On December 2, 2008, the US Environmental Protection Agency (EPA) proposed a rule that would make it easier to manage pharmaceuticals that would be hazardous wastes when disposed. The proposal would simplify compliance with the hazardous waste rules for companies, like hospitals, pharmacies, clinics, veterinary facilities, university health clinics, nursing homes, distributors, retailers and any other establishment, that may have excess, expired or damaged pharmaceutical products that need to be disposed. The proposed rule would also simplify compliance with the hazardous waste rules for pharmaceutical manufacturers and distributors, as well as other companies that process commercial returns of excess, expired or damaged hazardous waste pharmaceuticals, including through reverse distribution programs. Comments on the proposed rule must be received by EPA on or before February 2, 2009. The proposed rule appears in 73 Fed. Reg. 73520 (December 2, 2008) and can be found by clicking on the following link:
What problems does the proposed rule attempt to address?
Companies that sell pharmaceuticals (pharmacies, other retailers, and distributors) or stock them for use by patients (hospitals, clinics, veterinary and extended care facilities) may have hundreds of different excess, expired or damaged pharmaceutical products that must be discarded. (See page 4 below for EPA’s proposed definition of “pharmaceutical.”) Under current hazardous waste rules, once a decision is made that a particular pharmaceutical must be discarded, that pharmaceutical is considered to be a waste and the entity that made the decision to discard the pharmaceutical is considered to be the “generator” of the waste. The generator then must determine whether the waste is a hazardous waste, and if so, manage it according to specific and complex hazardous waste rules.
It is often difficult for pharmacies, health care facilities, and similar companies to determine whether specific pharmaceuticals they discard are hazardous wastes because they lack information regarding the pharmaceutical’s composition, and company employees may not be familiar with the very detailed hazardous waste rules. A practical option is to send excess, out-of-date, and damaged pharmaceuticals to a centralized collection facility where experts familiar with both the composition of the products and the hazardous waste regulatory requirements would first determine whether the products could be recycled. For those pharmaceuticals that must be discarded, the experts would then determine which ones are hazardous wastes, and manage the hazardous wastes in accordance with applicable rules. This practical option raises questions, however, if the company that will be shipping the pharmaceuticals to the collection facility knows that the pharmaceuticals will be discarded before shipping. In that case, EPA historically has required the facility shipping the pharmaceuticals to determine whether they are hazardous wastes before shipment to the collection facility. Further, unless the facility generating the waste always discards less than 100 kg of pharmaceuticals per month, it must store the hazardous waste pharmaceuticals on-site in conformance with hazardous waste storage requirements, and then transport them off-site, usually within 90 days , with a properly completed hazardous waste manifest to a collection, storage, treatment of disposal facility that has a permit to receive hazardous waste.
EPA’s objective behind the proposed rule is to facilitate responsible management of excess, expired and damaged pharmaceuticals through commercial return programs, including reverse distribution. In the absence of responsible collection options, EPA is concerned that companies may dispose their excess, out-of-date or damaged products with their regular trash or down the sink and into the sewer. Such disposal practices can ultimately contaminate surface water, ground water and drinking water. Further, generators and receiving facilities that do not know which of their discarded drugs are hazardous wastes or do not understand their regulatory responsibilities for such wastes can face high-profile enforcement actions that are both expensive to defend and very damaging to the public image of health care companies.
How would the proposed rule address these problems?
The proposed rule would allow companies to send excess, expired or damaged pharmaceuticals to a centralized collection facility regardless of whether the company knows that the pharmaceuticals will be discarded. The pharmaceuticals would have to be sent to the collection facility in containers that are in good condition and marked “Universal Waste - Pharmaceuticals” or “Waste Pharmaceuticals.” The shipment must also be accompanied by a shipping document and the date of receipt must be noted. Other requirements regarding employee training, accumulation time limits, and spills would also apply. But all of these requirements are less burdensome than what would apply under current hazardous waste rules.
Hazardous waste experts at collection facilities, in turn, would determine which pharmaceuticals can be recycled, which are hazardous wastes, and then manage them accordingly. In this situation, the collection facility would not need a hazardous waste permit. Rather, within one year of determining which pharmaceuticals are hazardous wastes, they could send such hazardous waste pharmaceuticals off-site to a permitted hazardous waste facility for final treatment and/or disposal.
Note that the centralized collection facility could be operated by a company whose business is built around collection, sorting and properly managing discarded pharmaceuticals through reverse distribution or other commercial return programs. Pharmaceutical manufacturers and their distributors could also serve as centralized collection facilities without having to obtain hazardous waste permits.
EPA proposes to adopt these streamlined rules through its so-called “Universal Waste” program. This program has been very successful streamlining the hazardous waste regulation of other ubiquitous wastes like batteries, thermostats and certain light bulbs.
Will this rule affect rules enforced by other federal and state agencies that may apply to certain discarded pharmaceutical products (e.g., Department of Transportation (DOT) rules regarding the transportation of hazardous materials, Nuclear Regulatory Commission (NRC) rules regarding radioactive wastes Drug Enforcement Administration (DEA) rules regarding controlled substances, or state medical waste rules)?
No. This proposed rule only reduces the burdens of complying with EPA’s hazardous waste rules. Thus, it is only a first step in addressing the numerous regulatory issues posed when returning excess, expired and damaged pharmaceuticals that could be regulated under the rules of up to four different agencies.
Which discarded pharmaceuticals are hazardous wastes?
EPA and state agencies consider discarded pharmaceuticals to be “P- or U-listed” hazardous wastes if they contain any one of over 400 chemicals where the chemical is the “sole active ingredient” in the drug. In this context, the sole active ingredient would likely be the chemical compound that gives the drug its medicinal function, not inactive materials that are merely carrying or buffering the active ingredient. See 40 CFR § 261.33(d)(Comment). Further, where a pharmaceutical product has two active ingredients, it would not be a listed hazardous waste when discarded. In the proposed rule, EPA identifies certain pharmaceutical active ingredients that may be P- and U-listed hazardous wastes:
- P-listed hazardous wastes include drugs that contain as their sole active ingredient arsenic trioxide (P012), phentermine (CIV) (P046, listed as alpha, alpha-dimethylbenzeneethanamine), epinephrine (P042), physostigmine (P204), nicotine (P075), physostigmine salicylate (P188), nitroglycerin (P081), or warfarin (>0.3%) (P001).
- U-listed hazardous wastes include drugs that contain as their sole active ingredient chloral hydrate (CIV) (U034), paraldehyde (CIV) (U182), chlorambucil (U035), phenol (U188), cyclophosphamide (U058), reserpine (U200), daunomycin (U059), resorcinol (U201), dichlorodifluoromethane (U075), diethylstilbestrol (U089), selenium sulfide (U205), hexachlorophene (U132), streptozotocin (U206), lindane (U129), trichloromonofluoromethane (U121), melphalan (U150), uracil mustard (U237), mercury (U151), warfarin (< 0.3%) (U248), or mitomycin C (U010).
In addition, discarded pharmaceuticals would be hazardous waste if they exhibit any one of four hazardous waste characteristics - toxicity, ignitability, corrosivity or reactivity. Determining whether a particular discarded drug exhibits one of these characteristics is often difficult because it may take only very low levels of certain chemicals in a discarded drug to cause it to exhibit one of these characteristics. Whether a pharmaceutical product contains such chemicals often cannot be easily be determined without laboratory analysis. In any event, EPA has identified the following situations in which drugs might exhibit hazardous waste characteristics:
- Pharmaceuticals would be toxicity characteristic hazardous wastes if they contain specific part per million levels or higher of arsenic (D004), barium (D005), cadmium (D006), chloroform (D022), chromium (D007), lindane (D013), m-cresol (D024), mercury (D009), selenium (D010), or silver (D011). Hazardous wastes also include discarded drugs that are ignitable because they have a flash point less than 140° F, excluding solutions containing less than 24% alcohol. Other discarded drugs may exhibit the reactivity characteristic, such as nitroglycerine. Pharmaceuticals exhibiting the corrosivity characteristic are generally limited to compounding chemicals, including strong acids, such as glacial acetic acid, and strong bases, such as sodium hydroxide.
Under EPA’s proposal, containers (e.g., bottles, vials, IV bags, tubes of ointment/gels/creams, ampules, etc.) which hold any pharmaceutical hazardous wastes may also be considered pharmaceutical hazardous wastes and managed under the streamlined Universal Waste program.
How does the proposed rule define pharmaceutical?
The proposed rule defines a “pharmaceutical” as:
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 intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or injury in man or other animals; or 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 intended to affect the structure or function of the body in man or other animals. This definition includes products such as transdermal patches, and oral delivery devices such as gums or lozenges. This definition 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.
73 Fed. Reg. at 73543 (December 2, 2008). EPA also explains that the rule does not include waste generated by pharmaceutical manufacturers from their manufacturing and ancillary operations at their production plants.
When will the proposed rule be finalized and take effect?
EPA currently plans to finalize the proposed rule in 2010; it could take longer due to the change of Administration. After EPA finalizes the rule, it would normally take effect within sixty days in “nonauthorized” states and US territories, but only Iowa, Alaska and the various territories are “nonauthorized.” In the other 48 “authorized states,” the rule would not take effect until the state affirmatively adopts the rule through its own regulatory process, which typically takes one to three years after EPA adopts a final rule. Therefore, the benefits from this proposed rule are not likely to be available for at least two to five years. As a result, generators of excess, expired or damaged pharmaceuticals, and companies that take them back through collection programs will still need to comply with the existing more cumbersome hazardous waste rules until these new “Universal Waste” rules are adopted and become effective.