Data requirements for pesticide registration

In October of 1981, EPA decided to reorganize the guidelines and limit the regulation to a concise presentation of the data requirements and when they are required. Therefore, data requirements for pesticide registration pertaining to all former subparts of the guidelines are now specified In part 158 (40 FR 53192 November 24, 1982) which specifies the kinds of data and... 

In recent years, there have been a number of examples of such problems (Table II.). The proposed data requirements for pesticide registration prepared by the U.S. Environmental Protection Agency address this topic. This has been an extremely controversial regulatory problem. It is clearly important to know the composition of applied pesticides including the major associated contaminants in order to assess their potential for environmental impact, but as the quantitative significance of... 

Data Requirements for Pesticide Registration", Environmental Protection Agency, Federal Register, 1984, 49, 42856-905. 

Data Requirements for Pesticide Registration, Title 40 Code... 

USEPA] US Environmental Protection Agency. 2007a. Data requirements for pesticide registration. Available from http //www.epa.gov/opp00001/regulating/data requirements. htm. 

U.S. EPA, 1985. Data Requirements for Pesticide Registration Title 40, Code of Federal Regulations, Part 158. 

The discovery of brassinolide by scientists at USDA led to the development of a new group of plant growth substances, termed brassinosteroids, which have the potential for increasing crop yields and biomass. The chapter summarizes the USDA s contributions to brassinosteroids, which include isolation and identification of brassinolide, synthesis of brassinolide and its analogs, and limited biological and field studies on brassinosteroids. An overview of the current data requirements for the registration of brassinosteroids as biochemical pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act is presented. 

Code of Federal Regulations, Data Requirements for the Registration of Pesticides, 40CFR, Parts 152, 153, 156, 158, 162 and 163, U.S. Government Printing Office. 

The ability to perform quantitative assays on complex mixtures with little sample clean-up is perhaps the most attractive feature of immunoassays for application to agricultural chemistry. A large portion of the cost and labor involved in pesticide residue analysis is invested in sample extraction and clean-up steps to remove substances which may interfere with subsequent chemical analysis. Since most preparatory steps are not required prior to performing an immunoassay, samples can be analyzed much less expensively. This will permit the vast number of data points required for pesticide registration to be gathered in a more timely and cost-effective manner. Studies which were prohibitively expensive because they would have required large numbers of expensive assays can be completed using immunoassay procedures. Such studies may include analysis of pesticide movement from application areas and the rate of dissipation of pesticide from crop tissue, soils, and processed foods. 

An example of the kinds of data required for land disposal options would be Information on soll/pestlclde Interactions to determine the effect of the pesticide on the soil and soil on the pesticide. The physical composition of the soil and the physical properties of the pesticide and Its formulation will determine the adsorption, leaching, water dispersal, and volatilization of the pesticide which. In turn, determine the mobility of the pesticide In soil. Even pesticides of closely related structures may have very different soil retention properties. Much of this data will be available from that developed to meet other registration data requirements with the exception that disposal rates are often orders of magnitude higher than normal application rates and the difference must be considered. 

USEPA (1993). Subchapter E - Pesticide Programs Data Requirements for registration, 40 CFR 158 (revised). United States Environmental Protection Agency, Washington, DC, USA. 

In an apparent deviation from this general principle, namely that efficacy studies are not required to be conducted under GLP conditions, the US EPA regulations state, that certain efficacy studies on pesticides have to be conducted under GLP, namely when they are considered as required studies by the relevant US Federal Regulations (Data Requirements for Registration, 40 GFR 158). The EPA GLP regulation 40 GFR 160 dealing with pesticides... 

Brassinosteroids, therefore, would qualify for classification as biochemical pesticides. Once they are classified as biochemical pesticides, the data requirements for U.S. registration would be significantly reduced (because of a tier approach), especially in the areas of toxicology, ecology and wildlife, and environmental fate. Because of their low use volume, brassinosteroids are unlikely to leave any residues in crops, and they would qualify for exemption from the requirement of a tolerance. If that were the case, what applicants seeking U.S. registrations need to do is to develop data on product chemistry and acute toxicology, as well as use profiles for their products, which will be dealt with on a case-by-case basis. 

Guidelines for Registration of Microbial/Biological Pesticides, 1985", Agriculture Canada. "Guidelines for Registering Pesticides in the United States. Subpart M Data Requirements for Biorational Pesticides", Environmental Protection Agency, 1980. 

EC document S ANCO/3030/99 rev.4 11/07/00. Technical material and preparations guidance for generating and reporting methods of analysis in support of pre- and post registration data requirements for Annex II (part A, Section 4) and Annex III (part A, Section 5) of Directive 91/414. http //ec.europa.eu/food/plant/pesticides/approval active substances/docs/ wrkdocl3 en.pdf. Accessed 15 Oct 2013... 

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