[Federal Register Volume 61, Number 231 (Friday, November 29, 1996)]
[Rules and Regulations]
[Pages 60622-60628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30469]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300445; FRL-5575-1]
RIN 2070-AB78
Imidacloprid Pesticide Tolerance; Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
combined residues of the insecticide imidacloprid in or on the raw
agricultural commodity garden beets roots and tops and turnip roots and
greens in connection with EPA's granting of emergency exemptions under
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act
authorizing use of imidacloprid on garden beet roots and tops and
turnip roots and greens in California. This regulation establishes
maximum permissible levels for residues of imidacloprid on turnips and
beets 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 be revoked automatically without further
action by EPA on November 29, 1997.
DATES: This regulation becomes effective November 29, 1996. This
regulation expires and is revoked automatically without further action
by EPA on November 29, 1997. Objections and requests for hearings must
be received by EPA on January 28, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300445], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
number, [OPP-300445], should be submitted to: Public Response and
Program Resources Branch, Field Operations Division (7506C), 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. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: [email protected]. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by
[[Page 60623]]
the docket number [OPP-300445]. No Confidential Business Information
(CBI) should be submitted through e-mail. Electronic copies of
objections and hearing requests on this rule may be filed online at
many Federal Depository Libraries. Additonal information on electronic
submission can be found below in this document.
FOR FURTHER INFORMATION CONTACT: By mail: Margarita Collantes,
Registration Division (7505W), Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. Office location, telephone number, and
e-mail address: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis
Highway, Arlington, VA 22202, (703) 308-83427, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing tolerances for
residues of the insecticide imidacloprid, 1-[(6-chloro-3-
pyridinyl)methyl]-N-nitro-2-imidazolidinimine in or on garden beet
roots at 0.3 part per million (ppm), in or on garden beet tops at 3.5
ppm, in or on turnip roots at 0.3 ppm and in or on turnip greens at 3.5
ppm. These tolerances will expire and be revoked automatically without
further action by EPA on November 29, 1997.
I. Background And Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures.
New section 408(b)(2)(A)(i) 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, 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 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) 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. Section 408(l)(6) also requires EPA to promulgate regulations
by August 3, 1997, governing the establishment of tolerances and
exemptions under section 408(l)(6) and requires that the regulations be
consistent with section 408(b)(2) and (c)(2) and FIFRA section 18.
Section 408(l)(6) allows EPA to establish tolerances or exemptions
from the requirement for a tolerance, in connection with EPA's granting
of FIFRA section 18 emergency exemptions, without providing notice or a
period for public comment. Thus, consistent with the need to act
expeditiously on requests for emergency exemptions under FIFRA, EPA can
establish such tolerances or exemptions under authority of section
408(e) and (l)(6) without notice and comment rulemaking.
In establishing section 18-related tolerances and exemptions during
this interim period before EPA issues the section 408(l)(6) procedural
regulation and before EPA makes its broad policy decisions concerning
the interpretation and implementation of the new section 408, EPA does
not intend to set precedents for the application of section 408 and the
new safety standard to other tolerances and exemptions. Rather, these
early section 18 tolerance and exemption decisions will be made on a
case-by-case basis and will not bind EPA as it proceeds with further
rulemaking and policy development. EPA intends to act on section 18-
related tolerances and exemptions that clearly qualify under the new
law.
II. Emergency Exemptions for Imidacloprid on Garden Beets and
Turnip Greens and FFDCA Tolerances
On August 6, 1966, the California Department of Pesticide
Regulations availed of itself the authority to declare the existence of
a crisis situation within the State, thereby authorizing use under
FIFRA section 18 of imidacloprid on table beets and turnips for control
of aphids. California has also requested a specific exemption for this
use. Emergency conditions are determined to exist due to the lack of
acceptable control with currently registered products and the loss of
the insecticide Phosdrin. Under moderate to severe infestation
conditions, the aphids are expected to cause serious reductions due to
contamination problems at harvest, primarily due to the large number of
aphids remaining on the crop. The overall threshold that the market
will allow is 2 aphids or less per plant.
As part of its assessment of these applications for crisis
declaration and emergency exemptions, EPA assessed the potential risks
presented by residues of imidacloprid in or on garden beets (roots and
tops) and turnips (roots and greens). In doing so, EPA considered the
new safety standard in FFDCA section 408(b)(2), and EPA decided to
grant the section 18 exemptions only after concluding that the
necessary tolerances under FFDCA section 408(l)(6) would clearly be
consistent with the new safety standard and with FIFRA section 18.
These tolerances for imidacloprid will permit the marketing of garden
beets and turnips treated in accordance with the provisions of the
section 18 emergency exemptions. Consistent with the need to move
quickly on the emergency exemptions 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 be revoked
automatically without further action by EPA on November 29, 1997, under
FFDCA section 408(l)(5), residues of imidacloprid not in excess of the
amounts specified in the tolerances remaining in or on garden beet
roots and tops and turnip roots and greens after that date will not be
unlawful, provided the pesticide is applied during the term of, and in
accordance with all the conditions of, the emergency exemptions. EPA
will take action to revoke these tolerances earlier if any experience
with, scientific data on, or other relevant information on this
[[Page 60624]]
pesticide indicate that the residues are not safe.
EPA has not made any decisions about whether imidacloprid meets the
requirements for registration under FIFRA section 3 for use on garden
beets and turnips or whether permanent tolerances for imidacloprid for
garden beets (roots and tops) and turnips (roots and greens) would be
appropriate. This action by EPA does not serve as a basis for
registration of imidacloprid by a State for special local needs under
FIFRA section 24(c). Nor does this action serve as the basis for any
State other than California to use this product on this crop under
section 18 of FIFRA without following all provisions of section 18 as
identified in 40 CFR part 166. For additional information regarding the
emergency exemptions for imidacloprid, contact the Agency's
Registration Division at the address provided above.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. For many
of these studies, a dose response relationship can be determined, which
provides a dose that causes adverse effects (threshold effects) and
doses causing no observed effects (the ``no-observed effect level'' or
``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). Various studies may be
used to determine the RfD although a longterm feeding study in dogs,
rats or mice is the type of study typically used for RfD determination.
The RfD is a level at or below which daily aggregate exposure over a
lifetime will not pose appreciable risks to human health. An
uncertainty factor (sometimes called a ``safety factor'') of 100 is
commonly used since it is assumed that people may be up to 10 times
more sensitive to pesticides than the test animals, and that one person
or subgroup of the population (such as infants and children) could be
up to 10 times more sensitive to a pesticide than another. In addition,
EPA assesses the potential risks to infants and children based on the
weight of the evidence of the toxicology studies and determines whether
an additional uncertainty factor is warranted. Thus, an aggregate daily
exposure to a pesticide residue at or below the RfD (expressed as 100
percent or less of the RfD) is generally considered acceptable by EPA.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or margin of exposure (MOE) calculation based on the
appropriate NOEL) will be carried out based on the nature of the
carcinogenic response and the Agency's knowledge of its mode of action.
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, and other non-
occupational exposures, such as where residues leach into groundwater
or surface water that is consumed as drinking water. Dietary exposure
to residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. The TMRC is a
``worst case'' estimate since it is based on the assumptions that food
contains pesticide residues at the tolerance level and that 100 percent
of the crop is treated by pesticides that have established tolerances.
If the TMRC exceeds the RfD or poses a lifetime cancer risk that is
greater than approximately one in a million, EPA attempts to derive a
more accurate exposure estimate for the pesticide by evaluating
additional types of information (anticipated residue data and/or
percent of crop treated data) which show, generally, that pesticide
residues in most foods when they are eaten are well below established
tolerances.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. Imidacloprid is already registered by EPA for turf pest
control. At this time EPA is not in possession of a registration
application for imidacloprid on beets and turnips. However, based on
information submitted to the Agency, 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 the time-limited
tolerances for residues of imidacloprid on garden beets and turnip
roots at 0.3 ppm and garden beet and turnip tops at 3.5 ppm. EPA's
assessment of the dietary exposures and risks associated with
establishing these tolerances follows.
A. Toxicological Profile
1. Chronic toxicity. Based on the available chronic toxicity data,
the Office of Pesticide Programs (OPP) has established the RfD for
imidacloprid at 0.057 milligrams(mg)/kilogram(kg)/day. The RfD for
imidacloprid is based on a 2-year feeding study in rats with a NOEL of
5.7 mg/kg/day and an uncertainty factor of 100. An increase in thyroid
lesions in males was the effect observed at the Lowest Effect Level
(LEL) at 16.9 mg/kg/day.
2. Acute toxicity. Based on the available acute toxicity data, OPP
has determined that the NOEL of 24 mg/kg/day from the developmental
toxicity study in rabbits should be used to assess risk from acute
toxicity. Maternal effects observed at the LEL of 72 mg/kg/day included
decreased body weight and increased resorptions and abortions. Fetal
effects observed at the LEL of 72 mg/kg/day included an increase in
skeletal abnormalities. The population subgroup of concern for this
risk assessment is females 13+ years and older. This subgroup is
representative for both maternal and fetal effects.
3. Carcinogenicity. Using its Guidelines for Carcinogen Risk
Assessment published September 24, 1986 (51 FR 33992), EPA has
classified imidacloprid as a Group E chemical, ``no evidence of
carcinogenicity for humans,'' based on the results of carcinogenicity
studies in two species. The doses tested are adequate for identifying a
cancer risk. Thus, a cancer risk assessment would not be appropriate.
B. Aggregate Exposure
Tolerances have been established (40 CFR 180.472) for the combined
residues
[[Page 60625]]
of imidacloprid (1-[6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine) and its metabolites containing 6-chloropyridinyl
moiety expressed in or on certain raw agricultural commodities ranging
from 0.02 ppm in eggs to 3.5 ppm in Brassica vegetable crop group
(cabbage, chinese cabbage, and Kale) and head and leaf lettuce. There
are no livestock feed items associated with these Section 18 requests,
so no additional livestock dietary burden will result from this Section
18 registration. Therefore, existing meat/milk/poultry tolerances are
adequate.
In conducting this exposure assessment, EPA has made very
conservative assumptions -- 100% of beets and turnips and all other
commodities having imidacloprid tolerances will contain imidacloprid
tolerance residues and those residues would be at the level of the
tolerance -- which result in an overestimate of human dietary exposure.
Thus, in making a safety determination for this tolerance, EPA is
taking into account this conservative exposure assessment.
1. Chronic exposure. Given the emergency nature of this request for
the use of imidacloprid and the resulting need for a timely analysis
and risk assessment, EPA has utilized the TMRC to estimate chronic
dietary exposure from the tolerances for imidacloprid on garden beets
and turnip roots at 0.3 ppm and garden beets and turnip tops at 3.5
ppm. The TMRC is obtained by multiplying the tolerance level residue
for beets and turnips by the average consumption data, which estimates
the amount of beets and turnips eaten by various population subgroups.
This calculation is performed as well for every food having existing
imidacloprid tolerances. The risk assessment is therefore considered to
be overestimated.
The Agency has extensive experience refining chronic dietary risk
assessments for a broad range of pesticide chemicals. It is OPP's
experience that when the chronic dietary risk assessment is refined
using anticipated residue contribution (ARC) estimates derived from
anticipated residue levels and percent crop treated data, the percent
of the RfD occupied by the ARC is generally in the range of an order of
magnitude lower than the percent of the RfD occupied by the unrefined
TMRC.
Other potential sources of exposure of the general population to
residues of pesticides are residues in drinking water and exposure from
non-occupational sources.
Review of terrestrial field dissipation data by the Agency
indicates that imidacloprid is persistent and leaches into groundwater.
There is no established Maximum Concentration Level (MCL) for residues
of imidacloprid in drinking water.
No drinking water health advisories have been issued for
imidacloprid. The ``Pesticides in Groundwater Database'' (EPA 734-12-
92-001, September 1992) has no information concerning imidacloprid. The
Agency does not have available data to perform a quantitative drinking
water risk assessment for imidacloprid at this time. Previous
experience with more persistent and mobile pesticides for which there
have been available data to perform quantitative risk assessments have
demonstrated that drinking water exposure is typically a small
percentage of the total exposure when compared to the total dietary
exposure. This observation holds even for pesticides detected in wells
and drinking water at levels nearing or exceeding established MCLs.
Based on this experience and OPP's best scientific judgement, and
considering the low percent of the RfD occupied by dietary exposure
estimates (15% RfD for U.S. population), EPA concludes that it is not
likely that the potential exposure from residues of imidacloprid in
drinking water added to the current dietary exposure will result in an
exposure which exceeds the RfD.
2. Acute exposure. EPA has not estimated non-occupational exposures
other than dietary for imidacloprid. Acceptable, reliable data are not
currently available with which to assess acute risk. Imidacloprid is
registered for turf pest control. While dietary and residential
scenarios could possibly occur in a single day, imidacloprid would
rarely be present on both the food eaten and the lawn on that single
day. Even assuming this were the case, it is yet more unlikely that
residues would be present at tolerance level on all food eaten that day
for which imidacloprid tolerances exist, as is assumed in the acute
dietary risk analysis, and on the lawn that same day. Because the acute
dietary exposure estimate assumes tolerance level residues and 100%
crop treated for all crops evaluated it is a large over-estimate of
exposure and it is considered to be protective of any acute exposure
scenario.
3. Cumulative effects note. At this time, the Agency has not made a
determination that imidacloprid and other substances that may have a
common mode of toxicity would have cumulative effects. For purposes of
this tolerance only, the Agency is considering only the potential risks
of imidacloprid in its aggregate exposure.
C. Determination of Safety for U.S. Population
1. Chronic risk. Using the conservative exposure assumptions
described above, taking into account the completeness and reliability
of the toxicity data, EPA has concluded that aggregate exposure to
imidacloprid will utilize 15% of the RfD for the U.S. population. EPA
generally has no concern for exposures below 100 percent 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. EPA concludes that there is a reasonable certainty that
no harm will result from aggregate exposure to imidacloprid residues.
2. Acute risk. For the population subgroup of concern, females 13+
and older (accounts for both maternal and fetal exposure), the
calculated Margin of Exposure (MOE) value is 480. MOE values over 100
do not exceed the Agency's level of concern for acute dietary exposure.
EPA concludes that there is a reasonable certainty that no harm will
result from aggregate exposure to imidacloprid residues.
D. Determination of Safety for Infants and Children
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 pesticide exposure during prenatal development to one or
both parents. Reproduction studies provide information relating to
effects from exposure to the pesticide on the reproductive capability
of mating animals and data on systemic toxicity.
In the rat developmental study, the maternal (systemic) NOEL was 30
mg/kg/day, based on decreased weight gain at the LOEL of 100 mg/kg/day.
The developmental (fetal) NOEL was 30 mg/kg/day based on increased wavy
ribs at the LOEL of 100 mg/kg/day.
In the rabbit developmental study, the maternal (systemic) NOEL was
24 mg/kg/day, based on decreased body weight, increased resorptions and
abortions, and death at the LOEL of 72 mg/kg/day. The developmental
(fetal) NOEL was 24 mg/kg/day, based on decreased body weight and
increased
[[Page 60626]]
skeletal anomalies at the LOEL of 72 mg/kg/day.
In the rat reproduction study, the maternal (systemic) NOEL was 55
mg/kg/day (the highest dose tested). The reproductive/developmental
NOEL (effect on the pup) was 8 mg/kg/day, based on decreased pup body
weight during lactation in both generations at the LOEL of 19 mg/kg/
day.
1. Chronic risk. Using the conservative exposure assumptions
described above, EPA has concluded that the percent of the RfD that
will be utilized by aggregate exposure to residues of imidacloprid
ranges from 12.2 percent for nursing infants, up to 31.0 percent for
children 1 to 6 years old. Therefore, taking into account the
completeness and reliability of the toxicity data and the conservative
exposure assessment, EPA concludes that there is a reasonable certainty
that no harm will result to infants and children from aggregate
exposure to imidacloprid residues.
2. Acute risk. At present, the acute dietary MOE for females 13+
years old (accounts for both maternal and fetal exposure) is 480. This
MOE calculation was based on the developmental NOEL in rabbits of 24
mg/kg/day. Maternal effects observed at the LEL of 72 mg/kg/day
included decreased body weight and increased resorptions and abortions.
Fetal effects observed at the LEL of 72 mg/kg/day included an increase
in skeletal abnormalities. This risk assessment also assumed 100% crop
treated with tolerance level residues on all treated crops consumed,
resulting in a significant over-estimate of dietary exposure. The large
acute dietary MOE calculated for females 13+ years old provides
assurance that there is a reasonable certainty that no harm will result
to both females 13+ years and the pre-natal development of infants from
aggregate residues of imidacloprid.
3. Chronic and acute risk determination factors. FFDCA section 408
provides that EPA shall apply an additional safety factor for infants
and children in the case of threshold effects to account for pre- and
post-natal toxicity and the completeness of the database unless EPA
concludes that a different margin of safety would be appropriate.
Taking into account current toxicological data requirements, the
database for imidacloprid relative to pre- (provided by rat and rabbit
developmental studies) and post-natal (provided by the rat reproduction
study) toxicity is complete. In the rat developmental study, the
developmental (fetus) and maternal (mother) NOELs occur at the same
dose level, 24 mg/kg/day. The same response is seen in the rabbit
developmental study with the developmental (fetus) and maternal
(mother) NOELs occurring at the same dose level of 30 mg/kg/day. This
suggests that there are no special prenatal sensitivities for unborn
children in the absence of maternal toxicity. However, a detailed
analysis of the developmental studies indicates that the skeletal
findings (wavy ribs and other anomalies) in both the rat and rabbit
fetuses are severe malformations which occurred in the presence of
slight toxicity (decreases of body weight) in the maternal animals.
Additionally, in rabbits, there were resorptions and abortions which
can be attributed to acute maternal exposure. This information has been
interpreted by the Toxicology Endpoint Selection Committee (TESC) as
indicating a potential acute dietary risk for pre-natally exposed
infants. However, as noted above, the acute dietary MOE for women 13+
years or older is 480. This large MOE demonstrates that the prenatal
exposure to infants is not a toxicological concern at this time.
In the case of the 2-generation rat reproduction study, the
maternal NOEL is 55 mg/kg/day and the NOEL for decreased pup body
weight during lactation is 8 mg/kg/day with the LOEL at 19 mg/kg/day.
This study shows that adverse postnatal development of pups occurs at
levels (19 mg/kg/day) which are lower than the NOEL for the parental
animals (55 mg/kg/day). Therefore, the pups are more sensitive to the
effects of imidacloprid than parental animals. The pup NOEL of 8 mg/kg/
day in the reproduction study is 1.4 times greater than the NOEL of 5.7
mg/kg/day from the 2-year rat feeding study which was the basis of the
RfD. Therefore the RfD is established at a level which is adequate to
assess reproductive pup effects from dietary exposure. In addition, the
TRMC estimate (worst case dietary exposure) was used to determine the
value for the most highly exposed infant and children subgroup
(children 1 to 6 years old). The TRMC value for this age group occupies
31.0% of the RfD.
Both chronic and acute dietary exposure risk assessments assume
100% crop treated and use tolerance level residues for all commodities
(TMRC estimate). Refinement of these dietary risk assessments by using
percent crop treated and anticipated residue data would greatly reduce
dietary exposure. Therefore, both of these risk assessments are also an
over-estimate of dietary risk. Consideration of anticipated residues
and percent crop treated would likely result in an ARC which would
occupy a percent of the RfD that is likely to be significantly lower
than the currently calculated TMRC value. Additionally, the acute
dietary MOE would be greater than the current MOE. This provides an
adequate safety factor for children during the prenatal and postnatal
development.
If an additional safety factor were deemed appropriate when
considered in conjunction with a refined exposure estimate it is
unlikely that the dietary risk will exceed 100 percent of the RfD and
likely that the acute MOE would be greater than the currently
calculated value should. Therefore, 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
The metabolism of imidacloprid in plants and animals is adequately
understood for the purposes of these tolerances. There are no Codex
maximum residue levels established for residues of imidacloprid on
sugar beets, sugar beet tops, turnip roots or turnip greens (tops).
There is a practical analytical method for detecting and measuring
levels of imidacloprid in or on food with a limit of detection that
allows monitoring of food with residues at or above the levels set in
these tolerances. EPA has provided information on this method to FDA.
The method is available to anyone who is interested in pesticide
residue enforcement from: By mail, Calvin Furlow, Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St. SW.,
Washington, DC 20460. Office location and telephone number: Crystal
Mall #2, Rm 1128, 1921 Jefferson Davis Hwy., Arlington, VA 22202, 703-
305-5805.
VI. Conclusion
Therefore, tolerances in connection with the FIFRA section 18
emergency exemptions are established for residues of imidacloprid in
beet and turnip roots at 0.3 ppm and beet and turnip tops at 3.5 ppm.
These tolerances will expire and be automatically revoked without
further action by EPA on November 29, 1997.
VII. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30
[[Page 60627]]
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 January 28, 1997, file written objections to any
aspect of this regulation (including the automatic revocation
provision) and may also request a hearing on those objections.
Objections and hearing requests must be filed with the Hearing Clerk,
at the address given above (40 CFR 178.20). A copy of the objections
and/or hearing requests filed with the Hearing Clerk should be
submitted to the OPP docket for this rulemaking. The objections
submitted must specify the provisions of the regulation deemed
objectionable and the grounds for the objections (40 CFR 178.25). Each
objection must be accompanied by the fee prescribed by 40 CFR
180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's 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
Confidential Business Information (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.
VIII. Public Docket
A record has been established for this rulemaking under docket
number [OPP-300445]. A public version of this record, which does not
include any information claimed as CBI, is available for inspection
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
The official record for this rulemaking, as well as the public
version, as described above, is kept in paper form. Accordingly, in the
event there are objections and hearing requests, EPA will transfer any
copies of objections and hearing requests received electronically into
printed, paper form as they are received and will place the paper
copies in the official rulemaking record. The official rulemaking
record is the paper record maintained at the address in ``ADDRESSES''
at the beginning of this document.
IX. Regulatory Assessment Requirements
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and, since this
action does not impose any information collection requirements as
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is
not subject to review by the Office of Management and Budget. In
addition, this action does not impose any enforceable duty or contain
any unfunded mandate as described in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104-4), or require prior consultation with State
officials as specified by Executive Order 12875 (58 FR 58093, October
28, 1993), or special considerations as required by Executive Order
12898 (59 FR 7629, February 16, 1994).
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted
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 General Accounting Office prior to publication of the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
Because FFDCA section 408(l)(6) permits establishment of this
regulation without a notice of proposed rulemaking, the regulatory
flexibility analysis requirements of the Regulatory Flexibility Act, 5
U.S.C. 604(a), do not apply.
List of Subjects In 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and record
keeping requirements.
Dated: November 20, 1996.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
Therefore, 40 CFR Chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.472 by revising the section heading and by adding
paragraph (d) to to read as follows:
Sec. 180.472 Imidacloprid; tolerances for residues.
* * * * *
(d) Time-limited tolerances are established for residues of the
insecticide imidacloprid 1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine in connection with use of the pesticide under section
18 emergency exemptions granted by EPA. The tolerances are specified in
the following table. Each tolerance expires and is automatically
revoked on the date specified in the table without further action by
EPA.
------------------------------------------------------------------------
Expiration/Revocation
Commodity Parts per million Date
------------------------------------------------------------------------
Beet roots.................. 0.3 November 29, 1997
Beet tops................... 3.5 November 29, 1997
Turnip roots................ 0.3 November 29, 1997
Turnip tops................. 3.5 November 29, 1997
------------------------------------------------------------------------
[[Page 60628]]
* * * * *
[FR Doc. 96-30469 Filed 11-27-96; 8:45 am]
BILLING CODE 6560-50-F