[Federal Register: February 16, 2005 (Volume 70, Number 31)]
[Rules and Regulations]
[Page 7876-7886]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16fe05-12]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0400; FRL-7695-7]
Avermectin B1 and its delta-8,9-isomer; Pesticide
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for the combined
residues of the insecticide/miticide 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 avocado at 0.020 ppm; food products in food
handling establishments (other than those already covered by higher
tolerances as a result of use on growing crops, and other than those
already covered by tolerances on milk, meat, and meat byproducts) at
0.01 ppm; herbs, subgroup 19A (except chives) at 0.030 ppm; meat and
meat byproducts of goat, hog, horse, poultry, and sheep at 0.02 ppm;
mint at 0.010 ppm; plum at 0.010 ppm; plum, prune, dried at 0.025 ppm;
vegetable, fruiting, group 8 at 0.020 ppm; and vegetable, leafy, except
Brassica, group 4 at 0.10 ppm. These tolerances were requested under
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the
Food Quality Protection Act of 1996 (FQPA) in petitions filed by
Syngenta Crop Protection, Inc. (formerly Novartis Crop Protection,
Inc.), Interregional Research Project Number 4, and Whitmire Micro-Gen
Research Laboratories, Inc.
DATES: This regulation is effective February 16, 2005. Objections and
requests for hearings must be received on or before April 18, 2005.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number OPP-2004-0400. All documents in the docket
are listed in the EDOCKET index at http://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S.
Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to
4 p.m., Monday through Friday, excluding legal holidays. The docket
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Thomas C. Harris, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 308-9423; e-mail address:
harris.thomas@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
[[Page 7877]]
B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm/
.
II. Background and Statutory Findings
As listed below, EPA published notices pursuant to section
408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of
pesticide petitions in the Federal Register requesting that 40 CFR
180.449 be amended by establishing a tolerance for combined residues of
the insecticide/miticide 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, as listed below. Note: Avermectin B1 is
also referred to as abamectin. Each notice included a summary of the
petition prepared by the registrant listed. There were no substantive
comments received in response to these notices of filing.
April 7, 2000, 65 FR 18328, FRL-6499-4, PP 9F5047: This
petition was filed by Novartis Crop Protection, Inc. (now Syngenta Crop
Protection, Inc.), P.O. Box 18300, Greensboro, NC 27419-8300 for
tolerances in or on vegetable, leafy, except Brassica, group 4 at 0.10
ppm; vegetable, fruiting, group 8 at 0.02 ppm (subsequently revised to
0.020 ppm); and plum at 0.01 ppm (subsequently revised to 0.010 ppm).
The petition was also subsequently revised to add a tolerance for plum,
prune, dried at 0.025 ppm.
September 27, 2000, 65 FR 58080, FRL-6746-4, PP 0F6146:
This petition was filed by Novartis Crop Protection, Inc. (now Syngenta
Crop Protection, Inc.), P.O. Box 18300, Greensboro, NC 27419-8300 for
tolerances in or on avocado at 0.02 ppm (subsequently revised to 0.020
ppm) and mint tops at 0.01 ppm (subsequently revised to simply mint at
0.010 ppm). Requests for tolerances for additional crops submitted in
that petition will be decided at a later date.
July 28, 2004, 69 FR 45039, FRL-7366-3, PP 2H5642: This
petition was filed by Whitmire Micro-Gen Research Laboratories, Inc.,
3568 Tree Court Industrial Blvd, St. Louis, MO 63122 for tolerances in
or on food products in food handling establishments at 0.001 ppm
(subsequently revised to 0.01 ppm). In addition, the petition was
subsequently revised to request tolerances for meat and meat byproducts
for goat, hog, horse, poultry, and sheep at 0.02 ppm.
July 28, 2004, 69 FR 45039, FRL-7366-3, PP 3E6557: This
petition was filed by Interregional Research Project Number 4, 681 U.S.
Hwy 1 South, North Brunswick, NJ 08902-3390 for tolerances in or on
herb crop subgroup 19A (except chives) at 0.03 ppm (subsequently
revised to 0.030 ppm).
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.`` Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see the final rule on
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for the combined residues of
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 avocado at 0.020
ppm; food products in food handling establishments (other than those
already covered by higher tolerances as a result of use on growing
crops, and other than those already covered by tolerances on milk,
meat, and meat byproducts) at 0.01 ppm; herbs, subgroup 19A (except
chives) at 0.030 ppm; meat and meat byproducts of goat, hog, horse,
poultry, and sheep at 0.02 ppm; mint at 0.010 ppm; plum at 0.010 ppm;
plum, prune, dried at 0.025 ppm; vegetable, fruiting, group 8 at 0.020
ppm; and vegetable, leafy, except Brassica, group 4 at 0.10 ppm. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by avermectin
B1 and its delta-8,9-isomer are discussed in Table 1 of this
unit as well as the no observed adverse effect level (NOAEL) and the
lowest observed adverse effect level (LOAEL) from the toxicity studies
reviewed.
Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
Guideline No. Study Type Results
------------------------------------------------------------------------
870.3100 Subchronic feeding NOAEL > 0.40 mg/kg/
study - rats day
LOAEL = not
established
------------------------------------------------------------------------
[[Page 7878]]
870.3150 Subchronic NOAEL = 0.25 mg/kg/
toxicity - dogs day
LOAEL = 0.50 mg/kg/
day based on body
tremors, one
death, liver
pathology,
decreased body
weight
------------------------------------------------------------------------
870.3200 21/28-Day dermal Study not
toxicity available
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL >
developmental in 1.6 mg/kg/day
rodents - rats Maternal LOAEL =
not established
Developmental
NOAEL > 1.6 mg/lg/
day
Developmental
LOAEL = not
established
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental in 1.5 mg/kg/day
rodents - CD-1 Maternal LOAEL =
mouse 3.0 mg/kg/day
based on hind
limb splay
Developmental
NOAEL < 0.75 mg/
kg/day
Developmental
LOAEL = 0.75 mg/
kg/day based on
cleft palate and
hindlimb
extension
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental in 1.0 mg/kg/day
nonrodents - Maternal LOAEL =
rabbits 2.0 mg/kg/day
based on
decreased body
weight, food
consumption and
water consumption
Developmental
NOAEL = 1.0 mg/kg/
day
Developmental
LOAEL = 2.0 mg/kg/
day based on
cleft palate,
clubbed foot,
delayed
ossification of
sternebrae,
metacarpals,
phalanges
------------------------------------------------------------------------
870.3800 2-Generation Parental/Systemic
reproduction and NOAEL = 0.40 mg/
fertility effects kg/day
- rat LOAEL =not
established
Reproductive NOAEL
= 0.40 mg/kg/day
LOAEL = not
established
Offspring NOAEL =
0.12 mg/kg/day
LOAEL = 0.40 mg/kg/
day based on
increased retinal
folds, increased
dead pups at
birth, decreased
viability and
lactation
indices,
decreased pup
body weight
------------------------------------------------------------------------
870.3800 1-Generation Parental/Systemic
reproduction and NOAEL = 1.0 mg/kg/
fertility effects day.
- rat LOAEL = 1.5/2.0
based on whole
body tremors,
ataxia, ptyalis,
ocular/nasal
discharges and
mortality
Reproductive NOAEL
= 3.0 mg/kg/day
Offspring NOAEL <
0.5 mg/kg/day
LOAEL = 0.5 mg/kg/
day based on
decreased pup
survival and body
weight between
days 1-21 and
delay in opening
of eyes
------------------------------------------------------------------------
870.3800 1-Generation Parental/Systemic
reproduction and NOAEL = 0.4 mg/kg/
fertility effects day
- rat LOAEL = not
established
Reproductive NOAEL
= 0.4 mg/kg/day
Offspring NOAEL
=0.1 mg/kg/day
LOAEL = 0.2 mg/kg/
day based on
reduced pup
weight, spastic
movements,
delayed incisor
eruption
------------------------------------------------------------------------
870.3800 1-Generation Parental/Systemic
reproduction and NOAEL = 0.4 mg/kg/
fertility effects day
- rat LOAEL = not
established
Reproductive NOAEL
= 0.4 mg/kg/day
Offspring NOAEL =
0.4 mg/kg/day
LOAEL = not
established
------------------------------------------------------------------------
870.4100 Chronic toxicity - NOAEL = 0.25 mg/kg/
dogs day
LOAEL = 0.5 mg/kg/
day based on
mydriasis, death
at 1.0 mg/kg/day
------------------------------------------------------------------------
870.4300 Combined chronic NOAEL = 1.5 mg/kg/
toxicity/ day
carcinogenicity - LOAEL = 2.0 mg/kg/
rats day based on
tremors
No evidence of
carcinogenicity
------------------------------------------------------------------------
870.4300 Combined chronic NOAEL = 4.0 mg/kg/
toxicity/ day
carcinogenicity - LOAEL = 8.0 mg/kg/
mice day based on
increased
mortality in
males, tremors,
body weight
decreases in
females,
dermatitis in
males,
extramedullary
hematopoiesis in
spleen of males
No evidence of
carcinogenicity
------------------------------------------------------------------------
870.5100 Gene mutation Negative both with
Ames/Salmonella E. and without S-9
coli/mammalian
gene mutation
assay.
------------------------------------------------------------------------
[[Page 7879]]
870.5100 Gene mutation Negative both with
Ames/Salmonella E. and without S-9
coli/mammalian up to 3,000 [mu]g/
gene mutation plate
assay.
------------------------------------------------------------------------
870.5100 Gene mutation Negative both with
Ames/Salmonella E. and without S-9
coli/mammalian
gene mutation
assay.
------------------------------------------------------------------------
870.5300 Gene mutation Negative
CHO/HGPRTforward
mutation assay.
------------------------------------------------------------------------
870.5300 Gene mutation Not mutagenic for
Mammalian cells in V79 cells in
culture in V79 absence of S-9,
cells. but in the
presence of S-9
appeared to have
a mutagenic
potential,
provided the test
cells had an
appropriate level
of sensitivity
------------------------------------------------------------------------
870.5395 Cytogenetics in No chromosomal
vivo micronucleus aberrations in
assay - male mice male mice, but
females not
tested
------------------------------------------------------------------------
870.5550 Other effects Single strand DNA
breaks at 0.3 and
0.6 mM in rat
hepatocytes in
vitro, but
negative when
hepatocytes from
rat at LD50 dose
level was used
------------------------------------------------------------------------
non-guideline Metabolism 69-82% of label is
excreted in feces
by day 7; T1/89/
21/13/23
/5/83/8 =1.2
days. The
reliability of
these data is
questionable
------------------------------------------------------------------------
non-guideline Metabolism Avermectin B1a did
not bioaccumulate
in rat tissues.
Half-life
slightly longer
in females than
in males for
several tissues
------------------------------------------------------------------------
non-guideline Metabolism The metabolism of
avermectin B1 in
rats results in
the formation of
24-OH-Me-B1a and
accounts for most
of the
radiolabeled
residues.
Avermectin B1a
does not
bioaccumulate
------------------------------------------------------------------------
870.7600 Dermal penetration Dermal penetration
is 1%
------------------------------------------------------------------------
Additional data, from studies conducted in CF-1 mice, are also
available and were included in a developmental toxicity review
conducted by the Agency. However, additional data were submitted by the
registrant documenting that the extreme sensitivity of CF-1 mice to
abamectin, resulting in developmental toxicity, was due to a genetic
lack of p-glycoprotein (a genetic finding specific to the CF-1 mouse
strain). EPA has concluded that the CF-1 mouse data are inappropriate
for use in risk assessment for abamectin.
B. Toxicological Endpoints
The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological level of concern
(LOC). However, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns. An UF of 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
Three other types of safety or uncertainty factors may be used:
``Traditional uncertainty factors;'' the ``special FQPA safety
factor;'' and the `` default FQPA safety factor.'' By the term
``traditional uncertainty factor,'' EPA is referring to those
additional uncertainty factors used prior to FQPA passage to account
for database deficiencies. These traditional uncertainty factors have
been incorporated by the FQPA into the additional safety factor for the
protection of infants and children. The term ``special FQPA safety
factor'' refers to those safety factors that are deemed necessary for
the protection of infants and children primarily as a result of the
FQPA. The ``default FQPA safety factor'' is the additional 10X safety
factor that is mandated by the statute unless it is decided that there
are reliable data to choose a different additional factor (potentially
a traditional uncertainty factor or a special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of
100 to account for interspecies and intraspecies differences and any
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor is
used, this additional factor is applied to the RfD by dividing the RfD
by such additional factor. The acute or chronic Population Adjusted
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this
type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the 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). An example of how such a probability risk is expressed
would be to
[[Page 7880]]
describe the risk as one in one hundred thousand (1 x 105),
one in a million (1 x 106), or one in ten million (1 x
107). 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
B1 and its delta-8,9-isomer used for human risk assessment
is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for Avermectin B1 and its delta-8,9-isomer for Use in
Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure/Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (general population, NOAEL = 0.25 mg/kg/day Special FQPA SF= 1 1-Year Oral Study in
including infants and children and UF = 1,0001............ aPAD = acute RfD / FQPA the Dog
females 13-50) Acute RfD = 0.00025 mg/ SF= 0.00025 mg/kg/day. LOAEL = 0.50 mg/kg/day
kg/day. based on mydriasis
seen at week 1 of
dosing.
-----------------------------------------------------------------------------------------
Chronic dietary(all populations) NOAEL = 0.12 mg/kg/day Special FQPA SF = 1 2-Generation
UF = 1,000\1\.......... cPAD = chronic RfD / reproduction in the
Chronic RfD = 0.00012 FQPA SF= 0.00012 mg/kg/ rat
mg/kg/day. day. LOAEL = 0.40 mg/kg/day
based on decreased pup
body weight and
viability during
lactation, and
increased incidence of
retinal rosettes in
F2b weanlings
-----------------------------------------------------------------------------------------
Short-term and intermediate-term NOAEL = 0.12 mg/kg/day Residential LOC for MOE 2-Generation
incidental oral (1 day-6 months) = 1,000\1\ reproduction in the
Occupational = NA...... rat
LOAEL = 0.40 mg/kg/day
based on decreased pup
body weight and
viability during
lactation, and
increased incidence of
retinal rosettes in
F2b weanlings
-----------------------------------------------------------------------------------------
Dermal (all durations) Oral study NOAEL = 0.12 Residential LOC for MOE 2-Generation
mg/kg/day (dermal = 1,000\1\ reproduction in the
absorption rate = 1%) Occupational LOC for rat
MOE = 100. LOAEL = 0.40 mg/kg/day
based on decreased pup
body weight and
viability during
lactation, and
increased incidence of
retinal rosettes in
F2b weanlings
-----------------------------------------------------------------------------------------
Inhalation (all durations) Oral study NOAEL = 0.12 Residential LOC for MOE 2-Generation
mg/kg/day (inhalation = 1,000\1\ reproduction in the
absorption rate = Occupational LOC for rat
100%) MOE = 100. LOAEL = 0.40 mg/kg/day
based on decreased pup
body weight and
viability during
lactation, and
increased incidence of
retinal rosettes in
F2b weanlings
-----------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) EPA classified Avermectin B1 as ``not likely to be carcinogenic to
humans'' based on the absence of significant tumor increases in two
adequate rodent carcinogenicity studies.
----------------------------------------------------------------------------------------------------------------
NA = Not Applicable
\1\Includes a 10X FQPA Safety Factor to account for the lack of a DNT study, the steepness of the dose/response
curve in several studies, and the severity of effects (death, neurotoxicity, and developmental toxicity) seen
at the LOAELs.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (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. Permanent tolerances were previously
established for almond; almond, hulls; apple; apple, wet pomace;
cattle, fat; cattle, meat byproducts; cattle, meat; celeriac, roots;
celeriac, tops; celery; citrus, dried pulp; citrus, oil; citrus; cotton
gin byproducts; cotton seed; cucurbits; grape; hop, dried cone;
lettuce, head; milk; pear; pepper; potato; strawberry; tomato; walnut.
Temporary tolerances were established for avocado, basil, spinach. Risk
assessments were conducted by EPA to assess dietary exposures from
avermectin B1 and its delta-8,9-isomer 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 1-day or
single exposure.
In conducting the acute dietary risk assessment EPA used the
Dietary Exposure Evaluation Model (DEEMTM) software with the
Food Commodity Intake Database (FCID) and the LifelineTM
model version 2.0), which incorporate food consumption data as reported
by respondents in the U.S. Department of Agricultural (USDA) 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
Percent crop treated and anticipated residues were used.
A highly refined Tier 3 acute dietary exposure assessment was
conducted for the general U.S. population and various population
subgroups. This was a probabilistic assessment using anticipated
residues from the current and previously submitted field trial and
market basket data, USDA Pesticide Data Program (PDP) monitoring data,
percent crop treated (%CT) estimates for most of the commodities, and
default DEEMTM version 7.76 processing factors when
monitoring data were not available.
The acute dietary exposure estimates are below EPA's level of
concern
[[Page 7881]]
(< 100% aPAD) at the 99.9th exposure percentile for the general U.S.
population (35% aPAD using LifelineTM and 34% aPAD using
DEEMTM software with the FCID and all other population
subgroups. The most highly exposed population subgroup is children 1- 2
years old, at 64% aPAD using LifelineTM and 65% aPAD using
DEEMTM/FCID. The acute assessment was highly refined;
however, inclusion of additional %CT data and modified concentration/
processing factors could aid in further refining the acute dietary
assessment.
ii. Chronic exposure. In conducting the chronic dietary risk
assessment EPA used the DEEMTM/FCID and the
LifelineTM model version 2.0, which incorporate 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 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, %CT
estimates for most of the commodities, and default DEEMTM
(version 7.76) processing factors when necessary.
The chronic dietary exposure estimates are below EPA's level of
concern (< 100% cPAD) for the general U.S. population (4% of the cPAD
using both models) and all population subgroups. The most highly
exposed population subgroup is children 1-2 years old, at 13% cPAD
using LifelineTM and 14 %cPAD using DEEMTM/FCID.
The chronic assessment was somewhat refined; inclusion of additional
anticipated residues, more %CT information, and modified concentration/
processing factors would further refine the chronic dietary assessment.
iii. Cancer. A cancer aggregate exposure assessment was not
performed because avermectin B1 is classified as ``not
likely to be carcinogenic to humans.''
iv. Anticipated residue and percent crop treated (PCT) information.
The Agency used the anticipated residues from field trial data, market
basket data, PDP monitoring data, and percent crop treated data to
conduct a dietary exposure analysis.
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 FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings: Condition 1,
that the data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
The Agency believes that the three conditions have been met. With
respect to condition 1, EPA finds that the PCT information is reliable
and has a valid basis. The Agency has utilized statistical data from a
number of public and proprietary sources including USDA/National
Agricultural Statistics Service, Doane, Maritz, Kline, and National
Center for Food and Agricultural Policy. The following PCT information
was used in this analysis: Almonds 21%; apples 9%; avocado 20%; basil
100%; casabas 1%; celeriac 100%; celery 51%; citrus (except orange)
49%; cotton 3%; cress (garden, upland) 1%; eggplant 6%; endive 9%;
grape 6%; hops 82%; lettuce 17%; melons (except casabas) 7%; mint 100%;
orange 26%; pear 62%; peppers 8%; plum 1%; potato 1%; squash and
cucumber 1%; spinach 9%; strawberry 44%; tomato 6%; walnut 2%.
With respect to conditions 2 and 3, the 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 consumption of food bearing
avermectin B1 and its delta-8,9-isomer 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 B1 and
its major soil degradates (a mixture of an 8-[alpha]-hydroxy and a ring
opened aldehyde derivative) 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
B1 and its major soil degradates (a mixture of an 8-[alpha]-
hydroxy and a ring opened aldehyde derivative).
The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or
the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/
EXAMS), to produce estimates of pesticide concentrations in an index
reservoir. The Screening Concentration In Ground Water (SCI-GROW) model
is used to predict pesticide concentrations in shallow ground water.
For a screening-level assessment for surface water, EPA will use FIRST
(a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model). The FIRST
model is a subset of the PRZM/EXAMS model that uses a specific high-end
runoff scenario for pesticides. Both FIRST and PRZM/EXAMS incorporate
an index reservoir environment, and both models include a percent crop
area factor as an adjustment to account for the maximum percent crop
coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a
[[Page 7882]]
screen for sorting out pesticides for which it is unlikely that
drinking water concentrations would exceed human health levels of
concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs), which are the model estimates of a
pesticide's concentration in water, to quantify drinking water exposure
and risk as a %RfD or %PAD. Instead drinking water levels of comparison
(DWLOCs) are calculated and used as a point of comparison against the
model estimates of a pesticide's concentration in water. DWLOCs are
theoretical upper limits on a pesticide's concentration in drinking
water in light of total aggregate exposure to a pesticide in food, and
from residential uses. Since DWLOCs address total aggregate exposure to
avermectin B1 and its degradates they are further discussed
in the aggregate risk sections in Unit E.
Based on the PRZM and EXAMS models/index reservoir scenario and
SCI-GROW models, the EECs of avermectin B1 and its major
soil degradates (a mixture of an 8-[alpha]-hydroxy and a ring opened
aldehyde derivative) for acute exposures are estimated to be 0.34 parts
per billion (ppb) for surface water and 0.0017 ppb for ground water.
The EECs for chronic exposures are estimated to be 0.14 ppb for surface
water and 0.0017 ppb for ground water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Avermectin B1 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. Because the FQPA requires
consideration of aggregate exposure to all likely non-occupational
uses, this assessment includes contact with Avermectin B1
from residential crack and crevice and lawn treatments as the most
common and worst-case contributors to such exposures. The MOEs for
applicable residential scenarios were calculated using limited exposure
monitoring data and the Standard Operating Procedures for Residential
Exposure Assessments (Draft, December 18, 1997), along with interim
changes presented in Science Advisory Council for Exposure SOP No.11
(February 22, 2001). For the indoor crack and crevice treatment,
measured airborne and surface residue data were available to perform an
assessment of postapplication inhalation, dermal and incidental oral
risks. Combined residential exposures/risks were estimated for adults
and for children.
Children's exposure from incidental ingestion of granules on
treated lawns was compared to the acute dietary NOAEL of 0.25 mg/kg/
day. The exposure/risk from this latter scenario was not combined with
other scenarios, nor was it included in the aggregate assessment,
because it is considered to be a one-time, episodic event, rather than
occurring for several days (or several months).
The MOEs for all residential scenarios are greater than the LOC of
1,000, and therefore, are not of concern.
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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to avermectin B1
and any other substances and avermectin B1 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 B1 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 concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's web site at http://www.epa.gov/pesticides/cumulative/
.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the 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. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
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 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.
E. Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency
[[Page 7883]]
calculates DWLOCs which are used as a point of comparison against EECs.
DWLOC values are not regulatory standards for drinking water. DWLOCs
are theoretical upper limits on a pesticide's concentration in drinking
water in light of total aggregate exposure to a pesticide in food and
residential uses. In calculating a DWLOC, the Agency determines how
much of the acceptable exposure (i.e., the PAD) is available for
exposure through drinking water (e.g., allowable chronic water exposure
(mg/kg/day) = cPAD - (average food + residential exposure)). This
allowable exposure through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by EPA's Office of Water are used to calculate DWLOCs: 2
liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concludes with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposure for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. If new
uses are added in the future, EPA will reassess the potential impacts
of residues of the pesticide in drinking water as a part of the
aggregate risk assessment process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
avermectin B1 and its delta-8,9-isomer will occupy 35% of
the aPAD for the U.S. population, 32% of the aPAD for females 13 years
and older, 62% of the aPAD for all infants (< 1 year old), and 65% of
the aPAD for children (1-2 years old). In addition, there is potential
for acute dietary exposure to avermectin B1 and its major
soil degradates (a mixture of an 8-[alpha]-hydroxy and a ring opened
aldehyde derivative) in drinking water. After calculating DWLOCs and
comparing them to the EECs for surface water and ground water, EPA does
not expect the aggregate exposure to exceed 100% of the aPAD, as shown
in Table 4 of this unit:
Table 3.--Aggregate Risk Assessment for Acute Exposure to Avermectin B1 and its degradates
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup aPAD (mg/ % aPAD/ Water EEC Water EEC Acute DWLOC
kg) (Food) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.00025 35 0.34 0.0017 5.7
--------------------------------------------------------------
All infants (< 1 year old) 0.00025 62 0.34 0.0017 0.94
--------------------------------------------------------------
Children (1-2 years old) 0.00025 65 0.34 0.0017 0.88
--------------------------------------------------------------
Children (3-5 years old) 0.00025 62 0.34 0.0017 0.94
--------------------------------------------------------------
Children (6-12 years old) 0.00025 36 0.34 0.0017 1.6
--------------------------------------------------------------
Youth (13-19 years old) 0.00025 29 0.34 0.0017 5.3
--------------------------------------------------------------
Females (13-49 years old) 0.00025 32 0.34 0.0017 5.1
--------------------------------------------------------------
Adults (20-49 years old) 0.00025 27 0.34 0.0017 6.3
----------------------------------------------------------------------------------------------------------------
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
avermectin B1 and its delta-8,9-isomer from food will
utilize 4.3% of the cPAD for the U.S. population, 5.8% of the cPAD for
all infants (< 1 year old), and 14% of the cPAD for children (1 -2
years old). Based upon the use pattern, chronic residential exposure to
residues of avermectin B1 and its delta-8,9-isomer is not
expected. In addition, there is potential for chronic dietary exposure
to avermectin B1 and its major soil degradates (a mixture of
an 8-[alpha]-hydroxy and a ring opened aldehyde derivative) in drinking
water. After calculating DWLOCs and comparing them to the EECs for
surface and ground water, EPA does not expect the aggregate exposure to
exceed 100% of the cPAD, as shown in Table 4 of this unit:
Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Avermectin B1 and its degradates
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD (mg/ % cPAD Water EEC Water EEC Chronic
kg) (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.00012 4.3 0.14 0.0017 4.0
--------------------------------------------------------------
All infants (< 1 year old) 0.00012 5.8 0.14 0.0017 1.1
--------------------------------------------------------------
Children (1-2 years old) 0.00012 14 0.14 0.0017 1.0
--------------------------------------------------------------
[[Page 7884]]
Children (3-5 years old) 0.00012 11 0.14 0.0017 1.1
--------------------------------------------------------------
Children (6-12 years old) 0.00012 6.7 0.14 0.0017 1.4
--------------------------------------------------------------
Youth (13-19 years old) 0.00012 4.2 0.14 0.0017 3.5
--------------------------------------------------------------
Females (13-49 years old) 0.00012 4.1 0.14 0.0017 3.5
--------------------------------------------------------------
Adults (20-49 years old) 0.00012 3.7 0.14 0.0017 4.0
----------------------------------------------------------------------------------------------------------------
3. Short-term Intermediate- term risk. Short-term/intermediate-term
aggregate exposure takes into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Avermectin B1 is currently registered for use that
could result in short-term/intermediate-term residential exposure and
the Agency has determined that it is appropriate to aggregate chronic
food and water and short-term/intermediate-term exposures for
avermectin B1.
Using the exposure assumptions described in this unit for short-
term/intermediate-term exposures, EPA has concluded that food and
residential exposures aggregated result in aggregate MOEs of 4,000 for
adults and 2,600 for children 1-2 years old. These aggregate MOEs do
not exceed the Agency's level of concern for aggregate exposure to food
and residential uses. In addition, short-term/intermediate-term DWLOCs
were calculated and compared to the EECs for chronic exposure of
avermectin B1 and its major soil degradates (a mixture of an
8-[alpha]-hydroxy and a ring opened aldehyde derivative) in ground
water and surface water. After calculating DWLOCs and comparing them to
the EECs for surface water and ground water, EPA does not expect short-
term/intermediate-term aggregate exposure to exceed the Agency's level
of concern, as shown in Table 5 of this unit:
Table 5.--Aggregate Risk Assessment for Short-Term/Intermediate-Term Exposure to Avermectin B1 and its
degradates
----------------------------------------------------------------------------------------------------------------
Aggregate Short-Term/
Aggregate Level of Surface Ground Intermediate-
Population Subgroup MOE (Food + Concern Water EEC Water EEC Term DWLOC
Residential) (LOC) (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Adults 4,000 1,000 0.14 0.0017 3.0
------------------------------------------------------------
Children (1-2 years old) 2,600 1,000 0.14 0.0017 0.56
----------------------------------------------------------------------------------------------------------------
5. Aggregate cancer risk for U.S. population. A cancer aggregate
risk assessment was not performed because avermectin B1 is
classified as ``not likely to be carcinogenic to humans.''
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to residues of avermectin B1 and its degradates.
IV. Other Considerations
A. Analytical Enforcement Methodology
1. Residue analytical method. Analytical methodologies for
enforcement of residues from the use of Avermectin B1 are
available in PAM II for citrus and processed fractions (Method I),
ginned cottonseed (Method IA), and bovine tissues and milk (Method II).
These methods are adequate for enforcement of the proposed tolerances.
2. Multiresidue methods testing. The 1990 Pestrak data base
indicates that Avermectin B1 and its delta 8,9-isomer are
not recovered or not likely to be recovered by Food and Drug
Administration multiresidue methods.
B. International Residue Limits
Codex has recommended several Maximum Residue Levels (MRLs) for
plant and cattle commodities (Pesticide Residues in Food-1997, Part 1).
The Codex residue definition (step 8/CXL) is ``sum of avermectin
B1a, avermectin B1b, 8,9-Z-avermectin
B1a and 8,9-Z-avermectin B1b for plants, and the
sum of avermectin B1a and 8,9-Z-avermectin B1a
for cattle commodities. The Codex limits of determination (equivalent
to EPA's limits of quantitation, (LOQ's)) for plant and livestock
commodities are < =0.01 ppm. (For plants, the LOQ ranges from 0.002 to
0.005 ppm for each of two peaks, one peak representing avermectin
B1a and its 8,9-Z-isomer and the other peak representing
avermectin B1b and its 8,9-Z-isomer. For cattle meat, the
Codex LOQ is 0.01 ppm.) The tolerance expression in Canada for plants
is ``avermectin B1a, avermectin B1b, and the 8,9-
Z-isomers.'' The tolerance expression in Mexico for plants is
avermectina. The Codex and the USA residue definitions are the same for
plants. The Codex definition does not include avermectin B1b
and 8,9-Z-avermectin B1b for livestock commodities whereas
the U.S. does include avermectin B1b and 8,9-Z-avermectin
B1b in livestock commodities.
C. Conditions
The following data are required. The product registrations for the
above new uses will be conditional and may be
[[Page 7885]]
rescinded if this information is not provided.
1. Storage stability data to support the storage interval of prunes
and to provide the storage information for prunes. The tolerance is
conservatively established using the maximum theoretical concentration
factor of 3.5x for plum, prunes, dried. This value will be reevaluated
once the required information is supplied.
2. A summary of the procedures for the processing of mint to mint
oil.
3. A developmental neurotoxicity study in the rat.
4. Acute and subchronic neurotoxicity studies in the rat.
5. A 28-day inhalation study (following the 90-day inhalation
toxicity study protocol). Thorough histopathological evaluation is
recommended to assess potential pulmonary toxicity resulting from long-
term or repeated exposure.
V. Conclusion
The following current temporary tolerances due to expire on
December 31, 2006 are hereby deleted: Avocado at 0.02 ppm, basil at
0.05 ppm, and spinach at 0.05. The following permanent tolerances are
also deleted: Celery at 0.05 ppm, head lettuce at 0.05 ppm, pepper at
0.02 ppm, and tomato at 0.01 ppm. In their place, new tolerances
without a time limitation are established for the combined residues of
the insecticide/miticide 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 avocado at 0.020 ppm; food products in food
handling establishments (other than those already covered by higher
tolerances as a result of use on growing crops, and other than those
already covered by tolerances on milk, meat, and meat byproducts) at
0.01 ppm; herbs, subgroup 19A (except chives) at 0.030 ppm; meat and
meat byproducts of goat, hog, horse, poultry, and sheep at 0.02 ppm;
mint at 0.010 ppm; plum at 0.010 ppm; plum, prune, dried at 0.025 ppm;
vegetable, fruiting, group 8 at 0.020 ppm; and vegetable, leafy, except
Brassica, group 4 at 0.10 ppm.
VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2004-0400 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 18,
2005.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St.,
NW., Washington, DC 20005. The Office of the Hearing Clerk is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2004-0400, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the
[[Page 7886]]
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
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have `` substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.
VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 7, 2005.
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 as follows.
0
i. By alphabetically adding the following commodities to the table in
paragraph (a) to read as follows
0
ii. By removing the entries for the commodities ``Celery''; ``Lettuce,
head''; ``Pepper''; and ``Tomato''; in the table in paragraph (a).
0
iii. The text of paragraph (b) is removed and reserved.
Sec. 180.449 Avermectin B1 and its delta-8,9-isomer;
tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Avocado.................................................... 0.020
* * * * *
Food products in food handling establishments (other than 0.01
those already covered by higher tolerances as a result of
use on growing crops, and other than those already covered
by tolerances on milk, meat, and meat byproducts).........
Goat, meat................................................. 0.02
Goat, meat byproducts...................................... 0.02
* * * * *
Herbs, crop subgroup 19A (except chives)................... 0.030
Hog, meat.................................................. 0.02
Hog, meat byproducts....................................... 0.02
* * * * *
Horse, meat................................................ 0.02
Horse, meat byproducts..................................... 0.02
* * * * *
Mint....................................................... 0.010
* * * * *
Plum....................................................... 0.010
Plum, prune, dried......................................... 0.025
* * * * *
Poultry, meat.............................................. 0.02
Poultry, meat byproducts................................... 0.02
Sheep, meat................................................ 0.02
Sheep, meat byproducts..................................... 0.02
* * * * *
Vegetable, fruiting, crop group 8.......................... 0.020
Vegetable, leafy, except Brassica, crop group 4............ 0.10
* * * * *
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 05-2985 Filed 2-15-05; 8:45 am]
BILLING CODE 6560-50-S