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Aminopyralid; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
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[Federal Register: June 2, 2004 (Volume 69, Number 106)] [Notices] [Page 31106-31110] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr02jn04-52] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-2004-0139; FRL-7359-3] Aminopyralid; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: 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. DATES: Comments, identified by docket ID number OPP-2004-0139, must be received on or before July 2, 2004. ADDRESSES: 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. FOR FURTHER INFORMATION CONTACT: Joanne Miller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-6224; e-mail address: Miller.Joanne@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultual producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: ? Crop production (NAICS code 110) ? Animal production (NAICS code 112) ? Food manufacturing (NAICS code 311) ? Pesticide manufacturing (NAICS code 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-2004-0139. 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.regulations.gov/ 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 [[Page 31107]] 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-2004-0139. 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 opp-docket@epa.gov, Attention: Docket ID number OPP-2004-0139. 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-2004-0139. 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-2004-0139. 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 [[Page 31108]] 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. List of Subjects Environmental protection, Agricultural commodities, Feed additives, Food additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 14, 2004. Betty Shackleford, Director, Registration Division, Office of Pesticide Programs. Summary of Petition The petitioner's summary of the pesticide petition is printed below as required by FFDCA section 408(d)(3). The summary of the petition was prepared by Dow AgroScience, LLC 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. Dow AgroSciences, LLC PP 7F4851 EPA has received a pesticide petition PP 7F4851 from Dow AgroSciences, LLC 9330 Zionsville Road, Indianapolis, IN 46268 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 combined residues of aminopyralid (XDE-750: 4-amino-3,6- dichloropyridine-2-carboxylic acid) and its glucose conjugate, expressed as total parent in or on the raw agricultural commodity grass forage at 25 parts per million (ppm), grass hay at 65 ppm, wheat forage at 2 ppm, wheat hay at 4 ppm, wheat grain at 0.05 ppm, wheat straw at 0.5 ppm, wheat bran at 0.1 ppm, wheat middlings at 0.02 ppm, wheat shorts at 0.05 ppm, wheat flour at 0.01 ppm, wheat germ at 0.02 ppm, wheat aspirated grain fractions at 0.5 ppm. Tolerances of the parent, aminopyralid (free) are also proposed for milk at 0.02 ppm, cream at 0.02 ppm, edible animal tissues except kidney at 0.05 ppm and kidney at 1.0 ppm. EPA has determined that the petition contains data or information regarding the elements set forth in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the petition. Additional data may be needed before EPA rules on the petition. A. Residue Chemistry 1. Plant metabolism. The nature of the residue in plants (grass and wheat) and in animals is adequately understood for the purpose of this tolerance. Based on the findings from these metabolism studies, the residues of concern in grass and wheat are the combined residues of aminopyralid and its glucose conjugates, expressed as the total parent. In animal commodities, the residue of concern is only the parent, aminopyralid (free). 2. Analytical method. Adequate analytical methods for enforcement purposes are available to monitor residues of aminopyralid in grass and wheat commodities, milk, meat and meat by-products. The analytical method uses liquid chromatography and positive ion electrospray tandem spectrometry (LC/MS/MS) with limits of quantitation (LOQ) of 0.01 ppm. The methods had been successfully validated independently by outside laboratories. Aminopyralid had also been tested through the Food and Drug Administration (FDA), Multi-residue Methodology, Protocols C, D, and E. 3. Magnitude of residues. Geographically representative field trials were conducted on grass pasture and wheat according to use patterns to support the proposed tolerances in these commodities. In addition, wheat processing and cow feeding studies were conducted to determine transfer of residues into wheat processed products, milk, meat and meat by-products. The proposed tolerances in grass and wheat commodities and in milk, meat and meat by-products are adequate to cover the highest residues from the maximum label use of aminopyralid in grass pasture and wheat. B. Toxicological Profile 1. Acute toxicity. Aminopyralid has low acute toxicity. The rat oral lethal dose (LD)50 is >5,000 milligrams/kilogram (mg/ kg) and the rat inhalation LC50 is >5.5 milligrams per liter (mg/L). In addition, aminopyralid is not a dermal sensitizer in guinea pigs, has no dermal irritation in rabbits, and shows ocular irritation in rabbits. 2. Genotoxicty. Short-term assays for genotoxicity consisting of a bacterial reverse mutation assay (Ames test), an in vitro assay for cytogenetic damage using the Chinese hamster ovary cells, an in vitro chromosomal aberration assay using rat lymphocytes, and an in vitro cytogenetic assay in the mouse bone marrow (micronucleus test) have been conducted with aminopyralid. Taken together, these studies show a lack of genotoxicity. 3. Reproductive and developmental toxicity. Developmental studies in rats and rabbits were conducted with aminopyralid. Studies with aminopyralid showed maternal no observed effect levels (NOELs) of 1,000 milligrams/kilogram/day (mg/kg/day) (rat) and 250 mg/kg/day (rabbit) and fetal NOELs of 1,000 mg/kg/day (rat) and 500 mg/kg/day (rabbit). These studies show that aminopyralid is not teratogenic nor will it interfere with in utero development. A multi-generation reproduction study conducted with aminopyralid in Sprague-Dawley rats showed a NOEL for reproductive effects of 1,000 mg/kg/day for males and 1,000 females (highest dose tested). The NOEL for neonatal effects was also 1,000 mg/ kg/day. 4. Subchronic toxicity. Aminopyralid showed a NOEL of 100 mg/kg/day in a 28-day rat dermal study. 90-day feeding studies with aminopyralid showed NOELs of 100 mg/kg/day in Fischer 344 rats, 257 mg/kg/day in Beagle dogs, and 1,000 mg/kg/day in CD-1 mice. 5. Chronic toxicity. Based on chronic testing with aminopyralid in the mouse, dog, and rat, a reference dose (RfD) of 0.5 mg/kg/day is proposed. The RfD has incorporated a 100-fold safety factor to the NOEL found in the rat chronic test. NOELs found in the chronic dietary studies are as follows: 96 mg/kg/day (male and female dogs), 250 mg/kg/ day in female mice and 1,000 mg/kg/day in male mice, and 50 mg/kg/day in male Fischer 344 rats and 500 mg/kg/day in female Fischer 344 rats. 6. Animal metabolism. Aminopyralid has been evaluated in a rat metabolism study. In summary, this study shows that aminopyralid is efficiently cleared through the urine and feces with an average of 74- 93% of the administered radioactivity excreted during the first 24- hours post-dose administration. Aminopyralid is rapidly absorbed and urinary and fecal elimination totaled 41-59 and 33-43% of the administered dose, respectively. Analysis of excreted material indicate no evidence of metabolism. Repeated administration of aminopyralid was not associated with accumulation in tissues. 7. Metabolite toxicology. No mammalian metabolites of aminopyralid [[Page 31109]] have been identified in the rat metabolism study. Nature of residue studies in wheat and grass (three species) revealed the presence of unchanged parent aminopyralid and glucose conjugates of aminopyralid. 8. Endocrine disruption. There is no evidence to suggest that aminopyralid has an effect on any endocrine system. C. Aggregate Exposure 1. Dietary exposure--i. Food. In conducting the potential dietary exposure and risk assessments, Dow AgroSciences used the Dietary Exposure Evaluation Model (DEEM), Version 7.87, Exponent) software that evaluated the individual food consumption as reported by respondents in the United States Department of Agriculture 1994-1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII). The dietary exposure assessment was performed using a conservative approach (Tier I) wherein the estimated theoretical maximum residue contribution (TMRC) was based on the assumptions that 100% of the crops were treated with aminopyralid and the residues were present at the proposed tolerance levels. The chronic population adjusted dose (cPAD) used was 0.50 mg/kg/ day based on a NOEL of 50 mg/kg/day from a 2-year combined chronic feeding/carcinogenicity rat study and an uncertainty factor of 100 (10 for intraspecies variation x 10 for interspecies variation). No additional FQPA safety factor is required. For the U.S. general population, the theoretical maximum residue contribution (TMRC) was estimated to be 0.000237 milligrams/kilogram (mg/kg/day) that utilized less than 0.1% of the chronic population adjusted dose (cPAD). The population subgroup with the highest potential exposure is children 1-2 years old with a TMRC of 0.000933 mg/kg/day that represents only 0.2% of the cPAD. The percent of the cPAD is significantly below the acceptable 100%, therefore, demonstrates no chronic dietary concern. No appropriate toxicological endpoint attributable to a single exposure was identified in the available toxicological studies on aminopyralid. Thus, the risk from acute exposure is considered negligible and no acute risk assessment was performed. ii. Drinking water. No monitoring exposure data are available to complete a comprehensive dietary exposure analysis and risk assessment for aminopyralid in drinking water. Guidance from EPA has indicated that Tier 1 screening level models, such as generic expected environmental concentration (GENEEC) and screening concentration in ground water (SCI-GROW), maybe used to estimate upper-bound pesticide residues in surface water and ground water when assessing potential exposure through drinking water. Estimated environmental concentrations (EEC) of pesticide in surface water or ground water are then compared to a drinking water level of comparison (DWLOC). DWLOC is not a regulatory standard for drinking water but a theoretical upper limit on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and from residential uses. DWLOC determines how much of the acceptable exposure PAD is available for exposure through drinking water. In calculating DWLOC, default values for body weights and water consumption were used: 2 Liter/70 kilogram (2L/70 kg) adult male, 2L/60 kg adult female and 1L/10 kg child. The concentration of aminopyralid in surface water using GENEEC is 4.4 [mu]g/L. For ground water, the estimated concentration by SCI-GROW is 1.6 [mu]g/L. As shown below the EECs in surface water and ground water are substantially below the DWLOC. Therefore, exposure to aminopyralid in drinking water would not result in unacceptable levels of aggregate human health risk. 2. Non-dietary exposure. Aminopyralid is not currently registered for use on any sites that would result in residential exposure. Therefore, considerations of aggregate exposure to aminopyralid will not include non-dietary or residential exposures. ------------------------------------------------------------------------------------------------------ cPAD/milligrams/ EEC [mu]g/Liter ([mu]g/L) Population Group kilogram body weight/ Dietary DWLOCb ----------------------------- day (mg/kg bwt/day) Exposurea Surface water Ground water ------------------------------------------------------------------------------------------------------ U.S. population (total) 0.50 0.000237 17492 4.4 1.6 --------------------------- All infants (< 1 year old) 0.50 0.000270 4997 4.4 1.6 --------------------------- Children (1-2 years old) 0.50 0.000933 4991 4.4 1.6 --------------------------- Females (13-49 years old) 0.50 0.000145 14996 4.4 1.6 ------------------------------------------------------------------------------------------------------ a From DEEM Analysis. b DWLOC = (cPAD - Dietary Exposure) x Body weight, kg/Drinking water consumption, L x 1,000. D. Cumulative Effects At this time, no data are available to determine whether aminopyralid has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, aminopyralid does not appear to produce a common toxic metabolite generated by other substances. For purposes of this tolerance action, therefore, it is assumed that aminopyralid does not have a mechanism of toxicity common with other substances. E. Safety Determination 1. U.S. population. Using the above conservative exposure assumptions, aggregate exposure to aminopyralid from the proposed tolerances in wheat and animal commodities will utilize less than 0.1% of the cPAD for the general U.S. population. The population subgroup with the highest exposure of 0.2% of the cPAD is children 1-2 years old. Generally, EPA has no concern for exposures below 100% of the cPAD because the cPAD represents the level at or below which daily aggregate dietary exposures over a lifetime will not pose appreciable risks to human health. No endpoint of concern was identified to quantitate acute-dietary risk to the general population, therefore, acute risk exposure is considered to be negligible. Additionally, the potential contribution of aminopyralid residues in drinking water to aggregate exposure is expected to be minimal. Calculated DWLOCs for assessing aggregate dietary risk ranged from 4991 [mu]g/L children 1-2 years old to 1,7492 [mu]g/L; U.S. population which are more than 4,000-10,000 greater than the potential environmental water concentration. Therefore, based on these risk assessments, Dow AgroSciences concludes, that there is reasonable [[Page 31110]] certainty that no harm will result to the U.S. population from aggregate exposure to aminopyralid residues. 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 aminopyralid relative to prenatal and postnatal effects for children is complete. Overall, aminopyralid had no effect on reproduction or embryo-fetal development at any dosage tested. No quantitative or qualitative susceptibility was seen following prenatal and postnatal exposures. In a 2-generation reproductive toxicity study in rats, no effects on reproductive performance or neonatal development were observed. Dow AgroSciences concluded that there is no indication of increased sensitivity of infants and children relative to adults and that no additional Food Quality Protection Act (FQPA) safety factor is required. Using the above conservative assumptions, aggregate exposure to aminopyralid will utilize only 0.1% of the cPAD for all infants < 1 year old, 0.2% of the cPAD for children 1-2 years old and 0.1% of the cPAD for children 6-12 years old. Even when considering the potential exposure to drinking water, the aggregate exposure is not expected to exceed 100% of the cPAD. Therefore, based on the completeness and reliability of the toxicity data and the conservative exposure assessment, Dow AgroSciences concludes, with reasonable certainty that no harm will result to infants and children from the aggregate exposure to aminopyralid residues. F. International Tolerances No Codex maximum residue levels are established for residues of aminopyralid on any food or feed crop. Therefore, no compatibility problems exist for the proposed tolerances. [FR Doc. 04-12020 Filed 6-1-04; 8:45 am] BILLING CODE 6560-50-S