CASING SCIENTIFIC

Regulatory Communiqué

February 2001

The purpose of this summary is to furnish health care organizations with a current status concerning efforts by federal authorities to regulate interstate shipments of non-infectious clinical specimens.

In September 1999, the U.S. Department of Health and Human Services ("HHS"), through the U.S. Centers for Disease Control ("CDC"), proposed to regulate interstate shipment of non-infectious clinical specimens. CDC published a "Notice of Proposed Rulemaking", and the public comment period for that proposal closed in December 1999.

A Notice of Proposed Rulemaking is usually an indication of what can be expected from a Final Rule, and this could be important as these proposed rules would alter packaging requirements for interstate shipment of diagnostic specimens, further aligning U.S. regulations with international rules.

In the past, the changes to U.S. regulations, whether they originated with the U.S. Department of Transportation, or some other department or agency of government, have focused on the smallest percentage of diagnostic specimen shipments: specimens known or likely to contain Infectious Substances.

These proposals deal with more stringent packaging and labeling of the largest share of interstate specimen shipments: non-infectious diagnostic specimens. They also propose, among other requirements, the creation of a new category of Infectious Substances that could require special tracking and would expand the list of Infectious Substances that require tracking and notification of the Centers for Disease Control before and after each shipment. Included in the proposed list is m. tuberculosis and human hantaan virus.

Public health authorities are concerned about the possibility of leaking packages of clinical specimens throughout the public transport system. These regulatory proposals when adopted—will be backed by U.S. statutes and address concerns for public health and safety through a standard set of rules, without exception for carriers or carrier groups—whether by air or ground, for all shipments to, from, and between the United States. It is reasonable to expect increased emphasis upon how specimens are defined by law and classified by World Health Organization risk groups.