FOSETYL-AL (ALIETTE) Pesticide Registration Standard (123301) June 1983 Office of Pesticides and Toxic Substances Environmental Protection 401 M Street, SW. Washington, D.C. Agency EPA =S40/RS-fl3-nin v_ ------- REPORT DOCUMENTATION »• **«>** ho. t PAGE PB84-206564 4. TMa .nd SuMRI. fqSETYL-AL (ALIETTE) Pesticide Registration Standard Ik Raport Data Issued 6/H3 c. 1, AutheHt) USEPA, Office of Pesticide Programs, Registration Division •. *arformlng Organization Rapt. No. 5¥0//2.J-^-o/0 t. Performing Organization N*m* and Addr»M U.S. Environmental Protection Agency 401 M Street, S.W. (TS-767) Washington,-J.C. 20460 IS. Prolact/Taafc/Work Unit N«. 11. Contract (O o» CranHG) No. <© IS) 12, Spom-oring CNrpinization Nvmtt and Address Same as #9 IS. Typa of Wapoft A P»riod Cowtil 14. IS. SupptamaRtary Note* IS. Abatract (Limit: 200 words) This document contains information regarding reregistration of pesticide products containing the subject active ingredient. The document includes how to register under a registration standard, regulatory position and rationale, and summaries of data requirements and data gaps. Also included is a bibliography containing citations of all studies revived by EPA in arriving at the positions and conclusions contained in the standard. 17. Oocunxnt Analyt)t a. Oaacriptor* 6. Itfantlfian/OpanCiidad Tarm» «. COSATI Flald/Croup It. Availability Stataman*. -tvL.Lp.U 19. Sacurtty Clams (Thl» Raport) 21, No. of Ca®»* Is-(I V A V L^.cf' 32 S& Security Ctaaa (Ttila Pa«a) 23. PHca Saa AN5I-Z39.18) Sm l«i(tr»ctlen> on *«»araa OTTIONAl FORM 272 <4-77} (Formerly NTIS-35) D»p«rtm«nt of Commarea ------- FOSETYL-AL PROJECT SUPPORT TEAM Fred Betz George Beusch Carolyn Gregorio Henry Jacoby Rick Johnson John Jordan Dennis McLane Science Integration Staff (HED) Residue Chemistry Branch (HED) Toxicology Branch (HED) Product Manager (RD) Special' Pesticide Review (RD) Exposure Assessment Branch (HED) Ecological Effects Branch (HED) This registration standard was written by the EPA Office of Pesticide Programs (EPA/OFP) in cooperation with Rhone Poulenc, Inc. Further information, is available from the Product Manager, Henry Jacoby, EPA/OP?. 401 M Street, S.W,, Washington, DC 20460, telephone (703) 557-1900. ------- REGULATORY POSITION AND RATIONALE Introduction This Registration Standard presents the regulatory position of the Environmental Protection Agency (the Agency) on registration of manufacturing-use products (MP) containing the fungicide Fosetyl-Al, aluminum tris (O-ethyl phosphonate). The Agency's position is based on a consideration of available data. Registration requests for products containing Fosetyl-Al will be evaluated based on this standard. This standard was developed with the cooperation of Rhone Poulenc, Incorporated. The topical discussions and data evaluation records (DER's) were written by Rhone Poulenc, Incorporated and submitted with each study to the Agency. The Agency reviewed and evaluated the data and critiqued and revised the DER's and topical discussions according to its findings. Although written by Rhone Poulenc, Incorporated, the DER's and topical discussion reflect the Agency's position on the subject. Description of Chemical Fosetyl-Al is the proposed American National Standards, Incorporated (ANSI) name for aluminum tris (O-ethyl phosphonate). The pesticidal uses of Fosetyl-Al are being developed by Rhone Poulenc, Inc.. It is marketed under the name Aliette1", The Chemical Abstracts Service (CAS 5 Registry Number is 39148-24-8. The OPP Internal Control Number (EPA Shaughnessy Number) is 123301. Fosetyl-Al is a white odorless powder. The empirical formula is C6H18AIO9P3. Fosetyl-Al melts with decomposition at temperatures greater than 200° celsius. The solubility of Fosetyl-Al in water at 20° celsius is 120 grams per liter. The structural formula, is: O II CH3CH2-0-P-0 H A1 Rhone Poulenc, Inc. is the sole producer of Fosetyl-Al. It is currently registered in ten foreign countries for use as a fungicide on fruits, vegetables, and ornamentals. Registration in the United States is pending for use as a pineapple seed piece (crowns) dip treatment and as a foliar spray on ornamentals. ------- C'. Regulatory Position Based on a scientific and technical evaluation of the available data, the Agency has made the following determinations; 1. The risk criteria found in section 162.11(a) of Title 40 Code of Federal Regulations were exceeded for Fosetyl-Al by exhibiting an oncogenic effect in rats fed Fosetyl-Al. However, based on the low level of exposure (i.e. mixer/loader, applicator, planter, and dietary) estimated to result from the two uses registerable under this Standard, a preplant dip for pineapple crowns and formulation for foliar application to field and greenhouse grown ornamentals, the Agency has determined that Fosetyl-Al is not likely to cause unreasonable adverse effects to either man or the environment. 2. Tolerances of 0.1 part per million (ppm) for pineapples and 0.1 ppm for pineapple forage must be established. 3. There is no need to establish reentry intervals for Fosetyl-Al. 4. Manufacturing-use pesticide products containing Fosetyl-Al as a sole active ingredient may be registered for sale, distribution, reformulation, and use, subject tn 4- Vv o f o Y*me a ri/^ r» i f i Atio cr\cr>i i tti 4-Vs ¦! e a a t w U11 w w a, JiIhD d X iwX1 Li X w X wXI m m O \m£ w JL JL JL. w LI x X X II J. o O C3> XXC»Lci X • D. Regulatory Rationale The Agency has determined that it can allow the registration of Fosetyl-Al after considering the following: 1. Fosetyl-Al degrades in the environment through the hydrolysis of the ethyl ester bond with subsequent degradation of the ethanol into carbon dioxide. The phosphorous acid metabolite is expected to form precipitates with aluminum, calcium or iron in the soil. The half life of Fosetyl-Al under aerobic ' conditions in soil is approximately one and one-half hours• The intermediate metabolites in grapes, pineapple and the rat are ethanol and phosphoric acid. The environmental fate of Fosetyl-Al is sufficiently understood to conclude that little if any environmental accumulation of the chemical will result. 2. Residues of Fosetyl-Al remaining in/on harvested pineapples grown from treated pineapple seed pieces are undetectable by a method sensitive to 0,10 ppm. However, the data developed with labeled Fosetyl-Al indicate that residues of Forsetyl-Al or its metabolites could remain in harvested pineapples at or below the level of detection. -2- ------- 3. No ecological hazards of concern resulting from the use of Fosetyl-Al on pineapple seed pieces or ornamentals have been identified in the studies reviewed. 4. Dietary and long term worker exposure to Fosetyl-Al and its degradates will be very low for pineapple crown treatment and for ornamental uses. 5. Positive oncogenic effects were observed in the rat ¦ two-year feeding study.. An in-depth animal-by-animal review has been undertaken by the Agency .and a provisional oncogenic risk assessment based on the rat feeding study was carried out. The provisional risks are shown below: Exposure Dietary Applicator Mixer/loader Planters* Pineapple Use 0.27-2.4 X 10-8 Not applicable 0.50-4.0 X 10-7 0.7-6.0 X 10~6 Ornamental Use none 0.20-2.0 X 10-8 1.0-9.0 X 10-9 ¦ Not applicable *Risk estimate for planters assumes planters will wear gloves that are impermeable to Fosetyl-Al. Because of these low levels of risk, the Agency has determined that the potential adverse effects associated with the registrable uses are negligible and do not constitute an unreasonable adverse effect. These risk estimates,, low as they are, are nonetheless likely to be overestimates of any actual risk exposure since they represent linear risk models at the level of detection, and uncertainties in other inputs to the risk model were assumed at conservative levels. E. Criteria for Registration Under This Standard To be covered by this Standard, products must contain Fosetyl-Al as the sole active ingredient, bear required labeling, and conform to the product composition, acute toxicity limits, and use pattern requirements listed in Section F of this document. F. ACCEPTABLE RANGES AND LIMITS 1. Product Composition Standard To be covered under this Standard, Manufacturing-use products must contain Fosetyl-Al as the sole active -3- ------- ingredient. Each with an appropriate certification of limits. 2. Acute Toxicity Limits The Agency will consider registration of technical grade products and MPs containing Fosetyl-Al for any acute toxicity category, provided that the labeling of those products bears appropriate precautionary statements. 3. Use Patterns To be registered under this Standard manufacturing-use products containing Fosetyl-Al may be labeled for formulation only into end-use products for: "Terrestrial, non-domestic, food uses on: pineapple crowns {seed pieces). "Terrestrial, non-domestic, non-food uses on: ornamentals (including azalea, boxwood, Japanese holly, juniper, Monterey pine, Pieris japonica, Pittosporium, rhododendron, and Schefflera). "Domestic, outdoor uses on: ornamentals {as specified above). "Greenhouse, non-food uses on: ornamentals (as specified above). REQUIRED LABELING All manufacturing-use products containing Fosetyl-Al must bear appropriate labeling as specified in 40 CFR 162.10. Other portions of the guidance package contain specific information regarding label requirements. 1. Use Pattern Statements The ingredient statement for MPs must list the active as: Aluminum tris (0-ethylphosphonate) %. In addition, all MPs must state that they are intended only for formulation into end-use products for any of the use patterns listed above. (Specify those sites listed in Use Patterns ih Section F. 3•) A limiting factor will be the data that support these use patterns. 2. Precautionary Statements Labels for all MP products containing Fosetyl-Al must bear statements reflecting the acute human toxicity of the compound. Fosetyl is in Toxicity Category I for eye -4- ------- irritation; Category III for oral, dermal and inhalation routes of exposure; and Category IV for dermal irritation The required precautionary statements associated with these Toxicity Categories are specified in 40 CFR §162.10 The following environmental hazard statement must appear on all manufacturing-use product labels: Do not discharge into lakes, streams, ponds or public water unless in accordance with NPDES permit. For guidance contact your Regional Office of the EPA Labeling statements to end-use products are not required to be included in this standard,* however, in order to reduce the oncogenic risks to pineapple seed piece planters, the following note to user must appear on the label for the pineapple use: Note to User; Gloves impermeable to Fosety1-A1 must be worn during the handling and planting of pineapple crowns (seed pieces). ------- GENERIC 1/ Data Requirement Composition TGAI TGAI TGAI 158.120 Product Chemistry Product Identity: 6 1-1 - Identity of Ingredients 61-2 - Statement of Composition 61-3 - Discussion of Formation of Ingredients Analysis and Certification of Product Ingredients 62-1 - Preliminary Analysis TGAI 62-2 - Certification of Limits TGAI 62-3 - Analytical Methods for TGAI Enforcement of Limits Physical and Chemical Characteristics 63-2 - Color TGAI 63-3 - Physical State TGAI 6 3-4 - Odor TGAI 63-5 - Melting Point TGAI 63-6 - Boiling Point TGAI TABLE A DATA REQUIREMENTS FOR FOSETYL-AL Does EPA Have Data Must Additional To Satisfy This Data Be Submitted Requirement? (Yes, Bibliographic Under FIFRA Section No or Partially) Citation 3(c)(2)(B)? Yes 00098326 No Yes 00098326 No Yes 00098326 No Yes 00098326 No Yes 00098326 No Yes 00098327 No Yes 00098325 No Yes 00098325 No Yes 00098325 No Yes 00098325 No Not applicable^/ ------- TABLE A GENERIC DATA REQUIREMENTS FOR FOSETYL-AL Data Requirement Composition Does EPA Have Data To Satisfy This 1/ Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c) (2) (B)? 158.120 Product Chemistry Product Identity: 6 3-7 - Density, Bulk Density, or Specific Gravity (continued) 6 3-8 - Solubility 63-9 - Vapor Pressure 63-10- Dissociation constant 63-11- Octanol/water partition coefficient 63-12- pH 63-13- Stability Other Requirements; 64-1 - Submittal of samples TGAI TGAI OR PAI TGAI OR PAI TGAI OR PAI PAI TGAI TGAI TGAI Yes Yes Not applicable-*^ Yes Yes Yes Yes Yes 00098325 00098325 00098325 00098325 00098325 00098325 No No No No No No4/ No 1/ Composition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; Choice = Choice of several test substances determined on a case-by-case basis. 2/ Data are not needed as Fosetyl-Al is a powder, boiling point is not relevant. 3/ Data are not needed as Fosetyl-Al is a non-volative. 4/ A three-month stability study was provided. The study is adequate to support registration of products for uses covered by this standard. Any additional uses will require a 12-month stability study. 7 ------- TABLE A GENERIC DATA REQUIREMENTS FOR FOSETYL-AL Data Requirement Composition Does EPA Have Data To Satisfy This _1/ Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? PAIRA and plant metabolites 158.125 Residue Chemistry 171-4 - Nature of Residue (Metabolism) - Plants PAIRA - Livestock 171-4 - Residue Analytical Method - Plant residues TGAI and metabolities - Animal residues TGAI and metabolities 171-4 - Storage Stability Data TEP 171-4 - Magnitude of the Residue- Residue Studies for Each Food Use Crop 1 (Pineapples) — Crop field trials PAI — Processed Food/Feed EP -- Meat/milk/poultry/eggs TEP/EP Yes Not applicable Yes Not applicable Yes Yes Not applicable Not applicable 00103249 00103250 00103250 GS-0260-061 00103250 GS-0260-061 No2/ No2/ No2/ No2/ Composition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP = Typical end-use product; EP = End-use product. Data support use on pineapple, additional crops or change in use pattern will require additional data. 8 ------- TABLE A GENERIC DATA REQUIREMENTS FOR FOSETYL-AL 1/ Data Requirement Composition Use 2/ Pattern Does EPA Have Data To Satisfy This Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.130 Environmental Fate DEGRADATION STUDIES-LAB; 161-1 - Hydrolysis Photodegradation 161-2 - In water 161-3 - On soil 161-4 - In air METABOLISM STUDIES-LAB; 162-1 - Aerobic Soil TGAI or PAIRA A,B,F,H TGAI or PAIRA A,B TGAI or PAIRA A, TGAI or PAIRA A, TGAI or PAIRA A,B,F,H 162-2 - Anaerobic Soil TGAI or PAIRA 162-3 - Anaerobic Aquatic TGAI or PAIRA 162-4 - Aerobic Aquatic TGAI or PAIRA MOBILITY STUDIES; 163-1 - Leaching and TGAI or PAIRA Adsorption/Desorption Leaching Adsorption A,B,F,H Yes Yes Yes Yes Yes No Not Applicable Not Applicable Yes 00098370 or 00098325 00098371 00098371 00098731 00106018 00098372 No No No No No No^/ No No No 00098375 00106019 9 ------- TABLE A GENERIF DATA REQUIREMENTS FOR FOSETYL-AL 1/ Data Requirement Composition Use 2/ Pattern Does EPA Have Data To Satisfy This Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.130 Environmental Fate (continued) 163-2 - Volatility (Lab) TEP 163-3 - Volatility (Field) TEP DISSIPATION STUDIES-FIELD: 164-1 - Soil TEP 164-2 - Aquatic (Sediment) TEP 164-3 - Forestry TEP 164-4 - Combination and TEP Tank Mixes 164-5 - Soil, Long-term TEP ACCUMULATION STUDIES: 165-1 - Rotational Crops PAIRA (Confined) 165-2 - Rotational Crops TEP (field) 165-3 - Irrigated Crops TEP A,F A, F No No No Not Applicable Not Applicable Not Applicable No No No No No4/ No4/ No5/ No No No No5/ No5/ No5/ No5/ 10 ------- TABLE A GENERIC DATA REQUIREMENTS FOR FOSETYL-AL Data Requirement V Use 2/ Composition Pattern Does EPA Have Data To Satisfy This Requirement? (Yes, Bibliographic No or Partially) Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.130 Environmental Fate (continued) 165-4 - In Fish TGAI or PAIRA A,F No No6/ 165-5 - In Aquatic Non-Target TEP Organisms Not Applicable No - Field exposure study TEP A No 1/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP = Typical end-use product. 2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor; I = Indoor. 3/ This requirement is waived based on the short half-life of Fosetyl-Al under aerobic conditions and the known fate of phosphates under anaerobic conditions. This waiver is for preplant pineapple dip only. Additional uses may require this study. 4 Not required because the active ingredient is a non-volatile salt. 5/ This requirement is waived based on the short half-life (1 J/2 hours) determined in the aerobic soil metabolism study. 6/ This requirement is waived because the octanol/water partition coefficient is low (ranges from 1.7 X 10"^ to 5.2 X 10-3) and the short half-life. 7/ Field study to determine potential exposure to pineapple planters. Contact the Agency concerning protocol and conduct of this study 11 ------- TABLE A GENERIC DATA REQUIREMENTS FOR FOSETYL-AL 1/ Data Requirement Composition Use 2/ Pattern Does EPA Have Data To Satisfy This Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.135 Toxicology ACUTE TESTING: 8 1-1 - Oral LD50 TGAI Rat/rabbit^/ 81-2 - Dermal LD50 TGAI 81-3 - Inhalation LC50 - Rat TGAI 81-7 - Acute Delayed TGAI Neurotoxicity - Hen SUBCHRONIC TESTING: 82-1 - 90-Day Feeding - Rodent, Non-rodent TGAI Rat Dog 82-2 - 21-Day Dermal TGAI 82-3 - 90-Day Dermal TGAI 82-4 - 90-Day Inhalation - TGAI Rat 82-5 - 90-Day Neurotoxicity- TGAI Hen/Mammal. A,B,F,H A,B,F,H A,B,F,H A,B,F,H Yes Yes Yes Npt Applicable Yes^/ Yes Not Applicable Not Applicable Not Applicable 00098330 00098331 00098332 00098336 00098337 00098338 No No No No No No No No 12 ------- TABLE A GENERIC DATA REQUIREMENTS FOR FOSETYL-AL 1/ Data Requirement Composition Use 2/ Pattern Does EPA Have Data To Satisfy This Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.135 Toxicology (continued) CHRONIC TESTING: 83-1 - Chronic Toxicity - TGAI 2 species: Rodent (Rat) A,B.F,H Yes 00098339 000983525/ No and Non-rodent (Dog) 00098340 83t2 - Oncogenicity Study - Rat and Mouse preferred TGAI A,B.F,H Yes 000983396/ 000983525/ 00098353 No 83-3 - Teratogenicity - 2 species Rabbit and Rat TGAI A,B.F,H Yes 00098347 00114091 No 83-4 - Reproduction, 2-generation TGAI A,B.F,H Yes 00098348 No 13 ------- TABLE A GENERIC DATA REQUIREMENTS FOR FOSETYL-AL 1/ Data Requirement Composition Use 2/ Pattern Does EPA Have Data To Satisfy This Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.135 Toxicology (continued) MUTAGENICITY TESTING: 84-2 - Gene Mutation TGAI A,B,F,H Ames test/S. Typhimurium (unactivated & activated) and Yeast Assay (D7)/S. Cerevisiae. 84-2 - Chromosomal Aberration TGAI A,B,F,H Induct. test/E. Coli.(unactivated & activated) and DNA Repair/E. Coli. 84-2 - Other Mechanisms of Mutagenicity TGAI A,B,F,H Micronucleus test/ mouse(oral route) SPECIAL TESTING 85-1 - General Metabolism PAI or PAIRA 85-2 - Domestic Animal Safety Choice Yes Yes Yes A,B,F,H Not Applicable Yes 00098343 00098345 00098343 00098345 00098345 00098358 No No No No No 14 ------- TABLE A GENERIC DATA REQUIREMENTS FOR FOSETYL-AL Data Requirement 1/ Use 2/ Composition Pattern Does EPA Have Data To Satisfy This Requirement? (Yes, Bibliographic No or. Partially) Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.135 Toxicology (continued) 1/ Composition: PAI = Pure active ingredient; PAIRA = Pure active ingredient, radiolabelled; Choice = Choice of several test substances determined on a case-by-case basis. 2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor; I = Indoor. 3/ The rabbit oral LD50 is used for support as it is the most sensitive species for the oral hazard. 4/ The 90-day feeding study requirements are superseded by the chronic feeding studies listed in 83-1. 5/ Study was conducted with phosphorous acid metabolite. 6/ The review of the rat study demonstrates a positive oncogenic effect at the 8,000 and 30,000-40,000 ppm dose levels. TJ Any request for additional uses of Fosetyl-Al must be supported by (a) either an application exposure study or estim- ates of applicator exposure and (b) either a dermal penetration study or estimates of dermal penetration. 15 ------- TABLE A GENERIC DATA REQUIREMENTS FOR FOSETYL-AL 1/ Data Requirement Composition Use 2/ Pattern Does EPA Have Data To Satisfy This Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.145 Wildlife and Aquatic Organisms AVIAN AND MAMMALIAN TESTING 71-1 - Avian Oral LD50 7 1-2 - Avian Dietary LC50 Bobwhite Quail Mallard Duck 71-3 - Wild Mammal Toxicity 71-4 - Avian Reproduction 71-5 - Simulated and Actual Field Testing - Mammals and Birds AQUATIC ORGANISM TESTING 72-1 - Freshwater Fish LC, 50 Bluegill Sunfish Rainbow Trout 72-2 - Acute LC^q Freshwater Invertebrates Daphnia magna TGAI TGAI TGAI TGAI TEP TGAI TGAI A,B,F,H A,B,F,H A, B,F,H A,B,F,H Yes Yes No No No Partial Partial 00098360 00098362 00098363 00119526 No No No3/ No4/ No4/ No 5/ No 5/ 16 ------- TABLE A GENERIC DATA REQUIREMENTS FOR FOSETYL-AL 1/ Data Requirement Composition Use 2/ Pattern Does EPA Have Data To Satisfy This Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.145 Wildlife and Aquatic Organisms (continued) 72-3 - Acute LC^q Estuarine TGAI and Marine Organisms Grass Shrimp 72-4 - Fish Early Life TGAI Stage and Aquatic Invertebrate Life-Cycle 72-5 - Fish - Life-Cycle TGAI 72-6 - Aquatic Organism 7 2-7 - Simulated or Actual Field Testing - Aquatic Organisms TGAI, PAI or Degradation Product TEP A,B,F,H Partial Not Applicable Not Applicable Not Applicable Not Applicable 00098368 Yes 6/ No No No No 17 ------- TABLE A GENERIC DATA REQUIREMENTS FOR FOSETYL-AL _1/ Use 2/ Does EPA Have Data To Satisfy This Requirement? (Yes, Bibliographic No or Partially) Citation Must Additional Data Be Submitted Under FIFRA Section Data Requirement Pattern 3(c)(2)(B)? 158.145 Wildlife and Aquatic Organisms (continued) 1/ Composition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient, TEP = Typical end-use product. 2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor; I = Indoor. 3/ This requirement is waived since the mammalian toxicity data indicate that the chemical will pose a low potential risk to wild mammals. 4/ This data requirement is waived for pineapple crown dip and ornamental use based on the short half-life of Fosetyl-Al under aerobic conditions and the octanol/water coefficient that indicate persistence and accumulation are not expected. These data may be required for additional uses. 5/ The rainbow trout and Daphnia magna studies have been received, however they have not been reviewed. 6/ This study alone is not sufficient to meet this requirement. However, the uses covered in this standard do not warrant any additional data. 18 ------- TABLE A GENERIC DATA REQUIREMENTS FOR FOSETYL-AL 1/ Data Requirement Composition Use 2/ Pattern Does EPA Have Data To Satisfy This Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.150 Plant Protection 121-1 - TARGET AREA PHYTOTOXICITY EP No No 3/ NONTARGET AREA PHYTOTOXICITY TIER I 122-1 - Seed Germination/ Seedling *Emergence 122-1 - Vegetative Vigor 122-2 - Aquatic Plant Growth TIER II3/ 123-1 - Seed Germination/ Seedling Emergence 123-1 123-2 124-1 124-2 Vegetative Vigor Aquatic Plant Growth TIER III 3/ Terrestrial Field Aquatic Field TGAI TGAI TGAI TGAI TGAI TGAI TEP TEP No No No No3/ No3/ No3/ 19 ------- TABLE A GENERIC DATA REQUIREMENTS FOR FOSETYL-AL 1/ Data Requirement Composition Use 2/ Pattern Does EPA Have Data To Satisfy This Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.150 Plant Protection (continued) \/ Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product. EP = End-use product. £/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor; I = Indoor. £/ The requirement for submission of these data is being reserved. 20 ------- TABLE A GENERIC DATA REQUIREMENTS FOR FOSETYL-AL 1/ Data Requirement Composition Use 2/ Pattern Does EPA Have Data To Satisfy This Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.155 Nontarget Insect NONTARGET INSECT TESTING- POLLINATORS 141-1 - Honeybee acute contact LD50 TGAI 141-2 - Honeybee - toxicity TEP of residues on foliage 141-3 - Wild bees important in TEP alfalfa pollination - toxicity of residues on foliage 141-4 - Honeybee subacute (Reserved) feeding study 141-5 - Field testing for TEP pollinators Not Applicable Not Applicable Not Applicable Not Applicable No No No No _1/ Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product. EP = End-use product. 2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, Food Crop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food; G = Forestry; H = Domestic Outdoor; I = Indoor. 3/ The requirement for submission of these data is being reserved. 21 ------- TABLE A PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOSETYL-AL Data Requirement Composition Does EPA Have Data To Satisfy This Y/ Requirement? (Yes, No or Partially) Bi b1i ographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.120 Product Chemistry Product Identity: 61—1 - Identity of Ingredients MP 61-2 - Statement of Composition MP 61-3 - Discussion of Formation MP of Ingredients Analysis and Certification of Product Ingredients 62-1 - Preliminary Analysis MP 62-2 - Certification of Limits MP 62-3 - Analytical Methods for MP Enforcement of Limits Physical and Chemical Characteristics 63-2 - Color MP 63-3 - Physical State MP 63-4 - Odor MP 63-7 - Density, bulk density, or MP specific gravity Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes 00098325 00098325 00098325 00098325 00098325 00098327 00098325 00098325 00098325 00098325 No No No No No No No No No No 22 ------- TABLE B PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOSETYL-AL Data Requirement Composition Does EPA Have Data To Satisfy This 1/ Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.120 Product Chemistry (continued) 63-12- pH 63-14- Oxidizing or action 63-15- Flammability 63-16- Explodability 63-17- Storage Stability 63-18- Viscosity 63-19- Miscibility Other Requirements 64-1 - Submittal of Samples MP MP MP MP MP MP MP Choice Yes Yes Yes Yes Yes Not applicable Not applicable 00098325 00098325 00098328 00098328 00098325 No No No No No 1/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP Typical end-use product; EP = End-use product; MP = Manufacturing-use product. Choice = Choice of several test substances determined on a case-by-case basis. Required for all uses. 23 ------- TABLE B PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FOSETYL-AL 1/ Data Requirement Composition Use 2/ Pattern Does EPA Have Data To Satisfy This Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA Section 3(c)(2)(B)? 158.135 Toxicology ACUTE TESTING 81-1 - Oral LD50 MP 81-2 - Dermal LD5Q MP 81-3 - Inhalation LC50 MP 8 1-4 - Primary Eye MP Irritation - Rabbit 81-5 - Primary Dermal MP Irritation 81-6 - Dermal Sensitization MP A,B,F,H A,B,F,H A,B,F,H A,B,F,H A,B,F,H A,B,F,H Yes Yes Yes Yes Yes Yes 00098330 00098331 00098332 00098333 00098334 00098335 No No No No No No V Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP = Typical end-use product; EP = End-use product; MP = Manufacturing-use product. Required for all uses. 2/ The use patterns are coded as follows: A = Terrestrial, Food Crop; B = Terrestrial, Non-Food; C = Aquatic, FoodCrop; D = Aquatic, Non-Food; E = Greenhouse, Food Crop; F = Greenhouse, Non-Food Crop; G = Forestry; H = Domestic Outdoor; I = Indoor. 24 ------- Registration Standards Case D260: Fosetyl-Al BIBLIOGRAPHY OF STUDIES CONSIDERED IN SUPPORT OP REGISTRATION UNDER THE STANDARD All studies in this bibliography are usable only with the permission of their submitter--Rhone-Poulenc—under the provisions of FIFRA §3(c)(1)(D)(i), for the ten-year period beginning with the date of first product registration under this standard. MRID CITATION 00098325 Rhone-Poulenc Chemical Company (1981) Product Chemistry: Fosetyl-Al. Includes method LS 74.783 dated July 7, 1980, method dated May 7, 1981 and undated method RE- 18-81. (Compilation! unpublished study received Apr 5, 1982 under 359-705; CDL:247159-A) 00098326 Bertrand, A. (1981) Fosetyl-Al; Composition•of the Technical Grade Industrial Product (Analysis of 5 Typical Batches): Ref: AG/CRLD/An AB/SV 164. Includes method P-286-06-80 and method P.306-03/81. (Unpublished study received Apr 5, 1982 under 359-705: prepared by Rhone-Poulenc Agrochimie, France, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.,* CDL:247159-B) 00098327 Rhone-Poulenc Agrochimie (1980) Fosetyl-Al or Ca (0—ethyl Phosphonate Salts of Aluminium or Calcium) Lodometric Determination in the Technical compounds and formulations. Method P-286-06-80 DAted July 17, 1980. (Translation; unpublished study received Apr 5, 1982 under 359-705; Submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247159-C) 00098328 Rhone-Poulenc Agrochimie (19??) Fosety-l-Al Technical Stability to Heat, Inflammability Explosivity: AG/RD/DARGOIRE SRPH JD/NC/177. (Unpublished study received April 5, 1982 under 359-705? submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.} CDL:247159-D) 00098330 Pasquet, J.; Mazuret, A.; Maratrat, 7; et al. (1977) LS 74- 783 (Aluminium Ethyl Phosphite,- 32 545 R.p., Aluminium Salt): Acute toxicity in the Rat and Rabbit: R.P./R.D./C.N.G. No. 19 143-E. (Translationj unpublished study received April 5, 1982 under 359-705? prepared by Rhone-Poulenc, France, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247160-B) 00098331 Pasquet, J.? Mazuret, A.? Kali fat, R; et al« (1981) Fosetyl- Al (32 545 R.P., Aluminium Salt): Acute Percutaneous Toxicity in the Rabbit: Reference C.R. Vitry/C.N.G. No. 21 162-E. (Translation; unpublished study received April 5, 1982 under 359-705; prepared by Rhone-Poulenc Industries, France, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247160-C) 25 ------- Fosetyl-Al Bibliography page 2 CITATION Coombs, D.W.; Clark, G.C. (1977) Acute Inhalation Toxicity in Rats: Four Hour Exposure to the Dust of LS 74.783 (Technical): RNP 79/77546. (Unpublished study received April 5, 1982 under 359-705; prepared by Huntingdon Research Centre, England, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N. J.; CDL:247160-D) Pasquet, J.; Mazuret, A.,* Maratrat, ?; et al. (1981) Fosetyl- Al (32 545 R.P., Aluminium Salt): Primary Eye Irritation in in the Rabbit: Reference C.R. Vitry/C.N.G. No. 21 163-E. (Translation; unpublished study received April 5, 1982 under 359-705; prepared by Rhone-Poulenc Industries, France, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247160-E) Pasquet, J.; Mazuret, A.; Maratrat, ?; et al. (1981) Fosetyl- Al (32 545 R.P., Aluminium Salt): Primary Skin irritation in in the Rabbit: Reference C.R. Vitry/C.N.G. No.. 21 164-E. (Translation; unpublished study received April 5, 1982 under 359-705; prepared by Rhone-Poulenc Industries, France, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247160-F) Elliott, P.H.; Seaber, J.A. (1979) Screening Test for Delayed Contact Hypersensitivity with Fosetyl-Al (LS 74-783) in the Albino Guinea Pig: 79443D/RNP/168. (Unpublished study received April 5, 1982 under 359-705; prepared by Huntingdon Research Centre, England, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247160-G) Coquet, B.; Guyot, D. ; Galland, L.; et al. (1977) LS 74783: 3 Month Oral Toxicity Study in the Rat: IFRED R 770359 (Translation; unpublished study received April 5, 1982 under 359-705; prepared by Institut Francais de Recherches et Essais Biologiques, France, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CLD:247161-A) Coquet, B.; Clair, M. (1977) LS 74783 (Aluminium Ethylphosphite) 3 Month Oral Toxicity Study in the Dog: IFRED R- 712110. A translation of: LS 74783 (Ethylphosphite D'Aluminium): Toxicite a Terme (3 mois) Par Voie orale Chez le Chien: IFREB-R 709235. (Unpublished study received April 5, 1982 under 359-705; prepared by Institut Francais de Recherches et Essais Biologiques, France, submitted by Rhone-Poulenc Chemical Co'., Monmouth Junction, N.J.; CLD:247161-B) Kynoch, S.R.; Lloyd, G.K.; Mallard, J.R.; et al. (1979) The Effect of Repeated Applications of LS 74783 Technical to the Skin of Rabbits for Twenty-one Days: RNP/123/79314. (Unpublished study received April 5, 1982 under 359-705; prepared by Huntingdon Research Centre, England, submitted by Rhone-Poulenc Chemical Co., Monmouth, N.J.,* CDL: 247161 -C ) 26 ------- Fosetyl-Al Bibliography page 3 MRID CITATION 00098339 Spicer, E. J. F.; Trumbull, R.R.; Blanchard, G.L.; et al« (1981) Chronic Toxicity (2 Year) and Carcinogenicity Study in Rats: IRDC Study No. 347-016. (Unpublished study received April 5, 1982 under 359-705; prepared by International Research and Development Corp., submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.j CDL:247162-66) 00098340 Spicer, Phillips, L.M.; Richter, W.R.; et al. (1981) Two-year Dietary Toxicity Study in Dogs: IRDC Study No. 347-023. (Unpublished study received April 5, 1982 under 359-705? prepared by International Research and Development Corp., submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.,- CDL:247167-A) 00098343 ' Bouanchaud, D.H.; Cartier, J.R.; Vessieres, ? (1981) Fosetyl-Al (32 545 R.P., Aluminum Salt); Supplementary Studies of Mutagenesis in Microorganisms: C.R. Vitry/C.N.G. No. 21 212. (Unpublished study received April 5, 1982 under 359-705? prepared by Rhone-Poulenc Industries, France submitted by Rhone-Poulenc Chemical Co., Monmouth J unction, N.J.; CDL:247173-B) 00098345 Cordier, A.; Fournier, E.; "Viziere, ? (1981) Fosetyl-Al (32 Sys R.P., Aluminium Salt): Micronucleus Test in the Mouse by the Oral Route: Reference C.R. Vitry/C.N.G. No 21 186-E. (Translation, unpublished study received April 5, 1982 under 359-705? prepared by Rhone-Poulenc Industries France, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J. ; CDL:247173-D) 00098347 Pasquet, J.; Le Bail, R.,; Cegeral, ? (1976) Compound LS 74-783? Oral Teratogenicity Study in the Rabbit: Report R.P./R.D./C.N.G. No. 18917-F. (Translation, unpublished study received April 5, 1982 under 359-705; prepared by Rhone-Poulenc, France, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.? CDL:247174-A) 00098348 Palmer, A.K.; Bottornley, A.M.; Barton, S.Jet al. (1981) Effect of LS 74-783 on Reproductive Function of Multiple Generations in the Rat: RNP/89/8Q745. (Unpublished study received April 5, 1982 under 359-705; prepared by Huntingdon Research Centre, England, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247174-C) 00098352 Spicer, E.J.F.; Phillips, L.M.? Richter, W.R.; et al. (1981) Life-time Chronic Toxicity and Carcinogenicity Study in- Rats: IRDC Study No. 347-022. (Unpublished study received April 5, 1982 under 359-705; prepared by International Research and Development Corp., Submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247176-82) 27 ------- Fosetyl-Al Bibliography page 4 MRID CITATION 00098353 Spicer, E.J.F.j Phillips, L.M.; Richter, W.R.; et al. (1981) 24-month Carcinogenicity Study in Mice: IRDC Study No. 347-021. (Unpublished study received April 5, 1982 under 359-705; prepared by International Research and Development Corp., submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.j CDL:247168-71) 00098358 Caillard, C.G.j Deregnaucourt, J.; Garret, C.; et al. (1980) ¦ Monoethylphosphonic Acid, Aluminium Salt (LS 74 783 = 32 545 R.P. , "Aluminium Salt): Effects in a Number of Pharmaco- logical Tests: R.P./R.D./C.N.G. No. 20 680-E. (Translation; unpublished study received April 5, 1982 under 359-705,* prepared by Rhone-Poulenc, France, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247183-E) 00098360 Roberts, N.L.j Phillips, C.N.K. (1981) The Acute Oral Toxicity (LD50) of LS 74.783 to the Bobwhite Quail: RHP 189 WL/81148. Final report. (Unpublished study received April 5, 1982 under 359-705; prepared by Huntingdon Research Centre, England, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247184-B) 00098362 Roberts, N.L.; Phillips, C.N.K.; Almond, R.H. (1982) The Subacute Dietary Toxicity (LC50) of LS 74.783 to the Bobwhite Quail: RNP 189 WL/81699. .Final report. (Unpublished study received April 5, 1982 under 359-705; prepared by Huntingdon Research Centre, England, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247184-D) 00098363 Roberts, N.L.; Phillips, C.N.K.; Almond, R.H. (1981) The Subacute Dietary Toxicity (LCjq) of LS 74.783 to the Mallard Duck: RNP 189 WL/81699. Final report. (Unpub- lished study received April 5, 1982 under 359-705; prepared by Huntingdon Research Centre, England, submitted by Rhone- Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247184-E) 00098368 Rhoderick, J.C.; Spare, W.C.; Hutchinson, C. (1981) The Acute Toxicity of Aluminum-ethyl-phosphonate to Grass Shrimp, Palaemonetes pugio: Project No. 381-2. (Unpublished study received April 5, 1982 under 359-705; prepared by Biospherics, Inc., submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.? CDL:247184-J) 00098370 Buys, M.; Bertrand,; Giraud, J.P. (1981) Fosetyl-al (Aluminium Tris-O-ethylphosphonate) Hydrolysis Study: Ref, AG/CRLD/An/ AB/MB/JPG/CB/613.81. (Unpublished study received April 5, 1982 under 359-705; prepared by Rhone-Poulenc Agrochemie S.A., France, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247185-B) 28 ------- Fosetyl-Al Bibliography page 5 CITATION Bertrand, A. (1981) Fosetyl-al: UV Absorption Characteristics: Ref. No. AG/CRLD/An/AB/DB/324/81. (Unpublished study received April 5, 1982 under 359-705; prepared by Rhone- Poulenc Agrochimie, France, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247185-C) Hascoet, M. ; Jamet, P. (1978) Aluminium Ithylphosphite Degradation in the Soil. (Translation France, Ministere de 1'Agriculture, Institut National de la Recherche Agronomique, Laboratoire de Phytopharmacie; unpublished study, received April 5, 1982 under 359-705; submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J., CDL;247185-D) Buys, M.; Giraud, J.P. (1981) Fosetyl-al (Aluminum Tris-O-ethyl- phosphonate) Soil Leaching Studies: Ref. AG/CRLD/An/ AB/MB/JPG/ CB/0 25.82. (Unpublished study received April 5, 1982 under 359-705,- prepared by Rhone-Poulenc Agrochemie, France, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:247185-G) Brockelsby, €•; Catchpole, A.; Crouch, R. (1977) Fungicides: Alu- minum Ethyl Phosphite (LS 74.783 or Aliette): Studies with the 14C-Labelled Compound in vines: AR/1257. (Unpublished study re- ceived June 8, 1982 under 359-706; prepared by May 6 Baker Ltd., Eng. submitted by Rhone-Poulenc, Inc., Monmouth Junction, N.J.; CDL:247647-B) Laurent, M.j Chabassol, Y. (1982) Fosetyl-Al (32 545 R.P. Alumin- ium Salt): Pineapple Metabolism Study: Report C.R. Vitry/CNG-An No. 4412-E. (Translation; unpublished study received Jun -8, 1982 under 359-706; submitted by Rhone-Poulenc, Inc. Monmouth Junction, N.J. ; CDL:247647-C) Buys, M.j Giraud, J.P. Alix, M.; et al. (1982) Fosetyl-Al (Aluminum Tris-o-ethylphosphonate) Soil Metabolism Study: Ref. AG/CRLD/ AN/ 262.82. (Unpublished study received April 5, 1982 under 359-705; prepared by Rhone-Poulenc Agrochemie S.A., France, submitted by Rhone-Poulenc Inc., Monmouth Junction, N.J.; CDL:247820-A) Bertrand, A.; Buys, M. (1982) Fosetyl-Al--Soil Sorption Studies: Ref. • AG/CRLD/AN/163.82. (Unpublished study received July 1*3, 1982 under 359-705,* prepared by Rhone-Poulenc Agrochimie S.A., France, submitted by Rhone-Poulenc, Inc., Monmouth Junction, N.J., CDL:247820-B) 29 ------- Fosetyl-Al Bibliography page 6 MRID CITATION 00114091 Palmer, A.K., James, R.W. (1977) Effect"of LS 74-783 on pregnancy . of the Rats RNP/33/76939. (Unpublished study received April 5, 1982 under 359-705; prepared by Huntingdon Research Centre, England; submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDLS'247174-B) 00119526 Biospherics, Inc. (1982) The Acute Toxicity of Fosetyl-Al to the Bluegill Sunfish (Lepomis macrochirus): Project No. 82-E-380-B. (Unpublished study received Oct. 28, 1982 under 359-705; submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, CDL:248674-A) GS-0260-61 Rhone Poulenc, Incorporated (19??) Residue Data in or on Pineapple Resulting From Aliette Dip and/or Foliar Treatments. (Unpublished study received May 31, 1982 under Pesticide Petition 2FG2702.) Prepared and submitted by Rhone-Poulenc, Incorporated, Monmouth Junction, N.J.; CDL:071591 S 01592. 30 ------- |