shipping of infectious substances and other biomedical materials annual update

Download Shipping of Infectious Substances and Other Biomedical Materials Annual Update

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  • ONLINE SELF-STUDY

    Shipping of Infectious Substances and Other Biomedical Materials

  • Course Objectives

    The purpose of this program is to:

    ensure the safe handling of hazardous materials using good sensible practices.

    recognize hazardous materials and realize there are special requirements

    comply with Federal and International regulations

    The basic goal for this training is to provide a framework for decisions

    Is material to be shipped a dangerous good, genetically modified, biological

    substance category B, or an exempt human specimen?

    Upon completion you will receive certification to ship hazardous materials

  • Course Objectives

    This training will increase your awareness of safety and compliance issues. If you need more information or help

    with shipping your package you can e-mail the EHS Shipping Specialist. The training will cover the topics

    listed below. Classification, identification, and packaging are three of the most important topics covered.

    Regulatory Oversight

    Dangerous Goods/Hazardous Materials

    Training Requirements

    Shippers & Operators Responsibilities

    Classification, Identification

    Packaging

    Shipping with dry ice and Overpacks

    Marking & labeling packages

    Shipping documentation

    Emergency Response

    Laboratory Security

    Accept or reject shipments by use of checklist

    http://ehs.unc.edu/staff/#biological

  • Regulatory Oversight

    Federal Regulations:

    U.S. Dept. of Transportation (DOT) 49 CFR

    Other federal requirements: CDC, OSHA, USDA, Department of Commerce, International Traffic and Arms

    (ITAR) and Toxic Substance Control Act (TSCA)

    DOT regulations primarily cover ground transportation. DOT is the organization that has the authority to fine you

    for violations. Their authority extends well beyond US boundaries. Import permits from the CDC or USDA

    may be needed if you are importing human etiological organisms or plant or animal pathogens.

    Department of Commerce licenses may be needed to export organisms, genetic elements, chemicals,

    technology or other commodities. TSCA Certification may be needed to import or export certain chemicals.

    International Regulations (Air shipments)

    International Civil Aviation Organization (ICAO)

    International Air Transport Association (IATA)

    Dangerous Goods Regulations (DGR)

    Internationally, the UN Committee of Experts (CoE) develops recommended procedures for the transport of all

    types of dangerous good except Radioactive material. The International Civil Aviation Organization (ICAO)

    uses the UN recommendations as the basis for developing the regulations for the safe transport of

    dangerous goods by air. IATA is the international trade organization that interprets ICAO regulations and

    provides the Dangerous Goods Regulations (DGR). The IATA regulations are more stringent than DOT. This

    training program follows the IATA regulations. IATA regulations are minimal requirements - your carrier can

    be more stringent.

    http://www.cdc.gov/http://www.aphis.usda.gov/

  • Regulatory Oversight

    Fines and Penalties

    "Violations contrary to the U.S. Code of Federal Regulations

    (CFR) 49, if substantiated, may result in the assessment of a

    civil penalty of up to $37,500 per violation, and deliberate

    violations may result in criminal prosecution of up to

    $500,000 and 5 years in prison."

    There has been an increase in the number of Federal

    Aviation Inspections (FAA) in response to the 1996 ValuJet

    crash, the September 11, 2001 attacks, and the UPS

    package bomb scare in November 2010.

    If you are receiving a HazMat package it is your

    responsibility to ensure the sender packages it correctly.

    Oxygen-generating canister like the ones on board the

    ValuJet flight 592

  • Definitions

    Infectious Substance - Class 6.2 Definition:

    Infectious substances are substances known to contain, or reasonably expected to

    contain, pathogens.

    Pathogens are defined as micro-organisms (including bacteria, viruses, rickettsia,

    parasites, fungi) and other agents such as prions which can cause disease in humans

    or animals.

    Critical to the infectious substance definition is the ability to cause disease.

    Note the reliance on your professional judgment when the words reasonably

    expected are used.

  • Definitions

    The IATA definition for infectious substances leaves out toxins. Toxins are placed in a

    separate category. They are treated like chemicals.

    Toxins from plant, animal or bacterial sources which do not contain any infectious

    substances or toxins that are not contained in substances which are infectious

    substances should be considered for classification in Division 6.1 and assignment to

    UN 3172 (for liquids) or UN 3462 (for solids).

    Contact EHS if you are shipping toxins as instructions for shipping toxins is not covered

    in this training module. Please be aware that many toxins (if shipped out of the US)

    are regulated by the Department of Commerce. There are significant fines

    associated with exporting toxins without a license

  • Definitions

    Biological products

    Those products derived from living organisms which are manufactured and distributed in

    accordance with the requirements of appropriate national authorities, which may have special

    licensing requirements, and are used either for prevention, treatment, or diagnosis of disease in

    humans or animals, or for development, experimental or investigational purposes related thereto.

    They include, but are not limited to, finished or unfinished products such as vaccines.

    Patient Specimens

    Patient Specimens are human or animal materials, collected directly from humans or animals,

    including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid

    swabs, and body parts being transported for purposes such as research, diagnosis,

    investigational activities, disease treatment and prevention.

    Cultures

    Laboratory stocks are the result of a process by which pathogens are intentionally propagated in

    order to generate high concentrations. This increases the risk of infection when exposure to

    them occurs. An example of this would be a patient sample of TB that has been cultured.

  • Training Requirements

    You must be currently certified to legally ship dangerous goods.

    Who needs to be certified?

    Anyone who

    prepares,

    classifies,

    packs,

    labels,

    or offers a dangerous good for transport.

    Certification is valid for 2 years. Completing this training one time is not enough. It must be renewed every 2 years to maintain shipping certification.

  • Classification and Identification of

    Dangerous Goods

  • What is a dangerous good?

    Any material that the Secretary of Transportation

    determines poses a risk to health, safety, property,

    or the environment.

    A dangerous good is any article or substance

    capable of posing a risk to health, safety, property,

    or the environment (IATA).

    A material or substance posing an unreasonable risk

    to health, safety, and property when transported

    (DOT).

  • Classification of Infectious

    Substances

    Infectious substances are divided into the following categories,

    Category A and Category B. The following are the proper

    shipping names for each category:

    Category A

    Infectious substances, affecting humans, UN 2814

    Infectious substances affecting animals, UN 2900

    Category B

    Biological Substances Category B, UN 3373

  • Classification

    Category A Infectious Substances - an infectious substance which is transported in a

    form that when exposure occurs, is capable of causing permanent disability, life

    threatening or fatal disease in otherwise healthy humans or animals. Examples of

    substances that meet this criteria are located in this table: Table 3.6.D.

    NOTE: An exposure occurs when an infectious substance is released outside of the

    protective packaging, resulting in physical contact with humans or animals.

    Infectious substances meeting the Category A criteria which cause disease in humans or

    both in humans and animals must be assigned to UN 2814 (Infectious substance,

    affecting humans).

    Infectious substances which cause disease only in animals must be assigned to UN 2900

    (Infectious substance, affecting animals).

    http://ehs.unc.edu/files/2015/07/table1.pdf

  • Classification

    Assignment to UN 2814 or UN 2900 must be based on the known medical history and

    symptoms of the source human or animal, endemic local conditions, or professional

    judgment concerning individual circumstances of the source human or animal.

    Example: A patient from a foreign country is admitted to the hospital. You think

    they may have Ebola. You will ship all body fluids as infectious substances

    (Category A) using all the applicable packaging and paperwork.

  • Classification

    Category B, Biological substance is an infectious substance which does no meet the

    criteria for inclusion in Category A.

    Example: A patient's body fluid infected with mycobacterium tuberculosis. A culture of

    this same organism would be a Category A infectious

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