[Federal Register Volume 73, Number 219 (Wednesday, November 12, 2008)]
[Rules and Regulations]
[Pages 66775-66780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26876]
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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: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
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: [email protected].
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]
BILLING CODE 6560-50-S