65FR36367 Imidacloprid; Pesticide Tolerances for Emergency Exemptions
robop...@us.govnews.org
Posting-number: Volume 65, Issue 111, Page 36367
[Federal Register: June 8, 2000 (Volume 65, Number 111)]
[Rules and Regulations]
[Page 36367-36373]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn00-20]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301004; FRL-6558-4]
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 stone fruit
(Crop Group 12). This action is in response to EPA's granting of
emergency exemptions under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of the pesticide on
stone fruit. This regulation establishes maximum permissible levels for
residues of imidacloprid on these food commodities. The tolerances will
expire and are revoked on December 31, 2001.
DATES: This regulation is effective June 8, 2000. Objections and
requests for hearings, identified by docket control number OPP-301004,
must be received by EPA on or before August 7, 2000.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the ``SUPPLEMENTARY
INFORMATION.'' To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301004 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9367; e-mail address:
ertman...@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected categories and entities may include, but are not
limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
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Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under ``FOR FURTHER INFORMATION
CONTACT.''
B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301004. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an
[[Page 36368]]
applicable comment period is available for inspection in the Public
Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The PIRIB telephone
number is (703) 305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(l)(6)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is
establishing tolerances for the combined residues of the insecticide
imidacloprid, in or on stone fruit at 1.0 part per million (ppm) and
the processed commodity prunes at 3.5 ppm. These tolerances will expire
and are revoked on December 31, 2001. EPA will publish a document in
the Federal Register to remove the revoked tolerances from the Code of
Federal Regulations.
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. EPA does not intend for its actions on
section 18-related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
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 the Federal Insecticide, Fungicide, and Rodenticide
Act (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
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Imidacloprid on Stone Fruit and FFDCA
Tolerances
There are two situations that have arisen, resulting in the present
emergency condition. First, currently there are no reliable
insecticides to control the green peach aphid (GPA) on peaches and
nectarines because of insecticide resistance. Second, aphids are a
vector for Plum Pox Virus (PPV), a disease that damages the fruits of
sensitive cultivars of stone fruits. The mechanism by which aphids
transmit PPV is called non- persistent transmission. Once an aphid
probes into infected plant tissue and acquires the virus, the virus can
only remain infectious and be transmitted for a short period of time
(minutes). Each aphid must feed directly on an infected plant, acquire
sufficient virus, and then fly immediately to the next plant in order
to effect a transmission.
PPV was discovered for the first time in the United States in 18
stone fruit orchards in Adams County, Pennsylvania in the fall of 1999.
Indications are that PPV has been in Pennsylvania for several years,
and it is possible that undetected infections of PPV exist in peach and
nectarine orchards in New Jersey, New York, and West Virginia. EPA has
authorized under FIFRA section 18 the use of imidacloprid on stone
fruit for control of aphids in New Jersey, New York, Pennsylvania and
West Virginia. After having reviewed the submissions, 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 stone fruit. In doing so, EPA considered the safety standard in
FFDCA section 408(b)(2), and EPA decided that the necessary tolerances
under FFDCA section 408(l)(6) would be consistent with the safety
standard and with FIFRA section 18. Consistent with the need to move
quickly on each 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 these tolerances without notice and opportunity
for public comment as provided in section 408(l)(6). Although these
tolerances will expire and are revoked on December 31, 2001, under
FFDCA section 408(l)(5), residues of the pesticide not in excess of the
amounts specified in the tolerance remaining in or on stone fruit after
that date will not be unlawful, provided the pesticide is applied in a
manner that was lawful under FIFRA, and the residues do not exceed a
level that was authorized by these tolerances at the time of that
application. EPA will take action to revoke these tolerances earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether imidacloprid
meets EPA's registration requirements for use on stone fruit 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 State other than New Jersey, New York, Pennsylvania, and
West Virginia to use this pesticide on this crop under section 18 of
FIFRA without following all provisions of EPA's regulations
implementing section 18 as identified in 40 CFR part 166. For
additional information regarding the emergency exemption for
imidacloprid, contact the Agency's Registration Division at the address
provided under ``FOR FURTHER INFORMATION CONTACT.''
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
imidacloprid and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
combined residues of imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as parent in or on stone fruit at
1.0 ppm and prunes 3.5 ppm. EPA's assessment
[[Page 36369]]
of the dietary exposures and risks associated with establishing these
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 in this unit.
B. Toxicological Endpoint
Only acute and chronic dietary endpoints were defined. The 10x FQPA
factor was reduced to 3x for acute and chronic exposure, and applies to
all population subgroups.
1. Acute toxicity. The acute reference dose (RfD) is 0.42
milligram/kilogram body weight/day (mg/kg bwt/day) based on a lowest
observed adverse effect level (LOAEL) of 42 mg/kg bwt/day based on
decreased motor activity in female rats. An additional 3x FQPA factor
was incorporated for all population subgroups to account for
neurotoxicity, structure-activity concerns and lack of a no observed
adverse effect level (NOAEL). The acute population adjusted dose
(aPAD), which is the reference dose (RfD/3) was calculated to be 0.14
mg/kg bwt/day. Acceptable acute dietary exposure (food plus water) of
100% or less of the aPAD is required for all population subgroups.
2. Short- and intermediate-term toxicity. Dermal and inhalation
short- and intermediate-term risk assessments are not required for
imidacloprid as dermal and inhalation exposure endpoints were not
identified due to the demonstrated absence of toxicity; however,
because imidacloprid is registered for use on turf, home gardens and
pets, EPA has identified potential short-term oral exposures to
children for these uses.
A short-term oral endpoint was not identified for imidacloprid.
According to current 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 (LOAEL = 42 mg/kg bwt/day) will be used to
incorporate the oral component into aggregate risk.
3. Chronic toxicity. EPA has established the RfD for imidacloprid
at 0.057 milligrams/kilograms/day (mg/kg/day). This RfD is based on
increased number of thyroid lesions at the LOAEL of 16.9/24.9 mg/kg
bwt/day (males and females, respectively). An additional 3x FQPA factor
was used for all population subgroups. The chronic population adjusted
dose (cPAD), which is the RfD/3, was calculated to be 0.019 mg/kg bwt/
day. Acceptable chronic dietary exposure (food plus water) of 100% or
less of the cPAD is required for all population subgroups.
4. Carcinogenicity. Imidacloprid has been classified by the Agency
as a Group E chemical, no evidence of carcinogenicity for humans, thus,
a cancer risk assessment is not required.
C. Exposures and Risks
1. From food and feed uses. Tolerances, some time-limited, are
currently established (40 CFR 180.472) for the combined residues of the
insecticide imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as parent, in or on a variety of
raw agricultural and animal commodities at levels ranging from 0.02 ppm
in eggs to 15 ppm in raisins, waste. Risk assessments were conducted by
EPA to assess dietary exposures and risks from imidacloprid as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. In conducting the acute dietary (food)
risk assessment, EPA used the Theoretical Maximum Residue Contribution
(TMRC) which assumes tolerance level residues and 100% crop-treated
(Tier 1). The analysis evaluates individual food consumption as
reported by respondents in the USDA Continuing Surveys of Food Intake
by Individuals conducted in 1989 through 1992. The model accumulates
exposure to the chemical for each commodity and expresses risk as a
function of dietary exposure. Resulting exposure values (at the 95th
percentile) and percentage of aPAD utilized ranged from 23% for the
U.S. population to 45% for children 1-6 years old.
ii. Chronic exposure and risk. In conducting the chronic dietary
(food only) risk assessment, EPA used: Tolerance level residues for
imidacloprid and percent crop- treated (PCT) information for some of
these crops.
The analysis evaluates individual food consumption as reported by
respondents in the USDA Continuing Surveys of Food Intake by
Individuals conducted in 1989 through 1992. The percentages of cPAD
consumed for the general population and subgroups of interest ranged
from 11% for nursing infants <1 year old to 51% for children 1-6 years
old.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid
basis to show what percentage of the food derived from such crop is
likely to contain such pesticide residue.
Condition 2, that the exposure estimate does not underestimate
exposure for any significant subpopulation group.
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F), EPA may require registrants to submit data on
PCT.
The Agency used PCT information as follows.
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed and are unlikely to underestimate an individual's acute dietary
exposure. The Agency is reasonably certain that the percentage of the
food treated is not likely to be an underestimated. As to Conditions 2
and 3, regional consumption information and consumption information for
significant subpopulation is taken into account through EPA's computer-
based model for evaluating the exposure of
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significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which imidacloprid
may be applied in a particular area.
2. From drinking water. There is no established Maximum Contaminant
Level for residues of imidacloprid in drinking water. No health
advisory levels for imidacloprid in drinking water have been
established.
Imidacloprid is persistent, water soluble, and fairly mobile. Thus,
residues of imidacloprid may be transported to both surface and ground
waters. As a condition of registration, the Agency is requiring the
submission of the results of two prospective ground water monitoring
studies. Results from these studies are not yet available.
i. Acute exposure and risk. Estimated concentrations of
imidacloprid in surface and ground water used for the acute exposure
analysis were 4.1 and 1.1 micrograms per liter (<greek-m>g/L) (parts
per billion (ppb)), respectively. These estimated concentrations of
imidacloprid in surface and ground water were based upon an application
rate of 0.5 lbs active ingredient/acre/year (ai/acre/year).
For purposes of risk assessment, the estimated maximum
concentration for imidacloprid in surface and ground waters (which is
4.1 <greek-m>g/L) should be used for comparison to the back-calculated
human health drinking water levels of concern (DWLOCs) for the acute
endpoint. The DWLOCs ranged from 800 <greek-m>g/L for children 1-6
years old to 3,900 <greek-m>g/L for the U.S. population. These figures
are well above the drinking water estimate concentration (DWEC) of 4.1
<greek-m>g/L.
ii. Chronic exposure and risk. Estimated concentrations of
imidacloprid in surface and ground water for chronic exposure analysis
were 0.1 and 1.1 <greek-m>g/L (ppb), respectively. These estimated
concentrations of imidacloprid in surface and ground water were based
upon an application rate of 0.5 lbs ai/acre/year.
For purposes of chronic risk assessment, the estimated maximum
concentration for imidacloprid in ground waters (which is 1.1
<greek-m>g/L) should be used for comparison to the back-calculated
human health DWLOCs for the chronic (non-cancer) endpoint. The DWLOCs
ranged from 90 <greek-m>g/L for children 1-6 years old to 490
<greek-m>g/L for the U.S. population. These figures are well above the
DWEC of 1.1 <greek-m>g/L.
3. From non-dietary exposure. Imidacloprid is currently registered
for use on the following residential non-food sites: ornamentals (e.g.,
flowering and foliage plants, ground covers, turf, lawns) tobacco, golf
courses, walkways, recreational areas, household or domestic dwellings
(indoor/outdoor), and cats/dogs.
i. Acute exposure and risk. Occupational/residential exposure risk
assessments (namely, short-term dermal, intermediate-term dermal, long-
term dermal, and inhalation) are not required owing to the demonstrated
absence of dermal and inhalation toxicity.
ii. Chronic exposure and risk. Occupational/residential exposure
risk assessments (namely, short-term dermal, intermediate-term dermal,
long-term dermal, and inhalation) are not required owing to the
demonstrated absence of dermal and inhalation toxicity.
iii. Short- and intermediate-term exposure and risk. Short- and
intermediate-term oral exposure are not expected for adult population
subgroups. However, since imidacloprid is registered for use on turf,
home gardens and pets, EPA has identified potential short-term oral
exposures to children for these uses. Thus, a residential short-term
risk assessment via the oral route is required. See Unit IV.E.4. for a
full discussion of this exposure and risk.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether imidacloprid has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
imidacloprid does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that imidacloprid has a common mechanism of
toxicity with other substances. For more information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961,
November 26, 1997).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. EPA has determined that the acute exposure to
imidacloprid from food will utilize 23% of the aPAD (95th percentile)
for the most highly exposed population subgroup (U.S. population--all
seasons). Despite the potential for exposure to imidacloprid in
drinking water, the Agency does not expect the aggregate exposure to
exceed 100% of the aPAD. The DWLOC calculated for the U.S. population
was 3,900 <greek-m>g/L, which is well above the DWEC of 4.1 <greek-m>g/
L.
2. Chronic risk. In conducting the chronic dietary (food only) risk
assessment, EPA used: Tolerance level residues for imidacloprid, and
PCT information for some of these crops. The analysis evaluates
individual food consumption as reported by respondents in the USDA
Continuing Surveys of Food Intake by Individuals conducted in 1989
through 1992. The percentage of cPAD consumed for the U.S. population
was 24%. The major identifiable subgroup with the highest aggregate
exposure is discussed below. EPA generally has no concern for exposures
below 100% of the cPAD because the cPAD represents the level at or
below which daily aggregate dietary exposure over a lifetime will not
pose appreciable risks to human health. Despite the potential for
exposure to imidacloprid in drinking water, the Agency does not expect
the aggregate exposure to exceed 100% of the cPAD. The DWLOC calculated
for the U.S. population was well above the DWEC of 1.1 <greek-m>g/L.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure.
Dermal and inhalation short- and intermediate-term risk assessments
are not required for imidacloprid, as dermal and inhalation exposure
endpoints were not identified due to the demonstrated absence of
toxicity. Short- and intermediate-term oral exposure are not expected
for adult population subgroups. A discussion of short- and
intermediate- term oral exposure and
[[Page 36371]]
risk for children 1-6 can be found in Unit IV.E.4.
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.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children--i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of imidacloprid, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity, and
the completeness of the data base unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans. EPA believes that reliable data
support using the standard MOE and uncertainty factor (usually 100 for
combined interspecies and intraspecies variability) and not the
additional tenfold MOE/uncertainty factor when EPA has a complete data
base under existing guidelines and when the severity of the effect in
infants or children or the potency or unusual toxic properties of a
compound do not raise concerns regarding the adequacy of the standard
MOE/safety factor.
ii. Developmental toxicity studies. In a developmental toxicity
study with Sprague- Dawley rats, groups of pregnant animals (25/group)
received oral administration of imidacloprid (94.2%) at 0, 10, 30, or
100 mg/kg bwt/day during gestation days 6 through 16. Maternal toxicity
was manifested as decreased body weight gain at all dose levels and
reduced food consumption at 100 mg/kg bwt/day. No treatment-related
effects were seen in any of the reproductive parameters (i.e., Cesarean
section evaluation). At 100 mg/kg bwt/day, developmental toxicity
manifested as wavy ribs (fetus = 7/149 in treated vs. 2/158 in controls
and litters, 4/25 vs. 1/25). For maternal toxicity, the LOAEL was 10
mg/kg bwt/day lowest dose tested (LDT) based on decreased body weight
gain; a NOAEL was not established. For developmental toxicity, the
NOAEL was 30 mg/kg bwt/day and the LOAEL was 100 mg/kg bwt/day based on
increased wavy ribs.
In a developmental toxicity study with Chinchilla rabbits, groups
of 16 pregnant does were given oral doses of imidacloprid (94.2%) at 0,
8, 24 or 72 mg/kg bwt/day during gestation days 6 through 18. For
maternal toxicity, the NOAEL was 24 mg/kg bwt/day and the LOAEL 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 LOAEL was 72 mg/kg bwt/day based on
decreased fetal body weight, increased resorptions, and increased
skeletal abnormalities.
iii. Reproductive toxicity study. In a 2-generation reproductive
toxicity study, imidacloprid (95.3%) was administered to Wistar/Han
rats at dietary levels of 0, 100, 250, or 700 ppm (0, 7.3, 18.3, or
52.0 mg/kg bwt/day for males and 0, 8.0, 20.5, or 57.4 mg/kg bwt/day
for females). For parental/systemic/reproductive toxicity, the NOAEL
was 250 ppm (18.3 mg/kg bwt/day) and the LOAEL 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 LOAEL to be 250 and 700 ppm, respectively, based upon the body
weight decrements observed in both sexes in both generations.
iv. Prenatal and postnatal sensitivity. The developmental toxicity
data demonstrated no increased sensitivity of rats or rabbits to in
utero exposure to imidacloprid. In addition, the multi-generation
reproductive toxicity study data did not identify any increased
sensitivity of rats to in utero or postnatal exposure. Parental NOAELs
were lower or equivalent to developmental or offspring NOAELs.
v. Conclusion. There is a need for a developmental neurotoxicity
study for assessment of potential alterations of functional
development. However, the Agency has determined that this data gap does
not preclude the establishment/continuance of tolerances. The 10x
safety factor to account for enhanced sensitivity of infants and
children (as required by FQPA) was reduced to 3x and the factor applies
to all population subgroups.
2. Acute risk. Using the conservative TMRC exposure assumptions
described above, and taking into account the completeness and
reliability of the toxicity data, EPA has estimated the acute exposure
to imidacloprid from food for the most highly exposed population
subgroup (children 1-6 years old) will utilize 45% of the aPAD. It was
determined that an acceptable acute dietary exposure (food plus water)
of 100% or less of the aPAD is needed to protect the safety of all
population subgroups. Despite the potential for exposure to
imidacloprid in drinking water, EPA does not expect the aggregate
exposure to exceed 100% of the aPAD for children 1-6 years old. The
maximum concentration of imidacloprid in surface and ground water for
acute exposure is very small (4.1 <greek-m>g/L) compared to the DWEC of
800 <greek-m>g/L.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to imidacloprid from
food will utilize 51% of the RfD for infants and children. EPA
generally has no concern for exposures below 100% of the RfD because
the RfD represents the level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to human
health. Despite the potential for exposure to imidacloprid in drinking
water, EPA does not expect the aggregate exposure to exceed 100% of the
cPAD for children 1-6 years old. The maximum concentration of
imidacloprid in surface and ground water for acute exposure is very
small (1.1 <greek-m>g/L) compared to the DWEC of 90 <greek-m>g/L.
4. Short- and intermediate-term risk. As noted earlier in this
document, dermal and inhalation short- and intermediate-term risk
assessments are not required for imidacloprid as dermal and inhalation
exposure endpoints were not identified due to the demonstrated absence
of toxicity. Short- and intermediate-term oral exposure are not
expected for adult population subgroups. However, since imidacloprid is
registered for use on turf, home gardens and pets, EPA has identified
potential short-term oral exposures to children for these uses.
A short-term oral endpoint was not identified for imidacloprid.
According to current EPA policy, if an oral
[[Page 36372]]
endpoint is needed for short-term risk assessment (for incorporation of
food, water, or oral hand-to-mouth type exposures into an aggregate
risk assessment), the acute oral endpoint (LOAEL = 42 mg/kg bwt/day)
will be used to incorporate the oral component into aggregate risk.
The margin of exposure for chronic dietary exposure (food only) and
residential exposure (hand-to-mouth from turf, garden, and pet uses)
for children ages 1-6 was calculated to be 300. The safe level for
imidacloprid is 300.
Potential short-term exposure from drinking water is at a level
below the Agency's level of concern with the DWLOC (2 <greek-m>g/L)
being greater than the DWEC of 1.1 <greek-m>g/L.
The Agency, concludes the short-term aggregate risk to the highest
exposed population subgroup (children 1-6 years old) from home garden,
turf, and pet uses of imidacloprid does not exceed EPA's level of
concern.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to imidacloprid
residues.
V. Other Considerations
A. Metabolism in Plants and Animals
The nature of imidacloprid residues in plants and in animals is
adequately understood. The residue of concern is imidacloprid and its
metabolites containing the 6- chloropyridinyl moiety, all expressed as
parent, as specified in 40 CFR 180.472.
B. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. The method may be requested from: Calvin Furlow,
PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-5229; e-mail address:
furlow...@epa.gov.
C. Magnitude of Residues
Crop field trials on peaches have been submitted, and the highest
residues of imidacloprid were found to be 0.77 ppm. For the purposes of
this section 18, the Agency will translate the peach residue data to
all stone fruit and tolerances will be set at 1.0 ppm.
The only processed commodity associated with stone fruit is prunes,
as plums can be processed into prunes. Since no processing study was
submitted, a default factor of 3.4 was used, and therefore, the
tolerance on prunes will be set at 3.5 ppm.
D. International Residue Limits
There are no Codex, Canadian, or Mexican Maximum Residue Limits for
imidacloprid on sweet corn. Thus, harmonization is not an issue for
these time-limited tolerances.
E. Rotational Crop Restrictions
The rotational crop restrictions follow the original section 3
labels. In addition, there is little concern over rotational crops for
this section 18 as stone fruit are rarely rotated to other crops.
VI. Conclusion
Therefore, the tolerances are established for the combined residues
of imidacloprid and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as parent, in or on stone fruit at 1.0 ppm and
prunes at 3.5 ppm.
VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301004 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before August 7,
2000.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
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.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompki...@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in
[[Page 36373]]
Unit VII.A., you should also send a copy of your request to the PIRIB
for its inclusion in the official record that is described in Unit
I.B.2. Mail your copies, identified by the docket control number OPP-
301004, to: Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460. In person or by courier, bring a copy
to the location of the PIRIB described in Unit I.B.2. You may also send
an electronic copy of your request via e-mail to: opp-d...@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 file
format or ASCII file format. Do not include any CBI in your electronic
copy. You may also submit an electronic copy of your request at many
Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
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(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Regulatory Assessment Requirements
This final rule establishes time-limited tolerances under FFDCA
section 408. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
This final rule does not contain any information collections subject to
OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any prior consultation
as specified by Executive Order 13084, entitled Consultation and
Coordination with Indian Tribal Governments (63 FR 27655, May 19,
1998); 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 or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 petition under FFDCA section 408, 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4).
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 this final rule in the Federal Register. This final
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: May 25, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
2. In Sec. 180.472, by alphabetically adding the following
commodities to the table in paragraph (b) to read as follows:
Sec. 180.472 Imidacloprid; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions.* * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per Revocation
million Date
------------------------------------------------------------------------
* * * * *
Prunes........................................ 3.5 12/31/01
* * * * *
Stone fruit, crop group 12.................... 1.0 12/31/01
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 00-14422 Filed 6-7-00; 8:45 am]
BILLING CODE 6560-50-F