02-6615. 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 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: [phone]; e-mail address: [e-mail].

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:

Categories	NAICS codes	Examples of 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 [phone].

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 [phone].

3. Electronically. You may submit your comments electronically by e-mail to: [e-mail], 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 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 B₁ a, and a maximum of 10% 4'-epi-methlyamino- 4'-deoxyavermectin B₁ b benzoate), and its metabolites 8,9 isomer of the B₁ a and B₁ b 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 the Federal 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.

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 99.9^th 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 B₁ a and B₁ b, 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 99.9^th 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 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.