Environmental Protection Agency (EPA).
This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of a certain pesticide chemical in or on various food commodities.
Comments, identified by docket identification (ID) number OPP-2005-0235, must be received on or before September 30, 2005.
Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Barbara Madden, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6463; 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 32532)
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this action under docket ID number OPP-2005-0235. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document electronically through the EPA Internet Start Printed Page 51803under 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.1 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 in 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-2005-0235. 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-2005-0235. In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system. If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I.C.2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID Number OPP-2005-0235.
3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID Number OPP-2005-0235. 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 Start Printed Page 51804the 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: August 19, 2005.
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 the petitioner 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
EPA has received a pesticide petition (PP 5E4573) from Interregional Research Project Number 4 (IR-4), 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390 proposing, pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR part 180 by establishing a tolerance for residues of fenarimol [alpha-(2-chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol] in or on the raw agricultural commodity filbert at 0.02 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 supports 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 residue in fenarimol-treated filbert has not been directly determined. Radioactive metabolism studies with apples and cherries indicate that fenarimol is the only significant component of the residue in apples and cherries. The residue of concern in filbert is fenarimol.
2. Analytical method. Analytical methodology used for filbert is a slight modification of the basic Pesticide analytical manual (PAM II) method for fenarimol (Method R039). Residues are extracted with methanol. Aqueous sodium chloride (5%) is added and the extract is partitioned with dichloromethane. Residues are cleaned up on a Florisil column and detected by Gas chromatography/electron capture detector (GC/ECD). Recoveries ranged from 84% to 97% in samples fortified with fenarimol at 0.02 ppm to 0.2 ppm. The limit of detection via this method is <0.02 ppm.
3. Magnitude of residues. IR-4 data from 4 residue trials show residues of fenarimol were <0.02 ppm in composite samples of filbert treated at 0.09 pound of active ingredient per acre (lb ai/A) and composite samples treated at 0.18 lb ai/A or two times the proposed maximum application rate. The data indicates that fenarimol residues would not be expected to accumulate to significant levels in filbert. Based on these results and for purposes of this petition, it is appropriate to base the magnitude of total terminal residues and proposed tolerance only on residues of the parent compound, fenarimol.
B. Toxicological Profile
1. Acute toxicity. The acute oral lethal dose (LD50) in the rat is 2,500 milligrams per kilogram (mg/kg) and the acute dermal LD50 in the rabbit is >2,000 mg/kg. The inhalation lethal concentration (LC50) in the rat is >2.04 mg/liter of air, which is the highest obtainable respirable aerosol concentration. Fenarimol produced no indications of dermal irritation in rabbits or sensitization in the guinea pig. End use formulations of fenarimol have similar low acute toxicity profiles.
2. Genotoxicity. Fenarimol tested negative in several assay systems for gene mutation, structural chromosome aberration, and other genotoxic effects. In a micronucleus test in the mouse, fenarimol did produce a significant increase in the percent of polychromatic erythrocytes with micronucleus at 24 hours but not at 48 or 72 hours. Moreover, a second test run at a higher dosage, which produced significant toxicity including death, was unequivocally negative.
3. Reproductive and developmental toxicity. A developmental toxicity study in rabbits was negative for teratogenic effects at all doses tested (0, 5, 10, and 35 mg/kg). A developmental toxicity study in rats demonstrated hydronephrosis at 35 mg/kg (doses tested were 0, 5, 10, and 35 mg/kg). A second developmental toxicity study in rats, with a postpartum evaluation, again demonstrated hydronephrosis at 35 mg/kg. Maternal toxicity (decreased body weight) was also observed at the 35 milligrams/kilogram/day (mg/kg/day) dose level. The no observed effect level (NOEL) for hydronephrosis and maternal toxicity is 13 mg/kg.
4. Chronic toxicity. A 2-year chronic toxicity and carcinogenicity study in rats fed diets containing 0, 50, 130, or 350 ppm (equivalent to 2.5, 6.5, or 17.5 Start Printed Page 51805mg/kg/day) resulted in a systemic NOEL of 130 ppm, equivalent to 6.5 mg/kg/day. An increase in fatty liver changes was observed in rats fed diets containing 350 ppm. There were no carcinogenic effects observed under the conditions of the study.
A second 2-year carcinogenicity study was conducted in rats fed diets containing 0, 12.5, 25, or 50 ppm, equivalent to 0, 0.63, 1.25, or 2.5 mg/kg/day. There was no apparent effect on survival, which was reduced in all treatment groups due to chronic respiratory disease. An increased incidence of fatty changes in the liver was observed at the top dose level of 50 ppm, and the NOEL was established as 25 ppm (1.2 mg/kg/day) in this study. A third 2-year carcinogenicity study was conducted at the same dose levels as above. The incidence of liver lesions was similar in the treated and control groups; thus the NOEL for liver effects in this study was greater than 50 ppm (2.5 mg/kg/day).
A 2-year feeding study was conducted in mice fed diets containing concentrations of 0, 50, 170, or 600 ppm, equivalent to 0, 7, 24.3, or 85.7 mg/kg/day. The 600 ppm dose level was shown to increase liver weight. There was no increase in cancer, and no toxicologically significant treatment related effects were observed at any dose level. The NOEL was determined to be 600 ppm (85.7 mg/kg/day).
In a 1-year chronic toxicity study, dogs were fed diets containing 0, 1.25, 12.5, or 125 mg/kg/day. The NOEL was 12.5 mg/kg/day based upon an increase in serum alkaline phosphatase, increased liver weights, an increase in p-nitroanisole o-demethylase activity, and mild hepatic bile stasis at the high dose level (125 mg/kg/day).
Based on the chronic toxicity data, the chronic Reference Dose (RfD) for fenarimol is established at 0.0006 mg/kg/day. The RfD for fenarimol is based on a 2-year chronic feeding study in rats with a NOEL of 6.5 mg/kg/day and an uncertainty factor of 1,000. For short-term <35 day risk assessments to females 13-50 years old, the Agency selected a LOAEL of 35 mg/kg/day based upon decreased fertility and dystocia in rats and an uncertainty factor of 3,000.
5. Animal metabolism. Metabolism studies conducted in rats show fenarimol is rapidly metabolized and excreted. Major metabolic pathways were oxidation of the carbinol-carbon atom, the phenyl rings and the pyrimidine ring.
6. Endocrine disruption. In a 3-generation reproduction study with rats and in subsequent special studies, fenarimol was determined to be a weak inhibitor of aromatase. Rats dosed at 0, 12.5, 25, or 50 ppm (equivalent to 0, 0.625, 1.25, or 2.5 mg/kg/day) demonstrated decreased fertility in males at 25 ppm and delayed parturition and dystocia in females at 25 and 50 ppm. The NOEL for reproductive effects was 12.5 ppm (0.625 mg/kg/day). The infertility effect in males is considered to be a species-specific effect mediated by the inhibition of aromatase, an enzyme which catalyzes the conversion of testosterone to estradiol. Estradiol plays an essential role in the developmental and maintenance of sexual behavior in rats.
Multi-generation reproduction studies in guinea pigs and mice were negative for reproductive effects at the highest dose levels tested, 35 mg/kg/day and 20 mg/kg/day, respectively. A NOEL of 35 mg/kg/day for reproductive effects relevant to humans was established based on the NOEL from the multi-generation reproduction study in guinea pigs.
C. Aggregate Exposure
1. Dietary exposure—i. Food. For the purposes of assessing the potential dietary exposure from use on filbert, an estimate of aggregate exposure is determined by basing the TMRC from previously established tolerances and the proposed tolerance on filbert for fenarimol at 0.02 parts per million (ppm) and assuming the 100% of the filbert crop has a residue of fenarimol at the tolerance level.
Exposure of humans to residues could also result if such residues are transferred to meat, milk, poultry, or eggs. Since there is no livestock feed commodity associated with filbert, there is no reasonable expectation that measurable secondary residues of fenarimol will occur in meat, milk, poultry, or eggs under the terms of the proposed use. Other established tolerances for fenarimol on food or feed crops in the United States are established under 40 CFR 180.421. The use of a tolerance level and 100% of crop treated clearly results in an overestimate of human exposure and a safety determination for use on filbert that is based on conservative exposure assessment.
ii. Drinking water. Based upon the available environmental studies conducted with fenarimol wherein its properties show little potential for mobility in soil and extremely rapid photolysis in water, there is no anticipated exposure to residues of fenarimol in drinking water.
2. Non-dietary exposure. The proposed use on filbert involves application of fenarimol to a crop grown in an agricultural environment. Thus, the potential for non-occupational, non-dietary exposure to the general population is not expected to be significant. There are no residential uses of fenarimol.
D. Cumulative Effects
There is no evidence that there is a common mechanism of toxicity with any other chemical compound or that potential toxic effects of fenarimol would be cumulative with those of any other pesticide chemical. Thus it is believed that it is appropriate to consider only the potential risks of fenarimol in its exposure assessment.
E. Safety Determination
1. U.S. population. It is concluded that aggregate exposure to fenarimol will utilize less than 2% of the chronic RfD for the U.S. general population and less than 14% of the acute RfD for females 13-50 at the 99.9 percentile level. 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. It is concluded that there is a reasonable certainty that no harm will result from aggregate exposure to fenarimol residues in or on filbert.
2. Infants and children. In assessing the potential for additional sensitivity of infants and children to residues of fenarimol, data from developmental toxicity studies in rats and rabbits and a multigeneration 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 to one or both parents. 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.
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 pre- and post-natal toxicity and the completeness of the data base. Based on the current toxicological data requirements, the data base for fenarimol relative to pre- and post-natal effects for children is complete. Further, for fenarimol, the NOEL in the chronic feeding study which was used to calculate the RID (6.5 mg/kg/day used by EPA or 1.2 mg/kg/day used by The World Health Start Printed Page 51806Organization) is already lower than the NOELs from the developmental studies in rats and rabbits.
Concerning the multi-generation reproduction study, the effects on reproduction are considered to be specific effect caused by aromatase inhibition. The aromatase enzyme promotes normal sexual behavior in rats and mice, but not in guinea pigs or primates, including humans. A NOEL of 35 mg/kg/day for reproductive effects relevant to humans was established based on the NOEL from the multi-generation reproduction study in guinea pigs. In addition, a NOEL of 13 mg/kg/day for developmental effects was established based upon the NOEL from the teratology study in rats. Therefore, it is concluded that an additional uncertainty factor is not needed and that the RfD at 0.065 mg/kg/day is appropriate for assessing risk to infants and children.
F. International Tolerances
There is no Codex or national maximum residue level established for fenarimol on filbert.End Supplemental Information
[FR Doc. 05-17195 Filed 8-30-05; 8:45 am]
BILLING CODE 6560-50-S