United States: EPA Proposes Long-Awaited Hazardous Waste Pharmaceuticals Rule: Implications To Healthcare Facilities

For the better part of a decade, the regulated community, policymakers, and regulators have grappled with how best to manage hazardous waste pharmaceuticals. On August 31, 2015, the curtain rose on a new era with the pre-publication of a new proposed standard for stemming the flood of pharmaceuticals entering our water supply and streamlining waste management practices to protect our nation's drug supply. On one hand, pharmaceutical waste falls squarely within the scope of the Federal Resource Conservation and Recovery Act (RCRA).1 On the other hand, the U.S. Environmental Protection Agency regulations implementing RCRA were clearly designed to apply to industrial facilities, and thus regulating hazardous pharmaceutical waste within RCRA's framework often seems like fitting a square peg into a round hole. Complicating the issue is that many states have issued their own policies related to managing hazardous pharmaceutical waste, and thus the regulated community has struggled to implement consistent, national programs under this patchwork of federal and state-specific requirements. In its pre-publication proposed rule, EPA has tried to strike a balance that is long overdue.

I. Regulatory Background.

Recognizing the need for a separate management structure for hazardous pharmaceutical waste, on December 2, 2008 EPA proposed a Universal Pharmaceutical Waste rule,2 which called for the management of hazardous waste pharmaceuticals through a simplified, streamlined alternate system like the one used for florescent light bulbs and waste batteries, rather than via the traditional RCRA Subtitle C requirements.3 Due to an abundance of negative public comments, EPA formally withdrew the proposed rule in 2012. Over the past several years, the regulated community has provided EPA with feedback on the challenges faced in managing hazardous waste pharmaceuticals in order to aid EPA in drafting a rule specific to healthcare facilities. EPA has listened attentively, and, in response, the pre-publication version of the proposed rule, Management Standards for Hazardous Waste Pharmaceuticals, was posted online by EPA on Monday, August 31, 2015.4

II. Proposed Rule – Generally.

In the rulemaking, EPA has proposed to add new subpart P under 40 C.F.R. Part 266, "Standards for the Management of Specific Hazardous Wastes and Specific Types of Hazardous Waste Management Facilities," which would create exclusive sector-specific regulations for managing hazardous waste pharmaceuticals5 by healthcare facilities6 and pharmaceutical reverse distributors. Under the proposed rule, all hazardous waste generators would be required to manage pharmaceuticals in accordance with the new subpart P regulations, rather than 40 C.F.R Part 262.7 The management requirements would not change when hazardous waste pharmaceutical generation varies from month to month.8 This is a significant change that greatly simplifies generator requirements. As noted below, many retail pharmacies have been required to register as Large Quantity Generators of hazardous waste (LQGs) based on their accumulation of greater than 2.2 pounds of nicotine cessation products.

The proposed rule creates separate management standards for creditable and non-creditable hazardous waste pharmaceuticals—termed "potentially creditable hazardous waste pharmaceuticals"9 and "non-creditable hazardous waste pharmaceuticals."10 "Potentially creditable hazardous waste pharmaceuticals" are subject to relaxed standards compared to the current LQG and Small Quantity Generator (SQG) regulatory requirements, and EPA directly indicates its acceptance of the practice of over-managing potentially creditable non-hazardous waste pharmaceuticals with the potentially creditable hazardous waste pharmaceuticals at the healthcare facility.11 For example, while a healthcare facility is subject to new notification and tracking requirements for shipments of potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor,12 manifesting requirements are eliminated and shipments may be made by common carrier.13 Potentially creditable hazardous waste pharmaceuticals are subject to very few onsite management requirements at the healthcare facility, and biennial reporting requirements are eliminated.14

"Non-creditable hazardous waste pharmaceuticals" are generally managed onsite similarly to current hazardous waste SQG requirements. When shipped offsite, non-creditable hazardous waste pharmaceuticals must be manifested and transported as hazardous waste, and sent to a RCRA interim status or permitted facility.15 Many requirements for non-creditable hazardous waste pharmaceuticals, however, are relaxed compared to current hazardous waste management standards, particularly compared to existing LQG requirements. For example, whereas LQGs and SQGs are only allowed to accumulate hazardous waste onsite for 90 days and 180 days, respectively, non-creditable hazardous waste pharmaceuticals may be accumulated onsite for up to one year. Biennial reporting requirements are also eliminated.16

While healthcare facilities generally would be subject to fewer requirements than under current LQG and SQG regulations, the new pharmaceutical reverse distributor requirements are similar to current LQG standards, with added inventory and tracking requirements. This article, however, focuses primarily on the proposed rule's effect on healthcare facilities.

III. EPA Goals

The proposed rule addresses two EPA goals, in addition to addressing stakeholder concerns regarding the current challenges of hazardous pharmaceutical waste management.

A. Sewer Ban

EPA intends to restrict the currently acceptable and common practice used by healthcare facilities of disposing of pharmaceuticals down the drain.17 If finalized, the proposed rule would prohibit the discharge of all hazardous waste pharmaceuticals. Specifically, the proposed rule states: "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."18 EPA identifies this prohibition as the largest quantified benefit of the proposed rule, and EPA anticipates a reduction of approximately 6,400 tons in the volume of hazardous waste pharmaceuticals discharged annually into waterways as a result of the sewering ban. EPA estimates cost savings of eliminated wastewater treatment to be $4.3 million annually.

While CESQGs are generally exempt from proposed subpart P of 40 C.F.R Part 266, the prohibition against sewering equally applies to CESQG healthcare facilities. EPA is particularly concerned that CESQG healthcare facilities are more likely to dispose of hazardous waste pharmaceuticals in the sewer.19 The rule would not prohibit discharge of non-hazardous pharmaceuticals, but EPA strongly recommends not sewering any waste pharmaceuticals.20 As discussed below, controlled substances are also prohibited from being sewered.

B. EPA and DEA Intersection

EPA also intends to clarify the intersection between RCRA hazardous waste regulations and the federal Drug Enforcement Administration (DEA) regulations for controlled substances. For any hazardous waste pharmaceutical that is also a controlled substance, a healthcare facility must currently manage the waste in compliance with both RCRA hazardous waste requirements and requirements of the Controlled Substances Act and DEA regulations. EPA believes that the duplicative regulation often incentivizes sewering hazardous waste pharmaceuticals that are also controlled substances.

Due to challenges associated with managing these wastes, EPA is proposing to conditionally exempt from RCRA regulatory requirements those pharmaceuticals that are both a RCRA hazardous waste and a DEA controlled substance, so long as the waste is collected, stored, transported, destroyed and disposed in compliance with all DEA requirements for controlled substances.21 Although DEA regulations alone would allow the use of other disposal technologies, the conditional exemption specifies that hazardous waste pharmaceuticals that are also controlled substances must be combusted at a permitted or interim status hazardous waste incinerator or a permitted municipal solid waste incinerator.22

IV. Implications for Healthcare Facilities.

The regulated community, policymakers, and regulators alike have anxiously awaited the proposed rule. Some states have awaited EPA rulemaking before issuing their own policies or new regulations on issues such as reverse distribution of pharmaceuticals.23 The question is now whether and to what extent the proposed rule, if finalized, would provide the relief sought by the regulated community and the clarity sought by regulators. Here we highlight several key issues.

A. Reverse Distribution and Point of Generation.

Reverse distribution is the process by which dispensers of pharmaceuticals send expired, damaged, recalled or discontinued pharmaceutical products to manufacturers, wholesalers or third-party service companies that facilitate processing and disposition of the returned products. In processing the items, the reverse distributor determines whether the items are eligible to receive a monetary credit from the manufacturer. RCRA and its implementing regulations do not explicitly address reverse distribution. However, prior EPA guidance24 and the preamble to EPA's 2008 proposed Universal Pharmaceutical Waste Rule25 established EPA's historical position that pharmaceutical products returned for credit via the reverse distribution process do not become wastes until a determination is made to discard them.

While most states seem to embrace EPA's historical position, a handful of states in recent years issued policies inconsistent with EPA's policy. This lack of uniformity has presented compliance challenges for the regulated community, particularly for companies operating in multiple states under a national waste management program. New Mexico, for example, issued a May 14, 2014 Fact Sheet For Hazardous Waste Pharmaceuticals, indicating that the New Mexico Environment Department "does not recognize the reverse distribution of expired hazardous waste pharmaceuticals," and that "[o]nce a product has expired it is considered a waste and must be disposed of in accordance with hazardous waste regulations." New York, however, has supported EPA's policy. In a December 9, 2014 guidance document titled Reverse Distribution/Reverse Logistics, the New York State Department of Environmental Conservation indicated that "[m]aterials shipped to a reverse distributor are considered products and not wastes until they are processed by the reverse distributor."

With regard to reverse distribution of hazardous waste pharmaceuticals, the proposed rule states, "[h]ealthcare facilities are prohibited from sending hazardous wastes other than potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor."26 In the preamble, EPA explicitly modifies its prior position regarding the waste status of creditable hazardous waste pharmaceuticals by stating:

EPA is proposing to reinterpret its position such that the decision to send a pharmaceutical to a reverse distributor is the point at which a decision has been made to discard the pharmaceutical. As a result, once the decision is made to send a hazardous waste pharmaceutical to a reverse distributor, it is a solid waste at the healthcare facility.27

This statement initially seems problematic for healthcare facilities, given that hazardous waste may not be sent to a pharmaceutical reverse distributor that is not licensed as a treatment, storage, and disposal facility (TSDF). However, throughout the proposed rule, EPA supports sending creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor even though these pharmaceuticals are deemed a waste at the healthcare facility. Expired hazardous waste pharmaceuticals may also be sent to a pharmaceutical reverse distributor as potentially creditable hazardous waste pharmaceuticals, provided the expired pharmaceuticals are less than one year past their expiration date.28 This framework runs counter to the above-discussed New Mexico policy, which disallows reverse distribution of any expired hazardous waste pharmaceuticals. The Minnesota Pollution Control Agency (MPCA) has taken a similar position to EPA's. In a May 6, 2011 MPCA guidance memo titled Reverse Distribution of Pharmaceuticals: Guidance for Minnesota Healthcare Providers, MPCA indicated that if pharmaceuticals are ultimately disposed by the reverse distributor rather than used for their intended purpose, the pharmaceutical is a waste at the store. Nonetheless, MPCA allows hazardous waste pharmaceuticals to be managed through the reverse distribution process, so long as the generator satisfies specific, stringent tracking requirements.29

The reverse distribution provisions in the proposed rule are generally favorable for healthcare facilities. If finalized, healthcare facilities would be subject to onsite management requirements for potentially creditable hazardous waste pharmaceuticals that are less stringent than LQG and SQG requirements, as well as new tracking requirements. Specifically, a healthcare facility shipping potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor must provide advance notice to the pharmaceutical reverse distributor of the intent to ship potentially creditable hazardous waste pharmaceuticals to the pharmaceutical reverse distributor. This notice must be provided before each shipment is sent.30 If the healthcare facility does not receive confirmation of receipt by the pharmaceutical reverse distributor within seven calendar days, the healthcare facility must contact the shipper and the pharmaceutical reverse distributor to report the discrepancy and determine the status of the shipment.31 This request is consistent with best management practices required by some states.32 The proposed rule does not provide further detail as to the level of effort for continued investigations if the shipment cannot be located.

B. Empty Container Residue

In a November 4, 2011 guidance document titled Containers that Once Held P-Listed Pharmaceuticals, EPA provided relief for healthcare facilities that otherwise would be subject to regulation as LQGs, based on the generation of small quantities of pharmaceutical waste regulated as a RCRA acute hazardous waste.33 Prior to this guidance, healthcare facilities counted the weight of containers having previously held P-listed weight toward the facility's generator status. Due to the very low LQG threshold of 2.2 pounds per calendar month for acute hazardous waste, many healthcare facilities were identified as LQGs because of the empty containers. In the November 2011 guidance, however, EPA clarified: "[I]t is only the residue in the non-RCRA-empty container that is considered a P-listed hazardous waste; the container itself is not a hazardous waste." EPA also stated: "[I]t is only the weight of the residue in the container that needs to be counted toward generator status; the weight of the container does not need to be counted toward generator status." Relying upon this EPA guidance, and analytical sampling to determine the appropriate weight of the residue, most retailers no longer count empty containers toward generator status. States have generally accepted EPA's November 4, 2011 guidance, with the exception of Hawaii.34

While healthcare facilities have followed this empty container guidance for several years, it was merely guidance. Now, however, EPA proposes a regulation specific to this issue, though slightly modified. EPA proposes different requirements for different types of containers, including unit-dose containers and dispensing bottles and vials; dispensed syringes; and other containers, including delivery devices. The preamble indicates that if finalized, the new regulation would replace the November 2011 guidance.

The proposed rule indicates that unit-dose containers and dispensing bottles and vials are considered empty, and the residues are not regulated as hazardous waste so long as all pharmaceuticals have been removed using practices commonly employed to remove materials from the container, and any dispensing bottle or unit-dose container in an original manufacturer's product package is destroyed prior to disposal in a manner that would prevent further use of the container.35 A driver for this change is EPA's goal to eliminate sewering pharmaceuticals, as EPA believes that when containers are rinsed, the rinsate is poured down the drain.36 EPA proposes a requirement that the original pharmaceutical packages be destroyed prior to being placed in the trash because of EPA's concern for potential diversion of pharmaceutical containers.37 The preamble notes that destruction could include crushing or shredding the container, but defacing the label is insufficient.38

The proposed rule would not regulate residues remaining in a dispensed syringe as hazardous waste provided the syringe has been used to administer a pharmaceutical to a patient and the syringe is placed in a sharps container (where appropriate) and managed in accordance with applicable medical waste regulations.39 EPA believes this conditional exemption is important to minimize the potential for healthcare workers to be accidentally stuck with needles, since sharps containers are generally more readily available than hazardous waste containers in a healthcare setting.40

As to other containers, including delivery devices, EPA proposes that hazardous waste residues remaining in unused or used containers, such as IV bags and tubing, inhalers, aerosols, nebulizers, tubes of ointment, gels, or creams, would be regulated as hazardous waste.41 EPA notes that there is generally more residue remaining in these types of containers. EPA again notes the importance of not emptying residue into the sink, which the Agency recognizes has been common practice.42 Although the residue must be managed as a hazardous waste pharmaceutical, the proposed rule does not require the residue to be counted toward generator status.

C. Nicotine-Containing Products

Despite the relief afforded by EPA guidance issued November 4, 2011 that excludes the weight of P-listed pharmaceutical waste containers in determining generator status, nicotine-containing products, particularly nicotine replacement therapy (NRT) products (gums, lozenges, and patches) remain a driver for LQG registrations, particularly for retailers. As EPA notes in the proposed rule, "unused (unsold, expired, or returned) nicotine-containing products, including patches, gums, lozenges, inhalers, nasal sprays, and e-cigarettes, are classified as P075 listed acute hazardous wastes when discarded."43 Expired and customer-returned, unused NRT products are often managed as hazardous waste at retail facilities, since there has traditionally been little to no opportunity for credit of NRT products through the reverse distribution process. As such, the weight of such products can quickly push a retail facility over the 2.2-pound LQG acute hazardous waste threshold. Retailers have anxiously awaited relief from EPA on this issue.

The proposed rule does not directly address nicotine-containing products. However, EPA recognizes the challenges associated with these products, and proposes and requests comment on two potential management options: (1) an exemption from the P075 listing for FDA-approved OTC NRT products; and (2) a concentration-based exemption from the P075 listing for low-concentration nicotine-containing products.

As to the former option, EPA explains in the preamble that NRT products are approved by the Food and Drug Administration (FDA), indicating that the risk to those using these products has been evaluated.44 EPA is attempting to obtain the risk evaluation data for these products from FDA, which may show the exact concentration of nicotine in these products, as well as any human and animal toxicity data available.45 EPA also requests from the public any toxicity data for these products, particularly data that could be compared to EPA's acute toxicity criteria under 40 C.F.R. § 261.11(a)(2). Because e-cigarettes are not yet approved by the FDA, e-cigarettes would not likely be included in this type of exemption.46

As to the latter option, EPA notes that retail association comments have stressed that low concentrations of nicotine products, which generally contain less than three percent nicotine, should not be classified as acutely hazardous waste.47 EPA states that industry has not provided the Agency with toxicological data to demonstrate such products are not acutely toxic as defined under 40 C.F.R. § 261.11(a)(2). If based on the toxicological data, maximum concentrations of nicotine in these products show the products are not acutely toxic, EPA could propose a concentration-based exemption for the products, including e-cigarettes, from the P075 listing.48 However, depending on the toxicity data, EPA may also propose to list P075-exempt nicotine-containing products as non-acute hazardous waste on the U-list under 40 C.F.R. § 261.33(f).49 

EPA's willingness to issue a proposed rule exempting some nicotine-containing products from the P075 listing is viewed very favorably by the regulated community, particularly retailers. NRT products are the primary drivers for LQG notifications, and these products would be addressed under either proposed option, given the broad definition of pharmaceutical. EPA explains in the preamble that "pharmaceutical" is meant to include "medicinal gums or lozenges" as well as "medicinal dermal patches, with the primary purpose to deliver or dispense the pharmaceutical."50 It appears NRT would be addressed under either option, but EPA notes that e-cigarettes would likely only be covered by the latter option.

EPA's approach and the scope of the exemption for nicotine-containing products remains to be seen, and likely depends on availability and results of toxicity data provided to EPA by the regulated community during the public comment period. In addition to comments on the above approaches, EPA requests comment on any other approaches to amend the nicotine acute hazardous waste listing, as well as whether EPA should exempt other low-concentration NRT products from the P075 listing, such as inhalers and nasal sprays that are FDA-approved, but unlike the gum, lozenges, and patches, require a prescription for purchase.51 

During the public comment period, the regulated community should provide EPA with available toxicological data to support its position that some nicotine-containing products should be excluded from the P075 listing.

D. Large Quantity Generator Status – Likely Eliminated.

While many healthcare facilities, particularly retailers, are registered as LQGs solely because of NRT products, if finalized the proposed rule will likely eliminate the classification of healthcare facilities as LQGs, with the management of all pharmaceuticals, which is a broadly defined term, redirected to the new standards in 40 C.F.R 266, subpart P. Because the weight of hazardous waste pharmaceuticals—whether potentially creditable or non-creditable—will not count toward a healthcare facility's generator status, many healthcare facilities currently registered as LQGs will become either SQGs or CESQGs, depending on the weight of non-pharmaceutical hazardous waste generated at the facility. In eliminating LQG requirements that are onerous and ill-designed for retail waste management, this regulatory change would be of major benefit to healthcare facilities.

One potential wrinkle for healthcare facilities is whether e-cigarettes (which contain nicotine) will be considered a pharmaceutical. EPA specifically requests comment on whether e-cigarettes and nicotine-containing e-cigarette refill liquids (also called e-liquids or e-juice) should be included as a "pharmaceutical."52 If considered a pharmaceutical, just as is anticipated for NRT products, e-cigarettes and e-cigarette refill liquids would not impact a healthcare facility's generator status and would be managed under the new subpart P. If they are not considered pharmaceuticals, e-cigarettes would count toward a healthcare facility's generator status and be managed under the 40 C.F.R Part 262. Healthcare facilities should carefully analyze whether e-cigarettes and e-cigarette refill liquids alone (without NRT) could exceed the 2.2-pound LQG acute hazardous waste threshold. If so, healthcare facilities that sell e-cigarettes would still be classified as an LQG, and be required to manage all non-pharmaceutical waste in compliance with LQG requirements.

V. Applicability to States

The applicability of any given RCRA regulation to the states varies depending on whether EPA has granted authority to the State to administer its own hazardous waste management program, whether the regulation was issued under the authority of the Hazardous and Solid Waste Amendments of 1984 (HSWA), and, for authorized states, whether the regulation is more stringent or broader than existing federal requirements.53 In unauthorized states (Alaska and Iowa), new regulations apply on their effective date. In authorized states (all states except Alaska and Iowa), new regulations apply on their effective date for provisions enacted pursuant to HSWA authority, they are not effective for provisions enacted pursuant to non-HSWA authority. Rather, authorized states must modify their programs when EPA promulgates non-HSWA regulations that are more stringent or broader than the existing federal requirements. Authorized states are not required to modify their state programs when non-HSWA RCRA regulations are less stringent than prior regulations.

EPA's proposed action would add a new subpart P to 40 C.F.R. Part 266, which EPA is proposing primarily under non-HSWA authority. If finalized, the rule will become effective in Alaska and Iowa on the effective date specified in the regulations. The bulk of the rule would not be effective at that time in the remaining states. However, EPA notes in the preamble that because the Agency considers the proposed rule to be more stringent than the current federal standards, the authorized states would be required to modify their programs to adopt the amendments, when finalized. Because the sewering prohibition is proposed under HSWA authority, this prohibition would be effective in all states on the effective date of the final rule.

While the proposed rule is generally positive for the regulated community, the level of state support for the proposed rule remains to be seen. Based on the plethora of healthcare facilities that have registered as LQGS due to nicotine products, certain States have noted that the application of the current RCRA regulations to healthcare facilities has created an undue regulatory burden for the State. Based on current pharmaceutical waste policies in some states that conflict with the requirements of the proposed rule, however, it is reasonable to anticipate that reservations may be raised to certain aspects of the proposed rule.

VI. Conclusion

The proposed rule reflects a concerted effort by EPA to bring long-awaited reform to the hazardous waste pharmaceuticals regulatory framework through the establishment of sector-focused, uniform national standards. While there will be much to parse and scrutinize in the proposed rule, it could be just what the doctor ordered to cure the ill-suited regulatory patchwork that currently applies to the management of hazardous waste pharmaceuticals.

Footnotes

1 42 U.S.C. § 6901 et seq. (1976).

2 Proposed Amendment to the Universal Waste Rule: Addition of Pharmaceuticals, 73 Fed. Reg. 73,520 (Dec. 2, 2008).

3 40 C.F.R. pts. 260–270.

4 Pre-Publication Copy of the Management Standards for Hazardous Waste Pharmaceuticals Proposed Rule (Aug. 31, 2015) [hereinafter Pre-Publication Version], available at http://www2.epa.gov/hwgenerators/pre-publication-copy-management-standards-hazardous-waste-pharmaceuticals-proposed-rule.

5 "Pharmaceutical means 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, prescription drugs, over-the-counter drugs, residues of pharmaceuticals remaining in containers, personal protective equipment contaminated with pharmaceuticals, and clean-up material from spills of pharmaceuticals."

"Hazardous waste pharmaceutical means a pharmaceutical that is a solid waste, as defined in § 261.2, and is listed in part 261, subpart D, or exhibits one or more characteristics identified in part 261, subpart C." Proposed Rule 40 C.F.R. § 266.500Proposed Rule 40 C.F.R. § 266.500

6 "Healthcare facility means 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 veterinary clinics and hospitals." Proposed Rule 40 C.F.R. § 266.500.

7 There is one caveat to this requirement for CESQGs. Healthcare facilities that currently qualify as CESQGs will maintain this conditional exemption under 40 C.F.R. § 261.5 and will not be subject to most aspects of the proposal. Under the Proposed Rule, CESQGs may choose to send their potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor. However, unlike current practice, potentially creditable hazardous waste pharmaceuticals transported to a pharmaceutical reverse distributor must be counted when determining whether the healthcare facility is a CESQG under 40 C.F.R. 261.5, or whether it is regulated under the new Part 266. Pre-Publication Version, supra note 4, at 186.

8 Pre-Publication Version, supra note 4, at 47.

9 "Potentially creditable hazardous waste pharmaceutical means a hazardous waste pharmaceutical that has the potential to receive manufacturer's credit and is: (1) unused or un-administered; and (2) unexpired or less than one year past expiration date. The term does not include "evaluated hazardous waste pharmaceuticals," residues of pharmaceuticals remaining in containers, contaminated personal protective equipment, and clean-up material from the spills of pharmaceuticals." Proposed Rule 40 C.F.R. § 266.500.

10 "Non-creditable hazardous waste pharmaceutical means a hazardous waste pharmaceutical that is not expected to be eligible for manufacturer's credit." Proposed Rule 40 C.F.R. § 266.500.

11 Id. § 266.503 (a).

12 See Proposed Rule 40 C.F.R. § 266.509.

13 Pre-Publication Version, supra note 4, at 151.

14 Proposed Rule 40 C.F.R.§ 266.503(c).

15 Pre-Publication Version, supra note 4, at 10.

16 Id. at 241.

17 Id. at 20.

18 Proposed Rule 40 C.F.R. § 266.505.

19 Pre-Publication Version, supra note 4, at 112.

20 Id. at 115.

21 Id. § 266.056(a)-(b).

22 Id.

23 The Connecticut Department of Energy and Environmental Protection (DEEP), for example, established a Pharmaceutical Universal Waste Stakeholders Group to assist in developing regulations to allow hazardous pharmaceutical wastes to be managed as a Connecticut universal waste. Note, however, in the preamble to the proposed rule, EPA indicates that because the proposed rule is considered more stringent than either the "traditional RCRA" standards or the Universal Waste program, if finalized, both Florida and Michigan, which have added pharmaceuticals to their Universal Waste programs, must remove hazardous waste pharmaceuticals from their Universal Waste program when the states adopt the new regulations. Non-hazardous waste pharmaceuticals may continue to be managed as Universal Pharmaceutical Wastes. Pre-Publication Version, supra note 4, at 208-09. Other states may not add hazardous waste pharmaceuticals to their Universal Waste programs in the future. Id. at 209.

24 See Sylvia Lowrance to Mark J. Schulz on May 16, 1991 (RCRA Online # 11606); Alan Corson to Steven Wittner on May 13, 1981 (RCRA Online #11012).

25 Amendment to the Universal Waste Rule: Addition of Pharmaceuticals ,73 Fed. Reg. at 73,525.

26 Proposed Rule 40 C.F.R. § 266.503(b).

27 Pre-Publication Version, supra note 4, at 102.

28 Proposed Rule 40 C.F.R. § 266.500.

29 The proposed rule, however, places onerous inventory and tracking requirements on the pharmaceutical reverse distributor. For example, a pharmaceutical reverse distributor must maintain an inventory of all potentially creditable hazardous waste pharmaceuticals and "evaluated hazardous waste pharmaceuticals" that are accumulated onsite. The inventory of all potentially creditable hazardous waste pharmaceuticals must include, for example, the identity and quantity of each potentially creditable hazardous waste pharmaceutical. Id. § 266.510(a)(2). "Evaluated hazardous waste pharmaceutical means a hazardous waste pharmaceutical that was a potentially creditable hazardous waste pharmaceutical but has been evaluated by a pharmaceutical reverse distributor to establish whether it is eligible for manufacturer's credit and will not be sent to another pharmaceutical reverse distributor for further evaluation or verification." Id. § 266.500.

30 Id. § 266.509(a).

31 Id. § 266.509(c).

32 For example, Connecticut has required similar tracking procedures as interim management standards in Consent Orders issued by the State.

33 The most common example is the blood thinner Warfarin, which is regulated as a P-listed acute hazardous waste (P001).

34 Hawaii State Department of Health, P-listed Hazardous Waste Residue Determination (Jan. 29, 2015), available at http://health.hawaii.gov/shwb/hazfaq/.

35 Proposed Rule 40 C.F.R. § 266.507(a).

36 Pre-Publication Version, supra note 4, at 131.

37 Id. at 139–40.

38 Id.

39 Proposed Rule 40 C.F.R. § 266.507 (b).

40 Pre-Publication Version, supra note 4, at 141–42.

41 Id. at 142–43.

42 Id. at 143.

43 Id. at 202.

44 Id. at 203.

45 Id.

46 Id. at 203–04.

47 Id. at 204.

48 Id. at 205.

49 Id.

50 Id. at 30.

51 Id. at 205–06.

52 Id. at 206.

53 EPA explains that prior to HSWA's enactment, an authorized State administered its hazardous waste program completely independent of federal regulations, such that federal requirements no longer applied to the authorized state. When new, more stringent federal regulations were promulgated, the State was required to adopt equivalent authorities within a specific timeframe. Id. at 206–07. However, under RCRA Section 3006(g) (42 U.S.C. § 6926(g)), added by the HSWA, new requirements and prohibitions imposed under HSWA authority take effect in authorized States at the same time they take effect in unauthorized States.

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Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.