[Federal Register Volume 64, Number 96 (Wednesday, May 19, 1999)]
[Rules and Regulations]
[Pages 27192-27200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12593]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300856; FRL-6079-7]
RIN 2070-AB78


Emamectin Benzoate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues 
of the insecticide emamectin benzoate, 4'-epi-methylamino- 4'-
deoxyavermectin B1 benzoate (a mixture of a minimum of 90% 
4'-epi-methylamino-4'- deoxyavermectin B1a and a maximum of 
10% 4'-epi-methlyamino-4'deoxyavermectin B1b benzoate) and 
its metabolites 8,9 isomer of the B1a and B1b 
component of the parent insecticide (8,9 ZMA); 4'-deoxy-4'-epi-amino-
avermectin B1 (AB1a); 4'deoxy-4'-epi-(N-formyl-N-
methyl)amino-avermectin (MFB1a); and 4'-deoxy-4'-epi-(N-
formyl)amino-avermectin B1(FAB1a) (CAS No. 
137512-74-4) in or on Brassica, head & stem subgroup (5-A), head 
lettuce and celery. Novartis Crop Protection, Inc. requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act, as amended by 
the Food Quality Protection Act of 1996.

DATES: This regulation is effective May 19, 1999. Objections and 
requests for hearings must be received by EPA on or before July 19, 
1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300856], 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-300856], 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.

[[Page 27193]]

    A copy of objections and hearing requests filed with the Hearing 
Clerk may 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-300856]. 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: George T. LaRocca, 
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. 206, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, 703-305-6100, 
[email protected].

 SUPPLEMENTARY INFORMATION: In the Federal Register of July 2, 1997 (62 
FR 35804) (FRL-5722-9), EPA issued a notice pursuant to section 408 of 
the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as 
amended by the Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-
170) announcing the filing of a pesticide petition (6F4628) for 
tolerance by Novartis Crop Protection, Inc., P.O Box 18300, Greensboro, 
NC 27419-8300. This notice included a summary of the petition prepared 
by Novartis Crop Protection, Inc., the registrant. There were no 
comments received in response to the notice of filing.
    The petition requested that 40 CFR 180.505 be amended by 
establishing a tolerance for combined residues of the insecticide 
emamectin benzoate, 4'-epi-methylamino-4'-deoxyavermectin B1 
benzoate (a mixture of a minimum of 90% 4'-epi-methylamino-4'-
deoxyavermectin B1a and a maximum of 10% 4'-epi-methlyamino-
4'deoxyavermectin B1b benzoate) and its metabolites 8,9 
isomer of the B1a and B1b component of the parent 
insecticide (8,9 ZMA); 4'-deoxy-4'-epi-amino-avermectin B1 
(AB1a); 4'deoxy-4'-epi-(N-formyl-N-methyl)amino-avermectin 
(MFB1a); and 4'-deoxy-4'-epi-(N-formyl)amino-avermectin 
B1(FAB1a), in or on Brassica, head & stem 
subgroup (5-A), head lettuce and celery at 0.025 ppm part per million 
(ppm). Emamectin benzoate controls a broad spectrum of lepidopterous 
insects (including beet army worm, diamond back moths, cabbage loopers 
and fall army worms.

I. Background and Statutory Findings

    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....''
    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).

II. 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 emamectin 
benzoate and to make a determination on aggregate exposure, consistent 
with section 408(b)(2), for a tolerance for combined residues of 
emamectin benzoate, 4'-epi-methylamino-4'-deoxyavermectin B1 
benzoate (a mixture of a minimum of 90% 4'-epi-methylamino-4'-
deoxyavermectin B1a and a maximum of 10% 4'-epi-methlyamino-
4' deoxyavermectin B1b benzoate) and its metabolites 8,9 
isomer of the B1a and B1b component of the parent 
insecticide (8,9 ZMA); 4'-deoxy-4'-epi-amino-avermectin B1 
(AB1a); 4'deoxy-4'-epi-(N-formyl-N-methyl)amino-avermectin 
(MFB1a); and 4'-deoxy-4'-epi-(N-formyl)amino-avermectin 
B1(FAB1a) on Brassica, head & stem subgroup (5-
A), head lettuce and celery at 0.025 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 emamectin benzoate 
are discussed in this unit.
    1. Acute toxicology studies classify technical grade emamectin as 
having moderate acute toxicity and as being a severe eye irritant 
(Toxicity Category I). Emamectin falls into Toxicity Category 2 and 3 
for acute oral and dermal toxicity, respectively. Emamectin did not 
cause dermal irritation and is not a dermal sensitizer.
    2. A 13-week feeding study in rats resulted in a systemic toxicity 
no observable adverse effect level (NOAEL) of 2.5 mg/kg/day and a 
systemic toxicity lowest observable adverse effect level (LOAEL) of 5 
mg/kg/day, based on tremors, hind limb splaying, urogenital staining, 
histological changes in brain and spinal cord, sciatic and optic nerves 
and skeletal muscles in males, emaciation, reduced body weight and 
reduced food consumption in both sexes.
    3. A 14-week feeding study in dogs resulted in a systemic toxicity 
NOAEL of 0.25 mg/kg/day and a systemic toxicity LOAEL of 0.50 mg/kg/
day, based on microscopic pathological signs of neurotoxicity 
consisting of skeletal muscle atrophy and white matter multi focal 
degeneration in the brains of both sexes and white matter multi focal 
degeneration in the spinal cords of males.
    4. A chronic feeding study in rats resulted in a systemic toxicity 
NOAEL of 1.0 mg/kg/day and a systemic toxicity LOAEL of 2.5 mg/kg/day, 
based on increased incidence of neuronal degeneration in the brain and 
spinal cord, decreased rearing, and an increased incidence of animals 
with low arousal.
    5. A chronic feeding study in dogs resulted in a systemic toxicity 
NOAEL of 0.25 mg/kg/day. The systemic toxicity LOAEL was 0.5 mg/kg/day, 
based on axonal degeneration in the pons, medulla and peripheral nerves 
(sciatic, sural, and tibial) in both sexes, clinical signs of 
neurotoxicity (whole body tremors, stiffness of the hind legs),

[[Page 27194]]

spinal cord axonal degeneration, and muscle fiber degeneration in 
females.
    6. A 2-year chronic/carcinogenicity study is rats was conducted. 
The systemic toxicity NOAEL was 1.0 mg/kg/day. The systemic toxicity 
LOAEL was 2.5/5.0 mg/kg/day, based on marked neural degeneration in the 
brain and spinal cord of both sexes, brain white matter degeneration in 
males, and on decreased body weight, body weight gain, and food 
efficiency in males. There were no signs of carcinogenicity in this 
study.
    7. A 78-week carcinogenicity mouse study resulted in a systemic 
toxicity NOAEL of 2.5 mg/kg/day and a systemic toxicity LOAEL of 5.0 
mg/kg/day for males and 7.5 mg/kg/day for females, based on increased 
mortality, decreased weight gain, neurological signs, and increased 
incidence and severity of infections. There were no signs of 
carcinogenicity in this study.
    8. A developmental toxicity study in rabbits was conducted. The 
maternal toxicity NOAEL was 3 mg/kg/day. The maternal toxicity LOAEL 
was 6 mg/kg/day, based on a significant trend towards decreased body 
weight gain during the dosing period and increased clinical signs 
(mydriasis and decreased pupillary reaction). The developmental 
toxicity NOAEL was 6 mg/kg/day, however, the developmental toxicity 
LOAEL was not determined.
    9. A developmental toxicity study in rats was conducted. The 
maternal toxicity NOAEL was 2 mg/kg/day. The maternal toxicity LOAEL 
was 4 mg/kg/day, based on a significant trend towards decreased body 
weight gain during the dosing period. The developmental toxicity NOAEL 
was 4 mg/kg/day. The developmental toxicity LOAEL was 8 mg/kg/day, 
based on altered growth and an increased incidence of supernumerary 
rib.
    10. A 2-generation reproduction study in rats was conducted. The 
systemic toxicity NOAEL was 0.6 mg/kg/day. The systemic toxicity LOAEL 
of 1.8 mg/kg/day was based on decreased body weight gain and 
histopathological changes (neuronal degeneration in the brain and 
spinal cord) in both sexes and generations. The reproductive toxicity 
NOAEL was 0.6 mg/kg/day. The reproductive toxicity LOAEL of 1.8 mg/kg/
day was based on decreased fecundity and fertility indices and clinical 
signs (tremors and hind limb extension) in offspring of both 
generations.
    11. An acute neurotoxicity study was conducted in rats. A 
neurotoxicity NOAEL was not establisheD, since toxic signs of 
neurotoxicity as well as histological lesions in the brain, spinal cord 
and sciatic nerve occurred at all doses tested (27.4, 54.8 or 82.2 mg/
kg).
    12. A subchronic neurotoxicity study was conducted in rats. The 
neurotoxicity NOAEL was 1.0 mg/kg/day. The neurotoxicity LOAEL was 5.0 
mg/kg/day (highest dose tested) based on mild tremors, posture, 
rearing, excessive salivation, fur appearance, gait, strength, mobility 
and righting reflex.
    13. A dietary neurotoxicity study was conducted with CD-1 mice. The 
neurotoxicity NOAEL was 2.0 mg/kg/day (highest dose tested). No 
characteristic neuronal lesions were observed in the brain, spinal cord 
or sciatic nerve in mice of high dose group (2.0 mg/kg/day).
    14. A dietary neurotoxicity study was conducted with CF-1 mice. The 
neurotoxicity NOAEL was less than 0.1 mg/kg/day. One of the low-dose 
males had tremors, hunched posture and piloerection on day 14.
    15. A dietary neurotoxicity study was conducted with CF-1 mice. The 
neurotoxicity NOAEL was 0.075 mg/kg/day. The LOAEL was 0.10 mg/kg/day 
based on tremors observed beginning on day 3, decreases in body weight 
and food consumption as well as degeneration of the sciatic nerve.
    16. A developmental neurotoxicity study in rats was conducted. The 
maternal toxicity NOAEL was 3.6/2.5 mg/kg/day (highest dose tested). 
The developmental neurotoxicity NOAEL was 0.10 mg/kg/day (lowest dose 
tested). The LOAEL was 0.60 mg/kg/day based on the dose-related 
decrease in open field motor activity in females at postnatal day 17. 
This study was the basis of EPA's conclusion that emamectin 
demonstrated increased susceptibility.
    17. All required mutagenicity studies were conducted and found to 
be negative.
    18. A metabolism study in rats was conducted. Radiolabeled 
MAB1a benzoate was rapidly absorbed, distributed and 
excreted following oral and intravenus (i.v.) administration. The feces 
was the major route of excretion in oral and i.v. groups, while < 1% of 
the administered dose was recovered in the urine 7 days post dosing. 
Tissue distribution and bioaccumulation appeared minimal. The 
metabolism of MAB1a benzoate appears to involve primarily N-
demethylation to AB1a. AB1a was the only 
metabolite detected in the feces while unmetabolized parent compound 
represented a large amount of the radioactivity.
    19. Two bioequivalence studies were conducted with dogs. The first 
study demonstrated that MK-0243 benzoate MTBE solvate and MK-0243 
benzoate monohydrate were bioequivalent in male dogs following oral 
administration as indicated by similar plasma levels for the two 
compounds. The second study demonstrated that benzoate and HCl salts 
are bioequivalent after oral administration in male beagle dogs.
    20. A repeated-dose dermal toxicity study was conducted in rabbits 
using the 0.16 EC formulation (Proclaim ). The NOAEL was 100 mg/kg/day. 
The LOAEL was 250 mg/kg/day, based on systemic effects based on axonal 
degeneration of the sciatic nerve in both sexes (and possibly spinal 
cord axonal degeneration in one male).
    21. A dermal absorption study was conducted. A group of 4 male 
Rhesus monkeys received a dermal application of 0.8 mCi. H3-MAB1A and 
300 g of MK-244 on a shaved portion of the forearm. Blood and 
excreta were collected for 26 days following treatment. Dermal 
absorption was minimal and was approximately 1.79% of the administered 
dose. The dermal absorption factor is 1.8%

B. Toxicological Endpoints

    1. Acute toxicity. For acute dietary risk assessment, an acute 
Reference Dose (RfD) of 0.00075 mg/kg/day has been selected, based on 
the NOAEL of 0.075 mg/kg/day from a 15-day neurotoxicity study in mice 
and an uncertainty factor of 100 (10X for inter-species differences 
extrapolation and 10X for intra species variability). The endpoint is 
based on tremors observed beginning on day 3 at the LOAEL of 0.10 mg/
kg/day.
    2. Short- and intermediate-term toxicity. For dermal and inhalation 
risk assessments, the oral NOAEL of 0.075 mg/kg/day from the 15-day 
neurotoxicity study in mice was used for the short and intermediate-
term exposure scenarios because the neurotoxic clinical signs in mice 
were seen 3-5 days after dosing, which is appropriate for the short 
term exposure period of concern, and the toxicological profiles of 
emamectin benzoate and it metabolites indicated that mice are the most 
sensitive species. The intermediate-term exposure endpoint was based on 
tremors on day 3 of dosing, mortality (moribund sacrifices), clinical 
signs of neurotoxicity, decreases in body weight and food consumption 
and histopathological lesions in the sciatic nerve at the LOAEL of 0.10 
mg/kg/day.
    Since an oral NOAEL was selected for a dermal and inhalation risk 
assessment, a rate of 1.8% for dermal absorption and 100% for 
inhalation absorption was used when converting dermal and

[[Page 27195]]

inhalation exposures to oral equivalents. Dermal and inhalation risk 
assessments are necessary only for short-and intermediate-term 
exposures. The current use pattern does not indicate the need for a 
Long-Term dermal or inhalation exposure risk assessment.
    3. Chronic dietary toxicity. EPA has established the chronic RfD 
for emamectin benzoate at 0.00025 mg/kg/day. The RfD is based on the 
NOAEL of 0.075 mg/kg/day, from the 15-day neurotoxicity study in mice 
and an uncertainty factor of 300 (10X for inter-species differences 
extrapolation and 10X for intra species variability and 3X for use of a 
study of short duration). The endpoint is based on mortality (moribund 
sacrifices), clinical signs of neurotoxicity, decreases in body weight 
and food consumption and histopathological lesions in the sciatic nerve 
at the LOAEL of 0.10 mg/kg/day.
    4. Carcinogenicity. Emamectin benzoate was classified as a ``not 
likely'' human carcinogen. This classification was based on the lack of 
evidence of carcinogenicity in male and female rats/mice at doses that 
were judged to be adequate to assess the carcinogenic potential of the 
chemical.

C. Exposures and Risks

    1. From food and feed uses. There are currently no permanent 
tolerances for emamectin benzoate in/on raw agricultural commodities. A 
time-limited temporary tolerance was established for cabbage (head and 
Napa) at 0.025 ppm under FIFRA section 18 emergency exemptions. The 
tolerance expired on December 31, 1998.
    For the dietary risk assessment, chronic analysis used tolerance 
level residues and percent crop treated data at 25% for all 
commodities. Thus this risk assessment should be viewed as highly 
refined. Further refinement using anticipated residue values would 
result in a lower estimate of chronic dietary exposure.
    As a result of the retention of the FQPA safety factor, EPA will 
consider the population-adjusted-doses (PAD) for infants, children and 
females 13 years and older to be 0.00025 mg/kg/day for acute and 
0.000083 mg/kg/day for chronic dietary exposure. For other populations 
(i.e., adult males). exposures will be compared to the acute and 
chronic RfDs, 0.00075 mg/kg/day and 0.00025 mg/kg/day, respectively.
    Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of crop treated (PCT) for assessing chronic dietary risk 
only if the Agency can make the following findings: (1) That the data 
used are reliable and provide a valid basis to show what percentage of 
the food derived from such crop is likely to contain such pesticide 
residue; (2) that the exposure estimate does not underestimate exposure 
for any significant subpopulation group and; (3) if data are available 
on pesticide use and food consumption in a particular area, the 
exposure estimate does not understate exposure for the population in 
such area. In addition, the Agency must provide for periodic evaluation 
of any estimates used. To provide for the periodic evaluation of the 
estimate of percent of crop treated as required by the section 
408(b)(2)(F), EPA may require registrants to submit data on PCT.
    The Agency used PCT information as follows:
    A routine chronic dietary exposure analysis for Brassica, head & 
stem subgroup (5-A), head lettuce and celery was based on 25% PCT. For 
this action, residues were highly refined: 25% crop treated was 
assumed, along with residue levels at \1/2\ the limit of quantitation. 
Since emamectin is a new chemical, it is unlikely that it would be used 
on 25% of crops. Although dietary risk was not calculated based on the 
assumption of 100% crop treated, EPA is confident that the estimate of 
percent of crop treated which was used, 25%, is an over estimate, and 
does not expect more than 25% of any crop to be treated with emamectin.
    The Agency believes that the three conditions, discussed in section 
408 (b)(2)(F) in this unit concerning the Agency's responsibilities in 
assessing chronic dietary risk findings, have been met. EPA finds that 
the PCT information is reliable and has a valid basis. Before the 
petitioner can increase production of product for treatment of greater 
than a maximum of 0.09 lb ai/acre/season, permission from the Agency 
must be obtained. The regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the consumption of food bearing emamectin benzoate in a 
particular area. Risk assessments were conducted by EPA to assess 
dietary exposures from emamectin benzoate 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. An acute dietary risk assessment was 
performed for emamectin benzoate. EPA used Dietary Exposure Evaluation 
Model (DEEM) software to conduct an acute dietary analysis and used the 
acute RfD of 0.00075 mg/kg/day from the 15-day mouse study and the 
acute PAD of 0.00025 mg/kg/day for subgroups of concern (infants, 
children and females 13+). The DEEM detailed acute analysis estimates 
the distribution of single exposures for the overall U.S. population 
and certain subgroups. The analysis evaluates individual food 
consumption as reported by respondents in the USDA 1989-1991 Continuing 
Survey of Food Intake by Individuals (CSFII) and accumulates exposure 
to the chemical for each commodity. Each analysis assumes uniform 
distribution of emamectin in the commodity supply.
    EPA is generally concerned with acute exposures that exceed 100% of 
the PAD or RfD. For the population subgroups of concern, infants, 
children and females 13 years and older, the estimated 99.9th 
percentile of acute dietary exposure occupies 8% of the PAD, 65% of PAD 
and 27% of PAD, respectively.
    ii. Chronic exposure and risk. A chronic dietary risk assessment 
was performed for emamectin benzoate. The analysis used the chronic RfD 
of 0.00025 mg/kg/day and the chronic PAD of 0.000083 mg/kg/day for 
subgroups of concern. Tolerance level residues and 25% of crop treated 
information were

[[Page 27196]]

used. EPA is generally concerned with chronic exposures that exceed 
100% of the chronic RfD or PAD. For the population subgroups of 
concern, infants, children and females 13 years and older, the 
estimated exposure occupies < 1% of PAD, 5% of PAD and 5% of PAD, 
respectively.
    2. From drinking water. No Maximum Contaminant Level or health 
advisory levels have been established for residues of emamectin 
benzoate in drinking water.
    EPA does not have monitoring data available to perform a 
quantitative drinking water risk assessment for emamectin at this time. 
However, Environmental Fate data for this compound indicates that 
emamectin benzoate and its metabolites would be expected to be 
relatively immobile in the environment due to the high degree of 
sorption to particles.
    EPA used its Screening Concentration in Ground Water (SCI-GROW) 
screening model and environmental fate data to determine the estimated 
environmental concentration (EEC) for emamectin benzoate in ground 
water. The Pesticide Root Zone Model/Exposure Analysis Modeling System 
(PRZM/EXAMS) model was used to determine the EECs for emamectin 
benzoate in surface water. The EEC for emamectin benzoate in ground 
water was 6 ppt (parts per trillion) when applied at the maximum 
recommended application rate of 0.015 lbs ai/acre with a maximum of six 
applications. The EECs for surface water range from the peak 
concentration of 107.22 ppt to the 90 day average of 24.13 ppt when 
applied at the maximum label rate of 0.015 lb ai/acre and maximum of 
0.09 lb ai/acre/season. The computer generated EECs represent 
conservative estimates and should be used only for screening.
    The ground and surface water exposure estimates were calculated 
from the use of emamectin on cabbage. The drinking water values were 
calculated for the parent compound, emamectin; however, based on an 
evaluation of available data, these values can be considered to include 
both emamectin and its metabolites AB1a, MFB1a, 
and FAB1a. These estimates were compared to back-calculated 
Drinking Water Levels of Comparison (DWLOCs) for emamectin for risk 
assessment purposes.
    A DWLOC is a theoretical upper limit of a pesticide's concentration 
in drinking water in light of total aggregate exposure to that 
pesticide in food and through residential uses. A DWLOC will vary 
depending on the toxic endpoint, consumption and body weight. Different 
populations will have different DWLOCs. EPA uses DWLOCs internally in 
the risk assessment process as a surrogate measure of potential 
exposure associated with pesticide exposure through drinking water. In 
the absence of monitoring data for pesticides, the DWLOC is used as a 
point of comparison against conservative model estimates of potential 
pesticide concentration in water. DWLOC values are not regulatory 
standards for drinking water.
    i. Acute exposure and risk. The Agency has calculated the DWLOC for 
acute exposure to emamectin benzoate in drinking water for various 
population subgroups. The DWLOC's for emamectin benzoate (acute 
exposure) are summarized in the following table 1.

                                 Table 1.-- Summary of Acute DWLOC Calculations
----------------------------------------------------------------------------------------------------------------
                                                                        Acute Scenario
                                            --------------------------------------------------------------------
                                                        Acute    Maximum
           Population Subgroup\1\             Acute     Food      Water     SCI-GROW    PRZM/
                                             PAD (mg/ Exposure  Exposure  (g/  EXAMS  DWLOC(g/
                                             kg/day)   (mg/kg/   (mg/kg/       L)       (ppb)          L)
                                                        day)     day)\2\
----------------------------------------------------------------------------------------------------------------
U.S. Population............................  0.00025  0.000078  0.000172      0.006     0.107              6
Children (1-6 years).......................  0.00025  0.000163  0.000087      0.006     0.107              1
Females 13+ years/nursing..................  0.00025  0.000067  0.000183      0.006     0.107              5
----------------------------------------------------------------------------------------------------------------
\1\ Population subgroups chosen were U.S. population (70 kg. body weight assumed), and the two children
  subgroups with the highest food exposure (10 kg. body weight assumed).
\2\ Maximum Water Exposure (mg/kg/day) = Acute PAD (mg/kg/day) - ARC from DEEM (mg/kg/day)

    ii. Chronic exposure and risk. The Agency has calculated DWLOCs for 
chronic (non-cancer) exposure to emamectin benzoate and its metabolites 
for the U.S. population and selected subgroups. The DWLOCs for 
emamectin benzoate are summarized in the following table 2.

                                Table 2.-- Summary of Chronic DWLOC Calculations
----------------------------------------------------------------------------------------------------------------
                                                                      Chronic Scenario
                                          ----------------------------------------------------------------------
                                                      Chronic   Maximum
          Population Subgroup\1\            Chronic    Food      Water     SCI-GROW     PRZM/
                                           PAD (mg/  Exposure  Exposure  (g/   EXAMS  DWLOC(g/
                                            kg/day)   (mg/kg/   (mg/kg/      L)\3\      (ppb)          L)
                                                       day)     day)\2\
----------------------------------------------------------------------------------------------------------------
U.S. Population..........................  0.000083  0.000003   0.00008     0.0006     0.0203              3
Children (1-6 years).....................  0.000083  0.000004   0.00008     0.0006     0.0203              1
Females (13+ years)......................  0.000083  0.000004   0.00008     0.0006     0.0203              2
----------------------------------------------------------------------------------------------------------------
\1\ Population subgroups chosen were U.S. population (70 kg. body weight assumed), the infant or children
  subgroup with the highest food exposure (10 kg. body weight assumed), and females 13+ (60 kg body weight
  assumed).
\2\Maximum Water Exposure (mg/kg/day) = Chronic RfD (mg/kg/day) - ARC from DEEM (mg/kg/day)
\3\ The crop producing the highest level was used.


[[Page 27197]]

    The estimated maximum concentrations of emamectin and its 
metabolites in surface and ground water are less than the DWLOCs as a 
contribution to acute and chronic aggregate exposure. The estimated 
concentrations of emamectin and its metabolites in ground and surface 
water are conservative estimates. Therefore, the Agency concludes with 
reasonable certainty that residues of emamectin in food and drinking 
water would not result in an unacceptable estimate of acute or chronic 
(non-cancer) aggregate human health risk at this time.
    3. From non-dietary exposure. There are no registered or proposed 
residential uses for emamectin benzoate. Therefore, there is no risk 
associated with non-dietary exposure.
    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.''
    Emamectin benzoate is synthetically derived from avermectin, which 
is derived from the antibiotic-producing actinomycetes, the source of 
all of the antibiotic fungicides. Streptomyces avermitilus produces the 
insecticide avermectin, which is a mixture of two homologs, avermectin 
B1a and B1b, which have 
equal biological activity. Currently, the only member of this class 
which is registered for agricultural uses is avermectin. Avermectin and 
ivermectin are structurally similar to emamectin. EPA does not have at 
this time available data to determine whether emamectin benzoate 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 upon a 
common mechanism, emamectin benzoate does not appear to produce a toxic 
metabolite produced by other substances. For the purpose of this 
tolerance action therefore, EPA has not assumed that emamectin benzoate 
has a common mechanism of toxicity with these other substances. An 
explanation of the current Agency approach to assessment of pesticides 
with a common mechanism of toxicity may be found in the final rule for 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

    1. Acute risk. Exposure to emamectin benzoate residues in food will 
occupy no more than 31% of the acute PAD for adult population subgroups 
and no more than 65% PAD for infant/children subgroups. Residue levels 
used for food-source dietary risk assessments were highly refined (used 
\1/2\ level of quantitation (LOQ) residues) and did incorporate 25% of 
crop treated information. Acute dietary exposure estimates were for the 
99.9th percentile. Estimated concentrations of emamectin 
residues in surface and ground water are lower than EPA's DWLOCs. 
Therefore, EPA does not expect acute aggregate risk to emamectin 
benzoate residues from food and water sources to exceed level of 
concern for acute dietary exposure.
    2. Chronic risk. The chronic dietary exposure to emamectin residues 
in food will occupy no more than 4% of the chronic RfD for adult 
population subgroups and no more than 5% PAD for infant/children 
subgroups. Residue levels used for food-source dietary risk assessments 
were highly refined and did incorporate percent of crop treated 
information, as indicated above. EPA generally has no concern for 
exposures below 100% of the PAD/RfD because of PAD/RfD represents the 
level at or below which daily aggregated dietary exposure over a 
lifetime will not pose appreciable risks to human health. The estimated 
concentrations of emamectin residues in surface and ground water are 
lower than the Agency's DWLOCs. Despite the potential for exposure to 
emamectin benzoate in drinking water, EPA does not expect the aggregate 
exposure to exceed 100% of the PAD/RfD. Therefore, EPA does not expect 
chronic aggregate risk to emamectin residues from food and water 
sources to exceed level of concern for chronic dietary exposure.
    3. Aggregate cancer risk for U.S. population. There is no evidence 
of carcinogenicity.
    4. 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 emamectin benzoate 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 emamectin benzoate, 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 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 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.
    For emamectin benzoate, the Agency has determined the tenfold 
safety factor for the protection of infants and children should be 
reduced to 3x. The rationale for reducing the FQPA Safety Factor is as 
follows:
     No increased susceptibility was demonstrated in rats or 
rabbits following in utero and/or postnatal exposure to emamectin. 
However, increased susceptibility was demonstrated in a developmental 
neurotoxicity study in rats.
     Although increased susceptibility was demonstrated in a 
developmental neurotoxicity study in rats, the Committee determined 
that the 10x factor should be reduced to 3x based on the following 
weight-of-the-evidence considerations in the developmental 
neurotoxicity study: (1) The LOAEL was based on a single effect/end 
point (i.e., decrease in open field motor activity); (2) theeffect at 
the LOAEL was seen only on postnatal day 17 and was not seen either on 
earlier (Day 13) or later (Day 21) evaluations whereas at the high dose 
(3.6/2.5 mg/kg/day), this effect was seen on postnatal days 13 and 17; 
(3) the effect at the LOAEL was not accompanied with other toxicity 
whereas at the high dose tremors and

[[Page 27198]]

hind limb splay were also seen; (4) the decreased performance was lower 
only when compared to the concurrent control; and (5) there was limited 
(only 2 studies) historical control data available for comparison.
    Exposure assessments do not indicate a concern for potential risk 
to infants and children because: (1) The dietary exposure estimates are 
based on market share data assuming 25% percent crop treated resulting 
in an overestimate of dietary exposure. This is considered an 
overestimate because the 25% figure is considered to be a conservative 
upper-bound estimate, since a new chemical would have a very small 
market share; (2) modeling data were used for the ground and surface 
source drinking water exposure assessments; the resulting estimates are 
considered to be reasonable upper-bound concentrations; (3) there are 
no registered residential uses.
    EPA also determined that the FQPA Safety Factor (3x) is applicable 
for acute dietary risk assessments for the general population including 
infants and children because the endpoint for this risk assessment is 
neurotoxicity (tremors), and to chronic dietary because the endpoint 
for this risk assessment is based on clinical signs of neurotoxicity 
histopathological lesions in the sciatic nerve following oral exposure. 
As a result of the retention of the FQPA Safety Factor, the Agency 
considered the PAD for infants, children and females 13 years and older 
to be 0.00025 mg/kg/day for acute and 0.000083 mg/kg/day for chronic 
dietary exposure. For other populations (i.e., adult males) exposures 
were compared to the acute and chronic RfDs, 0.00075 mg/kg/day and 
0.00025 mg/kg/day, respectively.
    ii. Conclusion. There is a complete toxicity database for emamectin 
benzoate and exposure data is complete or is estimated based on data 
that reasonably accounts for potential exposures. Taking into account 
the completeness of the data base, EPA concludes, based on reliable 
data, the use of the additional safety factor would be safe for infants 
and children.
    2. Acute risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to emamectin benzoate 
from food will utilize no more than 65% of the acute PAD/RfD for 
infants and children. EPA generally has no concern for exposures below 
100% of the PAD/RfD because the PAD/RfD represents the level at or 
below which daily aggregate dietary exposure over a lifetime will not 
pose appreciable risks to human health.
    3. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to emamectin benzoate 
from food will utilize no more than 5% of the chronic PAD/RfD for 
infants and children. EPA generally has no concern for exposures below 
100% of the PAD/RfD because the PAD/RfD represents the level at or 
below which daily aggregate dietary exposure over a lifetime will not 
pose appreciable risks to human health.
    4. 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 emamectin benzoate 
residues.

III. Other Considerations

A. Metabolism In Plants and Animals

    The following residues are required in the tolerance expression and 
dietary risk assessment for the proposed use: emamectin, 8,9-ZMA, and 
metabolites/photodegradates AB1a, MFB1a and 
FAB1a. Metabolites/photodegradates 8AOXOMA and 8AOHMA are 
also of toxicological concern, but based upon their relative levels to 
the emamectin and the other four emamectin-like residues (8,9-ZMA, 
AB1a, MFB1a and FAB1a), these are not 
needed in the tolerance expression or dietary risk assessment.
    No animal feed items are associated with the commodities for which 
permanent tolerances are proposed. Therefore, no animal metabolism or 
feeding studies are required.

B. Analytical Enforcement Methodology

    The proposed enforcement method for residues of emamectin on plant 
commodities is currently undergoing the Agency's method validation at 
this time. In the interim, EPA has conducted a preliminary review of 
the method and has indicated that it appears to be suitable for 
enforcement purposes pending the outcome of the actual method 
validation. Given that the registrant has provided concurrent 
fortification data to demonstrate that the method is adequate for data 
collection purposes and has provided the Agency with a successful 
Independent Laboratory Validation, coupled with the EPA laboratory's 
preliminary review, EPA concludes that the method is suitable as an 
enforcement method to support tolerances associated with this action.

C. Multiresidue Methods Testing

    Data previously submitted by the petitioner show that residues of 
emamectin are not likely to be recovered by FDA multiresidue methods. 
The petitioner submitted data pertaining to the multiresidue methods 
testing of emamectin (B1a and 
B1b components), AB1a, 
FAB1a, MFB1a and the 8,9-Z isomer 
(B1a component). The data have been forwarded to 
FDA for inclusion in PAM I.

D. Magnitude of Residues

    EPA has concluded that there were sufficient residue field trial 
data using the end use product Proclaim 1.6 EC and Proclaim 5 SG to 
support a 0.025 ppm tolerance on Brassica, head & stem subgroup (5-A), 
head lettuce and celery.

E. International Residue Limits

     There are currently no Codex, Canadian, or Mexican maximum residue 
limits on emamectin benzoate and its metabolites.

F. Rotational Crop Restrictions

    The confined rotational crop data base is adequate. No plantback 
restrictions need to be listed on the label.

G. Residues in Meat, Milk, Poultry and Eggs

    No animal metabolism or feeding studies were submitted with this 
petition. However, tolerances in milk, eggs, and animal tissues are not 
required at this time since no feed items are associated with the 
subject commodities for which permanent tolerances are being proposed.

IV. Conclusion

    Therefore, the tolerance is established for combined residues of 
emamectin benzoate, 4'-epi-methylamino-4'-deoxyavermectin B1 
benzoate (a mixture of a minimum of 90% 4'-epi-methylamino-4'-
deoxyavermectin B1a and a maximum of 10% 4'-epi-methlyamino-
4'deoxyavermectin B1b benzoate) and its metabolites 8,9 
isomer of the B1a and B1b component of the parent 
insecticide (8,9 ZMA); 4'-deoxy-4'-epi-amino-avermectin B1 
(AB1a); 4'deoxy-4'-epi-(N-formyl-N-methyl)amino-avermectin 
(MFB1a); and 4'-deoxy-4'-epi-(N-formyl)amino-avermectin 
B1(FAB1a) in Brassica, head & stem subgroup (5-
A), head lettuce and celery at 0.025 ppm

V. 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

[[Page 27199]]

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 July 19, 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 
regulation. 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, [email protected]. 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.

VI. Public Record and Electronic Submissions

    EPA has established a record for this regulation under docket 
control number [OPP-300856] (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 (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:

    [email protected].

    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.

VII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). 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 tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(d), 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

[[Page 27200]]

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.

VIII. 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: May 11, 1999.

Susan B. Hazen,

Actinig Director, 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. 180.505, by revising paragraph (a) to read as follows:


Sec. 180.505   Emamectin Benzoate; tolerances for residues.

    (a) General. Tolerances are established for the combined residues 
of the insecticide emamectin benzoate, 4'-epi-methylamino-4'-
deoxyavermectin B1 benzoate (a mixture of a minimum of 90% 
4'-epi-methylamino-4'-deoxyavermectin B1a and a maximum of 
10% 4'-epi-methlyamino-4'deoxyavermectin B1b benzoate) and 
its metabolites 8,9 isomer of the B1a and B1b 
component of the parent insecticide (8,9 ZMA); 4'-deoxy-4'-epi-amino-
avermectin B1 (AB1a); 4'deoxy-4'-epi-(N-formyl-N-
methyl)amino-avermectin (MFB1a); and 4'-deoxy-4'-epi-(N-
formyl)amino-avermectin B1(FAB1a) in or on the 
following commodities:

 
------------------------------------------------------------------------
                                                                  Parts
                           Commodity                               per
                                                                 million
------------------------------------------------------------------------
Brassica, head & stem subgroup (5-A)...........................   0.025
Celery.........................................................   0.025
Lettuce, head..................................................   0.025
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 99-12593 Filed 5-18-99; 8:45 am]
BILLING CODE 6560-50-F