Document ID: EPA-HQ-OPP-2007-0310-0004
Agency: epa
Document Type: Rule
Title: Spinosad; Pesticide Tolerance
Posted Date: 2007-12-05T05:00Z

[Federal Register: December 5, 2007 (Volume 72, Number 233)]
[Rules and Regulations]               
[Page 68534-68541]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de07-20]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0310; FRL-8339-8]

 
Spinosad; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
spinosad in or on spice, subgroup 19B, except black pepper; pineapple; 
and pineapple, process residue. Interregional Research Project Number 4 
(IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective December 5, 2007. Objections and 
requests for hearings must be received on or before February 4, 2008, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2007-0310. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at http://www.regulations.gov, or, 

if only available in hard copy, at the OPP Regulatory Public Docket in 
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., 
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The Docket Facility 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-5218; e-mail address: stanton.susan@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

[[Page 68535]]

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to 
any aspect of this regulation and may also request a hearing on those 
objections. You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in 40 CFR part 
178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2007-0310 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before January 4, 2008.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0310, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of May 9, 2007 (72 FR 26375) (FRL-8128-1), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 6E7148) 
by Interregional Research Project Number 4 (IR-4), 500 College Road 
East, Suite 201 W, Princeton, NJ 08540-6635. The petition requested 
that 40 CFR 180.495 be amended by establishing a tolerance for residues 
of the insecticide spinosad, in or on Spice crop subgroup 19B, except 
black pepper at 1.7 parts per million (ppm); pineapple at 0.02 ppm; and 
pineapple, process residue at 0.08 ppm. Spinosad is a fermentation 
product of Saccharopolyspora spinosa, consisting of two related active 
ingredients: Spinosyn A (Factor A; CAS  131929-60-7) or 2-[(6-
deoxy-2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-
(dimethylamino)-tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; 
CAS  131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-
manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-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-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-
dione. That notice referenced a summary of the petition prepared by Dow 
AgroSciences LLC, the registrant, which is available to the public in 
the docket, http://www.regulations.gov. Comments were received on the 

notice of filing from a private citizen. EPA's response to these 
comments is discussed in Unit IV.C. below.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of 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) of FFDCA 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) of FFDCA 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....'' These provisions were added to FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for residues of spinosad on spice, subgroup 19B, except 
black pepper at 1.7 ppm; pineapple at 0.02 ppm; and Pineapple, process 
residue at 0.08 ppm. EPA's assessment of 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. Specific information on the studies received and the nature 
of the adverse effects caused by spinosad as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule 
published in the Federal Register of September 27, 2002 (67 FR 60923) 
(FRL-7199-5), available on-line at http://www.epa.gov/fedrgstr/EPA-PEST/2002/September/Day-27/p24484.htm
.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the

[[Page 68536]]

human population as well as other unknowns. Safety is assessed for 
acute and chronic risks by comparing aggregate exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the LOC by all applicable UFs. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC to ensure that the margin of exposure (MOE) called for by the 
product of all applicable UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA uses in risk characterization 
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm
.

    The Agency has concluded that spinosad should be considered 
toxicologically identical to another pesticide, spinetoram. This 
conclusion is based on the following: (1) Spinetoram and spinosad are 
large molecules with nearly identical structures; and (2) the 
toxicological profiles for each are similar (generalized systemic 
toxicity) with similar doses and endpoints chosen for human-health risk 
assessment. Spinosad and spinetoram should be considered 
toxicologically identical in the same manner that metabolites are 
generally considered toxicologically identical to the parent.
    Although, as stated above, the doses and endpoints for spinosad and 
spinetoram are similar, they are not identical due to variations in 
dosing levels used in the spinetoram and spinosad toxicological 
studies. EPA compared the spinosad and spinetoram doses and endpoints 
for each exposure scenario and selected the lower of the two doses for 
use in human risk assessment. A summary of the toxicological endpoints 
for spinosad and spinetoram used for human risk assessment can be found 
at http://www.regulations.gov in the document Spinosad and Spinetoram. 

Human-Health Risk Assessment for Application of Spinosad to Pineapple 
and the Spice Subgroup (19B, except black pepper) at page 11 in docket 
ID number EPA-HQ-OPP-2007-0310.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spinosad, EPA considered exposure under the petitioned-for 
tolerances as well as all existing spinosad tolerances in 40 CFR 
180.495. Since spinosad and spinetoram are toxicologically identical, 
EPA considered exposure to both in assessing aggregate risk. EPA 
assessed dietary exposures from spinosad and spinetoram in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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. No such effects were 
identified in the toxicological studies for spinosad and spinetoram; 
therefore, a quantitative acute dietary exposure assessment is 
unnecessary.
    ii. Chronic exposure. Spinosad and spinetoram are registered for 
use on the same crops; however, EPA has concluded it would overstate 
exposure to assume that residues of both spinosad and spinetoram would 
appear on the same crop. It is unlikely that both will be applied to 
the same crop, since spinosad and spinetoram control the same pest 
species. Rather, EPA aggregated exposure from residues of spinosad and 
spinetoram by assuming that spinosad residues would be present in all 
commodities, because side-by-side spinosad and spinetoram residue data 
indicated that spinetoram residues were less than or equal to spinosad 
residues. EPA assumed that 100 percent of each food crop commodity 
would be treated with spinosad. For feed crop commodities, EPA summed 
the percentage of the crop that would be treated with spinosad and the 
percentage expected to be treated with spinetoram and used this 
estimate in conjunction with spinosad residue data to develop 
anticipated residues for livestock commodities.
    The chronic dietary exposure assessment was conducted using the 
Dietary Exposure Evaluation Model - Food Consumption Intake Database 
(DEEM\TM\-FCID), Version 2.03, which incorporates food consumption data 
from the United States Department of Agriculture (USDA) 1994-1996 and 
1998 Continuing Surveys of Food Intakes by Individuals (CSFII). In 
addition to the Percent Crop Treated (PCT) assumptions described above, 
EPA, in estimating chronic exposure, relied upon average field trial 
residues for apple, leafy vegetables (except Brassica), citrus and 
fruiting vegetables; tolerance level residues for the remaining food 
crop commodities; average feed crop residues for feed commodities from 
the following crops: Sweet corn forage, leaves of root and tuber 
vegetables and aspirated grain fractions; average residues from animal 
feeding and dermal magnitude of residue studies; and DEEM\TM\ (Version 
7.81) default processing factors for all commodities, excluding field 
corn (meal, starch, flour and oil), grape juice and wheat (flour and 
germ), where processing factors based on the results of processing 
studies were assumed.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, spinosad has been classified as ``Not likely to be 
carcinogenic to humans.'' Preliminary results of a carcinogenicity 
study in mice indicate that spinetoram is not carcinogenic to mice at 
doses up to 37.5 milligram/kilogram/day (mg/kg/day). Based on these 
preliminary results and spinetoram's structural and toxicological 
similarity to spinosad, spinetoram is also considered to be ``Not 
likely to be carcinogenic to humans.'' Consequently, a quantitative 
cancer exposure and risk assessment is not appropriate for spinosad or 
spinetoram.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must pursuant to FFDCA section 
408(f)(1) require that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
    a. The data used are reliable and provide a valid basis to show 
what percentage of the food derived from such crop is likely to contain 
such pesticide residue.
    b. The exposure estimate does not underestimate exposure for any 
significant subpopulation group.
    c. Data are available on pesticide use and food consumption in a 
particular area, the exposure estimate does not understate exposure for 
the population in such area. In addition, the Agency

[[Page 68537]]

must provide for periodic evaluation of any estimates used. To provide 
for the periodic evaluation of the estimate of PCT as required by FFDCA 
section 408(b)(2)(F), EPA may require registrants to submit data on 
PCT.
    The Agency used PCT information as follows:
    One-hundred percent crop treated was assumed for all food crop 
commodities and some feed crop commodities (aspirated grain fractions, 
sugarbeet molasses and cottonseed). For certain feed crop commodities, 
the Agency summed the projected PCT for spinosad and spinetoram and 
used the combined estimates in conjunction with average field trial 
residues to calculate cattle dietary burdens and anticipated residues 
of spinosad in meat and milk. The following combined projected PCT 
estimates were used: sweet corn forage (39%), sorghum grain (5%), 
soybean seed meal (5%) and leaves of root and tuber vegetables (50%).
    Spinetoram is a new, recently registered pesticide. EPA estimates 
an upper bound of projected percent crop treated (PPCT) for a new 
pesticide use by assuming that its actual PCT during the initial 5 
years of use on a specific use site will not exceed the recent PCT of 
the market leader (i.e., the one with the greatest PCT) on that site. 
EPA calls this the market leader PPCT estimate. In this specific case, 
the new use to be estimated is the combined use of spinosad together 
with that of spinetoram since the most new use of spinetoram will 
likely replace previous use of spinosad. An average market leader PCT, 
based on three recent surveys of pesticide usage, if available, is used 
for chronic risk assessment. The average market leader PCT may be based 
on one or two survey years if three are not available. Also, with 
limited availability of data, the average market leader PCT may be 
based on a cross-section of state PCTs. Comparisons are only made among 
pesticides of the same pesticide type (i.e., the leading insecticide on 
the use site is selected for comparison with the new insecticide), or, 
for refined estimates, among pesticides targeting the same pests. The 
market leader PCTs used to determine the average may be each for the 
same pesticide or for different pesticides for any year since the same 
or different pesticides may dominate for each year. Typically, EPA uses 
U.S. Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS) as the source for raw PCT data because it is publicly 
available. When a specific use site is not surveyed by USDA/NASS, EPA 
uses other sources including proprietary data.
    An estimated PPCT, based on the average PCT of the market leaders, 
is appropriate for use in chronic dietary risk assessment. This method 
of estimating PPCT for a new use of a registered pesticide or a new 
pesticide produces a high-end estimate that is unlikely, in most cases, 
to be exceeded during the initial 5 years of actual use. Predominant 
factors that bear on whether the PPCT could be exceeded may include 
PCTs of similar chemistries, pests controlled by alternatives, pest 
prevalence in the market and other factors. All relevant information 
currently available for predominant factors has been considered for the 
combined use of spinetoram and spinosad on each of these several crops. 
It is the Agency's opinion that it is unlikely that actual combined 
PCTs for spinetoram and spinosad will exceed the corresponding 
estimated PPCTs during the next 5 years.
    The PPCTs for the combined use of spinosad and spinetoram for 
chronic risk assessment were determined using the market leader 
approach for the feed commodities of sweet corn, grain sorghum, 
soybeans and turnip greens. For turnip greens, the PCTs of market 
leaders were averaged over states rather than years because only 1-year 
of data was available.
    The Agency believes that the three conditions listed in this Unit 
have been met. With respect to Condition 1, PCT estimates are derived 
from Federal and private market survey data, which are reliable and 
have a valid basis. The Agency is reasonably certain that the 
percentage of the food treated is not likely to be an underestimation. 
As to Conditions 2 and 3, regional consumption information and 
consumption information for significant subpopulations is taken into 
account through EPA's computer-based model for evaluating the exposure 
of significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which spinosad may 
be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for spinosad in drinking water. Because 
the Agency does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the environmental fate characteristics of 
spinosad. Further information regarding EPA drinking water models used 
in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm
.

    Based on the First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated environmental concentrations (EECs) of spinosad for acute 
exposures are estimated to be 34.5 parts per billion (ppb) for surface 
water and 1.1 ppb for ground water. The EECs for chronic exposures are 
estimated to be 10.5 ppb for surface water and 1.1 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. As explained above, an acute 
dietary risk assessment was not conducted for spinosad and spinetoram. 
For chronic dietary risk assessment, the water concentration of value 
10.5 ppb was used to access the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    The Agency has concluded that spinosad and spinetoram are 
toxicologically equivalent; therefore, residential exposure to both 
spinosad and spinetoram was evaluated. Spinosad is currently registered 
for the following residential non-dietary sites: Homeowner application 
to turf grass and ornamentals to control a variety of worms, moths, 
flies, beetles, midges, thrips, leafminers and fire ants (granular 
formulation). Spinetoram is registered for homeowner applications to 
gardens, lawns/ornamentals and turf grass for control of lepidopterous 
larvae (worms or caterpillars), dipterous leafminers, thrips, sawfly 
larvae, certain psyllids and leaf-feeding beetles and red imported fire 
ants.
    There is potential for residential handler and post-application 
exposures to both spinosad and spinetoram. Since spinosad and 
spinetoram control the same pests, EPA concludes that these products 
will not be used in

[[Page 68538]]

combination with each other and combining the residential exposures is 
unnecessary. Short-term residential inhalation risks were estimated for 
adult residential handlers, as well as short-term post-application 
incidental oral risks for toddlers, based on applications to home 
lawns, home gardens and ornamentals. Dermal exposures were not 
assessed, since no dermal endpoints of concern were identified in the 
toxicology studies for spinosad and spinetoram.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to spinosad and any other 
substances and 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 information regarding 
EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (``10X'') 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 database on toxicity and 
exposure unless EPA determines based on reliable data that a different 
margin of safety will be safe for infants and children. This additional 
margin of safety is commonly referred to as the FQPA safety factor. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The following acceptable 
studies are available for both spinosad and spinoteram: developmental 
toxicity studies in rats and rabbits and a two-generation reproduction 
study in rats. There is no evidence of increased susceptibility of rat 
or rabbit fetuses to in utero exposure to spinosad or spinetoram. In 
the spinosad and spinetoram rat and rabbit developmental toxicity 
studies, no developmental toxicity was observed at dose levels that 
induced maternal toxicity. In the spinosad two-generation reproduction 
study, maternal and offspring toxicity were equally severe, indicating 
no evidence of increased susceptibility. In the spinetoram 2-generation 
reproduction study, no adverse effects were observed in the offspring 
at dose levels that produced parental toxicity. Therefore, there is no 
evidence of increased susceptibility and there are no concerns or 
residual uncertainties for pre and/or post-natal toxicity.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for spinosad is complete. The toxicity 
database for spinetoram is adequate for this risk assessment despite 
the lack of a chronic toxicity study in rats. The preliminary review of 
a mouse carcinogenicity study for spinetoram provides evidence that the 
chronic toxicity of spinosad and spinetoram are comparable, since 
spinetoram produced similar toxicity at doses similar to those seen 
previously with spinosad. Therefore, it is expected that the ongoing 
spinetoram chronic carcinogenicity study in rats would produce similar 
chronic toxicity at a similar dose as was seen in the chronic toxicity 
study in rats with spinosad.
    ii. There is no indication that spinosad or spinetoram are 
neurotoxic chemicals and there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. There is no evidence that spinosad or spinetoram results in 
increased susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on tolerance-level residues or anticipated residues derived from 
reliable field trial data. 100 PCT was assumed for all commodities 
except certain feed crop commodities. The projected PCT estimates used 
for these commodities are conservative, high-end estimates developed 
using the market leader approach that are unlikely to be exceeded. 
Conservative ground and surface water modeling estimates were used. 
Similarly, conservative Residential SOPs were used to assess incidental 
oral exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by spinosad and spinetoram.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-term, intermediate-term, 
and long-term risks are evaluated by comparing aggregate exposure to 
the LOC to ensure that the MOE called for by the product of all 
applicable UFs is not exceeded.
    1. Acute risk. None of the toxicology studies available for 
spinosad or spinetoram has indicated the possibility of an effect of 
concern occurring as a result of a 1-day or single exposure; therefore, 
spinosad and spinetoram are not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to spinosad 
and spinetoram from food and water will utilize 81% of the cPAD for 
children, 1 to 2 years old, the population group with the greatest 
estimated exposure. Based on the use patterns, chronic residential 
exposure to residues of spinosad or spinetoram is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Spinosad and spinetoram are currently registered for uses that 
could result in short-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate chronic food and water 
and short-term exposures for spinosad and spinetoram. Using the 
exposure assumptions described in this unit for short-term exposures, 
EPA has concluded that food, water, and residential exposures 
aggregated result in aggregate MOEs of 650 to 710 for adults and 180 to 
300 for infants and children. The aggregate MOEs for adults are based 
on the residential turf scenario and include combined food, drinking 
water and handler inhalation exposures

[[Page 68539]]

to spinetoram. Inhalation exposures are not expected for residential 
handlers of spinosad, based on its granular formulation and low vapor 
pressure. The aggregate MOEs for infants and children include food, 
drinking water and incidental oral exposures on turf areas previously 
treated with spinosad or spinetoram. Dermal exposures were not assessed 
for adults or children, since a dermal endpoint of concern was not 
identified in the toxicology studies for spinosad or spinetoram.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Spinosad is 
not registered for use on any sites that would result in intermediate-
term (1-6 months) residential exposure. Therefore, the aggregate risk 
is the sum of the risk from food and water, which does not exceed the 
Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Based on the results 
of carcinogenicity studies with spinosad in rats and mice and the 
preliminary results of a carcinogenicity study with spinetoram in mice, 
spinosad and spinetoram are considered ``Not likely to be carcinogenic 
to humans.'' Spinosad and spinetoram are not expected to pose a cancer 
risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to spinosad and spinetoram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    DowElanco Method 97.05, an immunoassay particle-based method, and 
Dow AgroSciences Method GRM 03.15, a high performance liquid 
chromatography method with ultraviolet absorption detection (HPLC/UV), 
have been adequately validated and determined to be acceptable to 
enforce the tolerance expression in spices and pineapple, respectively. 
The methods may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone number: (410) 305-2905; e-mail address: 
residuemethods@epa.gov.

B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue levels (MRLs) for spinosad (i.e., the combined residues 
of spinosyn A and D).

C. Response to Comments

    Several comments were received from a private citizen, B. Sachau, 
objecting to establishing these tolerances for a variety of generalized 
and unsubstantiated reasons, including the lack of ``combinant'' 
testing and long-term testing, pesticide residues and unacceptable risk 
to Americans. The Agency has received these same or similar comments 
from this commenter on numerous previous occasions. Refer to Federal 
Registers of June 30, 2005 (70 FR 37683) (FRL-7718-3), January 7, 2005 
(70 FR 1349) (FRL-7691-4), and October 29, 2004 (69 FR 63083) (FRL-
7681-9) for the Agency's response to these objections. The commenter 
also objected to issuance of ``exemptions'' for this pesticide, an 
irrelevant comment in the context of this tolerance-setting action. 
Finally, this same commenter raised concerns about risk to insects and 
other animals from spinosad. EPA considers such environmental risks in 
deciding whether to register pesticide products under the Federal 
Insecticide, Fungicide and Rodenticide Act (FIFRA); however, the safety 
standard for approving tolerances under section 408 of the FFDCA 
focuses on potential harms to human health and does not permit 
consideration of effects on the environment. Therefore, the comment 
regarding risk to insects and other animals is not relevant to this 
tolerance action.

V. Conclusion

    Therefore, tolerances are established for residues of spinosad, 
consisting of two related active ingredients: Spinosyn A (Factor A; CAS 
 131929-60-7) or 2-[(6-deoxy-2,3,4-tri-O -methyl-[alpha]-L-
manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-tetrahydro-6-methyl-2H-
pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-
tetradecahydro-14-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-
dione; and Spinosyn D (Factor D; CAS  131929-63-0) or 2-[(6-
deoxy-2,3,4-tri-O-methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-
(dimethyl-amino)-tetrahydro-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-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione, in or on Spice, subgroup 
19B, except black pepper at 1.7 ppm; Pineapple at 0.02 ppm; and 
Pineapple, process residue at 0.08 ppm.
    The table of spinosad tolerances at 40 CFR 180.495(a) currently 
includes a third column for expiration/revocation dates. Since none of 
the existing tolerances are time-limited and EPA is not time-limiting 
the new tolerances for spice and pineapple commodities, there is no 
need for this column. Therefore, the third column of the table is being 
deleted.
    Time-limited tolerances were established at 40 CFR 180.495(b) for 
residues of spinosad in or on livestock commodities in connection with 
FIFRA section 18 emergency exemptions granted by EPA. All of these 
time-limited tolerances have expired and are no longer necessary, 
because permanent tolerances have been established on these commodities 
at higher levels. Therefore, these expired, time-limited tolerances for 
residues of spinosad (Factor A and Factor D) are revoked.
    Finally, EPA is correcting the commodity terminology for 
``Vegetable, brassica, leafy, group 5'' in 40 CFR 180.495(a) to read 
``Brassica, leafy greens, subgroup 5B'' at 10.0 ppm, to undo a 
transcription error. In 1998, EPA established spinosad tolerances for 
the two subgroups in Crop Group 5 - Brassica (Cole) Leafy Vegetables 
(40 CFR 180.41(c)(5). (63 FR 18329, April 15, 1998). The two subgroups 
in Group 5 are Crop Subgroup 5A - Head and Stem Brassica and Crop 
Subgroup 5B - Leafy Brassica Greens. Tolerances were established for 
the subgroups at levels of 2 ppm and 10 ppm respectively. No tolerance 
applying across the whole brassica crop group was established. 
Subsequently, in a rulemaking establishing spinosad tolerances for 
various non-brassica commodities the tolerance for the ``greens'' 
subgroup was incorrectly transcribed as a tolerance for the entire 
brassica group (70 FR 1349, January 7, 2005). This transcription error 
occurred when the tolerance table, as revised by the addition of the 
new non-brassica tolerances, was printed in the Federal Register. The 
changing of the subgroup tolerance to a group tolerance was clearly 
nothing more than a transcription error, because it was not mentioned 
in the notice of filing for the rulemaking or the preamble to the final 
rule. Moreover, it is inconsistent with the generic crop group 
regulation to establish both a crop group and subgroup of that crop 
group for the same pesticide because the former would displace the 
latter. This change merely corrects the tolerance regulation to specify 
the crop subgroup tolerance that was actually promulgated, since this 
tolerance is intended to cover only those commodities in the ``greens'' 
subgroup. A separate, lower tolerance of 2.0 ppm has been established 
to cover head and stem Brassica in subgroup 5A. The tolerance for the 
``greens'' subgroup was incorrectly modified in connection with the 
establishment of new spinosad

[[Page 68540]]

tolerances in the Federal Register of January 7, 2005 (70 FR 1349).
    EPA finds there is good cause to make these latter three changes 
without prior notice and comment because they are technical corrections 
which either eliminate obsolete or unused portions of the regulation or 
correct a transcription error. EPA concludes notice and comment are 
unnecessary on such changes.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA 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). Because this rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). 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., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000) do not apply to this rule. In addition, This 
rule does not 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).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
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 this final rule in the Federal 
Register. This final 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: November 27, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.495 is revised to read as follows:

Sec.  180.495  Spinosad; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
insecticide spinosad in or on the food commodities in the table to this 
paragraph. Spinosad is a fermentation product of Saccharopolyspora 
spinosa. The product consists of two related active ingredients: 
Spinosyn A (Factor A: CAS  131929-60-7) or 2-[(6-deoxy-2,3,4-
tri-O -methyl-[alpha]-L-manno-pyranosyl)oxy]-13-[[5-(dimethylamino)-
tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-
Indaceno[3,2-d]oxacyclododecin-7,15-dione; and Spinosyn D (Factor D; 
CAS  131929-63-0) or 2-[(6-deoxy-2,3,4-tri-O-methyl-[alpha]-L-
manno-pyranosyl)oxy]-13-[[5-(dimethyl-amino)-tetrahydro-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-methyl-1H-as-Indaceno[3,2-d]oxacyclododecin-7,15-
dione.

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Acerola..............................................                1.5
Alfalfa, seed........................................               0.15
Alfalfa, seed screenings.............................                2.0
Almond, hulls........................................                2.0
Amaranth, grain, grain...............................                1.0
Amaranth, grain, stover..............................                 10
Animal feed, nongrass, group, 18.....................               0.02
Animal feed, nongrass, group, 18, forage.............               35.0
Animal feed, nongrass, group, 18, hay................               30.0
Apple pomace.........................................                0.5
Artichoke, globe.....................................                0.3
Asparagus............................................                0.2
Atemoya..............................................                0.3
Avocado..............................................                0.3
Banana...............................................               0.25
Beet, sugar, molasses................................               0.75
Biriba...............................................                0.3
Brassica, head and stem, subgroup 5A.................                2.0
Brassica, leafy greens, subgroup 5B..................               10.0
Bushberry subgroup 13B...............................              0.250
Caneberry subgroup 13A...............................                0.7
Canistel.............................................                0.3
Cattle, fat..........................................                 50
Cattle, liver........................................                 10
Cattle, meat.........................................                2.0
Cattle, meat byproducts, except liver................                5.0
Cherimoya............................................                0.3
Citrus, oil..........................................                3.0
Citrus, dried pulp...................................                0.5
Coriander, leaves....................................                8.0
Corn, sweet, kernel plus cob with husks removed......               0.02
Cotton, gin byproducts...............................                1.5
Cotton, undelinted seed..............................               0.02
Cranberry............................................               0.01
Custard apple........................................                0.3
Egg..................................................               0.30
Feijoa...............................................                .05
Fig..................................................               0.10
Fish.................................................                4.0
Fish-shellfish, crustacean...........................                4.0
Fish-shellfish, mollusc..............................                4.0
Food commodities.....................................               0.02
Fruit, citrus, group 10..............................                0.3
Fruit, pome, group 11................................               0.20

[[Page 68541]]

Fruit, stone, group 12...............................               0.20
Goat, fat............................................                 50
Goat, liver..........................................                 10
Goat, meat...........................................                2.0
Goat, meat byproducts, except liver..................                5.0
Grain, aspirated fractions...........................                200
Grain, cereal, group 15..............................                1.5
Grain, cereal, group 16, forage, except rice.........                2.5
Grain, cereal, group 16, hay, except rice............               10.0
Grain, cereal, group, 16, stover, except rice........               10.0
Grain, cereal, group, 16, straw, except rice.........                1.0
Grape................................................               0.50
Grape, raisin........................................               0.70
Grass, forage, fodder and hay, group 17, forage......               10.0
Grass, forage, fodder and hay, group 17, hay.........                5.0
Guava................................................                0.3
Herb subgroup 19A, dried.............................                 22
Herb subgroup 19A, fresh.............................                3.0
Hog, fat.............................................                 33
Hog, meat byproducts.................................                8.0
Hog, meat............................................                1.5
Hop, dried cones.....................................                 22
Horse, fat...........................................                 50
Horse, liver.........................................                 10
Horse, meat..........................................                2.0
Horse, meat byproducts, except liver.................                5.0
Ilama................................................                0.3
Jaboticaba...........................................                0.3
Juneberry............................................               0.25
Lingonberry..........................................              0.250
Longan...............................................                0.3
Lychee...............................................                0.3
Mango................................................                0.3
Milk.................................................                7.0
Milk, fat............................................                 85
Nut, tree, group 14..................................               0.02
Okra.................................................               0.40
Onion, green.........................................                2.0
Papaya...............................................                0.3
Passionfruit.........................................                0.3
Pea and bean, dried shelled, except soybean, subgroup               0.02
 6C..................................................
Pea and bean, succulent shelled, subgroup 6B.........               0.02
Peanut...............................................               0.02
Peanut, hay..........................................               11.0
Peppermint, tops.....................................                3.5
Pineapple............................................               0.02
Pineapple, process residue...........................               0.08
Pistachio............................................              0.020
Poultry, fat.........................................                1.3
Poultry, meat........................................               0.10
Poultry, meat byproducts.............................               0.10
Pulasan..............................................                0.3
Rambutan.............................................                0.3
Rice, hulls..........................................                4.0
Salal................................................              0.250
Sapodilla............................................                0.3
Sapote, black........................................                0.3
Sapote, mamey........................................                0.3
Sapote, white........................................                0.3
Sheep, fat...........................................                 50
Sheep, liver.........................................                 10
Sheep, meat..........................................                2.0
Sheep, meat byproducts, except liver.................                5.0
Soursop..............................................                0.3
Soybean..............................................               0.02
Spanish lime.........................................                0.3
Spearmint, tops......................................                3.5
Spice, subgroup 19B, except black pepper.............                1.7
Star apple...........................................                0.3
Starfruit............................................                0.3
Strawberry...........................................                1.0
Sugar apple..........................................                0.3
Ti, leaves...........................................               10.0
Vegetable, bulb, group 3, except green onion.........               0.10
Vegetable, cucurbit, group 9.........................                0.3
Vegetable, foliage of legume, group 7................                8.0
Vegetable, fruiting, group 8.........................                0.4
Vegetable, leafy, except brassica, group 4...........                8.0
Vegetable, leaves of root and tuber, group 2.........               10.0
Vegetable, legume, edible podded, subgroup 6A........               0.30
Vegetable, root and tuber, group 1...................               0.10
Watercress...........................................                8.0
Wax jambu............................................                0.3
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertant residues. [Reserved]
[FR Doc. E7-23579 Filed 12-4-07; 8:45 am]

BILLING CODE 6560-50-S