Environmental Protection Agency (EPA).
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.
Comments, identified by docket identification (ID) number OPP-2005-0216, must be received on or before September 9, 2005.
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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Shaja R. Brothers, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-3194; e-mail address: email@example.com.End Further Info End Preamble Start Supplemental 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-2005-0216. 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 (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 Start Printed Page 46445electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or review 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 specific 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 allow 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-2005-0216. 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 firstname.lastname@example.org, Attention: Docket ID number OPP-2005-0216. 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-2005-0216.
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-2005-0216. 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 Start Printed Page 46446docket 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.Start List of Subjects
List of Subjects
- Environmental protection
- Agricultural commodities
- Feed additives
- Food additives
- Pesticides and pests
- Reporting and recordkeeping requirements
Dated: July 29, 2005.
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 Interregional Research Project Number 4 (IR-4), 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.
Interregional Research Project Number 4 (IR-4)
EPA has received a pesticide petition (5E6943) from Interregional Research Project Number 4 (IR-4), 681 U.S. Highway #1 S. North Brunswick, NJ 08902-3390 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 180.566, by establishing tolerances for residues of fenpyroximate in or on the raw agricultural commodities nut, tree, group 14 at 0.1 parts per million (ppm); pistachio at 0.1 ppm; almond, hulls at 1.8 ppm; fruit, citrus, group 10 at 0.4 ppm; fruit, citrus, dried pulp at 2.5 ppm; citrus, oil at 15 ppm; hop at 4.5 ppm; peppermint, tops at 3.0 ppm; and spearmint, tops at 3.0 ppm. 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. This notice includes a summary of the petition that was prepared by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, Wilmington, Delaware 19808.
A. Residue Chemistry
1. Plant metabolism. Fenpyroximate and the Z-isomer are the residues of concern for tolerance setting purposes in crops. The metabolism of fenpyroximate and its Z-isomer has been studied, and is adequately understood.
2. Analytical method. An enforcement method has been developed which involves extraction of fenpyroximate from crops with acetone, filtration, partitioning and cleanup, and analysis by gas chromatography using a nitrogen/phosphorous detector. This method allows detection of residues at or above the proposed tolerances. The method has undergone independent laboratory validation as required by PR Notices 88-5 and 96-1.
3. Magnitude of residues. The magnitude of residues for fenpyroximate, and the Z-isomer are adequately understood for the requested tolerances.
B. Toxicological Profile
An extensive battery of toxicology studies has been conducted with fenpyroximate. EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. An assessment of toxic effects caused by fenpyroximate, including the toxicological endpoints of concern, is discussed in Unit III.A. and Unit III.B. of the fenpyroximate final rule published in the June 10, 2004 issue of the Federal Register (69 FR 32457) (FRL-7362-9).
1. Animal metabolism. The qualitative nature of the residues of fenpyroximate, Z-isomer, and acid metabolite in animals is adequately understood.
2. Metabolite toxicology. No toxicologically significant metabolites were detected in plant or animal metabolism studies for citrus, hops, mint, and tree nuts.
3. Endocrine disruption. Chronic, lifespan, and multi-generational bioassays in mammals and acute and subchronic studies on aquatic organisms and wildlife did not reveal any endocrine effects for fenpyroximate. Any endocrine related effects would have been detected in this comprehensive series of required tests. The probability of any such effect due to agricultural uses of fenpyroximate is negligible.
C. Aggregate Exposure
1. Dietary exposure. Tolerances have been established (40 CFR 180.566) for the combined residues of fenpyroximate and its metabolites, in or on a variety of raw agricultural commodities. Acute and chronic dietary risk analyses were conducted to estimate the potential fenpyroximate and Z-isomer residues in or on the following crops: Citrus orange, citrus lemon, citrus grapefruit, citrus oil, mint oil, hops, almond, pecans, and pistachio, using modeling based on USDA survey data.
i. Food. The acute dietary exposure was based on the following assumptions: Residues at tolerance levels, 100% crop treated, and default Start Printed Page 46447processing factors for all proposed commodities (Tier 1, 95th percentile consumption). The chronic dietary exposure was based on the following assumptions: Residues at tolerance levels, 100% crop treated, using dietary exposure modeling, based on USDA survey data.
ii. Drinking water. The Agency does not have comprehensive monitoring data; therefore, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of fenpyroximate. The Agency uses the Food Quality Protection Act (FQPA) Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) to produce estimates of pesticide concentrations in an index reservoir to predict surface water concentrations. The Screen Concentrations in Groundwater (SCI-GROW) model is used to predict pesticide concentrations in shallow ground water.
Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a reference dose (%RfD) or population adjusted dose (%PAD). Instead, drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses.
The residue of concern in drinking water was determined to be fenpyroximate. There are no established maximum contaminant levels or health advisory levels for residues of fenpyroximate in drinking water. Laboratory and field data have demonstrated that fenpyroximate is immobile in soil and will not leach into ground water. Other data show that fenpyroximate is virtually insoluble in water. As a result, EPA concluded that residues reaching surface waters from field runoff will quickly absorb to sediment particles and be partitioned from the water column.
Estimates of the contribution of the petitioned crops to water concentrations were derived. The acute and chronic EEC's in surface water calculated by PRZM/EXAMS, Version 3.12, were 1.5 parts per billion (ppb), and 0.13 ppb respectively. In ground water, using Tier I SCI-GROW (Version 2.3), the estimated EEC was 0.006 ppb.
2. Non-dietary exposure. The term, residential exposure, is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fenpyroximate is not registered for use on any sites that would result in residential exposure.
D. Cumulative Effects
A determination has not been made that fenpyroximate has a common mechanism of toxicity with other substances. Fenpyroximate does not appear to produce a common toxic metabolite with other substances. A cumulative risk assessment was not performed for this analysis. Section 408(b)(2)(D)(v) of FFDCA requires that when considering whether to establish, modify, or revoke a tolerance the Agency considers, “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to fenpyroximate and any other substances. Fenpyroximate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, EPA has not assumed that fenpyroximate has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs (OPP) concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's Web site at http://www.epa.gov/pesticides/cumulative/.
E. Safety Determination
1. U.S. population—i. Acute risk. The acute dietary acute Population Adjusted Dose (aPAD) was set at 0.05 milligrams/kilogram/day (mg/kg/day) for females ages 13-49 years old based on a developmental toxicity study in rats that had an oral no observed adverse effect level (NOAEL) of 5.0 mg/kg/day. The resulting food exposure estimate for this population subgroup was less than 1% of the aPAD. The petitioned crops in addition to the registered crop uses accounted for less than 6% of the aPAD.
The addition of these new uses results in a DWLOC of approximately 1,400 ppb. Surface water concentration estimates increase from 1.5 ppb to 1.6 ppb with the added crops. The aggregate exposure will not exceed 100% of the aPAD.
ii. Chronic risk. The chronic dietary chronic Population Adjusted Dose (cPAD) was determined to be 0.01 mg/kg/day for the general population based on an oral NOAEL of 0.97 mg/kg/day in the 2-year rat chronic/carcinogenicity study. The Agency determined that exposure from currently registered crops utilize 8% of the cPAD. The additional new uses will result in a utilization of 10% of the cPAD. Using the exposure assumptions previously described, EPA has concluded that exposure to fenpyroximate from food, including the additional new uses, will utilize 10% of the cPAD for the U.S. population, 21% of the cPAD for all infants (<1 year old), and 33% of the cPAD for children (1-2 years old).
In addition, there is potential for chronic dietary exposure to fenpyroximate in drinking water. The DWLOC for the general population, infants (<1 year old) and children (1-6 years old) were 320 ppb, 82 ppb, and 71 ppb, respectively. Average yearly drinking water concentration in surface water was estimated at 0.13 ppb, and 0.006 ppb in ground water for both registered and petitioned uses. After calculating the DWLOCs and comparing them to the EECs for surface and ground water, the aggregate exposure will not exceed 100% of the cPAD.
2. Infants and children. The Agency confirmed the endpoint selection for fenpyroximate and evaluated the potential for increased susceptibility of infants and children from exposure to fenpyroximate (July 2003). Based on toxicological considerations, the special FQPA safety factor was set at 1X when assessing acute and chronic dietary exposures.
3. Aggregate cancer risk for U.S. population. Fenpyroximate is classified as not likely to be carcinogenic to humans; therefore, an aggregate cancer risk assessment was not performed.
4. Determination of safety. Based on these risk assessments, EPA concluded that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to fenpyroximate residues.Start Printed Page 46448
F. International Tolerances
Codex MRLs have been established for residues of fenpyroximate and Z-isomer on hops in Germany at 10 ppm.End Supplemental Information
[FR Doc. 05-15738 Filed 8-9-05; 8:45 am]
BILLING CODE 6560-50-M