Summary HM226

DATED HISTORICAL INFORMATION

Executive Summary
Hazardous Materials: Revisions to Standards for Infectious Substances

("HM226")

On February 14, 2003, the U.S. Department of Transportation implemented a broad range of regulatory changes that affect shipments of diagnostic specimens, infectious substances, biological products, and regulated medical waste. The focus of this summary is on diagnostic specimens and infectious substances.

    At the core of this change is a system of risk assessment that is now established as an umbrella over all materials with the potential for spreading infectious diseases. Decisions about transportation of specimens and other materials must be made on the basis of actual or potential risk to individuals or the community.

    This DOT regulation, together with its international counterparts, set forth a boundary between diagnostic specimens and infectious substances, and it regulates diagnostic specimen packaging for the first time in the United States based upon new defining criteria.

    The significant changes are outlined below:

Diagnostic Specimens:
    If a specimen is being transported for purposes of treatment or diagnosis it can be shipped as a diagnostic specimen in authorized packaging. This includes specimens that are known or suspected to contain a pathogen in Risk Group 2 or 3.
    Authorized packaging of diagnostic specimens depends upon the mode of transportation (air or ground) and whether the material is liquid or solid. The rules for shipment of liquid specimens by air are unique.

    General and special exceptions may apply and are listed under "Exceptions" in the attached summary and in the Hm226 regulation listed on the Home page under "Regulatory Updates".
Infectious Substances:
    Cultures of infectious substances in Risk Group 2, 3, or 4 are defined as Infectious Substances and are fully regulated under U.S. and international regulations.
    Specimens, other than cultures, known or suspected to container a pathogen in Risk Group 2, 3, or 4 are assigned to Division 6.2 and transported as Infectious Substances, if they are being transported for purposes of research.
    General and special exceptions may apply and are listed under "Exceptions" in the attached summary and in the HM226 regulation listed on the Home page under "Regulatory Updates".
This summary should be considered only in contemplation of the actual Final Rules as published by the U.S. Department of Transportation, the U.S. Postal Service hazardous materials regulations, and the dangerous goods regulations and technical publication of the International Air Transportation ("IATA") and the UN International Air Transport Organization ("ICAO")

Infectious Substances

Under the HM226 requirements, health care organizations must first reach a determination that establishes:

(1) when a specimen or material is considered an Infectious Substance,

(2) when a specimen or material is considered a Diagnostic Specimen, or

(3) when a specimen or material is excepted from the regulations

New Definition for Infectious Substances:

Under the new rules, an Infectious Substance is a material "known to contain or suspected of containing a pathogen. A pathogen is a virus, or micro-organism (including its viruses, plasmids, or other genetic elements, if any) or a proteinaceous infectious particle (Prion) that has the potential to cause disease in humans or animals.

A division 6.2 material must be assigned a World Health Organization Risk Group (Risk Group I through Risk Group IV).

"Assignment to a risk group is based on:

	known medical condition and history of the source patient or animal,
	endemic local conditions,
	symptoms of the source patient or animal,
	or professional judgment concerning individual circumstances of the source patient or animal"
	known infectious substances assigned to Risk Group 1 are excepted from the HMR under the HM226 Final Rule

Classification of Infectious Substances
According to Risk Groups

WHO Risk Groups:

Risk Group IV: A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly, and for which effective treatments and preventive measures are not usually available.

Risk to Individuals: High

Risk to the Community: High

Risk Group III: A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another, and for which effective treatments and preventive measures are available.

Risk to Individuals: High

Risk to the Community: Low

Risk Group II: A pathogen that can cause human or animal diseases but is unlikely to be a serious hazard, and, while capable of causing serious infection on exposure, for which there are effective treatments and preventive measures available and the risk of spread of infectious is limited.

Risk to Individuals: Moderate

Risk to the Community: Low

Risk Group I: A micro-organism that is unlikely to cause human or animal disease. A material containing only such micro-organisms is not subject to the requirements of the subchapter.

Risk to Individuals: None or very low

Risk to the Community: None or very low

New Responsibilities Imposed on Manufacturers of Class 6.2 Packaging

	A Division 6.2 label in compliance as of 9-30-02 may be used until 10-1-05
	Adoption of United Nations Division 6.2 certification markings (UN/4G Class 6.2)

	a water spray test is adopted into U.S. regulations replacing the water immersion test in the battery of Division 6.2 packaging performance qualification tests under Title 49 CFR, Subchapter C, part 178.609,
	Sec 178.609 requires a new standard for performance involving the puncture test: if the puncture rod penetrates the secondary packaging and penetrates any primary receptacles, the packaging, under these new standards, fails the packaging qualification test

Packaging Requirements for Division 6.2 Infectious Substances (Sec. 173.196)

A triple packaging meeting the test standards of Sec. 178.609

Marked as a UN/4G Class 6.2 packaging in conformance with Sec 178.503(f)

Consisting of the following components:

	A watertight primary receptacle
	A watertight secondary packaging
	For multiple fragile primary receptacles placed in a single secondary packaging, they must be wrapped individually to prevent contact between them
	An outer packaging of adequate strength for its capacity, mass, and intended use. The outer packaging must measure at least 100 mm (3.9 inches) at its smallest overall external dimension
	For liquid diagnostic specimens, an absorbent material placed between the primary receptacle and the secondary packaging. The absorbent material must be sufficient to absorb the entire contents of all primary receptacles.
	An itemized list of the contents enclosed between the secondary packaging and the outer packaging
	The primary receptacle or secondary packaging used for infectious substances must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 95 kPa (0.95 bar, 14 psi)
	The primary receptacle or secondary packaging used for infectious substances must be capable of withstanding without leakage temperatures in the range of �40 deg.C to +55 deg.C (-40 deg.F to +131 deg. F)
	Infectious substances must be packed according to �.additional requirements listed in HM226. Please refer to Sec. 173.196 of the Final Rule for additional information.
	This document is listed under "Regulatory Notices" at:

http://www.casingcorp.com

Reuse of Class 6.2 Packaging:

	"A Division 6.2 packaging to be reused must be disinfected prior to reuse by any means effective for neutralizing the infectious substance the packaging previously contained.
	A secondary packaging or outer packaging�.need not be disinfected prior to reuse of no leakage from the primary receptacle has occurred"

Diagnostic Specimens

Status of Diagnostic Specimens As Hazardous Materials:

The category "Diagnostic Specimens" is now listed in the Hazardous Material Tables of Title 49 CFR (U.S. Department of Transportation regulations) without being designated a UN identification number. Diagnostic Specimens are defined as hazardous materials, but are excepted from most of the requirements of the HMR.

New Definition of Diagnostic Specimens: a Diagnostic Specimen "means any human or animal material, including excreta, secreta, blood and its components, tissue, and tissue fluids being transported for diagnostic or investigational purposes, but excluding live infected humans or animals."

"A diagnostic specimen is not assigned a UN identification number¹ unless the source patient or animal has or may have a serious human or animal disease from a Risk Group 4 pathogen. [In this case], it must be:

	classed as Division 6.2,
	described as an Infectious Substance,
	and assigned to UN 2814 or UN 2900, as appropriate"

"Assignment to UN 2814 or UN 2900 is based on

	known medical condition and history of the patient or animal,
	endemic local conditions,
	symptoms of the source patient or animal,
	or professional judgment concerning individual circumstances of the source patient or animal." ¹ The International Civil Aviation Organization (ICAO) at the United Nations is presently considering the requirement of a UN number for diagnostic specimens. If ICAO adopts a UN number for diagnostic specimen shipments, the U.S. Department of Transportation may revise HM226 to reflect this possible change. In the meantime, diagnostic specimen packages are lawful shipments without being marked with a UN number.

Packaging Required For Shipment of Diagnostic Specimens:

General Requirements

Generally, unless Diagnostic Specimens are transported by ground based private or contract carriers using dedicated vehicles, these materials must conform to the following standards:

	"Diagnostic Specimens are excepted from all other requirements of [the requirements of Title 49 CFR (all of it), when offered for transportation or transported" when packaged as described below (diagnostic specimens shipped by aircraft are subject to incident reporting)¹
	A Diagnostic Specimen "meeting the definition of a hazard class other than Division 6.2 (Infectious Substances) must be offered for transportation or transported", as described below:

Diagnostic Specimens must be packaged in triple packaging consisting of:

	a primary receptacle,
	a secondary packaging, &

an outer packaging

Primary receptacles must be packed in secondary packaging in such a way that, under normal conditions of transport, they cannot break, be punctured, or leak their contents into the secondary packaging

Secondary packaging(s) must be secured in outer packaging(s) with suitable cushioning material such that any leakage of the contents will not impair the protective properties of the cushioning material or the outer packaging.

The completed package must be capable of successfully passing the drop test at a drop height of at least 1.2 meters (3.9 Feet)

The outer packaging must be clearly and durably marked with the words "Diagnostic Specimen"

International Biohazard Symbol: The orange-black international biohazard label is a requirement of OSHA for domestic shippers of diagnostic specimens. In the normal course of business, Air carriers usually inform their customers of the need for this warning label because their terminal facilities are subject to inspection by OSHA with authority to locate shippers and issue fines for violation of the universal precautions standard.

Liquid Diagnostic Specimens - must be packaged where the:

	primary receptacle must be leak-proof with a volumetric capacity of not more than 500 ml (16.9 ounces),
	Absorbent material must be placed between the primary receptacle and secondary packaging
	If several fragile primary receptacles are placed in a single secondary packaging, they must be individually wrapped or separated so as to prevent contact between them
	The absorbent material must be of sufficient quantity to absorb the entire contents of the primary receptacles.

The secondary packaging must be leak-proof

Diagnostic Specimen Shipments by Air:

Shipments by aircraft have an additional special requirement:

The primary receptacle or the secondary container must be capable of withstanding without leakage an internal pressure of 95 kpa (14 psi)

The outer packaging may not exceed 4 L (1 gallon) Diagnostic Specimen capacity

Solid Diagnostic Specimens:

	Must be packaged in a triple packaging
	Consisting of a sift-proof primary receptacle (capacity not greater than 500 g (1.1 pounds)
	If several fragile primary receptacles are placed in a single secondary packaging, they must be individually wrapped or separated so as to prevent contact between them
	A leak-proof secondary packaging is required
	For several primary receptacles in one secondary packaging, the outer packaging may not exceed 4 kg (8.8 pounds)

Training Requirements � Shipment of Diagnostic Specimens:

Shippers involved in packing diagnostic specimens are exempted from formal hazardous materials training and certification under Title 49 CFR. There is a requirement that persons preparing or transporting diagnostic specimens "must know about and be able to apply the requirements of Sec. 173.199 {Title 49 CFR} to specific shipments".

The record-keeping and certification requirements for training under Subpart H of part 172 are also excepted in connection with diagnostic specimen shipments.

Biological Products:

The Definition of a Biological Product under HM226

"Biological Product means a virus, therapeutic serum, toxin, product, or analogous product used in the prevention, diagnosis, treatment, or cure of diseases in humans or animals. A biological product includes a material manufactured and distributed in accordance with" government regulation. (Federal Register Vol. 67, No. 157, p. 53138)

"A Biological Product known to contain or suspected of containing a pathogen in Risk Group 2, 3, or 4 must be classed as Division 6.2, described as an infectious substance, and assigned to UN 2814 or UN 2900, as appropriate, unless otherwise excepted".

The Materials of Trade Exception and the exceptions granted to dedicated vehicles apply to Biological Products based upon their status as either (1) infectious, (2) diagnostic, or (3) total exception based upon the absence of any pathogens or a Risk Group 1 pathogen.

Materials Excepted from the HMR Under HM226

Materials of Trade Exceptions (MOTS):

The Materials of Trade exception that has been in effect has been expanded to include:

	Certain biological products,
	Diagnostic specimens
	Regulated medical waste
	Cultures and stocks
	& Infectious Substance

MOTS Exception for Infectious Substances Now Requires Performance Packaging:

Materials Excepted & Types of Packaging:

A Division 6.2 material, other than a Risk Group 4 material that is a diagnostic specimen, biological product, or regulated medical waste. The material must be contained in a combination packaging.

For Liquids, the inner packaging(s) of combination packages must be leak tight,

the outer packaging must contain absorbent material sufficient to absorb the entire contents of the inner packaging(s)

for sharps that can pierce certain types of packaging, the inner packaging of the combination packaging must be constructed of a rigid, puncture-resistant material

for all Division 6.2 materials, the outer packaging must be a strong, tight packaging that is securely sealed

all Division 6.2 packages under the MOTS exception must be marked with a common name or proper shipping name, and motor vehicle operators must be informed of the presence of hazardous material

For a diagnostic specimen or biological product, combination packaging(s) must conform to the following capacity limitations:

(A) One or more inner packaging(s) where the gross mass or capacity of each inner packaging does not exceed 0.5 kg (1.1 pound), or 0.5 L (17 ounces), and an outer packaging having a gross mass or capacity not exceeding 4 kg (8.8 pounds) or 4 L (1 gallon); or

(B) A single inner packaging with a gross mass or capacity not exceeding 16 kg (35.2 pounds) or 16 L (4.2 gallons) in a single outer packaging

(ii)) For a regulated medical waste, a combination packaging must consist of one or more inner packaging(s) having a gross mass or capacity not exceeding 4kg (8.8 pounds) or 4 L (1 gallon), and an outer packaging having a gross mass or capacity not exceeding 16 kg (35.2 pounds or 16 L (4.2 gallons)

Exceptions � Dedicated Vehicles in Ground Transport

	Diagnostic Specimens transported by private and contract carriers using dedicated vehicles are exempt as long as the specimens are within Risk Group 2 or Risk Group 3.
	Risk Group IV Diagnostic Specimens must conform to Division 6.2 standards of packaging.

Exceptions to Division 6.2 Requirements:

"The following are generally excepted from the requirements of Division 6.2:

	Specimens in Risk Group II and III that are derived from humans or animals and being transported for purposes of diagnosis, must be packaged and marked according to the performance standards of Diagnostic Specimens. These standards vary based on whether the specimen is solid or liquid and being shipped by air or ground.
	"A Biological Product known to contain or suspected of containing a micro-organism in Risk Group I, or that does not contain a pathogen.

A Diagnostic Specimen known to contain or suspected of containing a micro-organism in Risk Group I, or that does not contain a pathogen, or a diagnostic specimen in which the pathogen has been neutralized or inactivated so it cannot cause disease when exposure to it occurs

A Biological Product, including an experimental product or component of a product, subject to Federal approval, permit, or licensing requirements, such as those required by the Food and Drug Administration of the Department of Health and Human Services or the U.S. Department of Agriculture

Blood (A-81 Exception) collected for the purpose of blood transfusion or the preparation of blood products; blood products; tissues or organs intended for use in transplant operations; and human cell, tissues, and cellular and tissue-based products regulated under authority of the Public Health Service Act and/or the Food, Drug, and Cosmetic Act.

Blood (A-81 Exception) collected for the purpose of blood transfusion or the preparation of blood products and sent for testing as part of the collection process, except where the person collecting the blood has a reason to believe it contains an infectious substance, in which case the test sample must be shipped in accordance with Sec. 173.199

A Diagnostic Specimen or Biological Product when transported by a private or contract carrier in a motor vehicle used exclusively to transport Diagnostic Specimens or Biological Products.

Medical or clinical equipment and laboratory products may be transported aboard the same vehicle provided they are properly packaged and secured against exposure or contamination. If a Diagnostic Specimen or Biological Product meets the definition of regulated medical waste in paragraph (a) (5) of this section, it must be offered for transportation and transported in conformance with the appropriate requirements for regulated medical waste

Additional exceptions and conditions are listed in the regulation. The regulation is listed under "Regulatory Notices" at: http://www.casingcorp.com, including:

	regulated medical waste shipped by ground or air,
	environmental diagnostic specimens such as mold contaminated building materials,
	waste cultures and stocks,
	materials of trade exceptions,
	forensic materials,
	medical waste generated from households,
	animal waste, sewage, and other materials that can be reviewed directly in HM22

U.S. Department of Transportation

Questions & Requests for Letters of Interpretation of Final Rules

The hazardous materials information telephone number is 800 467 4922. This office fields questions from the public concerning the packaging and transport of hazardous materials in the U.S. In addition to this facility, DOT will respond to letters requesting the interpretation of the hazardous materials regulations within Title 49 CFR. Requests for "letters of interpretation" should be addressed to the U.S. Department of Transportation:

Ms. Ed Mazzullo, Director
DHM-10
DOT/RSPA/OHMS
400 7^th Street SW
Washington, D.C. 20590

Notes
¹While a material may be excepted from a hazard class under the Title 49 CFR regulations, it should be noted that some materials may contain other hazardous materials that are regulated by the hazardous materials regulations

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