BAD ACTORS

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WHO IS WHO ?

I have a notorious and almost legendary reputation for forgetfulness. I can be halfway through writing a blog and not remember what it was originally about. In fact, if it’s on my computer or tv, for the first time, I will very rarely watch a movie or show to its end, because I can not remember what happened at the beginning. But I think my biggest problem is, trying to remember the names of who the actors play. I think they should show the actors and who they are playing before the movie starts, in the opening credits, not when the movies over.

A THEATRICAL PRODUCTION

So, if you are like me and sometimes suffer from short term memory loss, I was hoping to review the good and the bad actors in the new hazardous waste pharmaceutical final rule. I say actors because when I am reading this new rule, I feel like I am watching a movie. That is because at least five of the major players seem to share the same middle, first or last names.. Don’t worry, I am not going to give you the story line today, only the cast of characters.

IT IS ABOUT DRUGS

Most movies are about the lives of humans, animals or insects, However this new rule is about the death and redemption of pharmaceuticals. Pharmaceuticals are defined as any drug or dietary supplement for use by humans or other animals; any electronic nicotine delivery system or any liquid nicotine packaged for retail sale for use in electronic nicotine delivery systems (e.g., pre-filled cartridges or vials). It also includes dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act; prescription drugs, as defined by 21 CFR 203.3, over-the-counter drugs; homeopathic drugs; compounded drugs; investigational new drugs; pharmaceuticals remaining in non-empty containers; personal protective equipment contaminated with pharmaceuticals; and cleaned up materials from spills of pharmaceuticals. 

 THE STAR

See “Hazardous Waste Pharmaceuticals”, would be the star of this show, this A-lister could only be played by a pharmaceutical that exhibits one or more characteristics identified as ignitable, corrosive, reactive or toxic in EPA 40 CFR part 261 subpart C or is listed in part 261 in the non-specific hazardous waste list, the specific hazardous waste list or the discarded waste  chemical list in subpart D.

THE SIDEKICK

And what is any good production without a good character actor, the costar, such as the sidekick, a Potentially credible hazardous waste pharmaceutical. This sidekick must be portrayed as a prescription hazardous waste pharmaceutical that has a reasonable expectation to receive manufacturer credit and in original manufacturer packaging (except pharmaceuticals that were subject to a recall), undispensed; and unexpired or less than one year past expiration date.

THE VILLAIN

Then of course there is always a scorned villain, the B-lister, a Non-creditable hazardous waste pharmaceutical. In this blockbuster it would be a prescription hazardous waste pharmaceutical that does not have a reasonable expectation to be eligible for manufacturer credit or a non-prescription hazardous waste pharmaceutical that does not have a reasonable expectation to be legitimately used/reused or reclaimed, like an investigational drug, free samples of pharmaceuticals received by healthcare facilities, residues of pharmaceuticals remaining in empty containers, contaminated personal protective equipment, floor sweepings and cleaned up material from the spills of pharmaceuticals.

 THE HENCHMEN

Most films, include a couple of lightweight henchmen, so in this production, they would be Non-hazardous waste pharmaceuticals. This type of pharmaceutical is a solid waste, but not a hazardous waste with very few lines in the regulations and Non-pharmaceutical hazardous wastes, a solid waste, that is also a hazardous waste but is not a pharmaceutical.

THE LOVE INTEREST 

Finally, the love interest, which is usually portrayed by a femme fatale or big dumb palooka, but in this case, it is an Evaluated hazardous waste pharmaceutical. A prescription hazardous waste pharmaceutical that has been evaluated by a reverse distributor in accordance with § 266.510(a)(3) and will not be sent to another reverse distributor for further evaluation or verification of manufacture credit.

LOCATION 

It’s not only the actors, but the production location, that matters. That’s because under the new rule any scenes at a Healthcare facility, would have to be shot at a location that provides preventative, diagnostic, therapeutic, rehabilitative, maintenance, or counseling services and assessments or procedures with respect to the physical or mental condition, or functional status, of a human or animal. This would encompass any backlot locations that distribute, sell or dispense pharmaceuticals, over-the-counter pharmaceuticals, dietary supplements, homeopathic drugs, or prescription pharmaceuticals. This would also  include wholesale distributors, third-party logistics providers that serve as forward distributors, military medical logistics facilities, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians' offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, pharmacies, including both long-term care, and mail-order, retailers of pharmaceuticals, veterinary clinics, and veterinary hospitals. 


Whereas, if the script called for a Long-term care facility, the location scouts would have to find a licensed entity that just provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility such as hospice facilities, nursing facilities, skilled nursing facilities, and the nursing and skilled nursing care portions of continuing care retirement communities.

DISTRIBUTORS AND CREDITS

This Hazardous waste pharmaceutical regulation also includes distributors and credits, not the film’s distributor or the actor credits but, Reverse distributors.  These extras receive and accumulate prescription pharmaceuticals that are Potentially credible hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer credit, and include forward distributors, third-party logistics providers, and pharmaceutical manufacturers that process prescription pharmaceuticals for the facilitation or verification of manufacturer credit.

DIRECTOR'S NOTE

And as with any film, there is always a disclaimer at the end, which states that the events presented are fictional and the people, do not Include any that are living or dead. So! Healthcare facilities do not include pharmaceutical manufacturers, reverse distributors or reverse logistics centers. The term Hazardous waste pharmaceutical does not include evaluated hazardous waste pharmaceuticals or non-prescription pharmaceuticals including, over-the-counter drugs, homeopathic drugs and dietary supplements if it has a reasonable expectation of being legitimately used/reused (e.g., lawfully redistributed for its intended purpose) or reclaimed and Long-term care facilities do not include group homes, independent living communities, assisted living facilities, and the independent and assisted living portions of continuing care retirement communities.

OPENING NIGHT

Opening night for the new rule is August 21, 2019, I will let you decide if this new rule is a comedy, drama, tragedy or romantic production. So, GO SEE, “THIS NEVER BEFORE SEEN”, “EDGE OF YOUR SEAT”, “INTRIGUING ENTERTAINMENT EXTRAVAGANZA DOUBLE FEATURE” ON A COMPUTER NEAR YOU, by downloading the final rule including it’s preamble at https://www.govinfo.gov/content/pkg/FR-2019-02-22/pdf/2019-01298.pdf .

Thank you for your attendance, readership and support
Robert J Keegan 
Publisher, President and Producer
Hazardous Materials Publishing Company
Transportation Skills Programs Inc



INCONCEIVABLE

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You keep using the word generator. I do not think it means what you think it means.

Whenever someone tells me they are a hazardous waste generator, I think of the movie, The Princess Bride. The villain, Vizzini (Wallace Shawn) constantly bested, repeatedly retorts with the word “ inconceivable‘. Finally, Inigo Montoya, (Mandy Patinkin), says to him, “You keep using that word, I do not think it means what you think it means”.

That is because, the word Hazardous waste “generator” really means a hazardous waste treatment storage disposal facility operator  who is under “conditions for exemption” from having a Treatment Storage Disposal Facility, (TSDF) permit under the Environmental Protection Agency in 40 CFR Part 262.1.

However, the worst part is most don’t realize when they do not mark their hazardous waste containers with the words “hazardous waste”, “an indication of the hazard”, (ie: “ignitable”) and the dates of accumulation, in their storage areas, they have failed to meet three of the exceptions in 40 CFR Sections 262.16 and 262.17, which exempts them from maintaining a TSDF permit.

Then the real trouble begins, because your State’s environmental protection agency might not issue you a fine, for those three transgressions, but, they could claim that you have failed to meet one or more of the exceptions that all generators must meet if they do not want to maintain a TSDF permit.

And though it might seem inconceivable to you, your company, could be cited by EPA for operating a “non permitted” treatment storage disposal facility. Any day now, if not already, hazardous waste generators will find themselves under new State and federal EPA, hazardous waste management requirements and interpretations as these amendments become part of approved state programs.

The most important thing to remember about these new regulations is that the “conditions for exemption” are requirements only for hazardous waste generators who do not want to apply for a TSDF permit and, that the “independent requirements” are for all hazardous waste generators whether they apply for a TSDF permit or not.

I have no doubt, you are meeting the older state and federal requirements for hazardous waste determination and recordkeeping, satellite and central accumulation areas and facility and waste storage unit closures. But, here are some of the changes you must now meet or at the very least be prepared for under the EPA’s Federal Hazardous Waste Generator Improvements Rule:

Small quantity generators are or will be required to re-notify EPA of their hazardous waste activities. Currently, under federal regulations, only large quantity generators are required to notify every two years. Under the new rule, all small quantity generators will start re-notifying every four years, starting September 2021.

Both large and small quantity generators must, or will be required to mark their containers in the central and satellite accumulation areas with the words “hazardous waste”,  in addition to the date accumulation begins on central storage area containers and any containers containing excess waste, over 55 gallons, in the satellite accumulation area.

But now, generators shall or will be required to add an “indication of the hazards” of the contents. For example, the name of the waste (ie: ignitable), a Department of Transportation hazard class label or placard, or a hazard warning or pictogram from the OSHA GHS Hazard Communication Requirements. Then as you, who are under the new changes already know, generators must include their waste codes on waste containers before they are allowed to be shipped off site.

You will also find, large quantity generator facility and hazardous waste storage unit clean closure requirements. To certify that each facility, once closed, and each on-site storage unit, when closed, is “clean-closed” properly. Failure to do so may trigger them to be managed as landfills, which, among other nightmares, might entail groundwater monitoring requirements.

Then, not least and not last, you have, or will be required to, beef up your Preparedness, Prevention and Emergency Procedure Plans, by adding new requirements for documenting what arrangements were made to authorities (local hospitals, rescue units, police and fire departments) or at the very least, documentation of the attempts, that were made by the generator.

Also, the next time a large quantity generator writes a new or updates their required Contingency Plan, they must also prepare and make available, a quick reference guide that summarizes the contingency plan, including: the types and amounts of hazardous waste that could be on their property at any one time, any special medical treatments or facilities that might be required, a map of the facility, the surrounding area and nearby fire hydrants.

This quick reference guide would also be required to include the name and contact information for your site’s emergency coordinator.   

And don’t worry just remember, it is not a “faux pas” to use the word “generator”, only not to understand it’s true meaning.

I hope to see you at one of my upcoming seminars. In the meantime, check out the generator improvements rule web page at:  https://www.epa.gov/hwgenerators/final-rule-hazardous-waste-generator-improvements , and also visit our website www.hazmat-tsp.com  to order “The Hazardous Materials, Substances  & Wastes Compliance Guide”.

Then if you still have any questions, corrections or concerns call me at (610)683-6721 or email me at rjkeegan@hazmat-tsp.com..

Thank you for your readership and support.

Robert J Keegan
Publisher and President
Hazardous Materials Publishing Company





I love crow.

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I have spent the last 25 years of my professional life eating crow. It has a lot to do with the job. At first, it is really hard to eat, but now I don’t mind, even though I have never liked the taste. I think the secret to enjoying crow, is how it’s served to you. See, as an EPA, DOT, OSHA comedian, instructor and publisher, in my small fiefdom, I reign over the hazardous, materials, waste, chemicals and substances requirements. I do this by covering transportation, environmental and worker protection interfaces, inconsistencies and overlaps, which I feel is the critical interface between these three agencies that everyone who uses chemicals must understand when they ship, store, use or dispose of them.

By memory, I can cite the 49 CFR, 172.200 hazardous materials and waste shipping paper regulations.  I am one of a small crowd that knows why DOT, EPA and OSHA all use the term hazardous substance and know every regulation for and differences between an empty drum, in a truck, a spill or in your plant. I know that testing is never required for a 29 CFR OHSA Safety Data Sheet and that the shipping and disposal sections on them is not mandatory and usually incomplete or wrong.

But, I don’t know my wife’s birthday, not sure how old my children are and sometimes I can’t spell my middle name. That is because, my days are immersed in regulatory subchapters, parts, subparts, sections and paragraphs, then at night as I sleep hazardous materials, hazardous substance, hazardous waste, and hazardous chemicals continue to dance in my head.  

For years, I’ve gone to great lengths, in my seminars, to talk about the 49 CFR 172.400, 4x4 inch square EMPTY label under the department of transportation and its use for empty radioactive containers. Often, it is mistaken for a mark but, it is really a label. I was always under the impression that it was only to be used for empty radioactive containers, to be placed over the diamond shaped radioactive hazard Class label when a container that had ‘previously’ contained a Class 7, radioactive material was being shipped back to the original supplier of the material. But, of course I was wrong. I recently found out the EMPTY label can also be used for empty packaging that formerly contained “any” class of hazardous material.

See, at my last seminar in Honolulu, I was approached at the end of the day, by a very good customer, who told me that I might be mistaken about the EMPTY labels uses, and of course not to embarrass me during the course of the seminar she waited until most of the participants had left. Not only that, she said she also had proof, a letter of interpretation that stated that the radioactive EMPTY label could be used on a container that had previously contained a hazardous material, but, now was completely purged and no longer contained any residue of the previous contents.

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I quickly scanned her letter of interpretation and told her “she” obviously misread the letter and I dismissed her, then went surfing. Then, three weeks later on my way home from the seminar in Puerto Rico, I found the copy of her DOT letter tucked into my computer bag. Upon further inspection of the letter, to my horror, I found out that she was correct. Apparently the empty label can be used for containers previously containing any hazardous material. I am such an ass.

It seems this letter of interpretation, #01-0169 on August 20, 2001,  by the department of transportation states :

“Specifically, you ask if the empty label required under 173.428 for an empty radioactive material package may be used for a cleaned and purged packaging that formerly contained a non-radioactive hazardous material.” So, “The answer is yes.” A shipper may apply the empty label depicted in § 172.450 to an empty packaging that formerly contained a hazardous material of any hazard class.”

But, what upset me the most, was the fact that I had not looked at nor discussed the letter, at the time it was originally presented to me. See, I wasn’t wrong, the label is “primarily” used for empty radioactive containers.  I was upset because this customer had only taken the time and effort to show me this information to make sure that my future presentations would be correct, where as I thought it was about her, it was about me.

Even worse, a few years ago I had a representative from one of the state environmental protection agency’s tell me that they were handing out and recommending these 49 CFR DOT mandatory EMPTY class 7, shipping labels for designating empty 40 CFR hazardous waste containers, no longer under the 90 or 180 day storage requirements. Signifying that the containers were, at the very least, below the 1 inch, 2.5 centimeter, federal non-acute empty hazardous waste container requirements under the environmental protection agency for hazardous waste generators under 40 CFR 261.7 Residue of hazardous waste an empty containers.  

At the time I had told him they could be only used for empty radioactive containers, which was wrong. However, in retrospect I would still would not recommend using a department of transportation shipping label to meet an environmental protection agency hazardous waste requirement.

Why would you use a DOT empty label on a container that was not regulated by the department of transportation, especially in light of the requirement to use it on empty radioactive containers. It seems crazy to me for someone to go back in to a regulation they are not under to label a container, that is not regulated under that regulation. Then, if these non RCRA empty packaging with residues were shipped off site for any reason, with the EMPTY marks still a fixed, the shipper would be in violation of 49 CFR 173.29 Empty packaging.

So, obviously, I wanted to update at the very least all of the people, I had personally chastised for using the empty mark for anything other than a container that previously contained a radioactive material. But more importantly, I wanted to say thank you to each and everyone of you that has come up to me after a seminar, called or sent me an email to correct “my” incomplete presentation.  

I still have a client, one of my favorites, who I run seminars for every year, that called me up a few days after his last seminar and pretended he did not know the answer to a question on material I had covered in his seminar. I didn’t realize until I got off the phone with him, that he knew the answer but, he really just wanted me to be the best I could be, without humiliating me.

I can’t think of a better way to be served crow.

If you ever have a question, comment or a correction please do not hesitate to contact me.

Thank you for your readership and support.

 

Robert J. Keegan
Publisher and President
Hazardous Materials Publishing Company