[Federal Register: September 23, 1998 (Volume 63, Number 184)] [Notices] [Page 50903-50906] >From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr23se98-69] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [PF-833; FRL-6026-1] Notice of Filing of Pesticide Petitions AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the initial filing of pesticide petitions proposing the establishment of regulations for residues of certain pesticide chemicals in or on various food commodities. DATES: Comments, identified by the docket control number PF-833, must be received on or before October 23, 1998. ADDRESSES: By mail submit written comments to: Public Information and Records Integrity Branch (7502C), Information Resources and Services Division, Office of Pesticides Programs, [[Page 50904]] Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person bring comments to: Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA. Comments and data may also be submitted electronically to: opp- email@example.com. Follow the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential business information should be submitted through e-mail. Information submitted as a comment concerning this document may be claimed confidential by marking any part or all of that information as ``Confidential Business Information'' (CBI). CBI should not be submitted through e-mail. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. All written comments will be available for public inspection in Rm. 119 at the address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. FOR FURTHER INFORMATION CONTACT: The Regulatory Action Leader listed in the table below: ------------------------------------------------------------------------ Office location/ Regulatory Action Leader telephone number Address ------------------------------------------------------------------------ Diana Horne................... 9th Floor, CM #2, 703- 1921 Jefferson 308-8367, e-mail: Davis Hwy, firstname.lastname@example.org Arlington, VA pa.gov. Sheila A. Moats............... 9th Floor, CM #2, 703- Do. 308-1259, e-mail: moats.sheila@epamail. epa.gov. ------------------------------------------------------------------------ SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as follows proposing the establishment and/or amendment of regulations for residues of certain pesticide chemicals in or on various food commodities under section 408 of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions contain data or information regarding the elements set forth in section 408(d)(2); 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. The official record for this notice of filing, as well as the public version, has been established for this notice of filing under docket control number [PF-833] (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The official record is located at the address in ``ADDRESSES'' at the beginning of this document. Electronic comments can be sent directly to EPA at: email@example.com Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comment and data will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file format. All comments and data in electronic form must be identified by the docket control number [PF-833] and appropriate petition number. Electronic comments on this notice may be filed online at many Federal Depository Libraries. List of Subjects Environmental protection, Agricultural commodities, Food additives, Feed additives, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 8, 1998. Kathleen D. Knox, Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs. Summaries of Petitions Petitioner summaries of the pesticide petitions are printed below as required by section 408(d)(3) of the FFDCA. The summaries of the petitions were prepared by the petitioners and represent the views of the petitioners. EPA is publishing the petition summaries verbatim without editing them in any way. 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. 2. Stoller Enterprises, Inc. PP 8F4960 EPA has received a pesticide petition (PP 8F4960) from Stoller Enterprises, Inc., 8580 Katy Freeway, Suite 200, Houston, Texas 70024, proposing pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for the biochemical pesticide, salicylic acid, in or on all raw agricultural commodities. Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Stoller Enterprises, Inc. has submitted the following summary of information, data and arguments in support of their pesticide petition. This summary was prepared by Stoller Enterprises, Inc. and EPA has not fully evaluated the merits of the petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary was not clear that it reflected the conclusion of the petitioner and not necessarily EPA. A. Product Name and Proposed Use Practices Salicylic acid will be incorporated into the end-use product, Adjust I, as an active ingredient. Adjust I is proposed [[Page 50906]] for use on a variety of agricultural, horticultural, and floricultural applications to enhance plant defense against pathogens. Depending on the crop, the first application of Adjust I is made at the 3-5 leaf stage or other prescribed growth stage. Subsequent applications may be made at 12-day intervals. The rate is 2 quarts of formulated product/acre per treatment. This equates to the application of 20 grams/acre salicylic acid. B. Product Identity/Chemistry 1. Identity of the pesticide and corresponding residues. Salicylic acid is a phenolic acid found in insects and plants as free acid or bound. The biochemical is a white, practically odorless, free-flowing crystalline powder. It is slightly soluble in water, forming acidic solutions. 2. Magnitude of the residue at time of harvest and method used to determine residue. An analytical method using High Performance Liquid Chromatography (HPLC), UV spectrophotometery, and Gas Chromatography for determining salicylic acid content in Adjust I is available. 3. A statement of why an analytical method for detecting the levels and measuring of the pesticide residue is not needed. Because this phenolic acid is found naturally in plants, residue analysis would not yield meaningful results, i.e., the analysis would not discern whether the salicylic acid source was the plant or from treatment. Additionally, phenolic levels harmful to plants and animals are highly unlikely to occur when the product is applied according to label instructions. C. Mammalian Toxicological Profile Salicylic acid is highly regulated in man and other organisms, the mechanisms of which are well understood. Salicylic acid has been administered to numerous species in long term dietary studies without adverse effects at a range of concentrations. The end-use product containing salicylic acid, Adjust I, has been evaluated for acute toxicity. Acute oral toxicity in rats is greater than 3,000 milligrams/ kilogram (mg/kg) (Toxicity Category III). Acute dermal toxicity in rabbits is greater than 5,050 mg/kg (Toxicity Category III). In an eye irritation study, there were no signs of irritation following administration of Adjust I (Toxicity Category IV). A rabbit dermal irritation study with Adjust I resulted in no signs of irritation (Toxicity Category IV). There was no indication of dermal sensitization in a guinea pig dermal sensitization study. Waivers have been requested for genotoxicity, reproductive and developmental toxicity, subchronic toxicity, chronic toxicity, and acute toxicity to nontarget species based on salicylic acid's ubiquity in nature, long history of medicinal uses, favorable toxicological profile in chronic toxicology studies, and inconsequential exposure resulting from label-directed use rates. D. Aggregate Exposure 1. Dietary exposure-- Food. Salicylic acid is ubiquitous in nature and is found in lower and higher plant species, insects, cosmetics, over-the-counter medications and natural and processed foods. Many items in the human daily diet contain appreciable quantities of free and bound salicylic acid. Dietary exposure due to topical applications of salicylic acid is difficult to estimate because of the phenolic acid's prevalence in skin care products and over-the-counter medications. Considering the low dose of salicylic acid required to achieve the desired effect, the levels of salicylic acid found naturally in the diet and the quantity consumed from processed foods, it can be concluded that incremental dietary exposure to salicylic acid resulting from Adjust I applications is negligible. 2. Drinking water. The active ingredient, salicylic acid, decomposes readily in water and sunlight. The oxidation reactions of ultraviolet radiation/H<INF>2</INF>0<INF>2</INF>/O<INF>2</INF> with either phenol or salicylic acid successfully degrade those compounds, which are building blocks of aquatic humic substances. Many compounds, including salicylic acid, have been identified by means of spectroscopy and chromatography. The degradation pathway is thought to involve hydroxylation of the aromatic ring and abstraction of a hydrogen atom to form 1,2-benzoquinone, which is cleaved to form muconic acid. The muconic acid is converted to maleic acid, fumaric acid, and oxalic acid. Fumaric and maleic acids eventually become malic acid, and the oxalic acid is degraded to formic acid and then CO<INF>2</INF>. These reactions demonstrate how phenolics substances are converted to biodegradable ones. 3. Non-dietary exposure. Adjust I is proposed for use on non- residential turf and ornamentals. Exposure from turf grass applications is expected to be minimal because turf users will be protected by shoes and socks. Further, based on the limited frequency of use on turf grass, this non-food use is not likely to result in potential chronic exposure and thus should not be factored into a chronic exposure assessment. Exposures resulting from application to ornamentals is also anticipated to be negligible because consumers normally will not be in contact with treated plants. E. Cumulative Exposure Salicylic acid is highly regulated in plants and mammals, the mechanisms of which are well understood. This phenolic acid is not intended for pesticidal use and does not share a common mechanism of toxicity with currently available pesticides, thus Adjust I anticipate no cumulative effects with other substances. F. Safety Determination 1. U.S. population. Because the use of salicylic acid will be delivered at label rates concentrations that are less than or equal to those found in plants, and because the active ingredient has a favorable toxicological profile, the use of the salicylic acid when delivered at label rates poses a negligible, or nonexistent, risk to the U.S. population. 2. Infants and children. Salicylic acid and its conjugates, esters, and metabolites are ingested and excreted daily. The compound and its analogs are ubiquitous in the food chain. When used at label rates, the product poses no threat to infants and children. In fact as the product replaces existing fungicides with less favorable toxicological profiles the risk to infants and children will be reduced. G. Effects on the Immune and Endocrine Systems There is no literature available to suggest the immune or endocrine systems will be compromised with the use of salicylic acid as an active ingredient at recommended rates. H. Existing Tolerances There are no known existing tolerances for the use of salicylic acid for use as a pesticide. I. International Tolerances There are no CODEX tolerances or international tolerance exemptions for salicylic acid at this time. [FR Doc. 98-25315 Filed 9-22-98; 8:45 am] BILLING CODE 6560-50-F
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