[Federal Register Volume 72, Number 25 (Wednesday, February 7, 2007)]
[Rules and Regulations]
[Pages 5624-5630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2003]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0918; FRL-8110-8]
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 bulb onions. 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 this pesticide on bulb onions. This regulation establishes a
maximum permissible level for residues of avermectin in this food
commodity. The tolerance expires and is revoked on December 31, 2009.
DATES: This regulation is effective February 7, 2007. Objections and
requests for hearings must be received on or before April 9, 2007, 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-2006-0918. All documents in the
docket are listed on the regulations.gov website. 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 either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the Office
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: 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
[[Page 5625]]
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.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket 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 pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
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. 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-2006-0918 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 April 9, 2007.
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-2006-0918, 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
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket'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 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 a time-limited tolerance for combined
residues of the insecticide avermectin B1 and its delta-8,9-
isomer in or on bulb onions at 0.005 parts per million (ppm). This
tolerance expires and is revoked on December 31, 2009. EPA will publish
a document in the Federal Register to remove the revoked tolerance from
the Code of Federal Regulations (CFR).
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 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 of the FFDCA 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 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) of the 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 the 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 the 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 of 1996
(FQPA). EPA has established regulations governing such emergency
exemptions in 40 CFR part 166.
III. Emergency Exemption for Avermectin on Bulb Onions and FFDCA
Tolerances
EPA has authorized under FIFRA section 18 the use of avermectin on
bulb onions for control of thrips in Colorado. Avermectin also goes by
the name abamectin, but the two names describe the same chemical. The
CAS number is the same for both (71751-41-2). After having reviewed the
materials submitted in support of the emergency exemption request, EPA
concurred with the applicant that emergency conditions existed for this
State.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of avermectin in or on bulb
onions. In doing so, EPA considered the safety standard in section
408(b)(2) of the FFDCA, and EPA decided that the necessary time-limited
tolerance under section 408(l)(6) of the 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 the
FFDCA. Although this tolerance expires and is revoked on December 31,
2009,
[[Page 5626]]
under section 408(l)(5) of the FFDCA, residues of the pesticide not in
excess of the amounts specified in the tolerance remaining in or on
bulb onions after that date will be lawful, provided the pesticide is
applied at a time and 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 EPA's registration requirements for use on bulb onions
or whether a permanent tolerance for this use would be appropriate.
Under these circumstances, EPA does not believe that this time-limited
tolerance serves as a basis for registration of avermectin by a State
for special local needs under FIFRA section 24(c). Nor does this time-
limited tolerance serve as the basis for any State other than Colorado
to use this pesticide on this crop under section 18 of FIFRA without
following all provisions of EPA's regulations implementing FIFRA
section 18 as identified in 40 CFR part 166. 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
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action. EPA has sufficient data to assess the hazards of
avermectin and to make a determination on aggregate exposure,
consistent with section 408(b)(2) of the FFDCA, for a time-limited
tolerance for combined residues of avermectin B1 and its
delta-8,9-isomer in or on bulb onions at 0.005 ppm. EPA's assessment of
the dietary exposures and risks associated with establishing the
tolerance 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 intraspecies 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 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 SF.
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 avermectin used for human risk assessment can be found in
a tolerance document published on February 16, 2005, titled
``Avermectin B1 and its delta-8,9-isomer; Pesticide
Tolerance'' (70 FR7876; FRL-7695-7).
B. Exposure Assessment
1. Dietary exposure from food and feed uses. EPA previously
established tolerances (40 CFR 180.449) for the combined residues of
avermectin B1 and its delta-8,9-isomer, in or on a variety
of raw agricultural commodities. Risk assessments were conducted by EPA
to assess dietary exposures from avermectin 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. The Dietary Exposure Evaluation Model (DEEM\TM\)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1994-1996 and 1998 nationwide Continuing
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure
to the chemical for each commodity. The following assumptions were made
for the 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, new field trial studies and food
handling establishment request. Estimated concentrations of avermectin
in drinking water were incorporated directly into the acute assessment.
ii. Chronic exposure. In conducting the chronic dietary risk
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 Tier 2 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,
percent of crop treated (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.
[[Page 5627]]
iii. Cancer. EPA did not perform a cancer aggregate exposure
assessment because avermectin B1 is classified as a Group E
chemical and is ``not likely to be carcinogenic to humans.''
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of the FFDCA authorizes EPA to use available data and information on
the anticipated residue levels of pesticide residues in food and the
actual levels of pesticide chemicals that have been measured in food.
If EPA relies on such information, EPA must pursuant to section
408(f)(1) 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. For the present action, EPA will issue such
Data Call-Ins for information relating to anticipated residues as are
required by FFDCA section 408(b)(2)(E) and authorized under FFDCA
section 408(f)(1). Such data call-ins 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 the FFDCA states that the Agency may use
data on the actual percent of food treated for assessing chronic
dietary risk only if the Agency can make the following findings:
Condition 1, that the data used are reliable and provide a valid basis
to show what percentage of the food derived from such crop is likely to
contain such pesticide residue; Condition 2, that the exposure estimate
does not underestimate exposure for any significant subpopulation
group; and Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of the FFDCA, 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%.
The Agency believes that the three conditions listed above have
been met. With respect to Condition 1, PCT estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average PCT for chronic dietary
exposure estimates. This weighted average PCT figure is derived by
averaging State-level data for a period of up to 10 years, and
weighting for the more robust and recent data. A weighted average of
the PCT reasonably represents a person's dietary exposure over a
lifetime, and is unlikely to underestimate exposure to an individual
because of the fact that pesticide use patterns (both regionally and
nationally) tend to change continuously over time, such that an
individual is unlikely to be exposed to more than the average PCT over
a lifetime. For acute dietary exposure estimates, EPA uses an estimated
maximum PCT. The exposure estimates resulting from this approach
reasonably represent the highest levels to which an individual could be
exposed, and are unlikely to underestimate an individual's acute
dietary exposure. The Agency is reasonably certain that the percentage
of the food treated is not likely to be an underestimation. As to
Conditions 2 and 3, regional consumption information and consumption
information for significant subpopulations is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which avermectin may
be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for avermectin 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 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 abamectin
represents the worst case potential contribution of abamectin 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 1-in-10 year annual mean concentration of 0.244 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-term 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:
Granular baits used to treat lawns, and indoor crack and crevice dust
products.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of
[[Page 5628]]
toxicity, EPA has not made a common mechanism of toxicity finding as to
avermectin and 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 not assumed that
avermectin has a common mechanism of toxicity with other substances.
For information regarding EPA's efforts to determine which chemicals
have a common mechanism of toxicity and to evaluate the cumulative
effects of such chemicals, see the policy statements released by EPA's
Office of Pesticide Programs concerning common mechanism determinations
and procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
C. Safety Factor for Infants and Children
In general. Section 408 of the FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database 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 MOE analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
For avermectin B1 EPA retained the default 10X factor
based on the following combination of factors:
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 milligrams/
kilogram/day (mg/kg/day)) was used as the basis for the cRfD 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.
The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against estimated drinking water
concentrations (EDWCs). The DWLOC values are not regulatory standards
for drinking water, but are theoretical upper limits on a pesticide's
concentration in drinking water in light of total aggregate exposure to
a pesticide in food and residential uses. More information on the use
of DWLOCs in dietary aggregate risk assessments can be found at http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf.
More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface and ground water EDWCs are
directly incorporated into the dietary exposure analysis, along with
food. This provides a more realistic estimate of exposure because
actual body weights and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. The resulting
exposure and risk estimates are still considered to be high end, due to
the assumptions used in developing drinking water modeling inputs. The
risk assessment for avermectin used in this tolerance document uses
this approach of incorporating water exposure directly into the dietary
exposure analysis.
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 42% of the aPAD for the U.S. population, 7%
of the aPAD for females 13 years and older, 89% of the aPAD for all
infants less than 1-year old and 71% of the aPAD for children 1-2 years
old.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
avermectin from food will utilize 9% of the cPAD for the U.S.
population, 21% of the cPAD for all infants less than 1 year old and
21% of the cPAD for children 1-2 years old. Based on the use pattern,
chronic residential exposure to residues of avermectin is not
expected..
3. Short-term and intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
Avermectin is currently registered for use(s) that could result in
short-term and intermediate-term residential exposure and the Agency
has determined that it is appropriate to aggregate chronic food and
water and short-term and intermediate-term exposures for avermectin.
Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded that food,
water and residential exposures aggregated result in the following
aggregate MOEs: 2,900 for the U.S. population, and 1,700 for children
1-2 years old. These aggregate MOEs do not exceed the Agency's level of
concern of 1,000 for aggregate exposure to food, water and residential
uses.
4. Aggregate cancer risk for U.S. population. EPA has not performed
a cancer aggregate risk assessment because avermectin has been
classified as a Group E chemical by the Agency and is ``not likely to
be carcinogenic to humans.''
5. Determination of safety. Based on these risk assessments which
indicate that all avermectin risks are below the Agency's levels of
concern, 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 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.
[[Page 5629]]
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
onions, therefore, harmonization is not an issue.
VI. Conclusion
Therefore, the time-limited tolerance is established for combined
residues of the insecticide avermectin B1 (a mixture of
avermectins containing greater than or equal to 80% avermectin
B1a (5-O-demethyl avermectin A1) and less than or
equal to 20% avermectin B1b (5-O-demethyl-25-de(1-
methylpropyl)-25-(1-methylethyl) avermectin A1)) and its
delta-8,9-isomer, in or on bulb onions at 0.005 ppm. The time-limited
tolerance expires and is revoked on December 31, 2009.
VII. Statutory and Executive Order Reviews
This final rule establishes a time-limited tolerance under section
408 of the FFDCA. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant 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 section 408 of the FFDCA, such as the
tolerance in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers, and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: January 24, 2007.
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 adding text after the heading in
paragraph (b) to read as follows:
Sec. 180.449 Avermectin B1 and its delta-8,9-isomer;
tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the residues of avermectin B1 and it delta-
8,9-isomer, in connection with use of the pesticide under section 18
emergency exemptions granted by EPA. The tolerances are specified in
the following table. The tolerances will expire on the dates specified
in the table.
[[Page 5630]]
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Commodity Parts per million Expiration/revocation date
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Onion, bulb 0.005 12/31/09
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* * * * *
[FR Doc. E7-2003 Filed 2-6-07; 8:45 am]
BILLING CODE 6560-50-S