§ 627.17 - Toxins.

The laboratory facilities, equipment, and procedures appropriate for work with toxins of biological origin must reflect the intrinsic level of hazard posed by a particular toxin as well as the potential risks inherent in the operations performed. All toxins must be considered to pose a hazard in an aerosol form. However, most toxins exert their effects only after parenteral exposure or ingestion, and a few toxins present a dermal hazard. In general, toxins of biological origin are not intrinsically volatile. Thus, the laboratory safety precautions appropriate for handling these materials closely parallel those for handling infectious organisms. The requirements in this section for the laboratory use of toxins of biological origin include the requirements in § 627.12(a) and the following:

(a) Vacuum lines. When vacuum lines are used with systems containing toxins, they will be protected with a HEPA filter to prevent entry of toxins into the lines (or sink drains when water aspirators are used).

(b) Preparation of concentrated stock solutions and handling closed primary containers of dry toxins. Preparation of primary containers of toxin stock solutions and manipulations of closed primary containers of dry forms of toxins will be conducted—

(1) In a chemical fume hood, a glove box, or a biological safety cabinet or equivalent containment system approved by the safety officer.

(2) While wearing eye protection if using an open-fronted containment system.

(3) Ensuring that gloves worn when handling toxins will be disposed of as toxin waste, with decontamination if required.

(4) With the room door closed and posted with a universal biohazard sign, or other sign, indicating that toxin work is in progress. Extraneous personnel shall not be permitted in the room during operations.

(5) Ensuring that toxins removed from hoods or biological safety cabinets are double-contained during transport.

(6) After verification of hood or biological safety cabinet inward airflow is made by the user before initiating work.

(7) Within the operationally effective zone of the hood or biological safety cabinet.

(8) Ensuring that nondisposable laboratory clothing is decontaminated before release for laundering.

(9) Ensuring that all individuals who handle toxins wash their hands upon each exit from the laboratory.

(10) With two knowledgeable individuals present whenever more than an estimated human lethal dose is handled in a syringe with a needle. Each must be familiar with the applicable procedures, maintain visual contact with the other, and be ready to assist in the event of an accident.

(c) Manipulations with open containers of dry forms of toxins. Handling dry forms of toxins in uncovered containers (for example, during weighing) will be performed following the requirements stated in §§ 627.12(a), 627.17 (a) and (b), and the following:

(1) Manipulations will be conducted in a HEPA filtered chemical fume hood, glove box, or biological safety cabinet. In addition the exhaust may be charcoal filtered if the material is volatile.

(2) When using an open-fronted fume hood or biological safety cabinet, protective clothing, including gloves and a disposable long-sleeved body covering (gown, laboratory coat, smock, coverall, or similar garment) will be worn so that hands and arms are completely covered. Eye and approved respiratory protection is also required. The protective clothing will not be worn outside of the laboratory and will be disposed of as solid toxin waste.

(3) Before containers are removed from the hood, cabinet, or glove box, the exterior of the closed primary container will be decontaminated and placed in a clean secondary container.

(4) When toxins are in use, the room will be posted to indicate “Toxins in Use—Authorized Personnel Only.” Any special entry requirements will be posted on the entrance(s) to the room.

(5) All operations will be conducted with two knowledgeable individuals present. Each must be familiar with the applicable procedures, maintain visual contact with the other, and be ready to assist in the event of an accident.

(6) Individuals handling toxins will wash their hands upon leaving the laboratory.

(d) Additional considerations of specific toxin properties. The following requirements are in addition to the requirements stated in the paragraphs above. Determine whether the material fits §627.17 (b) or (c), and complies with the appropriate section and the following when applicable:

(1) When handling dry forms of toxins that are electrostatic—

(i) Do not wear gloves (such as latex) that help to generate static electricity.

(ii) Use glove bag within a hood or biological safety cabinet, a glove box, or a class III biological safety cabinet.

(2) When handling toxins that are percutaneous hazards (irritants, necrotic to tissue, or extremely toxic from dermal exposure)—

(i) Gloves will be selected that are known to be impervious to the toxin and the diluent (when applicable) for the duration of the manipulations.

(ii) Disposable laboratory clothing will be worn, left in the laboratory upon exit, and disposed of as solid toxin waste.

(e) Aerosol exposures. The requirements found in § 627.17 (a) and (b) will be complied with plus the following:

(1) Chambers, nose-only exposure apparatus, and generation system must be placed inside a fume hood, glove box, or a Class III biological safety cabinet. Glove boxes and Class III biological safety cabinets will have HEPA filters on both inlet and outlet air ports.

(2) The atmosphere from within the exposure chamber will be HEPA filtered before release inside the hood, glove box, or cabinet.

(3) All items inside the hood, glove box, or Class III biological safety cabinet will be decontaminated upon removal. Materials such as experimental samples that cannot be decontaminated directly will be placed in a closed secondary container, the exterior of which will be decontaminated and labeled appropriately. Animals will have any areas exposed to toxin wiped clean after removal from the exposure apparatus.

(4) The interior of the hood, glove box, or cabinet containing the chamber and all items will be decontaminated periodically, for example, at the end of a series of related experiments. Until decontamintated, the hood, box, or cabinet will be posted to indicate that toxins are in use, and access to the equipment and apparatus restricted to necessary, authorized personnel.