[Federal Register Volume 66, Number 6 (Tuesday, January 9, 2001)]
[Rules and Regulations]
[Pages 1592-1599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-119]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301097; FRL-6760-2]
RIN 2070-6760-2


Spinosad; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of spinosad in or on alfalfa forage, alfalfa hay, sugar beets, 
sugar beet tops, sugar beet molasses, grass forage, grass hay, peanuts, 
and peanut hay and, modifies tolerances for livestock commodities on a 
time-limited basis. This action is in response to EPA's granting of an 
emergency exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act authorizing use of the pesticide on 
alfalfa, sugar beets, pastureland and rangeland, and peanuts. This 
regulation establishes maximum permissible levels for residues of 
spinosad on these food commodities. These tolerances will expire and 
are revoked on December 31, 2002.

DATES: This regulation is effective January 9, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301097, 
must be received by EPA on or before March 12, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301097 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number:(703)308-9367; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected categories and entities may include, but are not 
limited to:

------------------------------------------------------------------------
                                                 Examples of Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of This 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301097. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing tolerances for residues of the insecticide 
spinosad, in or on the following commodities: alfalfa, forage at 4.0 
parts per million (ppm); alfalfa, hay at 4.0 ppm; beet, sugar at 0.020 
ppm; beet, sugar, tops at 10.0 ppm; beet, sugar, molasses at 0.250 ppm; 
grass, forage at 7.0 ppm; grass, hay at 7.0 ppm; peanut at 0.020 ppm; 
and peanut, hay at 10.0 ppm.
    Furthermore, tolerances for livestock commodities are being 
modified, on a time-limited basis, as follows: meat of cattle, horses, 
goats, hogs, and sheep from 0.15 to 0.60 ppm; fat of cattle, horses, 
goats, hogs, and sheep from 3.5 to 15.0 ppm; meat byproducts (mbyp) of 
cattle, horses, goats, hogs, and sheep from 1.0 ppm to 3.50 ppm; milk, 
whole from 0.5 to 2.0 ppm; milk, fat from 5.0 ppm to 20.0 ppm; eggs 
from 0.02 to 0.030 ppm; and poultry, fat from 0.2 ppm to 0.30 ppm. 
These tolerances will expire and are revoked on December 31, 2002. EPA 
will publish a document in the Federal Register to remove the revoked 
tolerances from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of Federal Insecticide, Fungicide, and Rodenticide Act FIFRA. Such 
tolerances can be established without providing notice or period for 
public comment. EPA does not intend for its actions on section 18 
related tolerances to set binding precedents for the application of 
section 408 and the new safety standard to other tolerances and 
exemptions. Section 408(e) of the FFDCA allows EPA to establish a 
tolerance or an exemption from the requirement of a tolerance on its 
own initiative, i.e., without having

[[Page 1593]]

 received any petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by the Food Quality Protection Act (FQPA). EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Spinosad on Alfalfa, Pastureland and 
Rangeland, Peanuts, and Sugarbeets and FFDCA Tolerances

    The states of Texas, New Mexico, Kansas and Oklahoma all requested 
the use of spinosad to control an emergency situation with the beet 
armyworm on alfalfa. The states of Texas and New Mexico requested the 
use of spinosad to control an emergency situation with the beet 
armyworm in peanuts. The state of California requested the use of 
spinosad on sugar beets to control armyworms, and the state of Arkansas 
requested the use of spinosad to control armyworms in pastureland and 
rangeland. EPA has authorized under FIFRA section 18 the use of 
spinosad on alfalfa in Texas, New Mexico, Kansas, and Oklahoma to 
control the beet armyworm; on peanuts in Texas and in New Mexico to 
control the beet armyworm; on sugar beets in California to control 
armyworms; and on pastureland and rangeland in Arkansas for control of 
armyworms. After having reviewed the submissions, EPA concurs that 
emergency conditions exist for these states.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of spinosad in or on alfalfa, 
peanuts, sugar beets and pastureland and rangeland. In doing so, EPA 
considered the safety standard in FFDCA section 408(b)(2), and EPA 
decided that the necessary tolerances under FFDCA section 408(l)(6) 
would be consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemptions in 
order to address urgent non-routine situations and to ensure that the 
resulting food is safe and lawful, EPA is issuing these tolerances 
without notice and opportunity for public comment as provided in 
section 408(l)(6). Although these tolerances will expire and are 
revoked on December 31, 2002, under FFDCA section 408(l)(5), residues 
of the pesticide not in excess of the amounts specified in the 
tolerances remaining in or on alfalfa forage, alfalfa hay, sugar beets, 
sugar beet tops, sugar beet molasses, grass forage, grass hay, peanuts, 
peanut hay and the modified livestock commodity tolerances after that 
date will not be unlawful, provided the pesticide is applied in a 
manner that was lawful under FIFRA, and the residues do not exceed a 
level that was authorized by these tolerances at the time of that 
application. EPA will take action to revoke these tolerances earlier if 
any experience with, scientific data on, or other relevant information 
on this pesticide indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether spinosad meets 
EPA's registration requirements for use on many or whether permanent 
tolerances for these uses would be appropriate. Under these 
circumstances, EPA does not believe that these tolerances serve as a 
basis for registration of spinosad by a State for special local needs 
under FIFRA section 24(c). Nor do these tolerances serve as the basis 
for any States other than Texas, New Mexico, Kansas and Oklahoma for 
alfalfa; Texas and New Mexico for peanuts; California for sugarbeets; 
or Arkansas for pastureland and rangeland to use this pesticide on 
these crops under section 18 of FIFRA without following all provisions 
of EPA's regulations implementing section 18 as identified in 40 CFR 
part 166. For additional information regarding the emergency exemption 
for spinosad, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of spinosad 
and to make a determination on aggregate exposure, consistent with 
section 408(b)(2), for time-limited tolerances for residues of spinosad 
in or on alfalfa, forage at 4.0 ppm; alfalfa, hay at 4.0 ppm; beet, 
sugar at 0.020 ppm; beet, sugar, tops at 10.0 ppm; beet, sugar, 
molasses at 0.250 ppm; grass, forage at 7.0 ppm; grass, hay at 7.0 ppm; 
peanut at 0.020 ppm; and peanut, hay at 10.0 ppm, as well as the 
modified tolerances for livestock commodities as follows: meat of 
cattle, horses, goats, hogs, and sheep from 0.15 to 0.60 ppm; fat of 
cattle, horses, goats, hogs, and sheep from 3.5 to 15.0 ppm; meat 
byproducts of cattle, horses, goats, hogs, and sheep from 1.0 ppm to 
3.50 ppm; milk, whole from 0.5 to 2.0 ppm; milk, fat from 5.0 ppm to 
20.0 ppm; eggs from 0.02 to 0.03 ppm; and poultry, fat from 0.2 ppm to 
0.30 ppm. EPA's assessment of the dietary exposures and risks 
associated with establishing the tolerances follows.

A. 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 endpoint. 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 intra species differences.
    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

[[Page 1594]]

the RfD is equal to the NOAEL divided by the appropriate UF (RfD = 
NOAEL/UF). Where an additional safety factor is retained due to 
concerns unique to the FQPA, 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 FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (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 is expressed as 1 x 10-\6\ or one in a million). 
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 shown in the 
following Table 1:

       Table 1.--Summary of Toxicological Dose and Endpoints for Spinosad for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                FQPA SF\*\ and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of                       N/A                      N/A  No appropriate endpoint
 age                                                                                      available; risk
                                                                                          assessment not
                                                                                          required
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population                           N/A                      N/A  No appropriate endpoint
 including infants and children                                                           available; risk
                                                                                          assessment not
                                                                                          required
----------------------------------------------------------------------------------------------------------------
Chronic Dietary all populations         NOAEL = 2.68 mg/kg/day      FQPA SF = 1x cPAD =  Chronic Toxicity - Dog
                                        UF = 100 Chronic RfD =    chronic RfD FQPA SF =   LOAEL = 8.22 mg/kg/day
                                               0.027 mg/kg/day          0.027 mg/kg/day   based on vacuolation
                                                                                          in glandular cells
                                                                                          (parathyroid) and
                                                                                          lymphatic tissues,
                                                                                          arteritis and
                                                                                          increases in serum
                                                                                          enzymes such as
                                                                                          alanine
                                                                                          aminotransferase, and
                                                                                          aspartate
                                                                                          aminotransferase, and
                                                                                          triglyceride levels
----------------------------------------------------------------------------------------------------------------
Short-Term Dermal (1 to 7 days)                            N/A                      N/A  No appropriate endpoint
 (Residential)                                                                            available. No dermal
                                                                                          absorption expected
                                                                                          based on lack of
                                                                                          toxicity at 1000 mg/kg/
                                                                                          day in a 21-day dermal
                                                                                          toxicity study in rats
                                                                                          as well as molecular
                                                                                          structure and size.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Dermal (1 week to                        N/A                      N/A  No appropriate endpoint
 several months) (Residential)                                                            available. No dermal
                                                                                          absorption expected
                                                                                          based on lack of
                                                                                          toxicity at 1000 mg/kg/
                                                                                          day in a 21-day dermal
                                                                                          toxicity study in rats
                                                                                          as well as molecular
                                                                                          structure and size.
----------------------------------------------------------------------------------------------------------------
Long-Term Dermal (several months to                        N/A                      N/A  No appropriate endpoint
 lifetime) (Residential)                                                                  available; use pattern
                                                                                          does not indicate a
                                                                                          need for this risk
                                                                                          assessment
----------------------------------------------------------------------------------------------------------------
Short-Term Inhalation (1 to 7 days)                        N/A                      N/A  The low toxicity, use
 (Residential)                                                                            pattern and
                                                                                          application rate does
                                                                                          not indicate a need
                                                                                          for risk assessment
                                                                                          via this route.
----------------------------------------------------------------------------------------------------------------
Intermediate-Term Inhalation (1 week                       N/A                      N/A  The low toxicity, use
 to several months) (Residential)                                                         pattern and
                                                                                          application rate does
                                                                                          not indicate a need
                                                                                          for risk assessment
                                                                                          via this route.
----------------------------------------------------------------------------------------------------------------
Long-Term Inhalation (several months                       N/A                      N/A  The low toxicity, use
 to lifetime) (Residential)                                                               pattern and
                                                                                          application rate does
                                                                                          not indicate a need
                                                                                          for risk assessment
                                                                                          via this route.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)                          N/A                      N/A  No cancer endpoints
                                                                                          were identified, and
                                                                                          thus a cancer risk
                                                                                          assessment is not
                                                                                          required.
----------------------------------------------------------------------------------------------------------------
\*\The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
  unique to the FQPA.

B. 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. Tolerances range from 0.02 ppm 
(many commodities; limit of quantitation) to 20 ppm (aspirated grain 
fractions). Risk

[[Page 1595]]

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 acute dietary exposure risk assessment is not 
required because the Agency did not identify an acute dietary endpoint 
that was applicable to females (13+ years) or to the general 
population, including infants and children.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. Tolerance level residues were used for all 
commodities with the exception of the following: anticipated residues 
were used for the livestock feed commodities from alfalfa, peanuts, 
pastures and rangeland, and sugar beets. This Tier 2 DEEM analysis 
shows that dietary (food only) exposure estimates are below the 
Agency's level of concern for all population subgroups. The highest 
chronic dietary exposure was for children 1-6 years old at 0.015291 mg/
kg/day, representing 57% of the chronic PAD (cPAD). Exposure for the 
U.S. population was 0.007679 mg/kg/day, representing 28% of the cPAD.
    iii. Cancer. No cancer endpoints were identified, and thus a cancer 
risk assessment is not required.
    iv. Anticipated residue and percent crop treated information. 
Section 408(b)(2)(E) 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), 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.
    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 Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
SCI-GROW, which predicts pesticide concentrations in groundwater. In 
general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS 
(a tier 2 model) for a screening-level assessment for surface water. 
The GENEEC model is a subset of the PRZM/EXAMS model that uses a 
specific high-end runoff scenario for pesticides. GENEEC incorporates a 
farm pond scenario, while PRZM/EXAMS incorporate an index reservoir 
environment in place of the previous pond scenario. The PRZM/EXAMS 
model includes 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 coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever 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) from these models 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 below.
    Based on the PRZM/EXAMS and SCI-GROW models the estimated 
environmental concentrations (EECs) of spinosad for chronic exposures 
are estimated to be 0.057 parts per billion (ppb) for surface water and 
0.006 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    No acute dietary, cancer, short-term, intermediate-term, or chronic 
dermal or inhalation endpoints were identified by the Agency. Spinosad 
is currently registered on turf grass, creating a potential for non-
dietary oral exposure to children who ingest grass. To calculate a 
quantitative dietary risk from a potential ingestion of grass (in the 
absence of acute-, short-, or intermediate-term oral endpoints), the 
Agency would need to default to the chronic dietary endpoint. This 
scenario would represent a child eating grass for > 6 months 
continuously. Based on the low application rate for spinosad on turf 
(0.41 lbs.ai./A.), its non-systemic nature, its short half-life 
(especially in sunlight), and the rapid incorporation of spinosad 
metabolites into the general carbon pool, the Agency believes that 
residues of spinosad on turf grass after application would be low and 
decrease rapidly over time. The Agency believes that it is 
inappropriate to perform a quantitative dietary risk representing a 
chronic scenario from children eating spinosad residues on turf grass. 
Qualitatively, the risk from children eating spinosad residues on turf 
grass does not exceed the Agency's level of concern.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether spinosad has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
spinosad does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that spinosad has a common mechanism of toxicity 
with other substances. For information regarding

[[Page 1596]]

EPA's efforts to determine which chemicals have a common mechanism of 
toxicity and to evaluate the cumulative effects of such chemicals, see 
the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, 
November 26, 1997).

C. Safety Factor for Infants and Children

    1. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans.
    2. Developmental toxicity studies. There were no developmental 
effects that could be attributed to administration of spinosad 
technical to either rats or rabbits. The NOAEL for developmental 
toxicity is greater than or equal to 200 mg/kg/day (highest dose 
tested) for rats and greater than or equal to 50 mg/kg/day (highest 
dose tested) for rabbits.
    3. Reproductive toxicity study. The LOAEL for reproductive toxicity 
is 100 mg/kg/day based on both maternal and reproductive effects in 
rats including decreases in litter size, survival (F2 litters only), 
and body weights in the offspring, and increased incidence of dystocia 
and/or vaginal bleeding after parturition with associated increases in 
mortality in the dams. The NOAEL for reproductive (offspring and dams) 
and systemic (parental) toxicity is the same and is 10 mg/kg/day.
    4. 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. The Agency has removed the 
10x Safety Factor to account for enhanced sensitivity of infants and 
children based on (i) the completeness of the toxicological database, 
(ii) no indication of increased susceptibility of rat or rabbit fetuses 
to in utero and/or postnatal exposure, and (iii) no requirement for a 
developmental neurotoxicity study.

D. 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 the model estimates of 
a pesticide's concentration in water (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 + chronic non-dietary, non-occupational 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 USEPA Office of Water are used to calculate 
DWLOCs: 2L/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 groundwater are less than the 
calculated DWLOCs, OPP concludes with reasonable certainty that 
exposures to spinosad 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 
spinosad on drinking water as a part of the aggregate risk assessment 
process.
    1. Acute risk. No acute toxicological endpoint was identified by 
the Agency, and therefore this risk assessment is not required.
    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 28% of the cPAD for the U.S. population, 25% of 
the cPAD for all infants and 57% of the cPAD for children 1-6 years of 
age. Although spinosad is currently registered on turf grass, creating 
a potential for non-dietary oral exposure to children who ingest grass, 
the Agency believes that it is inappropriate to perform a quantitative 
dietary risk representing a chronic scenario from children eating 
spinosad residues on turf grass. Qualitatively, the risk from children 
eating spinosad residues on turf grass does not exceed the Agency's 
level of concern. In addition, despite the potential for chronic 
dietary exposure to spinosad in drinking water, after calculating 
DWLOCs and comparing them to conservative model estimated environmental 
concentrations of spinosad in surface and ground water, EPA does not 
expect the aggregate exposure to exceed 100% of the cPAD, as shown in 
the following Table 2:

                Table 2.--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           28        0.057        0.006          680
----------------------------------------------------------------------------------------------------------------
All Infants                                            0.027           25        0.057        0.006          200
----------------------------------------------------------------------------------------------------------------
Children 1-6 years of age                              0.027           57        0.057        0.006          120
----------------------------------------------------------------------------------------------------------------
Children 7-12 years of age                             0.027           40        0.057        0.006          160
----------------------------------------------------------------------------------------------------------------
Females 13-50 years of age                             0.027           24        0.057        0.006          610
----------------------------------------------------------------------------------------------------------------

[[Page 1597]]

 
Males 13-19 years of age                               0.027           26        0.057        0.006          700
----------------------------------------------------------------------------------------------------------------
Males 20+ years of age                                 0.027           23        0.057        0.006          730
----------------------------------------------------------------------------------------------------------------
Seniors 55+ years of age                               0.027           24        0.057        0.006          720
----------------------------------------------------------------------------------------------------------------

    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).
    Though residential exposure could occur with the use of spinosad, 
no toxicological effects have been identified for short-term toxicity. 
Therefore, the aggregate risk is the sum of the risk from food and 
water, which were previously addressed.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account non-dietary, non-occupational exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Though residential exposure could occur with the use of spinosad, 
no toxicological effects have been identified for intermediate-term 
toxicity. Therefore, the aggregate risk is the sum of the risk from 
food and water, which were previously addressed.
    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.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate high performance liquid chromatography using ultra violet 
detection and immunoassay methods exist to enforce tolerances for 
residues of spinosad in/on plant and animal matrices. The method may be 
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, 
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue levels 
(MRLs) established for spinosad. There are no international residue 
limits that affect this Section 18 exemption.

VI. Conclusion

    Therefore, the tolerance is established for residues of spinosad in 
or on alfalfa, forage at 4.0 ppm; alfalfa, hay at 4.0 ppm; beet, sugar 
at 0.020 ppm; beet, sugar, tops at 10.0 ppm; beet, sugar, molasses at 
0.250 ppm; grass, forage at 7.0 ppm; grass, hay at 7.0 ppm; peanut at 
0.020 ppm; and peanut, hay at 10.0 ppm. Furthermore, tolerances for 
livestock commodities are being modified, on a time-limited basis, as 
follows: meat of cattle, horses, goats, hogs, and sheep from 0.15 to 
0.60 ppm; fat of cattle, horses, goats, hogs, and sheep from 3.5 to 
15.0 ppm; meat byproducts of cattle, horses, goats, hogs, and sheep 
from 1.0 ppm to 3.50 ppm; milk, whole from 0.5 to 2.0 ppm; milk, fat 
from 5.0 ppm to 20.0 ppm; eggs from 0.02 to 0.03 ppm; and poultry, fat 
from 0.2 ppm to 0.30 ppm.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the 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 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
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 control number OPP-301097 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 12, 
2001.
    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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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) 260-4865.
    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

[[Page 1598]]

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 [email protected], or by mailing a request for information 
to Mr. Tompkins at Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460.
    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.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by the docket control number OPP-301097 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. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. 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).

VIII. Regulatory Assessment Requirements

    This final rule establishes time limited tolerances under FFDCA 
section 408. The Office of Management and Budget (OMB) has exempted 
these types of actions from review under Executive Order 12866, 
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). 
This final rule does not contain any information collections subject to 
OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., or impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Public Law 104-4). Nor does it require any prior consultation 
as specified by Executive Order 13084, entitled Consultation and 
Coordination with Indian Tribal Governments (63 FR 27655, May 19, 
1998); special considerations as required by Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or require OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under FFDCA section 408, such as the tolerances 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 FFDCA section 408(n)(4).

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and 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).

[[Page 1599]]

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: December 21, 2000.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


    2. Section 180.495 is amended by alphabetically adding commodities 
to the table in paragraph (b) to read as follows:


Sec. 180.495  Spinosad; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                            Expiration/
                 Commodity                    Parts per     revocation
                                               million         date
------------------------------------------------------------------------
Alfalfa, forage............................          4.0        12/31/02
Alfalfa, hay...............................          4.0        12/31/02
                  *        *        *        *        *
Beet, sugar................................        0.020        12/31/02
Beet, sugar, tops..........................         10.0        12/31/02
Beet, sugar, molasses......................        0.250        12/31/02
Cattle, fat................................         15.0        12/31/02
Cattle, mbyp...............................         3.50        12/31/02
Cattle, meat...............................         0.60        12/31/02
                  *        *        *        *        *
Eggs.......................................        0.030        12/31/02
Goats, fat.................................         15.0        12/31/02
Goats, mbyp................................         3.50        12/31/02
Goats, meat................................         0.60        12/31/02
Grass, forage..............................          7.0        12/31/02
Grass, hay.................................          7.0        12/31/02
Hogs, fat..................................         15.0        12/31/02
Hogs, mbyp.................................         3.50        12/31/02
Hogs, meat.................................         0.60        12/31/02
Horses, fat................................         15.0        12/31/02
Horses, mbyp...............................         3.50        12/31/02
Horses, meat...............................         0.60        12/31/02
Milk, fat..................................         20.0        12/31/02
Milk, whole................................          2.0        12/31/02
Peanut.....................................        0.020        12/31/02
Peanut, hay................................         10.0        12/31/02
Poultry, fat...............................         0.30        12/31/02
Sheep, fat.................................         15.0        12/31/02
Sheep, mbyp................................         3.50        12/31/02
Sheep, meat................................         0.60        12/31/02
------------------------------------------------------------------------

* * * * *
[FR Doc. 01-119 Filed 1-8-01; 8:45am]
BILLING CODE 6560-50-S