[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: opp-docket@epa.gov. 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,
larocca.george@epa.gov.
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="">1a 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="">1a, 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
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Acute Scenario
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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
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\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
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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
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\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, tompkins.jim@epa.gov. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
If a hearing is requested, the objections must include a statement
of the factual issues on which a hearing is requested, the requestor's
contentions on such issues, and a summary of any evidence relied upon
by the requestor (40 CFR 178.27). A request for a hearing will be
granted if the Administrator determines that the material submitted
shows the following: There is genuine and substantial issue of fact;
there is a reasonable possibility that available evidence identified by
the requestor would, if established, resolve one or more of such issues
in favor of the requestor, taking into account uncontested claims or
facts to the contrary; and resolution of the factual issues in the
manner sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection with an
objection or hearing request may be claimed confidential by marking any
part or all of that information as CBI. Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice.
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:
opp-docket@epa.gov.
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit will be kept in paper form.
Accordingly, EPA will transfer any copies of objections and hearing
requests received electronically into printed, paper form as they are
received and will place the paper copies in the official record which
will also include all comments submitted directly in writing. The
official record is the paper record maintained at the Virginia address
in ``ADDRESSES'' at the beginning of this document.
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
