[Federal Register Volume 64, Number 139 (Wednesday, July 21, 1999)]
[Rules and Regulations]
[Pages 39041-39049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18190]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300884; FRL-6088-3]
RIN 2070-AB78
Imidacloprid; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for the
combined residues of imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as parent in or on blueberries
and cranberries. This action is in response to EPA's granting of
emergency exemptions under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of the pesticide on
blueberries and cranberries. This regulation establishes maximum
permissible levels for residues of imidacloprid in these food
commodities pursuant to section 408(l)(6) of the Federal Food, Drug,
and Cosmetic Act, as amended by the Food Quality Protection Act of
1996. The tolerances will expire and are revoked on June 1, 2001.
DATES: This regulation is effective July 21, 1999. Objections and
requests for hearings must be received by EPA on or before September
20, 1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300884], must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees
[[Page 39042]]
accompanying objections and hearing requests shall be labeled
``Tolerance Petition Fees'' and forwarded to: EPA Headquarters
Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M,
Pittsburgh, PA 15251. A copy of any objections and hearing requests
filed with the Hearing Clerk identified by the docket control number,
[OPP-300884], must also be submitted to: Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. In person, bring a copy of objections
and hearing requests to Rm. 119, Crystal Mall #2, 1921 Jefferson Davis
Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of electronic objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket control number [OPP-300884].
No Confidential Business Information (CBI) should be submitted through
e-mail. Copies of electronic objections and hearing requests on this
rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Rm. 280, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9367,
[email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, is establishing a tolerance for combined residues of
the insecticide imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as parent, in or on blueberries
at 1.0 part per million (ppm) and cranberries at 0.5 ppm. This
tolerance will expire and is revoked on June 1, 2001. EPA will publish
a document in the Federal Register to remove the revoked tolerance from
the Code of Federal Regulations.
I. Background and Statutory Findings
The Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described in this preamble and
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Imidacloprid on Blueberries and
Cranberries and FFDCA Tolerances
Cranberries. The applicant states that the cranberry rootworm is
becoming a serious pest of cranberries in New Jersey. The infestations
of this insect are spreading from few acres in 1995 to several hundreds
of acres in 1998. Prior to 1995, cranberry rootworm was considered a
minor pest rarely requiring insecticide interventions. However, in 1997
and in 1998, severe infestations were seen in approximately 500 acres
around Chatsworth, Burlington County.
Most of the cranberry rootworm grubs are found in the top 6-8
inches from the ground surface area available for absorption of water
and nutrients. The affected vines become weak, often produce fewer
berries, and are easily rolled back as a mat. Severe infestations of
cranberry rootworm can kill the vines and reduce fruit yield. The
effect of cranberry rootworm feeding on roots is more severe under
moisture stress during summer months as vines are unable to uptake the
limited moisture available with reduced root systems. Replanting is
often necessary to fill dead patches as a result of rootworm injury.
Newly planted vines may take as long as 5 years to reach full yield
potential. Adults also skeletonize the foliage and affect the process
of photosynthesis.
Currently there are no soil insecticides registered for managing
cranberry rootworm in New Jersey. Lack of effective materials for use
against the grub stage has resulted in the present emergency condition
which left unchecked will cause significant crop losses to growers.
Blueberries (Oriental Beetle). The applicant states that the
Oriental beetle has recently become a serious pest of commercial
highbush blueberries. In surveys undertaken during 1995 and 1996, the
Oriental beetle was found to be the predominant grub species found in a
majority of locations surveyed in Atlantic and Burlington Counties. The
damage to blueberries is caused by grub stages feeding on fine fibrous
root hairs. Bushes that have sustained damage to the root system by
grubs show reduced vigor, are twiggy, have smaller leaves, and support
fewer berries than
[[Page 39043]]
uninfested bushes of the same age. Infested bushes can be easily pulled
off and growers often replace them with newer, younger bushes. In
contrast to the grubs feeding on the root system, adults do not feed
and therefore are not vulnerable to insecticide applications made above
the ground.
In blueberry fields in New Jersey, larvae become active and begin
feeding by late March. The majority of these grubs are found in the top
8 inches of soil. Pupation occurs during the last week of May to early
June with adults first appearing in the second week of June.
The most effective strategy in managing the Oriental beetle is to
apply insecticides targeting early instar grubs which are closer to the
soil surface. However, there are currently no soil insecticides
registered for use against any insect pest in blueberries. Out of
desperation, some growers have attempted the use of organophosphate and
carbamate insecticides targeting the adult stage. This strategy is
generally effective in killing the adults only if the adults come in
direct contact with the insecticide. Applications of insecticides
targeting adults have proven to be very ineffective and resulted in
unwarranted applications of organophosphate and carbamate insecticides.
Lack of effective materials for use against the grub stage has
resulted in the present emergency situation. Availability of effective
insecticides targeting the early instar grubs will alleviate this
problem and improve the management of Oriental beetle populations in
blueberries.
Blueberries (Blueberry Aphid). According to the applicant,
blueberry aphids, Fimbriaphis fimbriata and Illinoia pepperi are the
most important pests of highbush blueberries in New Jersey. The green
peach aphid Myzus persicae also occurs on blueberries on a regular
basis, but is of less significance. All of these species feed on plant
sap and reduce the vigor of the bushes. But more importantly, these
three species of aphids have recently been shown to be the vectors of
the Blueberry Scorch virus (BBScV), the most important viral disease of
blueberries in New Jersey. This virus is transmitted in a non-
persistent fashion, and in greenhouse experiments, the applicant has
shown that as little as 5 minutes of feeding any of the above three
species is sufficient to transmit the BBScV from an infected plant to a
non-infected plant.
The Blueberry Scorch disease (also known as Sheep Pen Hill disease)
was first detected in the early eighties. For several years this
disease was restricted to a few areas in Burlington County, but during
the past 3-4 years, there have been numerous fields that have become
100% infected with BBScV and showing visible symptoms of the disease.
This disease is now firmly established in all major blueberry producing
areas in Atlantic and Burlington counties. Primary symptoms of
Blueberry Scorch disease are blighting of both flowers and new
vegetative growth at full bloom and appearance of necrotic line patter
just prior to leaf drop in autumn. The blighted blossoms are often
retained throughout the summer but fail to develop into fruit and
infected plants are less vigorous than healthy plants. The major
problem in containing this disease is the inability to aggressively
rogue out infected bushes because disease symptoms may not manifest for
several years after the transmission of the causal agent (BBScV). This
allows for the rapid spread of the disease if infected plants (symptom
free) and aphids are present in a given location. Growers have no
option but to completely destroy or kill the bushes and replant with
new, clean bushes. Accurate estimates of total losses due to this
disease in New Jersey are yet to be determined.
Effective management of the aphid vectors is the only viable
strategy to contain the spread of the Blueberry Scorch disease; there
are no other methods available at the present time. Inadequate control
of aphids with the existing insecticides has resulted in the present
emergency situation which could cause severe crop loss to blueberry
growers if left unchecked. EPA has authorized under FIFRA section 18
the use of imidacloprid on blueberries for control of blueberry aphids
and the oriental beetle and cranberries for control of the cranberry
rootworm in New Jersey. After having reviewed the submission, EPA
concurs that emergency conditions exist for this State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of imidacloprid in or on
blueberries and cranberries. In doing so, EPA considered the safety
standard in FFDCA section 408(b)(2), and EPA decided that the necessary
tolerances under FFDCA section 408(l)(6) would be consistent with the
safety standard and with FIFRA section 18. Consistent with the need to
move quickly on the emergency exemptions in order to address an urgent
non-routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing these tolerances without notice and opportunity
for public comment under section 408(e), as provided in section
408(l)(6). Although these tolerances will expire and are revoked on
June 1, 2001, under FFDCA section 408(l)(5), residues of the pesticide
not in excess of the amounts specified in the tolerances remaining in
or on blueberries and cranberries after that date will not be unlawful,
provided the pesticide is applied in a manner that was lawful under
FIFRA, and the residues do not exceed a level that was authorized by
these tolerances at the time of that application. EPA will take action
to revoke these tolerances earlier if any experience with, scientific
data on, or other relevant information on this pesticide indicate that
the residues are not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether imidacloprid
meets EPA's registration requirements for use on blueberries and
cranberries or whether permanent tolerances for these uses would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of imidacloprid by a State
for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for any State other than New Jersey to
use this pesticide on this crop under section 18 of FIFRA without
following all provisions of EPA's regulations implementing section 18
as identified in 40 CFR part 166. For additional information regarding
the emergency exemption for imidacloprid, contact the Agency's
Registration Division at the address provided under the ``ADDRESSES''
section.
III. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
imidacloprid and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
combined residues of imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as parent on blueberries at 1.0
ppm and cranberries at 0.5 ppm. EPA's assessment of the dietary
exposures and
[[Page 39044]]
risks associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by imidacloprid are
discussed in this unit.
B. Toxicological Endpoint
Only acute and chronic dietary endpoints were defined. The 10X FQPA
factor was reduced to 3X for acute and chronic exposure, and applies to
all population subgroup.
1. Acute toxicity. The acute Reference Dose (RfD) is 0.42 mg/kg
bwt/day based on a lowest observed adverse effect level (LOAEL) of 42
mg/kg body weight/day (bwt/day) based on decreased motor activity in
female rats. An additional 3X FQPA factor was incorporated for all
population subgroups to account for neurotoxicity, structure-activity
concerns, and lack of a no observed adverse effect level (NOAEL). The
acute Population Adjusted Dose (aPAD), which is the RfD/3 was
calculated to be 0.14 mg/kg bwt/day. Acceptable acute dietary exposure
(food plus water) of 100% or less of the aPAD is required for all
population subgroups.
2. Short- and intermediate-term toxicity. Dermal and inhalation
short- and intermediate-term risk assessments are not required for
imidacloprid as dermal and inhalation exposure endpoints were not
identified due to the demonstrated absence of toxicity. However,
because imidacloprid is registered for use on turf, home gardens and
pets, EPA has identified potential short-term oral exposures to
children for these uses.
A short-term oral endpoint was not identified for imidacloprid.
According to current OPP policy, if an oral endpoint is needed for
short-term risk assessment (for incorporation of food, water, or oral
hand-to-mouth type exposures into an aggregate risk assessment), the
acute oral endpoint (LOAEL = 42 mg/kg bwt/day) will be used to
incorporate the oral component into aggregate risk.
3. Chronic toxicity. EPA has established the RfD for imidacloprid
at 0.057 milligrams/kilograms/day (mg/kg/day). This RfD is based on
increased number of thyroid lesions at the LOAEL of 16.9/24.9 mg/kg
bwt/day (males and females, respectively). An additional 3X FQPA factor
was used for all population subgroups. The chronic Population Adjusted
Dose (cPAD), which is the RfD/3 was calculated to be 0.019 mg/kg bwt/
day. Acceptable chronic dietary exposure (food plus water) of 100% or
less of the cPAD is required for all population subgroups.
4. Carcinogenicity. Imidacloprid has been classified by the Agency
as a Group E chemical, no evidence of carcinogenicity for humans, thus,
a cancer risk assessment is not required.
C. Exposures and Risks
1. From food and feed uses. Tolerances, some time-limited, are
currently established (40 CFR 180.472) for the combined residues of the
insecticide imidacloprid and its metabolites containing the 6-
chloropyridinyl moiety, all expressed as parent, in or on a variety of
raw agricultural and animal commodities at levels ranging from 0.02 ppm
in eggs to 15 ppm in raisins, waste. Risk assessments were conducted by
EPA to assess dietary exposures and risks from imidacloprid as follows:
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure.
In conducting the acute dietary (food) risk assessment, EPA used
the Theoretical Maximum Residue Contribution (TMRC) which assumes
tolerance level residues and 100% crop-treated (Tier 1). The analysis
evaluates individual food consumption as reported by respondents in the
USDA Continuing Surveys of Food Intake by Individuals conducted in 1989
through 1992. The model accumulates exposure to the chemical for each
commodity and expresses risk as a function of dietary exposure.
Resulting exposure values (at the 95th percentile) and percentage of
aPAD utilized ranged from 22% for the U.S. population to 44% for
children 1-6 years old.
ii. Chronic exposure and risk. In conducting the chronic dietary
(food only) risk assessment, EPA used tolerance level residues for
imidacloprid and percent crop-treated (%CT) information for some of
these crops. The analysis evaluates individual food consumption as
reported by respondents in the USDA Continuing Surveys of Food Intake
by Individuals conducted in 1989 through 1992. The percentages of cPAD
consumed for the general population and subgroups of interest ranged
from 9.2% for nursing infants <1 year old to 48.5% for children 1-6
years old.
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of crop treated (PCT) for assessing chronic dietary risk
only if the Agency can make the following findings: That the data used
are reliable and provide a valid basis to show what percentage of the
food derived from such crop is likely to contain such pesticide
residue; that the exposure estimate does not underestimate exposure for
any significant subpopulation group; and if data are available on
pesticide use and food consumption in a particular area, the exposure
estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of percent crop treated as required by the section 408(b)(2)(F), EPA
may require registrants to submit data on PCT.
As noted above, the Agency used an analysis that evaluated
individual food consumption as reported by respondents in the USDA
Continuing Surveys of Food Intake by Individuals conducted in 1989
through 1992.
The Agency believes that the three conditions, discussed in section
408 (b)(2)(F) concerning the Agency's responsibilities in assessing
chronic dietary risk findings, have been met. The PCT estimates are
derived from Federal and private market survey data, which are reliable
and have a valid basis. Typically, a range of estimates are supplied
and the upper end of this range is assumed for the exposure assessment.
By using this upper end estimate of the PCT, the Agency is reasonably
certain that that the percentage of the food treated is not likely to
be underestimated. The regional consumption information and
[[Page 39045]]
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which imidacloprid
may be applied in a particular area.
2. From drinking water. There is no established Maximum Contaminant
Level for residues of imidacloprid in drinking water. No health
advisory levels for imidacloprid in drinking water have been
established.
Imidacloprid is persistent, water soluble, and fairly mobile. Thus,
residues of imidacloprid may be transported to both surface and ground
waters. As a condition of registration, the Agency is requiring the
submission of the results of two prospective ground water monitoring
studies. Results from these studies are not yet available.
i. Acute exposure and risk. Estimated concentrations of
imidacloprid in surface and ground water used for the acute exposure
analysis were 4.1 and 1.1 g/L (ppb), respectively. These
estimated concentrations of imidacloprid in surface and ground water
were based upon an application rate of 0.5 lbs ai/A/year.
For purposes of risk assessment, the estimated maximum
concentration for imidacloprid in surface and ground waters (which is
4.1 g/L) should be used for comparison to the back-calculated
human health drinking water levels of concern (DWLOCs) for the acute
endpoint. The DWLOCs ranged from 780 g/L for children 1-6
years old to 3,900 g/L for the U.S. population. These figures
are well above the drinking water estimate concentration (DWEC) of 4.1
g/L.
ii. Chronic exposure and risk. Estimated concentrations of
imidacloprid in surface and ground water for chronic exposure analysis
were 0.1 and 1.1 g/L (ppb), respectively. These estimated
concentrations of imidacloprid in surface and ground water were based
upon an application rate of 0.5 lbs ai/A/year.
For purposes of chronic risk assessment, the estimated maximum
concentration for imidacloprid in ground waters (which is 1.1
g/L) should be used for comparison to the back-calculated
human health DWLOCs for the chronic (non-cancer) endpoint. The DWLOCs
ranged from 98 g/L for children 1-6 years old to 490
g/L for Non-hispanic males (other than black or white). These
figures are well above the DWEC of 1.1 g/L.
3. From non-dietary exposure. Imidacloprid is currently registered
for use on the following residential non-food sites: ornamentals (e.g.,
flowering and foliage plants, ground covers, turf, and lawns), tobacco,
golf courses, walkways, recreational areas, household or domestic
dwellings (indoor/outdoor), and cats/dogs.
i. Acute exposure and risk. Occupational/residential exposure risk
assessments (namely, short-term dermal, intermediate-term dermal, long-
term dermal, and inhalation) are not required owing to the demonstrated
absence of dermal and inhalation toxicity.
ii. Chronic exposure and risk. Occupational/residential exposure
risk assessments (namely, short-term dermal, intermediate-term dermal,
long-term dermal, and inhalation) are not required owing to the
demonstrated absence of dermal and inhalation toxicity.
iii. Short- and intermediate-term exposure and risk. Short- and
intermediate-term oral exposure are not expected for adult population
subgroups. However, since imidacloprid is registered for use on turf,
home gardens and pets, EPA has identified potential short-term oral
exposures to children for these uses. Thus, a residential short-term
risk assessment via the oral route is required.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether imidacloprid has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
imidacloprid does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that imidacloprid has a common mechanism of
toxicity with other substances. For more information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961,
November 26, 1997).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. EPA has determined that the acute exposure to
imidacloprid from food will utilize 22% of the aPAD (95th percentile)
for the most highly exposed population subgroup (U.S. population - all
seasons). Despite the potential for exposure to imidacloprid in
drinking water, the Agency does not expect the aggregate exposure to
exceed 100% of the aPAD. The DWLOC calculated for the U.S. population
was 3,900 g/L, which is well above the DWEC of 4.1 g/
L.
2. Chronic risk. In conducting the chronic dietary (food only) risk
assessment, EPA used tolerance level residues for imidacloprid and
percent crop-treated (%CT) information for some of these crops. The
analysis evaluates individual food consumption as reported by
respondents in the USDA Continuing Surveys of Food Intake by
Individuals conducted in 1989 through 1992. The percentage of cPAD
consumed for the U.S. population was 22%. EPA generally has no concern
for exposures below 100% of the RfD because the RfD represents the
level at or below which daily aggregate dietary exposure over a
lifetime will not pose appreciable risks to human health. Despite the
potential for exposure to imidacloprid in drinking water, the Agency
does not expect the aggregate exposure to exceed 100% of the cPAD. The
DWLOC calculated for the U.S. population was well above the DWEC of 1.1
g/L.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure.
Dermal and inhalation short- and intermediate-term risk assessments
are not required for imidacloprid as dermal and inhalation exposure
endpoints were not identified due to the demonstrated absence of
toxicity. Short- and intermediate-term oral exposure are not expected
for adult population subgroups.
4. Aggregate cancer risk for U.S. population. Imidacloprid has been
[[Page 39046]]
classified as a Group E chemical, no evidence of carcinogenicity for
humans, thus, a cancer risk assessment is not required.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to imidacloprid residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children-- i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of imidacloprid, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre- and postnatal toxicity and the
completeness of the data base unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a margin of exposure (MOE) analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans. EPA believes that reliable data support
using the standard MOE and uncertainty factor (usually 100 for combined
inter- and intra-species variability) and not the additional tenfold
MOE/uncertainty factor when EPA has a complete data base under existing
guidelines and when the severity of the effect in infants or children
or the potency or unusual toxic properties of a compound do not raise
concerns regarding the adequacy of the standard MOE/safety factor.
ii. Developmental toxicity studies. In a developmental toxicity
study with Sprague-Dawley rats, groups of pregnant animals (25/group)
received oral administration of imidacloprid (94.2%) at 0, 10, 30, or
100 mg/kg bwt/day during gestation days 6 through 16. Maternal toxicity
was manifested as decreased body weight gain at all dose levels and
reduced food consumption at 100 mg/kg bwt/day. No treatment-related
effects were seen in any of the reproductive parameters (i.e., Cesarean
section evaluation). At 100 mg/kg bwt/day, developmental toxicity
manifested as wavy ribs (fetus =7/149 in treated vs. 2/158 in controls
and litters, 4/25 vs. 1/25). For maternal toxicity, the LOAEL was 10
mg/kg bwt/day (LDT) based on decreased body weight gain; a NOAEL was
not established. For developmental toxicity, the NOAEL was 30 mg/kg
bwt/day and the LOAEL was 100 mg/kg bwt/day based on increased wavy
ribs.
In a developmental toxicity study with Chinchilla rabbits, groups
of 16 pregnant does were given oral doses of imidacloprid (94.2%) at 0,
8, 24, or 72 mg/kg bwt/day during gestation days 6 through 18. For
maternal toxicity, the NOAEL was 24 mg/kg bwt/day and the LOEL was 72
mg/kg bwt/day based on mortality, decreased body weight gain, increased
resorptions, and increased abortions. For developmental toxicity, the
NOAEL was 24 mg/kg bwt/day and the LOEL was 72 mg/kg bwt/day based on
decreased fetal body weight, increased resorptions, and increased
skeletal abnormalities.
iii. Reproductive toxicity study. In a 2-generation reproductive
toxicity study, imidacloprid (95.3%) was administered to Wistar/Han
rats at dietary levels of 0, 100, 250, or 700 ppm (0, 7.3, 18.3, or
52.0 mg/kg bwt/day for males and 0, 8.0, 20.5, or 57.4 mg/kg bwt/day
for females). For parental/systemic/reproductive toxicity, the NOAEL
was 250 ppm (18.3 mg/kg bwt/day) and the LOEL was 750 ppm (52 mg/kg
bwt/day), based on decreases in body weight in both sexes in both
generations. Based on these factors, the Agency determined that the
review be revised to indicate the parental/systemic/reproductive NOAEL
and LOEL to be 250 and 700 ppm, respectively, based upon the body
weight decrements observed in both sexes in both generations.
iv. Pre- and postnatal sensitivity. The developmental toxicity data
demonstrated no increased sensitivity of rats or rabbits to in utero
exposure to imidacloprid. In addition, the multi-generation
reproductive toxicity study data did not identify any increased
sensitivity of rats to in utero or postnatal exposure. Parental NOAELs
were lower or equivalent to developmental or offspring NOAELs.
v. Conclusion. There is a need for a developmental neurotoxicity
study for assessment of potential alterations of functional
development. However, the Agency has determined that this data gap does
not preclude the establishment/continuance of tolerances. The 10X
safety factor to account for enhanced sensitivity of infants and
children (as required by FQPA) was reduced to 3X and the factor applies
to all population subgroups.
2. Acute risk. Using the conservative TMRC exposure assumptions
described above, and taking into account the completeness and
reliability of the toxicity data, EPA has estimated the acute exposure
to imidacloprid from food for the most highly exposed population
subgroup (Children 1 - 6 yrs) will utilize 44% of the aPAD. It was
determined that an acceptable acute dietary exposure (food plus water)
of 100% or less of the aPAD is needed to protect the safety of all
population subgroups. Despite the potential for exposure to
imidacloprid in drinking water, EPA does not expect the aggregate
exposure to exceed 100% of the aPAD for children 1-6 years old. The
maximum concentration of imidacloprid in surface and ground water for
acute exposure is very small (4.1 g/L) compared to the DWEC of
780 g/L.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to imidacloprid from
food will utilize 48% of the cPAD for infants and children. EPA
generally has no concern for exposures below 100% of the cPAD because
the cPAD represents the level at or below which daily aggregate dietary
exposure over a lifetime will not pose appreciable risks to human
health. Despite the potential for exposure to imidacloprid in drinking
water, EPA does not expect the aggregate exposure to exceed 100% of the
cPAD for children 1-6 years old. The maximum concentration of
imidacloprid in surface and ground water for acute exposure is very
small (1.1 g/L) compared to the DWEC of 98 g/L.
4. Short- or intermediate-term risk. As noted earlier in this
document, dermal and inhalation short- and intermediate-term risk
assessments are not required for imidacloprid as dermal and inhalation
exposure endpoints were not identified due to the demonstrated absence
of toxicity. Short- and intermediate-term oral exposure are not
expected for adult population subgroups. However, since imidacloprid is
registered for use on turf, home gardens and pets, EPA has identified
potential short-term oral exposures to children for these uses.
A short-term oral endpoint was not identified for imidacloprid.
According to current OPP policy, if an oral endpoint is needed for
short-term risk assessment (for incorporation of food, water, or oral
hand-to-mouth type exposures into an aggregate risk assessment), the
acute oral endpoint (LOAEL = 42 mg/kg bwt/day) will be
[[Page 39047]]
used to incorporate the oral component into aggregate risk.
The margin of exposure for chronic dietary exposure (food only) and
residential exposure (hand-to-mouth from turf, garden, and pet uses)
for children age 1-6 was calculated to be 302. The safe level for
imidacloprid is 300.
Potential short-term exposure from drinking water is at a level
below the Agency's level of concern with the DWLOC (10 g/L)
being greater than the DWEC of 1.1 g/L.
The Agency concludes the short-term aggregate risk to the highest
exposed population subgroup (children, 1 to 6 years old) from home
garden, turf, and pet uses of imidacloprid does not exceed EPA's level
of concern.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to imidacloprid
residues.
IV. Other Considerations
A. Metabolism in Plants and Animals
The nature of imidacloprid residues in plants and in animals is
adequately understood. The residue of concern is imidacloprid and its
metabolites containing the 6-chloropyridinyl moiety, all expressed as
parent, as specified in 40 CFR 180.472.
B. Analytical Enforcement Methodology
Adequate enforcement methodology (example - gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm 101FF, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5229.
C. Magnitude of Residues
Based on data submitted by the Applicant, the Agency is
establishing time-limited tolerances for residues of imidacloprid and
its metabolites containing the 6-chloropyridinyl moiety, all expressed
as parent in or on blueberries at 1.0 ppm and cranberries at 0.5 ppm.
D. International Residue Limits
There are no CODEX, Canadian, or Mexican Maximum Residue Limits
(MRL) for imidacloprid on cranberry and blueberries. Thus,
harmonization is not an issue for these time-limited tolerances.
E. Rotational Crop Restrictions
The rotational crop restrictions follow the original section 3
labels. For the use of Provado 1.6 Flowable and Admire 2 Flowable, most
vegetables can be immediately plantedback while all other crops have a
12-month plantback interval.
V. Conclusion
Therefore, the tolerance is established for the combined residues
of imidacloprid and its metabolites containing the 6-chloropyridinyl
moiety, all expressed as parent, in or on blueberries at 1.0 ppm and
cranberries at 0.5 ppm.
VI. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(l)(6) as was provided in the old section 408 and in
section 409. However, the period for filing objections is 60 days,
rather than 30 days. EPA currently has procedural regulations which
govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by September 20, 1999, file written objections to
any aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the Hearing Clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection.'' For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697, [email protected]. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is genuine and substantial issue of fact;
there is a reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of such issues
in favor of the requestor, taking into account uncontested claims or
facts to the contrary; and resolution of the factual issues in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection with an
objection or hearing request may be claimed confidential by marking any
part or all of that information as CBI. Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice.
VII. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300884] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
[email protected]
E-mailed objections and hearing requests must be submitted as an
ASCII
[[Page 39048]]
file avoiding the use of special characters and any form of encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes tolerances under section 408 of the
FFDCA. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require special considerations
as required by Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(l)(6), such as the
tolerances in this final rule, do not require the issuance of a
proposed rule, the requirements of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance actions published on May
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
IX. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 1, 1999.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180-[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a, 321q and 371.
2. In Sec. 180.472, in paragraph (b), by aphabetically inserting
the following commodities to the table.
Sec. 180.472 Imidacloprid; tolerance for residues.
* * * * *
(b)* * *
------------------------------------------------------------------------
Parts Expiration/
Commodity per revocation
million date
------------------------------------------------------------------------
Blueberries....................................... 1.0 6/1/01
* * * * *
Cranberries....................................... 0.5 6/1/01
[[Page 39049]]
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-18190 Filed 7-20-99; 8:45 am]
BILLING CODE 6560-50-F