United States: EPA Proposes New Management Standards For Hazardous Waste Pharmaceuticals Rule

Last Updated: September 20 2015
Article by David G. Dickman, Bernice I. Corman and John B. Mavretich

On August 31, the Environmental Protection Agency (EPA) released its proposed rule for Management Standards for Hazardous Waste Pharmaceuticals (Proposed Rule) prior to its publication in the Federal Register. The proposal would create a new Subpart P under existing Resource Conservation and Recovery Act (RCRA) regulations exclusively for managing hazardous waste pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors. Currently, there are no RCRA regulations that focus specifically on the management of hazardous wastes from hospitals, pharmacies, reverse distributors and other healthcare-related facilities; such facilities are currently required to comply with the same RCRA hazardous waste regulations as many other types of industries that generate wastes.

By issuing this proposed rule, EPA has tentatively decided not to add hazardous waste pharmaceuticals to the existing federal universal waste program, as EPA had initially proposed in 2008. This means that hazardous waste pharmaceuticals may no longer be added as a category of hazardous waste for management under the Universal Waste program, as had previously been done in Michigan and Florida. Because the proposed rule requirements are more stringent than the standards for the Universal Waste program, if the rule is finalized, both states will be required to amend their programs to adopt standards at least as stringent as those in the new Subpart P.

What the Proposed Rule Covers

EPA is proposing an expansive definition of "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, 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.

The Rule would govern the management of "Hazardous Waste Pharmaceuticals," which include any pharmaceuticals that are currently listed as a hazardous waste under 40 C.F.R. Part 261, Subpart D, or that have any of the characteristics of hazardous waste listed in in 40 C.F.R. Part 261, Subpart C (ignitability, corrosivity, reactivity, toxicity).

Who It Covers

The Rule as proposed would apply to "healthcare facilities," which include:

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.

Of note, the definition includes locations that sell pharmaceuticals over the internet, through the mail, or through other types of distribution mechanisms, and also includes entities that engage in drug compounding. It does not include pharmaceutical manufactures and their representative, wholesalers, or any other entity involved in the manufacturing, processing, or wholesale distribution of over-the-counter or prescription pharmaceuticals, unless they meet the definition of a pharmaceutical reverse distributor. These are entities that receive and accumulate potentially hazardous waste pharmaceuticals "for the purpose of facilitating or verifying manufacturer's credit" upon the return of unused and/or expired pharmaceuticals. The EPA's definition of a pharmaceutical reverse distributor is different than and broader in scope than the definition of that term as used by the Drug Enforcement Administration.

EPA is proposing that a healthcare facility that is currently considered either a traditional large quantity generator (LGQ) or a small quantity generator (SQG) be subject to Subpart P if it generates (or accumulates) more than 100 kg of hazardous waste per month or more than one (1) kg of acute hazardous waste per month. An acute hazardous waste is generally, but not necessarily solely, any P-listed hazardous waste. A healthcare facility that is currently considered to be a conditionally exempt small-quantity generator (CESQG) (generates less than or equal to 100 kg of hazardous waste, and less than or equal to 1 kg of acutely hazardous waste) will be able to maintain its conditional exemption under 40 C.F.R. § 261.5 and will not be subject to most aspects of the proposed rule. However, EPA is proposing a ban on sewer disposal of hazardous waste pharmaceuticals by all healthcare facilities, including CESQG facilities. Additionally, currently, CESQG facilities are limited in where they may send their hazardous wastes for treatment and disposal; the rule proposes to allow CESQG healthcare facilities to send their potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor.

Requirements under the Proposed Rule

The applicable handling and disposal requirements would depend upon whether the hazardous waste pharmaceutical is eligible for a manufacturer's credit. If it is not eligible, it "must be transported as hazardous waste, including the use of the hazardous waste manifest, and sent to a RCRA interim status or permitted facility." However, the Rule as proposed would allow creditable hazardous waste pharmaceuticals to be shipped to pharmaceutical reverse distributors for processing of the manufacturer's credit.

New Subpart P would contain separate requirements for healthcare facilities and reverse distribution facilities. Healthcare facilities would be responsible for, among other requirements:

  • Training employees to be "thoroughly familiar with proper waste handling and emergency procedures";
  • Maintaining inventories of non-creditable hazardous waste pharmaceuticals;
  • Disposing of hazardous waste pharmaceuticals within one year; and
  • Preventing disposal of hazardous waste pharmaceuticals into a sewer system.

Reverse distribution facilities would be allowed to accept and accumulate potentially creditable hazardous waste pharmaceuticals without a permit, provided that they comply with the requirements of new Subpart P. These requirements include, but are not limited to:

  • Complying with specific packaging, labeling, and marking requirements;
  • Maintaining an inventory of all potentially creditable hazardous waste pharmaceuticals;
  • Creating and enforcing minimum security requirements; and
  • Properly disposing of the potentially creditable hazardous waste pharmaceuticals within 90 days.

EPA will accept comments on the Proposed Rule for 60 days following its publication in the Federal Register.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions