[Federal Register Volume 62, Number 131 (Wednesday, July 9, 1997)]
[Rules and Regulations]
[Pages 36691-36698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17930]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300511; FRL-5729-4]
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
combined residues of imidacloprid in or on the crop group citrus fruits
and processed commodity dried citrus pulp. This action is in response
to EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of
the pesticide on citrus. This regulation establishes a maximum
permissible level for residues of imidacloprid in this food commodity
pursuant to section 408(l)(6) of the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996. These
tolerances will expire and are revoked on December 31, 1998.
DATES: This regulation is effective July 9, 1997. Objections and
requests for hearings must be received by EPA on or before September 8,
1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300511], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300511], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services 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: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300511]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration
Division 7505C, Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location,
telephone number, and e-mail address: Crystal Mall #2, 1921 Jefferson
Davis Hwy., Arlington, VA, (703) 308-9367, e-mail:
ertman.andrew@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
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
combined residues of the insecticide imidacloprid, in or on the crop
group citrus fruits at 1 part per million (ppm) and the processed
commodity dried citrus pulp at 5 ppm. These tolerances will expire and
are revoked on December 31, 1998. EPA will publish a document in the
Federal Register to remove the revoked tolerances from the Code of
Federal Regulations.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq . The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described below and discussed in
greater detail in the final rule establishing the time-limited
tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-5572-9).
New section 408(b)(2)(A)(I) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerance 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 Citrus and FFDCA
Tolerances
The State of Florida has requested a specific exemption for the use
of imidacloprid on citrus for the control of
[[Page 36692]]
the brown citrus aphid (BrCA) and the citrus leafminer (CLM). The BrCA
is a potentially devastating pest that impacts citrus by feeding on
newly developing foliage and by transmitting citrus tristeza virus
(CTV). The citrus leafminer, since its initial discovery in May 1993,
has become a major economic pest to citrus nurseries and young citrus
groves by feeding on newly developing foliage.
The Applicant asserts that CTV could potentially affect citrus
yield in the following three ways: (1) threatened losses of $500
million for sweet orange and grapefruit trees budded on sour orange
rootstock; (2) if CTV stem pitting strains became endemic throughout
the Florida grapefruit industry, yields from grapefruit trees on CTV
tolerant rootstock could be reduced by 45% on a continuing basis, fruit
size would be reduced, and production costs increased; and (3) if CTV
became endemic throughout Florida, yields of sweet orange would be
reduced by 5-20%, and production costs increased.
As for yield losses caused by the CLM, the Applicant indicates that
defoliation caused by CLM could result in up to a 44% reduction in
yield, translating into a net loss of approximately $145/acre.
For the BrCA, the registered alternatives are either ineffective
due to labeled use restrictions and length of efficacy or are broad
spectrum insecticides that, if used as needed to control the BrCA,
would dramatically upset established populations of beneficials. The
registered alternatives for the CLM have not provided adequate control
of this pest, with the most effective alternatives demonstrating a 14-
day suppression of the CLM. Additionally, the CLM is difficult to
control with foliar sprays because it is protected from foliar-applied
insecticides by the mined leaf cuticle, and leaf margins role inward
over the pupae, protecting it. Florida indicated that imidacloprid had
demonstrated as much as 15 weeks of control, and since it is a systemic
insecticide, would be particularly effective against these type of
pests, due to their feeding habits.
EPA has authorized under FIFRA section 18 the use of imidacloprid
on citrus for control of the brown citrus aphid and citrus leafminer in
Florida. 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
citrus fruits and dried citrus pulp. In doing so, EPA considered the
new safety standard in FFDCA section 408(b)(2), and EPA decided that
the necessary tolerance under FFDCA section 408(l)(6) would be
consistent with the new safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing 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 December 31, 1998, under FFDCA section 408(l)(5),
residues of the pesticide not in excess of the amounts specified in the
tolerances remaining in or on citrus fruits and dried citrus pulp after
that date will not be unlawful, provided the pesticide is applied in a
manner that was lawful under FIFRA. 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 citrus or whether
permanent tolerances for this use would be appropriate. Under these
circumstances, EPA does not believe that these tolerance 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 Florida to use this pesticide 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 exemption 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. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal 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). 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% or less of the RfD) is
generally considered acceptable by EPA. EPA generally uses the RfD to
evaluate the chronic risks posed by pesticide exposure. For shorter
term risks, EPA calculates a margin of exposure (MOE) by dividing the
estimated human exposure into the NOEL from the appropriate animal
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This
100-fold MOE is based on the same rationale as the 100-fold uncertainty
factor.
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 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.
[[Page 36693]]
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure that the
public is adequately protected from any pesticide exposure scenario.
Both short and long durations of exposure are always considered.
Typically, risk assessments include ``acute'', ``short-term'',
``intermediate term'', and ``chronic'' risks. These assessments are
defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High-end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days, and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 3
sources are not typically added because of the very low probability of
this occurring in most cases, and because the other conservative
assumptions built into the assessment assure adequate protection of
public health. However, for cases in which high-end exposure can
reasonably be expected from multiple sources (e.g. frequent and
widespread homeowner use in a specific geographical area), multiple
high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e., the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. (Toxicity results at lower
levels when the dosing duration is increased.)
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
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, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). 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. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
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% 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.
Percent of crop treated estimates are derived from federal and
private market survey data. 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 percent of crop
treated, the Agency is reasonably certain that exposure is not
understated for any significant subpopulation group. Further, regional
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations
including several regional groups, to pesticide residues. For this
pesticide, the most highly exposed population subgroup (children 1-6
years old) was not regionally based.
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. EPA has sufficient data to assess the hazards of
imidacloprid and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
combined residues of imidacloprid on the citrus fruits crop group at 1
ppm and the processed commodity dried citrus pulp 5 ppm. EPA's
assessment 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 below.
1. Acute toxicity. NOEL = 24 mg/kg/day. The Agency recommends use
of the NOEL of 24 mg/kg/day, based on decreased body weight, increased
resorptions, increased abortions, and increased skeletal abnormalities
at the lowest effect level (LEL) of 72 mg/kg/day, from the
developmental toxicity study in rabbits. This risk assessment should
evaluate acute dietary risk to females 13+ years.
2. Short - and intermediate - term toxicity. For short- and
intermediate-term MOE calculations, the Agency determined that
available data do not demonstrate that imidacloprid has dermal or
inhalation toxicity potential. Therefore, short-or intermediate-term
dermal and inhalation risk assessments are not required. This decision
was based on the fact that no effects were observed at the highest dose
level tested (0.191 mg/L) in a 28-day inhalation toxicity study in
rats, and that no systemic toxicity was observed at dose
[[Page 36694]]
levels up to 1,000 mg/kg/day in a 21-day dermal toxicity study in
rabbits.
3. Chronic toxicity. EPA has established the RfD for imidacloprid
at 0.057 milligrams/kilogram/day (mg/kg/day). This RfD is based on a
NOEL of 5.7 mg/kg/day from a 2-year feeding/carcinogenicity study in
rats. An uncertainty factor of 100 was applied to take into account
inter-species sensitivity and intra-species variation. The lowest
observed effect level (LOEL) of 16.9 mg/kg/day was based on increased
thyroid lesions in males.
4. Carcinogenicity. Imidacloprid has been classified as a Group E
chemical, no evidence of carcinogenicity for humans, by the Agency.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.472) for the combined residues of imidacloprid, in or on a
variety of raw agricultural commodities. Tolerances range from 0.02 ppm
in eggs to 6 ppm in cottonseed. 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 one day or single exposure. The acute dietary (food only) risk
assessment used Theoretical Maximum Residue Contribution (TMRC). The
resulting high-end exposure estimate of 0.1 mg/kg/day, which results in
a dietary (food only) MOE of 240 for females 13+ years, should be
viewed as a conservative risk estimate; refinement using anticipated
residue values and percent crop-treated data in conjunction with Monte
Carlo analysis would result in a lower acute dietary exposure estimate.
ii. Chronic exposure and risk. In conducting this exposure
assessment, the Agency has made very conservative assumptions -- 100%
of citrus commodities and all other commodities having imidacloprid
tolerances will contain imidacloprid residues and those residues would
be at the level of the tolerance -- which result in an overestimate of
human dietary exposure. This chronic dietary (food only) exposure
should be viewed as a conservative risk estimate; refinement using
anticipated residue levels and percent crop-treated values analysis
would result in a lower dietary exposure estimate. Thus, in making a
safety determination for this tolerance, EPA is taking into account
this conservative exposure assessment. The existing imidacloprid
tolerances (published, pending, and including the necessary Section 18
tolerances) result in a Theoretical Maximum Residue Contribution (TMRC)
that is equivalent to the following percentages of the RfD:
------------------------------------------------------------------------
Subpopulation TMRC %RfD
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U.S. population................. 0.011276 20%
Nursing infants................. 0.009403 17%
Non-nursing infants (<1 year="" 0.022489="" 40%="" old).="" children="" (1-6="" years="" old)........="" 0.024609="" 43%="" children="" (7-12="" years="" old).......="" 0.016932="" 30%="" u.s.="" population="" -="" winter........="" 0.011763="" 21%="" northeast="" region................="" 0.012362="" 22%="" western="" region..................="" 0.011992="" 21%="" hispanics.......................="" 0.012485="" 22%="" non-hispanic="" others.............="" 0.013116="" 23%="" ------------------------------------------------------------------------="" the="" subgroups="" listed="" above="" are:="" (1)="" the="" u.s.="" population="" (48="" states);="" (2)="" those="" for="" infants="" and="" children;="" and,="" (3)="" the="" other="" subgroups="" for="" which="" the="" percentage="" of="" the="" rfd="" occupied="" is="" greater="" than="" that="" occupied="" by="" the="" subgroup="" u.s.="" population="" (48="" states).="" 2.="" from="" drinking="" water.="" based="" on="" data="" available="" to="" the="" agency,="" imidacloprid="" is="" persistent="" and="" could="" potentially="" leach="" into="" groundwater.="" there="" is="" no="" established="" maximum="" contamination="" level="" (mcl)="" for="" residues="" of="" imidacloprid="" in="" drinking="" water.="" no="" health="" advisory="" levels="" for="" imidacloprid="" in="" drinking="" water="" have="" been="" established.="" the="" ``pesticides="" in="" groundwater="" database''="" has="" no="" entry="" for="" imidacloprid.="" chronic="" exposure="" and="" risk.="" because="" the="" agency="" lacks="" sufficient="" water-related="" exposure="" data="" to="" complete="" a="" comprehensive="" drinking="" water="" risk="" assessment="" for="" many="" pesticides,="" epa="" has="" commenced="" and="" nearly="" completed="" a="" process="" to="" identify="" a="" reasonable="" yet="" conservative="" bounding="" figure="" for="" the="" potential="" contribution="" of="" water-related="" exposure="" to="" the="" aggregate="" risk="" posed="" by="" a="" pesticide.="" in="" developing="" the="" bounding="" figure,="" epa="" estimated="" residue="" levels="" in="" water="" for="" a="" number="" of="" specific="" pesticides="" using="" various="" data="" sources.="" the="" agency="" then="" applied="" the="" estimated="" residue="" levels,="" in="" conjunction="" with="" appropriate="" toxicological="" endpoints="" (rfds="" or="" acute="" dietary="" noels)="" and="" assumptions="" about="" body="" weight="" and="" consumption,="" to="" calculate,="" for="" each="" pesticide,="" the="" increment="" of="" aggregate="" risk="" contributed="" by="" consumption="" of="" contaminated="" water.="" while="" epa="" has="" not="" yet="" pinpointed="" the="" appropriate="" bounding="" figure="" for="" exposure="" from="" contaminated="" water,="" the="" ranges="" the="" agency="" is="" continuing="" to="" examine="" are="" all="" below="" the="" level="" that="" would="" cause="" imidacloprid="" to="" exceed="" the="" rfd="" if="" the="" tolerance="" being="" considered="" in="" this="" document="" were="" granted.="" the="" agency="" has="" therefore="" concluded="" that="" the="" potential="" exposures="" associated="" with="" imidacloprid="" in="" water,="" even="" at="" the="" higher="" levels="" the="" agency="" is="" considering="" as="" a="" conservative="" upper="" bound,="" would="" not="" prevent="" the="" agency="" from="" determining="" that="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" if="" the="" tolerance="" is="" granted.="" 3.="" from="" non-dietary="" exposure.="" imidacloprid="" is="" currently="" registered="" for="" use="" on="" the="" following="" residential="" non-food="" sites:="" ornamental="" flowering="" plants,="" ornamental="" ground="" covers,="" ornamental="" woody="" plants,="" ornamental="" turf,="" ornamental="" lawns,="" household="" and="" domestic="" dwellings="" (indoor/outdoor),="" wood="" protection,="" and="" pets.="" because="" the="" agency="" has="" determined="" that="" imidacloprid="" has="" no="" dermal="" or="" inhalation="" toxicological="" potential="" and="" has="" not="" identified="" a="" chronic="" toxicological="" endpoint,="" epa="" does="" not="" expect="" any="" harm="" from="" non-dietary="" exposure="" to="" imidacloprid.="" 4.="" cumulative="" exposure="" to="" substances="" with="" common="" mechanism="" of="" toxicity.="" section="" 408(b)(2)(d)(v)="" requires="" that,="" when="" considering="" whether="" to="" establish,="" modify,="" or="" revoke="" a="" tolerance,="" the="" agency="" consider="" ``available="" information''="" concerning="" the="" cumulative="" effects="" of="" a="" particular="" pesticide's="" residues="" and="" ``other="" substances="" that="" have="" a="" common="" mechanism="" of="" toxicity.''="" [[page="" 36695]]="" the="" agency="" believes="" that="" ``available="" information''="" in="" this="" context="" might="" include="" not="" only="" toxicity,="" chemistry,="" and="" exposure="" data,="" but="" also="" scientific="" policies="" and="" methodologies="" for="" understanding="" common="" mechanisms="" of="" toxicity="" and="" conducting="" cumulative="" risk="" assessments.="" for="" most="" pesticides,="" although="" the="" agency="" has="" some="" information="" in="" its="" files="" that="" may="" turn="" out="" to="" be="" helpful="" in="" eventually="" determining="" whether="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" toxicity="" with="" any="" other="" substances,="" epa="" does="" not="" at="" this="" time="" have="" the="" methodologies="" to="" resolve="" the="" complex="" scientific="" issues="" concerning="" common="" mechanism="" of="" toxicity="" in="" a="" meaningful="" way.="" epa="" has="" begun="" a="" pilot="" process="" to="" study="" this="" issue="" further="" through="" the="" examination="" of="" particular="" classes="" of="" pesticides.="" the="" agency="" hopes="" that="" the="" results="" of="" this="" pilot="" process="" will="" increase="" the="" agency's="" scientific="" understanding="" of="" this="" question="" such="" that="" epa="" will="" be="" able="" to="" develop="" and="" apply="" scientific="" principles="" for="" better="" determining="" which="" chemicals="" have="" a="" common="" mechanism="" of="" toxicity="" and="" evaluating="" the="" cumulative="" effects="" of="" such="" chemicals.="" the="" agency="" anticipates,="" however,="" that="" even="" as="" its="" understanding="" of="" the="" science="" of="" common="" mechanisms="" increases,="" decisions="" on="" specific="" classes="" of="" chemicals="" will="" be="" heavily="" dependent="" on="" chemical="" specific="" data,="" much="" of="" which="" may="" not="" be="" presently="" available.="" although="" at="" present="" the="" agency="" does="" not="" know="" how="" to="" apply="" the="" information="" in="" its="" files="" concerning="" common="" mechanism="" issues="" to="" most="" risk="" assessments,="" there="" are="" pesticides="" as="" to="" which="" the="" common="" mechanism="" issues="" can="" be="" resolved.="" these="" pesticides="" include="" pesticides="" that="" are="" toxicologically="" dissimilar="" to="" existing="" chemical="" substances="" (in="" which="" case="" the="" agency="" can="" conclude="" that="" it="" is="" unlikely="" that="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" activity="" with="" other="" substances)="" and="" pesticides="" that="" produce="" a="" common="" toxic="" metabolite="" (in="" which="" case="" common="" mechanism="" of="" activity="" will="" be="" assumed).="" 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.="" c.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" an="" acute="" aggregate="" risk="" assessment="" takes="" into="" account="" exposure="" from="" dietary="" food="" and="" water.="" for="" imidacloprid,="" no="" data="" were="" available="" to="" epa="" from="" possible="" exposure="" to="" contaminated="" drinking="" water.="" thus,="" this="" risk="" assessment="" is="" based="" on="" acute="" dietary="" risk="" from="" food="" only.="" for="" the="" population="" subgroup="" of="" concern,="" females="" 13+="" years,="" the="" calculated="" moe="" value="" is="" 240.="" this="" moe="" does="" not="" exceed="" the="" agency's="" level="" of="" concern="" for="" acute="" dietary="" exposure.="" 2.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" and="" taking="" into="" account="" the="" completeness="" and="" reliability="" of="" the="" toxicity="" data,="" epa="" has="" concluded="" that="" aggregate="" dietary="" exposure="" to="" imidacloprid="" will="" utilize="" 20%="" of="" the="" rfd="" for="" the="" u.s.="" population.="" 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="" dietary="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" since="" epa="" has="" determined="" that="" there="" is="" no="" dermal="" or="" inhalation="" toxicity="" potential="" for="" imidacloprid,="" non-dietary,="" non-occupational="" exposure="" is="" not="" a="" concern.="" the="" agency="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" chronic="" aggregate="" exposure="" to="" imidacloprid="" residues.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" because="" the="" agency="" has="" determined="" that="" imidacloprid="" has="" no="" dermal="" or="" inhalation="" toxicity="" potential,="" short-term="" or="" intermediate-term="" dermal="" and="" inhalation="" risk="" assessments="" are="" not="" required.="" d.="" aggregate="" cancer="" risk="" for="" u.s.="" population="" since="" imidacloprid="" has="" been="" classified="" as="" a="" group="" e="" chemical,="" no="" evidence="" of="" carcinogenicity="" for="" humans,="" a="" cancer="" risk="" assessment="" was="" not="" required.="" e.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" infants="" and="" children="" 1.="" safety="" factor="" for="" infants="" and="" children.--a.="" in="" general.="" in="" assessing="" the="" potential="" for="" additional="" sensitivity="" of="" infants="" and="" children="" to="" residues="" of="" imidacloprid,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" two-="" generation="" reproduction="" study="" in="" the="" rat.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" 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.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" tenfold="" margin="" of="" safety="" for="" infants="" and="" children="" in="" the="" case="" of="" threshold="" effects="" to="" account="" for="" pre-and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" database="" 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="" 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.="" b.="" developmental="" toxicity="" studies.="" from="" the="" developmental="" toxicity="" study="" in="" rats,="" the="" maternal="" (systemic)="" noel="" was="" 30="" mg/kg/day.="" the="" maternal="" (systemic)="" loel="" of="" 100="" mg/kg/day="" was="" based="" on="" decreased="" weight="" gain.="" the="" developmental="" (fetal)="" noel="" was="" 30="" mg/kg/day.="" the="" developmental="" (fetal)="" lel="" of="" 100="" mg/kg/day="" was="" based="" on="" increased="" wavy="" ribs.="" from="" the="" developmental="" toxicity="" study="" in="" rabbits,="" the="" maternal="" (systemic)="" noel="" was="" 24="" mg/kg/day.="" the="" maternal="" (systemic)="" loel="" of="" 72="" mg/kg/day="" was="" based="" on="" decreased="" body="" weight,="" increased="" abortions,="" and="" death.="" the="" developmental="" (fetal)="" noel="" was="" 24="" mg/kg/day.="" the="" developmental="" (fetal)="" loel="" of="" 72="" mg/kg/day="" was="" based="" on="" decreased="" body="" weight="" and="" increased="" skeletal="" anomalies.="" c.="" reproductive="" toxicity="" study.="" from="" the="" reproductive="" toxicity="" study="" in="" rats,="" the="" maternal="" (systemic)="" noel="" was="" 55="" mg/kg/day="" at="" the="" highest="" dose="" tested="" (hdt).="" the="" reproductive/developmental="" (pup)="" noel="" was="" 8="" mg/kg/day.="" the="" reproductive/developmental="" (pup)="" [[page="" 36696]]="" loel="" of="" 19="" mg/kg/day="" was="" based="" on="" decreased="" pup="" body="" weight="" during="" lactation="" in="" both="" generations.="" d.="" pre-="" and="" post-natal="" sensitivity.="" the="" toxicological="" database="" for="" evaluating="" pre-="" and="" post-natal="" toxicity="" for="" imidacloprid="" is="" complete.="" in="" the="" case="" of="" the="" developmental="" toxicity="" studies,="" the="" developmental="" and="" maternal="" noels="" for="" both="" rats="" and="" rabbits="" occur="" at="" the="" same="" dose="" level="" for="" each="" species="" (24="" mg/kg/day="" for="" rabbits="" and="" 30="" mg/kg/day="" for="" rats)="" which="" suggests="" that="" there="" is="" no="" extra="" sensitivity="" for="" unborn="" children="" in="" the="" absence="" of="" maternal="" toxicity.="" however,="" a="" detailed="" analysis="" of="" the="" developmental="" toxicity="" studies="" indicates="" that="" the="" skeletal="" findings="" (wavy="" ribs="" and="" other="" anomalies)="" in="" both="" the="" rat="" and="" rabbit="" fetuses="" are="" severe="" effects="" which="" occurred="" in="" the="" presence="" of="" slight="" maternal="" toxicity="" (decreases="" of="" body="" weight).="" additionally,="" in="" rabbits,="" there="" were="" increases="" in="" resorptions="" and="" abortions="" which="" can="" be="" attributed="" to="" acute="" maternal="" exposure.="" this="" information="" has="" been="" interpreted="" by="" the="" agency="" as="" indicating="" a="" potential="" acute="" dietary="" risk="" for="" pre-natally="" exposed="" infants.="" the="" acute="" dietary="" moe="" for="" females="" 13+="" years="" is="" 240.="" this="" large="" moe,="" based="" on="" conservative="" exposure="" assumptions,="" demonstrates="" that="" pre-natal="" exposure="" to="" imidacloprid="" is="" not="" a="" toxicological="" concern="" at="" this="" time.="" in="" the="" case="" of="" the="" 2-generation="" reproductive="" toxicity="" study="" in="" rats,="" the="" parental="" noel="" is="" 55="" mg/kg/day="" (hdt).="" the="" reproductive="" noel="" is="" 8="" mg/kg/day="" based="" on="" decreased="" pup="" body="" weight="" during="" lactation="" observed="" at="" the="" loel="" of="" 19="" mg/kg/day.="" the="" results="" of="" this="" study="" indicate="" that="" adverse="" reactions="" to="" imidacloprid="" by="" the="" 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="" and="" for="" the="" purpose="" of="" this="" section="" 18="" an="" additional="" 3x="" safety="" factor="" should="" be="" added="" to="" the="" rfd.="" the="" aggregate="" risk="" estimate="" for="" the="" most="" highly="" exposed="" infant="" and="" children="" subgroup="" (children="" 1-6="" years="" old)="" occupies="" 129%="" of="" the="" rfd="" (including="" the="" 3x="" additional="" safety="" factor).="" both="" chronic="" and="" acute="" dietary="" exposure="" risk="" assessments="" assume="" 100%="" crop="" treated="" and="" use="" tolerance="" level="" residues="" for="" all="" commodities.="" refinement="" of="" these="" dietary="" risk="" assessments="" by="" using="" percent="" crop="" treated="" information="" and="" anticipated="" residue="" data="" would="" reduce="" dietary="" exposure.="" therefore,="" both="" of="" these="" risk="" assessments="" are="" over-estimates="" of="" dietary="" risk.="" consideration="" of="" anticipated="" residues="" and="" percent="" crop="" treated="" would="" likely="" result="" in="" an="" anticipated="" residue="" contribution="" (arc)="" which="" would="" occupy="" a="" percentage="" of="" the="" rfd="" that="" is="" likely="" to="" be="" significantly="" lower="" than="" the="" currently="" calculated="" tmrc="" value,="" and="" aggregate="" risk="" estimates.="" therefore,="" epa="" concludes="" that="" extension="" of="" this="" time-limited="" tolerance="" should="" not="" pose="" an="" unacceptable="" risk="" to="" infants="" and="" children.="" 2.="" acute="" risk.="" at="" present,="" the="" acute="" dietary="" moe="" for="" females="" 13+="" years="" (accounts="" for="" both="" maternal="" and="" fetal="" exposure)="" is="" 240.="" 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="" agency="" does="" not="" expect="" that="" aggregate="" exposure="" (food="" plus="" water)="" would="" result="" in="" an="" unacceptable="" acute="" dietary="" moe.="" the="" large="" acute="" dietary="" moe="" calculated="" for="" females="" 13+="" years="" provides="" assurance="" that="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" for="" both="" females="" 13+="" years="" and="" the="" pre-natal="" development="" of="" infants="" from="" exposure="" to="" imidacloprid.="" 3.="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" imidacloprid="" from="" food="" will="" utilize="" 48%="" of="" the="" rfd="" for="" nursing="" infants,="" and="" 129%="" of="" the="" rfd="" for="" children="" 1-6="" years="" old="" (including="" the="" additional="" 3x="" safety="" factor).="" this="" chronic="" aggregate="" (food="" only)="" exposure="" should="" be="" viewed="" as="" a="" conservative="" risk="" estimate;="" refinement="" using="" anticipated="" residue="" levels="" and="" percent="" crop-treated="" values="" analysis="" would="" result="" in="" a="" lower="" aggregate="" exposure="" estimate.="" despite="" the="" potential="" for="" exposure="" to="" imidacloprid="" in="" drinking="" water="" and="" from="" non-dietary,="" non-occupational="" exposure,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100%="" of="" the="" rfd.="" 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.="" v.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" nature="" of="" the="" residue="" in="" plants="" and="" animals,="" is="" adequately="" understood.="" the="" residue="" of="" concern="" is="" imidacloprid="" and="" its="" metabolites="" containing="" the="" 6-chloropyridinyl="" moiety,="" all="" expressed="" as="" parent="" as="" specified="" in="" 40="" cfr="" 180.472.="" b.="" analytical="" enforcement="" methodology="" an="" adequate="" common="" moiety="" gc/ms="" enforcement="" method="" is="" available="" for="" the="" determination="" of="" the="" regulated="" imidacloprid="" residues="" in="" citrus="" commodities.="" bayer="" method="" 00200="" has="" successfully="" completed="" an="" epa="" tolerance="" method="" validation.="" copies="" of="" the="" method="" have="" been="" forwarded="" to="" fda="" for="" publication="" in="" pam="" volume="" ii.="" c.="" magnitude="" of="" residues="" combined="" residues="" of="" imidacloprid="" and="" its="" regulated="" metabolites="" are="" not="" expected="" to="" exceed="" 1.0="" ppm="" in/on="" the="" citrus="" crop="" group="" or="" 5="" ppm="" in/="" on="" the="" processed="" commodity="" dried="" citrus="" pulp="" as="" a="" result="" of="" this="" section="" 18="" use.="" secondary="" residues="" in="" animal="" commodities="" are="" not="" expected="" to="" exceed="" existing="" tolerances="" as="" a="" result="" of="" this="" section="" 18="" use.="" d.="" international="" residue="" limits="" there="" are="" no="" codex,="" canadian,="" or="" mexican="" residue="" limits,="" therefore="" harmonization="" is="" not="" an="" issue="" for="" this="" action.="" e.="" rotational="" crop="" restrictions="" citrus="" crops="" are="" not="" rotated="" to="" other="" crops,="" thus="" rotational="" crop="" concerns="" are="" not="" germane="" to="" this="" action.="" vi.="" conclusion="" therefore,="" tolerances="" are="" established="" for="" combined="" residues="" of="" imidacloprid="" on="" the="" citrus="" fruits="" crop="" group="" at="" 1="" ppm="" and="" dried="" citrus="" pulp="" at="" 5="" ppm.="" 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="" 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="" 8,="" 1997,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" above="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" rulemaking.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" [[page="" 36697]]="" 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="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300511]="" (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="" 1132="" of="" the="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" arlington,="" va.="" electronic="" comments="" may="" be="" sent="" directly="" to="" epa="" at:="">opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
IX. Regulatory Assessment Requirements
This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or 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 these tolerances and exemptions that are
established on the basis of a petition under FFDCA section 408 (d),
such as the tolerances in this final rule, do not require the issuance
of a proposed rule, the requirements of the Regulatory Flexibility Act
(RFA) (5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency has
previously assessed whether establishing tolerances, exemptions from
tolerances, raising tolerance levels or expanding exemptions might
adversely impact small entities and concluded, as a generic matter,
that there is no adverse economic impact. The factual basis for the
Agency's generic certification for tolerance actions published on May
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
X. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has 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 this rule in
today's Federal Register. This 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: June 30, 1997.
James Jones,
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 and 371.
2. In Sec. 180.472, by adding the text of paragraph (b) to read as
follows:
Sec. 180.472 1-[(6-Chloro-3-pyridinyl)methyl]-N-nitro-2-
imidazolidinimine].
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the insecticide imidacloprid in connection
with use of the pesticide under section 18 emergency exemptions granted
by EPA. These tolerances will expire and are revoked on the dates
specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
Citrus fruits crop group........ 1.0 December 31, 1998
[[Page 36698]]
Dried citrus pulp............... 5.0 December 31, 1998
------------------------------------------------------------------------
* * * * *
[FR Doc. 97-17930 Filed 7-8-97; 8:45 am]
BILLING CODE 6560-50-F
