Pesticide data requirements

Table I. A Partial List of Pesticide Data Requirements...

FIFRA Sections 3 and 4 pertain to registration and reregistration of pesticides, with clearly defined data requirements as outlined in Tide 40 of the US. Code of federal Regulations (51). About 120 different studies are Hsted, most of which are to be done on technical-grade active ingredients (TGAIs). 

Pesticide Assessment Guidelines, Data Requirements Subdivision D, Product Chemistry E, Ha ard Evaluation—Wildlife and Aquatic Organisms F, Ha ard Evaluation—Human and Domestic Animals G, Product Peformance H, Eabeling , Experimental Use Permits J, Ha ard Evaluation—Nontafget Plants K,... 

Harmonization of Environmental Chemistry and Fate Data Requirements Under NAFTA, Regulatory Proposal PRO 2001-02, Health Canada, Pesticide Regulatory Management Agency. Also available on the World Wide Web http //www.hc-sc.gc.ca/pmra-arla/english/pdf/pro/pro2001-02-e.pdf. 

At the fundamental level of equilibrium modeling the advantages are many. The model can combine a number of compartments through simple relationship to describe a realistic environment within which chemicals can be ranked and compared. Primary compartments that chemicals will tend to migrate toward or accumulate in can be identified. The arrangement of compartments and their volumes can be selected to address specific environmental scenarios. Data requirements are minimal, if the water solubility and vapor pressure of a chemical are known, other properties can be estimated, and a reasonable estimate of partitioning characteristics can be made. This is an invaluable tool in the early evaluation of chemical, whether the model be applied to projected environmental hazard or evaluation of the behavior of a chemical in an environmental application, as with pesticides. Finally, the approach is mathematically very simple and can be handled on simple computing devices. 

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... 

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. 

U.S. Environmental Protection Agency, Pesticide Registration Proposed Data Requirements, Federal Register, Vol 47, No. 227, November 24, 1982. 

The data required for the risk assessment in relation to human health can be categorized as data on the identity of the substance, its physico-chemical and toxicological properties, and on exposure. The minimum data set required for a risk assessment depends on the chemical use category (industrial chemical, pesticide, biocide, food additive, food contact material, etc.), the regulation involved, and the goal of the risk assessment. This chapter will focus on the data used in the hazard assessment. 

If the assessment endpoint is a distribution, or a statistic from a distribution (e.g., 95th percentile), it is essential to be clear how the distribution is interpreted (Suter 1998, p 129). If it is a frequency distribution, to what statistical population does the distribution refer For example, does the distribution represent a population of individuals, an assemblage of species, a number of locations treated with pesticides, or a series of time periods The answer to this question has substantial implications for the structure of the assessment model and the types of data required. 

FDA Guidelines for Chemistry and Residue Data Requirements of Pesticide Petitions, Internal Document of the Bureau of Science, Food and Drug Administration, Department of Health, Education and Welfare, Washington, D.C. 20204, dated March, 1968. 

The development of processes to determine aggregate and cumulative exposures adequately to pesticides will require the use of sophisticated modeling practices to generate sufficient data to guide such assessments. An accurate knowledge of pesticide use and pest management practices is essential to modeling efforts. 

Pesticide Registration Data Proposed Data Requirements Part III", U.S. Environmental Protection Agency 1982, 40 CFR 158, 53192-53202, EPA 79. 

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... 

U.S. Environmental Protection Agency Pesticides Registration Proposed Data Requirements, 24, Nov. 1982, 40 CFR Part 158, Federal Register 1982, (227) 53182. 

Figure 5.1 Tiered data requirements for estimating operator exposure for use in risk assessment and regulation of pesticides (AOEL, acceptable operator exposure level)...

Compared with the occupational exposnre of applicators and workers following pesticide application in the field, post-application residential exposure to pesticides used in and around the home is lower in level, but encompasses a wider variety of scenarios, such as age distribution, activity patterns and product use. Typically, few data are available on residential exposure, while a large body of data does exist for occupational exposures. Residential exposure assessment and modeling may benefit from the new data requirements under the United States Food Qnality Protection Act of 1996 (Lewis et al, 1994 Hill et al., 1995 Lu and Fenske, 1998 USEPA, 1990 Whitmore et al., 1994). In occupational exposnre assessment, a database approach is favored, while in residential exposure assessment a mechanistic and statistical modeling approach is dominant. 

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