Microbial pesticides

The GLP requirements for mixtures with carrier (40 CFR 160.113) were originally intended to address problems associated with the incorporation of test and control substances into feed, water, and other media for toxicology studies however, now these same requirements pertain to all other GLP-required studies, including those pertaining to re-entry and worker safety. The requirement involves (1) substantiation of test, control, and reference substance concentration through periodic analyses (2) verification of homogeneity and (3) determination of stability and, if applicable, also solubility. All of these requirements usually require chemical analysis, although bioassay may be necessary for microbial pesticides. 

Microbial nitrile hydratase, 76 400 Microbial oxidations, 76 401 Microbial pesticides, 78 525... 

Table 15.2 Oxidation reactions in microbial pesticide metabolism (Bollag and Liu 1990)...

Microbial pesticides include any microorganism that can be used as a pesticide, as defined by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) [28]. Biopesticide microorganisms include, but are not limited to, protozoa, algae, fungi, bacteria, and viruses. 

Animal dander Dust mite Molds Cockroach Microbial pesticides... 

Microbial pesticides are evaluated for toxicity and infectivity prior to making regulatory decisions. As traditional dose-response-based risk assessments are not considered appropriate for microbial pesticides, regulatory jurisdictions do not typically require occupational and bystander exposure data. However, a small number of studies have monitored airborne concentrations (colony forming units/m ) of microbial pesticides following application (Teschke et al 2001), and the utility of these data should be considered by the regulatory community. 

EPA (2007a). Data requirements for biochemical and microbial pesticides. Fed Reg 72, 60988-61025. 

Part 158 in Title 40 of the Code of Federal Regulations was finalized in 1984 (14). In the final rule, the term Biorational Pesticide was dropped and the term Biochemical and Microbial Pesticides was adopted to describe this class of pest control agents (Figure 4). The general characteristics of biochemical and microbial pesticides remained essentially unchanged. 

Biochemical and microbial pesticides are generally distinguished from conventional chemical pesticides by their unique modes of action, low use volume, target species... 

Greater than 99 percent of the registered pesticides contain chemicals as their active ingredients. The remainder contain bacteria, fungi, viruses or protozoans as their active components and are commonly referred to as microbial pesticides. Microbial-based products achieve their pesticidal activity by pathogenic... 

This situation appears to be changing. Advances in molecular biology and genetic manipulation techniques over the past fifteen years have prompted a renewed interest in microbial pesticides. Genetic engineering techniques are being used to overcome some of the problems that have hindered the success of microbial pesticides. 

A few of these new products are now at the stage where they are ready for small scale field testing. This chapter summarizes EPA s current regulatory program for genetically engineered microbial pesticides and presents a case history for one of the experimental products the Agency has evaluated. 

Large scale experimental applications of microbial pesticides are usually undertaken prior to registration in order to further evaluate product efficacy or to develop other data necesary to... 

Figure 1. Relationship between Stages of Microbial Pesticide Development and Level of EPA Oversight...

The policy also contained guidance on the kinds of data and information that should be provided to enable the Agency to evaluate the submitted request to conduct a small scale field test. This policy statement was reiterated in a proposed interagency policy statement issued December 31, 1984 (7) and was subsequently revised and set forth on June 26, 1986 as part of a final interagency policy statement (8). Under the June 26, 1986 policy statement, EPA reviews all genetically engineered microbial pesticides before they may be legally applied in the environment. 

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