billion (ppb)), respectively. These estimated concentrations of
imidacloprid in surface and ground water are based upon an application
rate of 0.5 lbs active ingredient per acre per year (ai/A/year).
For purposes of risk assessment, the estimated maximum
concentration for imidacloprid in surface and ground waters (which is
4.1 <greek-m>g/L) should be used for comparison to the back-calculated
human health drinking water levels of concern (DWLOCs) for the acute
endpoint. These DWLOCs for various population categories are summarized
in the following Table 3.

[[Page 66441]]

Table 3.--Drinking Water Levels of Concern for Acute Exposure to
Imidacloprid\1\
------------------------------------------------------------------------
Acute
RfD Food Max. Water DWLOC4, 5, 6
Population Category\2\ (mg/ Exposure Exposure\3\ (<greek-m>g/
kg/ (mg/kg/ (mg/kg/day) L)
day) day)
------------------------------------------------------------------------
U.S. Population (48 states)
(male)..................... 0.42 0.051 0.089 3100
U.S. Population (48 states)
Females.................... 0.42 0.051 0.089 2700
Nursing Infants (<1 year
old)....................... 0.42 0.096 0.044 440
------------------------------------------------------------------------
\1\ Values are expressed to two significant figures.
\2\ Within each of these categories, the subgroup with the highest food
exposure was selected.
\3\ Maximum Water Exposure (Chronic or Acute) (mg/kg/day) = Chronic or
Acute RfD (mg/kg/day)/3 (to account for FQPA factor of 3X) - Food
Exposure (mg/kg/day).
\4\ DWLOC(<greek-m>g/L) = Max. water exposure (mg/kg/day) x body wt (kg)/
(10-3 mg/<greek-m>g) * water consumed daily (L/day).
\5\ EPA Default body weights are: General U.S. Population, 70 kg; Males
(13+ years old), 70 kg; Females (13+ years old), 60 kg; Other Adult
Populations, 70 kg; and, All Infants/Children, 10 kg.
\6\ EPA Default daily drinking rates are 2 L/day for adults and 1 L/day
for children.

ii. Short-term risk. For purposes of risk assessment, the
estimated maximum concentration for imidacloprid in surface and ground
waters (which is 4.1 <greek-m>g/L, see above) should be used for
comparison to the back-calculated human health drinking water levels of
concern (DWLOCs) for the short-term endpoint.
EPA has calculated a DWLOC for short-term exposure to imidacloprid
in drinking water for the population subgroup Children, 1 to 6 years
old. This DWLOC is for short-term exposure to imidacloprid from home
garden and turf uses. A DWLOC for short-term exposure from imidacloprid
pet uses was not determined as the exposure level from the home garden
and turf uses is higher than that of the pet uses. Thus, the DWLOC for
the imidacloprid pet uses will be higher than that of the home garden
and turf uses. The DWLOC for short-term exposure to imidacloprid is
summarized in the following Table 4.

Table 4.--Drinking Water Levels of Concern for Short-Term Exposure to Imidacloprid\1\
----------------------------------------------------------------------------------------------------------------
Max.
Total Exposure
Exposure\2\ from Bodyweight Daily Water DWLOC4, 5, 6
Population Subgroup (mg/kg bwt/ Water\3\ (kg) Consumption (<greek-m>g/
day) (mg/kg (Liters) L)
bwt/day)
----------------------------------------------------------------------------------------------------------------
Children (1-6 years).............................. 0.080 0.060 10 1 600
----------------------------------------------------------------------------------------------------------------
\1\ Values are expressed to two significant figures.
\2\ Total Exposure = sum of exposures from chronic food plus home turf and garden uses.
\3\ Maximum Water Exposure (Short-term) (mg/kg/day) = Acute RfD (mg/kg/day)/3 (to account for FQPA factor of 3X)
- Total Exposure (mg/kg/day).
\4\ DWLOC(<greek-m>g/L) = Max. water exposure (mg/kg/day) x body wt (kg)/(10-3 mg/<greek-m>g) * water consumed
daily (L/day).
\5\ EPA Default body weight is: All Infants/Children, 10 kg.
\6\ EPA Default daily drinking rate is 1 L/day for children.

The DWLOC for short-term exposure to imidacloprid was calculated
relative to the Acute RfD 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 (from DEEM) plus the oral exposure from
imidacloprid home garden and turf uses was subtracted from one-third
the Acute RfD to obtain the acceptable short-term exposure to
imidacloprid in drinking water. The value of one-third the Acute RfD
was utilized to account for the FQPA Safety Factor of 3X. DWLOCs were
then calculated using default body weights and drinking water
consumption figures.
iii. Chronic exposure and risk. Estimated concentrations of
imidacloprid in surface and ground water for chronic exposure analysis
are 0.1 and 1.1 <greek-m>g/L (ppb), respectively. These estimated
concentrations of imidacloprid in surface and ground water are 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 surface and ground waters (which is
1.1 <greek-m>g/L) should be used for comparison to the back-calculated
human health drinking water levels of concern (DWLOCs) for the chronic
(non-cancer) endpoint. These DWLOCs for various population categories
are summarized in the following Table 5.

[[Page 66442]]

Table 5.--Drinking Water Levels of Concern for Chronic Exposure to Imidacloprid\1\
----------------------------------------------------------------------------------------------------------------
Food
Chronic Exposure Max. Water DWLOC4, 5, 6
Population Category\2\ RfD (mg/ (mg/kg/ Exposure\3\ (<greek-m>g/
kg/day) day) (mg/kg/day) L)
----------------------------------------------------------------------------------------------------------------
U.S. Population (48 states) (male)................................ 0.057 0.0032 0.0158 550
Females U.S. Population (48 states)............................... 0.057 0.0032 0.0158 470
Children (1-6).................................................... 0.057 0.0074 0.0116 120
Non-hispanic other than black or white............................ 0.057 0.0036 0.0154 540
----------------------------------------------------------------------------------------------------------------
\1\ Values are expressed to two significant figures.
\2\ Within each of these categories, the subgroup with the highest food exposure was selected.
\3\ Maximum Water Exposure (Chronic or Acute) (mg/kg/day) = Chronic or Acute RfD (mg/kg/day)/3 (to account for
FQPA factor of 3X) - Food Exposure (mg/kg/day).
\4\ DWLOC(<greek-m>g/L) = Max. water exposure (mg/kg/day) x body wt (kg)/(10-3 mg/<greek-m>g) * water consumed
daily (L/day).
\5\ EPA Default body weights are: General U.S. Population, 70 kg; Males (13+ years old), 70 kg; Females (13+
years old), 60 kg; Other Adult Populations, 70 kg; and, All Infants/Children, 10 kg.
\6\ EPA Default daily drinking rates are 2 L/day for adults and 1 L/day for children.
\7\ Total Exposure for Short-term Exposure = sum of exposures from chronic food plus home turf and garden uses.

iv. Conclusions concerning residues in drinking water (all time
periods). The estimated concentrations of imidacloprid in surface and
ground water are less than the Agency's levels of concern for
imidacloprid in drinking water as a contribution to acute, short-term
and chronic aggregate exposure. Therefore, taking into account the
present uses and uses proposed in this section 18, EPA concludes with
reasonable certainty that residues of imidacloprid in drinking water
(when considered along with other sources of acute, short-term and
chronic exposure for which EPA has reliable data) would not result in
an unacceptable estimate of acute, short-term and chronic aggregate
human health risk at this time.
EPA bases this determination on a comparison of estimated
concentrations of imidacloprid in surface water to back-calculated
``levels of concern'' for imidacloprid in drinking water. These levels
of concern in drinking water were determined after EPA has considered
all other non-occupational human exposures for which it has reliable
data, including all current uses, and uses considered in these actions.
The estimate of imidacloprid in surface water is derived from water
quality models that use conservative assumptions (health-protective)
regarding the pesticide transport from the point of application to
surface and ground water. Because EPA considers the aggregate risk
resulting from multiple exposure pathways associated with a pesticide's
uses, levels of concern in drinking water may vary as those uses
change. If new uses are added in the future, EPA will reassess the
potential impacts of imidacloprid in drinking water as a part of the
acute, short-term and chronic aggregate risk assessment process.
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, et al.),
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 because of 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 because of the
demonstrated absence of dermal and inhalation toxicity.
iii. Short- and intermediate-term exposure and risk. Oral exposure
due to the registered residential uses of imidacloprid may result.
Thus, a residential short-term risk assessment via the oral route is
required. See Unit III(D)(4) of this preamble for a full discussion of
this exposure and risk.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
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).

C. Aggregate Risks and Determination of Safety for U.S. Population

1. 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 will utilize 12% of the Acute RfD for the
most highly exposed population subgroup (U.S. population - all
seasons). All other population subgroups which include adults have
acute risk estimates (food only) below that of the population subgroup
U.S. Population - all seasons. For imidacloprid, it was determined that
an acceptable acute dietary exposure (food plus water) of 33.3% or less
of the Acute RfD is needed to protect the safety of all population
subgroups. The estimated exposures at the 99th percentile for all
population subgroups that include adults utilize less than 33.3% of the
Acute RfD.
Despite the potential for exposure to imidacloprid in drinking
water, EPA does not expect the aggregate exposure to exceed 33.3% of
the Acute RfD for adults. Under current Agency

[[Page 66443]]

guidelines, the registered non-dietary uses of imidacloprid do not
constitute an acute exposure scenario. EPA concludes that there is a
reasonable certainty that no harm will result to adults from acute
aggregate exposure to imidacloprid residues.
2. Chronic risk. Using the partially refined exposure assumptions
described in Unit III(B)(1)(ii) of this preamble, and taking into
account the completeness and reliability of the toxicity data, the
Agency has estimated the chronic exposure to imidacloprid from food
will utilize 6.2% of the chronic RfD for the most highly exposed adult
population subgroup, non-hispanic (other than black or white). All
other population subgroups which include adults have chronic (non-
cancer) risk estimates (food only) below that of the population
subgroup non-hispanic (other than black or white). For imidacloprid, it
was determined that an acceptable acute dietary exposure (food plus
water) of 33.3% or less of the chronic RfD is needed to protect the
safety of all population subgroups. The estimated exposures for all
adult population subgroups utilize less than 33.3% of the chronic RfD.
Despite the potential for exposure to imidacloprid in drinking
water, EPA does not expect the aggregate exposure to exceed 33.3% of
the Chronic RfD. Under current Agency guidelines, the registered non-
dietary uses of imidacloprid do not constitute a chronic exposure
scenario. EPA concludes that there is a reasonable certainty that no
harm will result to adults from chronic aggregate exposure to
imidacloprid residues.
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. A discussion of short and intermediate
term oral exposure and risk for children 1-6 years old can be found in
Unit III.D.4 of this preamble.
4. Aggregate cancer risk for U.S. population. Imidacloprid has been
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.

D. 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 two-
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 post-natal 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 LOEL 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 LOEL 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 two-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 post-natal 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

[[Page 66444]]

in Unit III.B.1.i of this preamble, and taking into account the
completeness and reliability of the toxicity data, EPA has estimated
the acute exposure to imidacloprid from food will utilize 23% of the
Acute RfD for the most highly exposed population subgroup that includes
children (Nursing infants, <1 year). All other population subgroups
which include children have acute risk estimates (food only) below that
of the population subgroup Nursing Infants (<1 year). For imidacloprid,
it was determined that an acceptable acute dietary exposure (food plus
water) of 33.3% or less of the Acute RfD is needed to protect the
safety of all population subgroups. The estimated exposures for all
population subgroups at the 99th percentile utilize less than 33.3% of
the Acute RfD.
Despite the potential for exposure to imidacloprid in drinking
water, EPA does not expect the aggregate exposure to exceed 33.3% of
the Acute RfD. Under current EPA guidelines, the registered non-dietary
uses of imidacloprid do not constitute an acute exposure scenario. EPA
concludes that there is a reasonable certainty that no harm will result
to children from acute aggregate exposure to imidacloprid residues.
3. Chronic risk. Using the partially refined exposure assumptions
described above, and taking into account the completeness and
reliability of the toxicity data, EPA has estimated the chronic
exposure to imidacloprid from food will utilize 13% of the Chronic RfD
for the most highly exposed population subgroup that includes children
(Children, 1-6 years old). All other population subgroups which include
children have chronic risk estimates (food only) below that of the
population subgroup Children, 1-6 years old). For imidacloprid, it was
determined that an acceptable acute dietary exposure (food plus water)
of 33.3% or less of the Chronic RfD for all population subgroups is
needed to protect the safety of all population subgroups. The estimated
exposures for all population subgroups which include children utilize
less than 33.3% of the Acute RfD. Despite the potential for exposure to
imidacloprid in drinking water, EPA does not expect the aggregate
exposure to exceed 33.3% of the Chronic RfD. Under current EPA
guidelines, the registered non-dietary uses of imidacloprid do not
constitute a chronic exposure scenario. EPA concludes that there is a
reasonable certainty that no harm will result to children from chronic
aggregate exposure to imidacloprid residues.
4. Short- or intermediate-term risk. 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, a
short term residential oral risk assessment is required. In addition to
its food uses, imidacloprid is registered for use on turf, home gardens
and pets. EPA has identified potential short-term oral exposures to
children for these uses. These exposures include the following
scenarios:
\ 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.
According to current EPA policy, these exposures are considered to be
short-term oral exposures. Incidental ingestion of pesticide residues
on pets from hand-to mouth transfer may occur during the same period as
the exposures from the turf and home garden uses. However, children's
exposures from pet and turf uses are not expected to both occur at the
high-end level. Therefore, these exposures were considered in separate
estimates of risk.
A short-term oral endpoint was not identified for imidacloprid.
According to current EPA 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 (Acute RfD = 0.42 mg/kg bwt/day) will be used to
incorporate the oral component into aggregate risk. Short-term
aggregate exposure is defined by EPA to be average food and water
exposure (chronic exposure) plus residential exposure. The short-term
risk estimates for the population subgroup Children, 1 to 6 years old,
is summarized below in Tables 6 and 7. This population subgroup was
chosen because it has the highest chronic food exposure and because
toddlers have the highest exposure from the residential uses.

Table 6.--Short-Term Aggregate Exposure and Risk (Includes Turf and Garden Uses of Imidacloprid)
----------------------------------------------------------------------------------------------------------------
Chronic
Food Residential Total Percent
Population Subgroup Exposure Exposure\1\ Exposure\2\ Acute
(mg/kg (mg/kg bwt/ (mg/kg bwt/ RfD\3\
bwt/day) day) day)
----------------------------------------------------------------------------------------------------------------
Children (1 to 6 years old).................................... 0.0074 0.072 0.079 19%
----------------------------------------------------------------------------------------------------------------
\1\ Residential Exposure = total of imidacloprid exposure from incidental ingestion of residues on lawns from
hand-to-mouth transfer plus ingestion of pesticide-treated grass plus ingestion of soil from treated gardens.
\2\ Total Exposure = Chronic Food Exposure plus Residential Exposure.
\3\ Percent Acute RfD = Total Exposure (mg/kg bwt/day) x 100% Acute RfD (0.42 mg/kg bwt/day)

[[Page 66445]]

Table 7.--Short-Term Aggregate Exposure and Risk (Includes The Pet Use of Imidacloprid)
----------------------------------------------------------------------------------------------------------------
Chronic
Food Residential Total Percent
Population Subgroup Exposure Exposure\1\ Exposure\2\ Acute
(mg/kg (mg/kg bwt/ (mg/kg bwt/ RfD\3\
bwt/day) day) day)
----------------------------------------------------------------------------------------------------------------
Children (1 to 6 years old).................................... 0.0074 0.058 0.065 16%
----------------------------------------------------------------------------------------------------------------
\1\ Residential Exposure = total of imidacloprid exposure from incidental ingestion of residues on pets from
hand-to-mouth transfer.
\2\ Total Exposure = Chronic Food Exposure plus Residential Exposure.
\3\ Percent Acute RfD = Total Exposure (mg/kg bwt/day) x 100% Acute RfD (0.42 mg/kg bwt/day)

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

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-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 22202, (703-305-5229).

C. Magnitude of Residues

A study on field corn RAC's has been submitted. This study has not
been reviewed in detail. Residues of imidacloprid and its metabolites
containing the 6-chloropyridinyl moiety, all expressed as parent, are
not expected to exceed 0.1 ppm in field corn forage, 0.2 ppm in field
corn stover (fodder) and 0.05 ppm in field corn grain. Since this
section 18 proposed use is a seed treatment, a tolerance for aspirated
grain fractions is not required.
A study on field corn processing has been submitted. In this study,
field corn grown from imidacloprid-treated (3.5-7 oz ai/A, 7X) seed
were harvested at maturity and processed by wet and dry milling. All
processed fractions contained residues of imidacloprid and its
metabolites at levels less than the limit of quantification (<0.05ppm).
Residues of imidacloprid and its metabolites did not concentrate into
the field corn processed products. The Agency concludes tolerances for
imidacloprid and its metabolites are not required for field corn
processed commodities.

D. International Residue Limits

There are no CODEX, Canadian, or Mexican maximum Residue Limits
(MRL) for imidacloprid on field corn. Thus, harmonization is not an
issue for this section 18.

E. Rotational Crop Restrictions

Data concerning the metabolism of imidacloprid in rotational crops
were previously submitted. In conjunction with this study, EPA has
concluded that a rotation interval of 12 months is appropriate for all
crops except those with imidacloprid tolerances which may be rotated at
anytime. In conjunction with PP 6F4765, tolerances for inadvertent
residues in/on the crop groups Cereal Grains, Forage, Fodder and Straw
of Cereal Grains, Legume Vegetables and the Foliage of Legume
Vegetables; and the crops sweet corn, soybeans and safflower have been
proposed in conjunction with a 30-day plantback interval for these
crops.
EPA has recently recommended in favor of the granting of these
tolerances and the 30-day plant back interval. EPA concludes the
following rotation restriction is adequate for this section 18: Any
crops, except those having imidacloprid tolerances, sweet corn,
soybeans and safflower and the crops of the crop groups Cereal Grains
and Legume Vegetables, may be planted back one year following
imidacloprid applications. The crops sweet corn, soybeans, and
safflower, and the crops of the crop groups Cereal Grains and Legume
Vegetables may be rotated 30-days after the last imidacloprid
treatment. Other crops having imidacloprid tolerances/uses may be
rotated at anytime.

V. Conclusion

Therefore, the tolerance is established for combined residues of
imidacloprid and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as parent in field corn forage at 0.1 ppm, field
corn stover (fodder) at 0.2 ppm, and field corn grain at 0.05 ppm 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(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by February 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 above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's

[[Page 66446]]

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 rulemaking under docket
control number [OPP-300758] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C)
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov.

Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

This final rule establishes tolerances under FFDCA section 408
(l)(6). The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4). Nor does it require 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
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 has previously assessed whether
establishing tolerances, exemptions from tolerances, raising tolerance
levels or expanding exemptions might adversely impact small entities
and concluded, as a generic matter, that there is no adverse economic
impact. The factual basis for the Agency's generic certification for
tolerance actions published on May 4, 1981 (46 FR 24950), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.

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 to 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.

[[Page 66447]]

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 to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: November 16, 1998.

James Jones,

Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

1. The authority citation for part 180 continues to read as
follows:

Authority: 21 U.S.C. 346a and 371.

2. In Sec. 180.472, the table to paragraph (b) by adding
alphabetically entries for field corn forage, field corn stover
(fodder), and field corn grain, to read as follows:

Sec. 180.472 Imidacloprid; tolerances for residues.

* * * * *
(b) Section 18 emergency exemptions. * * *

------------------------------------------------------------------------
Parts
Commodity per Expiration/Revocation
million Date
------------------------------------------------------------------------

* * * * *
Field corn forage.................... 0.1 5/1/00
Field corn stover (fodder)........... 0.2 5/1/00
Field corn grain..................... 0.05 5/1/00

* * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 98-31686 Filed 12-1-98; 8:45 am]
BILLING CODE 6560-50-F

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