[Federal Register Volume 62, Number 209 (Wednesday, October 29, 1997)]
[Rules and Regulations]
[Pages 56082-56089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-28641]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300567; FRL-5750-8]
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 the 
combined residues of avermectin in or on basil. This action is in 
response to an emergency exemption request under section 18 of the 
Federal Insecticide, Fungicide, and Rodenticide Act permitting use of 
the pesticide on basil. 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, 1998.

DATES: This regulation is effective October 29, 1997. Objections and 
requests for hearings must be received by EPA on or before December 29, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300567], 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-300567], 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. 1132, 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: [email protected]. Copies of 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 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300567]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Daniel Rosenblatt, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location, telephone

[[Page 56083]]

number, and e-mail address: CM #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, (703) 308-9375, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for 
the combined residues of the miticide avermectin B1 and its 
delta-8,9-isomer, in or on basil at 0.05 parts per million (ppm). This 
tolerance will expire and is revoked on September 30, 1998. EPA will 
publish a document in the Federal Register to remove the revoked 
tolerance from the Code of Federal Regulations.

I. Background and Statutory Authority

    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 below 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 implementation of the FQPA, EPA does not intend for 
its actions on such tolerance 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 Basil and FFDCA 
Tolerances

    Basil is a leafy herb that is produced for the fresh and dried 
markets. California submitted information to EPA that indicates that 
the leafminer (Liriomyza sp.) poses a significant threat to the 
profitable production of basil. Basil affected by leafminer can be 
rendered unmarketable because they feed on the plant's leaves and may 
also make them susceptible to disease. California determined that the 
conditions for a leafminer 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 basil for control of leafminer in California.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of avermectin in or on basil. 
In doing so, EPA considered the new 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 new 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, 
1998, under FFDCA section 408(l)(5), residues of the pesticide not in 
excess of the amounts specified in the tolerance remaining in or on 
basil after that date will not be unlawful, provided the pesticide is 
applied in a manner that was lawful under FIFRA. 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 basil 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 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 above.

III. Risk Assessment and Statutory Findings

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides based primarily on toxicological studies using 
laboratory animals. These studies address many adverse health effects, 
including (but not limited to) reproductive effects, developmental 
toxicity, toxicity to the nervous system, and carcinogenicity. Second, 
EPA examines exposure to the pesticide through the diet (e.g., food and 
drinking water) and through exposures that occur as a result of 
pesticide use in residential settings.

A. Toxicity

    1. Threshold and non-threshold effects. For many animal studies, a 
dose response relationship can be determined, which provides a dose 
that causes adverse effects (threshold effects) and doses causing no 
observed effects (the ``no-observed effect level'' or ``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the

[[Page 56084]]

study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the Reference Dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 100 is commonly used since it is assumed 
that people may be up to 10 times more sensitive to pesticides than the 
test animals, and that one person or subgroup of the population (such 
as infants and children) could be up to 10 times more sensitive to a 
pesticide than another. In addition, EPA assesses the potential risks 
to infants and children based on the weight of the evidence of the 
toxicology studies and determines whether an additional uncertainty 
factor is warranted. Thus, an aggregate daily exposure to a pesticide 
residue at or below the RfD (expressed as 100% or less of the RfD) is 
generally considered acceptable by EPA. EPA generally uses the RfD to 
evaluate the chronic risks posed by pesticide exposure. For shorter 
term risks, EPA calculates a margin of exposure (MOE) by dividing the 
estimated human exposure into the NOEL from the appropriate animal 
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This 
100-fold MOE is based on the same rationale as the 100-fold uncertainty 
factor.
    Lifetime feeding studies in two species of laboratory animals are 
conducted to screen pesticides for cancer effects. When evidence of 
increased cancer is noted in these studies, the Agency conducts a 
weight of the evidence review of all relevant toxicological data 
including short-term and mutagenicity studies and structure activity 
relationship. Once a pesticide has been classified as a potential human 
carcinogen, different types of risk assessments (e.g., linear low dose 
extrapolations or MOE calculation based on the appropriate NOEL) will 
be carried out based on the nature of the carcinogenic response and the 
Agency's knowledge of its mode of action.
    2. Differences in toxic effect due to exposure duration. The 
toxicological effects of a pesticide can vary with different exposure 
durations. EPA considers the entire toxicity data base, and based on 
the effects seen for different durations and routes of exposure, 
determines which risk assessments should be done to assure that the 
public is adequately protected from any pesticide exposure scenario. 
Both short and long durations of exposure are always considered. 
Typically, risk assessments include ``acute,'' ``short-term,'' 
``intermediate term,'' and ``chronic'' risks. These assessments are 
defined by the Agency as follows.
    Acute risk, by the Agency's definition, results from 1-day 
consumption of food and water, and reflects toxicity which could be 
expressed following a single oral exposure to the pesticide residues. 
High end exposure to food and water residues are typically assumed.
    Short-term risk results from exposure to the pesticide for a period 
of 1-7 days, and therefore overlaps with the acute risk assessment. 
Historically, this risk assessment was intended to address primarily 
dermal and inhalation exposure which could result, for example, from 
residential pesticide applications. However, since enaction of FQPA, 
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from 
food, water, and residential uses when reliable data are available. In 
this assessment, risks from average food and water exposure, and high-
end residential exposure, are aggregated. High-end exposures from all 3 
sources are not typically added because of the very low probability of 
this occurring in most cases, and because the other conservative 
assumptions built into the assessment assure adequate protection of 
public health. However, for cases in which high-end exposure can 
reasonably be expected from multiple sources (e.g. frequent and 
widespread homeowner use in a specific geographical area), multiple 
high-end risks will be aggregated and presented as part of the 
comprehensive risk assessment/characterization. Since the toxicological 
endpoint considered in this assessment reflects exposure over a period 
of at least 7 days, an additional degree of conservatism is built into 
the assessment; i.e., the risk assessment nominally covers 1-7 days 
exposure, and the toxicological endpoint/NOEL is selected to be 
adequate for at least 7 days of exposure. (Toxicity results at lower 
levels when the dosing duration is increased.)
    Intermediate-term risk results from exposure for 7 days to several 
months. This assessment is handled in a manner similar to the short-
term risk assessment.
    Chronic risk assessment describes risk which could result from 
several months to a lifetime of exposure. For this assessment, risks 
are aggregated considering average exposure from all sources for 
representative population subgroups including infants and children.

B. Aggregate Exposure

    In examining aggregate exposure, FFDCA section 408 requires that 
EPA take into account available and reliable information concerning 
exposure from the pesticide residue in the food in question, residues 
in other foods for which there are tolerances, residues in groundwater 
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or 
buildings (residential and other indoor uses). Dietary exposure to 
residues of a pesticide in a food commodity are estimated by 
multiplying the average daily consumption of the food forms of that 
commodity by the tolerance level or the anticipated pesticide residue 
level. The Theoretical Maximum Residue Contribution (TMRC) is an 
estimate of the level of residues consumed daily if each food item 
contained pesticide residues equal to the tolerance. In evaluating food 
exposures, EPA takes into account varying consumption patterns of major 
identifiable subgroups of consumers, including infants and children. 
The TMRC is a ``worst case'' estimate since it is based on the 
assumptions that food contains pesticide residues at the tolerance 
level and that 100% of the crop is treated by pesticides that have 
established tolerances. If the TMRC exceeds the RfD or poses a lifetime 
cancer risk that is greater than approximately one in a million, EPA 
attempts to derive a more accurate exposure estimate for the pesticide 
by evaluating additional types of information (anticipated residue data 
and/or percent of crop treated data) which show, generally, that 
pesticide residues in most foods when they are eaten are well below 
established tolerances.
    Percent of crop treated estimates are derived from federal and 
private market survey data. Typically, a range of estimates are 
supplied and the upper end of this range is assumed for the exposure 
assessment. By using this upper end estimate of percent of crop 
treated, the Agency is reasonably certain that exposure is not 
understated for any significant subpopulation group. Further, regional 
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations 
including several regional groups, to pesticide residues. For this 
pesticide, the most highly exposed population subgroup (non-nursing 
infants <1 year old) was not regionally based.

[[Page 56085]]

IV. Aggregate Risk Assessment and Determination of Safety

    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 B1 and its delta-8,9-isomer 
on basil at 0.05 ppm. 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 
B1 and its delta-8,9-isomer are discussed below.
    1. Acute toxicity. For acute dietary risk assessment, EPA 
recommends use of a NOEL of 0.06 mg/kg/day from the developmental 
toxicity study in mice. The effects observed at the Lowest Effect Level 
(LEL) of 0.10 mg/kg/day involved cleft palate. For the purposes of this 
action, an MOE of 300 is considered necessary to be adequately 
protective for dietary (food only) exposure.
    2. Short - and intermediate - term toxicity. For short- and 
intermediate-term MOE calculations, EPA recommends use of the 
developmental NOEL of 0.2 mg/kg/day from the oral developmental 
toxicity study in mice. At the LEL of 0.4 mg/kg/day, there was an 
increased incidence of cleft palate.
    3. Chronic toxicity. EPA has established the RfD for avermectin at 
0.0004 milligrams/kilogram/day (mg/kg/day). This RfD is based on a 2-
generation rat reproductive toxicity study with a NOEL of 0.12 mg/kg/
day and an uncertainty factor of 300. In addition to the uncertainty 
factor of 100 for inter- and intra-species variations, a Modifying 
Factor (MF) of 3 was used. The MF was used because of the severity of 
the effects (pup deaths) and the steep dose-response curve. At the LEL 
of 0.40 mg/kg/day, there was decreased pup body weight and viability 
during lactation as well as an increased incidence of retinal rosettes 
in F2b weanlings.
    4. Carcinogenicity. Avermectin has been classified by EPA as a 
Group E (``evidence of non-carcinogenicity for humans'') chemical. 
Therefore, a cancer risk assessment is not needed.

B. Exposures and Risks

    1.  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, ranging from 0.005 ppm in cottonseed to 0.05 ppm in 
celery. Risk assessments were conducted by EPA to assess dietary 
exposures and risks from avermectin B1 and its delta-8,9-
isomer 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 one day or single exposure. In a separate and earlier registration 
action, the Agency required the development of more highly refined 
residue and exposure information to support the pesticide. In response, 
in October 1996, EPA received a Monte Carlo analysis for all uses of 
avermectin at that time. Since that analysis was generated before this 
section 18 action was submitted, EPA does not have information on acute 
exposures for basil. Further, the Agency is not currently updating or 
revising Monte Carlo analysis developed by registrants. Therefore, the 
acute exposure assessment for this action does not include data 
associated with the consumption of basil. In spite of the above 
exception, data available to EPA suggest a high-end exposure estimate 
of 0.000078 mg/kg/day for uses of avermectin. This results in a dietary 
(food only) MOE of 769 for females 13 years and older, the population 
subgroup of concern. In EPA's judgement, the addition of basil to acute 
exposure and risk calculations would not produce acute risks (food 
only) that exceed a level of concern.
    ii. Chronic exposure and risk. As part of this action, EPA reviewed 
information that establishes chronic dietary exposure estimates for 
avermectin. This chronic dietary (food only) risk assessment used 
anticipated residue refinement for commodities with tolerances for 
avermectin, but did not incorporate any refinement for percent of crop 
treated (default of 100% was assumed). Therefore, the resulting 
exposure estimates should be viewed as partially refined; further 
refinement for percent of crop treated would result in lower dietary 
exposure estimates. The existing avermectin tolerances plus the 
proposed tolerances associated with the section 18 use of the chemical 
result in an Anticipated Residue Contribution that ranges from 5% of 
the RfD for the U.S. Population to 12% of the RfD for non-nursing 
infants less than a year old.
    2. From drinking water. In examining aggregate exposure, FQPA 
directs EPA to consider available information concerning exposures from 
the pesticide residues 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 uses). Based on data available to EPA, 
avermectin is moderately persistent and not very mobile. It is not 
likely to be found extensively in ground water, but could be found in 
surface water. Under anaerobic conditions in the absence of light, 
avermectin does not degrade. No Health Advisories or Maximum 
Contaminant Levels for avermectin in drinking water have been 
established.
    Because the Agency lacks sufficient water-related exposure data to 
complete a comprehensive drinking water risk assessment for many 
pesticides, EPA has commenced and nearly completed a process to 
identify a reasonable yet conservative bounding figure for the 
potential contribution of water-related exposure to the aggregate risk 
posed by a pesticide. In developing the bounding figure, EPA estimated 
residue levels in water for a number of specific pesticides using 
various data sources. The Agency then applied the estimated residue 
levels, in conjunction with appropriate toxicological endpoints (RfD's 
or acute dietary NOEL's) and assumptions about body weight and 
consumption, to calculate, for each pesticide, the increment of 
aggregate risk contributed by consumption of contaminated water. While 
EPA has not yet pinpointed the appropriate bounding figure for exposure 
from contaminated water, the ranges the Agency is continuing to examine 
are all below the level that would cause avermectin to exceed the RfD 
if the tolerance being considered in this document were granted. The 
Agency has therefore concluded that the potential exposures associated 
with avermectin in water, even at the higher levels the Agency is 
considering as a conservative upper bound, would not prevent the Agency 
from determining that there is a reasonable certainty of no harm if the 
tolerance is granted.
    3. From non-dietary exposure. Avermectin is currently registered 
for use on the following residential non-food sites: ornamental crops 
(herbaceous and woody), turf, households (indoor and outdoor), and

[[Page 56086]]

non-food areas of food handling establishments.
    i. Chronic exposure and risk. Given the uses for avermectin, a 
chronic non-dietary exposure scenario would not be expected.
    ii. Short- and intermediate-term exposure and risk. EPA assessed 
indoor residential risk characterization data to evaluate short- and 
intermediate-term exposure and risk. Based on the assumptions for 
exposure total oral, dermal, and respiratory estimated absorbed daily 
exposure could total .00023 mg/kg/day. This correlates to a total 
short- and intermediate-term indoor residential MOE of 870 for the U.S. 
population.
    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.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will increase the Agency's scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better determining which chemicals 
have a common mechanism of toxicity and evaluating the cumulative 
effects of such chemicals. The Agency anticipates, however, that even 
as its understanding of the science of common mechanisms increases, 
decisions on specific classes of chemicals will be heavily dependent on 
chemical specific data, much of which may not be presently available.
    Although at present the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to which the common mechanism 
issues can be resolved. These pesticides include pesticides that are 
toxicologically dissimilar to existing chemical substances (in which 
case the Agency can conclude that it is unlikely that a pesticide 
shares a common mechanism of activity with other substances) and 
pesticides that produce a common toxic metabolite (in which case common 
mechanism of activity will be assumed).
    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.

C. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. The population subgroup of concern is females 13 
years and older. The MOE for this subgroup from food exposures is 769. 
Despite the potential for exposures to avermectin from drinking water, 
EPA does not expect the acute aggregate risk to exceed levels of 
concern.
    2. Chronic risk. Using the ARC exposure assumptions described 
above, EPA has concluded that aggregate exposure to avermectin from 
food will utilize 5% of the RfD for the U.S. population. The major 
identifiable subgroup with the highest aggregate exposure is non-
nursing infants <1 year old ``discussed below''. EPA generally has no 
concern for exposures below 100% of the RfD because the RfD represents 
the level at or below which daily aggregate dietary exposure over a 
lifetime will not pose appreciable risks to human health. Based on the 
nature of the residential uses, a chronic scenario would not be 
expected. Despite the potential for exposure to avermectin in drinking 
water and from non-dietary, non-occupational exposure, EPA does not 
expect the aggregate exposure to exceed 100% of the RfD. EPA concludes 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to avermectin residues.
    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.
    As referenced above, for short- and intermediate-term exposures, 
EPA assessed information that addresses this topic in relation to human 
exposure associated with residential use through oral, dermal, and 
respiratory exposures. The anticipated MOE was 803 for the U.S. 
population. EPA considers this MOE to be adequately protective.

D. Aggregate Cancer Risk for U.S. Population

    Avermectin has been classified as a Group E ``evidence of non-
carcinogenicity for humans'' chemical by EPA. Therefore, a cancer risk 
assessment is not needed.

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 two-
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 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 100-
fold safety factor (usually 100 for combined inter- and intra-species 
variability) and not the additional tenfold safety 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 safety factor.
    ii. Developmental toxicity studies. In the mouse developmental 
toxicity analysis, the maternal (systemic) NOEL was 0.05 mg/kg/day 
based on mortality

[[Page 56087]]

at the Lowest-observed effect level (LOEL) of 0.075 mg/kg/day. The 
developmental (fetal) NOEL was 0.2 mg/kg/day based on cleft palate at 
the LOEL of 0.4 mg/kg/day. The Delta-8,9-Isomer was also tested for 
developmental toxicity in the mouse. In the mouse developmental study 
for the isomer, the maternal (systemic) NOEL was 0.10 mg/kg/day, based 
on mortality at the LOEL of 0.20 mg/kg/day. The developmental (fetal) 
NOEL was 0.06 mg/kg/day, based on cleft palate at the LOEL of 0.10 mg/
kg/day.
    In the rat developmental study, the maternal (systemic) NOEL was 
greater than or equal to 1.6 mg/kg/day. The developmental (fetal) NOEL 
was 1.6 mg/kg/day. In the rabbit developmental study, the maternal 
(systemic) NOEL was 1.0 mg/kg/day, based on decreased body weight and 
decreased food and water consumption at the LOEL of 2.0 mg/kg/day. The 
developmental (fetal) NOEL was 1.0 mg/kg/day, based on clubbed foot, 
and delayed ossification of sternebrae, metacarpals, and phalanges at 
the LOEL of 2.0 mg/kg/day.
    iii. Reproductive toxicity study. In the 2-generation rat 
reproductive toxicity study, the maternal (systemic) NOEL was 0.4 mg/
kg/day highest dose tested (HDT). The developmental (pup) NOEL was 1.2 
mg/kg/day, based on decreased viability indices, decreased pup body 
weight, and retinal fold in weanlings at the LOEL of 0.4 mg/kg/day. The 
reproductive (pup) NOEL was 0.4 mg/kg/day (HDT).
    iv. Pre- and post-natal sensitivity. Both the delta-8,9-isomer of 
avermectin and avermectin per se exhibit cleft palate in CF1 mouse 
developmental studies. The NOEL for cleft plate for the delta-8,9-
isomer is 0.06 mg/kg/day with the LOEL at 0.10 mg/kg/day. For 
avermectin per se, the NOEL for cleft palate is 0.2 mg/kg/day with the 
LOEL at 0.4 mg/kg/day. Therefore, pre-natal sensitivity to the 
regulated residue for avermectin is demonstrated when considering these 
developmental findings in the CF1 Mouse. An additional 3-fold 
uncertainty factor has been added to account for these developmental 
findings.
    An acute dietary risk assessment is needed based on the results of 
the developmental study in mice with the delta-8,9-isomer. This risk 
assessment will evaluate acute dietary risk to females 13 years and 
older. For the purpose of the section 18, an MOE of 300 is considered 
necessary to be adequately protective for dietary (food only) exposure.
    To evaluate the pre-natal risks, the acute dietary MOE calculations 
for females 13 years and older has been conducted using the lowest NOEL 
for all developmental studies for cleft palate (0.06 mg/kg/day).
    The results of the rat reproduction study required that a Modifying 
Factor of 3 be added to the usual uncertainty factor of 100 used for 
the RfD. EPA used this Modifying Factor in developing this analysis. 
Typically, the Agency uses a modifying factor of 10 when no study is 
available and uses a modifying factor of 3 when a study exists which 
shows effects in the fetus before they appear in the parent.
    2. Acute risk. The acute dietary MOE for females 13 years and older 
(accounts for both maternal and fetal exposure) is 769. This MOE 
calculation is based on the developmental NOEL in mice of 0.06 mg/kg/
day. This estimate is based on Monte Carlo modeling incorporating 
anticipated residue and percent of crop treated refinement. In EPA's 
judgement, the large acute dietary MOE provides assurance that there is 
a reasonable certainty of no harm for females 13 years and older and 
the pre-natal development of infants.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
avermectin from food will utilize 12% of the RfD for non-nursing 
infants less than a year old and 8% of the RfD for children 1-6 years 
old. EPA generally has no concern for exposures below 100% of the RfD 
because the RfD represents the level at or below which daily aggregate 
dietary exposure over a lifetime will not pose appreciable risks to 
human health. Based on the nature of the residential uses, a chronic 
scenario would not be expected. Despite the potential for exposure to 
avermectin in drinking water and from non-dietary, non-occupational 
exposure, EPA does not expect the aggregate exposure to exceed 100% of 
the RfD. EPA concludes that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to 
avermectin residues.
    4. Short- or intermediate-term risk. The anticipated MOEs for 
short- and intermediate-term exposures for infants and children do not 
pose a level of concern. The calculated MOEs range from 716 for non-
nursing infants to 787 for children 7-12 years old.

V. Other Considerations

A. Metabolism In Plants and Animals

    The nature of the residue in plants and animals is adequately 
understood. As cited at 40 CFR 180.449, the regulable residues are 
avermectin B1 and its delta-8,9-isomer.

B. Analytical Enforcement Methodology

    Merck Method 10001, rev. 2, a high pressure liquid chromatography 
(HPLC)-fluorescence method, may be used to enforce the tolerance 
expression. This method has been submitted to FDA for publication in 
PAM Volume II.

C. Magnitude of Residues

    Residues of avermectin B1 and its delta 8,9-isomer are 
not expected to exceed 0.05 ppm on basil as a result of this section 18 
use. Secondary residues are not expected in animal commodities as no 
feed items are associated with this use.

D. International Residue Limits

    No Codex MRLs have been established for avermectin residues on 
basil.

VI. Conclusion

    Therefore, the tolerance is established for combined residues of 
avermectin B1 and its delta-8,9-isomer in basil at 0.05 ppm.

VII. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) 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 December 29, 1997, 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 above (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). 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

[[Page 56088]]

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.

VIII. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300567] (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 1132 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    [email protected].


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above 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 rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.

IX. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408(l)(6). 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 specified 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 these tolerances and exemptions that are 
established under FFDCA section 408 (1)(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. 601et 
seq.) do not apply. Nevertheless, the Agency has 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 acations published on May 4, 1981 (46 FR 
24950), and was provided to the Chief Counsel for Advocacy of the Small 
Business Administration.

X. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in 
today's Federal Register. This is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: October 22, 1997.

James Jones,
Acting 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. 346a and 371.

    2. Section 180.449 is amended in paragraph (b) by alphabetically 
adding a commodity to the table to read as follows:

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

*       *        *       *       *
    (b) *    *    *

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    revocation date 
------------------------------------------------------------------------
Basil...........................  0.05 ppm            9/30/98           
                                                                        
         *        *        *        *        *        *        *        
------------------------------------------------------------------------


[[Page 56089]]

*       *        *       *       *

[FR Doc. 97-28641 Filed 10-28-97; 8:45 am]
BILLING CODE 6560-50-F