[Federal Register Volume 67, Number 54 (Wednesday, March 20, 2002)]
[Notices]
[Pages 12990-12993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6615]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1070; FRL-6824-4]


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 control number PF-1070, must be 
received on or before April 19, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-1070 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Thomas C. Harris, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-9423; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
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 Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-1070. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-1070 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters

[[Page 12991]]

and any form of encryption. Electronic submissions will be accepted in 
Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic 
form must be identified by docket control number PF-1070. Electronic 
comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. 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 version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified 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 
control 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 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: March 7, 2002.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by Syngenta Crop Protection and represents the 
view of the petitioner. EPA is publishing the petition summary verbatim 
without editing it in any way. The petition summary announces the 
availability of a description of the analytical methods available to 
EPA for the detection and measurement of the pesticide chemical 
residues or an explanation of why no such method is needed.

Syngenta Crop Protection

PP 7F4845

    EPA has received a pesticide petition (7F4845) from Syngenta Crop 
Protection, Inc. (formerly Novartis Crop Protection, Inc.), P.O. Box 
18300, Greensboro, NC 27419 proposing, pursuant to section 408(d) of 
FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a 
tolerance for residues of emamectin benzoate, 4'-epi-methylamino- 4'-
deoxyavermectin B1 benzoate (a mixture of a minimum of 90% 
4'-epi- methylamino-4'- deoxyavermectin B1a, and a maximum 
of 10% 4'-epi-methlyamino- 4'-deoxyavermectin B1b benzoate), 
and its metabolites 8,9 isomer of the B1a and B1b 
component of the parent insecticide in or on the raw agricultural 
commodities fruiting vegetables (except cucurbits) group at 0.02 parts 
per million (ppm), brassica leafy vegetables group at 0.025 ppm, 
turnip, tops at 0.025 ppm, leafy vegetables (except brassica) group at 
0.1 ppm, cottonseed at 0.025 ppm, cotton gin byproducts at 0.5 ppm. 
This notice is an update to a notice of filing originally published on 
August 29, 1997 (62 FR 45804) (FRL-5738-2). This new notice represents 
an amendment to the original petition (7F4845) which only included the 
fruiting vegetables (except cucurbits) group. EPA has determined that 
the petition contains data or information regarding the elements set 
forth in section 408(d)(2) of the FFDCA; 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.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of emamectin benzoate in plants 
has been studied 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 (HPLC-
fluorescence methods) are available for enforcement purposes.
    3. Magnitude of residues. The appropriate number of residue trials 
have been conducted for cotton, tomatoes, peppers, leaf lettuce, 
spinach, head lettuce, celery, and mustard greens. These trials were 
conducted in the major U.S. growing areas for these crops. Processing 
studies were conducted to provide tomato product, cottonseed hull, 
meal, and refined oil samples for analysis.

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 theFederal Register of May 19, 1999 (64 FR 27192) (FRL-6079-7).

C. Aggregate Exposure

    1. Dietary exposure. Emamectin benzoate tolerances have been 
established for head lettuce, celery, and head and stem brassica 
vegetables. Syngenta assessed chronic exposure by using the mean of the 
field trial residue values and projected market share values. The acute 
exposure assessment was performed as a Tier 3, 5000 iteration, Monte 
Carlo analysis. Actual field trial residue values were utilized along 
with market share for each crop.

[[Page 12992]]

    i. Food. Chronic dietary exposure to emamectin benzoate is 
negligible. Exposure calculations made from conservative residue values 
generated from field trials conducted at maximum application rates and 
minimum pre-harvest intervals show that chronic exposure is only 1.1% 
of the population adjusted dose (PAD) for the most sensitive 
subpopulation (non-black/non-white/non-hispanics). The second most 
sensitive subpopulation is children (1-6 years old) with an exposure of 
1.0% of the chronic PAD. The chronic PAD is based on a no observable 
adverse effect level (NOAEL) of 0.075 milligrams/kilogram body weight/
day (mg/kg bwt/day) based on a 15-day neurotoxicity study in mice and 
an uncertainty factor of 900. This uncertainty factor is due to a 100-
fold safety factor for interspecies and intraspecies variation and an 
additional 9-fold safety factor for use of a toxicological study of 
short duration (3x) plus a FQPA safety factor (3x).
     Acute exposure for the most sensitive subpopulation is 26.8% of 
the acute PAD (aPAD) for non-nursing infants <1 year). The exposure to 
the U.S. population is 16.7% of the aPAD. These exposures were compared 
to the same toxicological endpoint as described above for the chronic 
assessment except an uncertainty factor of 300 was assumed (100-fold 
for interspecies and intraspecies variation and a 3-fold FQPA safety 
factor.
    ii. Drinking water--a. Chronic exposure. The estimated maximum 
concentrations of emamectin benzoate in surface and ground water are 
0.00137 parts per billion (ppb) (Day 56 EEC/3 from GENEEC) and 0.00600 
ppb (SCI-GROW), respectively. The chronic PAD for emamectin benzoate is 
0.000083 mg/kg bwt/day. From the chronic dietary exposure analysis, an 
exposure estimate of 0.0000006 mg/kg bwt/day was determined for the 
U.S. population and 0.0000007, 0.0000008, and 0.0000009 mg/kg/day for 
the females (13+/nursing), children (1-6 years) and non-hispanic/non-
white/non-black subgroups, respectively. Based on EPA's ``Interim 
Guidance for Conducting Drinking Water Exposure and Risk Assessments'' 
document (December 2, 1997), chronic drinking water levels of 
comparison (DWLOC) for emamectin benzoate were calculated to be 3 ppb 
for the U.S. population and 2, 1, 3 ppb for the females (13+/nursing), 
children (1-6 years), and non-hispanic/non-white/non-black subgroups, 
respectively. Based on this analysis, emamectin benzoate estimated 
environmental concentrations (EECs) do not exceed the calculated 
chronic DWLOCs.
    b. Acute exposure. The estimated maximum concentrations of 
emamectin benzoate in surface and ground water are 0.09688 ppb (peak 
EEC from GENEEC) and 0.00600 ppb (SCI-GROW), respectively. The aPAD for 
emamectin benzoate is 0.00025 mg/kg bwt/day. From the acute dietary 
exposure analysis, the highest acute food exposure from the uses of 
emamectin benzoate was 0.000042 mg/kg/day at the 99.9th 
percentile for the U.S. population and 0.000058 and 0.000067 mg/kg/day 
for the children (1-6 years) and non-nursing infants (<1 yr) subgroups, 
respectively. Using this information, acute DWLOCs for emamectin 
benzoate were calculated to be 7 ppb for the U.S. population and 2 ppb 
and 2 ppb for the children (1-6 years), and non-nursing infants (<1 yr) 
subgroups, respectively. Based on this analysis, emamectin benzoate 
EECs do not exceed the calculated acute DWLOCs.
    2. Non-dietary exposure. No products containing emamectin benzoate 
have yet been registered under the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) for any non-food use. No significant non-
dietary, non-occupational exposure is anticipated.

D. Cumulative Effects

     Emamectin benzoate is synthetically derived from avermectin, which 
is derived from Streptomyces avermitilus, which produces the 
insecticide avermectin, which is a mixture of two homologs, avermectin 
B1a and B1b, which have 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 
available data to determine whether emamectin benzoate has a common 
mechanism of toxicity with other substances or how to include this 
pesticide in a cumulative risk assessment. Unlike other pesticides for 
which EPA has followed a cumulative risk approach based upon a common 
mechanism, emamectin benzoate does not appear to produce a toxic 
metabolite produced by other substances. For the purpose of this 
tolerance action, therefore, Syngenta has not assumed that emamectin 
benzoate has a common mechanism of toxicity with 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 16.7% of the aPAD for adult 
population subgroups and no more than 26.8% of the aPAD for infant/
children subgroups. Residue levels used for food-source dietary risk 
assessments were highly refined and did incorporate percent of crop 
treated information. Acute dietary exposure estimates were for the 
99.9th percentile. Estimated concentrations of emamectin 
residues in surface and ground water are lower than the DWLOCs. 
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 will occupy no more than 0.7% of the chronic RfD for 
adult population subgroups and no more than 1.0% PAD for children, 1-6 
years old, subgroups. Residue levels used for food-source dietary risk 
assessments were highly refined 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 
DWLOCs. 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.
    2. Infants and children. For emamectin benzoate, the Agency has 
determined the tenfold safety factor for the protection of infants and 
children should be reduced to 3x. The rationale for reducing the FQPA 
safety factor is as follows: No increased susceptibility was 
demonstrated in rats or rabbits following in utero and/or postnatal 
exposure to emamectin. However, increased susceptibility was 
demonstrated in a developmental neurotoxicity study in rats.
     Although, increased susceptibility was demonstrated in a 
developmental neurotoxicity study in rats, 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: (1) 
The lowest observed adverse effect level (LOAEL) was based on a single 
effect/end point (i.e., decrease in open field motor activity); (2) 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; (3) the effect at the LOAEL was not accompanied with other 
toxicity whereas, at the high dose tremors and hind limb splay were 
also seen; (4) the decreased performance was lower only when compared 
to the concurrent control; and (5) there was limited (only

[[Page 12993]]

two studies) historical control data available for comparison.
     Syngenta believes the clinical signs of avermectin-family 
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 data base for emamectin 
benzoate and exposure data are complete or are conservatively estimated 
based on data that reasonably account 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.

F. International Tolerances

     No Codex maximum residue levels have been established for residues 
of emamectin benzoate.
[FR Doc. 02-6615 Filed 3-19-02; 8:45 am]
BILLING CODE 6560-50-S