According to a source from the ICAMA, China has established its rules of toxicological study for microbial pesticide and the rules have been fully implemented last September, which could be considered as a major step forward in China’s safety evaluation and regulatory practice on bio-pesticide products.
The testing rule, “NY/T 2186-2012 Microbial Pesticide Toxicological Test Guidelines” consists of six parts:
Part 1: Acute oral toxicity/Pathogenicity study;
Part 2: Acute pulmonary toxicity/pathogenicity study;
Part 3: Acute injection toxicity/pathogenicity study
Part 4: Cell culture study
Part 5: Sub-chronic toxicity/pathogenicity study;
Part 6: Reproductive/fertility effects study;
The ICAMA pointed out that the above guidelines learned from other developed countries and were adapted to fit China’s unsophisticated bio-pesticide registration system. The guidelines detailed the terminology and definition, requirements on testing sample, principles and procedures of testing methods, as well as how to evaluate the toxicological data generated from the tests.
The toxicological tests in these guidelines are specified for biological characteristics of the microorganisms, thus the studies of toxicity, pathogenicity and infectivity should be all carried out. The test animals are simultaneously administered through oral, inhalation and injection, then, the toxicological, pathogenic and infectious reports are generated. Depending on the outcome of the acute tests, the sub-chronic and reproductive tests would be carried out if necessary.
Among the new bio-pesticides denied of full ICAMA registration, their data gap is mainly centered upon the toxicological sector as the registration applicants are always unclear about how the toxicological studies of their microbial products should be carried out or which part of the data could be waived. The ICAMA commented that the guidelines are “reasonable for China’s review practice on microbial pesticides.”
This article is contributed by Zhang Liying and Tao Chuanjiang, officials from the ICAMA.
