[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: [email protected]. Copies of electronic objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket control number [OPP-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; 
[email protected].

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, [email protected]. Requests for 
waiver of tolerance objection fees should be sent to James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
    If a hearing is requested, the objections must include a statement 
of the factual issues on which a hearing is requested, the requestor's 
contentions on such issues, and a summary of any evidence relied upon 
by the requestor (40 CFR 178.27). A request for a hearing will be 
granted if the Administrator determines that the material submitted 
shows the following: There is genuine and substantial issue of fact; 
there is a reasonable possibility that available evidence identified by 
the requestor would, if established, resolve one or more of such issues 
in favor of the requestor, taking into account uncontested claims or 
facts to the contrary; and resolution of the factual issues in the 
manner sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32). Information submitted in connection with an 
objection or hearing request may be claimed confidential by marking any 
part or all of that information as CBI. Information so marked will not 
be disclosed except in accordance with procedures set forth in 40 CFR 
part 2. A copy of the information that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice.

VII. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket 
control number [OPP-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:
    [email protected]
    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