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-2003-0407, must be received on or before February 27, 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:
Susan Stanton, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5218; 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 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. Docket. EPA has established an official public docket for this action under docket ID number OPP-2003-0407. 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 4144receipt 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-2003-0407. 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-2003-0407. 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-2003-0407.
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-2003-0407. 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 pesticide petitions 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: January 7, 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 Bayer CropScience 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 4145pesticide chemical residues or an explanation of why no such method is needed.
Rutgers State University
PP 1E6318, PP 1F6290, PP 2F6445, PP 2F6479, PP 3E6776, PP 3E6583
EPA has received pesticide petitions (PP 1F6290, PP 2F6445, PP 2F6479) from Bayer CropScience, 2 T.W. Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709 and pesticide petitions (PP 1E6318, PP 3E6583, PP 3E6776) from the Interregional Research Project Number 4 (IR-4), Technology Centre and Rutgers State University of New Jersey, 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 180.436 by establishing a tolerance for residues of cyfluthrin (cyano (4-fluoro-3-phenoxyphenyl)methyl-3-(2,2-dichloroethenyl)-2,2-dimethyl-cyclopropanecarboxylate) in or on raw agricultural commodities as follows:
1. PP 1F6290 proposes tolerances for tree nuts, Crop Group 14 at 0.01 parts per million (ppm), almond hulls at 1.0 ppm, and pistachio at 0.01 ppm.
2. PP 1E6318 proposes tolerances for tuberous and corm vegetable subgroup at 0.01 ppm.
3. PP 2F6445 proposes tolerances for wheat forage, wheat hay and wheat straw at 5.0 ppm, wheat shorts at 3.5 ppm, leafy vegetable group at 6.0 ppm, leafy brassica greens subgroup at 7.0 ppm, fruiting vegetable group at 0.5 ppm, cucurbit vegetable crop group at 0.10 ppm, pome fruit group at 0.10 ppm, pome fruit wet pomace at 0.30 ppm, and stone fruit group at 0.30 ppm.
4. PP 2F6479 proposes tolerances for grape at 0.8 ppm, grape, raisin at 3.5 ppm, peanut at 0.01 ppm, and peanut, hay at 6.0 ppm.
5. PP 3E6583 proposes tolerances for turnip greens at 7 ppm.
6. PP 3E6776 proposes tolerances for grass forage at 6 ppm, grass hay at 8 ppm, and pea and bean, dried shelled, except soybean, subgroup 6C at 0.15 ppm.
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.
A. Residue Chemistry
1. Plant metabolism. The metabolism of cyfluthrin in plants is adequately understood. Studies have been conducted to delineate the metabolism of radiolabeled cyfluthrin in various crops all showing similar results. The residue of concern is cyfluthrin.
2. Analytical method. Adequate analytical methodology using GC/EC detection is available for enforcement purposes.
3. Magnitude of residues. Complete residue data are available for cyfluthrin on the crops and crop groupings in PP 1F6290, PP 2F6445, and PP 2F6479. The data support the requested tolerances.
Tuberous and corm vegetable subgroup in PP 1E6318. IR-4 received a request from the Agricultural Experiment Station of Mississippi for the use of cyfluthrin on sweet potato to control numerous insect pests. Cyfluthrin is already registered on potato with a tolerance of 0.01 ppm, and potato is the representative commodity of the tuberous and corm vegetable subgroup, 1C. Since sweet potato is a member of subgroup 1C, IR-4 is proposing that EPA references the registrant's potato data to establish a tolerance for the subgroup.
Turnip greens in PP 3E6583. IR-4 received a request from the Agricultural Experiment Stations of Arkansas, Oklahoma, and Tennessee for the use of cyfluthrin on turnip greens to control numerous insect pests. A tolerance of 7 ppm has been established for cyfluthrin on mustard greens. Mustard greens are the sole representative crop for Crop Subgroup 5B:
Leafy Brassica greens. The EPA HED Chemistry Science Advisory Council has approved the inclusion of turnip greens in Crop Subgroup 5B, thus the data on mustard greens are sufficient to establish a tolerance on turnip greens.
Grasses and dried shelled pea and bean (except soybean subgroup 6C) in PP 3E6776. IR-4 has received requests from the state of California for the use of cyfluthrin on grass. To support this .request, magnitude of residue data were collected from four supervised crop field trials with grass at application rates of 0.024 0.03 lb a.i./A with pre-harvest interval(s) of 0 days for grass forage and 6-7 days for hay. The results from these trials show that the residues of cyfluthrin in grass forage ranged from 0.24 ppm to 4.8 ppm after a total application rate of 0.024 0.03 lb a.i./A and a PKI of 0 days, and the residues of cyfluthrin in grass hay ranged from 0.62 ppm to 6 ppm after a total application rate of 0.024 0.03 lb a.i./A and a pre-harvest interval (PHI) of 6-7 days. The nature of the residues of cyfluthrin are adequately understood and an acceptable analytical method is available for enforcement purposes. Data on dry peas and beans were submitted to EPA in PP 0E6075; however, the tolerance action included dry pea only. The data volume that contained dry bean data was only reviewed for the dry pea data that it contained. IR-4 requests that this data volume be reviewed for the dry bean data it contains and that these data, combined with the established dry pea tolerance, be used to set a subgroup 6C tolerance for cyfluthrin.
B. Toxicological Profile
1. Acute toxicity. There is a full battery of acute toxicity studies for cyfluthrin supporting an overall toxicity Category II for the active ingredient.
2. Genotoxicty. Based on the results of a complete genotoxicity data base, there is no evidence of mutagenicity activity in a battery of studies, including several gene mutation assays (reverse mutation and recombination assays in bacteria and a Chinese hamster ovary(CHO)/HGPRT assay), a structural chromosome aberration assay (CHO/sister chromatid exchange assay), and an unscheduled DNA synthesis assay in rat hepatocytes. All tests were negative for genotoxicity.
3. Reproductive and developmental toxicity. A developmental toxicity study in rats indicated a maternal no observed adverse effect level (NOAEL) of 3 milligrams/kilogram body weight day (mg/kg bwt/day) based on reduced body weight gain and food consumption at 10 mg/kg bwt/day. The developmental NOAEL was 10 mg/kg bwt/day, based on reduced fetal body weights and increased skeletal variations at the maternally toxic dose of 40 mg/kg bwt/day. An oral developmental toxicity study in rabbits with a maternal NOAEL of 20 mg/kg bwt/day and a maternal lowest observed adverse effect level (LOAEL) of 60 mg/kg bwt/day, based on decreased body weight gain and decreased food consumption during the dosing period. A fetal NOAEL of greater than 180 mg/kg bwt/day was also observed in this study. A two-generation reproduction study in rats indicated parental and offspring NOAELs of 3.0 mg/kg bwt/day, based on reductions in body weight and food consumption in the parents and course tremors and decreased mean litter weights in the offspring at 9.0 mg/kg bwt/day. The NOAELs were confirmed in a supplemental two-generation study.
4. Subchronic toxicity. In a 28-day oral gavage study in rats, cyfluthrin demonstrated a NOAEL of 20 mg/kg bwt/day, based on clinical signs of Start Printed Page 4146neurotoxicity, decreased body weight gain and changes in liver and adrenal weights at 80 and 40 mg/kg bwt/day, respectively. In a 90-day feeding study in rats, the resulting NOAEL was 9.5 mg/kg bwt/day, based on decreased body weight gain, gait abnormalities, skin lesions and mortality seen at 37.5 mg/kg bwt/day. A 6-month toxicity feeding study in dogs established a NOAEL of 5 mg/kg bwt/day. The LOAEL was 15 mg/kg bwt/day based on clinical signs of neurotoxicity and gastrointestinal disturbances.
Two subchronic inhalation studies were conducted with cyfluthrin. In the first study, cyfluthrin was administered via inhalation for 5 days per week for 3 weeks. The resulting NOAEL was 1.4 mg/m3, based on treatment-related behavioral effects, body weight decreases and organ weight changes at 10.5 mg/m3. In the second study cyfluthrin was administered via inhalation for 13-weeks. The resulting NOAEL was 0.09 mg/m3, based treatment-related behavioral effects in females and increased urinary protein in males at 0.71 mg/m3.
5. Neurotoxicity. An acute neurotoxicity study in rats was conducted using beta-cyfluthrin. The NOAEL for this study is 2 mg/kg, based on clinical signs, changes in FOB parameters and decreases in motor activity noted at 10 mg/kg. In a subchronic neurotoxicity study with beta-cyfluthrin the resulting NOAEL was 8 mg/kg, based on clinical signs, changes in FOB parameters, and slightly decreased body weight gain and food consumption. There is no indication of delayed neurotoxicity as a result of exposure to cyfluthrin.
6. Chronic toxicity. A 12-month chronic feeding study in dogs established a NOAEL of 2.4 mg/kg bwt/day (males) and 3.6 mg/kg bwt/day (females). The LOAEL for this study is established at 11 mg/kg bwt/day, clinical signs, gait abnormalities and abnormal postural reactions in males and females. A 24-month chronic feeding/carcinogenicity study in rats demonstrated a NOAEL of 2.6 mg/kg bwt/day and LOAEL of 11.6 mg/kg bwt/day, based on decreased body weights. A 24-month carcinogenicity study in mice was conducted. The NOAEL was 31.9 (males) and 140.6 (females) mg/kg/bwt/day. The LOAEL was 114.8 mg/kg bwt/day (males) based on ear skin lesions and reduced body weight gains, and 309.7 mg/kg bwt/day (females) based on clinical signs, macroscopic and microscopic pathology findings and reduced body weights, body weight gains, and food consumption. Under the conditions of these studies, there was no evidence of carcinogenic potential.
7. Animal metabolism. A metabolism study in rats showed that cyfluthrin is rapidly absorbed and excreted, mostly as conjugated metabolites in the urine, within 48 hours. An enterohepatic circulation was observed.
8. Metabolite toxicology. No toxicology data have been required for cyfluthrin metabolites. The residue of concern is cyfluthrin.
9. Endocrine disruption. There is no evidence of endocrine effects in any of the studies conducted with cyfluthrin, thus, there is no indication at this time that cyfluthrin causes endocrine effects.
C. Aggregate Exposure
1. Dietary exposure. The insecticide cyfluthrin has uses on food crops in agriculture and also non-dietary uses for homeowners. Aggregate exposure for cyfluthrin should consider dietary exposure, both food and drinking water and non-dietary exposure both applicator and postapplication exposure. For the dietary exposure an acute Population Adjusted Dose (PAD) of 0.02 mg/kg bwt/day was selected using an uncertainty factor of 100 based on the acute neurotoxicity study. A chronic PAD of 0.024 mg/kg bwt/day was based on the chronic toxicity test in dogs with an uncertainty factor of 100.
i. Food. Chronic and acute dietary exposure estimates resulting from the above listed proposed and pending uses and the registered uses of cyfluthrin are well within acceptable limits for all sectors of the population. Potential dietary exposures from food were estimated using the Dietary Exposure Evaluation Model (DEEMTM) software system (Exponent, Inc.) and the 1994-96 and 1998 USDA consumption data. For the chronic analysis, mean residue values were calculated from the appropriate field trial studies conducted for cyfluthrin and submitted as part of the cyfluthrin petitions. For the acute analysis, the entire distribution of field trial residue values was used for non-blended and partially blended commodities and the mean value used for blended commodities. Processing factors were obtained from GLP processing studies for the appropriate commodities. Percent crop treated values were obtained from Doane Market Research Data for registered crops, using the mean value for the chronic analysis and the maximum value of the last 3 years for the acute analysis. Percent crop treated values for pending and proposed crops were based on Bayer CropScience market projections at market maturity. Using these data and assumptions for the chronic analysis, the most highly exposed subpopulation was children 1-2 years utilizing 5.4% (0.001288 mg/kg bwt/day) of the chronic PAD. The U.S. population utilized 1.5% (0.00037 mg/kg bwt/day) of the chronic PAD. For the acute analysis the most highly exposed sub-population was again children 1-2 years at 52.1% (0.010427 mg/kg bwt/day) of the acute PAD and the U.S. population at 34.8% (0.006952 mg/kg bwt/day) of the acute PAD. Actual exposures are likely to be much less, because of the many conservative assumptions incorporated in this analysis.
ii. Drinking water. EPA's Standard Operating Procedure (SOP) for Drinking Water Exposure and Risk Assessments was used to perform the drinking water assessment. This SOP uses a variety of tools to conduct drinking water assessment. These tools include water models such as SCI-GROW for potential ground water exposure concentrations, and FIRST and/or PRZMS/EXAMS for surface water exposure concentrations, and monitoring data. If monitoring data are not available, then the models are used to predict potential residues in surface water and ground water and the highest is assumed to be the drinking water residue. In the case of cyfluthrin, monitoring data do not exist; therefore, SCI-GROW and FIRST were used to estimate a water residue. The calculated drinking water levels of comparison (DWLOC) for chronic exposure for all adults and toddlers exceed the drinking water estimated concentration (EDWC) from the models. The chronic DWLOC for adults is 830 ppb. The chronic DWLOC for children 1-2 years is 239 ppb. The chronic EDWC for the worst case chronic scenario is 0.16 parts per billion (ppb) (FIRST). The acute DWLOC for adults is 467 ppb and for children 1-2 years is 96 ppb. The maximum acute EDWC from modeling is 2 ppb (FIRST). There is no contribution from ground water exposure as modeled by SCI-GROW.
2. Non-dietary exposure. Non-occupational exposure to cyfluthrin may occur as a result of inhalation or contact from indoor residential, indoor commercial, and outdoor residential uses. Pursuant to the requirements of FIFRA as amended by the Food Quality Protection Act of 1996 non-dietary and aggregate risk analyses for cyfluthrin were conducted. The analyses include evaluation of potential non-dietary acute application and post-application exposures. Non-occupational, non-dietary exposure was assessed based on the assumption that a flea infestation control scenario represents a “worst case” scenario. For the flea control Start Printed Page 4147infestation scenario indoor fogger, and professional residential turf same day treatments were included for cyfluthrin. Deterministic (point values) were used to present a worse case upper-bound estimate of non-dietary exposure. The non-dietary exposure estimates were expressed as systemic absorbed doses for a summation of inhalation, dermal, and incidental ingestion exposures. These worst case non-dietary exposures were aggregated with chronic dietary exposures to evaluate potential health risks that might be associated with cyfluthrin products. The chronic dietary exposures were expressed as an oral absorbed dose to combine with the non-dietary systemic absorbed doses for comparison to a systemic absorbed dose no observed effect level (NOEL). Results for each potential exposed subpopulation (adults, children 1-6 years, and infants <1 year) were compared to the systemic absorbed dose NOEL for cyfluthrin to provide estimates of margins of exposure (MOE). The large MOEs for cyfluthrin clearly demonstrate a substantial degree of safety. The total non-dietary MOEs are 3,800, 2,700, and 2,500 for adults, children 1-6 years, and infants (<1 year), respectively. The aggregate MOE for adults is approximately 3,700 and the MOEs for infants and children exceed 2,400. The non-dietary methods used in the analyses can be characterized as highly conservative due to the conservatism inherent in the calculation procedures and input assumptions. An example of this is the conservatism inherent in the jazzercise methodology's over-representation of residential post-application exposures. Therefore, it can be concluded that large MOEs associated with potential non-dietary and aggregate exposures to cyfluthrin will result in little or no health risks to exposed persons. The aggregate risk analysis demonstrates compliance with the health-based requirements of the Food Quality Protection Act of 1996 for the current label uses. The additional use of cyfluthrin on the proposed new uses will have no impact on the analysis for non-dietary exposure.
D. Cumulative Effects
Bayer will submit information for EPA to consider concerning potential cumulative effects of cyfluthrin consistent with the schedule established by EPA in the Federal Register of August 4, 1997 (62 FR 42020) (FRL-5734-6) and other EPA publications pursuant to FQPA.
E. Safety Determination
1. U.S. population. Using the assumptions and data described above, based on the completeness and reliability of the toxicity data, it is concluded that chronic dietary exposure to the proposed uses of cyfluthrin will utilize at most 1.5% of the chronic PAD for the U.S. population. The acute dietary exposure to cyfluthrin will utilize at most 34.8% of the acute PAD. The actual exposure both acute and chronic is likely to be much less as more realistic data and models are developed. EPA generally has no concern for exposures below 100% of the PAD because the PAD represents the level at or below which daily aggregate exposure over a lifetime will not pose appreciable risk to human health. Drinking water levels of comparison based on the dietary and aggregate exposures are much greater than highly conservative estimated levels, and would be expected to be well below the 100% level of the PAD, if they occur at all. Large margins of safety exist for the non-dietary and aggregate exposure. Therefore, there is a reasonable certainty that no harm will occur to the U.S. population from aggregate exposure (food, drinking water, and non-dietary) to residues of cyfluthrin.
2. Infants and children. The relevant toxicity studies as discussed in the toxicology section above show no extra sensitivity of infants and children to cyfluthrin; therefore, the FQPA safety factor can be removed. Using the assumptions and data described in the exposure section above, the percent of the chronic PAD that will be used for exposure to residues of cyfluthrin in food for children 1-2 years (the most highly exposed sub-population) is 5.4%. Infants utilize 1.2% (0.000056 mg/kg bwt/day) of the chronic PAD. For the acute assessment, children 1-2 years utilize 52.1% of the acute PAD and infants utilize 34.5% of the acute PAD. As in the adult situation, drinking water levels of comparison are higher than the worst case drinking water estimated concentrations and are expected to use well below 100% of the PAD, if they occur at all. As with adults, large margins of safety exist for the non-dietary and aggregate exposure for infants and children. Therefore, there is a reasonable certainty that no harm will occur to infants and children from aggregate exposure to residues of cyfluthrin.
F. International Tolerances
There are no Codex maximum residue levels established for cyfluthrin on the commodities proposed in these petitions.End Supplemental Information
[FR Doc. 04-1240 Filed 1-27-04; 8:45 am]
BILLING CODE 6560-50-S