[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.
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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)="">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\="">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:="">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
