By Patricia Payne, president, JBM Associates, Inc.; consultant, APHL
If you have completed any packaging and shipping training, you are undoubtedly aware that you must always follow the packaging instructions as written in the hazardous materials transportation regulations. However, sometimes it may be as safe, less costly or more efficient to do it another way. In some instances, it may be impossible to follow the current regulations.
If you have ever encountered any of those situations, a legal alternative is available in the form of a special permit. A special permit is a document that permits a person to perform a function that is not otherwise allowed under the Hazardous Materials Regulations (HMR). A special permit sets forth alternative requirements, or variances, to the requirements of the HMR. The Pipeline and Hazardous Materials Safety Administration (PHMSA) is authorized to issue such variances if the proposed method achieves a safety level that is at least equal to that required under federal hazmat law or is in the public interest if a required safety level does not exist.
In the past, special permits have been issued to clinical and research laboratories and medical facilities for a variety of reasons. Two of the reasons were:
- To allow transport of a Category A infectious substance in non-Class 6.2 packaging, and
- To conduct exercises with mock specimens to test preparedness for chemical exposure due to a terrorist event.
Clinical and research labs maintain stocks of infectious substances for a variety of reasons, including quality control, method validation and training purposes. Permits have been requested and issued for the motor vehicle transport of stocks of Biological Substances Category B from one location to another in the freezers in which they were stored instead of packaging separately, according to the HMR. This saved both time and money in transporting those cultures to a new facility.
When the first patients with Ebola were being treated in the US, it became apparent that packaging did not exist to hold the quantities of Category A infectious substances being generated from the biological waste produced by patient treatment. The biological waste generated from treatment of patients with most infectious agents is classified as Regulated Medical Waste. However, the waste generated from an Ebola patient is classified as an Infectious Substance Affecting Humans and must be packed in Class 6.2 UN specification packaging. Because packaging did not exist to hold the quantities being generated, a special permit was issued to package that waste in a manner not otherwise allowed by the HMR.
For preparedness purposes, public health agencies often develop exercises or drills to prepare for shipping infectious agents in the event of a public health threat or outbreak. Because the drills evaluate the participants’ ability to correctly package an infectious agent being sent to a reference lab without delay but are not evaluating the actual testing of those agents, infectious agents are not required to be placed in the package during these exercises. However, the HMR prohibits offering a package marked as containing hazardous materials if it does not contain a known or suspected hazardous material. In the past, special permits have been issued to allow chemical terrorism exercises to test preparedness for shipping samples for Rapid Toxic Screens using mock Category B infectious substances. Currently, a special permit request is in preparation for drills testing preparedness for correctly packaging a Category A infectious substance, such as Ebola. For obvious reasons, the permit will request that mock non-infectious agents be substituted for the purposes of the drill.
It is important to note that special permits must be requested in writing at least 120 days in advance and that you must wait for approval before packaging in a non-compliant manner. Permits are generally issued for the use of one agency. However, other agencies can request to use the same permit and be granted party status to use it.
The PHMSA website provides information on the process for requesting a special permit, a searchable database of previously issued permits and contact information for support.
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This post wasn’t written by an APHL staff member and the views expressed in the post are those of the guest author and do not necessarily reflect the views or opinions of APHL. If the post contains an evaluation or opinion about a product or service, this represents the guest blogger’s personal belief and does not represent APHL’s endorsement or critique.