Ask X3What does 49 CFR 173.134 (Class 6, Division 6.2—Definitions and exceptions) require?
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As Ask X3, your fleet-compliance assistant, here is the answer based strictly on 49 CFR 173.134:
According to 49 CFR 173.134, Division 6.2 (Infectious substances) materials are defined and classified based on whether they contain a pathogen (a microorganism or agent like a bacterium, virus, parasite, fungus, or prion) that can cause disease in humans or animals.
Under this regulation, you must properly classify and assign appropriate identification numbers (such as UN2814, UN2900, UN3291, UN3373, or UN3549) to these materials depending on their specific category and type, which include:
* Category A: Infectious substances capable of causing permanent disability or a life-threatening or fatal disease when exposure occurs (assigned to UN2814, UN2900, or UN3549).
* Category B: Infectious substances not generally capable of causing permanent disability or life-threatening/fatal disease upon exposure, including those for diagnostic or investigational purposes (described as “Biological substance, Category B” and assigned to UN3373).
* Regulated medical waste (clinical/biomedical waste): Wastes or reusable materials derived from medical treatment, immunization, or biomedical research. Those containing Category A substances must be classed accordingly and assigned to UN2814, UN2900, or UN3549.
* Biological products, cultures, patient specimens, sharps, toxins, and used health care products: Each is specifically defined to determine proper handling and classification.
Additionally, 49 CFR 173.134 outlines specific exceptions for materials that are *not* subject to regulation as Division 6.2 materials. These exceptions include:
* Materials that do not contain an infectious substance or are unlikely to cause disease.
* Non-infectious biological materials (such as non-infectious cells, tissues, blood/plasma from healthy individuals, or DNA/RNA).
* Materials containing micro-organisms that are non-pathogenic, or pathogens that have been neutralized/inactivated so they no longer pose a health risk (e.g., via steam sterilization or chemical disinfection).
* Materials with a low probability of containing an infectious substance or where the concentration is naturally occurring in the environment (like foodstuffs or certain environmental water, dust, or mold samples).
* Certain federally approved biological products, experimental/investigational products, or medical devices.
* Blood and blood products collected for transfusion or transplant use (along with tissues, organs, and human cells regulated under the Public Health Service Act or Food, Drug, and Cosmetic Act), as well as routine test samples associated with them (unless the collector has reason to believe an infectious substance is present).
* Dried blood spots or fecal occult blood screening specimens placed on absorbent filter paper.
* Certain Division 6.2 materials (other than Category A) contained in patient samples or biological products when transported by a private or contract carrier in a motor vehicle used exclusively for those materials.