United States Prevention, Pesticides EPA712-C-08-023 Environmental Protection And Toxic Substances October 2008 Agency (7101) &EPA Fate, Transport and Transformation Test Guidelines OPPTS 835.6400 Combination and Tank Mixes Field Dissipation i ------- INTRODUCTION This guideline is one of a series of test guidelines that have been developed by the Office of Prevention, Pesticides and Toxic Substances (OPPTS), United States Environmental Protection Agency for use in the testing of pesticides and toxic substances, and the development of test data to meet the data requirements of the Agency under the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and section 408 of the Federal Food, Drug and Cosmetic (FFDCA) (21 U.S.C. 346a). OPPTS developed this guideline through a process of harmonization of the testing guidance and requirements that existed for the Office of Pollution Prevention and Toxics (OPPT) in Title 40, Chapter I, Subchapter R of the Code of Federal Regulations (CFR), the Office of Pesticide Programs (OPP) in publications of the National Technical Information Service (NTIS) and in the guidelines published by the Organization for Economic Cooperation and Development (OECD). For additional information about OPPTS harmonized guidelines and to access this and other guidelines, please go to http://www.epa.gov/oppts and select "Test Methods & Guidelines" on the left side menu. ------- OPPTS 835.6400 Combination and tank mixes field dissipation (a) Scope—(1) Applicability. This guideline is intended for use in meeting testing requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.). It describes procedures that, if followed, would result in data that would generally be of scientific merit for the purposes described in paragraph (b) of this guideline. (2) Background. The source materials used in developing this OPPTS test guideline are OPP 164-4, Dissipation studies for combination products and tank mix uses, OPP 160-4 General test standards, and OPP 160-5 Reporting and evaluation of data (Pesticide Assessment Guidelines, Subdivision N - Chemistry: Environmental Fate, EPA report 540/9-82-021, October 1982). (b) Purpose. The objective of this study is to determine the dissipation characteristics of a pesticide in soil when applied as a tank mix or in combination with other pesticides, whether in a combination product or pursuant to labeling directions recommending the simultaneous or serial application of two or more products. Information from these studies allows the Agency to ascertain if overall soil persistence of pesticides is affected by the simultaneous or serial application of two or more pesticides. (c) General considerations—(1) Uses supported by study data. A laboratory or field soil dissipation study supports the registration of an end-use product containing more than one active ingredient intended for use as a component in tank mixtures, or customarily applied serially with another pesticide product. (2) Endangered species. Field studies should not be conducted in critical habitats or areas containing or suspected to contain endangered or threatened plants or animals that may be threatened by the test to be conducted. (d) Test method—(1) Test substance, (i) For studies on combination products, if the end- use product contains two or more active ingredients (combination product), the test substances should be the end-use product and similarly formulated products containing each active ingredient singly. (ii) For studies on tank mixtures, if the use directions state that two or more end-use products containing different active ingredients may be applied as a tank mixture, the test substances should be the mixture of the end-use products prepared in accordance with the label directions, and each separate end-use product. (iii) For studies or serial applications, if the use directions state that two or more end-use products containing different active ingredients may be applied serially, the test substances should consist of the two or more end-use products to be used in the sequence specified in the label directions. (2) Application. The test substance(s) should be applied at the highest rate recommended by product labeling and as follows: ------- (i) For combination products, apply the test substances at the label-recommended field application rates to both light and heavy-textured soils. Incorporate the test substances into the soil if recommended by label directions. (ii) For tank-mixed pesticides, apply the test substances at the label-recommended field application rates to both light and heavy-textured soils. Incorporate each test substance into the soil if recommended by label directions. (iii) For serially-applied pesticides, apply the test substances individually and as the sequential combination at the label-recommended field application rates to both light- and heavy- textured soils. Incorporate each test substance into the soil if recommended by label directions. (3) Soil sampling. Soil from the treated area or laboratory container should be sampled following treatment for the purpose of ascertaining the extent of pesticide dissipation. (i) Soil samples obtained from the intended site(s) of application or from the laboratory containers immediately prior to application of the test substance should be used as experimental controls. (ii) Sampling times should include pre-application, date of application, and immediate post- application. In the case of multiple applications, only immediate post-application samples (and not pre-application and date-of-application samples) are to be taken in addition. (iii) Soil samples should be taken in increments to a depth of 15 cm, unless results of studies on pesticide mobility indicate that the test substance is likely to leach into soil deeper than 15 cm. (iv) If data on leaching indicate that the test substance is likely to leach into soil deeper than 15 cm, or if the pesticide is incorporated into soil deeper than 5 cm, samples should be taken to a depth sufficient to include most of the leached pesticide. (4) Test duration. Residue data should be collected until patterns of decline of the test substance and patterns of formation and decline of degradation products are established in soil, or for a maximum duration of six months, whichever occurs sooner. (e) Reporting and evaluation of data. Reporting units should be in the metric system, but the English system may be used in addition. The systems should not be mixed (e.g., kilograms/acre). (1) Test method. A statement regarding the test method used, including a full description of the experimental design and procedures. (2) Test substance. The test substance should be identified including: (i) Chemical name and percentage of active ingredient, molecular structure of the active ingredient, and qualitative and quantitative description of the chemical composition, and the names and quantities of known contaminants and impurities. ------- (ii) Manufacturer and lot and sample numbers of the test substances. (iii) Properties of the test substance, including physical state, pH, and stability. (3) Control values. Due to the wide diversity of pesticide properties, use patterns, and organisms likely to be exposed in the field environment, specific reporting elements for control values (as to source, sampling regime, and total number submitted) will depend upon the complexity and variability of the environment in which the test is to be conducted. (4) Test equipment. A description of the test equipment used, and photographs or detailed descriptions of nonstandard equipment. (5) Water. Characteristics of water obtained from a use site should be reported (e.g., pH, temperature, oxygen content, flow rate, and percent of suspended solids). (6) Soils. Characteristics of soils/sediments should be reported, including texture (percent sand, silt, and clay), percent organic matter, moisture content, pH, cation exchange capacity, and bulk density (under field conditions). (7) Protocol development. Kaufman et al (paragraph (f)(l)) contains procedures for the effect of methylcarbamates on acylanilide herbicide residues in soil. J. Agr. Food Chem. 18:204- 206. Kaufman et al (paragraph (f)(2)) provides techniques for methylcarbamate inhibition of phenylcarbamate metabolism in soil. J. Agr. Food Chem. 18:513-519. (8) Analysis and identification of degradation products. Analysis and identification of pesticide residues in field studies should be reported only for those degradation products that were found to form in the laboratory studies. This position is taken because the purpose of field studies is to derive levels of degradation products as a result of pesticide use under field conditions. (9) Calculation and tabular, graphic information. The principal mathematical equations used in generating and analyzing data, as well as representative calculations using these equations. When rates of formation and decline of parent compounds or their degradates are reported in any test, data should be expressed as amounts, concentrations, and corresponding percentages. Rate constants, when appropriate, should be reported in conjunction with rate data. Tabular data, as well as graphs for decline curves and soil sorption, should be submitted. (f) References. The following references should be consulted for additional information on this guideline: (1) Kaufman, D.D., J. Blake, and D.E. Miller. 1971. Methylcarbamates affect acylanilide herbicide residues in soil. J. Agr. Food Chem. 18: 204-206. (2) Kaufman, D.D., P.C. Kearney, D.W. Von Endt, and D.E. Miller. 1970. Methylcarbamate inhibition of phenylcarbamate metabolism in soil. J. Agr. Food Chem.18:513- 519. ------- |