

[Federal Register: March 8, 2006 (Volume 71, Number 45)]
[Rules and Regulations]               
[Page 11519-11526]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr06-6]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0510; FRL-7758-2]

 
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/on the following commodities: Alfalfa seed; alfalfa seed 
screenings; banana; food commodities; animal feed, nongrass, group 18, 
forage; animal feed, nongrass, group 18, hay; peanut, hay; vegetable, 
bulb, group 3, except green onion; onion, green; grass, forage, fodder 
and hay, group 17, forage; grass, forage, fodder and hay, group 17, 
hay; grain, cereal, group 16, stover, except rice; grain, cereal, group 
16, forage, except rice; grain, cereal, group 16, hay, except rice; 
grain, cereal, group 16, straw, except rice; peppermint, tops; and 
spearment tops. The Interregional Research Project Number 4 (IR-4)] on 
behalf of the registrant, Dow AgroScience, LLC requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act of 1996 (FQPA). In addition, EPA is 
deleting certain spinosad tolerances that are no longer needed as a 
result of this action. Also, the term ``Food commodities'' replaces the 
commodity name ``all commodities in connection with the quarantine 
eradication programs against exotic, non-indigenous, fruit fly species, 
where a separate higher tolerance in not already established'' as 
previously listed under Sec. 180.495(b).

DATES: This regulation is effective March 8, 2006. Objections and 
requests for hearings must be received on or before May 8, 2006.

ADDRESSES: To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number EPA-HQ-OPP-2005-0510. All documents in the 
docket are listed in the EDOCKET index at http://www.epa.gov/edocket. 

Although listed in the index, some information is not publicly 
available, i.e., 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 either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7610, e-mail address: jackson.sidney@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:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 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 and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/, you may 

access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www. 

epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR 
part 180 is available at E-CFR Beta Site Two at http://www. 

gpoaccess.gov/ ecfr/. To access the OPPTS Harmonized Guidelines 
referenced in this document, go directly to the guidelines at http://www.epa.
 gpo/opptsfrs/ home/guidelin. htm/


II. Background and Statutory Findings

    In the Federal Register of July 20, 2005 (70 FR 41730)(FRL-7721-6), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of several pesticide petitions (PP 
3E6699, 3E6780, 3E6782, 3E6802, 3E6804, and 4E6811) by the 
Interregional Research Project Number 4 (IR-4), 681 U. S. Highway 
1 South, North Brunswick, NJ 08902-3390. The petitions 
requested that 40 CFR 180.495 be amended by establishing a tolerance 
for residues of the insecticide spinosad, in or on the following raw 
agricultural commodities (RACs):
    PP 3E6699 proposes to establish tolerances for banana and plantain 
at 0.25 parts per million (ppm).

[[Page 11520]]

    PP 3E6780 proposes to establish tolerances for food commodities at 
0.02 ppm.
    PP 3E6782 proposes to establish tolerances for spearmint, tops at 
5.0 ppm and peppermint, tops at 5.0 ppm.
    PP 3E6802 proposes to establish tolerances for animal feed, 
nongrass, group 18, forage at 20 ppm; animal feed, nongrass, group 18 
hay at 25 ppm; and peanut, hay at 25 ppm.
    PP 3E6804 proposes to establish tolerances for vegetable, bulb, 
except green onion, group 3 at 0.1 ppm and onion, green at 2.0 ppm.
    PP 4E6811 proposes to establish tolerances for: grass, forage, 
fodder and hay, group 17, forage at 1.5 ppm; grass, forage, fodder and 
hay, group 17, hay at 5 ppm; corn, field, stover; corn, pop, stover; 
and corn, sweet, stover at 5.0 ppm; corn, field, forage; corn, sweet, 
forage; and corn, pop, forage at 1.5 ppm; teosinte, forage at 1.5 ppm; 
millet, pearl, forage; and millet, proso, forage at 1.5 ppm; millet, 
pearl, hay; millet, proso, hay; millet proso,straw at 5.0 ppm; sorghum, 
forage, forage and sorghum, grain, forage at 1.5 ppm; sorghum, forage, 
hay; and sorghum, grain, stover at 5.0 ppm; wheat, forage at 1.5 ppm; 
wheat, hay and wheat, straw at 5.0 ppm; barley, straw and barley, hay 
at 5.0 ppm; rye, forage at 1.5 ppm; rye, straw at 5 ppm; oat, forage at 
1.5 ppm; oat, hay and oat, straw at 5.0 ppm; triticale, forage at 1.5 
ppm; and triticale, hay at 5.0 ppm.
    That notice included a summary of the petition prepared by by Dow 
AgroSciences, LLC, Indianapolis IN, 46268, the registrant. One comment 
was received in response to the notice of filing. A discussion of the 
commenter's concerns is presented in Unit IV. C. - Public Comments.
    Several of the proposed petitions described in Unit II. were 
subsequently amended by the petitioner as follows:
    Tolerances for animal feed, nongrass, group 18, forage at 35 ppm; 
animal feed, nongrass, group 18 hay at 30 ppm; and separate tolerances 
for alfalfa seed at 0.15 ppm; and alfalfa, seed screenings at 2 ppm; 
banana at 0.25 ppm; grass, forage, fodder and hay, group 17, forage at 
10 ppm; grain, cereal, group 16, stover, except rice at 10 ppm; grain, 
cereal, group 16, forage, except rice at 2.5 ppm; peppermint, tops at 
3.5 ppm; and spearmint, tops at 3.5 ppm. In addition, tolerance for 
grain, cereal, group 16, stover, except rice at 10 ppm replaces the 
proposed 5.0 ppm tolerance for corn, field, stover; corn, pop, stover; 
corn, sweet, stover, and sorghum, grain, stover and the tolerance for 
grain, cereal, group 16, forage, except rice at 2.5 ppm replaces 
proposed tolerance of 1.5 ppm for corn, field, forage; corn, pop, 
forage; corn, sweet, forage; teosinte, forage; millet, pearl, forage; 
millet, proso, forage; sorghum, forage, forage; sorghum, grain, forage; 
wheat, forage; rye, forage; oat, forage; and triticale, forage. 
Tolerance for grain, cereal, group 16, hay, except rice at 10 ppm 
replaces proposed tolerance of 5.0 ppm for millet, pearl, hay; millet, 
proso, hay; sorghum, forage, hay; wheat, hay; barley, hay; oat, hay; 
and triticale, hay. Finally, tolerance for grain, cereal, group 16, 
straw, except rice at 1.0 ppm replaces proposed tolerance of 5.0 ppm 
for millet, proso, straw; wheat, straw; barley, straw; rye, straw; and 
oat, straw.
    EPA is also deleting several established tolerances in 
Sec. 180.495(a) and Sec. 180.495(b) that are no longer needed, as a 
result of this action.
    The tolerance deletions under Sec. 180.495(a) are being replaced by 
the establishment of the crop group tolerance for grain, cereal, group 
16, stover, forage, hay, and straw. The tolerance deletions under 
Sec. 180.495(b) are time-limited tolerances established under section 
18 emergency exemptions that are superceded by the establishment of 
general tolerances for spinosad under Sec. 180.495(a).
    The revisions to Sec. 180.495 are as follows:
    Delete the tolerances established under Sec. 180.495(a) for 
residues of spinosad in or on corn, forage at 1.0 ppm; corn, hay at 1.0 
ppm; corn stover at 1.0 ppm; corn straw at 1.0 ppm; sorghum, forage at 
1.0 ppm; sorghum, forage, hay at 1.0 ppm; sorghum, grain, stover at 1.0 
ppm; sorghum, straw at 1.0 ppm; wheat, forage at 1.0 ppm; wheat, hay at 
1.0 ppm and wheat, straw at 1.0 ppm. Tolerances for grain, cereal, 
group 16, stover, except rice at 10 ppm; grain, cereal, group 16, 
forage, except rice at 2.5 ppm; grain, cereal, group 16, hay, except 
rice at 10 ppm; and for grain, cereal, group 16, straw, except rice at 
1.0 ppm replace these tolerances by this action under Sec. 180.495 (a).
    Delete the time-limited tolerance for all commodities in connection 
with the quarantine eradication programs against exotic, non-
indigenous, fruit fly species, where a separate higher tolerance is not 
already established at 0.02 ppm; alfalfa, forage at 4.0 ppm; alfalfa, 
hay at 4.0 ppm; grass, forage at 7.0 ppm; grass, hay at 7.0 ppm; 
peanut, hay at 10 ppm and onion, dry bulb at 0.10 ppm. Permanent 
tolerances for food commodities at 0.02 ppm; peanut, hay at 11 ppm; 
grass, forage, fodder and hay, group 17, forage at 10 ppm; grass, 
forage, fodder and hay, group 17, hay at 5 ppm; grain, cereal, group 
16, stover, except rice at 10 ppm and vegetable, bulb, except green 
onion, group 3 at 0.1 ppm are established by this action under 
Sec. 180.495(a).
    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 define ``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 the FFDCA and a complete 
description of the risk assessment process, at http://www. epa.gov/ 

fedrgstr/EPA-PEST/1997/ November/Day-26/ p30948.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 a tolerance for residues of spinosad on: 
Alfalfa seed at 0.15 ppm; alfalfa seed screenings at 2.0 ppm; banana at 
0.25 parts per million (ppm); food commodities at 0.02 ppm; spearmint, 
tops at 3.5 ppm; peppermint, tops at 3.5 ppm; animal feed, nongrass, 
group 18, forage at 35 ppm; animal feed, nongrass, group 18, hay at 30 
ppm; alfalfa, seed at 0.15 ppm; alfalfa, seed screenings at 2.0 ppm; 
peanut, hay at 11 ppm; vegetable, bulb, group 3, except green onion, 
group 3 at 0.1 ppm; onion, green at 2.0 ppm; grass, forage, fodder and 
hay, group 17, forage at 10 ppm; grass, forage, fodder and hay, group 
17, hay at 5 ppm; grain, cereal, group 16, stover, except rice at 10 
ppm; grain, cereal, group 16, forage, except rice at 2.5 ppm; grain, 
cereal, group 16, hay, except rice at 10 ppm; grain, cereal, group 16, 
straw, except rice at 1.0 ppm.

[[Page 11521]]

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by spinosad as well as 
the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-
adverse-effect-level (LOAEL) from the toxicity studies reviewed are 
discussed in the Federal Register of September 27, 2002 (67 FR 60923) 
(FRL-7199-5).

B. Toxicological Endpoints

    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 
adverse effects of concern are identified 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. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for 
intraspecies differences.
    Three other types of safety or UFs may be used: ``Traditional UF`` 
the ``special FQPA safety factor;'' and the ``default FQPA safety 
factor.'' By the term ``traditional UF,'' EPA is referring to those 
additional UF's used prior to FQPA passage to account for database 
deficiencies. These traditional UFs have been incorporated by the FQPA 
into the additional safety factor for the protection of infants and 
children. The term ``pecial FQPA safety factor'' refers to those safety 
factors that are deemed necessary for the protection of infants and 
children primarily as a result of the FQPA. The ``default FQPA safety 
factor'' is the additional 10X safety factor that is mandated by the 
statute unless it is decided that there are reliable data to choose a 
different additional factor (potentially a traditional UF or a special 
FQPA safety factor).
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (aRfD or cRfD) where 
the RfD is equal to the NOAEL divided by an UF of 100 to account for 
interspecies and intraspecies differences and any traditional UFs 
deemed appropriate (RfD = NOAEL/UF). Where a special FQPA safety factor 
or the default FQPA safety factor is used, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of safety factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk). An example of how such a probability risk is expressed 
would be to describe the risk as one in one hundred thousand (1 X 
10-5), one in a million (1 X 10-6), or one in ten 
million (1 X 10-7). Under certain specific circumstances, 
MOE calculations will be used for the carcinogenic risk assessment. In 
this non-linear approach, a ``point of departure'' is identified below 
which carcinogenic effects are not expected. The point of departure is 
typically a NOAEL based on an endpoint related to cancer effects though 
it may be a different value derived from the dose response curve. To 
estimate risk, a ratio of the point of departure to exposure (MOEcancer 
= point of departure/exposures) is calculated.
    A summary of the toxicological endpoints for spinosad used for 
human risk assessment is discussed in Unit III., B. of the Spinosad 
Final Rule published in the Federal Register of September 27, 2002 (67 
FR 60923) (FRL-199-5).

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 RACs. Risk assessments were conducted by EPA to assess 
dietary exposures from spinosad in food as follows:
    i. Acute exposure. Acute dietary risk assessments are performed for 
a food-use pesticide, if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a 1-day or 
single exposure. 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 data base including oral developmental toxicity 
studies in rats and rabbits. In the acute neurotoxicity study, the 
NOAEL was 2,000 milligram/kilograms/day (mg/kg/day), highest dose 
tested. An acute dietary risk assessment is not required.
    ii. Chronic exposure. Chronic dietary risk assessments were 
conducted using the Dietary Exposure Evaluation Model - Food 
Consumption Intake Database (DEEMTM/FCID), ver. 2.03; acute 
and cancer endpoints were not identified which incorporates the food 
consumption data from the U.S. Department of Agriculture Continuing 
Surveys of Food Intakes by Individuals (CSFII; 1994-1996, and 1998). 
The chronic dietary analyses assumed average/projected percent crop 
treated estimates, projected percent head treated resulting from the 
dermal and premise treatments to ruminants, average field trial 
residues, experimentally determined processing factors, and anticipated 
livestock residues. For drinking water, the chronic analyses assumed 
the modeled tier 1 FIRST chronic surface water estimate resulting from 
the application of spinosad to turf (highest registered/proposed rate). 
The chronic analysis used average field trial residues for grape, 
barley grain, corn grain, oat grain, rice grain, and wheat grain. The 
chronic analysis also used processing factors from the grape, corn and 
wheat processing studies. The resulting exposure estimates were 96% the 
cPAD and are therefore, less than EPA's level of concern (children 1-2 
years old were the most highly exposed subpopulation).
    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 risk 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 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

[[Page 11522]]

anticipated. Following the initial data submission, EPA is authorized 
to require similar data on a time frame it deems appropriate. As 
required by section 408(b)(2)(E) of FFDCA, EPA will issue a Data Call-
In for information relating to anticipated residues to be submitted no 
later than 5 years from the date of issuance of this tolerance final 
rule.
    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:
    The chronic analysis assumed tolerance level residues for all crop, 
poultry, and egg commodities, and anticipated residues for ruminant and 
milk commodities. The Agency used PCT information as follows: Almond 
5%; apple 30%; apricot 10%; avocado 5%; bean, green 10%; broccoli 40%; 
cabbage 30%; cantaloupes 10%; cauliflower 45%; celery 50%; cherry 25%; 
collards 25%; cotton 5%; cucumber 20%; eggplant 15%; green, mustard 
15%; green, turnip 5%; kale 30%; citrus (5%; excluding lemon and 
orange), 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%; corn, sweet < 1%; 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%; 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 < 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 United States Department of Agriculture/National Agricultural 
Statistics Service (USDA/NASS), Proprietary Market Surveys, and the 
National Center for Food and Agriculture Policy (NCFAP) for the most 
recent six years.
    EPA projects PCT for a new insecticide use by assuming that the PCT 
for the insecticide's initial five years will not exceed the average 
PCT of the dominant insecticide (the one with the largest PCT) within 
all insecticides over three latest available years. The PCTs included 
in the average may be each for the same insecticide or for different 
insecticidessince the same or different insecticides may dominate for 
each year selected. Typically, EPA uses USDA/NASS as the source for raw 
PCT data because it is non-proprietary and directly available without 
computation.
    This method of projecting PCT for a new insecticide use, with or 
without regard to specific pest(s), produces an upper-end projection 
that is unlikely, in most cases, to be exceeded in actuality because 
the dominant insecticide is well-established and accepted by farmers. 
Factors that bear on whether a projection based on the dominant 
insecticide could be exceeded are whether the new insecticide is more 
efficacious or controls a broader spectrum of pests than the dominant 
insecticide, whether it is more cost-effective than the dominant 
insecticide, and whether it is likely to be readily accepted by growers 
and experts. These factors have been considered for this insecticide 
new use, and they indicate that it is unlikely that actual PCT for this 
new use will exceed the PCT for the dominant insecticide in the next 
five years.
    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. Based on the 

First Index Reservoir Screening Tool and Screening concentration in 
Groundwater models, the EECs of spinosad for acute exposures are 
estimated to be 25.2 parts per billion (ppb) for surface water and 
0.037 ppb for ground water. The EECs for chronic exposures are 
estimated to be 2.3 ppb for surface water and 0.037 ppb for ground 
water.
    Modeled estimates of drinking water concentrations were directly 
entered into the DEEM-FCID. For chronic dietary risk assessment, the 
surface water value (chronic; 56-day average) of 2.3 ppb was used for 
all direct and indirect sources of water. The surface water estimate 
was used for all direct and indirect sources of water. The surface 
water estimate was used for direct and indirect sources of water as it 
is greater than the ground water estimate.
    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 turf/lawn and ornamental/garden pest control (i.e., 
worms, moths, flies, beetles, midges, thrips, leafminers, fire ants, 
etc.), indoor pest control, termiticides, and flea and tick control on 
pets). A summary of the residential uses for spinosad is discussed in 
Unit III.C. of the final rule published in the Federal Register of 
September 27, 2002 (67 FR 60923) (FRL-7199-5).
    Spinosad is currently registered for use on the following 
residential non-dietary sites: Turf and ornamentals. Granular 
(homeowner) and emulsifiable concentrate (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 potential toddler short-term, non-dietary oral exposures 
(hand-to-mouth, object-to-mouth, ingestion of granulars, and soil 
ingestion). An endpoint attributable to a single exposure (acute 
exposure) has not been identified; therefore, episodic ingestion of 
granules was not assessed. The resulting combined short-term incidental 
oral MOEs were 640 and are therefore, less than the Agency's level of

[[Page 11523]]

concern. EPA concludes that all other registered/proposed application 
scenarios will not result in residential exposures.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the 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 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 data base 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 UFs 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. There is a complete toxicity data base for spinosad 
and exposure data are complete or are estimated based on data that 
reasonably account for potential exposures. EPA determined that the 10X 
SF to protect infants and children should be removed. The FQPA factor 
is removed because:
    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 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

    The Agency currently has two ways to estimate total aggregate 
exposure to a pesticide from food, drinking water, and residential 
uses. First, a screening assessment can be used, in which the Agency 
calculates drinking water levels of comparison (DWLOCs) which are used 
as a point of comparison against estimated environmental concentrations 
(EECs). The DWLOC values are not regulatory standards for drinking 
water, but are theoretical upper limits on a pesticide's concentration 
in drinking water in light of total aggregate exposure to a pesticide 
in food and residential uses. In calculating a DWLOC, the Agency 
determines how much of the acceptable exposure (i.e., the PAD) is 
available for exposure through drinking water e.g., allowable chronic 
water exposure (mg/kg/day) = CPAD - (average food + residential 
exposure). This allowable exposure through drinking water is used to 
calculate a DWLOC.
    A DWLOC will vary depending on the toxic endpoint, drinking water 
consumption, and body weights. Default body weights and consumption 
values as used by the EPA's Office of Water are used to calculate 
DWLOCs: 2 liter (L) / 70 kg (adult male), 2L / 60 kg (adult female), 
and 1L / 10 kg (child). Different populations will have different 
DWLOCs. Generally, a DWLOC is calculated for each type of risk 
assessment used: Acute, short-term, intermediate-term, chronic, and 
cancer.
    When EECs for surface water and ground water are less than the 
calculated DWOCs, EPA concluded with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposures for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses changes. When 
new uses are added EPA reassesses the potential impacts of residues of 
the pesticide in drinking water as a part of the aggregate assessment 
process.
    More recently the Agency has used another approach to estimate 
aggregate exposure through food, residential and drinking water 
pathways. In this approach, modeled surface and ground water EECs are 
directly incorporated into the dietary exposure analysis, along with 
food. This provides a more realistic estimate of exposure because 
actual body weights and water consumption from the CSFII are used. The 
combined food and water exposures are then added to estimated exposure 
from residential sources to calculate aggregate risks. The resulting 
exposure and risk estimates are still considered to be high end, due to 
the assumptions used in developing drinking water modeling inputs.
    1. Acute risk. Acute aggregate risk consists of the combined 
dietary exposures from food and drinking water sources. The total 
exposure is compared to the acute RfD. An acute RfD was not identified 
since no effects were observed in oral toxicity studies that could be 
attributable to a single dose. Therefore, the Agency concludes that 
there is a reasonable certainty of no acute harm from aggregate 
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 30% of the cPAD for the U.S. 
population, 36% of the cPAD for all infants, and 96% of the cPAD for 
children 1-2 years old. Based on the use pattern, chronic residential 
exposure to

[[Page 11524]]

residues of spinosad is not expected. In addition, there is potential 
for chronic dietary exposure to spinosad in drinking water. Dietary 
exposure analysis included drinking water, therefore, exposure 
estimates represent aggregate chronic exposure. 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).
    In general, aggregate exposures are calculated by summing dietary 
(food and water) and residential exposures (residential or other non-
occupational exposures). Based on the anticipated residential exposure 
scenarios and since acute and cancer risk assessments are not required, 
only short-term (residential, food and water) and chronic (food and 
water) aggregate exposure assessments were conducted.
    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. Table 1 of this unit is a summary of the 
short-term aggregate exposure and risk estimates. Since the resulting 
aggregate MOEs are greater than or equal to 150, short-term aggregate 
exposure to spinosad from food and residential uses is below the 
Agency's level of concern.

                     Table 1.--Aggregate Risk Assessment for Short-Term Exposure to spinosad
----------------------------------------------------------------------------------------------------------------
                                                                            Chronic
                                                                            Food and   Residential    Aggregate
              Population/Subgroup                NOAEL (mg/   Target MOE     Water         Oral     MOE2 (food +
                                                  kg/day)                   Exposure    Exposure1    water, and
                                                                          (mg/kg/day)  (mg/kg/day)  residential)
----------------------------------------------------------------------------------------------------------------
All infants (< (1 year old)                              4.9          100     0.009605       0.0076           280
----------------------------------------------------------------------------------------------------------------
Children (1-2 years old)                                4.9          100     0.025784       0.0076           150
----------------------------------------------------------------------------------------------------------------
Children (3-5 years old)                                4.9          100     0.019729       0.0076           180
----------------------------------------------------------------------------------------------------------------
Children (6-12 years old)                               4.9          100      0.01259       0.0076           240
----------------------------------------------------------------------------------------------------------------
1 residential exposure = sum of hand-to-mouth, object-to-mouth, and soil ingestion residue estimates.
2 Aggregate MOE = NOAEL divided by (Chronic Food Exposure + Residential Exposure)

    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

    The Agency concludes that currently available enforcement methods 
are sufficient to enforce tolerances associated with the petition under 
consideration. 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 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: Paul Golden, U.S EPA/OPP/BEAD/ACB, 
Environmental Science Center, 701 Mapes Road, Fort Meade, MD 20755-
5350; telephone number: (410) 305-2960; Fax (410) 305-3091; e-mail 
address: residuemethods@epa.gov.

B. International Residue Limits

    There are no Canadian or Mexican maximum residue limits in/on corn 
forage (5 ppm), corn fodder (5 ppm), wheat fodder (1 ppm), and wheat 
straw (1 ppm). The Agency concluded that the appropriate cereal grain 
forage, stover, hay and straw tolerances for the United States are 2.5 
ppm, 10 ppm, and 1.0 ppm, respectively. There are Codex MRLs for 
spinosad in corn forage (5 ppm), corn fodder (5 ppm), wheat fodder (1 
ppm) and wheat straw (1 ppm). Based on available data and applications 
proposed for the United States, the Agency concluded that the 
appropriate cereal grain forage, stover, hay and straw tolerances for 
the United States are 2.5 ppm, 10 ppm, and 1.0 ppm, respectively. The 
Codex MRLs for corn forage and fodder are based on field residue data 
from the United States. The Codex tolerances for corn forage and fodder 
are based on a dry weight basis whereas in the United States tolerances 
for corn forage and fodder are based on an as-fed basis. When 
evaluating data on an as-fed basis there is a high moisture content 
that will substantially increase the tolerance level compared to 
evaluating the same data on a dry weight basis. Therefore it is not 
appropriate to harmonize the tolerance values for these commodities. 
Therefore, harmonization is not an issue for these commodities.

C. Public Comments

    One comment was received from a private citizen who opposed the 
authorization to sell to any pesticide that leaves a residue on food. 
The Agency has received this same comment from this commenter on 
numerous previous occasions and rejects it for the reasons previously 
stated in the Federal

[[Page 11525]]

Register of January 7, 2005 (70 FR 1349) (FRL-7691-4).

V. Conclusion

    Therefore, the tolerance is established for residues of spinosad, a 
naturally occurring product consisting of: Spinosyn A (2-[(6-deoxy-
2,3,4-tri-O-methyl-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 (2-[(6-deoxy-
2,3,4-tri-O-methyl-L-mannopyranosyl)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-4,14-methyl-1H-
as-Indaceno[3,2-d]oxacyclododecin-7,15-dione) in/on the following 
commodities: Alfalfa seed at 0.15 ppm; alfalfa seed screenings at 2.0 
ppm; banana at 0.25 ppm; food commodities at 0.02 ppm; spearmint, tops 
at 3.5 ppm; peppermint, tops at 3.5 ppm; animal feed, nongrass, group 
18, forage at 35 ppm; animal feed, nongrass, group 18 hay at 30 ppm; 
peanut, hay at 11 ppm; vegetable, bulb, group 3, except green onion, 
group 3 at 0.1 ppm; onion, green at 2.0 ppm; grass, forage, fodder and 
hay, group 17, forage at 10 ppm; grass, forage, fodder and hay, group 
17, hay at 5 ppm; grain, cereal, group 16, stover, except rice at 10 
ppm; grain, cereal, group 16, forage, except rice at 2.5 ppm; grain, 
cereal, group 16, hay, except rice at 10 ppm; grain, cereal, group 16, 
straw, except rice at 1.0 ppm.

VI. Objections and Hearing Requests

    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. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number EPA-HQ-OPP-2005-0510 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 8, 
2006.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    2. Mail your written request to: Office of the Hearing Clerk 
(1900L), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number, EPA-HQ-OPP-2005-0510 to: Public 
Information and Records Integrity Branch, Information Technology and 
Resource Management Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. In person or by courier, bring a copy to the 
location of the PIRIB described in ADDRESSES. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. 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 due to its lack of 
significance, 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). 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

[[Page 11526]]

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 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 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 rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and 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: February 17, 2006.
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 amended:
0
i. In paragragh (a), in the table, by removing: Corn, forage at 1.0 
ppm; corn, hay at 1.0 ppm; corn stover at 1.0 ppm; corn straw at 1.0 
ppm; grass, forage, fodder and hay, group 17 at 0.02 ppm; sorghum, 
forage at 1.0 ppm; sorghum, forage, hay at 1.0 ppm; sorghum, grain, 
stover at 1.0 ppm; sorghum, straw at 1.0 ppm; wheat, forage at 1.0 ppm; 
wheat, hay at 1.0 ppm and wheat, straw at 1.0 ppm; and by 
alphabetically adding the commodities as set forth below.
0
ii. In paragraph (b), in the table, by removing: All commodities in 
connection with the quarantine eradication programs against exotic, 
non-indigenous, fruit fly species, where a separate higher tolerance in 
is not already established at 0.02 ppm; alfalfa, forage at 4.0 ppm; 
alfalfa, hay at 4.0 ppm; grass, forage at 7.0 ppm; grass, hay at 7.0 
ppm; peanut, hay at 10 ppm and onion, dry bulb at 0.10 ppm.
    The additions read as follows:


Sec.  180.495  Spinosad; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Alfalfa, seed..............................................         0.15
Alfalfa, seed screenings...................................          2.0
Animal feed, nongrass, group, 18, forage...................         35.0
Animal feed, nongrass, group, 18, hay......................         30.0
                                * * * * *
Banana.....................................................         0.25
Food commodities...........................................         0.02
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
                                * * * * *
Grass, forage, fodder and hay, group 17, forage............         10.0
Grass, forage, fodder and hay, group 17, hay...............          5.0
                                * * * * *
Onion, green...............................................          2.0
                                * * * * *
Peanut, hay................................................         11.0
Peppermint, tops...........................................          3.5
                                * * * * *
Spearmint, tops............................................          3.5
                                * * * * *
Vegetable, bulb, group 3, except green onion...............         0.10
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 06-1939 Filed 3-7-06; 8:45 am]

BILLING CODE 6560-50-S
