Environmental Protection Agency (EPA).
This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.
Comments, identified by docket ID number OPP-2004-0045, must be received on or before April 23, 2004.
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: firstname.lastname@example.org.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 111)
- Animal production (NAICS 112)
- Food manufacturing (NAICS 311)
- Pesticide manufacturing (NAICS)
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. EPA Docket. EPA has established an official public docket for this action under docket ID number OPP-2004-0045. 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, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Start Printed Page 13834 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-2004-0045. 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 email@example.com, Attention: Docket ID number OPP-2004-0045. 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-2004-0045.
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, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID number OPP-2004-0045. 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 Start Printed Page 13835assigned 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: March 15, 2004.
Director, Registration Division, Office of Pesticide Programs.
Summary of Petitions
The petitioner's summary of the pesticide petitions is printed below as required by FFDCA section 408(d)(3). The summary of the petitions 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)
PP 1E6261, PP 1E6331, PP 1E6336, and PP 3E6588
EPA has received pesticide petitions (PP 1E6261, PP 1E6331, PP 1E6336, and PP 3E6588) from IR-4, 681 U.S. Highway #1 South, 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 180.466, by establishing tolerances for residues of the insecticide fenpropathrin, alpha-cyano-3-phenoxybenzyl 2,2,3,3-tetramethylcyclopropanecarboxylate in or on the following raw agricultural commodities: Currant 3.0 parts per million (ppm) (PP 1E6261), vegetables, fruiting, group 08, except tomato at 1.0 ppm (PP 1E6331) pea, succulent at 0.02 ppm (PP 1E6336), and bushberry subgroup 13B, lingonberry, juneberry, and salal at 3.0 ppm (PP 3E6588). EPA has determined that the petitions contain 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 petitions. Additional data may be needed before EPA rules on the petitions. This notice includes a summary of the petitions prepared by Valent U.S.A. Corporation, P.O. Box 8025, Walnut Creek, CA 94596-8025.
A. Residue Chemistry
1. Plant metabolism. The plant metabolism of fenpropathrin has been studied in five different crop plant species: Cotton, apple, tomato, cabbage, and bean. Each of the studies involved foliar treatment of the plants under either greenhouse or field conditions. In all studies the total toxic residue is best defined as parent, fenpropathrin. The primary metabolic pathway for fenpropathrin in plants is similar to that in mammals. There are no qualitatively unique plant metabolites.
2. Analytical method. Adequate analytical methodology is available to detect and quantify fenpropathrin at residue levels in numerous matrices. The methods use solvent extraction and partition and/or column chromatography clean-up steps, followed by separation and quantitation using capillary gas liquid chromatography (GLC) with FID. The extraction efficiency has been validated using radiocarbon samples from the plant and animal metabolism studies. The enforcement methods have been validated at independent laboratories and by EPA. The limit of quantification (LOQ) for fenpropathrin in raw agricultural commodity samples is usually 0.01 ppm.
3. Magnitude of residues. Residue data has been submitted for vegetables, fruiting, group 08, except tomato; pea, succulent; bushberry subgroup 13B; lingonberry; juneberry; and salal. The requested tolerances are adequately supported.
B. Toxicological Profile
An assessment of the toxic effects caused by fenpropathrin is discussed in Unit III.A. and Unit III.B. of the Federal Register dated December 3, 1999 (64 FR 67905) (FRL-6392-6).
1. Animal metabolism. Four metabolites were found in the urine of rats dosed with alcohol labeled fenpropathrin. The major metabolites were the sulfate conjugate of 3-(4'-hydroxyphenoxy)benzoic acid and 3-phenoxybenzoic acid (22-44% and 3-9% of the administered dose, respectively). The major urinary metabolites of the acid-labeled fenpropathrin were TMPA-glucuronic acid and TMPA-CH2OH (11-26% and 6-10% of the administered dose, respectively). None of the parent chemical was found in urine.
The major elimination products in the feces included the parent chemical (13-34% of the administered dose) and four metabolites. The fecal metabolites (percentage of administered dose) included CH2OH-fenpropathrin (9-20%), 4'-OH-fenpropathrin (4-11%), COOH-fenpropathrin (2-7%), and 4'-OH-CH2OH-fenpropathrin (2-7%). There are no qualitatively unique plant metabolites. The primary aglycones are identical in both plants and animals; the only difference is in the nature of the conjugating moieties employed.
2. Metabolite toxicology. The metabolism and potential toxicity of the small amounts of terminal plant metabolites have been tested on mammals. Glucoside conjugates of 3-phenoxy-benzyl alcohol and 3-phenoxybenzoic acid, administered orally to rats, were absorbed as the corresponding aglycones following cleavage of the glycoside linkage in the gut. The free or reconjugated aglycones were rapidly and completely eliminated by normal metabolic pathways. The glucose conjugates of 3-phenoxybenzyl alcohol and 3-phenoxy-benzoic acid are less toxic to mice than the corresponding aglycones.
3. Endocrine disruption. No special studies to investigate the potential for estrogenic or other endocrine effects of fenpropathrin have been performed. However, as referenced above (see toxicological profile), a large and detailed toxicology data base exists for the compound including studies acceptable to the Agency in all required categories. These studies include evaluations of reproduction and reproductive toxicity and detailed pathology and histology of endocrine organs following repeated or long-term exposure. These studies are considered capable of revealing endocrine effects and no such effects were observed.
C. Aggregate Exposure
1. Dietary exposure. Chronic and acute dietary exposure analyses were performed for fenpropathrin using anticipated residues, and accounting for proportion of the crop treated. The crops included in the analyses are the Start Printed Page 13836raw agricultural commodities cottonseed, currants, peanuts, strawberries, soybeans, lingonberry, juneberry, salal, and grapes, and the crop groupings succulent shelled pea (6B), head and stem brassica (5A), fruiting vegetables (8), cucurbit vegetables (9), citrus fruits (10), bushberry (13B) and pome fruits (11); processed products from these crops; and the resulting secondary residues in meat, milk, and eggs. Soybeans (and soybean products) were entered into the analyses using tolerance-level residues and 1% of the crop treated for chronic assessments, and 2% of the crop treated for acute assessments. Proportion of crop treated was assumed to be equal for all crops in a crop grouping.
i. Food—a. Acute. Acute dietary exposure was calculated for the U.S. population, females (13+), males (20+ years) and five children subgroups. At the 99.9th percentile of exposure, the acute population adjusted dose (aPAD) of 0.06 milligrams/kilogram body weight/day (mg/kg bwt/day) is not exceeded.
b. Chronic. Chronic dietary exposure was calculated for the U.S. population and 25 population subgroups. Chronic dietary exposure was at or below 0.6% of the chronic population adjusted dose (cPAD) of 0.025 mg/kg bwt/day, with apples being the commodity contributing the most to chronic exposure. Generally speaking, the Agency has no cause for concern if total residue contribution for published and proposed tolerances is less than 100% of the cPAD.
ii. Drinking water. Since fenpropathrin is applied outdoors to growing agricultural crops, the potential exists for fenpropathrin to reach ground water or surface water that may be used for drinking water. To further quantify exposure from drinking water, potential surface water and ground water concentrations for fenpropathrin were estimated using First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Groundwater (SCI-GROW) modeling. Use on citrus, the most intense field use, was modeled. SCI-GROW modeling indicated that fenpropathrin would not be detected in ground water. FIRST modeling of potential surface water concentrations of fenpropathrin yielded annual average parts per billion (0.833 ppb) and peak day (1.030 ppb) concentrations. These estimated drinking water environmental concentrations (DWEC) can be used for chronic and acute exposures, respectively.
2. Non-dietary exposure. No endpoints of concern were identified by the Health Effects Division, Hazard Identification Assessment Review Committee for dermal or inhalation exposures of any duration. Thus, no risk assessment is needed.
D. Cumulative Effects
There are numerous other pesticidal compounds, pyrethroids and the natural pyrethrins, that are structurally related to fenpropathrin and may have similar effects on animals. In consideration of potential cumulative effects of fenpropathrin and other substances that may have a common mechanism of toxicity, there are currently no available data or other reliable information indicating that any toxic effects produced by fenpropathrin would be cumulative with those of other chemical compounds, or other pyrethroids. Thus, only the potential risks of fenpropathrin have been considered in this assessment of aggregate exposure and effects.
Valent will submit information for EPA to consider concerning potential cumulative effects of fenpropathrin consistent with the schedule established by EPA at 62 FR 42020 (August 4, 1997) (FRL-5734-6) and other EPA publications pursuant to the Food Quality Protection Act.
E. Safety Determination
1. U.S. population—i. Acute. The potential acute exposure from food to the U.S. population and various non-child/infant population subgroups provide values well below the aPAD. In a conservative policy, the Agency has no cause for concern if total acute exposure calculated for the 99.9th percentile is less than 100% of the aPAD. Acute DWLOC values are not exceeded by modeled DWEC values. It can be concluded that there is a reasonable certainty that no harm will result to the overall U.S. population and many non-child/infant subgroups from aggregate, acute exposure to fenpropathrin residues.
ii. Chronic. Using the dietary exposure assessment procedures, the calculated chronic dietary exposure resulting from residue exposure from existing and proposed uses of fenpropathrin is minimal. The estimated chronic dietary exposure from food for the overall U.S. population and many non-child/infant subgroups ranges from 0.6% (children 1-6 years old, 0.000155 mg/kg bwt/day) to 0.1% (several groups) of the cPAD. Generally, the Agency has no cause for concern if total residue contribution is less than 100% of the cPAD. Chronic drinking water levels of concern (DWLOC) values are not exceeded by modeled drinking water estimated concentration (DWEC) values. It can be concluded that there is a reasonable certainty that no harm will result to the overall U.S. population and many non-child/infant subgroups from aggregate, chronic dietary exposure to fenpropathrin residues.
2. Infants and children. The estimated chronic dietary exposure from food to infant and child subgroups ranges from 0.6% children 1-6 years old, 0.000155 mg/kg bwt/day to 0.1% nursing infants, 0.000026 mg/kg bwt/day of the cPAD. Generally, the Agency has no cause for concern if total residue contribution is less than 100% of the cPAD. Chronic DWLOC values are not exceeded by modeled DWEC values. It can be concluded that there is a reasonable certainty that no harm will result to infant and child subgroups of the U.S. population from aggregate, chronic exposure to fenpropathrin residues.End Supplemental Information
[FR Doc. 04-6571 Filed 3-23-04; 8:45 am]
BILLING CODE 6560-50-S