ON JUNE 22, 2004, the U.S. Department of Transportation's (DOT) Research and Special Programs Administration (RSPA) published an important determination regarding medical waste transportation regulations that may affect states' rules and the manner in which states enforce those rules.
The decision was based on a conflict between Massachusetts' and federal regulations. However, medical waste generators and transporters face similar problems in many jurisdictions.
The Hazardous Materials Transportation Act (HMTA) states that the DOT has exclusive authority to regulate certain areas of transportation including the description and classification of materials, packaging, shipping documents, reporting and labeling requirements. Massachusetts regulations included many requirements for these same areas.
The commonwealth acknowledged that some of its rules were not compliant with federal law, but claimed that its requirements were legitimate. Maine also claimed that a state should be allowed to regulate these areas because of homeland security needs.
The RSPA concluded that manifest requirements not substantially similar to the federal shipping paper are invalid and that those appearing to be the same would not be pre-empted as long as a state applies and enforces them in the same manner as required by federal law.
Specifically, the RSPA found that the following Massachusetts requirements violated federal law:
Containers must be rodent proof and fly tight;
Bags must be 3 mils. thick;
Pathological waste and contaminated animal carcasses must be double-bagged;
A distinctive label must be used on sharps containers;
A package label with the name, address and telephone number of the generator must be used;
The name and location of the delivery site must be on a manifest;
The disposal facility must return the signed original manifest to the generator; and
The generator must keep multiple manifest copies for three years (federal law requires 375 days).
If a state applies and enforces the following manifest requirements in the same manner as federal law, then the rules do not violate federal law:
The manifest must include a description of the waste, total quantity and container type; and
The generator must sign the manifest.
These requirements are the same as the RSPA's shipping paper rules as long as the terms used match the federal regulations, which are very specific, (i.e. “PGII” to identify the packing group type). If a state requires different terms, then the state's requirements would be pre-empted.
The decision is extremely important. First, the RSPA rejected the notion that a state's regulations can be substantially different from the federal rules for homeland security reasons. The RSPA said that the agency had rejected adding disposal facility information to its shipping paper in a recent federal rulemaking for the very reason Maine claimed Massachusetts should be allowed to require it — security risks.
Second, many states have regulations that, like Massachusetts', are not substantially similar to federal requirements. These state regulations create confusion, force noncompliance when the regulated community cannot physically comply with both and unnecessarily increase costs.
The Medical Waste Institute is a policy-making group within the National Solid Wastes Management Association advocating for and providing information to medical waste companies. The Institute filed a pre-emption determination on August 30, 2002, because members complained they were unable to comply with both sets of regulations. A previous pre-emption determination requested by the Institute involved local routing restrictions in Pennsylvania where a town council adopted the restrictions without following federal procedures for public input and approval.
Alice Jacobsohn is EIA's director of public affairs and industry research. She also is director of the Medical Waste Institute.