Document ID: EPA-HQ-OPP-2005-0212-0003
Agency: epa
Document Type: Rule
Title: Emamectin; Pesticide Tolerance
Posted Date: 2006-04-12T13:53:09Z

[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:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Apple, wet pomace....................................              0.075
Cotton, gin byproduct................................              0.050
Cotton, undelinted seed..............................              0.025
Fruit, pome, group 11................................              0.025
Tomato, paste........................................              0.150
Turnip, greens.......................................              0.050
Vegetable, Brassica, leafy, group 5..................              0.050
Vegetable, fruiting (except Cucurbits), group 8......              0.020
Vegetable, leafy, except Brassica, group 4...........              0.100
------------------------------------------------------------------------

    (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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