[Federal Register Volume 70, Number 163 (Wednesday, August 24, 2005)]
[Notices]
[Pages 49607-49611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16806]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0212; FRL-7728-3]


Emamectin; Notice of Filing a Pesticide Petition to Establish a 
Tolerance for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket identification (ID) number OPP-
2005-0212, must be received on or before September 23, 2005.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

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:<a href="/cdn-cgi/l/email-protection#4e262f3c3c273d603a2621232f3d0e2b3e2f60292138"><span class="__cf_email__" data-cfemail="610900131308124f15090e0c0012210411004f060e17">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111)
    <bullet> Animal production (NAICS code 112)
    <bullet> Food manufacturing (NAICS code 311)
    <bullet> Pesticide manufacturing (NAICS code 32532)
     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 (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 Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket ID number OPP-2005-0212. The official public docket 
consists of the documents specifically referenced in this action, any 
public comments received, and other information related to this action. 
Although, a part of the official docket, the public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. The official public docket 
is the collection of materials that is available for public viewing at 
the Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall <greek-i>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.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/.
     An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public 
comments, access the index listing of the contents of the official 
public docket, and to access those documents in the public docket that 
are available electronically. Although, not all docket materials may be 
available electronically, you may still access any of the publicly 
available docket materials through the docket facility identified in 
Unit I.B.1. Once in the system, select ``search,'' then key in the 
appropriate docket ID number.
     Certain types of information will not be placed in the EPA 
Dockets. Information claimed as CBI and other information whose 
disclosure is restricted by statute, which is not included in the 
official public docket, will not be available for public viewing in 
EPA's electronic public docket. EPA's policy is that copyrighted 
material will not be placed in EPA's electronic public docket but will 
be available only in printed, paper form in the official public docket. 
To the extent feasible, publicly available docket materials will be 
made available in EPA's electronic public docket. When a document is 
selected from the index list in EPA Dockets, the system will identify 
whether the document is available for viewing in EPA's electronic 
public docket. Although, not all docket materials may be available 
electronically, you may still access any of the publicly available 
docket materials through the docket facility identified in Unit I.B. 
EPA intends to work towards providing electronic access to all of the 
publicly available docket materials through EPA's electronic public 
docket.
     For public commenters, it is important to note that EPA's policy 
is that public comments, whether submitted electronically or on paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
     Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

     You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are

[[Page 49608]]

submitted within the specified comment period. Comments received after 
the close of the comment period will be marked ``late.'' EPA is not 
required to consider these late comments. If you wish to submit CBI or 
information that is otherwise protected by statute, please follow the 
instructions in Unit I.D. Do not use EPA Dockets or e-mail to submit 
CBI or information protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also, include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2005-0212. The system is an ``anonymous access''system, which means 
EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to <a href="/cdn-cgi/l/email-protection#69061919440d060a020c1d290c1908470e061f"><span class="__cf_email__" data-cfemail="cba4bbbbe6afa4a8a0aebf8baebbaae5aca4bd">[email protected]</span></a>, 
Attention: Docket ID number OPP-2005-0212. In contrast to EPA's 
electronic public docket, EPA's e-mail system is not an ``anonymous 
access'' system. If you send an e-mail comment directly to the docket 
without going through EPA's electronic public docket, EPA's e-mail 
system automatically captures your e-mail address. E-mail addresses 
that are automatically captured by EPA's e-mail system are included as 
part of the comment that is placed in the official public docket, and 
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit I.C.2. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID number OPP-2005-0212.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
<greek-i>2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
number OPP-2005-0212. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

     Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is CBI). Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
     In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

     You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

     EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in FFDCA section 408(d)(2); however, 
EPA has not fully evaluated the sufficiency of the submitted data at 
this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: August 9, 2005.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

     The petitioner's summary of the pesticide petition is printed 
below as required by FFDCA section 408(d)(3). The summary of the 
petition was prepared by Syngenta Crop Protection, and represents the 
view of the petitioner. The petition summary announces the availability 
of a description of the analytical methods available to EPA for the 
detection and

[[Page 49609]]

measurement of the pesticide chemical residues or an explanation of why 
no such method is needed.

 Syngenta Crop Protection

 PP 3F6574

     EPA has received a pesticide petition (3F6574) from Syngenta Crop 
Protection, Inc., P.O. Box 18300, Greensboro, NC 27419 proposing, 
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing 
tolerances for residues of emamectin benzoate, 4'-epi-methylamino- 4'-
deoxyavermectin B<INF>1</INF> benzoate (a mixture of a minimum of 90% 
4'-epi-methylamino-4'- deoxyavermectin B<INF>1a</INF> and a maximum of 
10% 4'-epi-methlyamino-4'deoxyavermectin B<INF>1b</INF> benzoate), and 
its metabolites 8,9 isomer of the B<INF>1a</INF> and B<INF>1b</INF> 
component of the parent insecticide in or on the raw agricultural 
commodities pome fruit at 0.02 parts per million (ppm).

A. Residue Chemistry

    1. Plant metabolism. The metabolism of emamectin benzoate in plants 
has been studied and the nature of the residue has been determined in 
lettuce, cabbage, and sweet corn. The major portion of the residue is 
parent compound and its delta 8,9-photoisomer. The metabolism of 
emamectin has also been investigated in goats and poultry to 
characterize the fate of residues that may be present in animal feed 
items.
    2. Analytical method. Adequate analytical methods (High Production 
Liquid Chromatography -fluorescence methods) are available for 
enforcement purposes.
    3. Magnitude of residues. The appropriate number of residue trials 
has been conducted for the representative commodities of the pome fruit 
crop group (Crop Group 11). Those representative commodities are apples 
and pears. These trials were conducted in the major U.S. growing areas 
for these crops. Processing studies were conducted to provide wet apple 
pomace and juice for analysis and to determine if a tolerance in these 
commodities is necessary.

B. Toxicological Profile

     A full description of the studies describing the toxicity, animal 
metabolism, metabolite toxicology, and endocrine disruption of 
emamectin benzoate can be found in the posting for its first tolerances 
in the Federal Register. (64 FR 27192-27200, May 19, 1999).

C. Aggregate Exposure

    1. Dietary exposure. A Tier III acute and chronic dietary exposure 
evaluation was made using the Dietary Exposure Evaluation Model 
(DEEM<SUP>TM</SUP>, version 7.76 from Exponent. Empirically derived 
processing studies for apple juice (0.27X), apple wet pomace (3.79X), 
cottonseed meal (0.12X), cottonseed oil (0.43X), tomato puree (0.32X), 
and tomatoes after washing (0.53X) were used in these assessments. The 
apple juice processing factor was used as a surrogate for pear juice; 
all other processing factors used DEEM<SUP>TM</SUP> defaults. All 
consumption data for these assessments were taken from the USDA's 
Continuing Survey of Food Intake by individuals (CSFII) with the 1994-
96 consumption database and the Supplemental CSFII children's survey 
(1998) consumption database. These exposure assessments included all 
registered and pending uses on crops, including leafy vegetables (crop 
group 4), head and stem Brassica vegetables (crop group 5A), Brassica 
leafy vegetables (crop group 5B), fruiting vegetables (crop group 8), 
pome fruit (crop group 11), cotton, and turnip tops. Secondary residues 
in animal commodities were estimated based on theoretical worst-case, 
yet nutritionally adequate, animal diets and transfer information from 
feeding studies.
    i. Food. For the purposes of assessing the potential dietary 
exposure under the proposed tolerances, Syngenta Crop Protection has 
estimated aggregate exposure from all crops for which tolerances are 
established or proposed. These assessments utilized residue data from 
field trials where emamectin benzoate was applied at the EPA-approved 
maximum use rate and samples were harvested at the minimum pre-harvest 
interval to maximize anticipated residues. Percent of crop treated 
values were estimated based upon economic, pest and competitive 
pressures. The values used in these assessments were: Turnip tops 100%, 
celery 100%, Brassica vegetables 100%, tomatoes 11%, head lettuce 52%, 
leafy vegetables 5.9%, peppers 20%, cotton 2.3%, and pome fruit 35%.
    a. Acute exposure. An acute reference dose (aRfD) for emamectin 
benzoate of 0.00025 milligrams/kilogram body weight/day (mg/kg bwt/day) 
for infants, children, and females 13 years and older was based upon a 
0.075 mg/kg bwt/day NOAEL from a 15-day neurotoxicity study in mice, 
using an uncertainly factor of 100X. An additional Food Quality 
Protection Act (FQPA) safety factor of 3X was also applied. For the 
purpose of aggregate risk assessment, the exposure value was expressed 
in terms of margin of exposure (MOE), which was calculated by dividing 
the no observable effect level (NOAEL) by the exposure for each 
population subgroup. In addition, exposure was expressed as a percent 
of the acute reference dose (% aRfD). Acute exposure to the most 
exposed sub-population (children 1 and 2 years old) resulted in a MOE 
of 403 (74% of the aRfD of 0.00025 mg/kg bwt/day). Since the benchmark 
MOE for this assessment was 300, and since EPA generally has no concern 
for exposures below 100% of the RfD, Syngenta believes that there is a 
reasonable certainty that no harm will result from dietary (food) 
exposure to residues arising from the current uses and the proposed 
pome fruit use for emamectin benzoate.
    b. Chronic exposure. A chronic reference dose (cRfD) for emamectin 
benzoate of 0.000083 mg/kg bwt/day for infants, children, and females 
13 years and older was based upon a 0.075 mg/kg bwt/day NOAEL from a 
15-day neurotoxicity study in mice, using an uncertainly factor of 
100X. An FQPA safety factor of 3X was also applied, plus an additional 
3X safety factor for use of a toxicology study of short duration. The 
emamectin benzoate Tier III chronic dietary exposure assessment was 
based upon residue field trial results. For the purpose of aggregate 
risk assessment, the exposure values were expressed in terms of MOE, 
which was calculated by dividing the no observable effect level (NOAEL) 
by the exposure for each population subgroup. In addition, exposure was 
expressed as a percent of the reference dose %RfD. Chronic exposure to 
the most exposed sub-population (children 1 and 2 years old) resulted 
in a MOE of 4,411 (21% of the cRfD of 0.000083 mg/kg bwt/day). Since 
the benchmark MOE for this assessment was 900, and since EPA generally 
has no concern for exposures below 100% of the RfD, Syngenta believes 
that there is a reasonable certainty that no harm will result from 
dietary (food) exposure to residues arising from the current and 
proposed uses for emamectin benzoate.
    ii. Drinking water--a. Chronic exposure. The estimated maximum 
concentrations of emamectin benzoate in surface and ground water are 
0.02 parts per billion (ppb), (Pesticide Root Zone Model/Exposure 
Modeling System (PRZM/EXAMS)) and 0.0005 ppb (screening concentration 
in ground water (SCI-GROW)), respectively. The chronic PAD for 
emamectin benzoate is 0.000083 mg/kg bwt/day for the females 13+ years, 
infants' and children's subgroups and 0.00025 mg/kg bwt/day for all 
other population subgroups.

[[Page 49610]]

 From the chronic dietary exposure analysis, the highest exposure 
estimate of 0.000017 mg/kg bwt/day was determined for the children's 
(1-2 years old) subgroup. Based on EPA's ``Interim Guidance for 
Conducting Drinking Water Exposure and Risk Assessments'' document 
(December 2, 1997), chronic drinking water levels of comparisons 
(DWLOCs) for emamectin benzoate were calculated to be 0.7 ppb for the 
children's (1-2 years old) subgroup. Based on this analysis, emamectin 
benzoate estimated environmental concentrations (EECs) do not exceed 
the calculated chronic DWLOC.
    b. Acute exposure. The estimated maximum concentrations of 
emamectin benzoate in surface and ground water are 0.1 ppb PRZM/EXAMS 
and 0.0005 ppb SCI-GROW, respectively. The acute population adjusted 
dose (aPAD) for emamectin benzoate is 0.00025 mg/kg bwt/day for the 
females 13+ years, infants' and children's subgroups and 0.00075 mg/kg 
bwt/day for all other population subgroups. From the acute dietary 
exposure analysis, the highest acute food exposure from the uses of 
emamectin benzoate was 0.000186 mg/kg/day (children 1-2 years old) at 
the 99.9<SUP>th</SUP> percentile of exposures. Using this information, 
acute DWLOC for emamectin benzoate was calculated to be 0.6 ppb for the 
children's (1-2 years old) subgroup. Based on this analysis, emamectin 
benzoate EECs do not exceed the calculated acute DWLOC.
    2. Non-dietary exposure. No products containing emamectin benzoate 
are registered under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) for any non-food use. No significant non-
dietary, non-occupational exposure is anticipated.
    3. Aggregate Exposure. Based on the completeness and reliability of 
the toxicity data supporting these petitions, Syngenta believes that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to residues arising from all current and proposed emamectin 
benzoate uses, including anticipated dietary exposure from food, water, 
and all other types of non-occupational exposures.

D. Cumulative Effects

     Emamectin benzoate is synthetically derived from avermectin, which 
is derived from Streptomyces avermitilus. Streptomyces avermitilus 
produces the insecticide avermectin, which is a mixture of two 
homologs, avermectin B<INF>1a</INF> and B<INF>1b</INF>, each having 
equal biological activity. Currently, the only other member of this 
class that is registered for agricultural uses is abamectin. Abamectin 
and ivermectin are structurally similar to emamectin. EPA does not 
have, at this time, data to determine whether emamectin benzoate has a 
common mechanism of toxicity with other substances or the means to 
include this pesticide in a cumulative risk assessment. Unlike other 
pesticides for which EPA has followed a cumulative risk approach based 
upon a common mechanism of toxicity, emamectin benzoate does not appear 
to produce a toxic metabolite that is produced by other substances. For 
the purpose of this tolerance action; therefore, Syngenta has assumed 
that emamectin benzoate does not have a mechanism of toxicity common to 
these other substances.

E. Safety Determination

    1. U.S. population--i. Acute risk. Exposure to emamectin benzoate 
residues in food will occupy no more than 74% of the aPAD for the most 
sensitive population subgroup (children 1-2 years old). Residue values 
used for these dietary risk assessments were from field trials and did 
incorporate percent of crop treated information. Acute dietary exposure 
estimates were determined at the 99.9<SUP>th</SUP> percentile of acute 
exposures. Estimated concentrations of emamectin residues in surface 
and ground water are lower than the DWLOC. Therefore, Syngenta does not 
expect acute aggregate risk to emamectin benzoate residues from food 
and water sources to exceed the level of concern for acute dietary 
exposure.
    ii. Chronic risk. The chronic dietary exposure to emamectin 
residues in food is no more than 21% for the most sensitive population 
subgroup (children 1-2 years old). Residue values used for these 
dietary risk assessments were from field trials and did incorporate 
percent of crop treated information, as indicated above. The estimated 
concentrations of emamectin residues in surface and ground water are 
lower than the DWLOC. The expected chronic aggregate risk to emamectin 
residues from food and water sources would not be expected to exceed 
the level of concern for chronic dietary exposure.
     Syngenta has considered the potential aggregate exposure from 
food, water and non-occupational exposure routes and concluded that 
aggregate exposure is not expected to exceed 100% of the acute and 
chronic reference doses. Thus there is a reasonable certainty of no 
harm to infants and children from the aggregate exposure to residues of 
emamectin benzoate in food and water.
    2. Infants and children. For emamectin benzoate, the Agency has 
determined that the 10x safety factor for the protection of infants and 
children should be reduced to 3x. The rationale for reducing the FQPA 
Safety Factor is based on the fact that no increased susceptibility was 
demonstrated in rats or rabbits following in utero and/or postnatal 
exposure to emamectin.
     Although, increased susceptibility was demonstrated in a 
developmental neurotoxicity study in rats, the EPA determined that the 
10x factor should be reduced to 3x based on the following weight-of-
the-evidence considerations in the developmental neurotoxicity study:
    i. The LOAEL was based on a single effect/end point (i.e., decrease 
in open field motor activity).
    ii. The effect at the LOAEL was seen only on postnatal day 17 and 
was not seen either on earlier day 13 or later day 21 evaluations 
whereas at the high dose (3.6/2.5 mg/kg/day), this effect was seen on 
postnatal days 13 and 17;
    iii. The effect at the LOAEL was not accompanied with other 
toxicity whereas at the high dose, tremors and hind limb splay were 
also seen.
    iv. The decreased performance was lower only when compared to the 
concurrent control, and;
    v. There were limited (only 2 studies) historical control data 
available for comparison.
     Syngenta believes that the clinical signs of avermectin-family 
based neurotoxicity seen in neonatal rats are unlikely to be useful 
predictors of human risk. Young rats are considerably more sensitive to 
avermectin-type compounds than either adult rats or humans and other 
primates. (In neonatal rats, unlike humans, the P-glycoprotein levels 
are only a small fraction of the levels seen in adult rats.) Moreover, 
data from clinical experience with ivermectin, a related human drug, 
and studies on ivermectin and abamectin, a related pesticide, 
demonstrate that both the neonatal rat and the CF-1 mouse overpredict 
the toxicity of the avermectin-type compounds to humans and to non-
human primates.
    3. Conclusion. There is a complete toxicity database for emamectin 
benzoate and exposure data is complete or is conservatively estimated 
based on data that reasonably accounts for potential exposures. Based 
on these risk assessments, Syngenta concludes that, there is a 
reasonable certainty that no harm will result to infants and children 
from aggregate exposure to emamectin benzoate residues.

[[Page 49611]]

F. International Tolerances

     No codex maximum residue levels (MRLs) have been established for 
residues of emamectin benzoate.
[FR Doc. 05-16806 Filed 8-23-05; 8:45 am]
BILLING CODE 6560-50-S


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