Biosafety & IBC Overview

Tim Muller, MS, CBSPUniversity Biosafety Officer

Biosafety and Risk Groups• Biosafety is the development and implementation of

administrative policies, work practices, facility design, and safety equipment to prevent transmission of biologic agents to workers, other persons, and the environment.

• The World Health Organization (WHO) has recommended an agent risk group classification for laboratory use that describes four general risk groups based on these principal characteristics and the route of transmission of the natural disease.

• The NIH Guidelines for Research involving Recombinant DNA Molecules established a comparable classification and assigned human etiological agents into four risk groups on the basis of hazard.

Risk Groups and Biosafety Levels

• A risk assessment will determine the degree of correlation between an agent’s risk group classification and biosafety level.

• Biosafety Levels (BSL) consist of combinations of laboratory practices and techniques, safety equipment, and laboratory facilities. – The CDC publication “Biosafety in

Microbiological and Biomedical Laboratories (BMBL)” has ranked four different biosafety levels based on risk, with BSL-1 being the lowest and BSL-4 being the highest.

RISK GROUPCLASSIFICATION

NIH GUIDELINES FOR RESEARCHINVOLVING RECOMBINANT DNA

WORLD HEALTH ORGANIZATIONLABORATORY BIOSAFETY MANUAL

Risk Group 1 Agents that are not associated withdisease in healthy adult humans.

(No or low individual and community risk) A microorganism that is unlikely to cause human or animal disease.

Risk Group 2 Agents that are associated with humandisease which is rarely serious and forwhich preventive or therapeuticinterventions are often available.

(Moderate individual risk; low community risk)A pathogen that can cause human or animal disease but is unlikely to be a serious hazard to laboratory workers, the community, livestock or the environment. Laboratory exposures may cause serious infection, but effective treatment and preventive measures are available and the risk of spread of infection is limited.

CLASSIFICATION OF INFECTIOUS MICROORGANISMS BY RISK GROUP

RISK GROUPCLASSIFICATION

NIH GUIDELINES FOR RESEARCHINVOLVING RECOMBINANT DNA

WORLD HEALTH ORGANIZATIONLABORATORY BIOSAFETY MANUAL

Risk Group 3 Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventionsmay be available (high individual risk but low community risk).

(High individual risk; low community risk)A pathogen that usually causes serioushuman or animal disease but does notordinarily spread from one infectedindividual to another. Effective treatmentand preventive measures are available.

Risk Group 4 Agents that are likely to cause serious or lethal human disease for whichpreventive or therapeutic interventions are not usually available (high individual risk and high community risk).

(High individual and community risk)A pathogen that usually causes serioushuman or animal disease and that can bereadily transmitted from one individual to another, directly or indirectly. Effectivetreatment and preventive measures are not usually available.

CLASSIFICATION OF INFECTIOUS MICROORGANISMS BY RISK GROUP

Laboratory Postings• Labs are posted with appropriate

BSL signage for PI disclosed biological agents.

• Posting for BSL-1 and BSL-2 labs include the following: – Medical Surveillance Cues (2)– Basic Biosafety Training (2)– Standard Microbiological

Practices (1 & 2)– Facility Requirements (1 & 2)– Waste Disposal (1 & 2)– PI Contact Info (1 , 2 & 3)– Biological Materials in lab (W/S)

Routes of Disease TransmissionRoutes of Disease TransmissionContact

• Mucous membrane (mouth, nose, etc.)

• Eyes• Skin abrasions/cuts • Parenteral (needlesticks)• Fomites - contaminated

environmental surfacesIngestion• Contaminated food or drink

Aerosol• Inhalation in lungs• Intranasal

Standard Microbiological Practices• Restrictive access to lab

• Authorized personnel only • Principal Investigator / Supervisor :

• Controls lab access • Ensures compliance with institutional policies and

procedures• Ensures personnel have been advised of hazards and

received appropriate safety training• Theft prevention /Biosecurity

• Hand washing• Soap and water for 15 seconds• After removing gloves• After working with hazardous materials• Before leaving the lab

• No eating, drinking or food storage in lab• Use break rooms• Common areas

• No mouth pipetting• Use mechanical pipetting devices

Standard Microbiological Practices

• Personal Protective Equipment (PPE) to be used for laboratory procedures– Lab coats

• Remove before leaving lab area• Don’t launder at home

– Autoclave (decontaminate) before sending to a commercial laundry service

– Eye and face protection (goggles, mask, face shield or other splatter guard)• When working outside the Biological

Safety Cabinet (BSC)• Decontaminate before reuse

– Use an appropriate disinfectant

– No shorts or open-toed shoes

Standard Microbiological Practices• Personal Protective Equipment (PPE) • Gloves

• Selection based on a risk assessment – Chemical compatibility

• Wear two pairs of gloves when appropriate• Latex alternative available• Replace as needed, when compromised or visibly

contaminated• Wash hand after removal

• Don’t wash or reuse disposable gloves• Remove before leaving the lab

– Respirators • Risk Assessment – BHC (272-5993)• Proper selection (particulate, chemical or both)• Medically cleared to wear – EOHS (272-8043)• Respirator fit testing / training – SRS (277- 9006)

Standard Microbiological Practices• Handle sharps safely (needles / syringes,

scalpel blades, glass pipettes, slides, etc.)• Avoid manipulating needles after use

• No Bending• No Shearing• No Breaking• No Recapping

• Place used needles, syringes, glass pipettes and other contaminated sharps in sharps containers consistent with 29 CFR 1910.1030 (OSHA Bloodborne Pathogens Standard)

• Closable• Puncture resistant• Leak proof on sides and bottom• Red / fluorescent orange container or

orange-red BioHaz label

Standard Microbiological Practices• Handle sharps safely

• Use mechanical method to handle broken glassware (place contaminated sharps in sharps container)

• Brush and dustpan• Tongs• Forceps

• Use plasticware instead of glassware to reduce chances of sharps injuries or accidental inoculations

• Pipettes • Serological • Pasteur

• Misc. lab containers

Standard Microbiological Practices• Perform procedures to minimize splashes

or aerosols– Pipette carefully– Transfer biological solutions with caution

• Decontaminate work surfaces with an appropriate disinfectant– After completing work– After spills (potentially infectious materials)– Splashes (potentially infectious materials)

• Decontaminate all cultures, stocks and potentially infectious materials before disposal– Appropriate disinfectant / adequate contact time

• Bleach (final volume adjusted to 10%) for 30 minutes. Use copious amounts of water after discharge into the drain/sewer to reduce corrosion

Standard Microbiological Practices• Biomedical waste disposal (infectious or

potentially infectious materials) – Use red bags consistent with 29 CFR

1910.1030 (OSHA Bloodborne Pathogens Standard)– Acceptable waste (Biomedical Waste Contractor

policy)• Gloves• PPE• Lab supplies / Plastic items (without sharp edges)• Sealed / closed sharps containers

(no uncontained sharps in red bags)

Institutional Biosafety Committee (IBC)• The IBC is a safety committee that reviews research

with recombinant or synthetic nucleic acid molecules and Risk Group 2 and higher biological agents.

• The IBC has expertise in the following area:– rDNA / nucleic acid technology– Microbiology– Biological and animal containment– Biosafety / general safety– Public health– Epidemiology– Veterinary medicine – Occupational medicine

Institutional Biosafety Committee (IBC)• The IBC meets quarterly (Feb, May, Aug and Nov) to

review & approve submitted research protocols.– Protocol submission deadline is three weeks prior to the

scheduled IBC meeting.

• Research protocols and procedures requiring IBC review must be approved by the IBC before initiation.

• The Biohazard Compliance (BHC) Office administratively manages the IBC for UNM. The BHC website contains information on the IBC, biosafety related topics and contact information. http://hsc.unm.edu/som/biohazard/

Online Biosafety Training

Course Title BIO-H 107 The Safe Transport of Division 6.2 Infectious Substances,

Biological Specimens, Dry Ice & Related MaterialsBIO-H 111 ABSL-2 Working Safely with Laboratory Animals (ABSA video)

BIO-H 112 ABSL-3 Working Safely with Laboratory Animals (ABSA video)

BIO-H 117 Effective Use of Class II Biological Safety Cabinets

BIO-H 118 The Bad Laboratorian

BIO-H 119 Safe Use of Chemical Fume Hoods

Bio-H 122 Biosafety Training for BSL-1 & BSL-2 Laboratories

Bio-H 400 BSL-3 Concepts

BioHazard Compliance• Webpage– http://hsc.unm.edu/som/biohazard/

• Personnel– Biosafety Officer, Tim Muller• Reginald Heber Fitz Hall / RHFH.B83• 272-5993• tmuller@salud.unm.edu

– Biosafety Specialist, Monica Moya Balasch• Reginald Heber Fitz Hall / RHFH.B83• 272-8001• mmoya55@salud.unm.edu

Export ControlTim Muller, MS, CBSP

Foreign NationalsPermanent Residents

Dual Citizenship

Export Control

• Export control laws (“ECL”) are U.S. federal laws and regulations that regulate the export of strategically important products, services and technologies to foreign persons.

• Foreign person(s)– Any foreign government – Any foreign corporation or organization that is not

incorporated or organized to do business in the U.S.– Any individual who is not a U.S. citizen or lawful permanent

resident of the U.S. (green card holder)

Export Control• Federal Agencies

– State Department: International Traffic in Arms Regulations (ITAR) • Military technologies

– Commerce Department: Export Administration Regulations (EAR)• Dual use technologies with civilian or military applications

(e.g., biologicals, chemicals, satellites, software, computers)• EAR’s list of controlled technologies is called the Commerce

Control List (CCL) – Bureau of Industry and Security (BIS) website

– Treasury Department: Office of Foreign Assets Control (OFAC) • Prohibits certain transactions with countries subject to boycotts,

trade sanctions and embargoes (e.g., Balkans, Burma, Cuba, Iran, Iraq, Libya, North Korea, Sudan, Syria, and Zimbabwe)

Export Control

• Deemed Export• EAR 734.2(b)(2)(ii) - Any release of technology or

source code subject to the EAR to a foreign national. Such release is deemed to be an export to the home country or countries of the foreign national.

• This deemed export rule does not apply to persons lawfully admitted for permanent residence in the United States and does not apply to persons who are protected individuals under the Immigration and Naturalization Act (8 U.S.C. 1324b(a)(3)).

Export Control• EAR Technology Defined - Specific information necessary

for the development, production and use of a product.

• Development - is related to all stages prior to serial production, such as: design, design research, design analyses, design concepts, assembly and testing of prototypes, pilot production schemes, design data, process of transforming design data into a product, configuration design, integration design, layouts.

• Production - all production stages, such as: product engineering, manufacture, integration, assembly (mounting), inspection, testing, quality assurance.

• Use - Operation, installation (including on-site installation), maintenance (checking), repair, overhaul and refurbishing.

Export Control• Use of controlled technology (EAR) by a

foreign national does not required a license, unless all 6 components of the use definition are met.– Operation– Installation– Maintenance – Repair– Overhaul– Refurbishing

Export Control

• 2B352 Equipment capable of use in handling biological materials– Complete containment facilities (BSL-3 and BSL-4)– Fermenters with a capacity of 20L….– Spray drying equipment– Class III biological safety cabinets– Chambers designed for aerosol challenge testing

with microorganisms, viruses, or toxins and having the capacity of 1 m3 or greater.

Export Control• EAR Deemed Export Requirements • Foreign Nationals – EAR NLR (if not performing all components of Development

or Production or Use of controlled technology listed the CCL)

– Other exemptions available for academic institutions

• Permanent Resident– EAR NLR

• Dual Citizenship (US and X) – EAR NLR

Export Control

• Foreign Nationals – Disclosed to HSC Export Control• Export Control Exclusion Screening Form(s)– Sponsored Projects Office(SPO) / Preaward

– I-129 Form (Petition for a Nonimmigrant Worker)• Attestations for Export Control Compliance • H-1B, L-1 or O-1A beneficiaries

Export Control• Webpage–HSCexport@salud.unm.edu

– Tim Muller • Reginald Heber Fitz Hall / RHFH.B83• 272-5993• tmuller@salud.unm.edu