Start Properly Disposing of Your Unused and Expired Medications Today!

Start Properly Disposing of Your Unused and Expired Medications Today!

Basic Information

Legal Authority: 

  • 42 U.S.C. §6912 and 6921-6924

Code of Federal Regulations Citations

Docket Number

Rule Summary

The EPA Acting Administrator signed the final rule, titled, “Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine” on December 11, 2018 and it was published in the Federal Register (FR) on February 22, 2019.

This final rule establishes cost- saving, streamlined standards for handling hazardous waste pharmaceuticals to better fit the operations of the healthcare sector while maintaining protection of human health and the environment.

Importantly, this final rule will make our drinking and surface water safer and healthier by reducing the amount of hazardous waste pharmaceuticals entering our waterways by 1,644 to 2,300 tons on an annual basis by prohibiting all facilities subject to the rule from sewering them. This action will help address the issue highlighted by a growing body of publicly available studies documenting the presence of pharmaceuticals in drinking and surface waters as well as their negative impacts to aquatic and riparian ecosystems.

In addition, under this final rule, FDA-approved, over-the-counter nicotine replacement therapies (i.e., nicotine patches, gums and lozenges) will no longer be considered hazardous waste when discarded, which will result in significant cost savings and burden reduction in the management of these types of nicotine wastes.

Finally, the final rule reaffirms EPA’s long-standing policy that non-prescription pharmaceuticals and other unsold retail items that have a reasonable expectation of being legitimately used/reused or reclaimed are not solid waste. It also provides regulatory certainty that the Resource Conservation and Recovery Act (RCRA) applies when healthcare facilities send unused, unsaleable prescription hazardous waste pharmaceuticals to reverse distributors to receive manufacturer credit. Simultaneously, the rule incorporates flexibilities to accommodate current reverse distribution business practices to facilitate its implementation.

Webinar Recording and Slides Available

EPA presented a webinar about the contents of the final rule on February 14, 2019 and a recording of that webinar is now available. Click the “View Archive” button on the webinar web page to access the recording. Additionally, the presentation slides from the webinar can be found in the “Webinar Slides” tab on this same page. EPA will delivery this same presentation two more times in March, but due to high interest, these webinars are all full. If we are able to schedule additional deliveries of this presentation, we will post that information here.

Rule History

In 2008, EPA proposed to add pharmaceuticals to the types of hazardous wastes that could be managed as Universal Wastes (volume 73 of the Federal Register – FR – starting on page 73520, December 2, 2008). Although commenters supported the idea of new regulations for the management of pharmaceuticals, there were numerous concerns over the lack of notification requirements for those facilities that generate, handle or transport pharmaceutical “universal wastes” as well as for the lack of tracking requirements for the shipment of these wastes. Therefore, the Agency decided to not finalize the 2008 proposed rule, but rather develop another proposal for new standards for the management and disposal of pharmaceutical hazardous waste that are generated by healthcare-related facilities.

EPA issued a new proposal for the management of hazardous waste pharmaceuticals by healthcare facilities and reverse distributors on September 25, 2015 (80 FR 58014).  This proposal responded to the concerns raised on the universal waste proposal as well as feedback from the RCRA Retail Notice of Data Availability (79 FR 8926, February 14, 2014).

EPA significantly engaged states and other stakeholders on these issues over the years and carefully evaluated the comments from states, pharmacies, retailers, healthcare facilities, reverse distributors, environmental organizations, and other members of the public. This final rule incorporates certain significant changes from the proposal to address comments and provide additional flexibilities.

Additional Resources

5 Tips for Georgia Manufacturers to Better Manage Non-hazardous Waste

5 Tips for Georgia Manufacturers to Better Manage Non-hazardous Waste

There’s a prevailing idea among manufacturers that dealing with non-hazardous waste disposal is somehow less important or less stringent than managing hazardous items. This is not the case! Every manufacturer needs to comply with all federal non-hazardous waste disposal policies, and every Georgia manufacturer needs to follow those state-specific rules as well. So, as a manufacturer of this waste stream in Georgia, what do you need to do?

Non-hazardous Waste Disposal in Georgia: 5 Things Manufacturers Need to Know

1. Identify All Your Nonhazardous Waste

The first important step for any Georgia manufacturer is to assess all the waste generated in that facility. No waste management plan can even start to be implemented if you don’t know exactly what you produce, how much you produce, and what category of waste each type falls under.

Some manufacturers are under the false impression that non-hazardous means non-dangerous. However, even nonhazardous waste must be properly identified, stored, and disposed of, and the first step is realizing proper identification is even necessary and then following through with that.

The following are some common nonhazardous items that still require special disposal methods:

· Latex paint.

· Non-recyclable used car oil.

· Nonhazardous ink.

· Certain chemicals (confirm with the specific chemical’s SDS sheet)

2. Stop All Actions That Make You Noncompliant with Georgia Waste Management Laws

Once you know what you’re producing at your Georgia-based manufacturing facility, it’s vital to immediately stop any policy or action that puts you out of compliance with either federal or state waste disposal laws.

For example, if you’ve identified waste that is nonhazardous but is not simple municipal trash, you cannot throw that nonhazardous material into the trash can. Doing so could make you vulnerable to steep EPA fines. If you’re doing this wrong, stop as soon as possible!

3. Cradle to Grave Liability Still Applies to Nonhazardous Materials

Cradle to grave liability means you are ultimately responsible for your waste from the moment you generate it until the moment it is properly treated and disposed of. Even if you give that waste to a third party, you are still responsible and could face fines or other consequences if there was any damage because of that waste.

A lot of people know this about hazardous materials, but fewer people realize this still applies to nonhazardous as well. Therefore, make sure your waste management plans involve knowing exactly how and where all your waste is being shipped.

4. All the Paperwork for Hazardous Materials Applies to Nonhazardous

Just because waste is nonhazardous doesn’t mean you don’t need to fill out all the relevant paperwork, and in many cases, that’s just as intensive as it is for hazardous material. In particular, you still want the following: proof it’s been disposed of, proper labels, and any relevant shipping manifest. This will protect you in case of an audit, where you need to prove you’re operating in compliance.

5. Reach Out to a Reputable Local Waste Management Company

If you need help managing your waste or if you want the peace of mind that you’re in full compliance, start reaching out to local waste management companies.

As with the actual waste, some people think because it’s “just” nonhazardous it’s not as important to thoroughly vet the company that helps you manage it. Again, this is not the case. One of the most important waste management tips your Georgia facility can follow is to ensure you find a professional, reputable company to manage your waste.

To that end, do the following:

· Ensure the company has all proper permits and insurance to handle your waste streams. (A company will need different permits based on the type of waste they are accepting, whether or not they transport that waste, and other factors.)

· Confirm the company’s employees have undergone adequate training to handle your waste types.

· Get a sense of the company’s commitment to customer service. Being able to get your waste-related questions answered in a timely, accurate fashion could help you avoid a sizeable EPA fine.

· Ask for customer testimonials or read online reviews to get a sense of the company’s reputation.

· Ask how long the company has been in business in Georgia. This will let you know not only how experienced they are with waste disposal, but it will also tell you how long they have had to familiarize themselves with Georgia-specific laws.

· Ensure the end facility receiving the waste is also permitted and qualified to receive your waste type—whether it’s going to a Subtitle D landfill or for nonhaz incineration.

If you do work with a less-than-reputable company and they are caught being in noncompliance, at the very least, you’ll have to pay (in money and hassle) to get your waste back, and you’re also out whatever you paid the company in the first place. It can quickly become an expensive mess, so it’s worth your time to pick the right company the first time.

For more information about how to properly dispose of all waste types generated at your Georgia facility, please feel free to reach out to a representative of MCF Environmental Services, a waste management Atlanta company.

Pharmacies: How to Dispose of Expired Medication

Pharmacies: How to Dispose of Expired Medication

If you run a pharmacy, it’s critical you know all the steps necessary for proper pharmaceutical waste disposal. Failure to be fully compliant with local, state, and federal laws could result in massive fines, and any noncompliance could also present big environmental and safety concerns. The risks and consequences are high, so if you’re at all unsure about your Georgia pharmacy’s compliance, read on!

How to Dispose of Expired Medication from Your Georgia Pharmacy

Expired Medicine: Identification Is Key

The first step in any sound pharmacy waste management plan is proper identification. If you don’t know exactly what kind of waste stream you’re dealing with, you won’t be able to know what regulations you need to follow in terms of storage, shipment, and treatment.

Expired medication can fall in a number of different categories—all of which require slightly different disposal protocol. Some of those categories include the following:

  • Controlled substances.
  • Hazardous waste.
  • Nonhazardous waste.

If you’ve decided to work with a medical waste management company to help you handle all your generated waste, you need to make sure of two important things.

  1. The Georgia-based company you’ve decided to work with must be permitted to handle the type of waste you generate. For example, if your pharmacy produces hazardous materials, the company must be specifically permitted for that waste type. Those permits (and insurance) should also be valid for Georgia.
  2. The company must be using accurate and appropriate methods of identification. This could include analytical testing and/or checking against SDS sheets.

Remember, without proper identification, you cannot ensure proper disposal!

Sharps and Expired Medicine Need to Be Disposed of Differently

Pharmacies can produce a variety of waste types, and it’s important to remember that proper expired medication disposal is fundamentally different from proper sharps disposal.

If your pharmacy offers shots or engages in any other activity that results in biomedical waste, you must follow the proper steps for regulated medical waste disposal. This entail putting any and all sharps in the proper sharps bins and other red bag waste in designated red bags.

Failure to comply here could put people and the environment at risk. Not using sharps bins could lead to people being stuck by used needles, and not properly segregating your waste into the red bags could ultimately lead to improper waste treatment.

It’s also vitally important that no expired medication ends up in these red bags. Expired medicine should never go in a red bag, and it should certainly never be thrown into the trash, put down the drain, flushed down the toilet, or otherwise improperly disposed of. Not only is it dangerous for the environment, but it could lead to big fines for your pharmacy.

As the Generator of the Pharmaceutical Waste, You’re Ultimately Liable

Even if you’re working with a third party, it’s crucial to remember you are the generator of this waste, and that means you assume cradle to grave liability. Whatever happens with that waste, until it is properly treated and disposed of, you are legally and financially responsible. Even if an accident involving your waste occurs while in the care of a company you’ve hired, you could still have to deal with the financial and legal fallout.

This is why choosing a medical waste management company is such an important decision. (If you’re feeling confused or overwhelmed by that prospect, here are some tips to help.)

For more information about what Georgia-based pharmacies need to do when disposing of expired medications, reach out today to a representative of MCF Environmental Services, an Atlanta waste management company!

Recycling Hazardous Waste—What Your Georgia Manufacturer Should Know

Recycling Hazardous Waste—What Your Georgia Manufacturer Should Know

If you’re a manufacturer of hazardous materials, you might have heard about recycling hazardous waste. If you’re considering this option for anything generated at your facility, however, there are some important things you need to know before you jump into this process.

Georgia Manufacturers and Recycling Hazardous Waste

The Quality of the Hazardous Material Matters

As hazardous waste disposal guidelines have consistently become more stringent over time, the prevalence of recycling that material has diminished. In order to be eligible for recycling, the waste must now be very clean. That means no grit or excess water mixed into the material itself.

Especially when it comes to waste generated in a manufacturing setting, this often isn’t the case, meaning much of the generated waste today is no longer a feasible candidate for recycling.

The number of companies that handle this process has similarly dwindled, and that is largely due to the fact that the waste simply isn’t clean enough to safely or effectively qualify for reuse or repurposing.

Want to Recycle Hazardous Waste? Determine If It’s Worth It

While this kind of recycling is less common today, it certainly still occurs. As such, it is often done onsite. The waste itself is sucked out of its drum or container and run through a truck that is fitted with a specialized cleaning system. In terms of cost, that means this process involves the price of the driver and the truck, all of which can quickly become expensive.

If your Georgia-based manufacturer is seriously considering the benefits of recycling, it’s important to run the numbers first and determine if it even makes financial sense to pursue. Many companies will simply find the system cost prohibitive, and even for those where it ends up being a financial draw, there’s the effort, time, and associated hassle to consider as well. When it comes to manufacturing, as with any business, time is money, and if recycling is going to absorb your resources and available time, that’s another form of expense you must consider.

Still Have Questions? Reach Out to Local Hazardous Waste Management Companies

Even with the stricter regulations regarding recycling, there are some companies that would benefit from instating this process. Since it’s such a case-by-case basis, the best course of action would be to reach out to your local waste management companies. A reputable company should be able to answer all your relevant questions, as well as tell you what is and isn’t recyclable of the byproducts produced at your manufacturing facility.

A good waste management company should also be able to provide general information about this disposal process as well as information about how that process would work at your specific manufacturing site.

Whether you’re just in the information-gathering stage or you’re moving forward with recycling your generated waste, always make sure to work locally. A local company should have knowledge regarding all the state-specific regulations you’ll be required to comply with (in addition to the federal regulations).

For any questions about this recycling process or for other waste management tips that can save your manufacturer time and money, feel free to reach out to a representative of MCF Environmental Services today, a waste management Atlanta company.

Pick a Hazardous Waste Management Company—8 Tips for GA Manufacturers

Pick a Hazardous Waste Management Company—8 Tips for GA Manufacturers

When selecting a hazardous waste management company, your Georgia-based manufacturer needs to keep many things in mind. With such an important decision, though, it’s no surprise that many factors must go in to the decision process. To make things a bit easier, here are eight waste management tips to guide your Georgia manufacturer in this crucial decision.

8 Things Every Georgia Manufacturer Should Check before Selecting a Hazardous Waste Management Company

  1. Check the waste management company has proper insurance.

As the generator, you are ultimately responsible for any accident involving your waste, and that includes during transport. Make sure the company you choose to work with has adequate insurance to cover any accident.

The type of waste being handled should dictate the type and amount of insurance. For example, hazardous materials are going to require a substantial amount of insurance, while non-hazardous waste is going to require less.

  1. Ensure the company is permitted for the type of waste you generate.

The necessary permits vary according to waste type. If you’re exclusively generating nonhazardous waste, the company only needs to be permitted for that subset of waste. However, if you generate any hazardous material that the company will need to transport or treat, they need to be specifically permitted for that.

  1. Verify all drivers have the proper DOT training.

All drivers should be properly trained to handle every aspect of that job, and that includes proper DOT training. Because these drivers are also handling paperwork, they should be specifically trained and prepared to handle a shipping manifest and a bill of lading. Drivers should also be knowledgeable, professional, and adept and experienced at handling hazardous materials specifically.

  1. Check for any fines or past violations.

If a company has had any breach in local, state, or federal regulations, there should be a record of that violation. Before committing to any given company, check online for such violations. Take into account when the violation occurred, how many violations are found, and the severity of any given breach.

  1. Ask about the company’s waste management price.

While price isn’t everything, it is (of course) important. Make sure the price you’re offered is competitive but not suspiciously low. As with any industry, a price that’s too good to be true probably is. A very low quote might mean poor customer service, an increased chance of violations and fines, or many hidden surcharges.

Remember, much of the cost structure has to do with transportation fees. Therefore, if you choose a company that has its own trucks, you should get a better price than with a company that has to contract out this work.

As a rule of thumb, shop around, get multiple quotes, consult testimonials, and ask lots of questions!

  1. Put a premium on customer service.

One quality that many manufacturers overlook in their waste management companies is customer service. However, having knowledgeable drivers and employees who will answer your questions quickly and accurately can be the difference between being slapped with a fine and complying with all Georgia and federal laws.

  1. Ask to see the company’s most recent audit.

A hazardous waste audit will give you important company-specific information (how long the company has been in business, the number of employees, their permits, their insurance, and so on), but it will also show all violations that came up during that audit. Especially with a full audit that takes several days, it’s extremely rare to get zero violations. However, you can ascertain the severity of those violations and if they properly corrected every found error.

  1. Get a clear quote with cost analysis.

A quote is just a number if you don’t know exactly what it means. A good quote will give you a cost analysis and break down, line item by line item, everything that goes into that number. This way, you aren’t surprised by hidden fees or surcharges when it comes time to pay the invoice.

Note, certain charges are common within the industry, including a stop charge (typically around $50), a 15 percent fuel charge, and an energy surcharge. Nearly every company charges these, so if they don’t show up on your quote, that’s a red flag that you’re not getting the full picture regarding what you’ll be expected to pay.

For more information and tips about how your Georgia-based manufacturer should choose a waste management company, feel free to contact a representative of MCF Environmental Services, an Atlanta waste management company.

Georgia Manufacturers’ Transport Fees—Hazardous Waste Disposal Costs

Georgia Manufacturers’ Transport Fees—Hazardous Waste Disposal Costs

As a Georgia manufacturer, you likely have need of safe, reliable, legal, and cost-effective hazardous waste disposal, and a big component of that has to do with transportation fees. With that in mind, what factors affect this transport fee, and what can Georgia-based manufacturers expect when it comes to shouldering this expense?

Waste Disposal Costs for Georgia Manufacturers: All about Transportation Fees

The Cost of Waste Disposal Isn’t Federally Mandated

If you’re a Georgia-based manufacturer, the first important fact to consider when shopping around for the right waste management company is that transportation fees are not set by any overarching federal body. That is, the price will fluctuate from private company to private company.

Therefore, you want to get multiple quotes in order to throw out any bids that are outliers—either too high or too low. This helps ensure you aren’t overpaying, but it also makes sure you’re working with a reputable company that can safely and legally deal with your RCRA hazardous waste.

Waste Disposal Cost: The Type of Waste Matters

When trying to determine what to expect in terms of pricing for transporting hazardous waste, Georgia manufacturers should be aware that this fee will fluctuate according to the kind of waste you need transported.

For example, if you produce any nonhazardous waste and need that transported from your premises, this is going to be significantly cheaper than hazardous waste transport. In fact, non-hazardous waste or dry freight transport can be as little as half the cost of comparable transport for hazardous materials.

By and large, this comes down to a liability issue. If there’s an accident involving nonhazardous material during transport, that’s going to pose less of a financial and safety issue than an accident involving hazardous material.

Another significant factor is how much training and certification must go into becoming a driver who handles hazardous materials. As the generator, some of that associated pricing is folded into your overall waste disposal costs.

Industry Standard for Hazardous Waste Disposal in Georgia

Understanding that any transport fees are variable and based on many factors, Georgia-based manufacturers can expect to pay in the ballpark of $45 per drum for this transport fee.

Other factors to consider include the following:

  • Expect to pay a cost per container rather than a lump sum.
  • A stop charge typically runs about $50.
  • Industry standard for fuel is around 22 percent.

Every state must comply with all EPA regulations, and Georgia is no exception. Whatever the federal standard is, Georgia must follow that. (Note, in any given state, it is acceptable to be more stringent than federal regulations but not less stringent. Florida, for example, is one state that does impose stricter waste rules than the federal government actually requires.)

Still Have Questions about the Cost of Waste Disposal?

Whether you’re the environmental manager of a large manufacturing company or the operations manager, owner, or person who handles all hazardous and nonhazardous waste generated by your small to midsize manufacturer, you might still have questions surrounding this transportation fee for your waste.

If you want clarification or need more information about how to plan for this expense, feel free to reach out to a representative of MCF Environmental Services, an Atlanta waste management company.