ABSA Comments on Health Canada Revisions

a letter written by Debra Hunt, DrPh, RBP, CBSP
Past-President, ABSA
4 March 2002

Maureen Best
Director, Office of Laboratory Security
Health Canada
0700A1 Tunney's Pastrue
Ottawa, ON K1A 0L2
March 4, 2002

Dear Ms. Best,
The American Biological Safety Association (ABSA) is an organization of biological safety practitioners who work in a variety of academic, governmental, and private work environments. We appreciate the opportunity to submit comments to you regarding the draft of third edition of "The Laboratory Safety Guidelines". Please consider the comments which follow.

General Comments
This is a comprehensive document regarding the pertinent aspects of biological safety that must be address in work places. It pulls together a number of topics that may be addressed separately in other guidance documents. The information detailed typically is both current and timely regarding breaking biological safety issues.

Specific Comments
Our specific comments will be provided as per to corresponding pages and sections in your document.

Chapter 2 Biological Safety
Biological Safety
P10: It is confusing that the use of risk groups was noted in the introduction, but then there is extensive definition and discussion of risk groups. Also, risk group classification is not a "system". Risk group lists are just a simple tool that contribute to the overall risk assessment. Risk group lists represent an effort to classify organisms according to the risk group definitions. It may be better for experts to provide such guidance, in the framework of recommendations, rather than leaving this determination up to individuals who may have limited knowledge or expertise in risk assessment.

Section 2.2 Containment Level 2 (CL2)
P11: The containment level (CL) descriptions represent statements that are equivalent to risk group definitions, but leave it entirely up to the discretion of the individual researcher, hopefully in consultation with a competent biosafety officer, to make the determination as to which containment level is required. For example, the organisms for which CL2 is required are those transmitted primarily "through the ingestion, inoculation, and [/or?] mucous membrane route[s]". This definition would allow both researchlaboratory and industrial-laboratory scale work with HIV to be done at CL2. P11: In the second sentence there is mention of primary exposure routes. Listed are, "inoculation and mucous membrane route as primary exposure routes." These terms can be ambigious and not what is always recognized as the classical primary exposure routes. Primary exposure routes that should be listed are "ingestion, inhalation, percutaneous, and skin contact".

P12: The risk assessment section says that the biosafety officer must take immunocompetence into consideration in individual cases when containment levels are being determined. The biosafety officer is going to be very busy if laboratory staff cannot be empowered to make their own determinations, especially for CL1 and CL2. This approach further suggests that the biosafety officer will be informed by staff, or will have the authority to ask, if the person's immune status is compromised. This approach further indicates that all individuals should be considered, e.g. visitors and maintenance staff. The best approach may be to post virtually all labs as off limits to immunocompromised people.

P14: Where there is a description of the activities of the Biological Safety Officer, there should be some reference noted that the biological safety officer should be responsible for the proper training of persons involved in the shipment of diagnostic specimens, and infectious substances and other biological matter. Although this training may be overseen by another department or group, the biological safety officer is most often looked to for assistance in this area. The biological safety officer should be determined as the party that ensures that this activity is conducted.

P15: The roles and responsibilities of the Institutional Biosafety Committee (IBC) need to be developed and defined in the same level of detail as those of the Biological Safety Officer. This is especially needed with respect to the mandate for such a committee to be established; the current language indicating that this must be done when the facility reaches "a large enough size" does not provide effective guidance. It would also be unwieldy to have "at least one member of each research staff and technical staff" sit on the IBC of a large institution. Following the National Institute of Health (NIH) IH Guidelines, the committee should strive to have expertise to cover the areas of research that is reviewed.

Chapter 3
Handling Infectious Substances
1. Minimizing infectious aerosols
P17 : The flaming of loops should be banned; this practice must not merely just be avoided.

P17: "Percutaneous" is indicated in the means of exposure. This list should agree with the routes indicated on page 11.

P17: The practices outlined for minimizing infectious aerosols would be required for virtually all laboratories, even those working with organisms that do not cause disease in healthy adults.

P18 : Many clinical laboratories that do PCR testing have moved to the use of plasma transfer tubes that have screw caps. The threads on these tubes keep the lid secure on frozen tubes of plasma while these specimen thaw to ambient temperature. The lids will otherwise have a tendency to pop off and spatter or splash. Since many of the PCR tests are tests for infectious agents, the use of these tubes avoids a possible exposure the facial mucous membrane surfaces. The use of these types of caps should be encouraged in your document for these types of specimens.

P18: Also in,"pouring infectious material", instruction is given to avoid pouring off supernatant after centrifugation, but then it is indicated that it is a "safe" procedure to pour off supernatant through a funnel. These appear to be conflicting instructions. It should be clarified that the described use of the funnel is warranted when pouring is unavoidable.

P18: There is a general trend towards heavy reliance on BSCs. While this equipment provides state-of-the-art protection, it should be recognized that all facilities cannot afford this equipment. Furthermore, there may be alternative practices that provide adequate protection. For example, "open tubes of hazardous material in a biological safety cabinet." Perhaps these tubes could safely be opened by following the guidance provided for withdrawing a needle for a stoppered bottle. Or, opening tubes in a fume hood might provide appropriate protection for the worker in some situations.

2. Operational Practices for Laboratories
P19: The facility safety manual should be reviewed and updated annually or when procedures not covered in the manual are introduced to the facility. Placing the annual frequency into the requirements will better help the biological safety officer and management to identify operations that may have come into the facility without proper review.

P20 : A sentence should be added indicating that children and non-research animals are not permitted in the laboratory or laboratory support areas.

P.20 : A sentence should be added indicating the use of low protein, powder free disposable latex gloves be worn for protection against bloodborne pathogens. Gloves of non-latex materials should also be available for workers who have latex allergies or other sensitivities to glove materials.

P20 : The use of sharps with engineered sharps injury protection should be required whenever the devices are commercially available and when they do not compromise employee safety or the quality of the work.

P21: A performance specification for disinfectants to be used should be referenced. Tuberculocidal grade products are recommended as the minimum criteria for any disinfection activity. Commercial products should also be used as per the manufacturer's instructions.

Containment Level 3
P23: A specific, minimum frequency for smoke testing should be noted if these guides are to have to force of law. If the scope of work within the facility warrants a greater smoke testing frequency, then it should be greater than the minimum frequency for those operations.

P24: It is good to see that there is a requirement for the containment laboratory to locked, and not just to have locks. This may give some incentive for them to be used.

P25: In point number 18, the reference should read, "arthropods", not insects.

Containment Level 4
P.26: The 5th requirement should read, "Cultures and stocks of infectious agents must be stored in a secure area inside of the containment laboratory and an inventory of pathogens maintained."

P.27: The frequency of the tests of the positive pressure suits should be specified. Monthly or quarterly would be advisable.

Chapter 4 Laboratory Design and Physical Requirements
P30: The listing appear to be missing some things which are considered to be requirements for all labs, no matter what the use - chemical, biological or radioactive materials, such as impervious surfaces and inward air flow.

P34: The difference between points 1 and 2 isn't clear. It doesn't make sense that, for CL1 benchtops could be nonabsortive [1] but are required to be chemical resistant [2].

P37: Directional inward airflow should be a requirement for CL1 and CL2 facilities.

P44: Fume hoods are not noted as appropriate containment for any materials in use in the laboatory.

Chapter 6 Large Scale Production of Microoorganisms Operational Practices and Physical Requirements
P 60: The wording of item #5 implies that a high efficiency particulate (HEPA) filter or equivalent is required for all organisms, even yeast and bacteria. A HEPA filter is needed only for viruses, not bacteria. Bacteria and fungi can be adequately contained by parallel 0.2micron or 0.45 micron filters. HEPA filters are not as well suited as other bacterial grade filters for this use and create unnecessary costs and maintenance. Filters should be selected for the type of organism in use. This needs to be stated elsewhere in this section where guidance is being provided regarding the selection and use of filters.

P61, In section 3.2.2, A Class III BSC is designed to prevent leakage, but its use is hardly necessary for most Risk Group 2 agents. Although leakage is to be prevented, a gas-tight unit is not needed. An alternative example would be to note that it be "placed in a containment device". The current recommendation makes sense for a Risk Group 3 agent, not for a Risk Group 2 agent.

P61: In section 3.2.9, the same issue regarding HEPA filters raised earlier applies here. HEPA filters are not always required for containment of the organisms being processed.

P61, In section 3.2.10, It the rationale is unclear for requiring sensing devices for the integrity and alarm of containment of Risk Group 2 organisms. It does not seem warranted by the typical modes of transmission of these agents. It makes sense for Risk Group 3 agents where one is concerned about aerosol or insect transmission.

Chapter 8 Selected Guidelines for Work with Unique Hazards
2. Handling Cell Lines in the Laboratory
P77: Tissues and body fluids from macaques are always handled as if it were potentially infected with Cercopithecine herpesvirus. Increasing the containment to level 3, where the containment is designed for to protect against airborne transmission, for suspect material should not be necessary. Providing splash and respiratory protection to the worker should be sufficient to address the risk.

P78: Self-self experiments pose very low community risk. Certainly this practice should be discouraged. It does seem excessive to prohibit it.

P83: the sixth point should read, "...using safety sealed buckets/rotors that are opened and ..."

Containment Guidelines for Working with Arthropods
P86: Addressing these arthropod containment recommendations according to the CL1- CL4 scheme fails to speak to the unique hazards posed by arthropod vectors. Perhaps this section of the Laboratory Safety Guidelines should simply adopt the Arthropod Containment Guidelines of the American Committee of Medical Entomology. Introduction - The effort to paraphrase the Arthropod Containment Guidelines results in misstatements. Not all mosquitoes species carry disease. As adults, some mosquito species only feed on plants and others do not feed at all. And insects in other orders, such as the beetle Tenebrio molitor, may harbor pathogen.

Arthropod Containment Levels - Arthropods that harbor a pathogen don't fit the containment level set for direct work with pathogens. The containment level of a pathogen is supposed to consider the activities to be undertaken. Thus it doesn't make sense to say that the containment level of an infected arthropod must always be at least that of the pathogen within the arthropod. The assessment should be risk based. For example, the pathogen within the arthropod could be passing through a stage in its lifecycle where it is totally harmless to humans.

P87: "Containment level 2 must also be used for genetically modified arthropods." Chapter 2 says that CL2 applies to organism with an exposure hazard through ingestion, inoculation, and mucous membrane. There is no exposure hazard in the usual sense of human health for work with recombinant Drosophila. This is unclear in practical terms. A typical fruit fly genetics lab provides no containment for these recombinant insects. It is reasonable to recommend that escapes be prevented but it makes little sense to shoehorn containment into the requirements of CL2 just because an organism is genetically modified.

P88: Putting different vector species in separate rooms would be a nicety if such space were available. More realistically, species are segregated by shelf.

Arthropod Manipulations - The statement concerning enrollment in a health and medical surveillance program does not belong buried in this section. More problematic, it isn't apparent why work in general with arthropods would justify this expense. There are few pathogens vectored by arthropods for which such a program is appropriate.

P89: There references to "NIH Guidelines" in the references as specific citations from the Federal Register. These guidelines are modified on an on-going basis. The reference to them may best be as, "the most current version" of the "NIH Guidelines for research involving recombinant DNA molecules". Provision of the web address below would help ensure that the most current information is accessed. http://oba.od.nih.gov/rdna/nih_guidelines_oba.html.

Thank you for the opportunity to have provided this input.

Sincerely,

Debra Hunt, DrPh, RBP, CBSP
Past-President, ABSA



Citation:
Debra Hunt, ABSA Comments on Health Canada Revisions, American Biological Safety Association (4 March 2002),
http://www.absa.org/0203canada.html.

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