[Federal Register Volume 72, Number 54 (Wednesday, March 21, 2007)]
[Rules and Regulations]
[Pages 13168-13174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4760]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0579; FRL-8114-4]


Spinosad; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes and amends tolerances for residues 
of spinosad in or on certain commodities. The Interregional Research 
Project Number 4 (IR-4) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA).

DATES: This regulation is effective March 21, 2007. Objections and 
requests for hearings must be received on or before May 21, 2007, 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-2006-0579. 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: Sidney Jackson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: [email protected].

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:
     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 provides 
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.

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 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, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. 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-2006-0579 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 on or before May 21, 2007.
    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 your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0579, 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,

[[Page 13169]]

excluding legal holidays). Special arrangements should be made for 
deliveries of boxed information. The Docket telephone number is (703) 
305-5805.

II. Background and Statutory Findings

    In the Federal Register of July 14, 2006 (71 FR 40105) (FRL-8077-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 
6E7068 and 3E6802) by the IR-4, 500 College Rd. East, Suite 201 W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.495 be 
amended by establishing a tolerance for residues of the insecticide 
spinosad, in or on hops at 22 parts per million (ppm) (under PP 6E7068) 
and amaranth, grain, stover at 10 ppm; cattle, meat at 2 ppm; sheep, 
meat at 2 ppm; goat, meat at 2 ppm; horse, meat at 2 ppm; poultry, meat 
at 0.1 ppm; cattle, fat at 50 ppm; sheep, fat at 50 ppm; goat, fat at 
50 ppm; horse, fat at 50 ppm; poultry, fat at 1.3 ppm; milk at 7.0 ppm; 
milk, fat at 85 ppm; and egg at 0.3 ppm (under PP 3E6802).
    Additionally, existing tolerances for meat byproducts which are 
currently based on residues in liver will be amended to establish 
separate liver tolerances and lower the meat byproducts tolerances 
which will now be based on residues in the kidney as follows: Cattle, 
meat byproducts, except liver at 5 ppm; sheep, meat byproducts, except 
liver at 5 ppm; goat, meat byproducts, except liver at 5 ppm; horse, 
meat byproducts, except liver at 5 ppm; poultry meat byproducts 
tolerance raised from 0.03 ppm and set at 0.1 ppm; cattle, liver at 10 
ppm; sheep, liver at 10 ppm; goat, liver at 10 ppm; and horse, liver at 
10 ppm (under PP 3E6802). That notice referenced a summary of the 
petition prepared by Dow AgroScience, the registrant, that is available 
in the docket for this rulemaking. There were no comments received in 
response to the notice of filing.
    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....''
    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 of FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm and http://www.epa.gov/fedrgstr/EPA-PEST/2003/July/Day-30/p19357.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section 
408(b)(2) of FFDCA, for tolerances for residues of spinosad in or on 
hop, dried cones at 22 ppm; amaranth, grain, stover at 10 ppm; cattle, 
meat at 2.0 ppm; sheep, meat at 2.0 ppm; goat, meat at 2.0 ppm; horse, 
meat at 2.0 ppm; poultry, meat at 0.10 ppm; cattle, fat at 50 ppm; 
sheep, fat at 50 ppm; goat, fat at 50 ppm; horse, fat at 50 ppm; 
poultry, fat at 1.30 ppm; milk at 7.0 ppm; milk, fat at 85 ppm; and egg 
at 0.30 ppm. Additionally, existing tolerances for meat byproducts 
which are based on residues in liver will be amended to establish 
separate liver tolerances and lower the meat byproducts tolerances 
which will now be based on residues in the kidney as follows: Cattle, 
meat byproducts, except liver at 5.0 ppm; sheep, meat byproducts, 
except liver at 5.0 ppm; goat, meat byproducts, except liver at 5.0 
ppm; horse, meat byproducts, except liver at 5.0 ppm; poultry meat 
byproducts tolerance raised from 0.03 ppm and set at 0.10 ppm; cattle, 
liver at 10 ppm; sheep, liver at 10 ppm; goat, liver at 10 ppm; and 
horse, liver at 10 ppm. EPA's assessment of exposures and risks 
associated with establishing these tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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 toxic 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 Federal 
Register of September 27, 2002 (67 FR 60923) (FRL-7199-5).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which the NOAEL from the toxicology study 
identified as appropriate for use in risk assessment is used to 
estimate the toxicological level of concern (LOC). However, the lowest 
dose at which the LOAEL is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases. More information 
can be found on the general principles EPA uses in risk 
characterization at http://www.epa.gov/pesticides/health/human.htm.
    A summary of the toxicological endpoints for spinosad used for 
human risk assessment can be found at http://www.regulations.gov in the 
following indices:
    1. Docket ID number EPA-HQ-OPP-2006-0579, entitled Application of 
Spinosad to Hops and as a Mosquito Larvicide. Human Health Risk 
Assessment, dated August 2, 2006.
    2. Docket ID number EPA-HQ-OPP-2005-0510, entitled PPs 3E6699, 
3E6780, and 4E6811. Application of Spinosad to Mint; Banana; Plantain; 
Peanut; Bulb Vegetables; Legume Vegetables; Forage, Fodder, and Straw 
of Cereal Grains (crop group 16); Grass Forage, Fodder, and Hay (crop 
group 17); and Nongrass Animal Feeds (crop group 18) and Application of 
Spinosad for Control of Fruit Flies. HED Risk Assessment, dated 
September 15, 2005.

[[Page 13170]]

C. Exposure Assessment

    1. Dietary exposure 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. Risk assessments were 
conducted by EPA to assess dietary exposures from spinosad 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.
    The Agency did not select a dose and endpoint for an acute dietary 
risk assessment due to the lack of toxicological effects of concern 
attributable to a single exposure (dose) in studies available in the 
database including oral developmental toxicity studies in rats and 
rabbits. In the acute neurotoxicity study, the NOAEL was 2,000 
milligrams/kilograms/day (mg/kg/day), highest dose tested. An acute 
dietary exposure assessment is not required.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the Dietary Exposure Evaluation Model software 
with the Food Commodity Intake Database (DEEM-FCID\TM\) version 2.03 
(acute and cancer endpoints were not identified), which incorporates 
food consumption data as reported by respondents in the U.S. Department 
of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys 
of Food Intake by Individuals (CSFII), and accumulated exposure to the 
chemical for each commodity. The chronic dietary analyses assumed 
average/projected percent crop treated (PPCT) estimates; projected 
percent head treated resulting from the dermal and premise treatments 
to ruminants, average field trial residues, and experimentally 
determined processing factors; and anticipated livestock residues. The 
chronic analysis assumed tolerance level residues for all crop, 
poultry, and egg commodities and anticipated residues for ruminant and 
milk commodities.
    iii. Cancer. Spinosad has been classified as not likely to be 
carcinogenic in humans based on the results of a carcinogenicity study 
in mice and the combined chronic toxicity and carcinogenicity study in 
rats. Therefore, a quantitative cancer exposure assessment was not 
performed.
    iv. Anticipated residue and percent crop treated (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 chemicals 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. Following the initial data submission, EPA is authorized 
to require similar data on a time frame it deems appropriate. For the 
present action, EPA will issue such data call-ins for information 
relating to anticipated residues as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such data 
call-ins 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 the Agency can make the following findings: Condition 1, 
that 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; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
Condition 3, if 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 must provide for periodic evaluation of any estimates used. To 
provide for the periodic evaluation of the estimate of PCT as required 
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit 
data on PCT.
    The Agency used PCT information as follows: Almond 5%; apple 30%; 
apricot 10%; avocado 5%; broccoli 40%; brussel sprout 15%; cabbage 30%; 
cantaloupes 10%; cauliflower 45%; celery 50%; cherry 25%; citrus 5%, 
excluding lemon, tangerine, and orange; collards 25%; corn, sweet 1%; 
cotton 5%; cucumber 20%; eggplant 15%; green, mustard 15%; green, 
turnip 5%; kale 30%; lemon 10%; lettuce 50%; nectarine 30%; orange 10%; 
peach 5%; pear 10%; pepper 35%; potato 5%; prune and plum 10%; spinach 
30%; squash 10%; strawberry 35%; tangerine 10%; tomato 20%; and 
watermelon 5%.
    Exposure analysis also incorporated projected percent ruminant head 
treated resulting from the registered dermal and premise use (dairy 
cattle 23% and beef cattle 31%, actual data are not available despite 
this being a registered use) and projected PCT for alfalfa of 1%.
    EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available Federal, State, and private market survey data for that use, 
averaging by year, averaging across all years, and rounding up to the 
nearest multiple of five except for those situations in which the 
average PCT is less than one. In those cases assumed not less than 1%, 
is used as the average and 2.5% is used the maximum. EPA uses a maximum 
PCT for acute dietary risk analysis. The maximum PCT figure is the 
single maximum value reported overall from available Federal, State, 
and private market survey data on the existing use, across all years, 
and rounded up to the nearest multiple of five. In most cases, EPA uses 
available data from USDA/National Agricultural Statistics Service 
(USDA/NASS), Proprietary Market Surveys, and the National Center for 
Food and Agriculture Policy (NCFAP) for the most recent 6 years.
    EPA estimates PPCT for a new pesticide Use for use in chronic 
dietary risk assessment by assuming that the PCT during the pesticide's 
initial 5 years of use on a specific use site will not exceed the 
average PCT of the dominant pesticide (i.e., the market leader 
pesticide with the greatest PCT) on that site over the three most 
recent pesticide usage surveys. Comparisons are only made among 
pesticides of the same pesticide types (i.e., the dominant insecticide 
on the use site is selected for comparison with the new insecticide). 
The PCTs included in the average may be each for the same pesticide or 
for different pesticides since the same or different pesticides may 
dominate for each year selected. Typically, EPA uses data from the 
USDA/NASS as the source for the PCT data because they are publicly 
available. When a specific use site is not surveyed by USDA/NASS, EPA 
uses other data which may include proprietary data.
    The estimated PPCT, equivalent to the average PCT of the market 
leader is appropriate for use in the chronic dietary risk assessment. 
This method of estimating a PPCT for a new use of a registered 
pesticide produces a high-end estimate that is unlikely, in most cases, 
to be exceeded during the initial 5 years of actual use.
    The predominant factors that bear on whether the estimated PPCT 
could be exceeded are whether the new pesticide use is more efficacious 
or controls a broader spectrum of pests than the dominant pesticides, 
whether there are

[[Page 13171]]

concerns with pest pressure as indicated in emergency exemption 
requests or other readily available information, and/or other factors 
based on analysis of additional information. All information readily 
available has been considered for spinosad on dairy cattle, beef cattle 
and alfalfa, and it is the opinion of the Agency that it is unlikely 
that actual PCTs for spinosad on these sites will exceed the 
corresponding estimated PPCTs during the next 5 years. For cattle, the 
estimated PPCTs likely would not be exceeded because spinosad generally 
is more expensive than the leading alternative insecticides although it 
has efficacy on the same order for the targeted pests. For alfalfa, its 
estimated PPCT likely also would not be exceeded because it is 
considerably more expensive than the leading alternative, and 
treatments for the targeted pest, armyworms, have been relatively small 
on average over the past 8 years.
    The Agency believes that the three conditions listed in Unit 
III.C.1.iv. 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 exposure 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 physical 
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.
    Typically, EPA evaluates the potential for human exposure to 
pesticides in drinking water through an assessment of available surface 
water and ground water monitoring data and modeling. For spinosad, no 
monitoring data were available for use in this drinking water 
assessment. Therefore, potential human exposures to spinosad were 
evaluated through modeling. Estimated exposure concentrations (EECs) in 
surface water were calculated using Pesticide Root Zone Model/Exposure 
Analyses Modeling System (PRZM/EXAMS). Ground water concentrations were 
modeled using Screening Concentration in Ground Water (SCI-GROW) 
(version 2.3). Drinking water residues were then incorporated into the 
DEEM-FCID\TM\ into the food categories ``water, direct, all sources'' 
and ``water, indirect, all sources.''
    Available environmental fate data indicate that the spinosad 
transformation products maintain the basic ring structure of spinosad 
and that combined spinosad and its transformation products are stable. 
Therefore, the Agency concluded that a total residue method should be 
used when estimating spinsad residues in water, and that spinosad and 
its transformation products are stable under the aqueous photolysis, 
aerobic soil metabolism, and anaerobic aquatic metabolism conditions.
    Based on modeling results from surface water FQPA Index Reservoir 
Screening Tool (FIRST) and ground water SCI-GROW drinking water 
concentrations from application of spinosad to turf (4 x 0.4 pound 
active ingredient/acre (lb ai/acre); re-entry interval (RTI) = 7 days; 
highest registered/proposed rate excluding the mosquito larvicide use): 
The EECs of spinosad for acute exposures are 34.5 parts per billion 
(ppb), 10.5 ppb for chronic exposures, and 1.1 ppb for ground water. 
The dietary exposure assessment assumed a water concentration of 10.5 
ppb for all water sources (direct and indirect). Modeled estimates of 
drinking water concentrations were directly entered into the dietary 
exposure model (DEEM-FCID\TM\).
    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).
    Spinosad is currently registered for use on numerous crops with 
tolerances for combined residues of spinosad ranging from 0.01 to 200 
ppm, as well as residential, non-dietary sites including turf and 
ornamentals to control a variety of worms, moths, flies, beetles, 
midges, thrips, leafminers, and fire ants. Granular (homeowner) and EC 
(commercial applicators) formulations are registered. No dermal 
endpoints were identified and based on the granular formulation and 
low-vapor pressure for spinosad, residential handler/applicator and 
post-application dermal/inhalation exposure assessments were not 
conducted. The Agency concluded that there is a potential for toddler 
short-term, non-dietary, oral exposures (hand-to-mouth, object-to-
mouth, ingestion of granulars, and soil ingestion). Since EPA did not 
identify an acute dietary endpoint, episodic ingestion of granulars was 
not assessed.
    The Agency notes that the registered fruit fly bait application 
scenario permits application to non-crop vegetation and this use may 
result in residential exposures. Based on the application rates (fruit 
fly bait--0.0003 lb ai/acre and turf/ornamental--0.41 lbs ai/acre), EPA 
concludes that residential exposure resulting from the fruit fly 
application will be insignificant when compared to the exposure 
resulting from the turf/ornamental application. Therefore, quantitative 
analysis of the residential exposure resulting from the fruit fly bait 
application was not performed.
    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 
the policy statements released by

[[Page 13172]]

EPA's Office of Pesticide Programs concerning common mechanism 
determinations and procedures for cumulating effects from substances 
found to have a common mechanism on 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 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. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. 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 safety 
factor value based on the use of traditional uncertainty factors and/or 
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no indication of 
increased susceptibility of rat and rabbit fetuses to in utero and/or 
postnatal exposure to spinosad.
    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 toxicological database for spinosad is complete for FQPA 
assessment.
    ii. There is no evidence of increased susceptibility of rat or 
rabbit fetuses following in utero exposure in the developmental studies 
with spinosad, and there is no evidence of increased susceptibility of 
young rats in the reproduction study with spinosad.
    iii. There are no residual uncertainties identified in the exposure 
databases; the dietary food exposure assessment (chronic only; no acute 
endpoint was identified) is refined using anticipated residues 
calculated from field trial data and available PCT information.
    iv. EPA has indicated that the dietary drinking water exposure is 
based on conservative modeling estimates.
    v. EPA Residential Standard Operational Procedures (SOPs) were used 
to assess post-application exposure to children as well as incidental 
oral exposure of toddlers, so these assessments do not underestimate 
the exposure and risks posed by spinosad.

E. Aggregate Risks and Determination of Safety

    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 uncertainty/
safety factors. For linear cancer risks, EPA calculates the probability 
of additional cancer cases given aggregate exposure. Short-, 
intermediate-, 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 uncertainty/safety factors is not exceeded.
    1. Acute risk. As there were no toxic effects attributable to a 
single dose, an endpoint of concern was not identified for the general 
population or to the subpopulation females 13-50 years old. No acute 
risk is expected from exposure to spinosad.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to spinosad 
from food and water will utilize 37% of the cPAD for the U.S. 
population, 32% of the cPAD for all infants less than a year old, and 
86% of the cPAD for children 1-2 years old. Based on the use pattern, 
chronic residential exposure to residues of spinosad is not expected. 
Therefore, EPA does not expect the aggregate exposure to exceed 100% of 
the cPAD.
    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 is currently registered for uses (turf and ornamental 
application) that could result in short-term residential exposures 
(incidental oral exposures to toddlers). This incidental oral exposure 
is combined with chronic dietary (food and water) exposure for 
determination of aggregate short-term exposure. The Agency uses chronic 
dietary exposure when conducting short-term aggregate assessments as it 
has been determined this will more accurately reflect exposure from 
food than will acute exposure.
    Upon analyses of all available data, resulting aggregate MOEs are 
greater than or equal to 160. Therefore, the Agency concludes that 
short-term aggregate exposure to spinosad from food and residential 
uses is below the LOC.
    4. Aggregate cancer risk for U.S. population. Spinosad has been 
classified as ``not likely to be carcinogenic in humans'' based on the 
results of a carcinogenicity study in mice and the combined chronic 
toxicity and carcinogenicity study in rats. Therefore, spinosad is not 
expected to pose a cancer risk to humans.
    5. 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, and to infants and children from aggregate 
exposure to spinosad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There is a practical method; liquid chromatography mass 
spectroscopy-accelerated climate prediction initiative (LCMS-ACPI) for 
detecting and measuring levels of spinosad in or on food with a limit 
of detection (0.002 ppm) that allows monitoring of food with residues 
at or above the level set for these tolerances. The method has 
undergone successful EPA laboratory validation.
    Adequate enforcement methodology using high pressure liquid 
chromatography with ultraviolet detector (HPLC/UV) is available to 
enforce the tolerances in plants. Adequate livestock methods are 
available for tolerance enforcement. Method RES 94094 (GRM 95.03) is an 
HPLC/UV method suitable for determination of spinosad residues in 
ruminant commodities. Method GRM 95.03 has undergone successful 
independent laboratory validation (ILV) and EPA laboratory validation, 
and has been forwarded to the Food and Drug Administration (FDA) for 
inclusion in PAM Volume II. Method GRM 95.15 is another HPLC/UV method 
suitable for determination of spinosad residues in poultry commodities. 
This method has been forwarded to FDA for inclusion in PAM Volume II. 
Method RES 95114, an immunoassay method for determination of spinosad 
residues in ruminant commodities, underwent a successful ILV and EPA 
laboratory validation. It has been submitted to FDA for inclusion in 
PAM Volume II. The methods may be requested from: Chief, Analytical 
Chemistry Branch, Environmental Science Center, 701 Mapes Road, Fort 
Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: 
[email protected].

[[Page 13173]]

B. International Residue Limits

    No Codex, Canadian, or Mexican maximum residue limits (MRLs) have 
been established for residues of spinosad on the raw agricultural 
commodities associated with this action.

V. Conclusion

    Therefore, tolerances are established for residues of spinosad. 
Spinosad is a fermentation product of Saccharopolyspora spinosa. The 
product consist of two selected 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 hop, dried cones 
at 22 ppm and amaranth, grain, stover at 10 ppm; cattle, meat at 2.0 
ppm; sheep, meat at 2.0 ppm; goat, meat at 2.0 ppm; horse, meat at 2.0 
ppm; poultry, meat at 0.10 ppm; cattle, fat at 50 ppm; sheep, fat at 50 
ppm; goat, fat at 50 ppm; horse, fat at 50 ppm; poultry, fat at 1.3 
ppm; milk at 7.0 ppm; milk, fat at 85 ppm; egg at 0.30 ppm; cattle, 
meat byproducts, except liver at 5.0 ppm; sheep, meat byproducts, 
except liver at 5.0 ppm; goat, meat byproducts, except liver at 5.0 
ppm; horse, meat byproducts, except liver at 5.0 ppm; poultry meat 
byproducts tolerance raised from 0.03 ppm and set at 0.10 ppm; cattle, 
liver at 10 ppm; sheep, liver at 10 ppm; goat, liver at 10 ppm; and 
horse, liver at 10 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to petitions 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 final rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this final 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). 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 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); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled 
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers, and food retailers, not 
States. This action does not alter the relationships or distribution of 
power and responsibilities established by Congress in the preemption 
provisions of section 408(n)(4) of FFDCA. For these same reasons, the 
Agency has determined that this final rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This final rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this final rule.

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: March 5, 2007.
Lois Rossi,
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:


[[Page 13174]]


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


0
2. The table in paragraph (a) of Sec.  180.495 is amended by:
0
i. Alphabetically adding amaranth, grain, stover; cattle, liver; goat, 
liver; hop, dried cones; horse, liver; and sheep, liver.
0
ii. Revising the remainder of the entries listed.
    The additions and revisions to the table in paragraph (a) read as 
follows:


Sec.  180.495  Spinosad; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   Revocation Date
------------------------------------------------------------------------
                                * * * * *
Amaranth, grain, stover...........                 10               None
                                * * * * *
Cattle, fat.......................                 50               None
Cattle, liver.....................                 10               None
Cattle, meat......................                2.0               None
Cattle, meat byproducts, except                   5.0               None
 liver............................
                                * * * * *
Egg...............................               0.30               None
                                * * * * *
Goat, fat.........................                 50               None
Goat, liver.......................                 10               None
Goat, meat........................                2.0               None
Goat, meat byproducts, except                     5.0               None
 liver............................
                                * * * * *
Hop, dried cones..................                 22               None
Horse, fat........................                 50               None
Horse, liver......................                 10               None
Horse, meat.......................                2.0               None
Horse, meat byproducts, except                    5.0               None
 liver............................
                                * * * * *
Milk..............................                7.0               None
Milk, fat.........................                 85               None
                                * * * * *
Poultry, fat......................                1.3               None
Poultry, meat.....................               0.10               None
Poultry, meat byproducts..........               0.10               None
                                * * * * *
Sheep, fat........................                 50               None
Sheep, liver......................                 10               None
Sheep, meat.......................                2.0               None
Sheep, meat byproducts, except                    5.0               None
 liver............................
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-4760 Filed 3-20-07; 8:45 am]
BILLING CODE 6560-50-S