United States Prevention, Pesticides EPA712-C-96-010 Environmental Protection and Toxic Substances August 1996 Agency (7101) &EPA Product Properties Test Guidelines OPPTS 830.1670 Discussion of Formation of Impurities ------- INTRODUCTION This guideline is one of a series of test guidelines that have been developed by the Office of Prevention, Pesticides and Toxic Substances, United States Environmental Protection Agency for use in the testing of pesticides and toxic substances, and the development of test data that must be submitted to the Agency for review under Federal regulations. The Office of Prevention, Pesticides and Toxic Substances (OPPTS) has developed this guideline through a process of harmonization that blended the testing guidance and requirements that existed in the Office of Pollution Prevention and Toxics (OPPT) and appeared in Title 40, Chapter I, Subchapter R of the Code of Federal Regulations (CFR), the Office of Pesticide Programs (OPP) which appeared in publications of the National Technical Information Service (NTIS) and the guidelines pub- lished by the Organization for Economic Cooperation and Development (OECD). The purpose of harmonizing these guidelines into a single set of OPPTS guidelines is to minimize variations among the testing procedures that must be performed to meet the data requirements of the U. S. Environ- mental Protection Agency under the Toxic Substances Control Act (15 U.S.C. 2601) and the Federal Insecticide, Fungicide and Rodenticide Act (7U.S.C. I36,etseq.). Final Guideline Release: This document is available from the U.S. Government Printing Office, Washington, DC 20402 on The Federal Bul- letin Board. By modem dial 202-512-1387, telnet and ftp: fedbbs.access.gpo.gov (IP 162.140.64.19), internet: http:// fedbbs.access.gpo.gov, or call 202-512-0132 for disks or paper copies. This guideline is available in ASCII and PDF (portable document format) from the EPA Public Access Gopher (gopher.epa.gov) under the heading "Environmental Test Methods and Guidelines." ------- OPPTS 830.1670 Discussion of formation of impurities. (a) Scope—(1) Applicability. This guideline is intended to meet test- ing requirements of both the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.) and the Toxic Substances Control Act (TSCA) (15 U.S.C. 2601). (2) Background. The source material used in developing this har- monized OPPTS test guideline is 40 CFR 158.167 Discussion of formula- tion of impurities. (b) Information required. The applicant must provide a discussion of the impurities that may be present in the product, and why they may be present. The discussion should be based on established chemical theory and on what the applicant knows about the starting materials, technical grade of active ingredient, inert ingredients, and production or formulation process. If the applicant has reasons to believe that an impurity that EPA would consider toxicologically significant may be present, the discussion must include an expanded discussion of the possible formation of the im- purity and the amounts at which it might be present. The impurities which must be discussed are the following, as applicable: (c) Technical grade active ingredients and products produced by an integrated system. (1) Each impurity associated with the active ingre- dient which was found to be present in any analysis of the product con- ducted by or for the applicant. (2) Each other impurity which the applicant has reason to believe may be present in his product at any time before use at a level «0.1 percent (1,000 ppm) by weight of the technical grade of the active ingredi- ent, based on what he knows about the following: (i) The composition (or composition range) of each starting material used to produce his product. (ii) The impurities which he knows are present (or believes are likely to be present) in the starting materials, and the known or presumed level (or range of levels) of these impurities. (iii) The intended reactions and side reactions which may occur in the production of the product, and the relative amounts of byproduct impu- rities produced by such reactions. (iv) The possible degradation of the ingredients in the product after its production but prior to its use. (v) Post-production reactions between the ingredients in the product. (vi) The possible migration of components of packaging materials into the pesticide. ------- (vii) The possible carryover of contaminants from use of production equipment previously used to produce other products or substances. (viii) The process control, purification and quality control measures used to produce the product. (d) Products not produced by an integrated system. Each impurity associated with the active ingredient which the applicant has reason to believe may be present in the product at any time before use at a level >0.1 percent (1,000 ppm) by weight of the product based on what he knows about the following: (1) The possible carryover of impurities present in any registered product which serves as the source of any of the product's active ingredi- ents. The identity and level of impurities in the registered source need not be discussed or quantified unless known to the formulator. (2) The possible carryover of impurities present in the inert ingredi- ents in the product. (3) Possible reactions occurring during the formulation of the product between any of its active ingredients, between the active ingredients and inert ingredients, or between the active ingredient and the production equipment. (4) Post-production reactions between any of the product's active in- gredients and any other component of the product or its packaging. (5) Possible migration of packaging materials into the product. (6) Possible contaminants resulting from earlier use of equipment to produce other products. (e) Expanded discussion. On a case-by-case basis, the Agency may require an expanded discussion of information on impurities: (1) From other possible chemical reactions. (2) Involving other ingredients. (3) At additional points in the production or formulation process. ------- |