Biohacking/Genetic modification/Regulations 2000 summary

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GMO requirements, as they apply to LHS Biohacking

Documents:

1: "The Genetically Modified Organisms (Contained Use) Regulations 2000" http://www.legislation.gov.uk/uksi/2000/2831/pdfs/uksi_20002831_en.pdf

Summary of regulations

It's about protecting practitioners from harm arising from GMO experiments; and also about protecting the environment.

6: Before doing any GM, the practitioner must carry out a risk assessment. A risk assessment is a formal document that must be stored for 10 years and be made available to the Government if requested.

Before doing any GM in a new location, the practitioner must have notified the Government, and received an acknowledgement of receipt (which will happen within 10 days). For class 2 organisms, the requirements are more strict: the practitioner must also have received a go-ahead from the Government (which will happen within 45 days). For class 3 and 4 organisms, the requirements are even more strict, but we don't care about them because we will never work with class 3 or 4 organisms.

There are separate requirements for genetic modification of non-micro organisms, but we don't care about them because we plan only to work with micro-organisms for now.

Notifications of intent, submitted by practitioners to the Government, will be examined for:

  1. Conformity with regulations
  2. Accuracy and completeness
  3. Correctness of the risk assessment from Regulation 6.
  4. Adequacy of waste management and emergency response procedures
  5. "The correctness of the class assigned to the activity involving genetic modification of micro-organisms" (ie. have we chosen the correct class (1) for our work.

After we submit a notification, we may be asked for more information. If we get such a request, we can't go ahead with GM until given permission in writing. If we have already started GM, we must stop, and destroy all GM organisms.

15: The Government can tell us to stop whenever it likes, even if it has previously allowed us to perform GM.

We must notify the Government if anything changes, including:

  • Change of location
  • Cessation of, or re-commencement of, GM activities
  • If we become aware of any new risks (including arising from changes to the location)

16: We must set up a safety committee, and that safety committee must assist in performing the risk assessment.

17: General safety requirements:

  1. We must ensure that the level of exposure of humans and the environment to GMOs is as low as it can practically be.
  2. We must ensure that harm to humans arising from GM is as low as it can practically be.

Refer to Schedule 7 (below) for guidelines for good microbiological practice.

GMOs must be contained. Practitioners must check that the containment levels are adequate "at suitably regular intervals". Practitioners must also re-evaluate containment critiera if he/she suspects they are no longer adequate.

20: We must have an emergency plan, which will describe measures to take in the event of any foreseeable accident involving GMOs. The plan must be reviewed and/or revised "at suitably regular intervals".

Practitioners must inform emergency services of the plan and its contents (NFD: this seems odd to me. This is regulation 20, section 4a).

The emergency plan must be publicly available.

21: If there is an accident, we have to inform the Government according to a set of criteria (21 (1))

22: If we can't disclose information to the Government because it's confidential, we have to justify that non-disclosure. Some things can't be confidential. (NFD: reg. 22 won't apply to us.)

24: The Government will keep our notification on file, along with notifier's contact details, date of notification, and any other correspondence. The register can be browsed by members of the public.

25: The Government can except certain people, classes of people, organisms, or classes of organisms from its own regulations.

27: We have to pay a fee to notify. If we withdraw the notification, or don't provide requested information, we don't get the fee back.

28: If we disagree with a Government decision, we can appeal to the Secretary of State.

Schedule 1: Classes of GM activity

  1. "Activities of no or negligible risk, for which containment level 1 is appropriate to protect human health and the environment."
  2. (and 3, and 4) Activities of low, moderate, or high risk, respectively.

Schedule 2: Examples of techniques consistuting GM

  1. Recombinant nucleic acid techniques
  2. Direct injection of genetic material into an organism
  3. Cell fusion (creating a new cell with hybrid genetic material) through means that don't occur naturally

Examples of techniques which are not GM:

  1. IVF
  2. Natural processes including conjugation, transduction or transformation (selective breeding)
  3. Polyploidy induction (increasing the number of chromosomes in a cell without changing their information)

Techniques to which the regulations do not apply:

  1. Mutagenesis
  2. Cell fusion that occurs naturally (i.e. amoebae sharing geneting material)
  3. Self-cloning, which means taking genetic material from one cell and placing it in a similar cell.

Schedule 3: Safety assessment (i.e. regulation 6) requirements

We must take into account harmful effects associated with:

  • a) the recipient micro-organism
  • b) the inserted genetic material
  • c) the vector (i.e. plasmid for our work)
  • d) the donor micro-organism (this doesn't apply to us currently)
  • e) the resulting GMO

... where harmful effects include disease to humans, disease to animals, disease to plants, adverse effects if there is an accident and we can't treat the resulting disease, adverse effects if there is an accident and the GMO escapes, adverse effects resulting from natural transfer of genetic material (NFD: I think this means -- if the GMO organism 'breeds' with a non-GMO organism), adverse effects resulting from interaction between GMO and non-GMO at the facility

To perform a safety assessment we must:

  1. identify harmful properties of the recipient and (if applicable) donor
  2. identify harmful properties of the vector
  3. consider community legislation, in particular Council Directive 90/679/EEC(a)
  4. identify the level of risk associated with the GMO
  5. consider the characteristics of the environment likely to be exposed, the characteristics of the GM activity itself, and any GM activities which cannot be controlled by standard lab procedures -- and adjust the level of risk accordingly (as per point 4)
  6. Select appropriate containment measures (see Schedule 8)
  7. Assign the appropriate containment level (see below)
  8. Classify the activity as per the containment level class
  9. Review and reconsider the classification after completing the rest of the assessment

To select the appropriate containment level, we must (see Schedule 3, Part 4, for the instructions for this part, as they are concise and specific).

Schedule 4

This is about risk assessments for non-micro-organisms, so I skipped it (NFD).

Schedule 5: Information required for a notification.

We need:

  • a) Name, address, telephone, fax number of notifier
  • b,c) Name of the employee of the notifier responsible for supervision and safety of GM activities, along with information on his/her training and qualifications
  • d) Details of the GM safety committee established
  • e) Address and description of the GM location
  • f) Nature of work
  • g) Class of activity (NFD: ?)
  • h) If this is the first time a premises is being used: a safety assessement (as per regulation 6), any advice from the safety committee (as per regulation 16), information on waste management, and confirmation that we have informed emergency services and other affected bodies (LHS Trustees I guess) of emergency plan
  • i) (non-micro-organism GM info skipped)

Schedule 6: Notification for class-2 GMs, class-3/4 GMs, and non-micro-organism GMs.

Skipped.

Schedule 7: Principles of good microbiological practice

  • a) Keep workplace and environmental exposure to GMOs as low as practical
  • b) Exercise engineering control measures at source (NFD: ?) and supplement with appropriate clothing & equipment
  • c) testing and maintaining control measures & equipment
  • d) testing for GMOs outside the containment area
  • e) providing appropriate training
  • f) formulating and implementing local codes of practice
  • g) displaying biohazard signs
  • h) providing washing and decontamination facilities
  • i) keeping adequate records
  • j) prohibiting eating, drinking, smoking, applying cosmetics, or storing food for human consumption
  • k) prohibiting mouth pipetting (NFD: who the hell does this)
  • l) providing written SOPs
  • m) having appropriate disinfectants and specified disinfection procedures
  • n) providing safe storage for contaminated equipment (where appropriate)

Schedule 8: Containment measures

Worth referring to this section in full. For class 1, we need:

NOTE: "modulo R.A." means "To the extent that the risk assessment indicates that it is required". A lot of the regulations are not set in stone but rely on the risk assessment.

For working in a lab:

  • Bench must be impervious to water, resistant to acids, alkalis, solvents, disinfectants, and decontamination agents; and must be easy to clean
  • Autoclave required on site. If not actually in the lab, there must be procedures for safe transfer of GMOs from lab to autocalve.
  • Suitable protective clothing required
  • Rodents and insects which could disseminate the GMO must be controlled modulo R.A.
  • Disinfection procedures required modulo R.A.
  • GMOs must be inactivated before disposal (e.g. as waste)
  • Observation window required modulo R.A.
  • Safe storage of GMMs modulo R.A.

For working in a non-lab environment:

  • Viable micro-organisms must be in a closed system, i.e. separated from outside world, modulo R.A.
  • Aerosols must be controlled, modulo R.A.
  • Cultures must be inactivated before removal from closed system, modulo R.A.
  • Area must be designed to prevent spillage of entire closed system, modulo R.A.
  • Biohazard signs must be posted, modulo R.A.
  • Benches must be resistant to water, acids, alkalis, disinfectants and decontamination agents; benches must be easy to clean.
  • Controlled areas must be adequately ventilated minimise air contamination, modulo R.A.
  • Decontamination and washing facilities and procedures
  • Work clothing required (nb not protective clothing but also not, e.g., bikinis)
  • GMOs and contaminated waste material must be inactivated "before final discharge"

Schedule 9: Fees

Notification under regulation 9(1): £200 (NFD: 9(1) is class 1 micro-organism GM) Changes to previous notification under regulation 15(3): £300 Request under regulation 18(2) after a nofication: £300 (18(2) is a subsequent notifcation following a safety assessment that a containment measure previously thought to be required is not required)

Schedule 10: Transitional provisions

This is about coming in to compliance with the act if you were doing GM before the act became law (and were in compliance with an earlier act). Skipped.

Schedule 11: Appeals

This is about appealing a decision made by the Government. It is about the specific protocol for appeals, and the time limits and rights of appellant and Government. Skipped.

Explanatory note

Worth reading, as it is "not part of the Regulations" and thus not written in legalese. Essentially: the risk assessment is the most important part of the whole process -- it informs much of the application and requirements, for example. The rest is a quick executive summary of the entire act.