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| Sampling Kits New Federal Sample Shipping Regulations |
| New Federal Shipping Regulations
require that samples submitted through private carrier (UPS, Fed Ex, etc.)
or the United States Postal Service must be packaged in triple packaging
consisting of: |
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| Contact between primary containers must not occur during shipping. Insert the sample vials into the cardboard racks. |  |
| All primary containers must be placed in a leak-proof secondary container (heavy duty Zip lock bag). Ensure that the bag is properly sealed. The secondary container must contain sufficient absorbent material (paper towel) to absorb the entire contents of the package should the vials leak. |  |
An inventory
of contents must be placed in a single Zip lock bag in the shipping box
outside of the secondary container. Do not ship unprotected styrofoam
containers. They are too easily broken or punctured. Styrofoam shipping
containers must be placed inside a cardboard container. The outside of
the cardboard container must have the words "Diagnostic
Samples" and the international symbol for "BIOHAZARD"
must be prominently displayed. |
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New regulations may delay the shipment of improperly packaged samples to the lab. Please ensure that they are adequately refrigerated, properly labeled and addressed. Whenever possible ship samples early in the week to avoid arrival on the weekend. |
| QMPS will make compliance of the new regulations as simple as possible for our clients. We are providing appropriate packaging and shipping materials at a nominal cost to expedite transportation of diagnostic samples to the lab. Improved packaging should eliminate delivery delays and ensure good quality samples and more reliable test results. |
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| This helps you in the following ways: | ||||||||||||||||||||||||||||||||||||
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Kit Costs:
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Contact any Quality Milk Production Services lab to purchase this kit. |
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*Shipping: Based on UPS Ground Service Rates (shipping via USPS is acceptable also) Prices effective May, 2003 |
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Executive
Summary (top)
Hazardous Materials: Revisions to Standards for Infectious Substances
(“HM226”)
Background
Spring 1991: The Institute of Medicine, a component of the National Academy of Sciences, issued a press release that was first published by the Washington Post and reprinted in the Los Angeles Times. The announcement indicated that U.S. federal health officials were alarmed by the global threat from the spread of infectious diseases.
Prior to the Institute of Medicine announcement, shipments of diagnostic specimens were unregulated in the United States. A federally sponsored assessment of the resurgence of infectious diseases was initiated, with consultation of interested parties, and coordination with the United Nations.
In the first week of October 1994, the late Dr. Richard C. Knudsen, of the U.S. Centers for Disease Control, finalized a plan that reflected the views of the U.S. Department of Transportation and CDC. This document proposed that U.S. diagnostic specimen shipments should be regulated and that diagnostic specimen shipments using air transportation should be required to meet the standards of IATA Packing Instruction 650. The proposal was the beginning of HM226: an alignment of more stringent U.S. and international rules. In December 1994, U.S. federal regulations were initiated to regulate Infectious Substance shipments in the U.S.
On August 12, 2002, the U.S. Department of Transportation (“DOT”) issued a Final Rule under U.S. transportation regulations. The rule affects the way in which the broad categories of infectious substances, diagnostic specimens, biological products, and regulated medical waste are defined, classified, packaged, and transported.
This regulation affects all shipments, by air or ground transportation within and between the United States and generally effect the alignment of U.S. DOT regulations (Title 49 CFR) with the international rules for air shipment of Infectious Substances and Diagnostic Specimens: the ICAO Technical Instructions.
The effective date for this new final rule has been extended from the initial effective date of October 1, 2002 to February 14, 2003.
The information contained in this summary is condensed from the Federal Register dated August 14, 2002, (Vol. 67, Number 157). It is only a summary and the information contained herein should be construed in light of the regulation (HM226) in its entirety, as published in the Federal Register. For your convenience, the electronic version is listed under “Regulatory Notices” at http://www.casingcorp.com
Casing Scientific PO Box 820369
Dallas, Texas 75382-0369 Tel 800 358 6866 Fax 888 661 9606
Email: casing@prodigy.net Home:http://www.casingcorp.com
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 infectious substances
assigned to Risk Group 1 are excepted from the HMR under the HM226 Final Rule
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
Packaging Requirements for Division 6.2 Infectious Substances (Sec. 173.196)
Reuse of Class 6.2
Packaging:
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 number 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:
Assignment to UN 2814 or UN
2900 is based on
Diagnostic Specimens
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:
(1) “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
(2) 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:
Shippers involved in packing diagnostic specimens are exempted from formal hazardous materials training and certification under Title 49 CFR. This area is also excepted from record keeping and certification training requirements for hazardous materials. 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.
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:
MOTS Exception for Infectious Substances Now Requires Performance
Packaging for Purposes
Materials Excepted & Types of Packaging
Exceptions – Dedicated Vehicles in Ground Transport
Exceptions to Division 6.2 Requirements:
U.S. Postal Service
The U.S. Postal Service is a substantial carrier of specimen material, including Diagnostic Specimens, Infectious Substances, and clinical specimens.
Under U.S. law, only the Postal Service can propose regulations for mailing hazardous materials, and presently, the Postal Service is considering changing government postal service packaging requirements in parallel with the Title 49 CFR (HM226) changes.
Presently, parcels of specimens that are shipped within Postal Zones 1 through 4 are mailed within a radius of 500 miles from their origin and can be carried, by first class mail, entirely by ground transport on U.S. Postal Service Trucks.
Parcels that are mailed to destinations in zones higher than Zone 4 generally exceed 500 miles distance from their origin and require air transport, if they are mailed “first class” or at a higher premium postage for priority mail or express mail service.
Recent restrictions by the Federal Aviation Administration and the self-imposed rules of the air carriers are complicating postal service operations due to restrictions.
A Notice of Proposed Rulemaking may be forthcoming by mid-December 2002, in order to complete the regulatory cycle by the February 14, 2003 effective date of HM226.
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:
Mr. Ed Mazzullo, Director
DHM-10
DOT/RSPA/OHMS
400 7th Street SW
Washington, D.C. 20590
Notes
1 While 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
Casing Scientific – PO
Box 920369 Dallas, Texas 75382 Tel 800 358 6866 Fax 888 661 9606
Email: casing@prodigy.net Home: http://www.casingcorp.com
