Program application approvals registration

FIFRA regulates the manufacture, sale, delivery and use of pesticides and pesticide products. It is basically a labelling law. Successful registration of a product, results in an accepted label which is the license to sell. Registration is product specific, not chemistry specific. 

The Directions for Use on the product label defines the limitations of using the product with regard to application site and dosage. Even if the product meets FDA requirements for a specific application, but the product label does not list the application, the product cannot be used. There is also the possibility that a competitor may have the same chemical as a Nalco product, but the product labels are different. This is because the EPA approved the product labels which are product specific, but the FDA approved the chemical for the application. 

Unlike the biocide regulations under the EPA, the FDA does not rely on product names or labels. Instead, FDA regulations are based upon chemistry only. The Act requires potential sellers of a food additive substance to establish the safety of the additive under prescribed conditions of use. The burden of establishing safety lies with the petitioner and not the US. government. If Nalco was to go through this procedure to get, for example, 176.170 approval for (MBT), this approval would apply to Nalco s 10% formulation (7619), as well as to 

To make these types of decisions as simple as possible, the FDA Compliance Sheet can be used to help identify approved fed locations. This approval sheet does not cover every possible application situations, but it can be used with confidence for the more common product uses. In the event the mill would like an official confirmation that a particular feed location is, or is not FDA approved, a letter can be prepared by Nalco s EH S Department. 

3 Pacific. The countries of the Pacific tend to use US FDA and sometimes EPA information. Some countries have specific rules that are followed. For example, Korea has the NIER (National Institute of Environmental Research), Australia the NICNASS, however, Indonesia is not regulated and Taiwan has no specific regulations for biocides. 

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