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 identification (ID) number OPP-2003-0228, must be received on or before March 26, 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:
Marilyn Mautz, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6785; 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-2003-0228. 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 EPA's 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 Start Printed Page 8646the 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-2003-0228. 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-2003-0228. 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-2003-0228.
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-2003-0228. 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 these petitions contain 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 these petitions. Additional data may be needed before EPA rules on the petitions.Start List of Subjects
List of Subjects
- Environmental protection
- Agricultural commodities
- Feed additives
- Food additives
- Pesticides and pests
- Reporting and recordkeeping requirements
Dated: February 12, 2004.
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
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 the petitioner and represents the view of the petitioner. The petitions summaries announces the availability of a description of the analytical methods available to EPA for the detection and measurement of the Start Printed Page 8647pesticide chemical residues or an explanation of why no such method is needed.
PP 2F6440 and 3F6595
EPA has received pesticide petitions (2F6440 and 3F6595) from Arvesta Corporation, 100 First Street, Suite 1700, San Francisco, CA 94105 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 the combined residues of acequinocyl (3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate) and its metabolite 2-dodecyl-3-hydroxy-1,4-naphthoquinone expressed as acequinocyl equivalents in or on the raw agricultural commodities as follows:
PP 2F6440. Fruit, pome group at 0.4 parts per million (ppm); apple, wet pomace at 1.0 ppm; fruit, citrus, group at 0.3 ppm; orange, oil at 30 ppm; almond and pistachio at 0.01 ppm; almond, hulls at 1.5 ppm; cattle, meat, and kidney at 0.01 ppm; cattle, liver, and fat at 0.02 ppm; and milk at 0.01 ppm.
PP 3F6595. Strawberries at 0.4 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 petition. Additional data may be needed before EPA rules on the petition.
A. Residue Chemistry
1. Plant metabolism. The nature of the residues of acequinocyl in plants is adequately understood based on three crops: Apples, oranges, and eggplant. The major residue in all plant metabolism studies is acequinocyl. A minor but significant metabolite is acequinocyl-OH (2-dodecyl-3-hydroxy-1,4-naphthoquinone). The proposed tolerance expression is the parent, acequinocyl and its hydroxy metabolite, acequinocyl-OH.
2. Analytical method. The analytical methods to quantitate residues of acequinocyl and acequinocyl-OH in/on fruit crops, almond nutmeats, and hulls utilize high pressure liquid chromatography (HPLC) using mass spectrometric/molecular size (MS/MS) detection. The analytical method to quantitate acequinocyl and acequinocyl-OH in various animal tissues and milk utilizes the same principles as in the crop method. After cleanup the purified extract is submitted for HPLC analysis using MS/MS detection. The target limit of quantitation (LOQ) for all matrices is 0.01 ppm.
3. Magnitude of residues. The proposed use of acequinocyl calls for a maximum application rate of 2 applications at 0.3 lb active ingredient per acre per application, with a 21-day interval between applications. The pre-harvest interval is 14 days for pome fruit, 7 days for citrus, almond, and pistachio and 1-day for strawberries.
i. Pome fruit. The maximum residues expressed as acequinocyl equivalents were 0.23 ppm in apple and 0.05 in pear. The results of the apple processing study indicated that acequinocyl residues do not concentrate in apple juice but do concentrate in wet apple pomace with a concentration factor of 3.5.
ii. Citrus. The maximum residues expressed as acequinocyl equivalents were 0.18 ppm in oranges, 0.08 ppm in grapefruit and 0.11 ppm in lemons. The results of the orange processing study indicated that acequinocyl residues do not concentrate in orange juice or dry pulp but do concentrate in the orange oil with a concentration factor of 165.
iii. Almonds. All residues in nutmeat were <0.01 ppm (LOQ). The maximum residues expressed as acequinocyl equivalents in hulls was 1.3 ppm.
iv. Strawberry. The maximum residues expressed as acequinocyl equivalents in/on strawberry fruit were 0.36 ppm.
The crop field trial data are adequate to support the proposed tolerances of 0.4 ppm for pome fruit, 0.3 ppm for citrus, 0.01 ppm for almond and pistachio, 1.5 ppm for almond hulls, 1.0 ppm for apple wet pomace, 30 ppm for orange oil and 0.4 ppm for strawberry fruit.
B. Toxicological Profile
1. Acute toxicity. Acequinocyl technical has low acute, dermal and inhalation toxicity in laboratory animals. The oral lethal dose (LD)50 (male and female) in the rat and mouse was >5,000 milligrams/kilogram (mg/kg). The dermal LD50 (male and female) was >2,000 mg/kg. The inhalation lethal concentration (LC)50 was reported as >0.84 milligram/Liter (mg/L). In the eye and dermal irritation studies, acequinocyl technical was not an eye or skin irritant to rabbits and was not a skin sensitizer in guinea pigs.
2. Genotoxicity. Acequinocyl was found to be negative in the Ames reverse mutation, mouse lymphoma, Chinese hamster lung (CHL) chromosome aberration and mouse micronucleus assays.
3. Reproductive and developmental toxicity—i. Rat teratology. Acequinocyl technical was administered by oral gavage to pregnant Sprague Dawley rats at dose levels of 0, 50, 150, 500, or 750 mg/kg/day. Common signs in the descendants included vaginal discharge, pallor, pale eyes, hypoactivity, piloerection, slow or irregular breathing, intra-uterine hemorrhage, and blood stained stomach and/or intestinal contents. Maternal no observed effect level (NOEL) = 150 mg/kg/day based on these signs. Developmental NOEL = 500 mg/kg/day based on increase in certain skeletal variants that may be attributed to the observed maternal toxicity.
ii. Rabbit teratology. Groups of New Zealand white rabbits received acequinocyl technical by gavage at doses of 0, 30, 60, or 120 mg/kg/day. Maternal NOEL = 60 mg/kg/day based on reduction in maternal body weight and 5 females were sacrificed at 120 mg/kg/day. Fetal NOEL = 60 mg/kg/day due to skeletal variations in the thoraco-lumbar ribs.
iii. Rat reproduction study. Acequinocyl technical was fed to 2-generations of male and female Sprague Dawley rats at dietary concentrations of 0, 100, 800, or 1,500 ppm (0, 7.3, 59, or 111 mg/kg/day for males and 0, 8.7, 69, or 134 mg/kg/day for females). Systemic and pup NOEL = 100 ppm (7.3 and 8.7 mg/kg/day).
iv. Systemic. Hemorrhage and swollen body parts were seen at 800 and 1,500 ppm in F1 males. At 800 and 1,500 ppm, treatment-related clinical signs, hemorrhagic effects, subcutaneous bleeding on body parts and/or cranium and/or brain were seen in the F1 pups. At 800 and 1,500 ppm toxicity seen in F2 pups included subcutaneous bleeding on body parts and/or cranium and/or brain at weaning.
4. Subchronic toxicity—i. Rat feeding study. Fischer rats received acequinocyl technical at dietary concentrations of 0, 100, 400, 1,600, or 3,200 ppm (0, 7.57, 30.4, 120, 253 mg/kg/day for males and 0, 8.27, 32.2, 129, 286 mg/kg/day for females respectively) for 13 consecutive weeks. Treatment-related yellow brown urine in all animals of both sexes at 400 ppm suggested the presence of the metabolite of the test material. Macroscopic examination on the surviving animals revealed no treatment-related abnormalities. At 3,200 and 1,600 ppm, macroscopic and microscopic examination of the mortalities revealed hemorrhaging of muscle and other organs. NOEL = 400 ppm (30.4 mg/kg/day for males and 32.2 mg/kg/day for females).
ii. Mouse feeding study. Groups of CD-1 (ICR) BR mice received acequinocyl technical by oral route at concentrations of 0, 100, 500, 1,000, or Start Printed Page 86481,500 ppm (0, 16, 81, 151, 295 mg/kg/day for males and 0, 21, 100, 231, 342 mg/kg/day for females respectively) for 13 weeks. At 100 ppm, there were hepatic histopathological lesions and an increase in relative liver weight. A clear NOEL for both sexes was not determined.
iii. Dog feeding study. Acequinocyl technical was administered via gelatin capsule to male and female Beagle dogs at dose levels of 0, 40, 160, 640, or 1,000 mg/kg/day once a day 7 days a week for 13 weeks. At 40, 160, and 640 mg/kg/day colored feces was observed in both sexes. At 160 and 640 mg/kg/day, treatment-related decrease in body weight gain in males and an increase platelet count for females was observed. Macroscopic and microscopic examinations on the surviving animals revealed no treatment-related abnormalities. A clear NOEL was not determined.
iv. A 28-day dermal toxicity. Groups of Sprague Dawley rats received daily dermal applications of acequinocyl technical at doses of 0, 40, 200, or 1,000 mg/kg/day for 6 hours/day for 28 days followed by a 14-day treatment free period only in the high dose group. There were no macroscopic findings. Red staining occurred on the back of the animals and was only seen in the morning after dosing. There was no evidence of systemic toxicity. NOEL = 1,000 mg/kg/day.
5. Chronic toxicity—i. Dog feeding study. Beagle dogs were dosed by capsule at 0, 5, 20, 80, or 320 mg/kg/day for 1-year with acequinocyl technical. Minor disturbances in platelet counts were observed in both sexes at 80 and 320 mg/kg/day. There were no treatment-related macroscopic histopathological findings. Colored feces and/or abnormally stained sawdust were observed for all treatment groups. Varying degrees of discoloration of the urine was observed for animals receiving 20 mg/kg/day or more. The discoloration was considered to be attributable to a colored metabolite of the test substance. NOEL = 20 mg/kg/day.
ii. Rat feeding/oncogenicity study. Groups of F344 rats received acequinocyl technical at dietary levels of 0, 50, 200, 800, or 1,600 ppm (0, 2.25, 9.02, 36.4, 74.0 mg/kg/day for males and 0, 2.92, 11.6, 46.3, 93.6 mg/kg/day for females respectively) for 2 years. NOEL = 200 ppm (9.02 and 11.6 mg/kg/day for males and females respectively). Corneal abnormalities and hypertrophy of the eye were observed in 800 ppm and 1,600 ppm males and 1,600 ppm females respectively. At 800 ppm and 1,600 ppm, prothrombin time (PT) was observed to be longer in males and shorter in females and activated partial thromboplastin time (APTT) longer in females. Reddish brown urine was observed in both males and females respectively. There was no incidence of tumors.
iii. Mouse oncogenicity study. Acequinocyl technical was administered in the diet of Crl:CD-1(ICR)BR mice at 0, 20, 50, 150, or 500 ppm for 80 weeks. NOEL = 20 ppm (lowest dose tested (LDT) equal to 2.7 and 3.5 mg/kg/day in males and females respectively), based on brown pigmented cells. At 50 and 500 ppm in both sexes, there was an increase incidence of fatty hepatocytes. Other associated findings were increased liver weight, slight increase in pale livers, or pale areas within livers. Glomerular amyloidosis was statistically increased in the 150 and 500 ppm males. Yellow brown urine was consistently found in both sexes at high dose. There was no increase in the incidence of tumors.
6. Animal metabolism. Sprague Dawley rats were dosed orally with acequinocyl labeled 14C-phenyl or 14C-dodecyl. Both labels were used in the single low dose (10 mg/kg) study. The high dose (500 mg/kg) and 14-day repeat dose studies (10 mg/kg/day) were conducted with 14C-phenyl acequinocyl only. Excretion was rapid, with most of the dose in the feces. Less than 15% of the radioactivity was found in the urine. Absorption was about 25-42% based on the bile duct cannulation studies, which found 20-33% of the administered dose in bile, plus 5-9% in urine plus cage wash. Acequinocyl was not detected in urine and was only a minor component (1-2%) in the feces. The major fecal metabolite (12-36%) was the 2-hydroxy-3-dodecyl-1,4-naphthalenedione (acequinocyl-OH or designated R1). Subsequent oxidation of the dodecyl chain yielded butanoic and hexanoic acids, the only measurable identified urinary metabolites. 2-(1,2-dioxotetradecyl)-benzoic acid comprised 19-40% of the radioactivity in the feces. There were no remarkable differences in metabolite disposition due to gender and no effect of pre-dosing for 2 weeks. The large dose slowed transit time and reduced absorption.
7. Metabolite toxicology. The toxicity of acequinocyl-OH is concurrently evaluated during toxicity testing because this metabolite is both a plant and animal metabolite and is formed in the course of toxicity tests and is considered not of toxicological concern.
8. Endocrine disruption. A standard battery of toxicity tests have been conducted on acequinocyl. No effects were seen to indicate that acequinocyl has an effect on the endocrine system.
C. Aggregate Exposure
1. Dietary exposure. Acute and chronic risk assessments were conducted to assess dietary exposures from acequinocyl in food using dietary exposure evaluation model (DEEM) and the following input parameters: Tolerance level residues (including a residue value of 0.3 ppm for citrus dry pulp); consumption data from the United States Department of Agriculture (USDA) 1994-1998 Continuing Survey of Food Intakes by Individuals (CSFII); 100% crop treated for all commodities; default processing factors for all commodities; acute toxicological endpoint of 30.4 mg/kg body weight (bwt) no observed adverse effect level (NOAEL); 0.304 mg/kg bwt acute reference dose (RfD) from the 90-day rat subchronic study; chronic toxicological endpoint of 2.7 mg/kg bwt NOAEL; 0.027 mg/kg bwt (chronic RfD) from the chronic mouse study.
i. Food. Acute dietary food exposure estimates to acequinocyl were less than 100% of acute RfD for the total U.S. population at 2.21%, females 13-50 years at 1.43%, all infants (<1 year) at 4.81%, children 1 to 6 years at 6.33%. The most highly exposed population was children 1 to 3 years at 8.18%. The chronic dietary food exposure estimates to acequinocyl are less than 100% of chronic RfD for the total U.S. population at 5.6%, females 13-50 years at 3.0%, all infants (<1 year) at 12.4%. The most highly exposed population was children 1 to 6 years at 21.2%.
ii. Drinking water. The available environmental fate data indicate that acequinocyl does not persist in the environment nor does it have the ability to leach into ground water resources. Acequinocyl degrades rapidly in the environment. Aqueous photolysis T1/2: 14 minutes, soil photolysis T1/2: 2 days, aerobic soil metabolism (4 soils) T1/2: <3 days, aerobic aquatic metabolism T1/2: 0.39 day in water and sediment, hydrolysis T1/2: pH4 = 74 days, pH7 = 2.2 days, pH9 = 1.3 hours. Acequinocyl shows low soil mobility. Based on First Index Reservoir Screening Tool (FIRST) and screening concentration in ground water (SCI-GROW) models, for acute exposures, the drinking water estimated concentration (DWEC) of acequinocyl is estimated to be 1.561 parts per billion (ppb) for surface water and 0.006 ppb for ground water. The acute DWEC of 1.561 ppb is the peak day FIRST concentration. The DWEC for chronic exposures is estimated to be 0.024 ppb for surface water and 0.006 ppb for ground water. The chronic DWEC of Start Printed Page 86490.024 ppb is the annual average FIRST concentration. To determine drinking water exposure, drinking water levels of comparison (DWLOCs) were calculated and used as a point of comparison against the model estimates of the pesticide concentration in drinking water. For acequinocyl, the acute and chronic DWLOC values were greater than the estimated concentration DWEC in surface water and ground water for each population group. Therefore, exposures to acequinocyl in drinking water do not pose a significant human health risk.
2. Non-dietary exposure. There are no residential uses for acequinocyl.
D. Cumulative Effects
There is no information available to indicate that toxic effects produced by acequinocyl are cumulative with those of any other compound.
E. Safety Determination
1. U.S. population. The acute dietary food exposure to acequinocyl was estimated at 2.21% of acute RfD for the total U.S. population. The calculated DWLOCs ranged from 2,791 to 10,405 ppb for all the population subgroups. The surface water and ground water DWECs for acequinocyl were estimated to be 1.561 ppb and 0.006 ppb, respectively. Since the acute DWECs are less than the DWLOCs for all population subgroups, the acute aggregate risk estimates are below the level of concern. The chronic dietary food exposure to acequinocyl was estimated at 5.6% of chronic RfD for total U.S. population. The calculated DWLOCs ranged from 213 to 892 ppb for all the population subgroups. The surface water and ground water DWECs for acequinocyl were estimated to be 0.024 ppb and 0.006 ppb, respectively. Since the chronic DWECs are less than the DWLOCs for all population subgroups, the chronic aggregate risk estimates are below the level of concern.
2. Infants and children. The acute dietary food exposure to acequinocyl was estimated at 4.81% of acute RfD for all infants (<1 year), 6.33% of acute RfD for children 1 to 6 and 8.18% of acute RfD for children 1 to 2 (most highly exposed). The calculated DWLOCs ranged from 2,791 to 10,405 ppb for all the population subgroups. The surface water and ground water DWECs for acequinocyl were estimated to be 1.561 ppb and 0.006 ppb, respectively. Since the acute DWECs are less than the DWLOCs for all population subgroups including infants, the acute aggregate risk estimates are below the level of concern. The chronic dietary food exposure to acequinocyl was estimated at 12.4% of chronic RfD for all infants (<1 year), and 21.2% of chronic RfD for children 1 to 6 (most highly exposed). The calculated DWLOCs ranged from 213 to 892 ppb for all the population subgroups. The surface water and ground water DWECs for acequinocyl were estimated to be 0.024 ppb and 0.006 ppb, respectively. Since the chronic DWECs are less than the DWLOCs for all population subgroups including infants, the chronic aggregate risk estimates are below the level of concern.
F. International Tolerances
To date, no Codex, Canadian or Mexican tolerances exists for acequinocyl.End Supplemental Information
[FR Doc. 04-3936 Filed 2-24-04; 8:45 am]
BILLING CODE 6560-50-S