[Federal Register Volume 63, Number 231 (Wednesday, December 2, 1998)]
[Rules and Regulations]
[Pages 66438-66447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31686]



[[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.

-----------------------------------------------------------------------

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: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-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: 
[email protected].

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) (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 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\  (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(g/L) = Max. water exposure (mg/kg/day) x body wt (kg)/
  (10-3 mg/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 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  (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(g/L) = Max. water exposure (mg/kg/day) x body wt (kg)/(10-3 mg/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 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 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\  (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(g/L) = Max. water exposure (mg/kg/day) x body wt (kg)/(10-3 mg/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:
    [email protected].

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

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