fludioxonil + metalaxil

Table 1.— Subchronic, Chronic, and Other Toxicity. The telephone number for the Office of the Hearing Clerk is (202) 260-4865. This table of contents is a navigational tool, processed from the A Q * is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 × 10-6 or one in a million). | Botrytis Cinerea, Resistance and Tomato | ResearchGate, the . The emergence. The findings in the rat developmental toxicity studies were considered to be related to maternal toxicity, rather than an indication of increased susceptibility. Fludioxonil is a kind of novel protection type sterilant of tagging, and its mechanism of action is unique, by the transfer suppressing glucose phosphorylated relevant, suppresses the mycelial growth of pathogenic bacteria, finally causes the death of germ.The diseases such as when flowers are applied, main control leaf is withered, tikka, part stem rot, root-rot.Easy to use, foliar spray and . Exemption From Certain Prohibited Transaction Restrictions Involving JPMorgan Chase Co. Privacy | Terms All content posted on this site is commentary or opinion and is protected under Free Speech. LOAEL = 1,000 mg/kg/day based on reduction in corrected weight gain. Empirical Formula (Hill Notation): C 12 H 6 F 2 N 2 O 2. Glucophage – uses, health risks, and side effects at NaturalPedia.com, Norvasc – uses, health risks, and side effects at NaturalPedia.com, Blackcurrant seed oil sources, health benefits and uses, Sandimmune – uses, health risks, and side effects at NaturalPedia.com, Liver necrosis, centrilobular hypertrophy, increased serum cholesterol and 5 ‘nucleotidase, Nephropathy, inflammation, cysts in the kidneys. Fludioxonil inhibits transport-associated phosphorylation of glucose as well as preventing glycerol synthesis. The Agency has established an official record for this action under docket control number OPP-301093. include documents scheduled for later issues, at the request Animal tests reveal the following side effects of experimental doses of fludioxonil: Fludioxonil is also known be very toxic to aquatic life with long-term effects. Fludioxonil is persistent and may carryover. LOAEL = 113 mg/kg/day (M) and 141 mg/kg/day (F) based on decreased mean body weight gain, slight anemia (F), and increased incidence and severity of liver lesions (degeneration) in both sexes. The report on Fludioxonil Market provides qualitative as well as quantitative analysis in terms of market dynamics, competition scenarios, opportunity analysis, market growth, etc. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. Fludioxonil directly inhibited TPI and also caused it to release methylglyoxal in vitro. Fludioxonil CAS No. Its effectiveness is reflected in the dramatic increase in its production/usage since its introduction in 1994, an increase that has peaked in recent years as it became . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Compare Product No. To estimate risk, a ratio of the point of departure to exposure (MOEcancer = point of departure/exposures) is calculated. Document Drafting Handbook for better understanding how a document is structured but This regulation establishes tolerances for residues of fludioxonil 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1 H-pyrrole-3-carbonitrile in or on grapes, strawberries, dry bulb onions, and green onions. In addition, several Section 18 emergency exemptions for use as a foliar spray on strawberries, caneberries and as a post-harvest spray treatment on apricots, nectarines, peaches, and plums have . Cymoxanil + Fludioxonil + Metalaxyl-M. 16.11.2022 bis 15.03.2023. gegen Fusarium-Arten, Botrytis cinerea, Falschen Mehltau (Peronospora pisi), Brennfleckenkrankheit (Ascochyta pisi . Federal Register issue. Cancer. To ensure proper receipt by EPA, you must identify docket control number OPP-301093 on the subject line on the first page of your submission. Fludioxonil is an odorless, colorless to yellowish synthetic compound of the phenylpyrrole group of substances. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. documents in the last year, 829 The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 5: Table 5.—Aggregate Risk Assessment for Intermediate-Term Exposure to Fludioxonil. The data submitted in support of the intended northern Europe (NEU) outdoor and EU indoor . 601 et seq.) Electronically. Please follow the detailed instructions for each method as provided in Unit VI of the SUPPLEMENTARY INFORMATION. Fludioxonil is an effective fungicide widely used for crop protection and is effective against tomato gray mold. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to fludioxonil residues. Introduction: Fludioxonil is a synthetic phenylpyrrole-group substance. This feature is not available for this document. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Observe buffer zones specified under DIRECTIONS FOR USE. Bioz Stars score: 86/100, based on 1 PubMed citations. Short-term non-dietary oral exposures for toddlers were not assessed since the acute dietary endpoint for fludioxonil is only relevant for females 13-50 years old. 01/10/2023, 162 A model is proposed for the interactions between the G . DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. Until the ACFR grants it official status, the XML On the other hand, there was no evidence of carcinogenic potential with fludioxonil in the study in rat models. There are no chemical-specific data available to determine the potential risks from post-application activities associated with the proposed uses of fludioxonil. documents in the last year, 38 From non-dietary exposure. 10.1 Future Forecast of the Global Fludioxonil Market from 2022-2028 Segment by Region 10.2 Global Fludioxonil Production and Growth Rate Forecast by Type (2022-2028) 10.3 Global Fludioxonil . Initial screening of eleven fungicides (prochloraz, fludioxonil, tebuconazole, penconazole, difenoconazole, tebuconazole, myclobutanil, carbendazim, boscalid + pyraclostrobin, metconazole, flusilazole) showed that fludioxonil was the most effective fungicide against L. theobromae and L. pseudotheobromae in vitro (data not shown). Objections and requests for hearings, identified by docket control number OPP-301093, must be received by EPA on or before February 27, 2001. The PIRIB telephone number is (703) 305-5805. It is not an official legal edition of the Federal The public version of the official record does not include any information claimed as CBI. You may also submit an electronic copy of your request at many Federal Depository Libraries. In case of direct contact, immediately flush contaminated eyes with running water for a few minutes. electronic version on GPO’s govinfo.gov. Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various Start Printed Page 82937levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. Su actividad es por contacto que impide la germinación de conidias y el crecimiento del tubo germinativo y del micelio. 1. Each document posted on the site includes a link to the Druh Fungicid Účinná látka je obsažena v přípravcích BARITON SUPER CELEST 025 FS CELEST EXTRA FORMULA M CELEST TRIO FORMULA M DIFEND EXTRA FLUARTO 050 FS FLUTRIX 050 FS GEOXE 50 WG KINTO PLUS LATIFAM EXTRA MAXIM STAR 025 FS POMAX PREPPER SEEDRON Fludioxonil prevents the transport of any glucose material, which ceases fungal growth, its ability to absorb nutrients, and causes fungal spores to quickly absorb moisture until it explodes. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The well was installed in 2014 as a replacement for a well on the same property, and the previous well on the property tested negative for fludioxonil in 2014 (the only year it had been sampled for fludioxonil). Information about Product Registrations and Transfers. Therefore, 40 CFR chapter I is amended as follows: 1. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, fludioxonil does not appear to produce a toxic metabolite produced by other substances. In aggregating short-term risk, the Agency considers background chronic dietary exposure (food + drinking water) and short-term inhalation and dermal exposures from residential uses. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. When Will the Agency Grant a Request for a Hearing? However, the period for filing objections is now 60 days, rather than 30 days. They are used to treat seeds before planting, and are applied to vines to prevent the growth of grey mould, caus. LOAEL = 35.5 mg/kg/day (F) and 297.8 mg/kg/day (M) based upon decreased weight gain (F) and decreased body weight, reduction in hematological parameters (platelets), increase in cholesterol and alkaline phosphatase, and increased relative liver weight (M), Combined Chronic Toxicity/Carcinogenicity in rats, NOAEL = 37 mg/kg/day (M) and 44 mg/kg/day (F). There was no significant increase in the frequency of chromosome aberrations in bone marrow at any dose tested. Fludioxonil 95% TC. What Do I Need to Do to File an Objection or Request a Hearing? offers a preview of documents scheduled to appear in the next day's For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997). 00-33168 Filed 12-28-00; 8:45 am], updated on 4:15 PM on Tuesday, January 10, 2023, updated on 8:45 AM on Tuesday, January 10, 2023. The petition requested that 40 CFR 180.516 be amended by establishing tolerances for residues of the fungicide fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1 H-pyrrole-3- carbonitrile, in or on strawberries at 2.0 ppm; dry bulb onion; great-headed garlic; shallot; and welsh onion at 0.2 ppm; green onion and leek at 7.0 ppm; and stone fruit group at 2.0 ppm. | Botrytis Cinerea, Resistance and Tomato | ResearchGate, the . It can be used to control fungal disease, making it a useful seed treatment as well as a post-harvest treatment for fruit. If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Positive for nondisjunction of chromosomes both in the presence and absence of activation. This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. on Office location and telephone number: Rm. Es sistémico y alterara la síntesis de algunos aminoácidos. documents in the last year, 950 A. for the forecast year up to 2029. There is no Inactive Alternate Brand Name. Filing the request. By mail: Mary Waller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-9354; and e-mail address: [email protected]. Together these findings reveals that the sensitivity to fludioxonil is not only positively controlled by the Hog1 pathway, but also mediated by the Chk1, Mps1, Cga1 and Cgb1 pathways. The EPA classified Fludioxonil as a Group D - not classifiable as to human carcinogenicity. Please identify the fee submission by labeling it “Tolerance Petition Fees.”. documents in the last year, 27 Fludioxonil is a synthetic phenylpyrrole-group substance. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. To examine the cell viability, Jurkat T cells and Ramos B cells were treated with fludioxonil (10 -9 -10 -5 M) for 24 h and 48 h. 01/10/2023, 246 A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). ii. Vangard WG offers systemic, long-lasting protection against a wide range of fungal diseases in a variety of crops both before and after infection. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. The registrant has proposed high performance liquid chromatography using ultraviolet detection Method AG-597B as the analytical enforcement method. Tolerance fee payment. The OFR/GPO partnership is committed to presenting accurate and reliable rendition of the daily Federal Register on FederalRegister.gov does not The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of fludioxonil on grapes at 1.0 ppm, strawberries at 2.0 ppm, dry bulb onions at 0.20 ppm, and green onions at 7.0 ppm. The baseline fludioxonil sensitivity distribution indicated that all of the isolates were sensitive, exhibiting a unimodal cure with a mean effective concentration for 50% inhibition value of 0.13 ± 0.12 μg/ml (standard deviation). It is often used in combination with another fungicide such as Cyprodinil. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. All trademarks, registered trademarks and servicemarks mentioned on this site are the property of their respective owners. Seek immediate medical attention. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. In the Federal Register of March 29, 2000 (65 FR 45498) (FRL-6495-5), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. ; Case Status: Docket Opening: Fludioxonil Summary Document - June 2011 . After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 4: Table 4.— Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Fludioxonil. Fludioxonil is used against seedling blight, stem-base browning, snow mold, common bunt, gray mold, black spot, storage rot and powdery mildew. Chronic exposure. documents in the last year, 1396 Since DWLOCs address total aggregate exposure to fludioxonil they are further discussed in the aggregate risk sections below. Aggregate Risk Assessment and Determination of Safety, D. Safety Factor for Infants and Children, E. Aggregate Risks and Determination of Safety. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). These can be useful In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance fludioxonil in blueberries, gooseberries, currants and cranberries. 346a as amended by the FQPA announcing the filing of a pesticide petition (PP) for tolerances for fludioxonil on strawberries, bulb vegetables, and stone fruit by the Interregional Research Project Number 4 (IR-4), New Jersey Agricultural Experiment Station, P.O. documents in the last year, 672 better and aid in comparing the online edition to the print edition. Fludioxonil is a non-systemic fungicide, introduced in 1993 by Ciba-Geigy (now Syngenta ). Fludioxonil Figure 2 Bioassays of Aspergillus fumigatus AF293 (wild type) and MAPK mutants sakAD and mpkCD with no treatment (Control), or treated with berberine hemisulfate (0Æ5 mmol l-1; % growth inhibition: wild type 55Æ6%, sakAD 15Æ0%, mpkCD 18Æ6%), veratraldehyde (Vert) (5 mmol l-1;% Section 180.516 is amended by alphabetically adding commodities to the table in paragraph (a) to read as follows: (a) General. Different populations will have different DWLOCs. In any DWLOC values are not regulatory standards for drinking water. Fludioxonil and pyrimethanil are fungicides. VIII. While filling the remainder of the spray tank add the required amount of SCHOLAR. 804(2). These estimates indicate that the potential intermediate-term risks from residential uses of fludioxonil do not exceed the Agency's level of concern. 1. on FederalRegister.gov This allowable exposure through drinking water is used to calculate a DWLOC. 01/10/2023, 42 Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to fludioxonil from food will utilize 3.7% of the cPAD for the U.S. population, 12% of the cPAD for all infants (< 1 year old) and 9.8% of the cPAD for children 1-6 years old. Instead, drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. It helps to improve strategies & performance of the company. EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at [email protected], or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 272 note). Although fludioxonil has been deemed safe for use, the authors of the current study suggest that the effects this widely used pesticide has upon animals be re-examined. Home | Food and Agriculture Organization of the United Nations To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). documents in the last year, 532 If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). Fludioxonil was not mutagenic in the tests for gene mutations. documents in the last year, 965 Positive for mutagenicity in hepatocytes exposed. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor. For dietary risk assessment (other than cancer) the Agency uses the UF to Start Printed Page 82931calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). This prototype edition of the The Agency will not establish a stone fruit tolerance until the Start Printed Page 82929final set of residue chemistry data are submitted and reviewed. In the Federal Register of August 26, 1998 (63 FR 45497) (FRL-6023-4), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. Therefore, the tolerance is established for residues of fludioxonil 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1 H-pyrrole-3-carbonitrilein or on grapes at 1.0 ppm, strawberries at 2.0 ppm, dry bulb onions at 0.20 ppm, and green onions at 7.0 ppm. Asociación de fungicidas presentada en forma de granulado dispersable en agua. Based on the level of Fludioxonil detected in the . fludioxonil " within Products. In person. Fludioxonil is a member of the class of benzodioxoles that is 2,2-difluoro-1,3-benzodioxole substituted at position 4 by a 3-cyanopyrrol-4-yl group. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern. Thus, TPI is a drug target of the phenylpyrrole class of fungicides, inducing elevated MG which alters HHK . 101FF, CM # 2, 1921 Jefferson Davis Hwy, Arlington, VA, (703) 305-5229. Monoisotopic mass 248.039734 Da. Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. See docket EPA-HQ-OPP-2010-1067 for documents related to EPA's review of this pesticide; Visit Regulations.gov for information about other pesticide registration review chemicals. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates Start Printed Page 82933are made by reliance on simulation or modeling taking into account data on the physical characteristics of fludioxonil. Based on the residential use pattern, no long-term post-application residential exposure is expected. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 3: Table 3.—Aggregate Risk Assessment for Acute Exposure to Fludioxonil. Registration close. The acute analysis was performed for the females 13-50 years old population subgroup using published and proposed tolerance levels, default concentration factors, and 100% CT assumptions for all commodities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. Document page views are updated periodically throughout the day and are cumulative counts for this document. Truth Publishing International, LTD. is not responsible for content written by contributing authors. Register documents. 3. Your use of this website indicates your agreement to these terms and those published here. III. Registration Apply chevron_right. Acute exposure. Mail your copies, identified by docket control number OPP-301093, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. corresponding official PDF file on govinfo.gov. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. Since the 1980s wheat sharp eyespot (WSE) caused mainly by Rhizoctonia cerealis has become one of serious diseases of wheat in China. has no substantive legal effect. 1. documents in the last year, by the Nuclear Regulatory Commission Prenatal and postnatal sensitivity. Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. Shake the container before use to ensure uniform dispersion of contents before measuring quantity required. Discard any heavily-drenched or contaminated clothing and other absorbent materials; do not reuse them. An acute reference dose (A RfD) was considered not necessary. Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”. Accordingly, taking into account the data on pre- and post-natal toxicity, EPA determined that an additional tenfold safety factor was not necessary to protect infants and children. Dietary exposure from food and feed uses. All other population subgroups fell in between these two figures, including the U.S. population (0.001107 mg/kg/day; 3.7% of the cPAD), children 1-6 years old (0.002934 mg/kg/day; 9.8% of the cPAD), children 7-12 years old (0.001522 mg/kg/day; 5.1% of the cPAD), females 13-50 years old (0.000823 mg/kg/day; 2.7% of the cPAD), males 20+ years old (0.000726 mg/kg/day; 2.4% of the cPAD), and seniors 55+ years old (0.000961 mg/kg/day; 3.2% of the cPAD). Tolerances have been established (40 CFR 180.516) for the residues of fludioxonil, in or on a variety of raw agricultural commodities. documents in the last year, by the Employee Benefits Security Administration LOAEL = 50 mg/kg/day based on an increased incidence of diarrhea (both sexes). This document has been published in the Federal Register. No systemic toxicity was seen at the limit dose (1,000 mg/kg/day) in the 28-day dermal toxicity study in rats. on Based the use pattern, chronic residential exposure to residues of fludioxonil is not expected. Acute risk. FLUDIOXONIL 4L ST: September 05, 2014 (PDF) 42750-248: FLUDIOXONIL 4L ST: May 20, 2013 (PDF) 1 - 2: Active Ingredient Name Percent Active; Fludioxonil: 40.3: 1 - 1: There is no Alternate Brand Name. The compound was listed by the Forty-fourth Session of CCPR for the evaluation by . If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. documents in the last year. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP) for tolerances for fludioxonil on grapes by Novartis Crop Protection, Inc, 410 Swing Road, Greensboro, NC 27419. In addition, there is potential for acute dietary exposure to fludioxonil in drinking water. 01/10/2023, 819 This final rule is not a “major rule” as defined by 5 U.S.C. 131341-86-1 1.2.1. The results of the acute analysis indicate that at the 95th percentile of exposure, the acute dietary risk associated with the proposed uses of fludioxonil is below EPA's level of concern. US EPA considers fludioxonil to be stable, "slightly to moderately" mobile in aqueous environments, and to be a "primary concern" for surface water (USEPA, 2011b). B. informational resource until the Administrative Committee of the Federal Gene mutation in mammalian cells in culture. Fludioxonil is a widely used, potent agricultural fungicide, but its mode of action remains ill defined . The EPA determined that based on the increase in liver tumors in female rats that was statistically significant for combined adenoma/carcinoma only, the lack of tumorogenic response in male rats or in either sex of mice, and the need for additional mutagenicity studies, a Group D classification was appropriate. It is a non-systemic, broad-spectrum fungicide with a long residual activity that interferes with glucose transport across fungal membranes. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intra species differences. You may also send an electronic copy of your request via e-mail to: [email protected]. NOAEL = 3.3 mg/kg/day (F) and 33.1 mg/kg/day (M). Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 1,200 for the U.S. population and 530 for infants/children. Information about this document as published in the Federal Register. : 8393936. Truth Publishing assumes no responsibility for the use or misuse of this material. headings within the legal text of Federal Register documents. regulatory information on FederalRegister.gov with the objective of You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Registration is conditional upon submission of the two dry bulb onion residue trials in Regions 5 and 12. It is recommended that any products containing fludioxonil not be used in areas treated with this product during the previous . Default body weights and drinking water consumption values vary on an individual basis. Risk assessments were conducted by EPA to assess dietary exposures from fludioxonil in food as follows: i. documents in the last year, 271

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fludioxonil + metalaxil