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Regulatory Changes

2015

ICAO/IATA Update for Used medical device exceptions: The ICAO and IATA exceptions for used medical devices were updated on January 1, 2015 to state that the medical device must be drained of any free liquid to the extent practicable. Additionally, the inner packagings must be secured in the outer packaging and that outer packaging must be rigid. This update also allows multiple methods to determine if the package is capable of passing the drop test by performing non-destructive testing and engineering analysis, testing articles of similar mass and size or other equivalent methods.

Shipping Exempt patient specimens with refrigerants: When shipping Exempt patient specimens using refrigerants, the refrigerant must be placed outside of the secondary packaging, and the secondary packaging must be securely placed inside of the outer packaging so that it does not move around after the refrigerant has melted or dissipated. If ice is used, the packaging must be leakproof; and if dry ice is used, the package must allow the release of CO2 gas. Either way, the primary receptacle and the secondary packaging must perform their containment function at the lower temperatures.

Changes to Overpack Marking: Overpacks containing Limited quantity packages must have the appropriate Limited quantity marking on the outside of the overpack. Additionally, when the term “Overpack” is required on the outside of the package, the letters must be at least 12 mm in height.

U.S. DOT Emergency response telephone numbers: The 24-hour emergency contact phone number must be numbers. It is no longer acceptable to substitute letters for number.

 

2014

U.S. DOT Hazard label changes

On October 1, 2014 the old versions of the Infectious substance and Class 9 Miscellaneous substances hazard labels were no longer permitted to be used. For the infectious substance hazard label, only those labels without the CDC information will be accepted.

On behalf of some of its members, the Council on the Safe Transport of Hazardous Articles (COSTHA) petitioned the DOT for an extension to this deadline for the old version of the Class 9 Miscellaneous substance hazard label (the one containing a horizontal line). The DOT responded on September 30, 2014 with a letter of interpretation, which states that, although the new label in the regulations does not include the horizontal, if the line is on the label used it doesn’t obscure the meaning of the label. Therefore, since it does not compromise safety, its use is optional for shipments within the U.S.

Transport Canada (TC) harmonizes with the UN

In December, 2014 Transport Canada introduced some regulatory changes that bring harmony to the differences between the Transport of Dangerous Goods Regulations (TDGR) and the UN Model Regulations (as well as other regulatory agencies) on certain types of shipments.

(TC) New exception for Excepted Quantities: The core of the Excepted quantity regulations in the TDGR is found in the Table of Excepted quantity codes. The TDGR table is the same as all other regulatory authorities, so the permitted quantities are the same. Any other requirements, including packaging, marking, labeling and documentation reflect the existing international regulations.

(TC) Genetically modified organisms or micro-organisms (GMOs) Transport Canada, in consultation with other regulatory authorities, concluded that GMOs do not pose imminent danger during transportation and therefore do not need to be regulated. Consequently, Transport Canada has removed the entries for UN 3245 in Schedule 1 and Schedule 3.

(TC) Shipments of Medical or Clinical Waste: Transport Canada has introduced new regulations for shipments of medical and clinical waste, adding UN number 3291 to Schedules 1 and 3, with the Proper shipping names Clinical waste, unspecified, n.o.s., (Bio) medical waste, n.o.s. and Regulated medical waste, n.o.s. The classification and packaging requirements for these types of shipments are very similar to the regulations published in the international regulations, including the UN model regulations.

(TC) Technical name for Category A infectious substances: Special Provision 16 was amended to require that the Proper shipping name for Category A infectious substances on the shipping document be similar to ICAO/IATA Special provision A140.

 

2013

Effective January 1, 2013, ICAO and IATA will no longer use the term “date” for training purposes. The word “month” has been substituted, meaning recurrent training is required only during the month of expiration rather than a specific day of the month.

 

Effective January 1, 2013 – In order to clearly indicate the dangerous goods contained in the package, the UN numbers marked on the outside must be a minimum size, depending on the capacity of the package. These requirements can be found in Table 2013-1. (ICAO 5;2.4.1.1, IATA 7.1.4.4.1).

Table 2013.1
Package Capacity Minimum UN number marking height
> 30 L or 30 kg 12 mm
> 5 L or 5 kg and < 30 L or 30 kg 6 mm
< 5 L or 5 kg Appropriate for the package

 

January 1, 2013 – ICAO/IATA added an exception to the regulations for shipments of very small quantities of dangerous goods, called De minimis quantities. De minimis quantities of dangerous goods are permitted as an Excepted quantity (Except code E3) where the quantity of dangerous goods is less than 1 mL or 1 g per inner packaging, and the total quantity of the package does not exceed 100 mL or 100 g. De minimis quantity packages are similar to Excepted quantity packages, including package testing. However, there are no marking, labeling or documentation requirements for De minimis quantity shipments. (ICAO 3;5.6, IATA 2.6.10).

 

After January 01, 2013 – When Limited quantity packages placed in an overpack are shipped by air, the Limited quantity mark must be replicated on the outside of the overpack, unless it is already visible (ICAO 5;2.4.10, IATA 7.1.7.1).

January 1, 2013 – ICAO and IATA added an exception to the regulations regarding shipments of used medical devices. Used medical devices are defined as medical equipment that has been in contact (contaminated) with a patient, and then being returned to the manufacturer (or another destination) for sterilization, repair or performance review. These devices are excepted from the transport regulations, provided they are neither medical waste or possibly infected with a Category A Infectious substance, and provided they are prepared according to the requirements found in the regulations (ICAO 2;6.3.2.3.7, IATA 3.6.2.2.3.7).

Effective January 1, 2013 – ICAO and IATA added a documentation requirement for shipments of Genetically modified organisms. According to Packing Instruction 959, the text “UN 3245”, “GMO” or “GMMO” (as appropriate) and the number of packages must be marked in the “Nature and Quantity of Goods” section when an air waybill is used. It is not necessary to include the number of packages if genetically modified organisms are the only items in the shipment.

 

In January 2013, ICAO and IATA clarified the classification and identification of formaldehyde solutions for air shipments. If the solution contains a formaldehyde concentration of 25% or more, it is classified as a Class 8 Corrosive liquid, and identified as UN 2209 Formaldehyde solution. If the percentage of formaldehyde is less than 25%, it is classified as a Class 9 Miscellaneous dangerous good and identified as UN 3334 Aviation regulated liquid n.o.s.

 

The U.S. DOT updated the regulations concerning the retention of the manufacturer’s closure instructions – if these instructions are not permanently embossed or printed on the package, the shipper must maintain a copy of the instructions for a period of 90 days from the time the shipment was offered for transport (49 CFR 173.22 (a) (4) (ii)).

 

Points of Interest

In December 2011, the U.S. and Canadian governments approved the formation of the Regulatory Cooperation Council (RCC) which is intended to help expedite shipments between the two countries. The main purpose of the RCC will be to establish levels of equivalence between the two countries and reduce duplication of industry standards. When the levels of equivalence are established, both countries will recognize the same standards. For more information see www.trade.gov/rcc

 

DOT/PHMSA Letters of Interpretation applicable to biological shipments

File Names:

Used Healthcare - contact lens May 2006
Determining minimal likelihood Jul 2006
Materials of Trade Exception Aug 2006
Minor variations in Category B packages Feb 2007
Drop testing Feb 2007
Puncture test March 2007
Patient specimens and formalin March 2007
Diagnostic specimens to Category B June 2007
Category B and dry ice packages from different vendors Jul 2007
In commerce shipping March 2008
Petri dishes as primary receptacles Dec 2008
Contaminated currency Dec 2008
H1N1 classification May 2009
Training for Category B shippers July 2009
Petri dishes as primary receptacles July 2009
Non-infectious mice Sept 2009
Classification of suspected or unknown samples Oct 2009
Infectious substances containing toxins Dec 2009
Petri dishes as primary receptacles Dec 2010
Training for veterinarians Jan 2011
Exclusive motor vehicle not for storage materials April 2011
Category B test conditioning Sept 2011
Clinical trial samples shipped as Exempt March 2012
Sharps - not used healthcare products April 2012
Category B marking May 2012
OSHA BBP substitute for shipper training May 2013
Motor vehicle transport Jul 2013

 

2012

According to ICAO/IATA Packing Instruction 202, open cryogenic receptacles manufactured after January 1, 2012 must be permanently marked with the following information:

  • The name and address fo the manufacturer
  • The model name or number
  • The batch or serial number
  • The proper shipping names and UN numbers for all allowed gases.
  • The capacity of the cryogenic receptacle in liters
These marks must be on the top end, neck or shoulder of the cryogenic receptacle. If the diameter of the cryogenic receptacle is 140 mm or greater, the markings must be at least 5 mm tall. Any open cryogenic receptacle manufactured before January 1, 2012 does not need to be marked with the information listed above.

 

On December 4, 2012, the Centers for Disease Control and Prevention (CDC) updated the Select Agent list. The updated list is available at: http://www.selectagents.gov/resources/List_of_Select_Agents_and_Toxins_2013-09-10.pdf

 

 

2011

ICAO/IATA Packing Instruction number changes - The following are the Packing Instruction number changes affecting 6.2 and related materials:

  • UN 2814/2900 Infectious substances affecting humans/animals – 602 to 620
  • UN 1845 Dry ice - 904 to 954
  • UN 3245 Genetically modified organisms – 913 to 959

 

ICAO/IATA added a new requirement for primary receptacles and inner packaging containing liquids. The closures of the receptacles must be secured by secondary or positive means. Secondary means may be achieved using tape, paraffin, crimp seals etc. If secondary means of closure are not possible, the receptacles must be placed in a leakproof liner. Since Category B substances and Exempt Patient specimens already have a secondary leakproof layer, the requirement to secure the closures with positive means does not apply to primary receptacles containing Category B Infectious substances or Exempt patient specimens, although it is a recommended practice. For Category A Infectious substance, Packing Instruction 620 indicates the closures of primary receptacles for liquid substances at ambient temperatures require their closures to be secured by secondary means [ICAO 4;1.1.4.1 or IATA 5.0.2.7]

 

ICAO/IATA added a new Special provision (A180) for shipments of specimens in small quantities of alcohol or similar substances. The specimens must be Exempt patient specimens or non-infectious specimens containing UN 1170 (Ethanol), UN 1198 (Formaldehyde solution, flammable or Formalin), UN 1987 (Alcohols, n.o.s.) or UN 1219 (Isopropanol).

 

Effective October 01, 2011, the CDC will no longer be the contact for spills and leaks in the U.S. After this date all spills and leaks must be reported to the local public health authority of the jurisdiction where the leak occurred. The U.S. Division 6.2 Infectious substance hazard label will no longer include the text regarding the CDC. However, use of the label referencing the CDC may still be used until September 30, 2014 49 CFR 172.432 http://www.gpo.gov/fdsys/pkg/FR-2011-07-20/pdf/2011-17687.pdf

 

Packing instruction 959 indicates that marking for Genetically Modified Organism (GMO) packages only require a diamond on point marking with UN 3245. The Proper shipping name is not required to be marked on the outside of the package.

 

FedEx has added a new Operator variation for shipments originating in the U.S. that require a Shipper’s Declaration. FX-18 states that “Beginning January 10, 2011 FedEx requires that all Shippers’ Declarations originating in the U.S.be prepared using an approved program.”

 

ICAO/IATA will allow genetically modified organisms to be excepted from the regulations, provided they have been authorized for use by an appropriate national authority. In order to be exempt from the regulations, the genetically modified organism must be approved by the appropriate national transportation authority of the State of origin, destination and any States the organism might transit through [ICAO 2;9.2.1 c) or IATA 3.9.2.5.3].

 

September 12, 2011 – Changes have been made by Canada Post to postal shipments of Exempt patient specimen packages, provided they are packaged according to ICAO and IATA requirements. See http://www.canadapost.ca/tools/pg/manual/PGabcmail-e.asp In order to determine whether a package meets Canada Post’s shipping guidelines, a sample of the packaging can be submitted for testing to:
Canada Post, Mail Standards and Testing, National Equipment Engineering, 2701 Riverside Drive, Suite N0625, OTTAWA ON K1A 0B1

 

 

2010

Effective March 2010 – The U.S. DOT altered the requirements for a security plan. For complete information see 49 CFR 172.802 or https://www.federalregister.gov/articles/2010/03/09/2010-4778/hazardous-materials-risk-based-adjustment-of-transportation-security-plan-requirements. In the U.S. there were no changes to Division 6.2, as Select Agents remain the only infectious substances that require a security plan.

 

2009

January 1, 2009 – The language on the Cargo Aircraft Only label changed from “Danger... Do Not Load in Passenger Aircraft” to “Cargo Aircraft Only” and “Forbidden in Passenger Aircraft”. The old labels were permitted until January 1, 2013 [ICAO 5:3.2.12 a) 1) or IATA 7.2.4.2].