Medical Waste or Infectious Substance or Hazardous Substance or

???

Who Regulates Med Waste Transportation

• ADEM• EPA• OSHA• PHMSA - Pipeline & Hazardous Materials Safety Admin.

• US-DOT

ADEM – Medical Waste

• A solid waste or combination of solid wastes which because of its infectious characteristics may either cause, or significantly contribute to, an increase in mortality or an increase in serious irreversible or incapacitating reversible illness, or pose a substantial present hazard or potential hazard to human health or the environment when improperly treated, stored, transported, disposed, or otherwise managed.

Infectious Agent - ADEM

• any organism (such as a virus or a bacterium) that is capable of causing disease or adverse health impacts in humans by invasion and multiplication in body tissues, fluids or secretions.

Medical Waste - EPA

Culture and stocks of infectious agents, human pathological wastes, human blood and blood products, used sharps, certain animal wastes, certain isolation wastes, and unused sharps.

Hazardous Substance - OSHA

Any biologic agent and other disease causing agent which after release into the environment and upon exposure, ingestion, inhalation, or assimilation into any person, either directly from the environment or indirectly by ingestion through food chains, will or may reasonably . . .

Hazardous Substance – {Con’t}

be anticipated to cause death, disease, behavioral abnormalities, cancer, genetic mutation, physiological malfunctions (including malfunctions in reproduction) or physical deformations in such persons or their offspring.

Hazardous Material – US-DOTInfectious Substance

A substance or material that the Secretary of Transportation has determined is capable of posing an unreasonable risk to health, safety, and property when transported in commerce, and has designated as hazardous under section 5103 of Federal hazardous materials transportation law (49 U.S.C. 5103).

Hazardous Material – {Con’t}

Infectious Substance

The term includes hazardous substances, hazardous wastes, marine pollutants, elevated temperature materials, materials designated as hazardous in the Hazardous Materials Table (see 49 CFR 172.101){Infectious Substance page 222 – Haz Class 6.2}, and materials that meet the defining criteria for hazard classes and divisions in part 173 of this subchapter.

Div. 6.2 Infectious Substance - DOT

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.

Div. 6.2 Infectious Substance – {Con’t}

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:

Category A: (DOT)

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.

Category A (Con’t): (DOT)

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.

Category B: (DOT)

• An infectious substance that is not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. This includes Category B infectious substances transported for diagnostic or investigational purposes.

Category B (Con’t): (DOT)

A Category B infectious substance must be described as “Biological substance, Category B” and assigned identification number UN 3373. This does not include regulated medical waste, which must be assigned identification number UN 3291.

What’s Left Out

Determination Time–Person with Fever in ER–Person in Exam Room needing Tests–When Someone Suspects Illness

Who Takes Precedence

• Let’s see

Preemption

The Federal hazmat law at 49 U.S.C. § 5125, and the HMR at 49 CFR Part 107 Subpart C provides that, unless authorized by another Federal law, a requirement of a State, local, or Indian tribe is preempted if:

Preemption {Con’t}

• Compliance with both (1) the State, local, or Indian tribe requirement, and (2) any requirement of the Federal hazmat law (or a regulation issued under the Federal hazmat law) is not possible; or

Preemption - {Con’t}

• The State, local, or Indian tribe requirement as applied or enforced is an obstacle to accomplishing and carrying out the Federal hazmat law (or a regulation issued under it);

Preemption - {Con’t}

• The State, local, or Indian tribe requirement concerns a covered subject, and is NOT "substantively the same" as any provision of, or a regulation under, the Federal hazmat law concerning that subject.

Covered subjects are:

• Designation, description, and classification of hazardous materials; • Packing, repacking, handling,

labeling, marking, and placarding of hazardous materials;

Covered subjects are: {Con’t}

• Preparation, execution, and use of shipping documents pertaining to hazardous materials andrequirements related to the number, content, and placement of such documents;

Covered subjects are: {Con’t}

• Written notification, recording and reporting of the unintentional release in transportation ofhazardous materials; and

Covered subjects are: {Con’t}

• Designing, manufacturing, fabricating, marking, maintaining, reconditioning, repairing, or testing of a package or container which is represented, marked, certified, or sold as qualified for use inthe transportation of hazardous materials.

"Substantively the same"

• means that the non-Federal requirement conforms in every significant respect to the Federal requirement. Editorial and other similar changes are permitted

Effective Date (2 years after Routing Standards)

Section 5125(c) of 49 U.S.C. provides that, beginning two years after issuance of Federal highway routing standards, State and Indian tribe highway routing designations, limitations and requirements relating to hazardous materials will be preempted unless they meet Federal procedural and substantive requirements.

Effective Date {Con’t}

• FMCSA has issued regulations and issues preemption determinations on highway routing of hazardous materials.

Talk Limited to US-DOT

Due to Time Restraints

Ex: Massachusetts

• [Summary] regulations on storage and disposal of infectious or physically dangerous medical or biological waste.

Ex: Massachusetts {Con’t}

• [Summary] Different requirements for packaging medical waste for transportation in commerce, labeling requirements, and contents and retention of manifest are preempted.

Ex: Massachusetts {Con’t}

• [Summary] Requirements that generator prepare and sign a shipping paper are not preempted to the extent that they are applied and enforced in the same manner as the HMR.

Massachusetts Ruling

• SUMMARY: Federal hazardous material transportation law preempts the following requirements because they are not substantively the same as requirements in the Federal hazardous material transportation law and the HMR:

Massachusetts Ruling {Con’t}

1. 105 CMR 480.100(a) that storage containers must be "rodent proof" and "fly-tight" when those containers are used for transporting medical waste in commerce, including preparing medical waste for transportation in commerce.

Massachusetts Ruling {Con’t}

2. 105 CMR 480.200(C) that 3 mil bags must be used for waste that is transported off-site.

Massachusetts Ruling {Con’t}

3. 105 CMR 480.200(E) that pathological waste and contaminated animal carcasses must be double-bagged in 3 mil bags when transported off-site for disposal.

Massachusetts Ruling {Con’t}

4.105 CMR 480.300(A) that a distinctive label must be used on a container of "sharp wastes * * * to indicate that it contains sharp waste capable of inflicting punctures or cuts" when those containers are used for transporting medical waste in commerce, including preparing medical waste transportation in commerce.

Massachusetts Ruling {Con’t}

5. 105 CMR 480.300(B) that a label with the name, address, and telephone number of the generator must be placed on "every container or bag of waste that has not been rendered noninfectious and which will be transported off the premises of the waste generator."

Massachusetts Ruling {Con’t}

6. 105 CMR 480.500(C) that the generator of medical waste must designate on a manifest the address of the delivery site, that the transporter and disposal facility must sign the manifest, and that the disposal facility must return the signed original to the generator.

Massachusetts Ruling {Con’t}

7. 105 CMR 480.500(E) that the generator must retain more than one copy of the manifest, and retain a copy of the manifest for more than 375 days after the material is accepted by the initial carrier.

Massachusetts [not preempted ]

A. 105 CMR 480.500(A) & (B) that the generator of medical waste to be transported in commerce must prepare a shipping paper or manifest that includes a description of the waste, the total quantity, and the type of container in which the waste is transported.

Massachusetts [not preempted ]

B. 105 CMR 480.500(C) that the generator of medical waste must sign the manifest.

Terms Applicable to Hospitals

• Person who offer [Offeror]for transport

• Shipper

Shippers Responsibilities

• Class & describe the material – 173.134

• Determine appropriate packaging – Part 178 [certified packaging and appropriate labels]

• Follow all closure requirements (prevent leaking) 178.2

Shipper’s Responsibilities {Con’t}

Training: [172.704]1. General Awareness / Familiarization2. Function-specific3. Safety / Emergency Response4. Security Awareness5. Recurrent

Ebola

• DOT Guidance for Preparing Packages of Ebola Contaminated Waste for Transportation and Disposal

• See Web Site

DOT Contact Info

• E-Mail training@dot.gov

• Phone (202) 366-2301

• Web phmsa.dot.gov/hazmat»Title 49 CFR Parts 171-180

173.134(b)(5) {p. 549}

Items NOT subject to Div. 6.2 RulesA material with LOW probability of

containing an Infectious Substance.

EX: … substances that have been treated … by steam sterilization, chemical disinfection, or other methods.

Thank You

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