[Federal Register Volume 64, Number 139 (Wednesday, July 21, 1999)]
[Rules and Regulations]
[Pages 39053-39059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18482]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300882; FRL-6086-7]
RIN 2070-AB78
Spinosad; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
[[Page 39054]]
ACTION: Final rule.
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SUMMARY: This regulation establishes a time-limited tolerance for
residues of spinosad in or on all commodities in connection with
quarantine eradication programs against exotic, non-indigenous, fruit
fly species, where a separate higher tolerance is not already
established. In this same action, EPA is also establishing a time-
limited tolerance for use of spinosad on cranberries. These actions are
in response to EPA's granting of emergency exemptions under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing
use of the pesticide under the conditions described above. This
regulation establishes a maximum permissible level for residues of
spinosad on these food commodities pursuant to section 408(l)(6) of the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996. The tolerance in connection with the use of
spinosad in quarantine eradication programs will expire and is revoked
on December 1, 2002. The time-limited tolerance for spinosad on
cranberries will expire and is revoked on June 1, 2001.
DATES: This regulation is effective July 21, 1999. Objections and
requests for hearings must be received by EPA on or before September
20, 1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300882], 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-300882], must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring a copy of
objections and hearing requests to Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epa.gov. Copies of electronic objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket control number [OPP-300882].
No Confidential Business Information (CBI) should be submitted through
e-mail. Copies of electronic objections and hearing requests on this
rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Daniel J. Rosenblatt,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Rm. 286, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-308-9375;
rosenblatt.dan@epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, is establishing tolerances for residues of the
insecticide spinosad on all commodities at 0.02 parts per million (ppm)
when used in connection with quarantine eradication programs against
exotic, non-indigenous, fruit fly species, where a separate higher
tolerance is not already established. This tolerance will expire and is
revoked on December 1, 2002. EPA is also establishing a tolerance for
residues of spinosad on cranberries when used under a section 18
emergency exemption. The tolerance for cranberries will expire and is
revoked on June 1, 2001. EPA will publish a document in the Federal
Register to remove the revoked tolerances from the Code of Federal
Regulations.
I. Background and Statutory Findings
The Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described in this preamble and
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Spinosad
The U.S. Department of Agriculture's Animal and Plant Health
Inspection Service (USDA/APHIS) is responsible for ensuring that new
and invasive pest species do not become established in the United
States. In order to engage in emergency eradication programs should an
infestation of a quarantined fruit fly
[[Page 39055]]
pest be discovered, USDA/APHIS applied for section 18 quarantine
exemptions to use, among other things, the pesticide spinosad against
these species in Florida.
Florida is vulnerable to outbreaks of non-indigenous fruit fly
species in the Tephritidae family. USDA/APHIS, working in conjunction
with the Florida Department of Agriculture and Consumer Services, has
eradicated numerous incipient populations of the Mediterranean fruit
fly over the past two seasons. The discovery of an outbreak of a
population of a new or non-established pest species carries significant
trade implications. The economic losses associated with an established
population of Mediterranean fruit flies or other Tephritidae pests
would be severe.
EPA concurs that an emergency situation exists in relation to these
pests and has authorized a section 18 quarantine exemption for use of
spinosad in quarantine programs against exotic, non-indigenous,
quarantined, fruit fly species. Time-limited tolerances are also needed
to support this exemption in a generic manner because outbreaks of
these pest species are possible in nearly all commercial agricultural
settings.
Separately, EPA also authorized an emergency exemption for the use
of spinosad on cranberries in order to control the sparganothis fruit
worm. Growers are experiencing loss of efficacy connected with use of
the historic pesticide controls and may be faced with yield loss at 20%
of the crop over previous growing seasons. On heavily fruiting, early
cultivars, damage may approach 35% crop loss. EPA concurs that
emergency conditions exist and has authorized spinosad's use on
cranberries in Massachusetts.
As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of spinosad in or on
cranberries and also on all commodities where a separate higher
tolerance is not already established. In doing so, EPA considered the
safety standard in FFDCA section 408(b)(2), and EPA decided that the
necessary tolerance under FFDCA section 408(l)(6) would be consistent
with the safety standard and with FIFRA section 18. Consistent with the
need to move quickly on the emergency exemption in order to address an
urgent non-routine situation and to ensure that the resulting food is
safe and lawful, EPA is issuing 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 the dates specified elsewhere in this document, under FFDCA
section 408(l)(5), residues of the pesticide not in excess of the
amounts specified in the tolerance remaining in or on cranberries or
all commodities where a separate higher tolerance is not established
after that date will not be unlawful, provided the pesticide was
applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by this tolerance at the time of
that application. EPA will take action to revoke this tolerance earlier
if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether spinosad meets
EPA's registration requirements for use on cranberries or all
commodities where a separate higher tolerance is not established or
whether a permanent tolerance for this use would be appropriate. Under
these circumstances, EPA does not believe that these tolerances serve
as a basis for registration of spinosad by a State for special local
needs under FIFRA section 24(c). Nor does this tolerance serve as the
basis for any States other than those where the exemptions were issued
to use this pesticide on these crops under section 18 of FIFRA without
following all provisions of EPA's regulations implementing section 18
as identified in 40 CFR part 166. For additional information regarding
the emergency exemption, contact the Agency's Registration Division at
the address provided under the ``ADDRESSES'' section.
III. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of spinosad
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for a time-limited tolerance for residues of
spinosad on cranberries and all commodities where a separate higher
tolerance is not established at 0.02 ppm. EPA's assessment of the
dietary exposures and risks associated with establishing the tolerance
follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by spinosad are
discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. No acute toxicity endpoint was selected by EPA
because a single exposure dose did not produce toxicological effects.
2. Short- and intermediate-term toxicity. No toxicology endpoint
was selected by EPA for these exposure durations.
3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for spinosad at 0.0268 milligram/kilogram/day (mg/kg/day). This RfD is
based on a no observed adverse effect level (NOAEL) of 2.68 mg/kg/day
established in a chronic toxicity study in dogs. The lowest observed
adverse effect level (LOAEL) was 8.46 mg/kg/day based on vacuolation in
glandular cells and lymphatic tissues, arteritis and increases in serum
enzymes such as alanine aminotransferase, and aspartate
aminotransferase, and triglyceride levels in dogs fed spinosad in the
diet at dose levels 1.44, 2,68, or 8.46 mg/kg/day for 52 weeks. A 100-
fold uncertainty factor (UF) was applied to the NOAEL of 2.68 mg/kg/day
to account for inter- and intraspecies variation.
4. Carcinogenicity. EPA has determined that there is no evidence of
carcinogenicity in studies involving spinosad in either the mouse or
rat. Therefore, a carcinogenic risk assessment is not required.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.495) for the residues of spinosad, in or on a variety of raw
agricultural commodities. For example, tolerances have been established
for the citrus fruits group, the fruiting vegetables group, and on meat
and milk. Risk assessments were conducted by EPA to assess dietary
exposures and risks from as follows:
[[Page 39056]]
i. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. EPA did not identify a toxicity endpoint
for this exposure duration. Therefore, a risk assessment for this
exposure scenario is not needed.
ii. Chronic exposure and risk. Based on a NOAEL of 2.68 mg/kg/day
and an uncertainty factor of 100, EPA performed a dietary risk
assessment which considered exposure that may result from use under
this section 18 as well as all other registered uses. The highest
exposed population subgroup based on a Tier 1 exposure analysis from
the dietary exposure evaluation system (DEEM) was children ages 1-6
years. This risk assessment also took into account the available
information on spinosad concerning the additional safety factor called
for by FQPA in order to protect infants and children. This calculation
builds additional safety factors, as needed, into the risk assessment
by using a ratio that compares the reference dose against the FQPA
safety factor that is appropriate for a particular pesticide. This
ratio is known as the population adjusted dose (PAD). In this case, EPA
concluded that the additional 10x safety factor for spinosad could be
removed. Section E of this unit contains the rationale for reducing the
10x safety factor for spinosad. EPA calculated that chronic dietary
(food only) exposure at tolerance levels will occupy 39% of the PAD.
Exposure estimates for adult populations are less than 29% of the PAD.
2. From drinking water. No chemical-specific drinking water
monitoring data are available. However, EPA used modeling data
involving both ground and surface water situations to determine
conservative estimated environmental concentrations (EECs). Also, EPA
back-calculated drinking water levels of comparison (DWLOCs) to
determine whether exposure to spinosad via drinking water is likely to
be of concern given the modeled EECs. EPA has concluded that drinking
water is not expected to be a significant source of exposure to
spinosad.
Data suggests that spinosad is not mobile or persistent, and
therefore, has little potential to leach to ground water or to be
transported to surface water in high concentrations. Although spinosad
has been shown to photolyze rapidly, EPA used the conservative soil
photolysis value of 82 days in modeling the persistence of the chemical
in surface waters.
i. Acute exposure and risk. The high-end EEC is based on the
highest registered application rate and results in an EEC of 0.092
micrograms/liter. The highest exposed population subgroup is children
1-6 years. The calculated DWLOC for that population subgroup is 165
micrograms/liter. This EEC value is over 1,000 times less than the
lowest DWLOC. Therefore, EPA concludes that drinking water is not
expected to be a significant source of exposure to spinosad.
ii. Chronic exposure and risk. The characteristics of spinosad
suggest that the exposure and risks from spinosad in drinking water are
analogous for acute and chronic exposures. No separate chronic analysis
is needed.
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 NOAELs) 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 it 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 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. Spinosad is currently registered for
use on the following residential non-food site: turf grass. This
registration creates the possibility of exposure to children involved
in pica behavior with the ingestion of grass or treated dirt. EPA
performed a qualitative analysis of the risks connected with this type
of exposure and concluded that based on the toxicology profile of
spinosad as well as a reasonable exposure situation that risk to
children from the turf use does not exceed the Agency's level of
concern.
i. Acute exposure and risk. Because no toxicological endpoint was
selected for acute exposures to spinosad, it is not necessary to
calculate a risk assessment to evaluate the acute non-dietary exposure
scenario.
ii. Chronic exposure and risk. EPA's Health Effect Division (HED)
performed a qualitative risk assessment to characterize the chronic
risks from non-dietary exposure to spinosad. Based on the low
application rate on turf (0.41 lb., AI/A.), its non-systemic nature,
its short half-life (especially in sunlight), and the rapid
incorporation of spinosad metabolites into the general carbon pool, EPA
believes that residues of spinosad on turf grass after application
would be low and decrease rapidly over time. EPA believes that a
quantitative risk assessment for this exposure duration is not
reasonable as it is unlikely that children would eat grass/dirt for
greater than 6 months continuously. Therefore, EPA believes it is
appropriate to use a qualitative assessment of this situation. EPA
believes that the risk from children eating turf grass does not exceed
the level of concern.
iii. Short- and intermediate-term exposure and risk. Because no
toxicological endpoint was selected for short- and intermediate-term
exposures to spinosad, it is not necessary to calculate a risk
assessment to evaluate this non-dietary exposure scenario.
4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether spinosad 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,
spinosad 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 spinosad has a common mechanism of toxicity
with other substances. For more information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such
[[Page 39057]]
chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62
FR 62961, November 26, 1997).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. As mentioned previously, no toxicology endpoint was
identified for this exposure duration. Thus, an aggregate risk
assessment for this situation is not needed.
2. Chronic risk. Using the theoretical maximum residue contribution
(TMRC) exposure assumptions described in this unit, EPA has concluded
that aggregate exposure to spinosad from food will utilize 29% of the
chronic PAD for the U.S. population. The major identifiable subgroup
with the highest aggregate exposure is children ages 1-6 years. A
separate risk assessment for this population subgroup is described in
section E of this unit. EPA generally has no concern for exposures
below 100% of the RfD or PAD 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 spinosad in drinking water and from non-dietary, non-
occupational exposure, EPA does not expect the aggregate exposure to
exceed 100% of the RfD or the PAD.
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.
No toxicology endpoint was selected for spinosad for these exposure
durations. Thus, a separate risk assessment for this exposure duration
for the U.S. population was not conducted by EPA.
4. Aggregate cancer risk for U.S. population. Toxicology data
suggest that spinosad does not induce cancer. Thus, a cancer risk
assessment was not performed and is not necessary.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children--i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of spinosad, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base unless EPA determines that a
different margin of safety will be safe for infants and children.
Margins of safety are incorporated into EPA risk assessments either
directly through use of a margin of exposure (MOE) analysis or through
using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk to humans. EPA believes that reliable data
support using the standard MOE and uncertainty factor (usually 100 for
combined inter- and intraspecies variability) and not the additional
tenfold MOE/uncertainty factor when EPA has a complete data base under
existing guidelines and when the severity of the effect in infants or
children or the potency or unusual toxic properties of a compound do
not raise concerns regarding the adequacy of the standard MOE/safety
factor.
ii. Developmental toxicity studies. In a prenatal developmental
toxicity study in rabbits, the NOAEL for maternal toxicity is
50 mg/kg/day. There were no developmental effects that could
be attributed to administration of spinosad. The NOAEL for
developmental toxicity is 50 mg/kg/day (highest dose
tested).
In a prenatal developmental toxicity study in rats, the NOAEL for
maternal toxicity is 200 mg/kg/day (highest dose tested).
There were no developmental effects that could be attributed to
administration of spinosad. The NOAEL for developmental toxicity is
200 mg/kg/day (highest dose tested).
iii. Reproductive toxicity study. In a 2-generation reproduction
study, for parental systemic toxicity, the NOAEL was 10 mg/kg/day and
the LOAEL was 100 mg/kg/day, based on increased heart, kidney, liver,
spleen and thyroid weights. For offspring toxicity, the NOAEL was 10
mg/kg/day and the LOAEL was 100 mg/kg/day, based on decreased litter
size, survival (F2), and body weights. Reproductive effects
at that dose level included increased incidence of dystocia and or
vaginal bleeding after parturition with associated increase in
mortality of dams.
iv. Pre- and postnatal sensitivity. There was no increased
susceptibility to rats or rabbits following in utero and or postnatal
exposure to spinosad.
v. Conclusion. Based on the existing toxicological data base, no
indication of increased susceptibility of rat or rabbit fetuses to in
utero and or postnatal exposure, and that there is no requirement for a
developmental neurotoxicity study, EPA determined that the 10x safety
factor for increased sensitivity of infants and children can be removed
(i.e., 1x).
2. Acute risk. No toxicology endpoint was selected for exposure to
spinosad based on acute exposure. Thus, EPA did not calculate a risk
assessment for this exposure duration for infants and children.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to spinosad from food
will utilize 39% of the chronic PAD for infants and children. EPA
generally has no concern for exposures below 100% of the chronic PAD
because the RfD or PAD 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 spinosad
in drinking water and from non-dietary, non-occupational exposure, EPA
does not expect the aggregate exposure to exceed 100% of the RfD.
4. Short- or intermediate-term risk. No toxicology endpoint was
selected for exposure to spinosad based on short- or intermediate-term
exposure. Thus, EPA did not calculate a risk assessment for these
exposure durations for infants and children.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to spinosad residues.
IV. Other Considerations
A. Metabolism in Plants and Animals
EPA has reviewed the results of plant and animal metabolism studies
in numerous crops and animals. The metabolism of spinosad is adequately
understood. EPA has concluded that the metabolism and fermentation
impurities of spinosad were of no more toxicological concern than the
two parent compounds (spinosyns Factor A and Factor D).
B. Analytical Enforcement Methodology
Enforcement methods have already been accepted and published to
enforce tolerances for spinosad.
[[Page 39058]]
C. Magnitude of Residues
No field trial data are available from the proposed use of spinosad
against the exotic fruit flies. However, based on the low use rate and
photodegradability of spinosad, EPA does not expect residues to be
detectable. An analysis of the expected residue level was calculated
based on the highest registered use rate for spinosad. Based on its
rapid incorporation into the general carbon pool, EPA believes that
residues will be most strongly influenced by the last application
rather than the seasonal rate. The low use rate suggests that residues
will be at or below 0.02 ppm, the level of quantitation.
D. International Residue Limits
No international tolerances for spinosad have been established that
correspond to these actions.
E. Rotational Crop Restrictions
There are no rotational crop restrictions connected with these
actions.
V. Conclusion
Therefore, the tolerances are established for residues of spinosad
in or on all commodities at 0.02 ppm when its use is associated with
quarantine eradication programs against exotic, non-indigenous, fruit
fly species where a separate higher tolerance is not already
established. Also, a tolerance of 0.02 ppm is established for spinosad
on cranberries when it is used in accordance with a FIFRA section 18
exemption.
VI. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation as was provided in
the old section 408 and in section 409. However, the period for filing
objections is 60 days, rather than 30 days. EPA currently has
procedural regulations which govern the submission of objections and
hearing requests. These regulations will require some modification to
reflect the new law. However, until those modifications can be made,
EPA will continue to use those procedural regulations with appropriate
adjustments to reflect the new law.
Any person may, by September 20, 1999, file written objections to
any aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the Hearing Clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection.'' For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697, tompkins.jim@epa.gov. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is genuine and substantial issue of fact;
there is a reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of such issues
in favor of the requestor, taking into account uncontested claims or
facts to the contrary; and resolution of the factual issues in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection with an
objection or hearing request may be claimed confidential by marking any
part or all of that information as CBI. Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice.
VII. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300882] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a tolerance under section 408 of the
FFDCA. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
Regulatory Planning and Review (58 FR 51735, October 4, 1993). This
final rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require special considerations
as required by Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
[[Page 39059]]
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(l)(6), such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
IX. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 30, 1999.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a), and 371.
2. Section 180.495, is amended, by adding new paragraph (b) to read
as follows:
Sec. 180.495 Spinosad; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Factor A is 2-[(6-deoxy-2,3,4-
tri-O-methyl-o-L-mannopyranosyl)oxy]-13-[[5-(dimethlamino)- tetrahydro-
6-methyl-2H-pyran-2-yl]oxy]9-ethyl-2,3,3a,5a,6,9,10,11,12,13,14,16a,
6b,tetradecahydro-14-methyl-1H-as-Indaceno[3,2d]oxacyclododecin-7,15-
dione. Factor D is 2-[6-deoxy-2,3,4-tri-O-methyl-o-L-
mannopyranosyl)oxy]13-[[5-(dimethylamino)-tetrahydri-6-methyl-2H-pyran-
2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-
tetradecahydro-4,14,dimethyl-1H-as-Indaceno[3,2d]oxacyclododecin-7,15-
dione.
------------------------------------------------------------------------
Expiration/
Commodity Parts per Revocation
million date
------------------------------------------------------------------------
Cranberries................................... 0.02 06/01/01
All commodities in connection with quarantine 0.02 12/01/02
eradication programs against exotic, non-
indigenous, fruit fly species, where a
separate higher tolerance is not already
established..................................
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-18482 Filed 7-20-99; 8:45 am]
BILLING CODE 6560-50-F
