Beveridge & Diamond
 

Proposed Universal Waste Rule Under RCRA to Include Pharmaceuticals

Beveridge & Diamond, November 21, 2008

On November 20, 2008, the Administrator of the U.S. Environmental Protection Agency (EPA) signed a proposed rule to amend the Universal Waste Rule under the Resource Conservation and Recovery Act (RCRA) to include pharmaceuticals as universal wastes.  If finalized, the rule would streamline regulatory requirements associated with generation, collection, and transportation of hazardous pharmaceutical wastes, while leaving unaltered hazardous waste regulations for recycling or disposal of such hazardous wastes.  EPA expects the proposed rule to primarily impact retail pharmacies, reverse distributors of pharmaceuticals, hospitals, and other health care facilities.  Comments on the proposal must be submitted to EPA within sixty (60) days following publication in the Federal Register, which is expected in approximately two weeks. 

Streamlined Management Requirements for Universal Wastes.  The proposed universal waste rule would streamline requirements placed on handlers (including generators) of pharmaceuticals and pharmaceutical containers that are RCRA hazardous wastes, including requirements for storage, labeling, transportation, training, response to releases, and notifications.  Generators of hazardous pharmaceutical wastes can choose whether to manage the wastes under the current hazardous waste regulations (40 C.F.R. Parts 260 to 268 and 270) or under the Universal Waste Rule (40 C.F.R. part 273). Universal wastes must be handled as hazardous wastes at a destination facility for recycling or disposal.

The proposed rule for pharmaceutical wastes provides requirements that are generally consistent with the requirements promulgated for other universal wastes.  Handlers of pharmaceutical universal wastes (including generators) would be required to:

·        Manage pharmaceutical universal wastes in a way that prevents releases of any universal waste or component of a universal waste to the environment;

·        Contain pharmaceutical universal wastes in containers that are structurally sound, compatible with the pharmaceutical universal wastes, and lacking evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions;

·        Determine whether a solid waste generated by sorting activities exhibits a characteristic of hazardous waste or is a listed hazardous waste and manage the waste according to applicable regulations; and

·        Label all pharmaceutical universal waste, or a container in which the pharmaceutical universal waste is contained, with either of the following phrases: “Universal Waste—Pharmaceuticals” or “Waste Pharmaceuticals.”

Universal wastes may be transported without a hazardous waste manifest.  Large quantity handlers of universal wastes (accumulating 5000 kg or more of all universal wastes—including pharmaceuticals, batteries, lamps, and mercury-containing equipment—at any given time) would be required to notify EPA of their universal waste activities and maintain certain records.  Handlers of pharmaceutical universal wastes would be allowed to sort such wastes provided the handler ensures compliance with applicable OSHA regulations and ensures that employees sorting pharmaceutical universal wastes are thoroughly familiar with proper pharmaceutical universal waste handling and emergency procedures.  

Definition of Pharmaceuticals.  EPA defines pharmaceuticals broadly under the proposed rule to include “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 [a] intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or injury in man or other animals; or . . . [b] that is intended to affect the structure or function of the body in man or other animals.”  The definition is meant to include pills or tablets, medicinal liquids, ointments and lotions, transdermal patches, and oral delivery devices such as gums or lozenges, but does not include sharps, infectious or biohazardous waste or residues resulting from the manufacture, production or distribution of pharmaceuticals.  EPA requests comment on whether this definition is clear and appropriate.

EPA’s definition of pharmaceutical would include “controlled substances” regulated by the Drug Enforcement Administration (DEA).  The proposed rule is not meant to alter existing DEA regulations, and EPA states any take back program that includes controlled substances that are also hazardous wastes must comply with both DEA and EPA regulations.

Reverse Distribution Systems.  EPA also requests comment on its understanding of reverse distribution systems for pharmaceuticals and when waste determinations are made in such systems.  EPA states in the preamble to the proposed rule that unused or expired pharmaceuticals sent to reverse distributors or returned to manufacturers are not considered wastes until it is determined that the pharmaceuticals will be discarded.  EPA also states that partially-used pharmaceuticals become pharmaceutical universal wastes on the date they are discarded, while unused pharmaceuticals become pharmaceutical universal wastes on the date the handler decides to discard them. 

The proposed universal waste rule does not cover reverse distribution of other, non-pharmaceutical consumer products, although EPA indicated as late as its April 2007 Regulatory Agenda that it was planning to propose a rule adding both pharmaceuticals and other consumer products to the Universal Waste Rule.  At that time, EPA likened consumer product reverse distribution systems to those of pharmaceuticals, where both types of products are returned to manufacturers for credit and decisions about discarding products are deferred to a centralized processing center.  The proposed rule signed on November 20, 2008 does not explain why consumer products were excluded from the current proposal.

Effect on States.  States that are authorized by EPA to conduct their own hazardous waste programs are not required to adopt the Universal Waste Rule to maintain authorization.  Authorized states may choose to adopt or not adopt the pharmaceutical universal waste rule, or they may issue rules allowing additional wastes to be managed as state universal wastes.  Michigan and Florida currently have universal waste rules that allow pharmaceuticals to be managed as universal wastes in those states.  EPA is requesting comment on how the proposed federal pharmaceutical universal waste rule will affect the Michigan and Florida programs.

For a printable PDF of the pre-publication copy of the proposed rule, please click here or go to:(http://www.epa.gov/epawaste/hazard/wastetypes/universal/pharm.htm).

For more information about the proposed rule, please contact Donald Patterson (dpatterson@bdlaw.com) or Elizabeth Richardson (erichardson@bdlaw.com).