Friday, September 11, 2015

On August 31, 2015, the Administrator of the U.S. Environmental Protection Agency (“EPA” or the “Agency”) signed a proposed rule that would establish special management standards for pharmaceutical wastes that are classified as hazardous wastes under the Resource Conservation and Recovery Act (“RCRA”). The new standards would include separate requirements for healthcare facilities and pharmaceutical reverse distributors, such as rules for storage, labeling, recordkeeping, reporting, and off-site shipment. The Proposed Rule would also conditionally exempt hazardous waste pharmaceuticals that qualify as controlled substances under the rules of the U.S. Drug Enforcement Administration (“DEA”), add new provisions for hazardous waste pharmaceuticals from households, and amend the requirements for residues of hazardous waste pharmaceuticals in containers. It requests comments on amending the acute hazardous waste listing for low-concentration nicotine products, and on a potential strategy for listing additional pharmaceutical wastes as hazardous.

This Proposed Rule follows up on a 2008 proposal to classify hazardous waste pharmaceuticals as “universal wastes,” which are subject to substantially reduced regulatory requirements under RCRA during generation, collection, and transport (but not during ultimate treatment or disposal). EPA abandoned that earlier proposal several years ago, following adverse public comments, particularly about allegedly inadequate notification and tracking mechanisms in the 2008 proposal. In the Proposed Rule, the Agency explicitly concludes that a universal waste approach is not appropriate for pharmaceutical wastes, and proposes to forbid states from maintaining or adopting such an approach in the future.

Key provisions of the proposal are summarized below. Public comments will be accepted until 60 days after the proposal is published in the Federal Register.

This proposal was issued together with a separate proposal to substantially revise the RCRA regulatory requirements for generators of hazardous waste.

Scope of the Proposed Rule: Hazardous Waste Pharmaceuticals from Healthcare Facilities and Pharmaceutical Reverse Distributors

The Proposed Rule would substantially change the requirements governing the generation and management of hazardous waste pharmaceuticals by healthcare facilities and pharmaceutical reverse distributors. Key terms under the Proposed Rule are explained briefly below.

Hazardous Waste Pharmaceuticals

Under the Proposed Rule, “hazardous waste pharmaceuticals” are those pharmaceuticals that are defined as solid wastes and are either explicitly listed as hazardous waste or exhibit a hazardous waste characteristic (i.e., ignitability, corrosivity, reactivity, or toxicity as measured under the Toxicity Characteristic Leaching Procedure (“TCLP”)). The definition of “pharmaceutical” would include dietary supplements, prescription drugs, over-the-counter drugs, residues of pharmaceuticals remaining in containers (including delivery devices but not sharps), personal protective equipment contaminated with pharmaceuticals, and clean-up material from pharmaceutical spills. EPA also requests comments on whether the definition should extend to electronic cigarettes and refills for such devices (see also the discussion of nicotine-containing wastes, further below).

Healthcare Facilities and Pharmaceutical Reverse Distributors

The Proposed Rule would define “healthcare facilities” broadly to include: hospitals, health clinics, physician’s offices, optical and dental providers, long-term care facilities, ambulance services, pharmacies, retailers of over-the-counter medications, and other entities. “Pharmaceutical reverse distributors” would be defined as any persons that receive and accumulate potentially creditable hazardous waste pharmaceuticals to facilitate manufacturers’ credits.

Proposed Rule Requirements: Healthcare Facilities and Pharmaceutical Reverse Distributors

The Proposed Rule would prohibit all healthcare facilities (including conditionally exempt small quantity generators) and pharmaceutical reverse distributors from disposing of hazardous waste pharmaceuticals through a public sewer system. Other Proposed Rule requirements are designed in part to facilitate compliance with this general “down the drain” disposal prohibition.

Hazardous waste pharmaceuticals managed under the new rules, which would be codified in Subpart P of 40 C.F.R. Part 266, would no longer be counted in calculating a site’s RCRA generator category. Healthcare facilities that qualify as conditionally exempt small quantity generators would be exempt from most of the Proposed Rule’s requirements. However, the Proposed Rule would permit these conditionally exempt small quantity generator healthcare facilities to send potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor. Conditionally exempt small quantity generator healthcare facilities could also send hazardous waste pharmaceuticals to another healthcare facility meeting certain requirements.

Healthcare Facility Requirements

Healthcare facilities covered by the Proposed Rule would be required to meet different requirements for the management of: (1) “non-creditable hazardous waste pharmaceuticals” (i.e., those hazardous waste pharmaceuticals not expected to be eligible for a manufacturer’s credit); and (2) “potentially creditable hazardous waste pharmaceuticals” (i.e., hazardous waste pharmaceuticals that could receive a manufacturer’s credit, but not including “evaluated hazardous waste pharmaceuticals” (as explained further below), pharmaceutical residues in containers, contaminated personal protective equipment, and clean-up material from pharmaceutical spills).

For the management of non-creditable hazardous waste pharmaceuticals, healthcare facilities under the Proposed Rule would be required to:

Make a hazardous waste determination for solid waste that is a pharmaceutical (specific waste codes would not be required);

Accumulate and transport non-creditable hazardous waste pharmaceuticals in containers that are structurally sound and not leaking or spilling; and

Keep records of manifests, exception reports, and analyses supporting hazardous waste determinations.

Healthcare facilities would also have to comply with requirements related to notification, personnel training, labeling, land disposal restrictions, rejected shipments, exception reporting, and release response. Under the proposed standards, healthcare facilities would be permitted to accumulate non-creditable hazardous waste pharmaceuticals on-site for up to a year without a permit or interim status (provided certain recordkeeping requirements are met). When shipping non-creditable hazardous waste pharmaceuticals off-site to a designated facility, healthcare facilities would be required to provide a manifest (but not specific waste codes), use a hazardous waste transporter, and comply with pre-transport packaging, labeling, marking, placarding, and shipping paper requirements.

The Proposed Rule has more limited requirements for healthcare facilities when managing potentially creditable hazardous waste pharmaceuticals, because these pharmaceuticals are often quickly shipped to the manufacturer for credit, minimizing diversion concerns. The Proposed Rule would require healthcare facilities generating potentially creditable hazardous waste pharmaceuticals to make a hazardous waste determination. Healthcare facilities would be prohibited from sending hazardous wastes other than potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor. When shipping potentially creditable hazardous waste pharmaceuticals off-site to a pharmaceutical reverse distributor, healthcare facilities would not need to provide a manifest or use a hazardous waste transporter. Instead, healthcare facilities would provide advance notice to the recipient pharmaceutical reverse distributor and comply with the pre-transport packaging, labeling, marking, placarding, and shipping paper requirements. The recipient pharmaceutical reverse distributor would then provide a confirmation that the shipment arrived and keep certain records.

Pharmaceutical Reverse Distributor Requirements

The Proposed Rule would create a new category under RCRA for pharmaceutical reverse distributors. Pharmaceutical reverse distributors could accept potentially creditable hazardous waste pharmaceuticals from off-site and accumulate potentially creditable hazardous waste pharmaceuticals or “evaluated hazardous waste pharmaceuticals.” Evaluated hazardous waste pharmaceuticals are hazardous waste pharmaceuticals that were potentially creditable hazardous waste pharmaceuticals but that have been evaluated by a pharmaceutical reverse distributor to determine their eligibility for manufacturer’s credit and that will not be sent to another pharmaceutical reverse distributor for further evaluation or verification. To accept potentially creditable hazardous waste pharmaceuticals from off-site and accumulate potentially creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals without a permit or interim status, pharmaceutical reverse distributors would need to meet requirements to:

Notify EPA of the pharmaceutical reverse distributor’s operations;

Satisfy inventory maintenance requirements for all potentially creditable and evaluated hazardous waste pharmaceuticals accumulated on-site;

Secure areas where potentially creditable and evaluated hazardous waste pharmaceuticals are kept;

Report any receipt of unauthorized hazardous waste from off-site; and

Maintain certain records, including the advance notification, delivery confirmation, and shipping papers for each shipment of potentially creditable hazardous waste pharmaceuticals received, and inventory and unauthorized hazardous waste reports.

Additionally, a pharmaceutical reverse distributor would be required to evaluate potentially creditable hazardous waste pharmaceuticals with 21 days of arrival to establish whether they will be transported to another pharmaceutical reverse distributor, for verification of manufacturer’s credit, or to a hazardous waste treatment, storage, or disposal facility. Unlike healthcare facilities, pharmaceutical reverse distributors without a permit or interim status can only accumulate potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals on-site for up to 90 calendar days, beginning when the pharmaceuticals arrive.

Within those 90 days, the Proposed Rule would require that the potentially creditable hazardous waste pharmaceuticals be managed in one of the following ways:

If they are from a healthcare facility, they may be transported to another pharmaceutical reverse distributor;

If they are from a pharmaceutical reverse distributor, they may be transported to another pharmaceutical reverse distributor that is also a pharmaceutical manufacturer; or

If they are from either source, they may be managed in accordance with the standards for evaluated hazardous waste pharmaceuticals (described below).

For evaluated hazardous waste pharmaceuticals, a pharmaceutical reverse distributor without a permit or interim status must meet additional requirements including: designating an on-site accumulation area, inspecting that area weekly, personnel training, labeling and management of containers, marking containers with relevant hazardous waste code(s), following specified procedures for rejected shipments, complying with land disposal restrictions, biennial reporting, exception reporting, and recordkeeping.

Pharmaceutical reverse distributors transporting potentially creditable hazardous waste pharmaceuticals off-site to another pharmaceutical reverse distributor would not need to provide a manifest or use hazardous waste transporters. Instead, pharmaceutical reverse distributors would provide advance notice to the recipient pharmaceutical reverse distributor and comply with pre-transport packaging, labeling, marking, placarding, and shipping paper requirements. The recipient pharmaceutical reverse distributor would then provide a confirmation that the shipment arrived and keep certain records.

Pharmaceutical reverse distributors transporting evaluated hazardous waste pharmaceuticals to an off-site permitted or interim status treatment, storage, or disposal facility would be required to provide a manifest (listing specific waste codes), use a hazardous waste transporter, and meet pre-transport packaging, labeling, marking, placarding, and shipping paper requirements.

Proposed Rule Provisions Applying Broadly to Healthcare Facilities, Pharmaceutical Reverse Distributors, and Other Entities

The Proposed Rule contains a few provisions that would apply not only to healthcare facilities and pharmaceutical reverse distributors, but also to other entities. These provisions include a new conditional exemption for hazardous wastes that are also DEA controlled substances, new provisions relating to hazardous waste pharmaceuticals from households, and revised rules for management of residues of hazardous waste pharmaceuticals in containers. Additionally, the Proposed Rule requests comments on amending the acute hazardous waste listing for low-concentration nicotine products and the potential listing of additional pharmaceuticals as hazardous wastes.

New Conditional Exemption for Hazardous Waste Pharmaceuticals that are DEA Controlled Substances

The Proposed Rule would conditionally exempt hazardous waste pharmaceuticals that are also controlled substances from all RCRA Subtitle C requirements, including the new 40 C.F.R. Part 266, Subpart P, as described above. To qualify for this exemption, the controlled substances must: (1) be combusted in a permitted large or small municipal waste combustor or a RCRA permitted or interim status hazardous waste combustor; and (2) be managed and disposed of in compliance with all applicable DEA regulations.

New Provisions for Hazardous Waste Pharmaceuticals from Households

The preamble to the Proposed Rule clarifies that hazardous waste pharmaceuticals collected by retail pharmacies and law enforcement in DEA authorized collection receptacles would qualify for the household hazardous waste exclusion. However, the Proposed Rule would effectively add an independent requirement that DEA-registered authorized collectors collecting controlled substances from ultimate users and commingling them with hazardous waste pharmaceuticals qualifying as household hazardous wastes ensure that these wastes be combusted in a municipal solid waste or hazardous waste combustor, and otherwise be managed in accordance with all applicable DEA regulations.

Revised Requirements for the Management of Hazardous Waste Pharmaceutical Residues in Containers

Under the Proposed Rule, EPA would amend the regulations that apply to containers with residues of hazardous waste pharmaceuticals. The proposed regulations would address three types of containers: (1) unit dose containers (e.g., unit dose packets, blister packs, or delivery devices) and dispensing bottles and vials; (2) dispensed syringes; and (3) other containers (e.g., IV bags and tubing, inhalers, and tubes of gels or ointments). For unit dose containers and dispensing bottles/vials, the residues (and containers) would not be regulated as hazardous wastes if all pharmaceuticals are removed using common practices and, if the container is the original manufacturer’s product package, that package is destroyed before disposal in a manner to protect against further use. Residues in a syringe would not be regulated as hazardous waste provided that the syringe was used to administer a pharmaceutical to a patient, placed in a sharps container, and managed in accordance with all applicable requirements. “Other” containers, including delivery devices, would be regulated as hazardous waste pharmaceuticals if the residues are listed or characteristic hazardous wastes.

Request for Comment on Potential Amendment of the Acute Hazardous Waste Listing for Low-Concentration Nicotine Products

Currently, nicotine and salts are listed as acutely hazardous wastes under RCRA (EPA Hazardous Waste No. P075). According to EPA, this listing extends to unused nicotine-containing products, such as gums, lozenges, patches, inhalers, nasal sprays, electronic cigarettes, and e-cigarette refill liquids (when discarded). One effect of the listing, as interpreted by the Agency, is that it causes large numbers of retail stores to be subject to full regulation as large quantity generators of hazardous wastes, whenever they have to discard more than 1 kg of these products in a calendar month (e.g., due to expiration, damage, product discontinuation, or other factors). A number of retail industry trade associations submitted comments to EPA, requesting that low-concentration nicotine products (such as the ones discussed above) be reclassified as non-acutely hazardous wastes, on the grounds that (1) the original listing was based on high-concentration nicotine pesticides that are now prohibited in the U.S., (2) the low-concentration products now being sold (which didn’t exist at the time of the listing) have nicotine concentrations that are >90% lower than the concentrations found in the old nicotine pesticides, (3) the original toxicity data relied on by EPA has been discredited and in any event would not support listing of the low-concentration products (as evidenced in part by the fact that the government and the medical community encourage millions of people to use gums and other products daily, without any acute toxicity concerns), and (4) the burdens on the retail industry are tremendous (well in excess of $40 million per year) and unjustified.

In the preamble to the Proposed Rule, EPA seeks comment on two approaches for responding to the retailers’ request. Under the first approach, EPA would issue an exemption for FDA-approved over-the-counter nicotine “smoking cessation” products. Apparently, these products would not simply be reclassified as non-acutely hazardous wastes, but would be exempt from RCRA regulation entirely. On the other hand, the exemption would not extend to smoking cessation products that require a prescription (e.g., inhalers and nasal sprays), or to e-cigarette products. Under the second approach, EPA would either exempt all low-concentration nicotine products (perhaps below 3%) from regulation or reclassify them as non-acutely hazardous wastes. To support either approach, the Agency states that it needs additional information, including human and/or animal toxicity data for the relevant products (as opposed to linear or other extrapolations from studies on concentrated nicotine). Although EPA has not formally proposed one approach or the other, it states that it can move forward with a regulatory change based on the request for comment (i.e., without another formal proposal).

Request for Comment on Strategy for Listing of Additional Pharmaceutical Wastes as Hazardous

In response to input from the EPA Office of Inspector General and others that the Agency has failed for decades to evaluate new pharmaceuticals for potential listing as RCRA hazardous wastes, the Agency requests comment on potential candidates for listing as hazardous wastes, as well as potential methods for identifying hazardous waste pharmaceuticals for listing. EPA also asks if/how it should take into account other regulatory regimes that might prevent mismanagement of pharmaceutical wastes, such that listing might not be necessary. The Agency emphasizes that it is not issuing a proposal on these issues, and therefore cannot take action without a separate proposal in the future.

Effect of the Rule in the States

EPA notes that the rule, when finalized, will generally not take effect in most states until the states act to adopt the rule as a matter of state law, because most portions of the rule would not be issued under the Hazardous and Solid Waste Amendments of 1984 (“HSWA”), which provides for an immediate effective date in all states for certain rules. The main exceptions are for the few states that do not have “authorized” RCRA programs (e.g., Alaska and Iowa), and for the proposed prohibition on sewering of hazardous waste pharmaceuticals (which EPA asserts is being proposed pursuant to HSWA).

The Agency claims that the proposed rule, “on the whole,” would be considered more stringent than current federal regulatory requirements for hazardous waste pharmaceuticals, and therefore will have to be adopted by all RCRA-authorized states. However, EPA acknowledges that some elements of the proposed rule may be less stringent, such that they would not have to be adopted by the states.

Finally, the Agency notes that two states (Florida and Michigan) have classified pharmaceutical wastes as “universal” hazardous wastes, thereby subjecting them to fewer regulatory requirements than currently apply under federal law. EPA specifies that these states will also have to adopt the new rule, and will have to remove hazardous waste pharmaceuticals from their universal waste programs (although they may continue to regulate non-hazardous waste pharmaceuticals as universal wastes, if they so choose).