Section 761.389 - Testing parameter requirementsThere are no restrictions on the variable testing parameters described in this section which may be used in the validation study. The conditions demonstrated in the validation study for these variables shall become the required conditions for decontamination using the solvent being validated and shall replace the comparable conditions in § 761.79(b)(3) through (b)(6) . There are limited potential options for varying a single requirement in this section. If you change one of these variable requirements, change it only in the way listed in this section and do not change any other validated conditions. If you desire to change more than one of the requirements in this section, you must conduct a new study to validate the decontamination under the desired conditions.
(a) The study apparatus is not standardized. Critical components of the study are the PCB material (for example MODEF or some other spiking solution), the volume of the soaking solvent, and the area of the contaminated surface. The EPA study used beakers and shallow dishes as the experimental vessels to contain the surface and solvent during the soaking process. In order to minimize surface-to-volume ratios, it is convenient to utilize flat contaminated surfaces and shallow solvent containers. During the validation study, use the same ratio of contaminated surface area to soak solvent volume as would be used during actual decontamination. It is also permissible to use a smaller surface area to soaking solvent volume than used in the validation study, so long as all other required parameters are used as validated in the confirmation required in § 761.386 (a) through (f) , and paragraphs (a) through (c) of this section. Do not use a larger surface-area-to-solvent-volumes ratio or different kind of solvent based on the results of the validation study.(b) Except for the minimum soak time of 1 hour (as required in § 761.386(c) ), the length of soak time is not otherwise restricted in the validation study. The soak time used in the validation study, however, is a use requirement for subsequent decontamination using the solvent being validated. It is permissible to use longer soak times for decontamination than the soak time used in the validation study, if all other parameters required in § 761.386 , and paragraphs (a) and (c) of this section are used.(c) There is no restriction on the kind of material containing PCBs to use to create the surface contamination for the validation study. There is also no restriction on the level of starting PCB surface concentration. It is permissible to use lower concentrations of PCB than the concentration used in the validation study, if all other parameters required in § 761.386 (a) through (f) , and paragraphs (a) through (c) of this section are used.