FR Doc 06-3308

[Federal Register: April 12, 2006 (Volume 71, Number 70)]
[Rules and Regulations]
[Page 18642-18650]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ap06-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0212; FRL-7765-4]

Emamectin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues
of emamectin and its metabolites in or on pome fruit (crop group 11).
It also revises the combined residues of emamectin and its metabolites
in or on various livestock commodities. Syngenta Crop Protection
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective April 12, 2006. Objections and
requests for hearings must be received on or before June 12, 2006.

ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2005-0212. All documents in the
docket are listed on the http://www.regulations.gov website. (EDOCKET, EPA's

electronic public docket and comment system was replaced on November
25, 2005, by an enhanced federal-wide electronic docket management and
comment system located at http://www.regulations.gov/. Follow the on-

line instructions.) Although listed in the index, some information is
not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Thomas Harris, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9423; e-mail address: harris.thomas@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System

[[Page 18643]]

(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other
Related Information?

In addition to using EDOCKET (http://www.epa.gov/edocket/), you may

access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180

is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/
.

II. Background and Statutory Findings

In the Federal Register of August 24, 2005 (70 FR 49607) (FRL-7728-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
3F6574) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro,
NC 27419. The original 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, in or on the raw agricultural
commodities pome fruit (crop group 11) at 0.02 parts per million (ppm).
That notice included a summary of the petition prepared by Syngenta
Crop Protection, the registrant. Comments were received on the notice
of filing. EPA's response to these comments is discussed in Unit IV.C.
Based on the EPA analysis of the residue chemistry and
toxicological databases, the petition was subsequently revised to
establish:
1. Permanent tolerances for the combined residues of emamectin (a
mixture of a minimum of 90% 4'-epi-methylamino-4'-deoxyavermectin
B1a and maximum of 10% 4'-epi-methylamino-4'-deoxyavermectin
B1b) and its metabolites 8,9-isomer of the B1a
and B1b component of the parent (8,9-ZMA), or 4'-deoxy-4'-
epi-amino-avermectin B1a and 4'-deoxy-4'-epi-amino-
avermectin B1b; 4'-deoxy-4'-epi-amino avermectin
B1a (AB1a); 4'-deoxy-4'-epi-(N-formyl-N-
methyl)amino-avermectin (MFB1a); and 4'-deoxy-4'-epi-(N-
formyl)amino-avermectin B1a (FAB1a) in or on the
following commodities: Fruit, pome, group 11 at 0.025 ppm and apple,
wet pomace at 0.075 ppm; and
2. Permanent tolerances for the combined residues of emamectin
(MAB1a + MAB1b isomers) and the associated 8,9-Z
isomers (8,9-ZB1a + 8,9-ZB1b) in/on the following
commodities: Cattle, fat at 0.010 ppm; cattle, liver at 0.050 ppm;
cattle, meat at 0.003 ppm; cattle, meat byproducts, except liver at
0.020 ppm; milk at 0.003 ppm; goat, fat at 0.010 ppm; goat, liver at
0.050 ppm; goat, meat at 0.003 ppm; goat, meat byproducts, except liver
at 0.020 ppm; horse, fat at 0.010 ppm; horse, liver at 0.050 ppm;
horse, meat at 0.003 ppm; horse, meat byproducts, except liver at 0.020
ppm; sheep, fat at 0.010 ppm; sheep, liver at 0.050 ppm; sheep, meat at
0.003 ppm; and sheep, meat byproducts, except liver at 0.020 ppm. With
the previous emamectin tolerance final rule, published in the Federal
Register of July 9, 2003 (68 FR 40791) (FRL-7316-6), the livestock
tolerances were mistakenly placed in paragraph (d) of 40 CFR 180.505
for inadvertent residues. In this action, the livestock tolerances are
being moved to paragraph (a)(2) of 40 CFR 180.505 which contains
general tolerances.
In addition, the following established tolerances will be deleted
from 40 CFR 180.505 since a tolerance for ``milk'' will be established:
Cattle, milk at 0.003 ppm; goats, milk at 0.003 ppm; hogs, milk at
0.003 ppm; horses, milk at 0.003 ppm; sheep, milk at 0.003 ppm.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for:
1. Permanent tolerances for the combined residues of emamectin (a
mixture of a minimum of 90% 4'-epi-methylamino-4'-deoxyavermectin
B1a and maximum of 10% 4'-epi-methylamino-4'-deoxyavermectin
B1b) and its metabolites 8,9-isomer of the B1a
and B1b component of the parent (8,9-ZMA), or 4'-deoxy-4'-
epi-amino-avermectin B1a and 4'-deoxy-4'-epi-amino-
avermectin B1b; 4'-deoxy-4'-epi-amino avermectin
B1a (AB1a); 4'-deoxy-4'-epi-(N-formyl-N-
methyl)amino-avermectin (MFB1a); and 4'-deoxy-4'-epi-(N-
formyl)amino-avermectin B1a (FAB1a) in or on the
following commodities: Fruit, pome, group 11 at 0.025 ppm and apple,
wet pomace at 0.075 ppm; and
2. Permanent tolerances for the combined residues of emamectin
(MAB1a + MAB1b isomers) and the associated 8,9-Z
isomers (8,9-ZB1a + 8,9-ZB1b) in/on the following
commodities: Cattle, fat at 0.010 ppm; cattle, liver at 0.050 ppm;
cattle, meat at 0.003 ppm; cattle, meat byproducts, except liver at
0.020 ppm; milk at 0.003 ppm; goat, fat at 0.010 ppm; goat, liver at
0.050 ppm; goat, meat at 0.003 ppm; goat, meat byproducts, except liver
at 0.020 ppm; horse, fat at 0.010 ppm; horse, liver at 0.050 ppm;
horse, meat at 0.003 ppm; horse, meat byproducts, except liver at 0.020
ppm; sheep, fat at 0.010 ppm; sheep, liver at 0.050 ppm; sheep, meat at
0.003 ppm; and sheep, meat byproducts, except liver at 0.020 ppm.
EPA's assessment of exposures and risks associated with
establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as

[[Page 18644]]

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. Specific information on the studies received and
the nature of the toxic effects caused by emamectin as well as the no
observed adverse effect level (NOAEL) and the lowest observed adverse
effect level (LOAEL) from the toxicity studies can be found in Unit III
of the final rule published in the Federal Register of July 9, 2003 (68
FR 40791).

B. Toxicological Endpoints

For hazards that have a threshold below which there is no
appreciable risk, the dose at which the NOAEL from the toxicology study
identified as appropriate for use in risk assessment is used to
estimate the toxicological level of concern (LOC). However, the LOAEL
is sometimes used for risk assessment if no NOAEL was achieved in the
toxicology study selected. An uncertainty factor (UF) is applied to
reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.

A summary of the toxicological endpoints for emamectin used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of July 9, 2003 (68 FR 40791).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.505) for the combined residues of emamectin, in
or on a variety of raw agricultural commodities and livestock.
Tolerances range from 0.002 to 0.150 ppm. Risk assessments were
conducted by EPA to assess dietary exposures from emamectin in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. The Dietary Exposure
Evaluation Model (DEEM\TM\) analysis evaluated the individual food
consumption as reported by respondents in the United States Department
of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys
of Food Intake by Individuals (CSFII) and accumulated exposure to the
chemical for each commodity. The following assumptions were made for
the acute exposure assessments: A highly refined, Tier 3, acute dietary
exposure assessment was conducted for the general U.S. population and
various other population subgroups. This was a probabilistic assessment
using anticipated residue estimates as well as EPA percent crop treated
(PCT) estimates for a number of commodities. For acute assessments,
maximum (rather than average) PCT estimates were used, specifically:
Apples 73%, pears 60%, broccoli 20%, cabbage 15%, celery 25%,
cauliflower 30%, cotton commodities 2.5%, lettuce 20%, peppers 2.5%,
spinach 2.5%, and tomatoes 2.5%. For crops not listed 100% PCT was
used. Anticipated residues were used for pome fruit based on average
field trial data. The recommended tolerance level residues were used
for all other crops and meat products. Additionally, default DEEM\TM\
(version 7.87) concentration factors were used for all commodities
except apple juice, for which a concentration factor was based on a
processing study.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 Nationwide CSFII, and accumulated exposure to the chemical for
each commodity. The following assumptions were made for the chronic
exposure assessments: A refined chronic dietary (food only) exposure
assessment was conducted for the general U.S. population and various
other population subgroups. The proposed and registered food uses of
emamectin were represented by a single point estimate of anticipated
emamectin residues in food. For chronic assessments, average (rather
than maximum) PCT estimates were used, specifically: Apples 14%, pears
15%, broccoli 10%, cabbage 5%, celery 10%, cauliflower 10%, cotton
commodities 1%, lettuce 10%, peppers 1%, spinach 1%, and tomatoes 1%.
For crops not listed 100% PCT was used. Anticipated residues were used
for pome fruit based on average field trial. The recommended tolerance
level residues were used for all other crops and meat products.
Additionally, default DEEM\TM\ (version 7.87) concentration factors
were used for all commodities except apple juice, for which a
concentration factor was based on a processing study.
iii. Cancer. Emamectin is classified as a ``not likely`` human
carcinogen based on the lack of evidence of carcinogenicity in male and
female rats or male and female mice at doses that were judged to be
adequate to assess the carcinogenic potential of the chemical.
iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of the FFDCA authorizes EPA to use available data and information on
the anticipated residue levels of pesticide residues in food and the
actual levels of pesticide chemicals that have been measured in food.
If EPA relies on such information, EPA must pursuant to section
408(f)(1) require that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. Following the initial
data submission, EPA is authorized to require similar data on a time
frame it deems appropriate. For the present action, EPA will issue such
data call-ins for information relating to anticipated residues as are
required by FFDCA section 408(b)(2)(E) and authorized under FFDCA
section 408(f)(1). Such data call-ins will be required to be submitted
no later than 5 years from the date of issuance of this tolerance.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings: Condition 1,
that the data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.

[[Page 18645]]

The Agency used PCT information as detailed above under Units
III.C.1.i and III.C.1.ii. Different PCTs were used for the acute versus
the chronic dietary risk from food and feed uses as explained in these
sections.
EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available Federal, State, and private market survey data for that use,
averaging by year, averaging across all years, and rounding up to the
nearest multiple of 5 percent except for those situations in which the
average PCT is less than one. In those cases < 1% is used as the average
and < 2.5% is used as the maximum. EPA uses a maximum PCT for acute
dietary risk analysis. The maximum PCT figure is the single maximum
value reported overall from available Federal, State, and private
market survey data on the existing use, across all years. In most
cases, EPA uses available data from USDA/National Agricultural
Statistics Service (USDA/NASS), Proprietary Market Surveys, and the
National Center for Food and Agriculture Policy (NCFAP) for the most
recent 6 years.
EPA projects PCT for a new pesticide use by assuming that the PCT
for the pesticide's initial 5 years will not exceed the average PCT of
the dominant pesticide (the one with the largest PCT) within its type
over 3 latest available years. The PCTs included in the average may be
each for the same pesticide or for different pesticides since the same
or different pesticides may dominate for each year selected. Typically,
EPA uses USDA/NASS as the source for raw PCT data because it is non-
proprietary and directly available without computation. When a specific
site is not covered in USDA/NASS, EPA uses proprietary data, which may
require computation. This method of projecting PCT for a new pesticide,
with or without regard to specific pest(s), produces an upper-end
projection that is unlikely, in most cases, to be exceeded in actuality
in the next 5 years because one or more of the following conditions
will likely apply: The dominant pesticide is better established and
accepted by farmers than the new pesticide, the dominant pesticide is
more efficacious than the new pesticide, the dominant pesticide
controls a broader spectrum and/or more important pests than the new
pesticide, the dominant pesticide is more cost-effective than the new
pesticide, and other conditions. These factors have been considered for
this pesticide's new use, and they indicate that it is unlikely that
actual PCT for this new use will exceed the PCT for the dominant
pesticide in the next 5 years.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for emamectin in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of emamectin. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
emamectin for acute exposures are estimated to be 0.57 parts per
billion (ppb) for surface water and 2.7 X 10^-4 ppb for
ground water. The EDWCs for chronic exposures are estimated to be 0.22
ppb for surface water and 2.7 X 10^-4 ppb for ground water.
Modeled EDWCs were directly entered into the dietary exposure model
(DEEM-FCID). For the acute dietary risk assessment, the full
distribution of estimated residues in surface water generated by the
PRZM-EXAMS model was input into the model. For chronic dietary risk
assessment, the annual average concentration of 0.22 ppb was used to
access the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Emamectin is not registered for use on any sites that would result
in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to emamectin and any other
substances and emamectin does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that emamectin has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. Emamectin causes increased
sensitivity of offspring relative to adults (as seen in the rat
reproductive toxicity study and the rat developmental neurotoxicity
study). EPA determined that the concern is low as to the qualitative
sensitivity seen in the reproduction study because:
i. There was a clear NOAEL for offspring toxicity;
ii. Effects unique to offspring (decreased fertility in
F1 adults, and clinical signs tremors and hind limb
extensions during and following lactation) were seen at the same dose
that caused parental systemic toxicity (decreased body weight gain and
histopathological lesions in the brain and spinal cord), and
iii. The decreased fertility seen in F1 adults may have
been due to histopathological lesions in the brain

[[Page 18646]]

and central nervous system (seen in both F0 and
F1 generations), rather than due to a direct effect on the
reproductive system.
As to the increased qualitative and quantitative susceptibility in
the rat developmental neurotoxicity study, EPA determined that the
concern is low because:
Although multiple offspring effects (including decreased
pup body weight, head and body tremors, hindlimb extension and splay,
changes in motor activity and auditory startle) were seen at the
highest dose, and no maternal effects were seen at any dose, there was
a clear NOAEL for offspring toxicity at the low dose, and
The offspring LOAEL (at the mid dose) is based on a single
effect seen on only one day (decreased motor activity on PND 17) and no
other offspring toxicity was seen at the LOAEL. Additionally, concern
is lessened because the dose selected for overall risk assessment
(based on a 15-day study in adult mice) is lower than the doses that
caused offspring toxicity in reproduction and developmental
neurotoxicity studies in rats; the endpoint selected is the most
sensitive end point (neurotoxicity) in the most sensitive species
(mice) and thus would address the concerns for any potential toxicity
in the offspring.
3. Conclusion. Although there is a complete toxicity database for
emamectin, exposure is estimated based on data that reasonably accounts
for potential exposures, and increased sensitivity in the young is
addressed by selection of a protective endpoint, EPA has retained a 10X
FQPA safety factor for chronic/long-term and intermediate-term
assessments due to the steepness of the dose-response curve, severity
of effects at the LOAEL (death and neuropathology), and the use of a
short-term study for long-term risk assessment. The steepness of the
dose-response curve and the severity of the effects at the LOAEL also
are the basis for EPA retaining a 3X FQPA safety factor for acute
assessments. A 3X FQPA factor was judged to be adequate (as opposed to
a 10X) because:
i. A NOAEL was established in this study;
ii. Although the effects of concern are seen after repeated dosing,
the NOAEL here is used for a single exposure risk assessment; and
iii. The most sensitive endpoint in the most sensitive species is
selected.
The exposure estimate was judged to reasonably account for exposure
based on:
The acute dietary food exposure assessment utilizes
anticipated residue estimates based on carefully reviewed field trial
data and PCT data for several commodities (100 PCT was assumed for
remaining commodities). By using the 99.9th percentile exposure values
for comparison to the aPAD, actual risks are not likely to be
underestimated.
The chronic dietary food exposure assessment utilizes
tolerance level residue estimates and PCT data for several commodities
(100 PCT was assumed for remaining commodities). This assessment is
somewhat refined and based on reliable data that is not likely to
underestimate exposure/risk.
The dietary drinking water assessment utilizes water
concentration values generated by model and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations which will not
likely be exceeded.
There are no proposed or existing residential uses for
emamectin.

E. Aggregate Risks and Determination of Safety

The Agency currently has two ways to estimate total aggregate
exposure to a pesticide from food, drinking water, and residential
uses. First, a screening assessment can be used, in which the Agency
calculates drinking water levels of comparison (DWLOCs) which are used
as a point of comparison against estimated environmental concentrations
(EECs). The DWLOC values are not regulatory standards for drinking
water, but are theoretical upper limits on a pesticide's concentration
in drinking water in light of total aggregate exposure to a pesticide
in food and residential uses. In calculating a DWLOC, the Agency
determines how much of the acceptable exposure (i.e., the PAD) is
available for exposure through drinking water e.g., allowable chronic
water exposure milligram/kilogram/day (mg/kg/day) = CPAD - (average
food + residential exposure). This allowable exposure through drinking
water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the EPA's Office of Water are used to calculate
DWLOCs: 2 liter (L) / 70 kg (adult male), 2L / 60 kg (adult female),
and 1L / 10 kg (child). Different populations will have different
DWLOCs. Generally, a DWLOC is calculated for each type of risk
assessment used: Acute, short-term, intermediate-term, chronic, and
cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, EPA concluded with reasonable certainty that
exposures to the pesticide in drinking water (when considered along
with other sources of exposures for which EPA has reliable data) would
not result in unacceptable levels of aggregate human health risk at
this time. Because EPA considers the aggregate risk resulting from
multiple exposure pathways associated with a pesticide's uses, levels
of comparison in drinking water may vary as those uses change. When new
uses are added EPA reassesses the potential impacts of residues of the
pesticide in drinking water as a part of the aggregate assessment
process.
More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface water and ground water EECs
are directly incorporated into the dietary exposure analysis, along
with food. This provides a more realistic estimate of exposure because
actual body weights and water consumption from the CSFII are used. The
combined food and water exposures are then added to estimated exposure
from residential sources to calculate aggregate risks. The resulting
exposure and risk estimates are still considered to be high end, due to
the assumptions used in developing drinking water modeling inputs.
1. Acute risk. The acute aggregate risk assessment takes into
account exposure estimates from dietary (food + drinking water)
consumption of emamectin. A highly refined, Tier 3, acute assessment
was conducted for all supported food uses and drinking water. The Tier
3 assessment was a probabilistic assessment using anticipated residue
estimates from the current and previously submitted field trial data,
PCT/projected market share estimates for a number of commodities (100%
for the rest), and default DEEM\TM\ 7.87 processing factors for all
commodities except apple juice, for which a concentration factor was
based on a processing study. The assessment was conducted using the
full distribution of estimated residues in surface water generated by
the PRZM-EXAMS model using the pome fruit crop group scenario for
drinking water.
The acute aggregate risk estimates for emamectin are below EPA's
LOC (< 100% aPAD) at the 99.9th percentile for the general U.S.
population (at 41% of the aPAD) and various other population subgroups.
The most highly exposed population subgroup was all infants (< 1 year
old) at 77% of the aPAD. Results are shown in the following Table.

[[Page 18647]]

2. Chronic risk. The chronic aggregate risk assessment takes into
account average exposure estimates from dietary consumption of
emamectin (food and drinking water).
The chronic aggregate risk estimates for emamectin are below EPA's
LOC for all population subgroups (8% of the cPAD for the U.S.
population and 23% of the cPAD for all infants (< 1 year old), the most
highly exposed subgroup). Results are shown in the following Table.

Table--Summary of Dietary (Food + Drinking Water) Exposure and Risk Estimates for Emamectin using DEEM\TM\-FCID
----------------------------------------------------------------------------------------------------------------
Acute Dietary\1\ Chronic Dietary\2\
----------------------------------------------------
Population Subgroup % aPAD at Cancer
Exposure 99.9th Exposure % cPAD Dietary
(mg/kg/day) percentile (mg/kg/day)
----------------------------------------------------------------------------------------------------------------
General U.S. Population 0.000103 41 0.000006 8 NA\3\
----------------------------------------------------------------------------------------------------------------
All Infants (< 1 year old) 0.000193 77* 0.000017 23* NA\3\
----------------------------------------------------------------------------------------------------------------
Children 1-2 years old 0.000172 69 0.000011 15 NA\3\
----------------------------------------------------------------------------------------------------------------
Children 3-5 years old 0.000149 59 0.000010 13 NA\3\
----------------------------------------------------------------------------------------------------------------
Children 6-12 years old 0.000105 42 0.000006 9 NA\3\
----------------------------------------------------------------------------------------------------------------
Youth 13-19 years old 0.000094 38 0.000004 6 NA\3\
----------------------------------------------------------------------------------------------------------------
Adults 20-49 years old 0.000058 23 0.000005 7 NA\3\
----------------------------------------------------------------------------------------------------------------
Adults 50+ years old 0.000052 21 0.000005 7 NA\3\
----------------------------------------------------------------------------------------------------------------
Females 13-49 years old 0.000060 24 0.000005 7 NA\3\
----------------------------------------------------------------------------------------------------------------
* The value for the highest exposed population.
1 Acute dietary endpoint of 0.00025 mg/kg/day applies to the general U.S. population and all population
subgroups.
2 Chronic dietary endpoint of 0.000075 mg/kg/day applies to the general U.S. population and all population
subgroups.
3 NA = not applicable. Emamectin is classified as a ``not likely'' human carcinogen based on the lack of
evidence of carcinogenicity in male and female rats or male and female mice at doses that were judged to be
adequate to assess the carcinogenic potential of the chemical.

3. Short- and intermeditate-term risk. Short- and intermediate-term
aggregate exposure takes into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Because there are no residential uses proposed for emamectin,
short- and intermediate-term aggregate risk assessments based on
exposure from oral, inhalation, and dermal routes were not performed.
Therefore, the aggregate risk is the sum of the risk from food and
water, which do not exceed the Agency's LOC.
5. Aggregate cancer risk for U.S. population. EPA has classified
emamectin as a ``not likely'' human carcinogen. This classification was
based on the lack of evidence of carcinogenicity in male and female
rats or male and female mice at doses that were judged to be adequate
to assess the carcinogenic potential of the chemical. Therefore,
exposure to emamectin is not expected to pose a cancer risk.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to emamectin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

1. Enforcement method for plant commodities. A high performance
liquid chromatography method with fluorescence detection (HPLC/FLD
Method 244-92-3) is available for the enforcement of established
tolerances for residues of emamectin and its metabolites in/on plants.
Method 244-92-3, Revision 1, is a similar HPLC/FLD method which is
available for enforcement of the tolerances on pome fruit. Method 244-
92-3, Revision 1, determines residues of B1a isomers (total
emamectin B1a and 8,9-ZB1a), B1b
isomers (emamectin B1b + 8,9-ZB1b), and the
photodegradates AB1 (L649), and MFB1 +
FAB1 (L599 + L831) in/on apple and pear and in apple
processed commodities. The LOQ is 0.005 ppm for each analyte in each
matrix.
2. Enforcement method for livestock commodities. An analytical
method (Method 244-95-1) is available for enforcement of tolerances for
residues of emamectin (MAB1a and MAB1b) and the
8,9-Z isomers in/on ruminant commodities. The LOQs are 0.0005 ppm for
each analyte (MAB1a + 8,9-ZB1a and
MAB1b + 8,9-ZB1b) in whole and skim milk and
0.002 ppm for each analyte (MAB1a + 8,9-ZB1a and
MAB1b + 8,9-ZB1b) in fat, liver, kidney, and
meat.
3. Multiresidue methods testing. Data previously submitted show
that residues of emamectin are not likely to be recovered by the Food
and Drug Administration (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).
Adequate enforcement methodology is available to enforce the
tolerance expression. The above methods have been forwarded to the Food
and Drug Administration for inclusion in PAM I or II. Alternately,
methods may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.

B. International Residue Limits

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

[[Page 18648]]

C. Response to Comments

Public comments were received from B. Sachau who objected to the
proposed tolerances stating that only a zero residue should be allowed.
She objected to utilizing a 1994 database since America has changed a
great deal since 1994 thus making the database outdated. She further
stated that testing conducted on mice and other animals has absolutely
no relevance to toxic effects on humans.
B. Sachau's comments contained no scientific data or evidence to
rebut the Agency's conclusion that there is a reasonable certainty that
no harm will result from aggregate exposure to emamectin including all
anticipated dietary exposures and all other exposures for which there
is reliable information. EPA does update the analysis inputs when new
information becomes available. For example, the risk assessment for
this final rule utilized dietary information from the USDA's CSFII from
1994-1996 and 1998. EPA has responded to B. Sachau's generalized
comments on numerous previous occasions. (See the Federal Register of
January 7, 2005 (70 FR 1349, 1354) (FRL-7691-4) and the Federal
Register of October 29, 2004 (69 FR 63083, 63096) (FRL-7681-9).

V. Conclusion

Therefore, the tolerances are established for combined residues of
1) emamectin (a mixture of a minimum of 90% 4'-epi-methylamino-4'-
deoxyavermectin B1a and maximum of 10% 4'-epi-methylamino-
4'-deoxyavermectin B1b) and its metabolites 8,9-isomer of
the B1a and B1b component of the parent (8,9-
ZMA), or 4'-deoxy-4'-epi-amino-avermectin B1a and 4'-deoxy-
4'-epi-amino-avermectin B1b; 4'-deoxy-4'-epi-amino
avermectin B1a (AB1a); 4'-deoxy-4'-epi-(N-formyl-
N-methyl)amino-avermectin (MFB1a); and 4'-deoxy-4'-epi-(N-
formyl)amino-avermectin B1a (FAB1a) in or on the
following commodities: Fruit, pome, group 11 at 0.025 ppm and Apple,
wet pomace at 0.075 ppm; and 2) for the combined residues of emamectin
(MAB1a + MAB1b isomers) and the associated 8,9-Z
isomers (8,9-ZB1a + 8,9-ZB1b) in/on the following
commodities: Cattle, fat at 0.010 ppm; cattle, liver at 0.050 ppm;
cattle, meat at 0.003 ppm; cattle, meat byproducts, except liver at
0.020 ppm; milk at 0.003 ppm; goat, fat at 0.010 ppm; goat, liver at
0.050 ppm; goat, meat at 0.003 ppm; goat, meat byproducts, except liver
at 0.020 ppm; horse, fat at 0.010 ppm; horse, liver at 0.050 ppm;
horse, meat at 0.003 ppm; horse, meat byproducts, except liver at 0.020
ppm; sheep, fat at 0.010 ppm; sheep, liver at 0.050 ppm; sheep, meat at
0.003 ppm; and sheep, meat byproducts, except liver at 0.020 ppm. In
addition, the following established tolerances will be deleted from 40
CFR 180.505 since a tolerance for ``milk'' will be established: Cattle,
milk at 0.003 ppm; goats, milk at 0.003 ppm; hogs, milk at 0.003 ppm;
horses, milk at 0.003 ppm; sheep, milk at 0.003 ppm. With the previous
emamectin tolerance final rule, published in the Federal Register of
July 9, 2003 (68 FR 40791) the livestock tolerances were mistakenly
placed in paragraph (d) of 40 CFR 180.505 for inadvertent residues. In
this action, the livestock tolerances are being moved to paragraph
(a)(2) of 40 CFR 180.505 which contains general tolerances.

VI. Objections and Hearing Requests

Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number EPA-HQ-OPP-2005-0212 in the subject line on
the first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before June 12,
2006.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St., NW.,
Washington, DC 20005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number EPA-HQ-OPP-2005-0212, to: Public
Information and Records Integrity Branch, Information Technology and
Resources Management Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the

[[Page 18649]]

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 issue(s) in the manner
sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32).

VII. Statutory and Executive Order Reviews

This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
Federalism(64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.

VIII. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

Dated: March 27, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.505 is revised to read as follows:

Sec. 180.505 Emamectin; tolerances for residues.

(a) General. (1) Tolerances are established for combined residues
of emamectin (a mixture of a minimum of 90% 4'-epi-methylamino-4'-
deoxyavermectin B1a and maximum of 10% 4'-epi-methylamino-
4'-deoxyavermectin B1b) and its metabolites 8,9-isomer of
the B1a and B1b component of the parent (8,9-
ZMA), or 4'-deoxy-4'-epi-amino-avermectin B1a and 4'-deoxy-
4'-epi-amino-avermectin B1b; 4'-deoxy-4'-epi-amino
avermectin B1a (AB1a); 4'-deoxy-4'-epi-(N-formyl-
N-methyl)amino-avermectin (MFB1a); and 4'-deoxy-4'-epi-(N-
formyl)amino-avermectin B1a (FAB1a) in or on the
following commodities:

(2) Tolerances are also established for combined residues of
emamectin (MAB1a + MAB1b isomers) and the
associated 8,9-Z isomers (8,9-ZB1a + 8,9-

[[Page 18650]]

ZB1b) in/on the following commodities when present therein
as a result of the application of emamectin to crops listed in the
table in paragraph (a)(1) of this section:

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat.......................................... 0.010
Cattle, liver........................................ 0.050
Cattle, meat......................................... 0.003
Cattle, meat byproducts, except liver................ 0.020
Goat, fat............................................ 0.010
Goat, liver.......................................... 0.050
Goat, meat........................................... 0.003
Goat, meat byproducts, except liver.................. 0.020
Horse, fat........................................... 0.010
Horse, liver......................................... 0.050
Horse, meat.......................................... 0.003
Horse, meat byproducts, except liver................. 0.020
Milk................................................. 0.003
Sheep, fat........................................... 0.010
Sheep, liver......................................... 0.050
Sheep, meat.......................................... 0.003
Sheep, meat byproducts, except liver................. 0.020
------------------------------------------------------------------------

(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect and inadvertant residues. [Reserved]

[FR Doc. 06-3308 Filed 4-11-06; 8:45 am]

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