As a service to my clients and colleagues, I am very
pleased to present a summary of important recent
biosafety changes prepared by Leslie Hofherr, MS,
MPH, CBSP. Leslie has rich experience in biosafety
and has assisted a number of my clients in biosafety
matters over the years.
Biosafety compliance guidance and regulatory
requirements have changed significantly in the last
3 years. Cal/OSHA has promulgated new regulations
covering aerosol transmissible diseases (ATDs) and
the primary biosafety compliance guidelines have
been updated. In the future we can expect an
increase in regulatory oversight of biohazardous
materials due to concerns of the general public and
congress for the spread of infectious diseases and
bioterrorism, and changes in technology.
Below
is a summary of some important changes and reminders
for biosafety compliance in the areas of:
The new standards focus primarily, but not entirely,
on employers working in the health care industry.
There are two new Cal/OSHA ATD standards.
The more narrow "zoonotics" standard, 8 CCR
5199.1, applies only to employers that
handle animals or animal by-products, and is
intended to prevent the transmission of
diseases between animals and humans.These
regulations require compliance by services
that capture, sample, transport or dispose
of birds and other wildlife; farms producing
animals or animal products (including
untreated animal products, byproducts or
wastes); slaughterhouses; veterinary animal
inspection; importers of live or untreated
animals or animal products; zoos; animal
parks; pet stores; and laboratory
operations.
These covered facilities and services must
follow the standard whenever an employee is
involved in capturing or sampling of animals
to detect the presence of infection with
zoonotic ATDs or is involved in the
transportation or disposal of animals
suspected to be infected with zoonotic ATD
or covered under a quarantine or alert
issued by Centers for Disease Control,
California Department of Food and
Agriculture, California Department of Fish
and Game, California Department Public
Health, U.S. Department of Agriculture or
U.S. Department of the Interior.
The much broader ATD standard, 8 CCR 5199,
covers, but is not limited to, health care
facilities including hospitals, nursing
facilities, clinics, medical offices,
long-term care providers, and emergency
services and transport providers. The
standard also covers other defined "high
risk" workplaces where the exposure of ATDs
is deemed more likely, including homeless
shelters, drug treatment programs,
correctional facilities, and air-handling
machinery maintenance or repair operations
where contamination might be expected. The
standard further covers certain laboratories
and police services.
There are four classes of employers
identified that have different compliance
requirements: Covered, Referring,
Laboratory, or Exempt employers. Below is a
summary of the Laboratory Employer
requirements.
Aerosol
Transmissible Diseases - Laboratories
Workers in clinical and research biological
laboratories are at risk of contracting
aerosol transmissible diseases (ATDs) due to
laboratory procedures that generate
aerosols. Laboratory workers have contracted
serious diseases including tuberculosis
(TB), SARS, and meningococcal disease.
Pathogens such as brucellosis, which are not
generally transmitted between people can
also be transmitted by laboratory aerosols.
The Aerosol Transmissible Disease (ATD)
standard (Section 5199) requires
laboratories to adopt standard biosafety
practices to protect laboratory workers when
handling materials containing pathogens that
may be spread through aerosols and which can
cause serious disease. A minimum list of
these pathogens is included in Appendix D of
the ATD Standard. The standard requires that
laboratories implement control measures that
are consistent with the recommendations of
the U.S. Centers for Disease Controls and
Prevention (CDC)for handling these
materials. When laboratory workers have
direct contact with patients the employer is
required to comply with other requirements
of the standard applicable to patient
contact.
The ATD standard requires laboratory
employers to use feasible engineering and
work practice controls to limit exposure to
aerosols, and to provide personal protective
equipment and respirators when that
equipment is necessary to control exposures.
In addition, the employer is required to
develop, implement, and annually review, a
written Biosafety Plan (BSP)that includes:
1. Identification of qualified biosafety
officer(s) who will be responsible for
implementing, reviewing and updating the
BSP, and for reviewing plans to modify the
facility.
2. A list of job classifications, tasks and
procedures in which employees may be exposed
to ATPs-L.
3. A list of the ATPs-L that are present or
anticipated to be present in materials in
the laboratory.
4. Safe handling procedures and a list of
prohibited practices, such as sniffing in
vitro cultures, that may increase
employee exposure to infectious agents.
5. Engineering controls, including
containment facilities such as biosafety
cabinets.
6. Procedures requiring the use of personal
protective equipment and/or respirators.
7. Effective decontamination and
disinfection procedures for laboratory
surfaces and equipment.
8. A requirement that all incoming materials
containing ATPs-L be treated as containing
the virulent or wild-type pathogen, until
procedures conducted at the laboratory
verify they are deactivated or attenuated.
9. Inspection procedures including an audit
of biosafety procedures, to be performed at
least annually.
10. Emergency procedures for uncontrolled
releases within the laboratory facility and
untreated releases outside the laboratory
facility including reporting such incidents
to the local health officer.
11. Procedures for medical surveillance,
including:
a. vaccinations as recommended by the CDC or
California Department of Public Health
b. annual tests for latent TB infection in
clinical laboratories and in laboratories
where materials containing M.
tuberculosis may be present.
c. medical follow-up for employees who have
had a significant exposure to an ATP-L
without benefit of applicable required
control measures.
12. Procedures for initial and annual
employee training.
13. Procedures to involve employees in the
evaluation of the effectiveness of the BSP
in their work areas.
The employer is required to keep records of
training, medical surveillance and exposure
incidents, inspections, and evaluation of
engineering controls and other control
measures.
Updated
CDC/NIH "Biosafety in Microbiological and
Biomedical Laboratories" (BMBL) to the 5th
edition, 2007
First introduced in 1984, BMBL is an advisory
document recommending best practices for the
safe conduct of work in biomedical and clinical
laboratories. Since its inception, it has become
one of the most frequently used codes of
practice in biosafety, and an authoritative
reference for: the development of laboratory
policies and procedures, the construction of new
laboratories, and the renovation of existing
laboratories. Periodic updates have been made to
the BMBL to "refine guidance based on new
knowledge and experiences and to address
contemporary issues that present new risks that
confront laboratory workers and the public
health".
General revisions include update of Biosafety
Level 1-4 containment criteria, agent summary
statements, risk assessment section, biosecurity
section, agricultural Biosafety Level 3 section,
and expanded guidance on a number of topics,
including decontamination, sterilization,
occupational medicine, and immunization.
Below are listed the major revisions for
Biosafety Level 1 (BSL-1) and BSL-2 compliance.
Biosafety Level 1 (BSL-1) Laboratory updates:
Standard Microbiological Practice
Access control to laboratory is enforced by
lab supervisor.
Sharps use policy and controls must be
developed and implemented to reduce sharps
injury.
Biohazard door card is required when
infectious agents are present in the
lab.
Agent infomation is posted on door card as
per the institutional policy.
Safety Equipment
Gloves must be worn to protect against
exposure and selected based on a risk
assessment.
Persons who wear contact lenses in the labs
should also wear eye protection.
Laboratory Facility
Chairs used in lab work must be covered with
non-porous materials that can be easily
cleaned and decontaminated with appropriate
disinfectant.
Provide all lab personnel with information
regarding immune competence, conditions that
may predispose them to infection, and
encouragement to self identify to your
healthcare provider.
A lab-specific biosafety manual is
required.
Document lab personnel proficiency in
standard and special microbiological
practices before they work with BSL-2
agents.
Spills involving infectious materials are
contained, decontaminated, and cleaned up by
staff properly trained and equipped
to work with infectious material.
All procedures involving the manipulation of
infectious materials that may generate an
aerosol should be conducted within a BSC or
other physical containment devices.
Safety Equipment
Eye and face protection, and gloves must be
disposed of with other contaminated lab
waste or decontaminated before reuse if
reusable.
Eye, face, and respiratory protection should
be used in rooms containing infected animals
as determined by the risk assessment.
Laboratory Facility
Lab doors should be self-closing and have
locks as described in the institutional
policies.
The sink should be located near the exit
door.
Lab windows that open to the exterior are
not recommended.
Vacuum lines should be protected with HEPA
filters or their equivalent and liquid
disinfectant traps as needed.
At least annual certification of Class II
Type A BSC required if BSC air is
re-circulated back into the lab. BSC must be
operated according to manufacturer's
recommendations. Institute provisions to
assure proper safety cabinet performance and
BSC air system operation must be verified.
A method for decontaminating all lab wastes
should be available in the facility (e.g.,
autoclave, chemical disinfection,
incineration, or other validated
decontamination method).
Cell
line use hazards and safety
Hazards
The risk of a laboratory infection
from working with cell cultures in general is low,
however, risk increases when working with human and
other primate cells, and primary cells from other
mammalian species. There are reports of infection of
laboratory workers handling primary rhesus monkey
kidney cells and the bloodborne pathogen risks from
working with primary human cells, tissues and body
fluids are widely recognized.
Potential laboratory hazards associated with human
cells and tissues include the bloodborne pathogens
HBV, HIV, HCV, HTLV, EBV, HPV and CMV as well as
agents such as Mycobacterium tuberculosis
that may be present in human lung tissue. Other
primate cells and tissues also present risks to
laboratory workers.Cells immortalized with viral
agents such as SV-40, EBV adenovirus or HPV, as well
as cells carrying viral genomic material also
present potential hazards to laboratory workers.
Tumorigenic human cells also are potential
hazards.There has been one reported case of
development of a tumor from an accidental
needle-stick.
All primary human cell cultures (explants) and
subsequent in vitro passages fall under the
OSHA BBP standard. To be exempted from the BBP
requirements, primary cell cultures and lines must
undergo testing and characterization (documented)
for blood-borne pathogens such as HBV, HCV and HIV
and others.
Safety precautions
Laboratory workers should never handle
autologous cells or tissues
Conduct a risk assessment based on the origin of
the cells or tissues (species and tissue type),
as well as the source (recently isolated or well
characterized
Human source cells require compliance with the
Cal/OSHA Bloodborne Pathogens (BBP) Standard and
BSL-2
Use "Universal Precautions" for all human and
primate cell cultures
Perform work involving human and primate cells
following BSL-2 containment
Perform all work in a biosafety cabinet (BSC)
Autoclave or disinfect all cell contaminated
materials prior to discarding
Wear PPE while performing work with cells - lab
coat, gloves, eye protection at a minimum
Follow occupational medicine program for BBP
Standard
Follow company specific BBP Exposure Control
Plan policies and procedures
NIH
Guidelines for Research Involving Recombinant
DNA Molecules Update September 2009
The "NIH Guidelines" provides biosafety guidance
covering uses of recombinant DNA. In September
2009 the "NIH Guidelines" were updated to better
cover recombinant influenza viruses uses. With
the advent of new recombinant technology
"designer" influenza viruses can be created
including the 1918 H1N1 strain. The amendments
clarify and augment the current guidance for
research with potentially pandemic influenza
virus and harmonize with the CDC/NIH
Biosafety in Microbiological and Biomedical
Laboratories (5th edition) and other
regulatory policies. Section III-D-7 provides
guidance regarding the biosafety level
containment for research with influenza viruses
generated by recombinant methods. In Appendix B,
the potentially pandemic influenza viruses human
H2N2 (1957-1968), 1918 H1N1, and HPAI H5N1 are
classified as Risk Group 3 agents. Appendix
G-II-C-5 provides additional biosafety guidance
for research with these influenza viruses
including Biosafety Level 3 enhanced
containment, practices and training, animal
containment and occupational health.
Some other actions at the NIH Office of
Biotechnology (OBA) in 2010:
At its December 7-8, 2010 meeting, the NIH
Recombinant DNA Advisory Committee (RAC)
discussed a proposal to certify
Kluyveromyces lactis as a new
host-vector system under the NIH
Guidelines for Research Involving
Recombinant DNA Molecules.
In July 2010,
the NIH Office of Biotechnology Activities
(OBA) published a proposal to revise the NIH
Guidelines to exempt the breeding of
well-characterized transgenic rodents that
can be maintained under Biosafety Level (BL)
1 conditions. This exemption would not
apply, however, to the breeding of rodents
that have a gene encoding more than fifty
percent of an exogenous eukaryotic virus or
those transgenic rodents in which the
transgene is under the control of a
gammaretroviral promoter. Currently these
proposed changes have not been incorporated
into the "NIH Guidelines".
In 2010, OBA sent a memorandum
to inform
OBA-registered investigators who are using
or propose to use lentiviral or retroviral
vectors in hematopoietic or other stem cells
that a "relative clonal dominance" was
detected during follow-up of a subject who
is participating in a French human gene
transfer trial being conducted for
individuals with β-Thalassemia Major and
Sickle Cell Anemia.
In March and May 2010, OBA proposed to
broadening the scope of the NIH Guidelines,
to encompass nucleic acids that are
synthesized chemically or by other means
without the use of recombinant technology,
changing the review level for recombinant or
synthetic experiments involving more than
half but less than two-thirds of the genome
of certain viruses in tissue culture, as
described in Section III-E-1 of the NIH
Guidelines, and Revising the criteria for
determining when introduction of a drug
resistance trait into a microorganism must
be reviewed and approved by the NIH
Director. Currently these proposed changes
have not been incorporated into the "NIH
Guidelines".
Synthetic
biology has advanced to the point where some
pathogens can be manufactured from scratch. This
technical leap has beneficent implications for
medical research and vaccine design, but it also
raises concerns that the technology could be
used to produce a deadly pathogen for nefarious
use. Federal government agencies have reviewed
the advances in synthetic biology but have not
moved to regulate its use yet."
Services I
Provide
Contact me and I would be happy to discuss ways I
can assist you and your company meet your
obligations and maintain a safe work place. Some of
the related services I provide include:
Hazardous waste auditing, minimization and
reporting
Online safety training
Bloodborne Pathogens (annual requirement)
Biosafety assistance
Hazard Communication
Chemical Hygiene Plan
Laser Safety
Biological Safety
Radiation Safety
Many others, please contact me
Served
by an Expert Arthur Mahoney, Principal Consultant
MS, CHMM, REA
For 17 years, he has been assisting public and
private companies to comply with safety,
hazardous material management, transportation
and safety concerns. He also provides chemical
inventory database services.
Leslie Hofherr, MS, MPH, CBSP
For over 20 years she has been assisting
companies and educational institutions in
biosafety and health and safety matters.
Feel free to contact us at 650-347-0417 or by
email.
Sincerely,
Arthur Mahoney
Hazard Solutions LLC
Disclaimer: The information presented
above should not be construed in any way
as legal advice or an interpretation of
regulations. It is meant to provide
basic information about topics that may
affect clients and colleagues.
