Spinosad; Pesticide Tolerance, 1349-1357 [05-88]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 5 (Friday, January 7, 2005)]
[Rules and Regulations]
[Pages 1349-1357]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-88]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2004-0042; FRL-7691-4]


Spinosad; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a tolerance for residues of 
spinosad in or on grain, cereal, group 15 at 1.5 ppm; grain as 
aspirated fractions at 200 ppm; rice hulls at 4 ppm; meat of cattle, 
goats, hogs, horse and sheep at 1.5 ppm; fat of cattle, goats, hogs, 
horse and sheep at 33 ppm; meat byproducts of cattle, goats, hogs, 
horse and sheep at 8 ppm; milk at 6 ppm; milk fat at 75 ppm; fat of 
poultry at 0.5 ppm; meat byproducts of poultry at 0.03 ppm; eggs at 
0.05 ppm. EPA is also deleting certain spinosad tolerances that are no 
longer needed as a result of this action. Dow AgroScience requested 
this tolerance 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 January 7, 2005. Objections and 
requests for hearings must be received on or before March 8, 2005.

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 OPP-2004-0042. All documents in the docket 
are listed in the EDOCKET index at https://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: George LaRocca, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 308-8587; e-mail address: larocca.george@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 (https://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at  https://
www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 
CFR part 180 is available at E-CFR Beta Site Two at  https://
www.gpoaccess.gov/ecfr/. To access the OPPTS Harmonized Guidelines 
referenced in this document, go directly to the guidelines at https://
www.epa.gpo/opptsfrs/home/guidelin.htm/.

 II. Background and Statutory Findings

    In the Federal Register of June 23, 2004 (69 FR 35024) (FRL-7358-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition PP 
3F6754 by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 
46268. The petition requested that 40 CFR 180.495 be amended by 
establishing a tolerance for residues of the insecticide spinosad, in 
or on the raw agricultural commodity stored grain (wheat, barley, corn, 
oats, rice, and sorghum milo) at 1 ppm , soybean, sunflower, peanut, 
and cotton seed at 1 part per million (ppm); and birdseed at 3 ppm. 
That notice included a summary of the petition prepared by 
DowAgroScience LLC, the registrant.
    Based on EPA's review, the petition described in Unit II. was 
revised by the petitioner (Dow AgroSciences) to propose tolerances for 
residues of spinosad for cereal grains group at 1.5 ppm; grain as 
aspirated fractions at 200 ppm; rice hulls at 4 ppm; meat of cattle, 
goats, hogs, horse and sheep at 1.5 ppm; fat of cattle, goats, hogs, 
horse and sheep at 33 ppm; meat byproducts of cattle, goats, hogs, 
horse and sheep at 8 ppm; milk at 6 ppm; milk fat at 75 ppm; fat

[[Page 1350]]

of poultry at 0.5 ppm; meat byproducts of poultry at 0.03 ppm; eggs at 
0.05 ppm. Residue data on stored seed (soybean, sunflower, cottonseed) 
and peanuts were not submitted, and thus not considered under this 
petition. The Agency does not establish tolerances for birdseed 
commodities.
    EPA is also revising or deleting existing tolerances for spinosad 
that are superceded or no longer needed, correcting administrative 
errors in existing tolerances, and updating tolerance terminology as 
follows:
    1. Tolerances for residues of spinosad in or on barley, grain; 
buckwheat, grain; corn, grain; corn, pop; corn pop, grain; grain, 
aspirated fractions; millet, pearl, grain; millet, proso, grain; oat 
grain; rye, grain; sorghum, grain; stored grains (barley, corn, oats, 
rice, sorghum/milo, and wheat); teosinte, grain; wheat bran; wheat, 
flour; wheat, grain; wheat midlings; wheat shorts are being revised or 
replaced as appropriate to reflect the new commodity terms and 
tolerance levels specified in Unit II.
    2. Time-limited tolerances established for residues of spinosad in 
or on beet, sugar, tops at 10 ppm in connection with Section 18 
exemption granted by EPA has expired and is being deleted. In a prior 
action, EPA established a spinosad tolerance for vegetables, leaves of 
root and tuber, group 2, which covers beet, sugar, tops. Time limited 
tolerances established for residues of spinosad in/or on coffee beans 
at 0.02 ppm in connection with an experimental use permit granted by 
EPA has expired and is being deleted.
    3. Administrative errors in existing tolerances for corn, stover; 
sorghum, grain stover and wheat straw are being corrected as follows: 
The existing tolerances for these commodities are repeated more than 
once in the table in paragraph (a) under Sec.  180.495 and are being 
deleted.
    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 the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

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 the 
commodities listed in Unit II. EPA's assessment of exposures and risks 
associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. 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 no adverse effects are observed (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 uncertainty factors may be used: 
``Traditional uncertainty factors;'' the ``special FQPA safety 
factor;'' and the ``default FQPA safety factor.'' By the term 
``traditional uncertainty factor,'' EPA is referring to those 
additional uncertainty factors used prior to FQPA passage to account 
for database deficiencies. These traditional uncertainty factors have 
been incorporated by the FQPA into the additional safety factor for the 
protection of infants and children. The term ``special 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 uncertainty factor 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 (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of 
100 to account for interspecies and intraspecies differences and any 
traditional uncertainty factors 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\).

[[Page 1351]]

 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 final rule 
published in the Federal Register of September 27, 2002 (67 FR 60923) 
(FRL-7199-5).

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 raw agricultural commodities. 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 one-day 
or single exposure. An endpoint was not identified for acute dietary 
exposure and risk assessment because no effects were observed in oral 
toxicity studies including developmental toxicity studies in rats or 
rabbits that could be attributable to a single dose (exposure). 
Therefore, an acute dietary exposure assessment was not performed.
    ii. Chronic exposure. In conducting the chronic dietary risk 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\T\), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: A chronic dietary exposure assessment (using tolerance-
level residues, DEEM default processing factors, and percent crop 
treated (CT) information including 10% CT for all proposed commodities) 
was conducted for the general U.S. population and various population 
subgroups. The estimated chronic dietary exposures for the U.S. 
population and all population subgroups, as represented by percent of 
the chronic Population Adjusted Dose (cPAD), is below EPA's level of 
concern (< 100% cPAD). The estimated exposure for the U.S. population 
is 21% of the cPAD. The estimated exposure for the most highly exposed 
subpopulation, children 1-2 years, is 62% of the cPAD.
    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 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.
    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. Percent crop treated for several crop commodities 
were reduced from 100% based on data submitted to EPA. The Agency used 
PCT information as follows:
Almond--5%;
Apple--28%;
Apricot --5%;
Avocado--5%;
Bean, snap--9%;
Bean/pea, dry--1%;
Broccoli--62%;
Cabbage--32%;
Cauliflower--54%;
Celery--78%;
Cherry--4%;
Collards--24%;
Cotton--3%;
Eggplant--14%;
Grapefruit--1%;
Grape, wine--1%;
Kale--32%;
Lemon--11%;
Lettuce, head--59%;
Lettuce, other--42%;
Mustard greens--17%;
Orange--6%;
Potato--1%;
Peach--4%;
Peanut--1%;
Pepper--45%;
Pistachio--1%;
Prune/plum--5%;
Spinach--32%;
Squash--1%;
Tangerine--6%;
Tomato, fresh--30%;
Tomato, processed--2%;
Turnip, greens--6%;
Watermelon--1%
Furthermore, an estimated 10% seed treatment for cereal grains was 
used.
    The Agency believes that the three conditions listed in Unit III.C. 
have been met. With respect to Condition 1, PCT estimates for existing 
uses are derived from Federal and private market survey data, which are 
reliable and have a valid basis. EPA uses a weighted average PCT for 
chronic dietary exposure estimates. This weighted average PCT figure is 
derived by averaging State-level data for a period of up to 10 years, 
and weighting for the more robust and recent data. A weighted average 
of the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. With respect to the projected PCT for the proposed used, 
the 10% projection is based upon a maximum percent seed supply treated 
with chlorphyrifos-methyl of 8% for wheat and 5% for barley and oats. 
Since spinosad is likely to be used in place of chlorphyrifos-methyl, 
historically the

[[Page 1352]]

most widely used insecticide for control of insects pests on stored 
grain this assessment assumes that the percent of seed treatment would 
approximate the maximum percent of the seed supply treated with 
chlorphyrifos-methyl. 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 spinosid 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.
    The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or 
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index 
reservoir. The SCI-GROW model is used to predict pesticide 
concentrations in shallow ground water. For a screening-level 
assessment for surface water EPA will use FIRST (a tier 1 model) before 
using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the 
PRZM/EXAMS model that uses a specific high-end runoff scenario for 
pesticides. Both FIRST and PRZM/EXAMS incorporate an index reservoir 
environment, and both models include a percent crop area factor as an 
adjustment to account for the maximum percent crop coverage within a 
watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a %RfD or %PAD. 
Instead drinking water levels of comparison (DWLOCs) are calculated and 
used as a point of comparison against the model estimates of a 
pesticide's concentration in water. DWLOCs are theoretical upper limits 
on a pesticide's concentration in drinking water in light of total 
aggregate exposure to a pesticide in food, and from residential uses. 
Since DWLOCs address total aggregate exposure to spinosad they are 
further discussed in the aggregate risk sections in Unit III.E.
    Based on the FIRST and SCI-GROW models, the EECs of spinosad for 
chronic exposures are estimated to be 2.3 ppb for surface water and 
0.037 ppb for ground water.
    The EECs for spinosad are based on application of the insecticide 
to turf at a maximum of four applications at a rate of 0.41 pound 
active per acre per application.
    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). 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).
    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.''
    EPA does not have, at this time, available data to determine 
whether spinosad has a common mechanism of toxicity with other 
substances. 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 OPP concerning 
common mechanism determinations and procedures for cumulating effects 
from substances found to have a common mechanism on EPA's web site at 
https://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 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.
    3. Conclusion. There is a complete toxicity data base for spinosad 
and exposure data are complete or are estimated based on data that 
reasonably accounts 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 data base 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,

[[Page 1353]]

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 percent crop treated 
(%CT) 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

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against EECs. DWLOC values are 
not regulatory standards for drinking water. DWLOCs 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). Default body weights and drinking water consumption 
values vary on an individual basis. This variation will be taken into 
account in more refined screening-level and quantitative drinking water 
exposure assessments. 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 DWLOCs, OPP concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which OPP has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because OPP 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 change. If new 
uses are added in the future, OPP will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    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 harm from acute 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 will utilize 21% of the cPAD for the U.S. population, 22% of 
the cPAD for all infants, and 62 % of the cPAD for children 1-2 years 
old. Based on the use pattern, chronic residential exposure to residues 
of spinosad is not expected. In addition, there is potential for 
chronic dietary exposure to spinosad in drinking water. After 
calculating DWLOCs and comparing them to the EECs for surface and 
ground water, EPA does not expect the aggregate exposure to exceed 100% 
of the cPAD, as shown in the Table below:

                     Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Spinosad
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population                                        0.027           36          2.3        0.037          600
------------------------------------------------
------------------------------------------------
------------------------------------------------
----------------------------------------------------------------------------------------------------------------

    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).
    A summary of the short-term risk for spinosad is discussed in Unit 
III.E. of the final rule published in the Federal Register of September 
27, 2002 (67 FR 60923) (FRL-7199-5).
    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

    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 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

[[Page 1354]]

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, US 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: RAM Mailbox.

B. International Residue Limits

    No Codex, Canadian, or Mexican maximum residue limits (MRLs) have 
been established for residues of spinosad on the raw agricultural 
commodity cereal grains.

C. Public Comments

    One comment was received in response to the notice of filing. In 
that comment, a B. Sachau objected to the proposed tolerances because 
of the amounts of pesticides already consumed and carried by the 
American population. She further indicated that testing conducted on 
animals have absolutely no validity and cruel to the test animals.
    The Agency understands the commenter's concerns and recognizes that 
some individuals believe that pesticides should be banned completely. 
However, under the existing legal framework provided by section 408 of 
the Federal Food, Drug and Cosmetic Act (FFDCA) EPA is authorized to 
establish pesticide tolerances or exemptions where persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by that statute.
    The Agency disagrees with the commenter's claims regarding animal 
testing. Since humans and animals have complex organ systems and 
mechanisms for the distribution of chemicals in the body, as well as 
processes for eliminating toxic substances from their systems, EPA 
relies on laboratory animals such as rats and mice to mimic the 
complexity of human and higher-order animal physiological responses 
when exposed to a pesticide. EPA is committed, however, to reducing the 
use of animals whenever possible. EPA-required studies include animals 
only when the requirements of sound toxicological science make the use 
of an animal absolutely necessary. The Agency's goal is to be able to 
predict the potential of pesticides to cause harmful effects to humans 
and wildlife by using fewer laboratory animals as models and have been 
accepting data from alternative (to animals) test methods for several 
years. As progress is made on finding or developing non-animal test 
models that reliably predict the potential for harm to humans or the 
environment, EPA expects that it will need fewer animal studies to make 
safety determinations.
    Finally, because the commenter has not provided the Agency with a 
specific rationale (including supporting information) as to why the 
Agency's action is inconsistent with the legal standards in section 408 
of FFDCA, EPA can not provide any more detailed response to the 
commenter's disagreement with the Agency's decision.

V. Conclusion

    Therefore, the tolerances are established for residues of spinosad, 
in or on the raw agricultural commodity grain, cereal, group 15 at 1.5 
ppm; grain as aspirated fractions at 200 ppm; rice hulls at 4 ppm; meat 
of cattle, goats, hogs, horse and sheep at 1.5 ppm; fat of cattle, 
goats, hogs, horse and sheep at 33 ppm; meat byproducts of cattle, 
goats, hogs, horse and sheep at 8 ppm; milk at 6 ppm; milk fat at 75 
ppm; fat of poultry at 0.5 ppm; meat byproducts of poultry at 0.03 ppm; 
eggs at 0.05 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 OPP-2004-0042 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 March 8, 
2005.
    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 issues(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.
     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.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania

[[Page 1355]]

Ave., NW., Washington, DC 20460-0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    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 OPP-2004-0042, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services 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. You may also send an electronic copy of 
your request via e-mail to: opp-docket@epa.gov. 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 issues(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 consensus standards pursuant o 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. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and 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.



[[Page 1356]]


    Dated: December 20, 2004.
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:

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

0
2. Section 180.495 is amended by revising the table in paragraph (a) 
and by removing from the table in paragraph (b) the entry ``Beet, 
sugar, tops'' to read as follows:


Sec.  180.495  Spinosad; tolerances for residues.

    (a) * * *

----------------------------------------------------------------------------------------------------------------
                        Commodity                             Parts per million       Expiration/Revocation Date
----------------------------------------------------------------------------------------------------------------
Acerola..................................................                      1.5                          None
Almond, hulls............................................                      2.0                          None
Amaranth, grain, grain...................................                      1.0                          None
Animal feed, nongrass, group, 18.........................                     0.02                          None
Apple pomace.............................................                      0.5                          None
Artichoke, globe.........................................                      0.3                          None
Asparagus................................................                      0.2                          None
Atemoya..................................................                      0.3                          None
Avocado..................................................                      0.3                          None
Beet, sugar, molasses....................................                     0.75                          None
Biriba...................................................                      0.3                          None
Brassica, head and stem, subgroup 5A.....................                      2.0                          None
Bushberry subgroup 13B...................................                    0.250                          None
Cranberry subgroup 13A...................................                      0.7                          None
Canistel.................................................                      0.3                          None
Cattle, fat..............................................                       33                          None
Cattle, meat.............................................                      1.5                          None
Cattle, meat byproducts..................................                        8                          None
Cherimoya................................................                      0.3                          None
Citrus, oil..............................................                      3.0                          None
Citrus, dried pulp.......................................                      0.5                          None
Coriander, leaves........................................                      8.0                          None
Corn, forage.............................................                      1.0                          None
Corn, hay................................................                      1.0                          None
Corn, stover.............................................                      1.0                          None
Corn, straw..............................................                      1.0                          None
Corn, sweet, kernel plus cob with husks removed..........                     0.02                          None
Cotton gin byproducts....................................                      1.5                          None
Cotton, undelinted seed..................................                     0.02                          None
Cranberry................................................                     0.01                          None
Custard apple............................................                      0.3                          None
Egg......................................................                     0.05                          None
Feijoa...................................................                      .05                          None
Fig......................................................                     0.10                          None
Fruit, citrus group......................................                      0.3                          None
Fruit, pome, group 11....................................                     0.20                          None
Fruit, stone, group 12...................................                     0.20                          None
Goat, fat................................................                       33                          None
Goat, meat byproducts....................................                        8                          None
Goat, meat...............................................                      1.5                          None
Grain, aspirated fractions...............................                      200                          None
Grain, cereal, group 15..................................                      1.5                          None
Grape....................................................                     0.50                          None
Grape, raisin............................................                     0.70                          None
Grass, forage, fodder and hay, group 17..................                     0.02                          None
Guava....................................................                      0.3                          None
Herb, dried, subgroup....................................                       22                          None
Herb, fresh, subgroup....................................                      3.0                          None
Hog, fat.................................................                       33                          None
Hog, meat byproducts.....................................                      8.0                          None
Hog, meat................................................                      1.5                          None
Horse, fat...............................................                       33                          None
Horse, meat byproducts...................................                      8.0                          None
Horse, meat..............................................                      1.5                          None
Ilama....................................................                      0.3                          None
Jaboticaba...............................................                      0.3                          None
Juneberry................................................                     0.25                          None
Leafy vegetables (except Brassica vegetables group)......                      8.0                          None
Legume vegetables, edible podded (Crop Subgroup 6A)......                     0.30                          None
Legume vegetables, dried shell pea and bean (Crop                             0.02                          None
 Subgroup 6C)............................................
Legume vegetables, succulent shelled pea and bean (Crop                       0.02                          None
 Subgroup 6B)............................................
Lingonberry..............................................                    0.250                          None
Longan...................................................                      0.3                          None
Lychee...................................................                      0.3                          None
Mango....................................................                      0.3                          None

[[Page 1357]]

 
Milk.....................................................                      6.0                          None
Milk, fat................................................                       75                          None
Nut, tree, group 14......................................                     0.02                          None
Okra.....................................................                     0.40                          None
Papaya...................................................                      0.3                          None
Passionfruit.............................................                      0.3                          None
Peanut...................................................                     0.02                          None
Pistachio................................................                    0.020                          None
Poultry, fat.............................................                      0.5                          None
Poultry, meat byproducts.................................                     0.03                          None
Poultry, meat............................................                     0.02                          None
Pulasan..................................................                      0.3                          None
Rambutan.................................................                      0.3                          None
Rice, hulls..............................................                      4.0                          None
Salal....................................................                    0.250                          None
Sapodilla................................................                      0.3                          None
Sapote, black............................................                      0.3                          None
Sapote, mamey............................................                      0.3                          None
Sapote, white............................................                      0.3                          None
Sheep, fat...............................................                       33                          None
Sheep, meat byproducts...................................                      8.0                          None
Sheep, meat..............................................                      1.5                          None
Sorghum, forage..........................................                      1.0                          None
Sorghum, forage, hay.....................................                      1.0                          None
Sorghum, grain, stover...................................                      1.0                          None
Sorghum, straw...........................................                      1.0                          None
Soursop..................................................                      0.3                          None
Soybean..................................................                     0.02                          None
Spanish lime.............................................                      0.3                          None
Star apple...............................................                      0.3                          None
Starfruit................................................                      0.3                          None
Strawberry...............................................                      1.0                          None
Sugar apple..............................................                      0.3                          None
Ti, leaves...............................................                     10.0                          None
Vegetable, brassica, leafy, group 5......................                     10.0                          None
Vegetable, cucurbit (cucumber, melon, squashes), group 9.                      0.3                          None
Vegetable, foliage of legume, group 7....................                      8.0                          None
Vegetable, fruiting, group 8.............................                      0.4                          None
Vegetable, leaves of root and tuber, group 2.............                     10.0                          None
Vegetable, root and tuber, group 1.......................                     0.10                          None
Watercress...............................................                      8.0                          None
Wax jambu................................................                      0.3                          None
Wheat, forage............................................                      1.0                          None
Wheat, hay...............................................                      1.0                          None
Wheat, straw.............................................                      1.0                          None
----------------------------------------------------------------------------------------------------------------


[FR Doc. 05-88 Filed 1-6-05; 8:45 am]
BILLING CODE 6560-50-S