Document ID: EPA-HQ-OPP-2008-0175-0001
Agency: epa
Document Type: Rule
Title: Avermectin: Pesticide Tolerances for Emergency Exemptions
Posted Date: 2008-11-12T05:00Z

[Federal Register: November 12, 2008 (Volume 73, Number 219)]
[Rules and Regulations]               
[Page 66775-66780]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12no08-15]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0175; FRL-8387-8]

 
Avermectin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
combined residues of the insecticide avermectin B1 and its 
delta-8,9-isomer in or on bean, lima, seed. This action is in response 
to EPA's granting of an emergency exemption under section 18 of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing 
use of the pesticide on large lima beans. This regulation establishes a 
maximum permissible level for residues of avermectin in this food 
commodity. The time-limited tolerance expires and is revoked on 
December 31, 2010.

DATES: This regulation is effective November 12, 2008. Objections and 
requests for hearings must be received on or before January 12, 2009, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0175. All documents in the 
docket are listed in the docket index available in http://
www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; e-mail address: ertman.andrew@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 code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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.

[[Page 66776]]

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

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR site at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect 
of this regulation and may also request a hearing on those objections. 
The EPA procedural regulations which govern the submission of 
objections and requests for hearings appear in 40 CFR part 178. You 
must file your objection or request a hearing on this regulation in 
accordance with the instructions provided in 40 CFR part 178. To ensure 
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2008-0175 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 January 12, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0175, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a 
time-limited tolerance for combined residues of the insecticide 
avermectin B1 and its delta-8,9-isomer in or on bean, lima, 
seed at 0.005 parts per million (ppm). This time-limited tolerance 
expires and is revoked on December 31, 2010. EPA will publish a 
document in the Federal Register to remove the revoked tolerances from 
the CFR.
    Section 408(l)(6) of 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 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 time-limited tolerances to set binding precedents 
for the application of section 408 of FFDCA and the new safety standard 
to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    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. . . 
.''
    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.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Avermectin on Large Lima Beans and FFDCA 
Tolerances

    The state of California asserts that large lima bean growers have 
few miticides to work with for controlling spider mites. Confirmed 
resistance to dicofol has been demonstrated in fields located in 
Stanislaus County. In 2006, two-spotted spider mite infestations were 
pervasive on some ranches and some growers experienced 30% crop losses 
despite use of the available registered alternatives. After having 
reviewed the submission, EPA determined that emergency conditions exist 
for this State, and that the criteria for an emergency exemption are 
met. EPA has authorized under FIFRA section 18 the use of avermectin on 
large lima beans for control of spider mites in California.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of avermectin in 
or on large lima beans. In doing so, EPA considered the safety standard 
in section 408(b)(2) of FFDCA, and EPA decided that the necessary 
tolerance under section 408(l)(6) of FFDCA would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in section 408(l)(6) of FFDCA. Although 
this time-limited tolerance expires and is revoked on December 31, 
2010, under section 408(l)(5) of FFDCA, residues of the pesticide not 
in excess of the amounts specified in the tolerance remaining in or on 
large lima beans after that date will not be unlawful, provided the 
pesticide was applied in a manner that was lawful under FIFRA, and the 
residues do not exceed a level that was authorized by this time-limited 
tolerance at the time of that application. EPA will take action to 
revoke this time-limited tolerance earlier if any experience with, 
scientific data on, or other relevant information on this pesticide 
indicate that the residues are not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions about whether 
avermectin meets FIFRA's registration requirements

[[Page 66777]]

for use on large lima beans or whether permanent tolerances for this 
use would be appropriate. Under these circumstances, EPA does not 
believe that this time-limited tolerance decision serves as a basis for 
registration of avermectin by a State for special local needs under 
FIFRA section 24(c). Nor does this tolerance serve as the basis for 
persons in any State other than California to use this pesticide on 
this crop under FIFRA section 18 absent the issuance of an emergency 
exemption applicable within that State. For additional information 
regarding the emergency exemption for avermectin, contact the Agency's 
Registration Division at the address provided under FOR FURTHER 
INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical 
residue....''
    Consistent with the factors specified in FFDCA 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 and to make a determination on aggregate 
exposure expected as a result of this emergency exemption request and 
the time-limited tolerance for combined residues of avermectin 
B1 and its delta-8,9-isomer in or on bean, lima, seed at 
0.005 ppm. EPA's assessment of exposures and risks associated with 
establishing the time-limited tolerance follows.

A. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for avermectin used for 
human risk assessment is discussed in a tolerance document entitled 
Avermectin B1 and its delta-8,9-isomer; Pesticide Tolerance 
(70 FR 7876, FRL-7695-7, February 16, 2005).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to avermectin, EPA considered exposure under the time-limited 
tolerance established by this action as well as all existing avermectin 
tolerances in (40 CFR 180.449). EPA assessed dietary exposures from 
avermectin in food as follows:
    i. Acute exposure. In estimating acute dietary exposure, EPA used 
food consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). The following assumptions were made 
for the acute exposure assessments: A Tier 3, acute probabilistic 
dietary exposure assessment was conducted for all supported food uses 
and drinking water. Acute anticipated residues for many foods were 
derived using market basket survey and new field trial studies. 
Estimated concentrations of avermectin in drinking water were 
incorporated directly into the acute assessment.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM/FCID which incorporates food consumption 
data as reported by respondents in the USDA 1994-1996 and 1998 
Nationwide CSFII, and accumulated exposure to the chemical for each 
commodity. Percent crop treated and anticipated residues refinements 
were used. A refined chronic dietary exposure assessment was conducted 
for the general U.S. population and various population subgroups. The 
assumptions of the assessment were anticipated residue estimates, PCT 
estimates for most of the commodities, and default DEEM processing 
factors when necessary. Estimated concentrations of avermectin in 
drinking water were incorporated directly into the chronic assessment.
    iii. Cancer. An aggregate exposure assessment for the purpose of 
assessing cancer risk was not performed because avermectin has been 
classified as ``not likely to be carcinogenic to humans.''
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food

[[Page 66778]]

derived from such crop is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used PCT information as follows:
    Almonds 21%; avocado 20%; balsam pear 1%; cantaloupe 7%; casabas 
1%; chayote fruit 1%; Chinese waxgourd 1%; cotton 3%; cress (garden, 
upland) 1%; cucumber 1%; grape 6%; hops 82%; honeydew melon 1%; plum 
1%; pumpkin 1%; squash 1%; strawberry 44%; walnut 2%; watermelon 7%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6 years. 
EPA uses an average PCT for chronic dietary risk analysis. The average 
PCT figure for each existing use is derived by combining available 
public and private market survey data for that use, averaging across 
all observations, and rounding to the nearest 5%, except for those 
situations in which the average PCT is less than one. In those cases, 
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA 
uses a maximum PCT for acute dietary risk analysis. The maximum PCT 
figure is the highest observed maximum value reported within the recent 
6 years of available public and private market survey data for the 
existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. As to Conditions b and c, 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 reliable information on the 
regional consumption of food to which avermectin may be applied in a 
particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for avermectin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of avermectin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm. Tier II 
screening models PRZM (Pesticide Root Zone Model) and EXAMS (Exposure 
Analysis Modeling System) were used to determine estimated surface 
water concentrations of avermectin based on the modeled scenario of one 
seed treatment to cucumbers followed by 3 aerial applications at a 7-
day interval in Florida. This use of avermectin represents the worst 
case potential contribution of avermectin to drinking water when 
considering currently registered uses, including this one. The full 
PRZM/EXAMS distribution was used for the acute dietary assessment, and 
the one in ten year annual mean concentration of 0.190 ppm was used for 
chronic dietary estimates. Modeled estimates of drinking water 
concentrations were directly entered into the dietary exposure model.
    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).
    Avermectin is currently registered for use on the following 
residential non-dietary sites: Residential lawn application for fire 
ant control and residential indoor crack and crevice application for 
cockroaches and ants. These registered residential uses may result in 
short- to intermediate-term exposures; however, based on current use 
patterns, long-term exposure (6 or more months of continuous exposure) 
to avermectin is not expected. Adults may be exposed through handling 
the pesticide and both adults and children may be exposed through 
contact with treated areas following application. Accordingly, handler 
and post-application exposures were assessed for two major categories 
of residential avermectin use which are considered to represent the 
reasonable high-end residential exposure potential:
    i. Granular baits used to treat lawns, and
    ii. Indoor crack and crevice dust products.
    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 has not found avermectin to share a common mechanism of 
toxicity with any other substances, and avermectin does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
avermectin does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at http://
www.epa.gov/pesticides/cumulative.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional SF when reliable data 
available to EPA support the choice of a different factor. For 
avermectin B1 EPA retained the default 10X factor based on 
the following combination of factors:

[[Page 66779]]

     There is residual uncertainty due to a data gap for a 
developmental neurotoxicity study (DNT), as well as data gaps for acute 
and subchronic neurotoxicity studies. These studies are required 
because avermectin B1 has been shown to be neurotoxic, with 
multiple neurotoxic clinical signs (including head and body tremors and 
limb splay) seen in multiple studies with multiple species.
     For several species, the dose-response curve appears to be 
steep.
     Severe effects were seen at the LOAELs in several studies 
(death, neurotoxicity, and developmental toxicity). Although increased 
susceptibility of the young was observed in several studies, the degree 
of concern with that susceptibility was judged to be low. Increased 
susceptibility (qualitative and/or quantitative) was seen in prenatal 
developmental toxicity studies in CD-1 mice and rabbits following in 
utero exposure to avermectin B1. There was also an increase 
in quantitative and qualitative susceptibility in the rat reproductive 
toxicity study. The concern for susceptibility seen in the 
developmental study with rabbits and in the reproductive toxicity study 
in the rat is low because the lowest NOAEL obtained (0.12 mg/kg/day) 
was used as the basis for the chronic RfD and other non-dietary risk 
assessment scenarios, which is protective of all of the developmental/
offspring effects seen in those studies. Similarly, the concern for 
susceptibility seen at the LOAEL in the CD-1 mouse developmental 
toxicity study is low, since the NOAEL in the rat reproductive toxicity 
study is lower than the dose at which effects were seen in the CD-1 
mouse.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to avermectin will occupy 93% of the aPAD for all infants less than 1 
year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
avermectin from food and water will utilize 20% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in the unit regarding residential 
use patterns, chronic residential exposure to residues of avermectin is 
not expected.
    3. Short-term and intermediate-term risk. Short-term aggregate 
exposure takes into account short-term residential exposure plus 
chronic exposure to food and water (considered to be a background 
exposure level).
    Avermectin is currently registered for uses that could result in 
short-term and intermediate-term residential exposure and the Agency 
has determined that it is appropriate to aggregate chronic exposure 
through food and water with short-term and intermediate-term 
residential exposures to avermectin.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded the combined 
short-term food, water, and residential exposures aggregated result in 
aggregate MOEs of 3,000 for the U.S. population, and 1,700 for children 
1-2 years old. These aggregate MOEs are greater than the Agency's level 
of concern of 1,000 for aggregate exposure to food, water and 
residential uses and therefore acceptable.
    4. Aggregate cancer risk for U.S. population. Avermectin has been 
classified as ``not likely to be carcinogenic to humans'' and therefore 
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, or to infants and children, from aggregate 
exposure to avermectin residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: residuemethods@epa.gov.

B. International Residue Limits

    There are no CODEX residue limits for residues of avermectin on 
bean, lima, seed.

VI. Conclusion

    Therefore, a time-limited tolerance is established for combined 
residues of the insecticide avermectin B1 and its delta-8,9-
isomer in or on bean, lima, seed at 0.005 ppm. This time-limited 
tolerance expires and is revoked on December 31, 2010.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under sections 408(e) and 
408(l)(6) 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 final 
rule has been exempted from review under Executive Order 12866, this 
final rule is not subject to Executive Order 13211, entitled Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 
13045, entitled Protection of Children from Environmental Health Risks 
and Safety Risks (62 FR 19885, April 23, 1997). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it 
require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance 
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal

[[Page 66780]]

governments, or on the distribution of power and responsibilities among 
the various levels of government or between the Federal Government and 
Indian tribes. Thus, the Agency has determined that Executive Order 
13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 9, 2000) do not apply to this final 
rule. In addition, this final rule does not impose any enforceable duty 
or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: October 31, 2008.
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 180.449 is amended by alphabetically adding a commodity to 
the table in paragraph (b) to read as follows:

Sec.  180.449  Avermectin B1 and its delta-8,9-isomer; 
tolerances for residues.

* * * * *
     (b) * * *

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
bean, lima, seed                                0.005           12/31/10
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-26876 Filed 11-12-08; 8:45 am]

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