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For dealing with the fungal diseases, it is usually applied in seed treatment as well as post-harvest treatment of fruits. In rats, fludioxonil produced a significant trend and pair-wise increase in hepatocellular tumors, combined, in female rats at doses adequate to assess carcinogenicity. ; Case Status: Docket Opening: Fludioxonil Summary Document - June 2011 . It is a kind of broad-spectrum, non-systemic fungicide, being used against Fusarium, Rhizoctonia, Alternaria and Botrytis cinerea. 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). 01/10/2023, 198 Chinese hamsters were orally dosed at levels from 1,250 to 5,000 mg/kg. 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. Kilani and Fillinger (2016) also reported that high resistance to fludioxonil Relevant identified uses Laboratory chemicals, for scientific research and development only supplier name Combi-Blocks, Inc. EPA did not identify a dermal endpoint of concern for the short-term duration. 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). These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. It interferes with glucose transport across fungal membranes. Acute risk. 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. Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Scholar SC is compatible with DPA (drenching) and fruit coatings/waxes (line sprays). fludioxonil. In one mouse study, there was a significant trend for malignant lymphomas in female mice up to 3,000 ppm. 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. Vangard WG offers systemic, long-lasting protection against a wide range of fungal diseases in a variety of crops both before and after infection. documents in the last year, 27 The PIRIB telephone number is (703) 305-5805. Sort by Relevance. Fludioxonil (211) First draft prepared by Dr Dugald MacLachlan, Department of Agriculture and Water Resources, Australia EXPLANATION Fludioxonil was evaluated for the first time by the JMPR in 2004 when an acceptable daily intake (ADI) of 0-0.4 mg/kg bw was established. Fludioxonil action has been shown to require group III HHKs and . 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. documents in the last year, 87 Start Printed Page 82934. Oats, barley, wheat, rice, triticale and rye; Amenity grassland, managed amenity turf, fodder rape, mustard and oilseed rape; Apples, pears, plums, blackberries, raspberries, strawberries, cranberries, blueberries, gooseberries, carrots, celery, black currants, red currants, white currants, broad beans, dwarf french beans, runner beans, crab apples, cherry tomatoes, sweet potatoes, sweet bell peppers, edible podded peas, quinces and ornamentals, among others. The 'Substance identity' section is calculated from substance identification information from all ECHA databases. Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). : 8393936. Su actividad es por contacto que impide la germinación de conidias y el crecimiento del tubo germinativo y del micelio. Both sexes of NMRI mice were dosed up to 5,000 mg/kg/day. Statistically significant trend for malignant lymphomas in females. 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). Based on the residential use pattern, no long-term post-application residential exposure is expected. Truth Publishing assumes no responsibility for the use or misuse of this material. Therefore, the short-term aggregate risk assessment is not required. A model is proposed for the interactions between the G . 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). There is a complete toxicity data base for fludioxonil and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. SWITCH is a co-formulation of cyprodinil and fludioxonil for the control of a range of diseases in ornamental plant production and in a range of both vegetable and fruit crops. From non-dietary exposure. 3. Fludioxonil is an effective fungicide widely used for crop protection and is effective against tomato gray mold. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. 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. DWLOC values are not regulatory standards for drinking water. LOAEL = 1,000 mg/kg/day based on reduction in corrected weight gain. Risk assessments were conducted by EPA to assess dietary exposures from fludioxonil in food as follows: i. This prototype edition of the Privacy | Terms All content posted on this site is commentary or opinion and is protected under Free Speech. Fludioxonil is persistent and may carryover. 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. Fludioxonil is a synthetic phenylpyrrole-group substance. 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). This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). 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. provide legal notice to the public or judicial notice to the courts. Fludioxonil is a synthetic compound of the phenylpyrrole group of substances. Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. 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: waller.mary@epa.gov. regulatory information on FederalRegister.gov with the objective of fludioxonil " within Products. 0.01. It is often used in combination with another fungicide such as Cyprodinil. 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. There are no chemical-specific data available to determine the potential risks from post-application activities associated with the proposed uses of fludioxonil. This document has been published in the Federal Register. EPA's assessment of exposures and risks associated with establishing the tolerances follows. Micronucleated hepatocytes were found in Phase II at the low and mid dose levels but not at the high dose level and not in Phase I. 2. the material on FederalRegister.gov is accurately displayed, consistent with The Public Inspection page may also The data submitted in support of the intended northern Europe (NEU) outdoor and EU indoor . However, the Agency has since received the additional mutagenicity studies and based on the negative preliminary findings of the studies, the fact that the statistical increase in liver tumors in female rats occurred only at the highest dose, the lack of tumorigenic response in male rats and mice, the Agency has concluded that fludioxonil does not pose a significant cancer risk. Application Advice close. Fludioxonil is an odorless, colorless to yellowish synthetic compound of the phenylpyrrole group of substances. headings within the legal text of Federal Register documents. the official SGML-based PDF version on govinfo.gov, those relying on it for All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before February 27, 2001. on NARA's archives.gov. legal research should verify their results against an official edition of on Office location and telephone number: Rm. 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). A summary of the toxicological endpoints for fludioxonil used for human risk assessment is shown in the following Table 2: Table 2.—Summary of Toxicological Endpoints Used for Human Risk Assessment*. Fludioxonil-carboxylic acid | C12H7F2NO4 | CID 153925794 - structure, chemical names, physical and chemical properties, classification, patents, literature . that fludioxonil posed a "negligible cancer risk" (USEPA, 2012). 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. NOAEL = 11.3 mg/kg/day (M) and 133 mg/kg/day (F). In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. Box 360277M, Pittsburgh, PA 15251. Start Printed Page 82936. 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. The Q * approach assumes that any amount of exposure will lead to some degree of cancer risk. The compound was listed by the Forty-fourth Session of CCPR for the evaluation by . Thus, TPI is a drug target of the phenylpyrrole class of fungicides, inducing elevated MG which alters HHK . The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. ( 2) Tolerances are established for residues of the fungicide fludioxonil, including its metabolites and degradates, in or on the commodities in the following table. The experiments were conducted at Hudiaba research station farm (River Nile State) and New halfa Research Station (Kassala State) for two consecutive seasons 2014/015 and 2015/016, to evaluate the effectiveness of Celest Top 312.5 FS (flowable solution) as seed dressing to control insect pests and seedling diseases of wheat. Box 231, Rutgers University, New Brunswick, NJ 08903. Chronic dietary exposure estimates ranged from 0.000609 mg/kg/day (2.0% of the cPAD) for males 13-19 years old, up to 0.003506 mg/kg/day (12% of the cPAD) for all infants (< 1 year old). Its mode of action is to inhibit transport-associated phosphorylation of . Based the use pattern, chronic residential exposure to residues of fludioxonil is not expected. Electronically. 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. documents in the last year, 86 Use the PDF linked in the document sidebar for the official electronic format. These tools are designed to help you understand the official document 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;% Intermediate-term, non-dietary ingestion exposure for toddlers is possible and was assessed using the intermediate-term dose and endpoint identified from the 13 week oral feeding study in rats. Do not eat, drink, use tobacco and cosmetic applications in areas where there is a potential for exposure to fludioxonil. allow fludioxonil contaminated waste water from the processing plants to enter lakes, streams, ponds or other waters. Fludioxonil inhibits transport-associated phosphorylation of glucose as well as preventing glycerol synthesis. Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). 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). There are no Codex Maximum Residue Limits (MRLs) for fludioxonil. 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 . In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure). No such correlation was found with fludioxonil . Fludioxonil is the only molecule of this chemical class and is used as a seed treatment on various crops, such as maize (corn), soybean, potato or cotton. The chronic DEEM® analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-92 nationwide CSFII and accumulated exposure to the chemical for each commodity using published and proposed tolerance levels, default concentration factors, and 100% crop treated (CT) assumptions for all commodities. Refer to the workplace regulations regarding proper handling of equipment before applying fludioxonil. documents in the last year, 965 1 There are no U.S. registrations as of July 28, 2021. for the forecast year up to 2029. documents in the last year, by the Equal Employment Opportunity Commission 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). has no substantive legal effect. 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. Prenatal and postnatal sensitivity. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 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. You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. publication in the future. The results of this analysis indicate that the chronic dietary risk associated with the existing uses and the proposed uses of fludioxonil is below EPA's level of concern. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. Chinese hamster V79 ovary cells were tested from 0.50 to 60 μg/mL. 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). To reduce runoff from treated areas into aquatic habitats avoid application to areas with a moderate to steep slope, compacted soil, or clay. Negative up to limit of solubility and cytotoxicity. Potentially affected categories and entities may include, but are not limited to: This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. 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. better and aid in comparing the online edition to the print edition. documents in the last year, 115 When Will the Agency Grant a Request for a Hearing? | Botrytis Cinerea, Resistance and Tomato | ResearchGate, the . For further discussion of the regulatory requirements of section 408 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7). 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. electronic version on GPO’s govinfo.gov. Asociación de fungicidas presentada en forma de granulado dispersable en agua. NOAEL = 3.3 mg/kg/day (F) and 33.1 mg/kg/day (M). 5. Information not marked confidential may be disclosed publicly by EPA without prior notice. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). 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. Aggregate cancer risk for U.S. population. This repetition of headings to form internal navigation links EPA has classified Fludioxonil as a Group D - not classifiable as to human carcinogenicity. In case of direct contact, immediately flush contaminated eyes with running water for a few minutes. There were no significant increases in the number or percentage of micronucleated polychromatic erythrocytes. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Tolerances are not being established for stone fruit at this time due to additional preliminary residue chemistry data (not yet available to the Agency for review) that indicate that a tolerance of 2.0 ppm may be too low for stone fruit. the Federal Register. 131341-86-1 1.2.1. do not apply. EPA does not have, at this time, available data to determine whether fludioxonil has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Fludioxonil Market growth drivers helps to understand operational and financial output of a business. For the purposes of this tolerance action, therefore, EPA has not assumed that fludioxonil has a common mechanism of toxicity with other substances. Intermediate-term risk. 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. 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. There was no evidence of unscheduled DNA synthesis in rat hepatocytes at doses from 4.1 to 5,000 μg/mL. 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 tompkins.jim@epa.gov, 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. Half-fill the spray or mixing tank with clean water or wax/oil emulsion (or aqueous dilution of a wax/oil emulsion) and start agitation. fludioxonil (0.1%; v/v) had 98 and 96% less (P<0.0001) decay than carrots treated with chlorinated water as control. Following the result of this study, fludioxonil at a rate of 0.1% (v/v) was approved for use in stored carrots in Israel and was incorporated into commercial production as a replacement of iprodione starting January 2021. These can be useful The MOEs for postapplication exposures from full lawn uses are 2,000 and 1,200 for adults and children, respectively. Any person who imports, manufactures or sells any food not in compliance with the requirements of the Pesticide Residues in Food Regulation (Cap 132CM) concerning pesticide residues commits an offence and is liable to a maximum fine of $50,000 and to imprisonment for six months upon conviction. The Agency's level of concern is for MOEs below 100. The EPA determined that based on the increase in liver tumors in female rats that was statistically significant for combined adenoma/carcinoma only, the lack of tumorogenic response in male rats or in either sex of mice, and the need for additional mutagenicity studies, a Group D classification was appropriate. For dealing with the fungal diseases, it is usually applied in seed treatment as well as post-harvest treatment of fruits. The high efficacy of this mixture in lettuce crops was also report-ed by Matheron and Porchas (2008). In addition, several Section 18 emergency exemptions for use as a foliar spray on strawberries, caneberries and as a post-harvest spray treatment on apricots, nectarines, peaches, and plums have been approved. You may also submit an electronic copy of your request at many Federal Depository Libraries. Global Fludioxonil Market is estimated to be valued US$ XX.X million in 2019. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Being broad spectrum fludioxonil is effective against most major seed diseases, including Seedling blight . The Public Inspection page Fludioxonil is the active ingredient in registered products used as a seed treatment for many crops (with the exception of tree crops and berries). Acute exposure. 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. 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). Fludioxonil is an effective fungicide widely used for crop protection and is effective against tomato gray mold. : 131341-86-1. for better understanding how a document is structured but These markup elements allow the user to see how the document follows the Aggregate Risk Assessment and Determination of Safety, D. Safety Factor for Infants and Children, E. Aggregate Risks and Determination of Safety. B. The EECs for chronic exposures are estimated to be 32 ppb for surface water and 0.35 ppb for ground water. 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. Each document posted on the site includes a link to the Fludioxonil proved to be potnet inhibitor of both iprodione-sensitive and -resistant isolates. The emergence. Novartis Crop Protection, Inc. and the Inter-Regional Project Number (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996. No systemic toxicity was seen at the limit dose (1,000 mg/kg/day) in the 28-day dermal toxicity study in rats. In this study, the sensitivity of 89 R. cerealis isolates to different fungicides was evaluated using mycelial growth inhibition assays. 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). The Agency has established an official record for this action under docket control number OPP-301093. On the other hand, there was no evidence of carcinogenic potential with fludioxonil in the study in rat models. corresponding official PDF file on govinfo.gov. 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. The mode of action of fludioxonil is the inhibition of transport-associated phosphorylation of glucose as well as preventing glycerol synthesis. On the other hand, US EPA considers fludioxonil to have "moderately high" adsorption coefficients and 01/10/2023, 246 Fludioxonil is used against seedling blight, stem-base browning, snow mold, common bunt, gray mold, black spot, storage rot and powdery mildew. Pendant SC Fungicide is a highly effective fungicide that controls a broad-spectrum of diseases from the leaf to the soil surface of turfgrasses. Different populations will have different DWLOCs. The President of the United States issues other types of documents, including but not limited to; memoranda, notices, determinations, letters, messages, and orders. It is not intended as a substitute for professional advice of any kind. Please follow the detailed instructions for each method as provided in Unit VI of the SUPPLEMENTARY INFORMATION. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/​opptsfrs/​home/​guidelin.htm. You may also deliver your request to the Office of the Hearing Clerk in Rm. Fludioxonil 95% TC. In one mouse study, there was a significant trend for malignant lymphomas in female mice up to 3,000 ppm. documents in the last year. The authority citation for part 180 continues to read as follows: Authority: 3. Tolerance fee payment. 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 residue data, the recommended tolerance for residues in/on almond is 0.2 ppm and the recommended tolerance for residues in/on pecan is 0.01 ppm. These estimates indicate that the potential intermediate-term risks from residential uses of fludioxonil do not exceed the Agency's level of concern. Positive for nondisjunction of chromosomes both in the presence and absence of activation. a. Ciba has submitted over 25 separate toxicology studies in support of tolerances for fludioxonil. Short-term inhalation endpoints were identified, however, they are not relevant for the short-term aggregate risk since homeowners would not be applying fludioxonil. ii. A tolerance is established for residue of the fungicide fludioxonil, 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1 H-pyrrole-3-carbonitrile) in or on the following food commodities: [FR Doc. The OFR/GPO partnership is committed to presenting accurate and reliable Wakil XL. ChemSpider ID 77916. documents in the last year, 1396 Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. This regulation is effective December 29, 2000. Fludioxonil is approved as a seed treatment for oats, barley, wheat, triticale, and rye. None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. Fludioxonil is also effective as an insecticide seed treatment against insect pests when combined with other formulations like hiamethoxam and metalaxyl-M, fludioxonil. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %RfD or %PAD. Molecular Weight: 248.19. documents in the last year, 483 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. Saturday, December 02, 2017 by Janine Acero, http://www.naturalpedia.com/fludioxonil-toxicity-side-effects-diseases-and-environmental-impacts.html. The findings in the rat developmental toxicity studies were considered to be related to maternal toxicity, rather than an indication of increased susceptibility. Beilstein No. An acute dose and endpoint was not selected for the U. S. population (including infants and children) because there were no effects of concern observed in oral toxicology studies, including maternal toxicity in the developmental toxicity studies in rats and rabbits, that are attributable to a single exposure dose. Registration Apply chevron_right. Biopesticides are certain types of pesticides derived from such natural materials as animals, plants, bacteria, and certain minerals. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for fludioxonil in drinking water. Introduction: Fludioxonil is a synthetic phenylpyrrole-group substance. 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. 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. 601 et seq.) Cumulative exposure to substances with a common mechanism of toxicity. and services, go to Register documents. documents in the last year, 877 This table of contents is a navigational tool, processed from the Gene mutation in mammalian cells in culture. Generally, a DWLOC is calculated for each type of risk assessment used: acute, short-term, intermediate-term, chronic, and cancer. Fludioxonil is persistent and may carryover. This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The registrant is seeking registration for the use of fludioxonil by commercial applicators on residential lawns. For complete information about, and access to, our official publications 272 note). In any Emergency telephone During normal business hours (Monday-Friday 8am-5pm PST), call 1-858-635-8950. . Federal Register. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Other types of entities not listed in the table could also be affected. Male mice singly dosed at 0, 1,250, 2,500, or 5,000 mg/kg/day and mated for 8 consecutive weeks had no evidence of a dominant lethal mutation, Available data do not indicate a need for acute or subchronic neurotoxicity studies, Subchronic neurotoxicity screening battery, NOAEL = 100 mg/kg/day; UF = 100; Acute RfD = 1.0 mg/kg/day, FQPA SF = 1X; aPAD = acute RfD/FQPA SF = 1.0 mg/kg/day, Developmental LOAEL = 1,000 mg/kg/day based on increased incidence of fetuses and litters with dilated renal pelvis and dilated ureter, NOAEL= 3.3 mg/kg/day; UF = 100; Chronic RfD = 0.03 mg/kg/day, FQPA SF = 1X; cPAD = chronic RfD/FQPA SF = 0.03 mg/kg/day, LOAEL = 35.5 mg/kg/day based on decreased weight gain in female dogs, Short-Term Dermal (1-7 days) (Occupational/Residential). Fludioxonil is intended to be used on wine and table grapes (WG formulation) and on wheat (FS formulation). Since DWLOCs address total aggregate exposure to fludioxonil they are further discussed in the aggregate risk sections below. There was no evidence of carcinogenicity in male rats, but there was a statistically significant increase, both trend and pairwise, of combined hepatocellular tumors in female rats. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. For adults, post-application exposures may result from dermal contact with treated turf. In addition, intermediate-term DWLOCs were calculated and compared to the EECs for chronic exposure of fludioxonil in ground and surface water. by the Securities and Exchange Commission For tree nut crop group 14-12, maximum fludioxonil residues in representative crops were not within a factor of five of each other. 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). Observe buffer zones specified under DIRECTIONS FOR USE. Fludioxonil is a broad-spectrum fungicide which is non-systemic with a long residual activity. documents in the last year, 38 For toddlers, dermal and non-dietary oral post-application exposures may result from dermal contact with treated turf as well as hand-to-mouth transfer of residues from turfgrass. NOAEL = 445 mg/kg day (M) and 559 mg/kg/day (F), LOAEL = 1052 mg/kg/day (M) and 1307 mg/kg/day (F) based on decreased body weight gain (F), increased alkaline phosphatase (M), increased relative liver weight, increased incidence of nephropathy and centrilobular hypertrophy (both sexes). Compare Product No. There is no Inactive Alternate Brand Name. The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). Molecular Formula CHFNO. documents in the last year, 829 Therefore, 40 CFR chapter I is amended as follows: 1. Filing the request. DYNA-SHIELD FLUDIOXONIL provides protection against decay, damping-off and blight for a strong start to help maximize yield potential. All Photos (1) Fludioxonil. | Botrytis Cinerea, Resistance and Tomato | ResearchGate, the . Do not include any CBI in your electronic copy. This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. About the Federal Register Description SDS Pricing; 74123: certified reference material, TraceCERT . It is not an official legal edition of the Federal This site displays a prototype of a “Web 2.0” version of the daily 01/10/2023, 162 It can be used to control fungal disease, making it a useful seed treatment as well as a post-harvest treatment for fruit. In person. In this well, fludioxonil has been detected at increasing concentrations for the past three consecutive years. Quality fludioxonil 50%WP 20%FS 2.5%FS fungicide - find quality fungicides, Agrochemicals & Pesticides & fungicides from Shenzhen Sunrising Industry Co., Ltd. of China Suppliers - 127902089. fludioxonil [fludioxonyl] 4-(2,2-difluor-1,3-benzodioxol-4-yl)-1H-pyrrol-3- karbonitril. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). documents in the last year, 11 C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. Fludioxonil TGAI Name and Address of Registrant (include ZIP Code): Albaugh, Inc. 1525 NE 36th St. Ankeny,IA50021 Note: Changes in labeling differing in substance from that accepted in connection with this registration must be submitted to and accepted by the Registration Division prior to use of the label in commerce. This risk assessment is not required. This site is part of the Natural News Network © 2012 All Rights Reserved. Open for Comment, Self-Regulatory Organizations; The Nasdaq Stock Market LLC, Economic Sanctions & Foreign Assets Control, Air Plan Partial Approval and Partial Disapproval; AK, Fairbanks North Star Borough; 2006 24-Hour PM2.5, Natural Disaster Procedures: Preparedness, Response, and Recovery Activities of the Corps of Engineers, GE-Hitachi Nuclear Energy Americas, LLC; GE-Hitachi Nuclear Test Reactor. To ensure proper receipt by EPA, your objections and hearing requests must identify docket control number OPP-301093 in Start Printed Page 82928the subject line on the first page of your response. Tolerances have been established (40 CFR 180.516) for the residues of fludioxonil, in or on a variety of raw agricultural commodities. The evidence is inadequate and cannot be interpreted as showing either the presence or absence of a carcinogenic effect. developer tools pages. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents? Dietary exposure from food and feed uses. Director, Registration Division, Office of Pesticide Programs. Classified as “Group D” by OPP Cancer Peer Review Committee. In this study, the effects of fludioxonil on human immune cell viability, apoptosis, cell cycle arrest, and mitochondrial membrane potential were examined in human immune cells, such as Jurkat T cells and Ramos B cells. The acute dietary exposure estimate at the 95th percentile of exposure for females 13-50 years old is 0.004512 mg/kg/day, representing 0.5% of the aPAD. 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. 804(2). 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 In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). LOAEL = 112 mg/kg/day (M) and 417 mg/kg/day (F) based on the increased incidence of mice convulsing when handled (M) and increased absolute liver weight and grossly enlarged livers (F). 1. B. It can be used to control fungal disease, making it a useful seed treatment as well as a post-harvest treatment for the following plants and crops: Products that contain fludioxonil as an active ingredient include: A material safety data sheet by the Syngenta Crop Protection website recommends the following steps to exposure controls and personal protection for the manufacture, formulation and packaging of fludioxonil: Fludioxonil is an odorless, colorless to yellowish, broad-spectrum fungicide. documents in the last year, 672 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. For acute dietary risk estimates, EPA's level of concern is >100% aPAD. CAS No. This feature is not available for this document. Fludioxonil is a widely used, potent agricultural fungicide, but its mode of action remains ill defined . There were no developmental findings in rabbits. on All trademarks, registered trademarks and servicemarks mentioned on this site are the property of their respective owners. This final rule is not a “major rule” as defined by 5 U.S.C. on EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. It helps to improve strategies & performance of the company. This notice included a summary of the petition prepared by the Interregional Research Project Number 4 (IR-4), the registrant. LOAEL = 428 mg/kg/day (M) and 462 mg/kg/day (F) based on decreased weight gain (both sexes), chronic nephropathy (M) and centrilobular hepatocyte hypertrophy (F). documents in the last year, by the Employee Benefits Security Administration Chronic exposure. Written objections and hearing requests may be submitted by mail, in person, or by courier. New Documents of the issuing agency. WG inhibits leaf penetration and growth of pathogens within plant tissue. 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. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. documents in the last year, by the Nuclear Regulatory Commission More information and documentation can be found in our documents in the last year, 950 LOAEL = 1,000 mg/kg/day based on increase in the fetal incidence and litter incidence of dilated renal pelvis and dilated ureter. While every effort has been made to ensure that on 95%TC SC WDG WP FS. Fludioxonil is not currently registered for residential (outdoor, non-food) uses. 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). documents in the last year, by the Engineers Corps The results showed that all R. cerealis isolates tested were sensitive to iprodione, difenoconazole and fludioxonil with mean . The registrant indicated that the requested residential uses are only for professional applications. Exemption From Certain Prohibited Transaction Restrictions Involving JPMorgan Chase Co. Since the Agency did not select a short-term endpoint for dermal exposure, only intermediate-term dermal exposures were considered. Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. 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. 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. Remove contact lenses first, if applicable. It is recommended that any products containing fludioxonil not be used in areas treated with this product during the previous season. Intermediate-term exposure is not expected from the proposed ornamental uses of fludioxonil. The Congressional Review Act, 5 U.S.C. However, in a second study up to 7,000 ppm, the limit dose, there was no evidence of carcinogenicity for either sex. 321(q), 346(a) and 371. 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. The report on Fludioxonil Market provides qualitative as well as quantitative analysis in terms of market dynamics, competition scenarios, opportunity analysis, market growth, etc. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC. It is recommended that any products containing fludioxonil not be used in areas treated with this product during the previous . Its excellent crop safety combined with exceptional activity at a low use rate against targeted fungi, such as snow mold, seedborne and soilborne Fusarium, seedling . The dermal MOE for postapplication exposure for the hand to mouth scenario is 13,000. An acute reference dose (A RfD) was considered not necessary. Information about this document as published in the Federal Register. 2. Monoisotopic mass 248.039734 Da. Section 180.516 is amended by alphabetically adding commodities to the table in paragraph (a) to read as follows: (a) General. Fludioxonil is a non-systemic fungicide, introduced in 1993 by Ciba-Geigy (now Syngenta ). Five fludioxonil-resistant mutants were subsequently induced by exposure to fludioxonil under laboratory conditions. Male rats were orally dosed 1250, 2500 and 5,000 mg/kg and hepatocytes were harvested. Home | Food and Agriculture Organization of the United Nations Global Fludioxonil Market Report delivers comprehensive analysis includes: In-depth qualitative & quantitative analysis of various market segments & regional outlook. Fludioxonil is one of two commercial fungicides, the other being fenpiclonil, derived from the compound pyrrolnitrin, which was first isolated from bacteria in the genus Pseudomonas [1, 2].It is a broad-spectrum fungicide used to control many crop pathogens before and after harvest [].It inhibits fungal growth by over-stimulating the high osmolarity glycerol (HOG) pathway to induce hyphal . Fludioxonil is a contact fungicide that penetrates the seed surface and concentrates around the seed, thus providing a long-lasting protection zone around the young seedling. The systemic exposure of operators, workers and bystanders to fludioxonil formulated as WG was estimated to be below the established AOEL, as well as for the FS formulation. 01/10/2023, 819 Your use of this website indicates your agreement to these terms and those published here. Positive for mutagenicity in hepatocytes exposed. Fludioxonil PESTANAL®, analytical standard; CAS Number: 131341-86-1; find Supelco-46102 MSDS, related peer-reviewed papers, technical documents, similar products & more at Sigma-Aldrich on FederalRegister.gov You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/​. iii. R&D Systems dimethomorph 1174 fludioxonil 1285 thiabendazole Dimethomorph 1174 Fludioxonil 1285 Thiabendazole, supplied by R&D Systems, used in various techniques. 1. It is effective against a range of fungal pathogens like seedling blight, stem-base browning, snow mold, and common bunt. Fludioxonil is an odorless, colorless to yellowish synthetic compound of the phenylpyrrole group of substances. The EPA classified Fludioxonil as a Group D - not classifiable as to human carcinogenicity. The nature of the toxic effects caused by fludioxonil are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed. The President of the United States manages the operations of the Executive branch of Government through Executive orders. Employee Benefits Security Administration, Establishing the President's Advisory Council on African Diaspora Engagement in the United States. Intermediate-Term (1 week - several months) Dermal (Occupational/ Residential), Oral study NOAEL= 64 mg/kg/day (dermal penetration = 40%), LOC for MOE = 100 (Occupational); LOC for MOE = 100 (Residential), Systemic LOAEL = 428 mg/kg/day based on decreased body weight gain in both sexes, chronic nephropathy in males, and centrilobular hepatocyte hypertrophy in females, Long-Term (several months-lifetime) Dermal (Occupational/ Residential), Oral study NOAEL = 3.3 mg/kg/day (dermal penetration = 40%), LOC for MOE = 100 (Occupational) LOC for MOE = 100 (Residential), Short-Term (1-7 Days) Inhalation (Occupational/Residential), NOAEL = 64 mg/kg/day (inhalation absorption rate = 100%), LOC for MOE = 100 (Occupational); LOC for MOE = 100 (Residential), Intermediate-term (1 week - several months) Inhalation (Occupational/Residential), 13 Week Oral Feeding Study - rat Systemic, LOAEL = 428 mg/kg/day based on decreased body weight gain in both sexes, chronic nephropathy in males, and centrilobular hepatocyte hypertrophy in females, Long-Term (several months-lifetime) Inhalation (Occupational/Residential), NOAEL = 3.3 mg/kg/day (inhalation absorption rate = 100%), LOC for MOE = 100 (Occupational); LOC for MOE = 100 (Residential), “Group D”- not classifiable as to human carcinogenicity via relevant routes of exposure. Acceptable oral rat and mouse carcinogenicity studies; evidence of carcinogenic and mutagenic potential. Catalase activity was found to be positively correlated with iprodione resistance (r= 0.77, P < 0.001) confirming that dicarboximide resistance is mediated by enhanced oxidative protective enzymes. To estimate risk, a ratio of the point of departure to exposure (MOEcancer = point of departure/exposures) is calculated. Bioz Stars score: 86/100, based on 1 PubMed citations. 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. 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. The Dietary Exposure Evaluation Model (DEEM® analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. 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 . For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. Fludioxonil and pyrimethanil are fungicides. A. Conclusion. Seek immediate medical attention. However, the period for filing objections is now 60 days, rather than 30 days. Document Drafting Handbook documents in the last year, 532 The information on this site is provided for educational and entertainment purposes only. informational resource until the Administrative Committee of the Federal We show here that the drug is active against a number of fungal pathogens of humans, underscoring the significance of understanding the drug's target and mode of action. Chinese hamster ovary cells were tested with and without metabolic activation from 1.37 to 700 μg/mL. 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. However, because of the powerful induction of polyploidy in the in vitro Chinese hamster ovary cell cytogenetic assay and the suggestive evidence of micronuclei induction in rat hepatocytes in vivo, additional mutagenicity testing was performed in an in vivo study specifically designed for aneuploidy analysis. In case of accidental ingestion, do not induce vomiting. documents in the last year, 1484 VIII. 101FF, CM # 2, 1921 Jefferson Davis Hwy, Arlington, VA, (703) 305-5229. When EECs for surface water and groundwater are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. It is used for the treatment of crops, particularly cereals, fruits and vegetables, and ornamental plants. Wear chemical-resistant gloves (barrier laminate, butyl rubber, nitrile rubber, neoprene rubber, PVC or Viton), coveralls, socks and chemical-resistant footwear. It is a non-systemic, broad-spectrum fungicide with a long residual activity that interferes with glucose transport across fungal membranes. Compliance with the tolerance levels specified in the following table is to be determined by measuring only the sum of . Copies for the Docket. daily Federal Register on FederalRegister.gov will remain an unofficial 1. Fludioxonil safety. A Rule by the Environmental Protection Agency on 12/29/2000. Application Advice . Therefore, international harmonization is not an issue at this time. The substance identifiers displayed in the InfoCard are the best available substance name, EC number, CAS number and/or the molecular and structural formulas. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. 3. 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.
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