Generators of regulated medical waste (RMW) in New Jersey may need to revise their handling, marking and storage practices and procedures to meet federal hazardous materials requirements (49 CFR parts 171-180) (the federal HMRs) following an announcement by the U.S. Department of Transportation (USDOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) that several provisions of the New Jersey Regulated Medical Waste Requirements (N.J.A.C. 7:26-3A, et seq.), which are enforced by the New Jersey Department of Environmental Protection (NJDEP), are preempted by federal law. The preemption announcement follows a review by the agency of the New Jersey RMW requirements at the request of the Healthcare Waste Institute to determine the requirements’ consistency with federal law. Specifically, the PHMSA determined that certain New Jersey requirements applicable to generators of RMW relating to the storage, packaging, labeling and marking of containers; the use of New Jersey-specific “tracking forms” and “exception reports”; and other requirements were not substantially the same as the applicable federal HMRs and were preempted by the Federal Hazardous Materials Transportation Act (49 U.S.C. 5101 et seq.).1 Based on its review, the PHMSA preempted nine New Jersey RMW requirements, including the following provisions applicable to generators of RMW:
- The requirement that generators separate sharps, fluids (in quantities larger than 20 cubic centimeters) and other RMW into containers prior to off-site shipment (N.J.A.C. 7:26-3A.10(a)). The New Jersey requirements were preempted because they were not as prescriptive as the federal HMRs and included a quantity exception with respect to fluids that is not present in the federal HMRs. Accordingly, generators need to review their packaging procedures to ensure compliance with the requirements of 49 CFR 173.197(b), (e)(2) (liquids) and (e)(3) (sharps).
- The provisions of N.J.A.C. 7:26-3A.11(d) that allow generators to ship oversized RMW without placing it in packaging as required by the federal HMRs. The preemption means that when shipping oversized RMW, generators must adhere to the bulk packaging requirements of 49 CFR 173.197.
- The requirement to label the exterior of each container of untreated RMW with the words “Medical Waste” or “Infectious Waste” (N.J.A.C. 7:26-3A.14(a)1). In most cases, the federal HMRs require either the words “Infectious Substance” or the “Biohazard” marking to be affixed to the exterior of all RMW packaging in accordance with 49 CFR 172.400(c).
- The requirement under N.J.A.C. 7:26-3A.15 that each generator mark each individual container of RMW “in accordance with applicable Federal regulations” and that such markings include the transporter’s name, the date of shipment, the intermediate transporter’s name and other specific information. In light of the preemption, under 49 CFR Part 172 (Subparts D and E), the markings on (most) RMW packaging need include only (i) the proper shipping name, (ii) an identification number, (iii) the consignor’s or consignee’s name and address, (iv) the words “Infectious Substance” or the “Biohazard” label, and (v) if applicable, orientation arrows.
- The requirement imposed on generators and generator/transporters to use New Jersey’s prescribed “tracking forms” to accompany shipments of RMW (N.J.A.C. 7:26-3A.19). The preemption impacts only the NJDEP’s ability to require generators to use the prescribed New Jersey forms. A generator may still choose to use the New Jersey tracking forms but must also ensure that it complies with the shipping documentation requirements of 49 CFR Part 172 (Subpart C).
Additionally, although not the focus of this alert, the PHMSA preempted certain New Jersey requirements applicable to transporters of RMW and certain vehicles used for the transport and shipment of RMW. The preempted regulations include:
- The requirements of N.J.A.C. 7:26-3A.28 concerning the placement of a water-resistant tag with certain transporter information below the generator’s markings on the exterior of RMW containers
- The requirements of N.J.A.C. 7:26-3A.30 concerning the marking of certain vehicles transporting RMW
- Certain requirements relating to the transportation of RMW by rail carriers (N.J.A.C. 7:26-3A.45 and N.J.A.C. 7:26-3A.46).
In response to the PHMSA announcement, the NJDEP issued a Compliance Advisory (available on the NJDEP website at http://www.nj.gov/dep/enforcement/advisories-hw.htm) and designated the following investigator as a contact for inquiries from the regulated community concerning the preempted requirements.
Amy Scaffidi, Investigator I
Bureau of Hazardous Waste/UST/Regulated Medical Waste Compliance and Enforcement
New Jersey Department of Environmental Protection
2 Riverside Drive, Suite 201
Camden, NJ 08103
Our Environment & Energy and Healthcare attorneys are available to respond to your questions and discuss the impact of the preemption of these RMW requirements on your RMW handling and storage practices and procedures.