[Federal Register Volume 64, Number 66 (Wednesday, April 7, 1999)]
[Rules and Regulations]
[Pages 16843-16850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8340]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300825; FRL-6070-6]
RIN 2070-AB78
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 avermectin in or on avocado. This action is in
response to EPA's granting of an emergency exemption under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing
use of the pesticide on avocado. This regulation establishes a maximum
permissible level for residues of avermectin B1 and its
delta-8,9-isomer in this food commodity pursuant to section 408(l)(6)
of the Federal Food, Drug, and Cosmetic Act, as amended by the Food
Quality Protection Act of 1996. The tolerance will expire and is
revoked on September 30, 2000.
DATES: This regulation is effective April 7, 1999. Objections and
requests for hearings must be received by EPA on or before June 7,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300825], must be submitted to: Hearing Clerk
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW.,
Washington, DC 20460. Fees accompanying objections and hearing requests
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O.
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing
requests filed with the Hearing Clerk identified by the docket control
number, [OPP-300825], must also be submitted to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring a copy of
objections and hearing requests to Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epa.gov. Copies of electronic objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
or ASCII file format. All copies of electronic objections and hearing
requests must be identified by the docket control number [OPP-300825].
No Confidential Business Information (CBI) should be submitted through
e-mail. Copies of electronic objections and hearing requests on this
rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Jacqueline E. Gwaltney,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Rm. 278 Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 703/305-6792,
gwaltney.jackie@epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408 and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a and (l)(6), is establishing a tolerance for
combined residues of the fungicide, in or on avocado at 0.02 ppm part
per million (ppm). This tolerance will expire and is revoked on
September 30, 2000. EPA will publish a document in the Federal Register
to remove the revoked tolerance from the Code of Federal Regulations.
I. Background and Statutory Findings
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures. These activities are described in this preeamble and
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
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.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and
[[Page 16844]]
implementation of the FQPA, EPA does not intend for its actions on such
tolerances to set binding precedents for the application of section 408
and the new safety standard to other tolerances and exemptions.
II. Emergency Exemption for Avermectin on Avocado and FFDCA
Tolerances
California submitted information to EPA that indicates that the
avocado thrip (Scirthothrips perseae) poses a significant threat to the
profitable production of avocado. Avocado affected by avocado thrip can
be rendered unmarketable because it causes severe scarring and damage
to small avocado fruit, fruit stems and tender leaf flushes. California
determined that the conditions for a avocado thrip outbreak were
favorable and invoked its authorities under 40 CFR 166.40 to declare a
crisis situation. After considering the implications connected with the
use of this pesticide under a crisis situation, EPA is establishing
this tolerance for the use of avermectin on avocado for the control of
avocado thrips in California.
EPA has authorized under FIFRA section 18 the use of avermectin on
avocado for control of avocado thrips in California. After having
reviewed the submission, EPA concurs that emergency conditions exist
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
avocado . In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency 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 under section 408(e), as provided in section 408(l)(6).
Although this tolerance will expire and is revoked on September 30,
2000, under FFDCA section 408(l)(5), residues of the pesticide not in
excess of the amounts specified in the tolerance remaining in or on
avocado after that date will not be unlawful, provided the pesticide is
applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by this tolerance at the time of
that application. EPA will take action to revoke this 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 tolerance is being approved under emergency conditions
EPA has not made any decisions about whether avermectin meets EPA's
registration requirements for use on avocado or whether a permanent
tolerance for this use would be appropriate. Under these circumstances,
EPA does not believe that this tolerance serves as a basis for
registration of avermectin by a State for special local needs under
FIFRA section 24(c). Nor does this tolerance serve as the basis for any
State other than California to use this pesticide on this crop under
section 18 of FIFRA without following all provisions of EPA's
regulations implementing section 18 as identified in 40 CFR part 166.
For additional information regarding the emergency exemption for
avermectin, contact the Agency's Registration Division at the address
provided under the ``ADDRESSES'' section.
III. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7) .
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of
avermectin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
combined residues of avermectin on avocado at 0.02ppm. EPA's assessment
of the dietary 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 are
discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. The acute dietary Reference Dose (RfD) is 0.0025
mg/kg from a 1-year dog study. The no observed adverse effect level
(NOAEL) is 0.25 mg/kg/day, and the lowest observed adverse effect level
(LOAEL) is 0.50 mg/kg/day based on mydriasis (pupil dilation) which was
observed after one week of dosing. An uncertainty factor of 100 to
account for interspecies extrapolation (10x) and intraspecies
variability (10x) was recommended (Hazard Identification Assessment
Review Committee (HIARC), 7/28/98).
2. Short- and intermediate-term toxicity. Short- and intermediate-
term dermal NOAELs of 0.25 mg/kg/day based on mydriasis after one week
of dosing in a 1-year dog study. Dermal absorption is considered to be
1%. Short- and intermediate-term inhalation NOAEL is a route-to-route
extrapolation from the oral NOAEL of 0.25 mg/kg/day based on mydriasis
after one week of dosing in a 1-year dog study. Oral and inhalation
absorption are both assumed to be 100% (HIARC, 7/28/98).
3. Chronic toxicity. EPA has established the RfD for avermectin at
0.0012 milligrams/kilogram/day (mg/kg/day) from a 2-generation
reproduction study in rats. The developmental NOAEL is 0.12 mg/kg/day,
and the developmental LOAEL is 0.40 mg/kg/day based on decreased pup
body weight and viability during lactation, and increased incidence of
retinal rosettes in F2b weanlings. An uncertainty factor of 100 to
account for interspecies extrapolation (10x) and intraspecies
variability(10x) was recommended.
4. Long-term. Long-term dermal NOAEL of 0.12 mg/kg/day based on
decreased pup body weight and viability during lactation, and increased
incidence of retinal rosettes in F2b weanlings in a 2-generation
reproduction study in rats. Dermal absorption is considered to be 1%
(HIARC, 7/28/98).
Long-term inhalation NOAEL is a route-to-route extrapolation from
the oral NOAEL of 0.12 mg/kg/day based on decreased pup body weight and
viability during lactation, and increased incidence of retinal rosettes
in F2b weanlings in a 2-generation reproduction study in rats. Oral and
inhalation absorption are both assumed to be 100% (HIARC, 7/28/98).
5. Carcinogenicity. At its July 27, 1996 meeting, the EPA RfD/Peer
Review Committee classified avermectin as a Cancer Group E chemical
based on the absence of significant tumor increases in two adequate
rodent carcinogenicity
[[Page 16845]]
studies. On July 28, 1998 the HIARC retained this classification. This
assessment is not required.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.449) for the combined residues of avermectin, in or on a
variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures and risks from avermectin
as follows:
i. Acute exposure and risk. 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. The avermectin acute (food only)
exposure analysis was recently completed in conjunction with the
section 3 human health risk assessment on grapes and peppers. The
analysis included avocados at the recommended time-limited tolerance of
0.02 ppm. The risk estimate should be viewed as highly refined.
Additional refinement would be unlikely to reduce risk estimates
significantly. In making a safety determination for this tolerance, EPA
is taking into account this refined exposure assessment. The resulting
calculations are presented below at the 99.9th percentile as either a
percent of the acute population adjusted dose (%PAD) or percent RfD
(%RfD) depending on the population. EPA is generally concerned with
acute exposures that exceed 100% of the acute RfD(aRfD)/PAD.
------------------------------------------------------------------------
Percent
ARC (mg/ Population Percent
Subgroup kg) adjusted Reference
dose dose
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U.S. population..................... 0.000086 35%PAD
Children (1-6 years)................ 0.000176 70
Females (13+/nursing)............... 0.000095 38
Males (13-19 years)................. 0.000048 2
------------------------------------------------------------------------
ii. Chronic exposure and risk. The avermectin chronic (food only)
exposure analysis was recently completed in conjunction with the
section 3 human health risk assessment on grapes and peppers. The
analysis included avocados at the recommended time-limited tolerance of
0.02 ppm. In conducting this chronic dietary risk assessment, EPA has
made somewhat conservative assumptions -- anticipated residues and
percent crop-treated data were used for selected crops -- which result
in an overestimate of human dietary exposure. This chronic dietary
(food only) exposure should be viewed as a partially refined risk
estimate; further refinement using additional percent crop-treated
values would result in a lower dietary exposure estimate. Thus, in
making a safety determination for this tolerance, EPA is taking into
account this partially refined exposure assessment. EPA is generally
concerned with chronic exposures that exceed 100% of the chronic RfD/
PAD. The existing avermectin tolerances (published, pending and new)
result in an ARC that is equivalent to the following percentages of the
RfD or PAD:
------------------------------------------------------------------------
Percent
Population Percent
Subgroup ARCFOOD adjusted Reference
dose dose
------------------------------------------------------------------------
U.S. Population...................... 0.000008 7
Non-nursing infants (< 1="" year).......="" 0.000023="" 19="" females="" (13+/nursing)................="" 0.000008="" 6="" males="" (20+="" years)....................="" 0.000008="">< 1="" ------------------------------------------------------------------------="" 2.="" from="" drinking="" water.="" modeling="" data="" (generic="" expected="" environmental="" concentration/screening="" concentration="" in="" ground="" water="" (geneec/scigrow))="" indicate="" worst="" case="" estimated="" environmental="" concentrations="" (eec)="" of="" 0.485="">g/L avermectin for acute and
0.239 g/L for chronic exposure, both in surface water from the
same use of avermectin on strawberries (the maximum use rate on the
label). Refined modeling data Pesticide Root Zone Model-Exposure
Analysis Modeling System (PRZM--EXAM) indicate a worst case EEC of 0.88
g/L for acute and 0.57 g/L for chronic, both
calculated for an avermectin use on strawberries grown on black plastic
mulch. EPA notes that the certainty of the concentrations estimated for
strawberries is low, due to uncertainty on the amount of runoff from
plant beds covered in plastic mulch and uncertainty on the amount of
degradation of avermectin on black plastic compared to soil.
EPA believes the estimates of avermectin exposure in water derived
from the PRZM-EXAMS model are significantly overstated for several
reasons. The PRZM-EXAMS model was designed to estimate exposure from
ecological risk assessments and thus uses a scenario of a body of water
approximating the size of a 1 hectare (2.5 acres) pond. This tends to
overstate drinking water exposure levels for the following reasons.
First, surface water source drinking water generally comes from bodies
of water that are substantially larger than a 1 hectare (2.5 acres)
pond. Second, the modeled scenario also assumes that essentially the
whole basin receives an application of the pesticide. Yet in virtually
all cases, basins large enough to support a drinking water facility
will contain a substantial fraction of the area which does not receive
pesticide. Third, there is often at least some flow (in a river) or
turnover (in a reservoir or lake) of the water so the persistence of
the pesticide near the drinking water facility is usually
overestimated. Fourth, even assuming a reservoir is directly adjacent
to an agricultural field, the agricultural field may not be used to
grow a crop on
[[Page 16846]]
which the pesticide in question is registered for use. Fifth, the PRZM-
EXAMS modeled scenario does not take into account reductions in
residue-loading due to applications of less than the maximum
application rate or no treatment of the crop at all (percent crop
treated data). Although there is a high degree of uncertainty to this
analysis, these are the best available estimates of concentrations of
avermectin in drinking water.
3. From non-dietary exposure. The avermectin non-dietary exposure
analysis was recently completed in conjunction with the section 3 human
health risk assessment on grapes and peppers. Avermectin's registered
residential uses include indoor crack/crevice and outdoor application
to lawns. For lawn uses, a risk assessment was conducted for adult
applicators and postapplication exposure to avermectin using the EPA's
Draft SOPs for Residential Exposure Assessments (12/18/97). For
children's postapplication exposure to avermectin from indoor crack/
crevice products, exposure studies were used to estimate risk. Short-
and intermediate-term risk for the registered uses do not exceed EPA's
level of concern. Chronic exposures for the residential uses are not
expected.
i. Chronic exposure and risk. Chronic exposures for the residential
uses are not expected.
ii. Short- and intermediate-term exposure and risk. Risk for the
registered uses do not exceed EPA's level of concern.
4. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether avermectin has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
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 more 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 final rule
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).
D. Aggregate Risks and Determination of Safety for U.S. Population
In examining aggregate exposures, FQPA directs EPA to consider
available information concerning exposures from the residue in food and
all other non-occupational exposures. The primary non-food sources of
exposure the Agency looks at include drinking water (whether from
ground or surface water), and exposure through pesticide use in
gardens, lawns or buildings (residential and other indoor and/or
outdoor uses). In evaluating food exposures, EPA takes into account
varying consumption patterns of major identifiable subgroups of
consumers, including infants and children.
1. Acute risk. Acute aggregate exposure takes into account acute
dietary food and water exposure. The registrant previously submitted an
acute dietary exposure analysis using probabilistic ``Monte Carlo''
modeling. EPA examined the assumptions made in conducting the analysis
and some of the residue files for accuracy and found the analysis
acceptable after correcting for the current acute RfD, updating %CT
data, and correcting concentration factors. EPA recalculated the
assessment using the submitted acute file and the correct acute RfD,
updated %CT data, correcting the residue files above to use one-half
limit of detection (LOD) and one-half limit of quantitation (LOQ) where
appropriate, and using the average field trial residue level and
previously established processing factors for blended commodities. In
addition, EPA's analysis included residues in pear juice for which no
data has been previously required. Since all other juices show
reductions in avermectin residues from the raw agricultural commodity,
EPA used the reduction factor for apples in the analysis. The dietary
(food only) acute %PAD ranges from 18% for nursing infants < 1="" year="" old="" to="" 70%="" for="" children="" 1-6="" yrs.="" this="" risk="" estimate="" should="" be="" viewed="" as="" highly="" refined="" since="" it="" used="" anticipated="" residue="" values="" and="" percent="" crop-treated="" data="" in="" conjunction="" with="" monte="" carlo="" analysis.="" the="" acute="" dietary="" exposure="" does="" not="" exceed="" epa's="" level="" of="" concern.="" the="" registrant="" is="" reminded="" that="" future="" probabilistic="" modeling="" submissions="" should="" follow="" epa's="" suggested="" guidelines="">http://www.epa.gov/fedrgstr/EPA-
PEST/1998/November/Day-05/o-p29665.htm).
Avermectin is a moderately persistent, but non-mobile compound in
soil and water environments. The GENEEC and SCI-GROW modeling data for
avermectin in drinking water indicate levels less than OPP's DWLOC for
acute exposure. Using the refined PRZM-EXAMS modeling data in drinking
water also indicates levels less than OPP's DWLOC for acute exposure,
with the exception of children 1-6 years old. EPA notes that the
certainty of the concentrations estimated for strawberries in the
refined estimates is low, due to uncertainty on the amount of runoff
from plant beds covered in plastic mulch and uncertainty on the amount
of degradation of avermectin on black plastic compared to soil.
Although the peak EEC of 0.88 g/L slightly exceeds the acute
DWLOC (0.74 g/L, considering the uncertain nature of the
modeling estimate, EPA does not expect aggregate acute exposure to
avermectin will pose an unacceptable risk to human health.
2. Chronic risk. Using the probabilistic ``MonteCarlo'' exposure
assumptions described in this unit, EPA has concluded that aggregate
exposure to avermectin from food will utilize 7% of the PAD for the
U.S. population. The major identifiable subgroup with the highest
aggregate exposure is non-nursing infants with 19% of the chronic PAD.
No chronic residential exposures are expected from use of avermectin.
Avermectin is a moderately persistent, but non-mobile compound in soil
and water environments. EPA does not expect aggregate chronic exposure
to avermectin will pose an unacceptable risk to human health.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure.
i. Short-term aggregate exposure takes into account chronic dietary
food and water (considered to be a background exposure level) plus
short-term residential uses which include dermal, inhalation, and oral
exposures. For children's postapplication exposure from crack and
crevice uses, the worst case exposure scenario, risks do not exceed
EPA's level of concern. The residential uses that were aggregated with
chronic dietary food and water are from lawn and crack and crevice uses
and include:
ADULT dermal exposure from the highest adult residential
applicator scenario (3.4E-7 mg/kg/day from belly grinder granular open
pour) and crack and crevice applicator scenario (2.1E-8 mg/kg/day) with
exposure from postapplication activities (3.0E-6 mg/
[[Page 16847]]
kg/day), and inhalation from turf and crack and crevice (3.9E-7 mg/kg/
day).
CHILDREN's oral exposure from turf and crack and crevice
hand-to-mouth, with turf incidental ingestion (3.8E-5 mg/kg/day),
dermal exposure from turf and crack and crevice (6.1E-6 mg/kg/day), and
inhalation exposure from crack and crevice (1.1E-4 mg/kg/day).
Using the exposures above, EPA calculated the short-term drinking water
level of concerns (DWLOCs). The DWLOC of 8.2 g/L for the U.S.
population is greater than the water EEC's. The DWLOC for infants/
children (0.75 g/L) is slightly exceeded by the PRZM-EXAMS
peak value of 0.88 g/L. However, as noted above for the acute
DWLOC, EPA is not concerned given the uncertainty of the estimated
water concentrations. EPA does not expect aggregate short-term exposure
to avermectin will pose an unacceptable risk to human health.
ii. The worst case intermediate-term exposures to avermectin for
adults are the same as those described above for short-term exposures.
Using the exposures above, EPA calculated the adult intermediate-term
DWLOC of 8.2 g/L, which is greater than the water EEC's. EPA
does not expect aggregate intermediate-term exposure to avermectin will
pose an unacceptable risk to adult human health.
iii. The worst case intermediate-term exposures to avermectin for
infants and children are the same as those described above. Since the
short- and intermediate-term NOAELs are the same, the DWLOC is also
equal to the 0.75 g/L short-term value. Again, given the
uncertainty in the 0.88 g/L PRZM-EXAMS value, EPA is not
concerned with the residues in drinking water at this time. EPA does
not expect aggregate intermediate-term exposure to avermectin will pose
an unacceptable risk to human health.
4. Aggregate cancer risk for U.S. population. At its July 27, 1996
meeting, the EPA RfD/Peer Review Committee classified avermectin as a
Cancer Group E chemical based on the absence of significant tumor
increases in two adequate rodent carcinogenicity studies. This risk
assessment was not required.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to avermectin residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children-- i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of avermectin, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre- and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a margin of exposure (MOE) analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans. EPA believes that reliable data support
using the standard MOE and uncertainty factor (usually 100 for combined
inter- and intra-species variability) and not the additional tenfold
MOE/uncertainty factor when EPA has a complete data base under existing
guidelines and when the severity of the effect in infants or children
or the potency or unusual toxic properties of a compound do not raise
concerns regarding the adequacy of the standard MOE/safety factor.
ii. Conclusion. There is a complete toxicity database for
avermectin and exposure data is complete or is estimated based on data
that reasonably accounts for potential exposures.
2. Acute risk. Acute aggregate exposure takes into account acute
dietary food and water exposure. The registrant previously submitted an
acute dietary exposure analysis using probabilistic ``Monte Carlo''
modeling. EPA examined the assumptions made in conducting the analysis
and some of the residue files for accuracy and found the analysis
acceptable after correcting for the current acute RfD, updating %CT
data, and correcting concentration factors. EPA recalculated the
assessment using the submitted acute file and the correct acute RfD,
updated %CT data, correcting the residue files above to use one-half
limit of detection (LOD) and one-half limit of quantitation (LOQ) where
appropriate, and using the average field trial residue level and
previously established processing factors for blended commodities. In
addition, EPA's analysis included residues in pear juice for which no
data has been previously required. Since all other juices show
reductions in avermectin residues from the raw agricultural commodity,
EPA used the reduction factor for apples in the analysis. The dietary
(food only) acute %PAD range from 18% for nursing infants < 1="" year="" old="" to="" 70%="" for="" children="" 1-6="" yrs.="" this="" risk="" estimate="" should="" be="" viewed="" as="" highly="" refined="" since="" it="" used="" anticipated="" residue="" values="" and="" percent="" crop-treated="" data="" in="" conjunction="" with="" monte="" carlo="" analysis.="" the="" acute="" dietary="" exposure="" does="" not="" exceed="" epa's="" level="" of="" concern.="" the="" registrant="" is="" reminded="" that="" future="" probabilistic="" modeling="" submissions="" should="" follow="" epa's="" suggested="" guidelines="">http://www.epa.gov/fedrgstr/EPA-
PEST/1998/November/Day-05/o-p29665.htm).
Avermectin is a moderately persistent, but non-mobile compound in
soil and water environments. The GENEEC and SCI-GROW modeling data for
avermectin in drinking water indicate levels less than OPP's DWLOC for
acute exposure. Using the refined PRZM-EXAMS modeling data in drinking
water also indicates levels less than OPP's DWLOC for acute exposure,
with the exception of children 1-6 years old. EPA notes that the
certainty of the concentrations estimated for strawberries in the
refined estimates is low, due to uncertainty on the amount of runoff
from plant beds covered in plastic mulch and uncertainty on the amount
of degradation of avermectin on black plastic compared to soil.
Although the peak EEC of 0.88 g/L slightly exceeds the acute
DWLOC (0.74 g/L, considering the uncertain nature of the
modeling estimate, EPA does not expect aggregate acute exposure to
avermectin will pose an unacceptable risk to human health.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to avermectin from food
will utilize 7% of the PAD for infants and children. The major
identifiable subgroup with the highest aggregate exposure is non-
nursing infants with 19% of the chronic PAD. No chronic residential
exposures are expected from use of avermectin. Avermectin is a
moderately persistent, but non-mobile compound in soil and water
environments. EPA does not expect aggregate chronic exposure to
avermectin will pose an unacceptable risk to human health.
4. Short- or intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure.
[[Page 16848]]
i. Short-term aggregate exposure takes into account chronic dietary
food and water (considered to be a background exposure level) plus
short-term residential uses which include dermal, inhalation, and oral
exposures. For children's postapplication exposure from crack and
crevice uses, the worst case exposure scenario, risks do not exceed
EPA's level of concern. The residential uses that were aggregated with
chronic dietary food and water are from lawn and crack and crevice uses
and include:
ADULT dermal exposure from the highest adult residential
applicator scenario (3.4E-7 mg/kg/day from belly grinder granular open
pour) and crack and crevice applicator scenario (2.1E-8 mg/kg/day) with
exposure from postapplication activities (3.0E-6 mg/kg/day), and
inhalation from turf and crack and crevice (3.9E-7 mg/kg/day).
CHILDREN's oral exposure from turf and crack and crevice
hand-to-mouth, with turf incidental ingestion (3.8E-5 mg/kg/day),
dermal exposure from turf and crack and crevice (6.1E-6 mg/kg/day), and
inhalation exposure from crack and crevice (1.1E-4 mg/kg/day).
Using the exposures above, EPA calculated the short-term drinking water
level of concerns (DWLOCs). The DWLOC of 8.2 g/L for the U.S.
population is greater than the water EEC's. The DWLOC for infants/
children (0.75 g/L) is slightly exceeded by the PRZM-EXAMS
peak value of 0.88 g/L. However, as noted above for the acute
DWLOC, EPA is not concerned given the uncertainty of the estimated
water concentrations. EPA does not expect aggregate short-term exposure
to avermectin will pose an unacceptable risk to human health.
ii. The worst case intermediate-term exposures to avermectin for
adults are the same as those described above for short-term exposures.
Using the exposures above, EPA calculated the adult intermediate-term
DWLOC of 8.2 g/L, which is greater than the water EEC's
provided by EFED. EPA does not expect aggregate intermediate-term
exposure to avermectin will pose an unacceptable risk to adult human
health.
iii. The worst case intermediate-term exposures to avermectin for
infants and children are the same as those described above. Since the
short- and intermediate-term NOAELs are the same, the DWLOC is also
equal to the 0.75 g/L short-term value. Again, given the
uncertainty in the 0.88 g/L PRZM-EXAMS value, EPA is not
concerned with the residues in drinking water at this time. EPA does
not expect aggregate intermediate-term exposure to avermectin will pose
an unacceptable risk to human health.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to avermectin residues.
IV. Other Considerations
Analytical Enforcement Methodology
Adequate enforcement methodology (example - gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm 101FF, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-5229.
V. Conclusion
Therefore, the tolerance is established for combined residues of
avermectin in or on avocado at 0.02 ppm.
VI. Objections and Hearing Requests
The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation as was provided in
the old section 408 and in section 409. However, the period for filing
objections is 60 days, rather than 30 days. EPA currently has
procedural regulations which govern the submission of objections and
hearing requests. These regulations will require some modification to
reflect the new law. However, until those modifications can be made,
EPA will continue to use those procedural regulations with appropriate
adjustments to reflect the new law.
Any person may, by June 7, 1999, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given under the ``ADDRESSES'' section (40
CFR 178.20). A copy of the objections and/or hearing requests filed
with the Hearing Clerk should be submitted to the OPP docket for this
rulemaking. The objections submitted must specify the provisions of the
regulation deemed objectionable and the grounds for the objections (40
CFR 178.25). Each objection must be accompanied by the fee prescribed
by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection.'' For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697, tompkins.jim@epa.gov. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is 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 in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). 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.
VII. Public Record and Electronic Submissions
EPA has established a record for this regulation under docket
control number [OPP-300825] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division
[[Page 16849]]
(7502C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov.
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes a 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). 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) (Pub. L. 104-4). Nor does it require any prior consultation as
specficed by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
special considerations as required by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since tolerances and exemptions that are established
on the basis of a petition under FFDCA section 408(l)(6), 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. Nevertheless, the Agency previously
assessed whether establishing tolerances, exemptions from tolerances,
raising tolerance levels or expanding exemptions might adversely impact
small entities and concluded, as a generic matter, that there is no
adverse economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide OMB, in a separately identified
section of the preamble to the rule, a description of the extent of
EPA's prior consultation with representatives of affected tribal
governments, a summary of the nature of their concerns, and a statement
supporting the need to issue the regulation. In addition, Executive
Order 13084 requires EPA to develop an effective process permitting
elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
IX. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and 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 the rule in the Federal Register. This 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: March 24, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.449, the table to paragraph (b) is amended by adding
an entry for avocado to read as follows:
[[Page 16850]]
Sec. 180.449 Avermectin B1 and its delta-8,9-isomer;
tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Parts Expiration/
Commodity per revocation
million date
------------------------------------------------------------------------
Avocado........................................ 0.02 9/20/00
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-8340 Filed 4-6-99; 8:45 am]
BILLING CODE 6560-50-F
