A Practical Approach, Second Edition=Ronald D. Ho.pdf

PERSPECTIVES ON THE DEVELOPMENTAL AND REPRODUCTIVE TOXICITY GUIDELINES 739The ICH guideline on Detection of Toxicity to Reproduction for Medicinal Products was thefirst to be approved. 2 Since 1994, it has been amended twice 3,4 to clarify testing procedures for themale fertility portion of the studies. A history of the regulatory activities and the ICH programregarding these guidelines can be found in the forerunner to this book. 36C. OECD GuidelinesThe Organisation for European Economic Co-operation (OEEC) was formed to administer Americanand Canadian aid under the Marshall Plan for the reconstruction of Europe following WorldWar II. At that time it consisted of its European founder countries plus the United States andCanada. The OECD took over from the OEEC in 1961. The OECD currently includes 30 membercountries in Europe, North America, Asia, and the Pacific.In 1979 to 1980, OECD assisted in updating and standardizing testing procedures for chemicals.53 More recently the OECD Pesticide Working Group, part of OECD’s Environment Program,was established as the first forum for national pesticide regulators from developed countries todiscuss common issues. The OECD Pesticide Working Group was established in 1994 as thePesticide Forum. 54 The purpose of the Pesticide Working Group is to assist countries in managingtheir task of conducting new risk assessments for hundreds of established pesticides, as well asassessments of the active ingredients in newer pesticides. The major activity areas of the PesticideWorking Group include conventional, biological, and antimicrobial pesticides. 54D. EPA GuidelinesThe EPA regulates pesticides and other chemicals for reproductive and developmental hazard andrisk under multiple federal statutes, the most important of which are the Federal Insecticide,Fungicide, and Rodenticide Act 55 and the Federal Food, Drug, and Cosmetic Act (FFDCA). 56 Underthe authority of FIFRA, the EPA reviews and registers pesticides for specific uses. It can alsosuspend or cancel pesticide registration if it deems the pesticide to be hazardous. Section 408 ofthe Federal Food, Drug, and Cosmetic Act 56 allows the EPA to establish maximum residue levels,or tolerances, for pesticides used in or on foods consumed by humans or animals. In 1996, theFood Quality Protection Act (FQPA) was enacted, amending FIFRA and FFDCA. The FQPAestablished higher safety standards for all pesticides used on foods, required uniformity in foodprocessing, and changed pesticide regulations by requiring greater health and environmental protectionfor infants and children. 57 The Office of Pollution Prevention and Toxics (OPPT), formedin 1977, 58 has the primary responsibility for administering the Toxic Substances Control Act. 59 Thislaw covers production and distribution of commercial and industrial chemicals produced by orimported into the United States.The EPA OPPTS has developed uniform guidelines for testing pesticides and other substancesto meet the EPA’s data requirements. 60 These data requirements are regulated by two laws, theToxic Substances Control Act 59 and the Federal Insecticide, Fungicide, and Rodenticide Act. 55Before the harmonization process, slightly different testing procedures and requirements existed inseparate publications by the OPPT, the Office of Pesticide Programs (OPP), and the OECD. 60The EPA works closely with the OECD to develop and carry out OECD Pesticide Programactivities. OPP is involved in cooperative work to harmonize pesticide data requirements, focustest guidelines on pesticide regulatory needs, and harmonize industry data submissions and governmentdata review formats and contents. OECD encourages the exchange of review reports andhas developed an electronic database to facilitate such exchanges and collaboration on reviews.OPP is also working with OECD countries on electronic data submission for industry. As the resultof international agreements, the OECD guidelines may be applied to EPA-regulated chemicals indevelopment.© 2006 by Taylor & Francis Group, LLC