ABSA comments on:
42 CFR Part 72
"Packaging and Handling of Infectious Substances and Select Agents"
(CDC NPRM, 1999)
a letter written by John H. Keene, Dr.PH, CBSP (ABSA)
President, American Biological Safety Association
21 December 1999
Ms. Nashandra Hayes
Office of Health and Safety
Centers for Disease Control and Prevention
1600 Clifton Road, Mail Stop - F05
Atlanta, GA 30333
December 21, 1999
Dear Ms. Hayes
The American Biological Safety Association (ABSA) is a professional organization of biological safety practitioners engaged in a variety of biological safety disciplines. It is recognized as the leading association of its kind in the world. We have reviewed the October 28, 1999, Centers for Disease Control and Prevention (CDC) proposed rule entitled, "Packaging and Handling of Infectious Substances and Select Agents" which was published in the Federal Register. We are submitting the following comments to you regarding this proposal.
On pages 58023-58024 of the document, CDC states, "There are several reasons why CDC regulates this area in addition to the other agencies listed above. The focus of the CDC regulation is on the protection of the public health by minimizing the potential for (1) Direct physical contact with the package contents by persons handling such packages during transit, (2) Contamination of the environment, and (3) The spread of disease into the community. The CDC regulations serve by filling in the gaps where there is no governance, by complementing the requirements of the other agencies where there is overlapping authority, and by providing CDC as a central reporting authority assures availability of CDC's infectious disease expertise to assist in the response when packages are damaged." Our comments will focus on these areas. With this proposal, CDC takes some steps needed to harmonize its requirements with those of other national and international agencies. Additional actions still need to be taken to address this objective and the ones above stated by CDC.
Section 72.2: Definitions
ABSA endorses the effort to harmonize definitions with those of the U.S. Department of Transportation (USDOT), the International Civil Aviation Organization (ICAO), and the International Air Transport Association (IATA). Here are some specific comments:
The change of the term "etiologic agent" to "infectious substance" used by ICAO/IATA is good. The USDOT is also already using this term. It will result in greater accuracy, less confusion with the preparation and handling of these shipments.
The definition for infectious substances should be clarified. The portion, "...may cause disease..." could be inclusive of organisms in Risk Group 1 which may be associated with human disease only under special circumstances. The use of alternative wording is suggested: "...causes or reasonably expected to cause human disease in healthy adult humans," or the adoption of a Risk Group classification would eliminate this problem.
The term "clinical specimen" should be changed to the term "diagnostic specimen". This term is already in use by ICAO/IATA. In the September 2, 1998 proposed USDOT rulemaking, "diagnostic specimen" has been used to refer to these materials. The use of "diagnostic specimen" will result in greater accuracy and less confusion with these shipments. This term should also be specifically inclusive of specimens of all types of clinical testing, such as forensic drug testing, paternity testing and blood bank testing. Adding the words, "or any other purposes" to this definition would accomplish this.
A more comprehensive definition of "biological product" is suggested. First, biological products should "mean a product derived from living organisms". This would place the definition in closer step with the ICAO/IATA terminology. Second, the expanded definition should include any biological products any in vitro medical device products that are regulated by the Food and Drug Administration (FDA) via the pre-market notification 510(k) and pre-market approval (PMA) process and regulated under CFR 809 and 812, as well as any biological products regulated under the section 802 of the Food, Drug, and Cosmetic Act.
Biological toxins remain in the CDC definition of infectious substances. ICAO/IATA requires biological toxins to be shipped as division 6.1 toxic substances. In the proposed USDOT rulemaking, biological toxins would not be inclusive in the USDOT "infectious substances" definition. CDC itself also indicates under its "Select Agent" requirements that biological toxins are to be handled as chemical toxins as per the OSHA chemical hygiene plan standard. CDC should separate biological toxins from its infectious substances definitions. Other agencies are regulating these materials, and they are being regulated by those agencies as hazardous, toxic chemicals.
CDC has not embraced the classification of infectious substances by risk group criteria in this proposal. This criteria is in use by ICAO/IATA and the World Health Organization (WHO), and others. This criteria is even referenced in the 1998 USDOT proposal for these materials. The BMBL does not have the same risk group classification criteria which is included in the ICAO/IATA and WHO criteria. Some shippers of infectious substances may not have sufficient knowledge to determine if the organism in the package is to be investigated at BSL-3 or BSL-4. If CDC provides a listing of the specific organisms with agent summaries which are included in the current BMBL, and gives the ICAO/IATA risk group classification criteria, then consistent and accurate classification decisions for shipments can be made.
Section 72.3 Transportation of Clinical Specimens; Minimum Packaging Requirements and
Section 72.4 Transportation of Infectious Substances; Minimum Packaging Requirements
The CDC proposal as written would require the labeling of primary clinical specimen and infectious substances containers. OSHA's Bloodborne pathogens Standard specifically exempts this labeling requirement for primary specimen containers. See 1910.1030 (g)(1)(i)(G): "Individual containers of blood or other potentially infectious materials that are placed in a labeled container during storage, transport, shipment or disposal are exempted from the labeling requirement."
A clinical specimen label bearing the universal biohazard symbol would be required on packages under the proposal. ICAO/IATA has no such requirement. Its application to a ground shipment of clinical specimens that is subsequently shipped in the air could result in confusion and rejection of the package by an IATA air carrier. The USDOT would not require such a label under its proposed rulemaking in this area. CDC, USDOT, and ICAO/IATA need to be consistent on this front.
The establishment of a drop test requirement for clinical specimen packages is endorsed. Other agencies (ICAO/IATA) also have this test as a minimum requirement. The net result will be that better packaging will be used more frequently than may be is currently in use. The USDOT has proposed an identical test requirement for clinical specimens. This requirement will enhance protection of the public and the environment.
Although the specific exclusion of formalin-bearing specimens is wise, specimens in formalin bearing prions warrant special concern. These biologically active compounds may still be active, despite the formalin. These materials need to be shipped with this biohazardous property as an active shipping consideration.
The proposed clinical specimens and infectious substances packaging requirements should indicate that primary or the secondary specimen packaging be capable of withstanding the required temperature and pressure extremes. Very few primary specimen containers are available and in use that could meet the requirements as currently worded in the proposal. This wording is in keeping with current ICAO/IATA packaging requirements and proposed USDOT packaging requirements for diagnostic specimens and infectious substances.
A watertight primary container that is capable of withstanding 95 kPA of pressure and -40 degrees C. To +55 degrees C. of temperature would be required for the shipment of clinical specimens and infectious substances. These extremes would not, typically, be experienced by clinical specimens shipped only on the ground. If a watertight package is properly used with the appropriate absorbent and other packaging described in the proposal, then the public and the environment should be adequately protected from clinical specimens shipped on the ground. If the shipper were to ship clinical specimens in the air, then the ICAO/IATA requirements would need to be addressed in these situations. For solid clinical specimens, it should also be stated that the temperature and pressure packaging parameters noted above do not need to be addressed. This would be in keeping with ICAO/IATA requirements.
The exclusion of plastic bags and paper envelopes as outer packaging would limit the use of innovative packaging for clinical specimens which has been emerging. Performance oriented packaging requirements will give shipper's a variety of packaging and shipping options. Performance based packaging is in keeping with international harmonization of these requirements.
72.5 Packaging and Method of Shipment of Special Infectious Substances; Failure to Receive
CDC is establishing a new set of requirements for a good number of infectious agents for which there are already requirements. ICAO/IATA mandates the preparation of a Shipper's Declaration for the air shipment of any hazardous material. As part of the requirements of package instruction 602, the shipper must state they have made prior arrangements with the receiving party before the package is shipped. The shipment can also be traced with the use of the airwaybill which typically must accompany the shipment. The Shipper's Declaration of Dangerous Goods mandates the entry of an emergency response phone number in the event of a package incident. For Select Agents shipments, Form EA 101 must be prepared and forwarded with such transfers. There are a variety of mechanisms already in place to address CDC's stated concerns. Before establishing these additional requirements, CDC should look at ways that these existing mechanisms can be used to accomplish its goals. If CDC feels that the shipment of special infectious substances, identified in the proposal, warrant special management, then it should require that: ICAO/IATA requirements for tracking infectious substances need to be observed for these shipments.
In the preamble to this proposal, CDC states that it seeks to fill in the gaps where there is no governance by complementing the requirements of other agencies where there is overlapping authority. CDC takes some steps towards harmonization of specimen shipping requirements with this proposal. As currently written, these steps are incomplete. ICAO/IATA Dangerous Goods requirements are widely used and annually reviewed and updated. Most government regulations are not scrutinized and revised at this frequency. The ICAO/IATA requirements reference international standards in use by much of the rest of the world for the shipment of these materials. Even the USDOT is embracing many of these international standards in its most recent proposed regulation of these materials. CDC should defer to ICAO/IATA for the shipment of clinical specimens and infectious substances and attempt, where appropriate to close gaps in all applicable transport standards.
We thank you for the opportunity to have provided input in this important proposed rulemaking.
John H. Keene, Dr.PH, CBSP (ABSA)
American Biological Safety Association
John H. Keene, ABSA comments on: 42 CFR Part 72 "Packaging and Handling of Infectious Substances and Select Agents" (CDC NPRM, 1999), American Biological Safety Association (21 December 1999),