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-2003-0071, must be received on or before June 30, 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:
Shaja R. Brothers, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: Start Printed Page 32498(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 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-2003-0071. 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 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-2003-0071. 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.Start Printed Page 32499
ii. E-mail. Comments may be sent by e-mail to firstname.lastname@example.org, Attention: Docket ID number OPP-2003-0071. 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-2003-0071.
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-2003-0071. 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: May 19, 2003.
Acting Director, Registration Division, Office of Pesticide Programs.
Summary of Petitions
The petitioner summary of the pesticide petitions is printed below as required by FFDCA section 408(d)(3). The summary of the petition was prepared by the Interregional Research Project Number (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 (IR-4)
PP 1E6302 and 2E6474
EPA has received pesticide petitions (1E6302 and 2E6474) from the Interregional Research Project Number (IR-4), 681 U.S. Highway #1 South, North Brunswick, NJ 08902 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing tolerances for residues of quinoxyfen 5,7-dichloro- 4-quinolyl 4-fluorophenyl ether in or on the following raw agricultural commodities: Grape at 0.70 parts per million (ppm) (1E6302), hop, dried at 5 ppm (1E6302), and cherry at 0.4 ppm (2E6474). 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 the registrant, Dow AgroSciences LLC, Indianapolis, IN 46268.
A. Residue Chemistry
1. Plant metabolism. The nature of residues is adequately understood for the purposes of these tolerances. Based on the findings from these studies, quinoxyfen is the primary residue in all crops and therefore, the only residue of concern. Metabolites were present at low levels (<10% of total radioactive residue).
Grape vineyard, cherry orchards, and hops are not normally rotated to succeeding crops, therefore, concerns on the residues in rotational crops are minimal. Nonetheless, a confined rotational crop study was conducted with quinoxyfen which confirmed Start Printed Page 32500minimal carryover of residues (> 0.003 μug/g) to succeeding crops.
2. Analytical method. A practical analytical method for detecting and measuring levels of quinoxyfen in or on cherries, hops, grapes and its products allows monitoring of residues at or above the tolerances set for these crops. The analytical method uses capillary gas chromatography and mass selective detection (GC-MSD) with limits of quantitation (LOQ) of 0.01 parts per million (ppm) for cherries, grapes, grape juice, raisins and 0.05 ppm for hops. An independent laboratory has validated the method using hops, which is typically the more difficult matrix to analyze.
3. Magnitude of residues. The magnitude of residues for grape, hops, and cherry is adequately understood.
B. Toxicological Profile
1. Acute toxicity. Quinoxyfen technical has low acute toxicity. The acute oral lethal dose (LD)50 in rats was >5,000 milligrams/kilogram (mg/kg) whereas, the dermal (LD)50 in rabbits was >2,000 mg/kg. The acute inhalation lethal concentration (LC)50 in rats was greater than the highest attainable aerosol concentration (3.38 mg/L). Quinoxyfen produced no dermal irritation and only mild eye irritation in rabbits. A guinea pig dermal sensitization study conducted by the modified Buehler method found no sensitization, whereas a study conducted by the Magnusson and Kligman maximization test showed a positive sensitization reaction. Formulations of quinoxyfen are water based suspension concentrates that have similar low acute toxicity. These suspension concentrates are classified as non-sensitizer, based on the results from testing in guinea pigs.
2. Genotoxicity. Quinoxyfen was negative for genotoxicity when tested in in vitro and in vivo systems.
3. Reproductive and developmental toxicity. Quinoxyfen did not have any effect on reproductive parameters at dose levels that induced treatment-related effects in parental rats. Transient decreases in pup body weights were seen prior to weaning, but dietary concentrations were targeted for adults and consumption of treated diets by the pups resulted in dose levels to the pups approximately 3-fold higher than in adults. Post-weaning weights were comparable to controls. A teratogenic potential for quinoxyfen was not demonstrated in either rats or rabbits at dose levels that induced maternal toxicity.
4. Subchronic and chronic toxicity. Quinoxyfen caused increased liver weights and microscopic hepatocellular hypertrophy when given at sufficiently high dose levels in rats and mice for 13 weeks; no effects were observed in the subchronic dog study at the highest dose tested. Very high dietary levels were associated with slight hepatocellular necrosis. Similar increases in liver weights were seen in chronic studies. In addition, increased kidney weights, and an increase in the incidence of chronic progressive glomerulonephropathy, were seen after 24 months in female rats given high dose levels of quinoxyfen. Chronic toxicity seen in dogs included liver effects as noted above, along with regenerative anemia at high dose levels.
Using the Guidelines for Carcinogen Risk Assessment published September 24, 1986 (51 FR 33992), it is proposed that quinoxyfen be classified as Group E for carcinogenicity (no evidence of carcinogenicity) based on the results of studies in two species. Dow AgroSciences believes there was no evidence of carcinogenicity in an 18-month mouse feeding study and a 24-month rat feeding study at any dosage tested.
5. Animal metabolism. Quinoxyfen is rapidly absorbed, extensively metabolized and rapidly eliminated in the urine and feces. Studies conducted with 14C-quinoxyfen, labeled in either the phenyl ring or the quinoline ring, indicated extensive cleavage of the diaryl ether linkage. There were no substantive differences in the metabolism and disposition of quinoxyfen between males and females, or between single or repeated exposure. Parent quinoxyfen was not found in the urine; although, it was identified in the feces. The major metabolites found in urine and/or feces included: (1) Acid-labile conjugates of the phenyl ring moiety (4-FP) and quinoline ring moiety (DCHQ); (2) lesser quantities of free 4-FP and DCHQ; and (3) isomers of fluorophenyl-ring hydroxy-quinoxyfen, both free and glucuronide and/or sulfate conjugates. Trace quantity of the 3-OH metabolite was also identified in the urine and feces of rats.
6. Metabolite toxicology. The nature of residue studies of quinoxyfen in plants indicated that the majority of applied radiolabeled material remained as the parent compound. Analyses from nature of residues studies in a number of crops revealed low residues of metabolites (<10% TRR) identified as: (1) A quinoline-ring hydroxylated metabolite, most likely 3-OH; (2) a cyclized deschloro photoproduct (CFBPQ); (3) 4-FP; and (4) a metabolite in which the fluorine was replaced by a hydroxyl group. Of these metabolites, 4-FP (formed by ether bridge cleavage), and DCHQ (corresponding to the other half of the molecule), as well as trace quantities of 3-OH, have been identified in rat urine and/or feces. These data suggest that most metabolites formed in plants are similarly formed in mammals and are of little toxicologic concern, based on the existing data for quinoxyfen.
7. Neurotoxicity. Quinoxyfen has been shown to have no neurotoxicologic potential based on acute and subchronic studies.
8. Endocrine disruption. There is no evidence from any studies to suggest that quinoxyfen has an effect on any endocrine system.
C. Aggregate Exposure
1. Dietary exposure. Potential dietary exposure and risk assessment was estimated using DEEM (Dietary Exposure Evaluation Model, Version 7.76) with USDA food consumption data continuing survey of food intake by individuals (CSFII) Survey 1994-1998.
i. Food—a. Acute No acute dietary risk for quinoxyfen was evaluated since no appropriate toxicity endpoint attributable to a single dose could be identified. Therefore, an acute reference dose was not established.
b. Chronic. The dietary exposure assessment was performed using a conservative approach (Tier I) and the estimated theoretical maximum residue contribution (TMRC) was based on the proposed tolerances for quinoxyfen on or in grapes, hops, and cherries with the assumption that 100% of these crops were treated with quinoxyfen.
ii. Drinking water. Based on the rapid degradation of quinoxyfen in water and its high tendency to sorb to soils, no surface water or ground water contamination is expected. This agrees with EPA Tier 1 modeling using SciGrow and GENEEC which estimated concentration of quinoxyfen at 0.006 μg/L in ground water and 241 μg/L in surface water, respectively.
2. Non-dietary exposure. Quinoxyfen is not currently registered for non-crop uses. Therefore, aggregate exposure to quinoxyfen will not include non-dietary, non-occupational exposures.
D. Cumulative Effects
The potential for cumulative effects of quinoxyfen and other substances that have a common mechanism of toxicity is also considered. Quinoxyfen is a member of the quinoline class of fungicides. No information is available to determine whether quinoxyfen has a common mechanism of toxicity with other pesticides. Therefore, it is appropriate to consider only the Start Printed Page 32501potential risks of quinoxyfen in an aggregate exposure assessment.
E. Safety Determination
1. U.S. population. The chronic dietary exposure was evaluated using a chronic reference dose (RfD) of 0.2 mg/kg/day based on a no observed adverse effect level (NOAEL) of 20 mg/kg/day from chronic rat, chronic dog, and rat reproduction studies and uncertainty factor of 100. No additional Food Quality Protecction Act (FQPA) uncertainty factor is needed.
For the U.S. general population, the TMRC was estimated to be 0.000192 mg/kg/day. Using the conservative exposure assumptions described in Section C. and based on the completeness and reliability of the toxicity data, the aggregate exposure to quinoxyfen utilizes 0.1% of the RfD for the U.S. population. EPA generally has no concern for exposures below 100% of the RfD because the RfD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Thus, there is a reasonable certainty that no harm will result from aggregate exposure to quinoxyfen residues from the proposed uses.
2. Infants and children. FFDCA section 408 provides that EPA may apply an additional safety factor for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base. Based on the current toxicological data requirements, the data base for quinoxyfen relative to prenatal and postnatal effects for children is complete.
In assessing the potential for additional sensitivity of infants and children to residues of quinoxyfen, data from developmental toxicity studies in rats and rabbits and a 2-generation reproduction study in the rat are considered. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from pesticide exposure during prenatal development. Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability and potential systemic toxicity of mating animals and on various parameters associated with the well-being of offspring.
The population subgroup with the highest potential exposure are children (1-6 yrs old) with TMRC of 0.00071 mg/kg/day. Using the conservative exposure assumptions previously described in Section C. the percent RfD utilized by the potential aggregate exposure to quinoxyfen residues is about 0.4% for children (1-6 yrs old), the population subgroup with highest potential exposure. Quinoxyfen had no effect on reproduction or embryo-fetal development at any dosage tested. Therefore, no additional FQPA uncertainty factor is needed. Based on the completeness and reliability of the toxicity data and the conservative exposure assessment, Dow AgroSciences concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to quinoxyfen residues from proposed uses.
The drinking water level of concern (DWLOC) for the general U.S. population and children 1-6 years old (population subgroup with the highest potential exposure) was calculated to be 6,993 μg/L and 1,993 μg/L, respectively. The DWLOCs are substantially greater than the estimated residue concentration in ground water or surface water; therefore, exposure to quinoxyfen would not result in unacceptable levels of aggregate human health risk.
F. International Tolerances
There are no codex maximum residue levels established for residues of quinoxyfen on grapes, hops, and cherries.End Supplemental Information
[FR Doc. 03-13562 Filed 5-29-03; 8:45 am]
BILLING CODE 6560-50-S