PESTICIEE ASSESSMENT GUIDELINES SUBDIVISION N CHEMISTRY: ENVIRONMENTAL FATE Series 162-1 Aerobic Soil Metabolism Studies ADDENDUM 5 ON DATA REPORTING Prepared by: Samuel M. Creager and E. Brinson Gonerly Exposure Assessment Branch Hazard Evaluation Division Edited by: Anne Bradford Exposure Assessment Branch Hazard Evaluation Division Project Manager: Elizabeth M.K. Leovey, PhD Hazard Evaluation Division Office of Pesticide Programs US Environmental Protection Agency ------- Subdivision N - Aerobic Soil Metabolism Studies Table of Contents of Addendum Discussion Page Introduction 2 Response to Public Comments 2 Guideline Title/Cover Page 5 Table of Contents 5 I. Abstract 5 II. Introduction 6 III. Materials/Mettods 6 IV. Results/Discussion 8 V. Conclusions 8 VI. Certification 8 VII. Tables/Figures 8 VIII. References 8 IX. Appendix(es) 9 -1- ------- PESTICIDE ASSESSMENT GUIDELINES ENVIRONMENTAL FATE Aerobic Soil Metabolism Studies Subdivision N, Section 162-1 DATA REPORTING INTRODUCTION A. Purpose Information from this study enables the Agency to determine what the aerobic soil metabolism rate and metabolic products are for the pesticide. The information is used to predict the likelihood of the compound persisting in the environment, and also whether degradates of concern are likely to be produced and to persist. B. Objective This Data Reporting Guideline (DRG) is designed to aid the petitioner/registrant in generating reports which are compatible with the Agency's review process. Data submitters are encouraged to submit complete reports for efficient review by the Agency- PR Notice 86-5, effective on November 1, 1986 (available from the Office of Pesticide Programs, US EPA), pertains to the physical formatting of reports (which are referred to as "studies") and submittal packages. Some of the requirements in PR Notice 86-5 are mandatory. RESPONSE TO PUBLIC COMMENTS The purpose of this section is to acknowledge and address the concerns ex- pressed in the letters of comment received by the Agency in response to the public notice in FEDERAL REGISTER, Volume 51, No. 199, p. 36753, Oct. 15, 1986. This addendum to the Pesticide Assessment Guidelines [Subdivision N] is to be considered an all-encompassing document. The Exposure Assessment Branch (EAB) has reviewed the comments submitted by the registrants and/or commit- tees in regard to the Data Reporting Guideline (DRG). This Guideline is not intended to create new data requirements, but to provide for consistent reporting of the necessary environmental fate data required to perform a scientifically sound hazard assessment. This approach should eliminate most, if not all, of the recycling of submissions between EAB scientists and the registrant. This discussion has been arranged to consider the general comments referring to environmental fate DRGs first, followed by the specific comments concerning this DRG. -2- ------- -3- General Comments 1. Comment on the location of a specific reporting item: Considering the need to maintain a consistent format, revisions were made to the DPS in response to these comments wherever possible. 2. Ingredient information from testing laboratories: It appears some sponsors do not make this information available to testing laboratories. In such a situation, the sponsor bears the responsibility since he is submitting the data for registration. 3. Standard evaluation procedures (SEPs): SEPs are guidance documents which explain the procedures used to eval- uate environmental effects data submitted to the Office of Pesticide Programs. They are also available from the National Technical In- formation Service. This DRG is compatible with the Agency's review procedures. 4. Appendix(es) - Inclusion of published and previously submitted data: Previously submitted material, both published and unpublished, may be "resubmitted" by reference to Agency file numbers [e.g. Master Record Identification (MRID) number]. In the case of published work which has not been submitted before, it is prudent to submit a copy with the application rather than to assume availability in Agency files. Study-Specific Comments 1. Comment - TABLE CF CONTENTS: Should the TABLE CF CONTENTS include the title of each table and figure or simply the page on which each section begins? Response; Each table and figure should be listed specifically in the TABLE OF CONTENTS. 2. Comment - Section I: The average temperature and temperature range should also be specified. Response; We agree, and have made this modification. 3. Comment - Section III: The use of the word 'narrative' is incorrect and [it should] be deleted or rewritten to convey the intended meaning. ------- -4- Response; We disagree, per the definition in Random House Collegiate Dictionary © 1973. 4. Comment - Section III: [Let] millicuries per millimole (mCi/mmol) and disintegrations per minute per microgram (dpm/ug) replace curies/mole and dpm/g... The millimole (or micromole) is more representative of the range of concentration used in studies [and] dpm/ug is preferred, as [it] is not only more generically accepted but also routinely used in calculations of pesticide concentration. Response; The Agency has no objection to the units this commenter prefers. In any case, units should be clearly specified and used consistently throughout a report. 5. Comment - Test Method: Further clarification is needed on pesticide treatment of the soil. It is assumed that the request pertains to prior treatment incurred under normal agricultural practice. If so, how historically inten- sive does the record need to be? Response; The request refers to actual pesticide treatment of the actual test soil. Ideally, test soil would have received no pesticide treatment for three to five years prior to the test. 6. Comment - Analytical Method(s); The request for method validation, recovery and sensitivity data, quality control procedures and results, would appear to relate to unlabeled (i.e., "cold") methods of analysis involving GLC or HPLC. If so, it should be so stated. Response; Method validation, sensitivity, recovery, and quality control are not concepts limited to any specific method(s) of analysis. Unless the method of analysis is a recognized standard method, the applicant should demonstrate that it actually measures what it is intended to measure. 7. Comment; Likewise, the inclusion of a "material balance" is not clearly understood and needs further clarification. ------- -5- Response; "Material balance" is a description of how completely the starting material (usually, but not always, radiolabeled) is recovered in the analyzed end products. For further details, see Subdivision N of the Pesticide Assessment Guidelines available from NTIS. 8. Comment; It is suggested that it be noted that figures and/or photographs are generally necessary only when specialized equipment is used. Response; The Agency agrees. 9. Comment; Having a separate heading of TABLES/FIGURES may be confusing. ...[I]t ought to be noted that tables and figures can be presented within the text of the results and discussion or as a separate section. Response; Small tables and figures which do not interrupt the flow of the text may be included in the main body of the report. However, extensive tables of data, full page graphs, etc. are preferably placed in a separate section at the end. GUIDELINE TITLE/COVER PAGE Title page and additional documentation requirements (i.e. requirements for data submission and statement of data confidentiality claims), if relevant to the study report, must precede the content of the study formatted below. These requirements are described in PR Notice 86-5. TABLE OF ODNTENTS This page should indicate the overall organization of the study and what material is on which page(s). Tables and figures should be listed in the table of contents. I. ABSTRACT This section should contain the overall summary of the study and mention at least the following points: A. The soil metabolism of the pesticide (use the name of the pesticide used throughout the report) was studied according to the general protocol of the Guidelines; ------- -6- B. Indicate the site of radiolabeling, if relevant; C. Indicate the concentration(s) of the pesticide studied; D. Indicate the soils in which the metabolism was conducted; E. Indicate that the study was conducted in darkness; F. Indicate half-life estimates for parent and significant degradates; G. Indicate the identity of the metabolic productsi and what percent of the initial pesticide concentration they each represent when analyzed throughout the study; H. Indicate the sampling intervals; and I. Indicate the temperature(s) at which the study was conducted, including average and range. II. INTRODUCTION This section should open with a description of the purpose of the study, what requirement it is intended to satisfy and (if applicable) how it supports the position of the registrant. Background and historical infor- mation relative to the study should be placed in this section. III. MATERIALS/METHODS The applicant may elect to describe materials and methods in separate sections or combine into a single section. The instructions below combine the two into one section. This section should be in narrative form. All details with regard to the materials, equipment, experimental design, and procedures used in con- ducting the study should be placed in this section. If the study was done in several phases, e.g. preliminary ("range-finding") and definitive, describe each phase in detail. In addition, the following are to be included, when appropriate: A. Chemical 1. Provide the chemical purity of the material, and state method of analysis if appropriate. 2. If radiolabelled material is used, then provide the chemical and radiochemical purity of the material, its activity in Curies/mole and disintegrations per minute per gram (dpm/g) or other specified standard units of radioactivity, the site of radiolabelling, the isotope used, and the source when appropriate. B. Soils Describe the characteristics of the soils used and their sources. Include the following items: ------- -7- 1. Percentage of sand, silt, clay; 2. Percentage of organic natter; 3. pH; 4. Cation exchange capacity; and 5. Moisture capacity. C. Equipment The description of the experimental design and equipment used should be placed here. D. Test method 1. General The detailed description of the test method should be placed here. For example: a. The method of preparation of soils and apparatus used (such as sieves); b. The set-up and arrangement of the test apparatus (such as biometer flasks, trapping solutions, and the like); c. The method of adding the pesticide to the soil; d. The method and technique of sampling the soil, handling the sample and, if applicable, storing the sample; e. The intervals of sampling and the number of replicates taken; f. Precautions for assuring complete recovery and trapping of volatile parent compound and/or products; g. The method of maintaining the temperature and darkness during the study; h. The level of moisture maintained in the soil during the study and how it was maintained; and i. The history of pesticide treatment of the soil. 2. Analytical Method(s) This should include the following data: a. The full description of each method used in this study; the method validation data, recovery and detection limit data, quality control procedures and results, sample chronatograms, sample calculations and a material balance; the detailed description of the procedures used in prep- aration and handling of the sample throughout the method ------- -8- (Note that methods for degradation products, when appropriate, are included); and b. The identity of the instrumentation, equipment and reagents used and the operating conditions of the instrumentation. IV. RESULTS/DISCUSSION A. This section should contain the scientific results of the study. B. The results of the analysis of the samples are to be placed in this section. C. This section also should contain the derived/projected half-lives for the parent compound and, when applicable, the metabolic products. V. CONCLUSIONS This section should contain the discussion of the degree and significance of the aerobic soil metabolism of the parent compound, and, when applic- able, the metabolic products. VI. CERTIFICATION This should include: A. Signatures of each of the senior scientific personnel responsible for the study; and B. Certification by the applicant that the report is a complete and unal- tered copy of the report provided by the testing facility (except for changes in the title page as required by PR Notice 86-5). VII. TABLES/FIGURES A. Figures/photographs of the equipment used in the methods and flow diagrams of particularly complex extraction/clean-up procedures are to be included here. B. This section should contain the table of structures and chemical names/designations for the parent compound and metabolic products discussed in the study. C. Narrative and tables explaining the steps taken in identifying and quantifying the parent compound and degradation products should be presented here; also, any graphical presentations of the data (accompanied by the tables of the actual values from which the graphs were constructed). D. Tables and figures should be numbered using arabic numerals for figures and roman numerals for tables. VII I. REFERENCES ------- -9- DC. APPEM)IX(ES) At the registrant's option, reprints of methods and other studies cited, raw data, graphs, printouts, calculations, copies of relevant letters/ memos and material not fitting in any of the other sections should be placed here. ------- |