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Submission Regulations

Federal Sample Shipping Regulations

Sampling Kits  

milk vials

 

Primary Container (milk sample vial) must be leak-proof.

 

 

 

vials in cardboard

 

Contact between primary containers must not occur during shipping. Insert the sample vials into the cardboard racks.

 

 

absorbent material for packing

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.

 

 

 

biohazard symbolAn 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.

 

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. Shipping materials are available at any QMPS lab. There is a small charge for shipping these materials to you.

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 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 at: http://www.casingcorp.com under “Regulatory Notices

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 if 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 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:

  • 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.

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:

  • 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. 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:

  • Certain biological products,

  • Diagnostic specimens

  • Regulated medical waste

  • Cultures and stocks

  • Infectious Substances

 

MOTS Exception for Infectious Substances Now Requires Performance Packaging for Purposes

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:

  • 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 and are 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 HM226

 

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

Quality Milk Production Services

Northern Laboratory
SUNY Canton
Canton, NY 13619
315-379-3930
877-645-5523
(fax) 315-379-3931
Central Laboratory
AHDC
240 Farrier Road
Ithaca, NY 14853
607-255-8202
877-645-5522
(fax) 607-253-4000
(email) qmps@cornell.edu
Western Laboratory
36 Center St, STE A
Warsaw, NY 14569
585-786-2555
1-877-645-5525 toll free
(fax)585-786-2550
Eastern Laboratory
111 Schenectady Ave.
Cobleskill, NY 12043
518-255-5681
877-645-5524
(fax) 518-255-5682