It is forbidden by law to acquire or work with genetically modified organisms (GMOs) without first having requested a licence with the UT's Biological Safety Officer (BVF). This licence must be applied for under the Genetically Modified Organisms Decree 2013 (Besluit genetisch gemodificeerde organismen milieubeheer 2013). Moreover, any activities in which pathogenic micro-organisms of category 2 and higher are used may only start after the Human Resources department has reported this to the labour inspectorate.

The regulations on working with biological agents and GMOs in a focussed manner include the procedures and requirements to be met within the UT when working with biological agents (e.g. human or animal materials) or GMOs. A detailed elaboration has been included in the abbreviated manual for the ML-I, ML-II laboratory (GMO lab) and/or laboratories for working with biological agents (human materials). The manual also includes information about safely working with animal materials, the GMO instruction film and hepatitis B vaccination.


Transport of GMO's and Biological Material

TRANSPORT OF GMO’S AND BIOLOGICAL MATERIAL

There are strict rules concerning the packaging and the transportation of Biological material. Road transportation of infectious material and genetically modified organisms (gmo) must be done by packaging the material according to legal rules included in the ADR, the European agreement concerning international transport of goods by road. Transport by air must be in accordance with the rules of the International Air Transport Association (IATA).

This procedure describes the rules in relation to the internal / external transport of biological agents and GMO material. The order / receipt of GMO material is always after consultation with the principal investigator (VM) of the project. The VM checks whether the material is granted under the license. In case of deliveries, the VM ensured that the recipient has an appropriate license for contained use.

Transportation of waste which might be contaminated with gmo’s or pathogenenic micro-organisms is, described in the waste management regulation University of Twente.

1 INTERNAL TRANSPORTATION

Non-infectious genetically modified organisms (gmo) (ML-I) are packed in a closed, unbreakable leak proof package with inscription GMO. The packaging can be done in a closable box which can be disinfected.

Infectious material (gmo’s from ML-II and empathogenes and microorganisms from risk class 2 or higher) must be transported in a closed, leak proof package, supplied with a Biohazard symbol. This can be a box which can be closed and disinfected.

2 EXTERNAL TRANSPORTATION

For external transportation and sending of biological material a triple containment is always necessary, it must consist of:

1.     Hermetically sealed, leak proof, unbreakable first container (Eppendorf tube, bottle etc.) in which the contents and the obligatory containment level is mentioned.

2.     Hermetically sealed, leak proof, unbreakable second container, in which the first container is surrounded by sufficient absorbing material for the whole contents

3.     The outside of the packaging of the triple containment must be a sturdy, f.i. a firm box.

In case the package contains (dry) ice or another cooling medium, then a suitable package must be used.

For transport of the various samples by road specific packing and labeling are a must. These are stated in the table. Next to that the following regulations must be applied:

1.     When transporting liquids the outside needs to have the following orientation sticker on oppposite sides of the package. Color black or red on white background.

2.     If the material is sent on dry ice addional specifications are required:

Maximum total weight of 25 kg per submission

Minimum size of box: 25x25x25

When transporting by road the package must be labelled with an extra label: UN 1845 on which the amoutn of dry ice is reported. When transporting by air the label for class 9 needs to be administered.

The amount of dry ice must be sufficient for at least 3 days (10KG). In all cases the box with dry ice needs to be padded with styrofoam or another dry filling material.

Packaging must be such that pressure build up is not possible inside the package. The primary and secondary package must be able to withstand low temperatures.

GENERAL

Every transport by road or air must be equipped with a freight letter in which is stated:

  • Place and date of drawn up;
  • Name and adress of sender;
  • Name and adress of carrier;
  • Name and adress of adressee;
  • Place and date of receipt of goods and the palce ment for deliverance of goods;
  • Correct transportname of amterial: see colum 4 of the table;
  • Gross weight or the amount of goods.

For shipment of GMOs / biological material, the compony Biologistic Services (http://biologistic.nl/) can be used. Compliance with the requirements regarding appropriate packaging, labels and shipping documents are secured in this way.

Table: Overview of the packaging and labelling demands for sending biological material

Biological material

Packaging material

Labeling:

Documents besides the freight letter and naming

Humane diagnostic and research material, not contaminated with pathogens class 3 or 4

(Cat B)*)

Triple containment of which the outside is sturdy

 

Biological Substance B

Animal diagnostic and research material, not contaminated with pathogens of risk class 3 or 4

(Cat B)*)

Triple containment of which the outside is sturdy

 

 

For Research and diagnostics only black and white letters

Trade document if the submission is within the EU (see work instruction and safe working with animal material) For outside EU: country specific demands.

Non infectious GMO’s

 

Triple containment of which the outside is sturdy

On the freight letter the indication:

”Genetically modified organisms”

Infectious material, pathogenic for man and animal of risk class 2 or higher and classified as Cat. A*)

UN approved sturdy packaging that also go for 2814

+

On the freight letter the indication: infectious substance affecting humans

Infectious material, pathogenic for animals

(Cat A)*)

UN approved sturdy packaging that also go for 2814

+ UN 2900 label

Freight letter with indication:

Infectious substance affecting animals

Remark: in case of combined air- and road transport follow the demands of airtravel.

*) Definition category A or B:

Category A is an infectious substance which is carried in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. Indicatieve examples of substances that meet these criteria are given in a table in the ADR-document (ADR 2.2.62.1.4.1).

Infectious substances meeting these criteria which cause disease in humans or both in humans and animals shall be assigned tot UN No. 2814. Infectious substances meeting these criteria which cause disease only in animals shall be assigned to UN No. 2900.

There is an exception for three microorganism on the Category A list. When the cultures of Mycobacterium tuberculosis, Shigella dysenteria type 1 en Escherichia coli verotoxigen are intended for diagnostic or clinical purpose, they may be classified as infectious substances of Category B.

If there is doubt as tot whether or not a substance meets the criteria it shall be included in Category A.

Category B substance is an infectious substance which does not meet the criteria for inclusion in Category A. Infectious substances in Category B shall be assigned tot UN No. 3373. An example is human materials (patient specimens) used for purposes such as research and diagnosis activities (not containing category A organisms).

Vaccination Protocol / needlestick injurie

In a number of projects at the UT, staff members and/or students work with human blood and/or blood products (blood cells). These projects involve a certain risk of accidental blood contact. This protocol is intended for the above staff members and students.

There may be blood contact if someone is injured by a contaminated needle or glassware. Splashes and aerosol formation may also cause contaminated material to enter the body via wounds, splits, eczema and via the mucous membrane of the eyes and mouth.

Based on Article 4.91 of the Working Conditions Decree, the working conditions policy rules provide that staff members in diagnostic and research laboratories who frequently come into contact with human blood or human blood products should be allowed by their employer to be vaccinated against hepatitis B (see Annex I).

Blood of (‘healthy’ or hospital) donors may contain viruses. The 'highest-risk' viruses are the hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). A vaccination is only available against hepatitis B.

Hepatitis B is a serious form of liver infection. After an infection, 90% of infected people are able to overcome the disease with their own immune system; 10% of infected people are not able to do so. These persons will continue to be contagious (sometimes without them knowing) and later have an increased risk of liver cirrhosis (atrophy due to scarring) or liver cancer.

People are vaccinated against hepatitis B with a non-infectious vaccine containing HBV surface proteins obtained through genetic modification. The vaccine is administered through three injections at 0, 1 and 6-month intervals. A titre test (4 to 8 weeks after the final dose) should demonstrate if the vaccination has produced sufficient results. A vaccination offers protection for at least fifteen years.

The vaccination can be administered by GGD Twente (Nijverheidstraat 30, 7511 JM  Enschede, 053-4876888). Depending on the age of the person concerned and any previous vaccinations, the GGD Twente will decide if a titre test should be performed first or if the 1st vaccination can be administered immediately. A vaccination card containing vaccination data will be issued afterwards. The faculty ensures that the registration card is registered. This card or a copy hereof must be stored for at least fifteen years.

HOW TO ACT IN CASE OF NEEDLESTICK INJURIES

People who are not vaccinated against hepatitis B and suffer a needlestick injury must be given immunoglobulins, depending on the risk of infection. Immunoglobulins should be given within 48 hours and provide full protection. A vaccination must be administered afterwards.

People who are vaccinated against hepatitis B still run a risk of infection with hepatitis C or HIV.

Any needlestick injuries should immediately be reported to the company doctor of the University of Twente (088-2726312). Depending on the nature of the contact and risk of infection, the company doctor may decide to take further action, for example a baseline serum, serological testing etc. Moreover, needlestick injuries must always be reported using the accident form.

Cleaning staff suffer needlestick injuries mostly because other people act negligently when it comes to sharp and dirty materials. Any unsafe situations should always be reported to the head of the lab, who can confront the negligent staff about their behaviour. The procedure used for cleaning staff who suffer needlestick injuries is the same as the procedure used for laboratory staff.

ANNEX I: POLICY RULE 4.91. (VACCINATION AGAINST HEPATITIS B)

Basis: Working Conditions Decree, Article 4.91(6), (8) and (9).

  1. Staff members who work in medical and paramedical professions and who run a risk of having intensive contact with human blood shall be allowed by their employer to be vaccinated against hepatitis B.
  2. The staff members referred to in the first paragraph shall, in any case, include:
    1. doctors, nurses and paramedics who often come into contact with human blood or with other patient materials contaminated with human blood;
    2. forensic pathologists and their staff who work with non-fixed, potentially contaminated materials;
    3. staff members who work on haemodialysis departments and who are directly involved in patient care or in the technique of the haemodialysis procedure, including technical maintenance staff;
    4. staff members in diagnostic and research laboratories who often come into contact with human blood or human blood products;
    5. obstetricians and maternity carers;
    6. dentists, oral hygienists, dentist's assistants and those who are indirectly involved in dental care of patients and run a risk of infection.
  3. Staff members who look after test animals in laboratories working with the hepatitis B virus shall be allowed by their employer to be vaccinated against hepatitis B.
  4. Staff members in hospitals who perform cleaning work or remove waste shall be allowed by their employer to be vaccinated against hepatitis B if there is a fair chance of infection.
  5. Staff members transporting non-fixed, potentially contaminated pathological materials shall be allowed by their employer to be vaccinated against hepatitis B if there is a fair chance of infection.
  6. A vaccination card shall be drawn up for staff members who are vaccinated against hepatitis B. This card shall at least specify the vaccination date and the antibody titres (after vaccination or after an interim check-up), along with the test date. Vaccinated staff members shall receive a copy of the vaccination data. On request, the vaccination card shall be provided to a designated supervisor and shall be stored by the institution for at least fifteen years.