COMMENT PERIOD RUNS UNTIL DECEMBER 24, 2015
The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing definition of hazardous wastes (e.g., discharged into sewers, disposed of or thrown out in a municipal solid waste or hazardous waste landfill, or incinerated) (Proposed Management Standards For Hazardous Waste Pharmaceuticals, 80 Federal Register 58014 - 58092 (September 25, 2015). The proposed rule also addresses discarded hazardous waste pharmaceuticals handled by reverse distributors (i.e., handlers of pharmaceuticals returned to the manufacturer for credit).
The comment period opened on October 2, 2015 and now is scheduled to end on December 24, 2015 (since EPA granted an additional 30 days for comment). The purpose of a public comment period is to allow potentially affected parties to inform EPA whether: (a) EPA properly understood the industry; (b) the assumptions that inevitably are used to assess the need and effect of the rule are too far afield from the real world; and (c) any changes may further lessen the regulatory burden (particularly for smaller facilities, which make up most of the affected facilities).
DOES THIS PROPOSED RULE AFFECT YOU?
According to EPA, a discarded pharmaceutical may already be regulated as an EPA hazardous waste if it is specifically listed as hazardous waste in EPA’s hazardous waste regulations (Proposed Management Standards For Hazardous Waste Pharmaceuticals, 80 Fed. Reg. at 58,036-58,38, 58,047) or if it exhibits one or more of the hazardous waste characteristics (ignitability, corrosivity, reactivity, or leachable levels of toxic substances are above regulatory limits). For example, pharmaceuticals mixed with alcohol may be a hazardous waste because of its flammability, even if the active pharmaceutical ingredient itself is not considered hazardous waste. Some pharmaceuticals are also separately regulated under the Controlled Substances Act (CSA), pursuant to U.S. Drug Enforcement Administration rules. The proposed rule applies to previously de minimis generators (i.e., conditionally exempt small quantity generators (CESQG), small quantity generators (SQGs), and large quantity generators (LQGs).
As a result, EPA (and many states and local jurisdictions) have taken the position that the handling and disposal of this hazardous waste derived from discarded pharmaceuticals must comply with the full panoply of requirements in the existing federal, state and local hazardous disposal regulations, even though those regulations were designed to address industrial hazardous wastes and are ill-suited to health care facilities.
EPA claims that 174,023 facilities will be covered by a final rule if no changes are made as a result of public comment. EPA divides the covered facilities into the following categories: Physicians’ Offices, Dental Offices, Other Health Practitioners (e.g., chiropractors), Pharmacies, Outpatient care centers, Veterinary clinics, Hospitals, Nursing Care Facilities, Continuing Care Retirement Communities, Medical Examiners and Coroners Offices, and Reverse Distributors (see Table below).
Click here to view the table.
However, as a practical matter, all of the health care facilities in the U.S. (612,648, not just 174,023) must perform at least some evaluation to determine whether a final rule applies to their facility. At least some paperwork requirements are imposed on an extraordinarily large number of small facilities.
Interestingly, EPA has repeatedly (at least nine times in the documents supporting this rule) stated that a significant number of violations of the existing hazardous waste regulations is occurring (e.g., “Other than the 7 percent of hazardous waste pharmaceuticals generated by pharmacies, all hazardous waste pharmaceuticals generated by SQG [small quantity generators] and CESQG other healthcare facilities are assumed not to be managed in compliance with RCRA.”). If this allegation is true, it may affect how different categories of health care industry view this proposed rule. It also may lead EPA, states and local governments to increase enforcement of the existing regulations if this proposed Pharmaceutical Hazardous Waste Management rule is not finalized.
EPA’S REASONS FOR ISSUING THESE PROPOSED RULES
The primary purposes for proposing this rule are: (a) to decrease the amount of pharmaceuticals discharged into the nation’s rivers, streams and lakes; and (b) to tailor the hazardous waste disposal requirements for the health care industry to lessen regulatory burdens yet ensure the proper disposal of discarded hazardous pharmaceutical wastes (see Environmental Alert: Recent Developments Regarding Disposal of Pharmaceutical Products (June 23, 2015). However, the administrative record contains sparse evidence that the current discharges of most (if not all) pharmaceuticals into surface water cause significant adverse impacts to human health or the environment. Also, although EPA has tried to tailor the rule to the health care industry, EPA concludes that “[t]his proposed rule is considered, on the whole, to be more stringent than the current federal standards.” Proposed Management Standards For Hazardous Waste Pharmaceuticals, 80 Fed. Reg. at 58074.
THE PROPOSED RULE APPLIES TO A BROAD SPECTRUM OF SMALL FACILITIES IN THE HEALTH CARE SECTOR
Health care facility in the proposed rule is defined as:
any person that (1) provides preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or (2) sells or dispenses over-the-counter or prescription pharmaceuticals. This definition includes, but is not limited to, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians’ offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, coroners and medical examiners, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of over-the-counter medications; and healthcare facilities and hospitals. Id. at 58,083.
According to EPA, approximately 83.4 percent of these covered facilities are CESQGs. To calculate how many health care facilities are affected, EPA assumed (based on surveys from three states) that 27.5 percent of the facilities (in each category listed above, except for hospitals and reverse generators) generate hazardous waste, which seems highly unlikely to be accurate.
EPA’S DEFINITION OF PHARMACEUTICALS IS EVEN BROADER
EPA defines “pharmaceutical” as:
any chemical or biological product that is intended for use in the diagnosis, cure, mitigation, care, treatment, or prevention of disease or injury of a human or other animal; or any chemical or biological product that is intended to affect the structure or function of the body of a human or other animal. This definition includes, but is not limited to: dietary supplements as defined by the Federal Food, Drug and Cosmetic Act (FD&C Act), prescription drugs, drugs, over-the-counter drugs, residues of pharmaceuticals remaining in containers, personal protective equipment contaminated with residues of pharmaceuticals, and clean-up material from the spills of pharmaceuticals.”
This proposed definition of “pharmaceutical” is intended to include all dose forms, including, but not limited to tablets, capsules, medicinal gums or lozenges, medicinal liquids, ointments and lotions, intravenous. Proposed Management Standards For Hazardous Waste Pharmaceuticals Id. at 58,021.
EPA also is clarifying that its proposed definition includes any items containing pharmaceutical residuals, such as dispensing bottles, IV bags and tubing, vials, unit dose packages, and delivery devices, such as syringes and patches. In addition, EPA is proposing that items contaminated with or containing residual pharmaceuticals, such as personal protective equipment containing trace amounts of pharmaceuticals or related spill clean-up materials (including loose tablets accumulated during pharmacy floor sweepings) also meet this proposed definition of pharmaceutical. However, this proposed definition does not include sharps (e.g., needles from IV bags or syringes). Proposed Management Standards For Hazardous Waste Pharmaceuticals, 80 Fed. Reg. at 58,021. This definition nonetheless is extraordinarily broad and is likely to cover many substances not typically thought of as pharmaceuticals.
The existing and proposed regulations use the three historic volume triggers CESQGs, SQGs, and LQGs (defined above). Acute hazardous wastes are listed in § 261.31 (see any chemicals listed with an H code at http://www.ecfr.gov/cgi-bin/text-idx?SID=dd50d482c62524e26dd54877c7ca1643&node=40:220.127.116.11.18.104.22.168&rgn=div8) or § 261.33(e) (see list at http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=2f6af648388726599b7462bf322429d0&mc=true&r=SECTION&n=se40.26.261_133in subsection (e)).
If finalized as proposed (which is unlikely since EPA will receive many comments), health care facilities that are currently small quantity generators (SQGs) or large quantity generators (LQGs) and all pharmaceutical reverse distributors, regardless of their RCRA generator category, will be required to manage their hazardous waste pharmaceuticals under this new proposed subpart P of 40 CFR part 266. Proposed Management Standards For Hazardous Waste Pharmaceuticals, 80 Fed. Reg. at 58,016.
Many of the requirements of the regulations appear to be genuine attempts to lessen the regulatory burden on health care facilities. The following focuses on a few of the more interesting provisions, particularly those that may increase the regulatory burden.
- Prohibition Of Sewering Hazardous Waste Pharmaceuticals
The most significant (and potentially troubling) requirement is that:
All healthcare facilities and pharmaceutical reverse distributors are prohibited from discharging hazardous waste pharmaceuticals to a sewer system that passes through to a publicly-owned treatment works. The exclusion in § 261.4(a)(1)(ii) for mixtures of domestic sewage and other wastes that pass through a sewer system to a publicly-owned treatment works does not apply to a hazardous waste pharmaceutical. § 266.505. 80 Fed. Reg. at 58,087.
This provision adds a new burden on health care facilities and may be particularly difficult for the CESQG health care facilities, which is the bulk of the regulated facilities.
- Creditable and Non-Creditable Pharmaceuticals Requirements
For the of health care facilities that are not CESQGs, the impact depends on whether they are returning creditable pharmaceuticals or non-creditable pharmaceuticals.
Creditable pharmaceuticals being returned have relatively minimal requirements. For example, the requirements for the management of non-creditable pharmaceuticals from health care facilities (except CESQGs) include greater:
- notification requirements;
- personnel training requirements;
- no central accumulation area and satellite accumulation area requirements, there are container and labeling standards;
- accumulation time limits and shipping procedures (including those for rejected shipments);
- reporting and recordkeeping requirements;
- procedures for responses to releases;
- must be sent to a hazardous waste RCRA permitted or interim status disposal; and
- conditions for health care facilities that accept hazardous waste pharmaceuticals from off-site CESQGs.(Id. at 58,030).
For pharmaceuticals that are also a DEA controlled substance, the EPA hazardous waste rule does not apply as long as they are combusted at a permitted or interim statute hazardous waste incinerator or a permitted municipal solid waste incinerator, but additional paper work and disposal requirements do apply (Proposed Management Standards for Hazardous Waste Pharmaceuticals at 58,049; 58,028-29).
EPA “does not think that disposal in landfills is the best option for hazardous waste pharmaceuticals,” but the proposed regulation allows continued disposal in municipal or non-municipal solid waste landfills. Proposed Management Standards For Hazardous Waste Pharmaceuticals, 80 Fed. Reg. at 58,042. Thus, the proposed regulation should not significantly add to landfilling costs.
- Large Quantity Generators
EPA is proposing to lessen the requirements on LQGs. The current federal regulations for LQGs include, but are not limited to the following: “obtaining an EPA Identification number; a 90-day limit for accumulating hazardous waste on-site (with relevant standards for the accumulation of hazardous waste) without having to obtain a RCRA permit or comply with the interim status standards, provided that they comply with the conditions for exemption set forth in § 262.34(a) such as management and labeling standards specific to the type of accumulation unit (e.g., container, tank); RCRA training of personnel; contingency planning; manifesting and recordkeeping and reporting (biennial report).” Id. 58,016.
Some of the major proposed changes include, but are not limited to:
- Modifying the training requirements for health care LQGs so they are similar to those that apply to SQGs and small quantity universal waste handlers, although as EPA points out, it may be more cost-effective to continue to use its existing training program if they generate other hazardous waste so as not to have different training programs.Id.58,032.
- Allowing health care facilities to “accumulate hazardous waste pharmaceuticals for up to one year, without having interim status or a RCRA permit,” since off-site shipments may not be cost-effective. Id.58,034.
- No longer requiring LQG health care facilities include their hazardous waste pharmaceuticals on their biennial report (BR). Id. 58,040.
EPA ESCALATES ITS “RECOMMENDATION” TO TREAT ALL PHARMACEUTICALS IN A MANNER SIMILAR TO HAZARDOUS WASTE PHARMACEUTICALS
EPA acknowledges that a “large portion of the pharmaceutical wastes generated at health care facilities will not meet the definition of a RCRA hazardous waste,” but cautions that “nonhazardous waste pharmaceuticals are still considered solid wastes under the federal regulations, and must be managed in accordance with applicable federal, state and/or local regulatory requirements.” Id. 58,029. The proposed rule allows a health care facility to “choose to manage its solid and hazardous waste pharmaceuticals together (as hazardous waste pharmaceuticals) under these new proposed regulations.” Id. At a minimum, EPA recommends that health care facilities follow the best management practices (BMPs) outlined in a the non-EPA ‘‘Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare Facilities in the United States,’’ (Revised August 2008). Id. This guidance recommends more stringent requirements on nonhazardous “wastes that possess hazardous waste-like qualities.” In fact, EPA “endorses” the recommendation in this guidance that “non-hazardous waste pharmaceuticals” be incinerated, “even when they do not possess hazardous waste-like qualities.” Id. 58,030.
Again, affected entities may want to comment.
In essence, EPA’s proposed rule will likely increase the cost of disposal for all covered health care facilities. The major concerns include:
- The Ban On Discharges Into Sewer Systems May Be Problematic.
Since the Clean Water Act, not RCRA, governs discharges into sewer systems, EPA’s legal authority is not clear. Specifically, EPA’s Office of Water has the authority to ban discharge into sewers. This would require a significant revision to the rule and recalculation of the administrative burdens. If CESQG health care facilities contribute a de minimis amount of pharmaceutical hazardous waste to local sewer systems, the likely environmental impact would be extremely small, if any.
The proposed rule: (a) does not include provisions governing enforcement of this ban; (b) on its face, seems to require zero discharge (i.e., there is no de minimis exemption as is often included in other regulations); and (c) is likely to trigger at least new inspections and possibly enforcement efforts by local sewer authorities in at least some states.
The EPA proposed rule may be used (or misinterpreted) by local sewage treatment authorities on a case-by-case basis to minimize discharges of pharmaceuticals into sewage treatment systems. For example, before the issuance of EPA’s proposed dental amalgam separator pretreatment rule in 2014, a patchwork of sewer authority local regulations required dental offices to install dental amalgam separators to minimize the discharge of mercury from sewage treatment plants into streams, rivers and lakes. These local rules were based on the general EPA Clean Water Act regulations requiring mercury reductions to prevent accumulation of methyl mercury in fish. The only way for sewer authorities to “enforce” a ban or even a limitation on a discharge from health care facilities is to have the numerous sewer agencies in the U.S. inspect and, if necessary, enforce against health care facilities and other non-hospital and non-reverse distributors.
EPA is specifically soliciting “comment on whether the ban on sewer disposal should be limited to those healthcare facilities that are currently LQGs and SQGs, and not extended to CESQGs.” Id. at 58,046. Affected CESQGs may well want to provide such comments.
- The Benefits Are Not Quantified.
Normally, EPA must quantity both the costs and the benefits. EPA has no information in the administrative record quantifying the low amount of pharmaceuticals being discharged into sewers by each of the categories of health care facilities. The EPA administrative record includes evidence that low concentrations of pharmaceuticals have been detected in drinking water (e.g., see Appendix F in the Regulatory Impact Assessment (Occurrence of APIs in Finished Drinking Water) and rivers and other water bodies, but the record does not compare these levels to legally enforceable regulator limits. In fact, most of the data does not exceed the proposed FDA 1 ppb screening level to trigger an environmental assessment for pharmaceuticals that demonstrate estrogenic, androgenic, or thyroid hormone pathway activity. EPA’s approach assumes that a problem exists regardless of the pharmaceutical, regardless of the level, and regardless of the differences in the receiving rivers, streams and lakes.
- EPA Appears To Have Exaggerated The Amount Of Pharmaceutical Hazardous Waste That Health Care Facilities Generate.
To determine the impact on individual health care companies or a segment of the health care industry, companies or trade/professional associations may want to attempt to determine, if practical: (a) which pharmaceuticals (as defined by EPA) they use; (b) whether the residual pharmaceuticals are discarded and where they are discarded; (c) whether the residuals are hazardous waste; and (d) the amount (per month) discarded by each of the categories of health care facilities. Of particular interest is what, if any, amount of “hazardous waste pharmaceutical” is discharged from health care facilities into the local sewer system. Of course, these assessments should also evaluate whether these requirements (e.g., the ban on sewer discharges, the reporting requirements and other requirements) are onerous, and if so, if less onerous alternatives exist, and whether they warrant filing comments individually or through your trade or professional association.
Industry trade or professional associations may want to consider whether to propose best management practices and/or de minimis exceptions to the sewer discharge ban.
Finally, health care companies should keep in mind that EPA national hazardous waste regulations do not pre-empt more stringent state or local requirements, only less-stringent requirements.