Does every laboratory have to maintain a biological agent inventory?
Dr. Alexander Heinick
A biological agent inventory must contain information on the classification of biological agents into risk groups. When must it be created?
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According to § 7 BioStoffV (documentation of risk assessment and recording obligations), the employer has theRisk assessmenttoThe documentation includes the following information: theType of activityincluding exposure conditions, theResulttheSubstitution test , the specifiedProtection levels to be takenProtective measuresand aJustification if there is a deviation from the given rules and findings of the Committee for Biological Agents (ABAS) (Section 7 Paragraph 1 Nos. 1-5 BioStoffV).
As part of this documentation, the employer mustdirectorythe used or occurringBiomaterials(biological substance list), as far as these are known. This list must contain information onClassification of biological agents into risk groups(RG) according to § 3 BioStoffV and to theirsensitizing and toxic effectsThe information must be accessible to all affected employees and their representatives.
In the case of activities ofProtection level 3 or 4the employer also has adirectoryabout theemployees(Section 7 (3) BioStoffV).
The documentation of the necessary information in the risk assessment as well as thedirectorycan howeverwaivedbe carried out if only activities involving biological substances of theRG 1 without sensitizing or toxic effectsbe performed.
Whether a biological substance register must be maintained depends primarily on whether biological substances are handled at all. If biological substances are not handled, then, of course, no register needs to be maintained. However, this also applies ifonly activities of risk group 1 without sensitizing or toxic effectsbe performed.