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 ID number OPP-2003-0205, must be received on or before August 15, 2003.
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:
Ann Sibold, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6502; 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 a commercial processor of food, or use pesticides to control pests in food processing operations. 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 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. EPA Docket. EPA has established an official public docket for this action under docket ID number OPP-2003-0205. 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. 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 Start Printed Page 42023receipt 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-2003-0205. 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-2003-0205. 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-2003-0205.
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-2003-0205. 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.Start List of Subjects
List of Subjects
- Environmental protection
- Agricultural commodities
- Feed additives
- Food additives
- Pesticides and pests
- Reporting and recordkeeping requirements
Dated: July 2, 2003.
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below as required by FFDCA section 408(d)(3). The summary of the petition was prepared by BASF Corporation 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 Start Printed Page 42024pesticide chemical residues or an explanation of why no such method is needed.
EPA has received a pesticide petition (PP 3F6560) from BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709-3528 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 a tolerance for residues of chlorfenapyr, [4-bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-pyrrole-3-carbonitrile] on all food items in food handling establishments where food products are held, processed, and/or prepared at 0.01 parts per million (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.
A. Residue Chemistry
1. Plant metabolism. The nature of the residues of chlorfenapyr in plants (tomato, citrus, potato and head lettuce) is adequately understood and the residue of concern consists of the parent molecule. The metabolic pathway of chlorfenapyr in the laying hen and the lactating goat was also similar to that in laboratory rats.
2. Analytical method. The GC analytical method, M 2398, which is proposed as the enforcement method for the residue of chlorfenapyr in or on food commodities, has a limit of quantitation (LOQ) of 0.01 ppm.
3. Magnitude of residues. A study, based on protocol recommendations outlined in EPA's Residue Chemistry Test Guidelines, (OPPTS Harmonized Test Guideline 860.1460: Food Handling), was conducted with chlorfenapyr formulated as a 24% wettable powder.
Applications were made to all potential sites within a commercial kitchen, including the perimeter of the restaurant kitchen, areas under cabinets and overhead cabinets, behind and on sides of cabinets and appliances, within the ceiling voids, and around pipes, cords, cables, counter legs, and wheels. The areas in which the product was applied are typical of those treated in a professional pest control operation in a commercial kitchen.
The test was conducted using a wettable powder (WP) formulation at the maximum label rate for indoor use of 0.5% active ingredient (a.i.)/1,000 ft2, which is also the approved maximum rate for indoor use in non-food/feed areas for the SC formulation (suspension in water), EPA Registration No. 241-392. The WP formulation has a larger particle size and will be more easily dispersed than the SC formulation, and therefore will best characterize the potential for exaggerated exposures to food items.
Results from this study were that magnitudes of residues in all composite meal samples, both covered and uncovered, were below the LOQ of 10 parts per billion (ppb). Thus, there is a reasonable expectation that no finite residues of chlorfenapyr will result in food items following crack and crevice or spot applications of either the 25% wettable powder or the 21% suspension concentrate.
B. Toxicological Profile
The toxicity of chlorfenapyr has been studied extensively and there is a complete data base to address the acute and chronic effects, effects on genetic material, the potential for carcinogenicity or teratogenicity, and effects on reproductive performance or growth of offspring. Toxicological data submitted previously that support this petition for tolerances of chlorfenapyr include:
1. Acute toxicity. Based on EPA's toxicity category criteria, the acute toxicity category for chlorfenapyr technical, EPA Registration No. 241-366, is Category II or moderately toxic (signal word WARNING) and the acute toxicity category for the 2SC formulation, EPA Registration Nos. 241-374 and 241-392, is Category III or slightly toxic (signal word CAUTION). Males appear to be more sensitive to the effects of chlorfenapyr than females. The acute toxicity profile indicates that absorption by the oral route appears to be greater than by the dermal route. The following are the results from the acute toxicity tests conducted on the technical material.
i. Rat Oral, LD50 of 441/1,152 milligrams/kilogram body weight (mg/kg bwt) modifying factor (M/F) - Toxicology Category II.
ii. Rabbit Dermal LD50: >2,000 mg/kg bwt M/F Toxicology Category III.
iii. Acute Inhalation LC50: 0.83/ >2.7 milligrams per liter (mg/L) M/F Toxicology Category III.
iv. Eye irritation: Moderately irritating - Toxicology Category III.
v. Dermal irritation: Non-irritating - Toxicology Category IV.
vi. Dermal sensitization: Non-sensitizer - Non sensitizer.
vii. Acute neurotoxicity: NOEL 45 mg/kg bwt. Not an acute neurotoxicant
2. Genotoxicity. Chlorfenapyr technical (94.5%) was examined in a battery of in vitro and in vivo tests to assess its genotoxicity and its potential for carcinogenicity. These tests are summarized below.
i. Microbial/Microsome Mutagenicity Assay: Non-mutagenic.
ii. Mammalian Cell CHO/HGPRT Mutagenicity Assay: Non-mutagenic.
iii. In vivo Micronucleus Assay: Non-genotoxic.
iv. In vitro Chromosome Aberration Assay in CHO: Non-clastogenic.
v. In vitro Abberation Assay in CHLC: Non-clastogenic.
vi. Unscheduled DNA Synthesis (UDS) Assay: Non-genotoxic.
3. Reproductive and developmental toxicity. Reproductive and developmental toxicity. Chlorfenapyr is neither a reproductive nor developmental toxicant and is not a teratogenic agent in the Sprague-Dawley rat or the New Zealand white rabbit. This is demonstrated by the results of the following studies:
i. Rat oral teratology. No observed effect level (NOEL) for maternal toxicity 25 mg/kg bwt/day and NOEL for fetal/developmental toxicity at 225 mg/kg bwt/day.
ii. Rabbit oral teratology. NOEL for maternal 5 mg/kg bwt/day and NOEL for fetal/developmental toxicity 30 mg/kg bwt/day.
iii. Rat 2-generation reproduction. NOEL for parental toxicity/growth and offspring development 60 parts per million (ppm) (5 mg/kg bwt/day) and NOEL for reproductive performance 600 ppm (44 mg/kg bwt/day)
4. Subchronic toxicity. The following are the results of the subchronic toxicity test that have been conducted with chlorfenapyr.
i. 28-Day rabbit dermal - NOEL 100 mg/kg bwt/day.
ii. 28-Day rat feeding - NOEL <600 ppm (<71.6 mg/kg bwt/day).
iii. 28-Day mouse feeding - NOEL <160 ppm (<32 mg/kg bwt/day).
iv. 13-Week rat dietary - NOEL 150 ppm (11.7 mg/kg bwt/day).
v. 13-Week mouse dietary - NOEL 40 ppm (8.2 mg/kg bwt/day).
vi. 13-Week dog dietary - NOEL 120 ppm (4.2 mg/kg bwt/day).
5. Chronic toxicity. Chlorfenapyr is not oncogenic in either Sprague-Dawley rats or CD-1 mice and is not likely to be carcinogenic in humans. The following are the results of the chronic toxicity tests that have been conducted with chlorfenapyr: Start Printed Page 42025
i. 1-Year neurotoxicity in rats. No observed adverse effect level (NOAEL) 60 ppm (2.6/3.4 mg/kg bwt/day M/F).
ii. 1-Year dog dietary. NOAEL 120 ppm (4.0/4.5 mg/kg bwt/day M/F).
iii. 24-Month rat dietary. NOAEL for chronic effects 60 ppm (2.9/3.6 mg/kg bwt/day M/F and NOAEL for oncogenic effects 600 ppm (31/37 mg/kg bwt/day M/F).
iv. 18-Month mouse dietary - NOAEL for chronic effects 20 ppm (2.8/3.7 mg/kg bwt/day M/F and NOEL for Oncogenic Effects 240 ppm (34.5/44.5 mg/kg bwt/day M/F).
6. Animal metabolism. A metabolism study was conducted in Sprague-Dawley rats at approximately 20 and 200 mg/kg bwt using radiolabeled chlorfenapyr. Approximately 65% of the administered dose was eliminated during the first 24 hours (62% in feces and 3% in urine) and by 48 hours following dosing, approximately 85% of the dose had been excreted (80% in feces and 5% in urine.) The absorbed chlorfenapyr-related residues were distributed throughout the body and detected in tissues and organs of all treatment groups. The principal route of elimination was via feces, mainly as unchanged parent plus minor N-dealkylated, debrominated, and hydroxylated oxidation products. The metabolic pathway of chlorfenapyr in the laying hen and the lactating goat was also similar to that in laboratory rats.
7. Metabolite toxicology. The parent molecule is the only moiety of toxicological significance in plant and animal commodities.
8. Endocrine disruption. Collective organ weights and histopathological findings from the 2-generation rat reproduction study, as well as from the subchronic and chronic toxicity studies in two or more animal species, demonstrate no apparent estrogenic effects or effects on the endocrine system. There is no information available which suggests that chlorfenapyr would be associated with endocrine effects.
C. Aggregate Exposure
1. Dietary exposure. Based on the completeness and reliability of the toxicity data and the exposure assessment conducted, BASF concludes that there is a reasonable certainty that no harm will result from aggregate exposure to chlorfenapyr, including all dietary exposure.
i. Food. There are currently no established U.S. permanent food tolerances for chlorfenapyr. There are two tolerance petitions pending at EPA; 0.5 ppm tolerance on imported citrus and 1.5 ppm tolerance on greenhouse grown vegetable, fruiting, crop group 8. A dietary exposure estimate based on theoretical maximum residue contribution (TMRC) was conducted using the Dietary Exposure Evaluation Model (DEEMTM) The TMRC is a “worst case” estimate for dietary exposure because it assumes that 100% of crop is treated and residues in the food are always found at the tolerance level. Additional assumptions used were all consumption of tomatoes-whole is from treated greenhouse grown tomatoes, greenhouse grown tomatoes are not processed, and all citrus juice in the U.S. is made from treated imported citrus pulp. Default processing factors were used to determine concentrations in processed fractions. The tolerance levels used in the dietary assessment were 0.5 ppm for citrus pulp, 1.5 ppm for vegetable, fruiting, group 8, and 0.01 ppm for all other crops.
a. Acute exposure. The acute RfD used for this evaluation was 0.45 mg/kg bwt calculated by applying the 100-fold safety factor to the NOEL from the acute neurotoxicity evaluation of chlorfenapyr. The acute exposure was evaluated at the 99.9th percentile. The most highly exposure sub-population was non-nursing infants (<1 yr old) which utilized 16.2% of the acute RfD. Therefore, based on the exposure assessment discussed above, BASF concludes there is a reasonable certainty that no harm will result from the acute dietary exposure to chlorfenapyr residues.
b. Chronic exposure. The chronic RfD used for this evaluation was 0.03 mg/kg bwt calculated by applying a 100-fold safety factor to the NOAEL from 1-year rat neurotoxicity study and the chronic feeding studies in the rat and mouse. The most highly exposure subpopulation was children 1-6 years of age which utilized 19.8% of the chronic RfD. Therefore, based on the exposure assessment discussed above, BASF concludes there is a reasonable certainty that no harm will result from the chronic dietary exposure to chlorfenapyr residues.
ii. Drinking water. There is no concern for exposure to residues of chlorfenapyr in drinking water based on the approved, pending and proposed directions for use and its physical and chemical properties. Approved uses in the U.S. include applications to ornamental plants inside greenhouses, to a narrow band of soil adjacent to buildings and to crack-and-crevice and spot treatments inside structures. A pending use expands greenhouse applications to vegetable, fruiting, crop group 8. The proposed use for food handling areas is also applied as a crack-and-crevice and spot treatment inside structures. Chlorfenapyr has extremely low water solubility (120 ppb at 25 °C)and is also immobile in soil and does not leach because it is strongly adsorbed to all common soil types.
2. Non-dietary exposure. Non-dietary exposure to chlorfenapyr is expected to be negligible based on assessments made by EPA for the approved use on ornamentals grown in greenhouses, as a termiticide and for indoor applications for general pest control. These assessments were based on the physico-chemical characteristics of the compound, the intended use pattern, and available information concerning its environmental fate. The vapor pressure of chlorfenapyr is less than 1 x 10-7 mm of mercury (Hg); therefore, the potential for non-occupational exposure by inhalation is insignificant. These assessments also apply to the pending use on greenhouse grown vegetable, fruiting, crop group 8 and the proposed use in food handling areas.
D. Cumulative Effects
The pyrrole insecticides represent a new class of chemistry with a unique mechanism of action. No other data are available that indicate that any toxicological effects produced by chlorfenapyr would be cumulative with those of any other compound.
The parent molecule, chlorfenapyr is a pro-insecticide that is converted to the active form, CL 303,268, via rapid metabolism by mixed function oxidases (MFOs). The active form uncouples oxidative phosphorylation in the insect mitochondria by disrupting the proton gradient across the mitochondrial membrane. The production of ATP is inhibited resulting in the cessation of all cellular functions. Because of this unique mechanism of action, it is highly unlikely, that toxic effects produced by chlorfenapyr would be cumulative with those of any other pesticide chemical.
In mammals, there is a lower titer of MFOs, and chlorfenapyr is metabolized by different pathways (including dehalogenation, oxidation and ring hydroxylation) to other polar metabolites without any significant accumulation of the potent uncoupler, CL 303,268. In the rat, approximately 85% of the administered dose is excreted in the feces within 48 hours, thereby reducing the levels of chlorfenapyr and CL 303,268 that are capable of reaching the mitochondria. This differential metabolism of chlorfenapyr to CL 303,268 in insects versus to other polar metabolites in mammals is responsible for the selective insect toxicity of the pyrroles.Start Printed Page 42026
E. Safety Determination
1. U.S. population. Using the exposure assumptions described above, BASF has estimated that chronic dietary aggregate exposure to chlorfenapyr for the U.S. population was 0.002615 mg/kg bwt/day or 8.7% of the chronic RfD of 0.03 mg/kg bwt/day. Other than children less than 12 years of age, hispanics are the U.S. population subgroup with the highest chronic exposure of 0.003403 mg/kg bwt/day, or 11.3% of the RfD. EPA has no concerns about exposure that are less than 100% of the RfD as the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. It is therefore, safe to conclude that there is reasonable certainty that no harm to the overall U.S. population will result from chronic exposure to chlorfenapyr residues.
2. Infants and children. Using the exposure assumption described above, BASF has estimated that the chronic dietary aggregate exposure to chlorfenapyr for children 1-6 years of age was 0.005936 mg/kg bwt/day, or 19.8% of the chronic RfD of 0.03 mg/kg bwt/day. Children 1-6 years of age were the sub-population that utilized the largest portion of the chronic RfD. It is therefore, safe to conclude that there is reasonable certainty that no harm to infants and children will result from chronic exposure to chlorfenapyr residues.
F. International Tolerances
No Codex or Canadian tolerances/limits for residues in any food presently exist for chlorfenapyr. In Mexico there is a MRL of 0.3 ppm for cottonseed.End Supplemental Information
[FR Doc. 03-17900 Filed 7-15-03; 8:45 am]
BILLING CODE 6560-50-S