05-16806. 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.

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: [phone]; e-mail address: [e-mail].

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 code 111)
• Animal production (NAICS code 112)
• Food manufacturing (NAICS code 311)
• 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 #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 [phone].

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 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 [e-mail], 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 #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 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 B₁ benzoate (a mixture of a minimum of 90% 4'-epi-methylamino-4'- deoxyavermectin B_1a and a maximum of 10% 4'-epi-methlyamino-4'deoxyavermectin B_1b benzoate), and its metabolites 8,9 isomer of the B_1a and B_1b 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^TM, 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^TM 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. 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^th 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_1a and B_1b, 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^th 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.

F. International Tolerances

No codex maximum residue levels (MRLs) have been established for residues of emamectin benzoate.