ME, MYSELF, AND I

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 I have low self-esteem and because of it, I am needy, ask my wife, children and customers, they know. That’s why I am a seminar instructor!  It’s one of the few jobs where you're able to charge for a service, and at the same time have a captive audience. Because of this and other proclivities, “me, myself and I”, are my favorite words. Entrenched behind a podium, or in the spotlight, is my terrene, for physical, spiritual and emotional rejuvenation.

And, since our seminar schedule only runs from October to June each year, by mid July, I once again find myself overtaken and consumed by shame, guilt and doubt. So you can surely understand how happy I was to receive a call from a long time sponsor.

His concern was packaging, in this particular case, it was a hazardous waste, if discarded, but it was not a hazardous material when shipped as a product.  A 40 CFR EPA hazardous waste, under the 49 CFR DOT hazardous materials shipping regulations, what should be, my bread and butter. 

He had a damaged electrical component, which was considered to be a hazardous waste, so it was required to be shipped on an EPA hazardous waste manifest. However, because of the size and shape of this piece of equipment, it could not be practically shipped in a traditional Department of Transportation specification container ( i.e. 1A1, steel drum, or off the shelf 4G, fiberboard box), that seem to be required by column 8 of the 49 CFR 172.101 Hazardous Material Table for the Shipping description. “NA3077, Hazardous Waste Solid, N.O.S., 9, PG III”.

NA3077, HAZARDOUS WASTE SOLID, N.O.S., 9, PG III

A lot of my customers ship hazardous waste. They know EPA hazardous waste, is always a DOT hazardous material when shipped for disposal. They know if the waste is a flammable liquid, they must ship it, as Class 3,  if a poison, as a Division 6.1 and if corrosive, the waste must be shipped as Class 8. Which makes perfect sense. What worries me is that, I’m not sure they all understand that if they ship any hazardous waste that meets no DOT hazard class definition, that hazardous waste must be shipped as a class 9. 

The Miscellaneous hazardous material or the Class 9 designation is not just for hazardous wastes, they’re also used when shipping hazardous substances and marine pollutants when they also meet no hazard classification under DOT, but are still regulated because of their constituent amounts or percentages, respectively. Think about  “Asbestos”, “PCBs”, and “Dry ice”, which are excellent examples of materials listed by proper shipping name in the 172.101 Hazardous Materials Table which meet none of the DOT hazard classes, but because of transportation safety concerns are regulated, as mentioned above, as class 9’s.

MISCELLANEOUS HAZARDOUS SUBSTANCE CLASS 9 

Because of its “lead” and the amounts, in my customers waste, it was not regulated as a product when shipped, because it met no DOT hazard class, we both agreed this hazardous waste should be shipped as Class 9.  Now, the Department of Transportation has provided a domestic “Generic N.O.S.” shipping name for materials which would not be regulated unless they were hazardous wastes, the proper shipping name HAZARDOUS WASTE LIQUID or SOLID, N.O.S,  9, PG III, and it is used consistently for wastes when they meet no DOT hazard class.

 So, I recommended the use of , “NA3077, Hazardous waste, solid, n.o.s., 9, PG III”, and then reviewed his limited container options, when using this name, namely the UN 1A1, steel drums, or the UN 4G, fiberboard boxes, authorized in column 8B non-bulk containers, in “173.213 Non-bulk packaging for solids in packing group III”. 

However, if these containers were not feasible, I mentioned, he could possibly manufacture, test and certify his own waste containers, to United Nation Specification requirements under 178.500, to the packing group III level, I even suggested he could search the DOT website or even call DOT to inquire about applying for, or joining a current packaging Special Permit, under Part 107. Which both, I admitted, seemed to me at the very least, very expensive and unnecessary.

DOING WHAT’S PROPER

I think one of the biggest mistakes we make when we ship hazardous materials, hazardous waste, marine pollutants and hazardous substances, is we fail to identify the material under the correct Proper Shipping Name. It’s not just the classification, more importantly it’s the identification of the material that matters. In most cases, shippers know the hazard class of the material, they know the packing group and they usually know if the material has a subsidiary hazard class. But, most people forget they must identify the material under one of 4 different and distinct proper shipping names.

THE 4 PROPER SHIPPING NAMES

All pure chemicals listed in the Hazardous Material Table, must be shipped using the proper chemical name as it appears in column number 2, of the 172,101 table, like 1) “Acetone” which is a Class 3 Flammable liquid or in the case of a waste; “Waste Acetone”, Class 3.  Then pure chemicals not listed or mixtures, must be described by “End-use” names, like, 2) “Paint”, as a Class 3. However if a pure chemical name or end-used name is not listed, the shipper must choose between a, 3) “Specific N.O.S., (not otherwise specified) name like Alcohols N.O.S. Class 3, or finally, 4) a “Generic N.O.S.” name such as Flammable liquid N.O.S. Class 3. 

 THE GOLDEN RULE

A few days later, I was so generously informed, by this same kind patron, that through his further research, namely his quick call to the Department of Transportation Hotline, (1-800-467-4922), A specialist had suggested that the shipping description “UN3363, Waste, Dangerous Goods in Apparatus”, Class 9,  would seem to be more appropriate for this waste shipment. With the word “waste” in front of the shipping name, as required by 49 CFR 171.101(c)(9)), the shipping name “Dangerous Goods in Apparatus”, for this Class 9, (with no packing group), would make available more appropriate packaging,(i.e. non-spec containers). By using this “Specific N.O.S.”, shipping name, column 8 would authorize the use of non UN specification containers. That is because, Section 173.222, Dangerous goods in equipment, machinery or apparatus allows for the use of any appropriate ”strong outside packaging” or even the “apparatus itself”, as the shipping container.

(https://www.ecfr.gov/cgi-bin/text-idx?SID=91859b974c0e0c88701554814437b32c&mc=true&node=se49.2.173_1222&rgn=div8  page 649)

UN3363, DANGEROUS GOODS IN EQUIPMENT, MACHINERY or APPARATUS, CLASS 9

WITH NO PACKING GROUP 

Section 173.222, states; that hazardous materials in machinery or apparatus does not require UN specification packaging, if the hazardous materials in machinery or apparatus is packaged in a strong outer packaging, or even it ‘s receptacle, if it affords adequate protection. 

The container, machinery or apparatus, must be marked with the “ID” number, “UN3363”, the shipping names, “Dangerous goods in machinery” or “Dangerous goods in apparatus,” and any required orientation marks under 172.312.

This only is provided, if the total net quantity of hazardous materials contained in one item of machinery or apparatus, does not exceed 1 kg (2.2 pounds), for solids or 0.5 L (0.1 gallons) for liquids. The package or receptacle must be secured and cushioned, to prevent any movement, or degradation, so that a release is unlikely, even in the event of damage.

“NO LABEL NO PLACARD”

Then as they like to say on TV, “THAT’S NOT ALL”. This Class. 9 Proper Shipping Name contains a Special Provision in column number 7, for which the shipping name “Hazardous Waste Solid N.O S.”, does not provide, Special provision 136. 

It seems that Special provision 136 states; that materials identified as “dangerous goods in apparatus” are also excepted from the Class 9 label, (unless offered by aircraft) and are never subject to vehicle placarding,


 CLASSIFICATION VERSUS IDENTIFICATION

It’s all about identification when shipping hazardous materials, hazardous wastes, hazardous substances and marine pollutants. Shipping containers, labels and placards are never based on the material’s hazard class. They are based solely on identification; the proper shipping name. I had forgotten the golden rule of shipping hazardous materials ; “IDENTIFICATION, NOT CLASSIFICATION, DETERMINES REGULATION”.

I see now, I was wrong, but I am glad together, we, that is, both my customer and I (mostly he and not I), were able to answer, the question he asked me. I am fading fast, so with over a month until my next seminar, please keep those cards, calls and emails coming.

Thank you for your readership and support.

Robert J Keegan 

Publisher and President 

Hazardous Material Publishing Company

Transportation Skills Program Inc

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