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Principles,  Practices and Hardware

George Church (Harvard), Megan Palmer (Stanford), David Kong (MIT), Jean-michel Molenaar (Tufts)

Risk/Safety Level: What is the Safety Level of Your Lab (e.g. BSL1, BSL2, other)? Do you have different spaces with different safety levels? If so, describe which activities are done in different spaces. Include a picture of your lab.

The safety level of the EMW Street bio lab is BSL1, we don’t have separate sections for different safety levels. We have a common lab where we do standard microbiological practices.

In the U.S., Biosafety level are defined in two documents generated at the federal level:

  1. Biosafety in Microbiological and Biomedical Research from the Center for Disease Control and Prevencion (CDC) http://www.cdc.gov/biosafety/publications/bmbl5/bmbl.pdf

  2. The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) detail safety practices and containment procedures for basic and clinical research involving recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules. https://osp.od.nih.gov/biotechnology/nih-guidelines/

The following standard practices, safety equipment, and facility requirements apply to BSL-1.

 A. Standard Microbiological Practices

1. The laboratory supervisor must enforce the institutional policies that control access to the laboratory.

 2. Persons must wash their hands after working with potentially hazardous materials and before leaving the laboratory.

 3. Eating, drinking, smoking, handling contact lenses, applying cosmetics, and storing food for human consumption must not be permitted in laboratory areas. Food must be stored outside the laboratory area in cabinets or refrigerators designated and used for this purpose.

4. Mouth pipetting is prohibited; mechanical pipetting devices must be used.

5. Policies for the safe handling of sharps, such as needles, scalpels, pipettes, and broken glassware must be developed and implemented. Whenever practical, laboratory supervisors should adopt improved engineering and work practice controls that reduce risk of sharps injuries.Precautions, including those listed below, must always be taken with sharp items. These include:

  •  Careful management of needles and other sharps are of primary importance. Needles must not be bent, sheared, broken, recapped, removed from disposable syringes, or otherwise manipulated by hand before disposal.

  •  Used disposable needles and syringes must be carefully placed in conveniently located puncture-resistant containers used for sharps disposal.

  •   Non-disposable sharps must be placed in a hard walled container for transport to a processing area for decontamination, preferably by autoclaving.

  •    Broken glassware must not be handled directly. Instead, it must be removed using a brush and dustpan, tongs, or forceps. Plastic ware should be substituted for glassware whenever possible.

6. Perform all procedures to minimize the creation of splashes and/or aerosols.

7. Decontaminate work surfaces after completion of work and after any spill or splash of potentially infectious material with appropriate disinfectant.

8. Decontaminate all cultures, stocks, and other potentially infectious materials before disposal using an effective method. Depending on where the decontamination will be performed, the following methods should be used prior to transport.

  • .Materials to be decontaminated outside of the immediate laboratory must be placed in a durable, leak proof container and secured for transport.

  •  Materials to be removed from the facility for decontamination must be packed in accordance with applicable local, state, and federal regulations.

9. A sign incorporating the universal biohazard symbol must be posted at the entrance to the laboratory when infectious agents are present. The sign may include the name of the agent(s) in use, and the name and phone number of the laboratory supervisor or other responsable personnel. Agent information should be posted in accordance with the institutional policy.

10. An effective integrated pest management program is required.

11. The laboratory supervisor must ensure that laboratory personnel receive appropriate training regarding their duties, the necessary precautions to prevent exposures, and exposure evaluation procedures. Personnel must receive annual updates or additional training when procedural or policy changes occur. Personal health status may impact an individual’s susceptibility to infection, ability to receive immunizations or prophylactic interventions. Therefore, all laboratory personnel and particularly women of childbearing age should be provided with information regarding immune competence and conditions that may predispose them to infection. Individuals having these conditions should be encouraged to self-identify to the institution’s healthcare provider for appropriate counseling and guidance.

B. Special Practices

None required.

C. Safety Equipment (Primary Barriers and Personal Protective Equipment)

1. Special containment devices or equipment, such as BSCs, are not generally required.

2. Protective laboratory coats, gowns, or uniforms are recommended to prevent contamination of personal clothing.

3. Wear protective eyewear when conducting procedures that have the potential to create splashes of microorganisms or other hazardous materials. Persons who wear contact lenses in laboratories should also wear eye protection.

4. Gloves must be worn to protect hands from exposure to hazardous materials. Glove selection should be based on an appropriate risk assessment. Alternatives to latex gloves should be available. Wash hands prior to leaving the laboratory. In addition, BSL-1 workers should:

a. Change gloves when contaminated, glove integrity is compromised, or when otherwise necessary.

b. Remove gloves and wash hands when work with hazardous materials has been completed and before leaving the laboratory.

c. Do not wash or reuse disposable gloves. Dispose of used gloves with other contaminated laboratory waste. Hand washing protocols must be rigorously followed.

D. Laboratory Facilities (Secondary Barriers)

1. Laboratories should have doors for access control.

2. Laboratories must have a sink for hand washing.

3. The laboratory should be designed so that it can be easily cleaned. Carpets and rugs in laboratories are not appropriate.

4. Laboratory furniture must be capable of supporting anticipated loads and uses. Spaces between benches, cabinets, and equipment should be accessible for cleaning.

a. Bench tops must be impervious to water and resistant to heat, organic solvents, acids, alkalis, and other chemicals.

b. Chairs used in laboratory work must be covered with a non-porous material that can be easily cleaned and decontaminated with appropriate disinfectant.

5. Laboratories windows that open to the exterior should be fitted with screens.

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Work Area: Which work areas do you use for handling biological materials? (e.g open benches, biosafety cabinet, fume hoods etc)? Include a picture of your work spaces.

 

In the EMW´s Street lab we use open benches, a biosafety cabinet and incubators to perform our work.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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​Training: Have you received, or will you receive, any ethics and/or safety training? Who provides this training? Briefly describe any topics covered.

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I´ve received training in biosafety, ethics and legislation for one semester at the Faculty of Exact and Natural Sciences of the National University of Asuncion.

Some topics covered were intellectual property, patents, Cartagena Protocol on the Safety of Biotechnology of the Convention on Biological Diversity, etc.

Also, at the EMW's Street bio I received a non-specific training about how to operate in BSL1 environments, good lab conduct, personal protection, before beginning any lab activity, before leaving the lab and emergency procedures.

 

Rules and Regulations: Which laws and regulations (locally, nationally and internationally) apply to your lab? Include links to any oversight institutions/organizations and policies, and describe which specific rules are pertinent to your lab and project and why.

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The City of Cambridge has a Cambridge Biosafey Committee that oversees these regulations at the local level. Establish policies, procedures and criteria to aid in the implementation of this chapter. http://cambridgema.iqm2.com/Citizens/Board/1136-Biosafety-Committee

 

Organization and Practices: How do you enforce these rules? Who is responsible for ensuring safety in you lab/space? What happens when safety issues are raised?

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I believe that we are all responsible for complying with good laboratory practices, as members of a laboratory, we have an obligation to know the biosecurity measures relating to our work. For that, we must be able to identify the risk group at the which the pathogen belongs to which we are in contact and, the level of biosecurity to which the laboratory. We should also be aware of the universal precautions that must be taken in any type of installation.

We must never forget that biosecurity is a concept applicable to any area of health, is not exclusive to the academic or research area.

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Uncertainties: Are there any areas where you are uncertain about how to apply these rules, and whether they are relevant to your lab and/or work?

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For now, I dont have any uncertain. Maybe find something difficult in the future.

 

Getting Help: Who can you work with to resolve any problems or uncertainties (both to figure out how you can adhere to standards and update them if needed)? How difficult are they to contact?

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Contact numbers can be obtained from each website of the institutions or organizations in charge of compliance with laws and regulations.

 

Beyond the Rules: Are there activities in your lab/project which you think may have ethical, safety or security concerns that are not fully covered by current rules and standards? If so, please briefly describe them.

 

I think there are not concerns about the activities because the practices done are based on standard practices.

 

Other Information: Is there anything else we should know about your lab?

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With Street Bio at EMW, we explore the interface between engineered biology and the street—the people, culture, and products that will shape how biology leaves the lab and enters our everyday lives. In 2015, EMW was the site and home for the international course, "How To Grow (Almost) Anything", led by Professor George Church of Harvard University. Street Bio also boosts events like bio-hackathons, organized with our friends at Synbiota and MIT Media Lab

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BONUS: Designing for Safety and Ethics: Do you think the design of current regulations is sufficient to ensure safe and ethical practices? If not, how else could you approach the design? We’re interested in your ideas for  strategies that could be used to promote safe and ethical practices as it becomes easier to grow almost anything (i.e. monitoring people or information, building safety into the design of equipment, etc). Can you think of any useful examples from other fields?

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Synthetic biology is like iron: with it you can make needles to sew or nails to hammer. There may be a double use, but to ensure that there is no ethical problem and good use of the technology, laboratories must exercise the utmost safety measures to ensure proper use and avoid deviation from the proposed use.

It is what are known as mechanisms of biological containment: to build biological safeguards to prevent that the designed organism can survive in places for which they were not.

No legislation or regulatory system, whether biosecurity codes, biosecurity standards, laws, regulations will never be sufficient considering how the technology advances, it is always important to establish an advance or an evolution of the regulations and code of ethics, both together help each other

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