FW: Re[2]: [Pharmwaste] What to restrict from drop-boxes?

Fri Jun 6 09:44:10 EDT 2014

More info on hazmat shipping, see below.  

From: Millerfl [mailto:millerfl at turbonet.com] 
Sent: Thursday, June 05, 2014 12:22 PM
To: Catherine
Subject: Re[2]: [Pharmwaste] What to restrict from drop-boxes?

With regard to shipping hazardous materials (other than hazardous waste) here's the parts of 49 CFR I believe come into play:

172.300   Applicability.

(a) Each person who offers a hazardous material for transportation shall mark each package, freight container, and transport vehicle containing the hazardous material in the manner required by this subpart.

172.301   General marking requirements for non-bulk packagings

(a) Proper shipping name and identification number. (1) Except as otherwise provided by this subchapter, each person who offers a hazardous material for transportation in a non-bulk packaging must mark the package with the proper shipping name and identification number (preceded by "UN", "NA" or "ID," as appropriate) for the material as shown in the §172.101 Hazardous Materials Table. The identification number marking preceded by "UN", "NA", or "ID" as appropriate must be marked in characters at least 12 mm (0.47 inches) high. Packages with a maximum capacity of 30 liters (8 gallons) or less, 30 kg (66 pounds) maximum net mass, or cylinders with a water capacity of 60 liters (16 gallons) or less must be marked with characters at least 6 mm (0.24 inches) high. Packages with a maximum capacity of 5 liters (1.32 gallons) or 5 kg (11 pounds) or less must be marked in a size appropriate for the size of the package.

172.302   General marking requirements for bulk packagings

(a) Identification numbers. Except as otherwise provided in this subpart, no person may offer for transportation or transport a hazardous material in a bulk packaging unless the packaging is marked as required by §172.332 with the identification number specified for the material in the §172.101 table

172.303   Prohibited marking

(a) No person may offer for transportation or transport a package which is marked with the proper shipping name, the identification number of a hazardous material or any other markings indicating that the material is hazardous (e.g., RQ, INHALATION HAZARD) unless the package contains the identified hazardous material or its residue.

172.304   Marking requirements

(a) The marking required in this subpart-

(1) Must be durable, in English and printed on or affixed to the surface of a package or on a label, tag, or sign.

(2) Must be displayed on a background of sharply contrasting color;

(3) Must be unobscured by labels or attachments; and

(4) Must be located away from any other marking (such as advertising) that could substantially reduce its effectiveness.

172.323   Infectious substances

(a) In addition to other requirements of this subpart, a bulk packaging containing a regulated medical waste, as defined in §173.134(a)(5) of this subchapter, must be marked with a BIOHAZARD marking conforming to 29 CFR 1910.1030(g)(1)(i)

172.324   Hazardous substances in non-bulk packagings.

For each non-bulk package that contains a hazardous substance-

(a) Except for packages of radioactive material labeled in accordance with §172.403, if the proper shipping name of a material that is a hazardous substance does not identify the hazardous substance by name, the name of the hazardous substance must be marked on the package, in parentheses, in association with the proper shipping name. If the material contains two or more hazardous substances, at least two hazardous substances, including the two with the lowest reportable quantities (RQs), must be identified. For a hazardous waste, the waste code (e.g., D001), if appropriate, may be used to identify the hazardous substance.

172.400   General labeling requirements

(a) Except as specified in §172.400a, each person who offers for transportation or transports a hazardous material in any of the following packages or containment devices, shall label the package or containment device with labels specified for the material in the §172.101 table and in this subpart:

(1) A non-bulk package;

(2) A bulk packaging, other than a cargo tank, portable tank, or tank car, with a volumetric capacity of less than 18 m3 (640 cubic feet), unless placarded in accordance with subpart F of this part;

(b) Labeling is required for a hazardous material which meets one or more hazard class definitions, in accordance with column 6 of the §172.101 table and the following table:

Hazard class or division

Label name

Label design or section reference

6.2

INFECTIOUS SUBSTANCE1 

172.432

172.401   Prohibited labeling.

(a) Except as otherwise provided in this section, no person may offer for transportation and no carrier may transport a package bearing a label specified in this subpart unless:

(1) The package contains a material that is a hazardous material, and

(2) The label represents a hazard of the hazardous material in the package.

172.101 Hazardous Materials Table

Symbols

Hazardous materials descriptions and proper shipping names

Hazard class or Division

Identification Numbers

PG

Label Codes

Special provisions
(§172.102)

(8)

(9)

(10)
Vessel
stowage

Packaging
(§173.***)

Quantity limitations
(see §§173.27 and 175.75)

Location

Other

Exceptions

Non-bulk

Bulk

Passenger aircraft/rail

Cargo aircraft only

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8A)

(8B)

(8C)

(9A)

(9B)

(10A)

(10B)

G

Infectious substances, affecting animals only 

6.2

UN2900

6.2

A82

134

196

None

50 mL or 50 g

4 L or 4 kg

B

40

G

Infectious substances, affecting humans

6.2

UN 2814

6.2

A82

134

196

None

50 mL or 50 g

4 L or 4 kg

B

40

173.134   Class 6, Division 6.2-Definitions and exceptions.

(a) Definitions and classification criteria. For the purposes of this subchapter, the following definitions and classification criteria apply to Division 6.2 materials.

(1) Division 6.2 (Infectious substance) means a material known or reasonably expected to contain a pathogen. A pathogen is a microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent, such as a proteinaceous infectious particle (prion), that can cause disease in humans or animals. An infectious substance must be assigned the identification number UN 2814, UN 2900, UN 3373, or UN 3291 as appropriate, and must be assigned to one of the following categories:

(i) Category A: An infectious substance in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. An exposure occurs when an infectious substance is released outside of its protective packaging, resulting in physical contact with humans or animals. A Category A infectious substance must be assigned to identification number UN 2814 or UN 2900, as appropriate. Assignment to UN 2814 or UN 2900 must be based on the known medical history or symptoms of the source patient or animal, endemic local conditions, or professional judgment concerning the individual circumstances of the source human or animal.

...

(5) Regulated medical waste or clinical waste or (bio) medical waste means a waste or reusable material derived from the medical treatment of an animal or human, which includes diagnosis and immunization, or from biomedical research, which includes the production and testing of biological products. Regulated medical waste or clinical waste or (bio) medical waste containing a Category A infectious substance must be classed as an infectious substance, and assigned to UN2814 or UN2900, as appropriate

What does all that mean?  Unless I've missed an exception or LOI from USDOT my reading of the CFR leads me to believe unused medications, and equipment containing unused medications (i.e. no known or probable contamination with pathogens) would not qualify as division 6.2 and therefore marking/labeling them as such would be inappropriate.  They should instead be marked/labeled in accordance with their actual hazard classifications (flammable, corrosive, poison, etc.). 

As Catherine pointed out, aerosols and other pressurized containers can be problematic for shipment by air.  Packages containing materials which can react with one another to create additional hazards in transit are forbidden so it's imperative to ensure such materials are properly segregated.  I know of no exemption which would allow incompatible materials to be packaged together whether they're bagged or not.  Inner and outer packages must conform with the requirements of the CFR, as well as requirements for sorbents and cushioning.

Fred

  _____  

-----Original Message-----
From: Catherine <zenllc at usfamily.net>
To: "Ed Gottlieb" <egottlieb at cityofithaca.org>, pharmwaste at lists.dep.state.fl.us
Date: 06/05/14 08:35
Subject: RE: [Pharmwaste] What to restrict from drop-boxes?

Hi Ed,

Good questions. 

Re: aerosols/inhalers, these become problematic with transportation rules, e.g. hazmat or when transporting via air where they can be prohibited. 

I think liquids are an issue because they may spill and then react with something else in the container.  Risk may be minimized if liquids are sealed in an outer zip-loc bag.  I don't know if there are documented problems, but certainly these are risks we want to avoid. 

Better to call "infectious" rather than "bio-hazard" waste-better explains risk. 

Hope this helps.

Very truly yours,

Catherine Zimmer, MS, BSMT

Zimmer Environmental Improvement, LLC

St. Paul, MN

Ph:  651.645.7509

zenllc at usfamily.net

From: pharmwaste-bounces at lists.dep.state.fl.us [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Ed Gottlieb
Sent: Thursday, June 05, 2014 2:36 AM
To: pharmwaste at lists.dep.state.fl.us
Subject: [Pharmwaste] What to restrict from drop-boxes?

Hi pharmwaste listserv,

All drop-box programs list items that are accepted and items that aren't. 

Sharps, bio-hazardous waste, chemotherapy medications, and thermometers are almost always listed as not accepted.  Some programs specifically restrict less (or more!) obvious items such as:  trash, mail, and guns.

I think we can all agree there are good reasons for not accepting any of these items.  

What about liquids, ointments, inhalers, and aerosol cans?  I regularly see these on "not accepted" lists.  

Most boxes have internal, removable totes that should be lined with a plastic bag.  Liquid spills should not be a problem from the clean-up perspective.  I've not seen any evidence that spilled liquids can cause dangerous chemical reactions to occur, an explanation I was given for one programs ban.  Are there documented problems caused by a spill of hydrogen peroxide, alcohol, or any other liquid medication?  Can explosive conditions develop?  Will active ingredients volatilize and contaminate the air if spilled alcohol dissolves medication it comes in contact with? 

Do inhalers and other aerosol cans actually cause problems in a drop-box or at the incinerator? 

I believe that most programs copy their "not accepted" list from an existing program.  Maybe some of these restricted items could be safely accepted?  Or, is it wiser to keep restricting them to avoid a possible hazard, however unlikely?

With luck, pharmacies will soon be launching their own programs, greatly expanding the accessability of take-back programs.  Can we offer them guidance on this issue?  Your thoughts are appreciated.

Ed

Ed Gottlieb
Chair, Coalition for Safe Medication Disposal
Industrial Pretreatment Coordinator
Ithaca Area Wastewater Treatment Facility
525 3rd Street
Ithaca, NY 14850
(607) 273-8381
fax: (607) 273-8433

  _____  

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