Whatever happened to..? An Update on EPA Hazardous Waste Rule Proposals for Contaminated Rags, Waste Pharmaceuticals, and Electronic Manifests

The proposed rule would apply to industrial wipes exhibiting a hazardous characteristic as a result of their use with solvents, and to industrial wipes contaminated with F001-F005 listed solvents or comparable P- and U-listed commercial chemical products that are spilled and cleaned up with industrial wipes.

In response to this proposed rule, EPA received comments questioning the validity of the risk screening analysis and the modeling assumptions used to support the proposal. Based on those comments, EPA revised its risk analysis and subsequently published a Notice of Data Availability on October 27, 2009 to provide the regulated community with an opportunity to comment on the revised risk analysis. This comment period was later extended to February 26, 2010.

EPA is now reviewing comments and a determination will be made on finalizing the rule after any required revisions to the risk analysis are completed. The current projected date for a final contaminated wipes rule is July 2012.

Addition of Hazardous Pharmaceutical Wastes to the Universal Waste Rule

On December 2, 2008 (73 FR 73520), EPA proposed to add hazardous pharmaceutical wastes to the Universal Waste Rule. A "pharmaceutical" is any chemical product, vaccine or allergenic (including any product with the primary purpose to dispense or deliver a chemical product, vaccine or allergenic), not containing a radioactive component, that is either (1) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or injury in man or other animals; or (2) intended to affect the structure or function of the body in man or other animals. It does not include sharps or other infectious or biohazardous waste, dental amalgams, medical devices not used for delivery or dispensing purposes, equipment, contaminated personal protective equipment or contaminated cleaning materials. A pharmaceutical universal waste includes any pharmaceutical that is a hazardous waste and any containers which have held any hazardous pharmaceutical waste that would be classified as hazardous waste under RCRA's empty container criteria.

The intent of the proposed rule is to make it easier to collect and properly dispose of hazardous pharmaceutical wastes, resulting in a simpler and more streamlined waste management system, while ensuring that these wastes are handled and disposed of in a manner that is protective of public health and the environment.

EPA received numerous comments on the proposed rule expressing concerns over the lack of notification and tracking requirements for those facilities handling and transporting universal pharmaceutical wastes. In response, EPA is now considering additional regulatory options to address those concerns. EPA does not have a projected date for finalizing this rulemaking.

Note: The universal waste regulations can vary between states and states can add different types of wastes. Both Florida and Michigan already include pharmaceutical wastes in their universal waste rules.

Electronic Manifest (e-Manifest) System

On May 22, 2001, EPA published a proposed rule that included several major revisions to the hazardous waste manifest system, including the adoption of an electronic manifesting system (e-Manifest) that would allow waste shipments to be tracked electronically. While most of the proposed changes to EPA's manifesting system were finalized in March 2005, action on the proposed e-Manifest system was postponed. Commenters generally supported an electronic tracking scheme, but several significant issues were raised that necessitated further analysis and input from stakeholders.

On April 18, 2006, EPA published a notice to request comment on the agency's preferred approach for electronically completing and transmitting manifests through a national, centralized e-Manifest system that would be established and maintained through user-fees. Comments strongly supported such a system, and generally supported EPA's position that use of e-Manifests should be at the option of the users rather than mandatory. However, concerns were raised that an optional system would create dual paper and electronic systems. In addition, industry and state stakeholders raised issues in response to EPA's position to allow confidential business information claims for e-Manifests. On February 26, 2008 EPA solicited additional comment on these two issues, followed in November 2008 by a meeting with state and industry representatives to discuss the agency's preferred approach for an e-Manifest system, and then by a series of webinars in 2009 to discuss topics that required further input.

EPA remains committed to finalizing regulations for an e-Manifest system and is currently developing a final rule that will authorize the use of electronic manifests and that will address issues raised by stakeholders. However, the promulgation of this rule is contingent upon the enactment of legislation providing EPA the authority to collect user-fees to fund the development and operation of the system, and there is currently no specified time frame for such legislation.

Deborah Hunsicker, REA, an STC Senior Analyst and regulatory specialist, located in Sagle, ID. She has over 20 years experience in environmental consulting and regulatory compliance. Deb is a recognized expert in federal and state hazardous waste and hazardous materials regulatory issues, and has assisted various legal and industrial clients in the development of customized environmental auditing protocols, legal requirements analyses, ongoing regulatory tracking, and compliance programs, as well as the assessment of enforcement options. For more information about these or other EPA proposed rules, contact Deb at (208)255-2780 or by email (DHunsicker@stcenv.com).