Understanding Biotechnology

What is Biotechnology

Overview of Biotechnology

History of Biotechnology

Why do we do biotechnology?

Biotechnology for the environment

Biotechnology for food and agriculture

(a) an organism that has been modified by gene technology; or

(b) an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology.

Genetically modified products

Definition: A genetically modified product (GM product) means a thing (other than a GMO) derived or produced from a GMO (section 10 of the GT Act).

Food made from gene technology is either defined as substantially different or substantially equivalent, in composition, nutrition, taste, smell, texture and functional characteristics, to conventional foods.

Safety of GM foods

All GM food sold in Australia must pass a thorough and rigorous safety assessment by FSANZ to gain approval for use. The safety assessments are based on all currently available data and if any safety concerns arise, the food will not be permitted in the food supply.

FSANZ will only approve genetically modified foods if they are as safe as their conventional counterparts, with no change in nutritional value. To date, 24 GM foods have been approved for use in Australia and New Zealand.

A GM food can only be permitted for use in Australia if:

• it has been assessed by FSANZ
• is found to be safe
• has been approved by FSANZ.

FSANZ's safety assessment process for genetically modified foods is based on concepts and principles developed by the World Health Organization (WHO), the Food and Agriculture Organization (FAO) of the United Nations, and the Organisation for Economic Co-operation and Development (OECD).

These principles require the cautious use of scientific, risk-based assessment methods and assessments on a case-by-case basis. The principles also require consideration of the genetic material and proteins introduced into the food and the intended and unintended effects of the genetic modification, such as changes to nutrient levels. They also require comparisons with any conventionally produced, unmodified version of an individual GM food, to look for changed characteristics.

FSANZ's safety guidelines are based on world best-practice standards.

All companies, both from Australia and overseas, must, by law, comply with Australian regulations before they can sell genetically modified products in Australia. Using FSANZ guidelines, information supplied by companies, and world scientific literature, FSANZ's experts assess the characteristics of GM foods to determine if they have been changed in any way that might make them unsafe.

The approval process for GM food is as follows.

1. An initial safety assessment report is prepared by FSANZ experts and approved by the FSANZ Board.
2. First round of public comment follows.
3. All submissions are collated and analysed.
4. A Draft Assessment Report is prepared and approved by FSANZ Board.
5. A second round of public comment follows.
6. All submissions are collated and analysed and a Final Assessment Report is prepared.
7. FSANZ Board approves the GM food and notifies the Australia and New Zealand Food Regulation Ministerial Council (ANZFRMC) of its decision prior to its gazettal. ANZFRMC can then request a review or allow it to be gazetted.

The process to final assessment can take approximately 12 months, but is subject to decision or review by the Ministerial.

Assessing the safety of GM foods

When applying, the producer provides information on:

• what the genetic modification is
• where the new genetic material came from
• how the gene was inserted into the plant
• nutritional values
• toxicity tests.

As a result, a large amount of scientific information is supplied with every application for food safety assessment by FSANZ. All scientific data obtained from the applicant must be generated according to international standards of good laboratory practice, in laboratories that are independently audited.

FSANZ supplements this data with information obtained from a variety of other sources, such as:

• peer-reviewed scientific literature
• general technical information
• independent scientists
• other regulator agencies
• international bodies
• the general community.

To make a safety assessment on GM foods, FSANZ requires specific information on the following.

1. The identity of host and donor organisms.
2. Any known pathogenicity in host or donor organisms.
3. The previous use of host and donor organisms in food production.
4. The new genetic material that has been introduced through genetic modification
   • origin, nature, purpose, function
   • method of introduction into the host organism.
5. The new genetic material in the GM organism
   • number of complete or incomplete copies present
   • stability.
6. The new protein in the GM organism
   • purpose, physical and biological characteristics
   • expression profile (which tissues the protein is found in, and when).
7. Potential adverse effects of the new protein, such as allergenicity and toxicity
   • similarity of new protein to known allergens or toxins
   • physical features that are characteristic of allergens
   • acute toxicity (animal studies).
8. Composition compared to its conventional counterpart: levels of nutrients, anti-nutrients, natural allergens and toxins.
9. Impact on human health from potential transfer of new genetic material to cells in the human digestive tract.
10. End uses of the food, including any requirement for processing prior to consumption.
11. If required, ability of the food to promote typical growth and well being (animal feeding studies).
12. Any other relevant information

Is it a food or food ingredient?

Each class possesses distinctive properties, allowing a separate safety assessment approach. This assessment scheme provides a general guide only. In practice, the type and extent of the safety assessment will largely depend on the nature of the food being considered in an application.

Group A consists of chemically-defined substances such as food additives, processing aids, and agricultural and veterinary chemicals.

Examples include:

• enzymes such as α-amylase (breaks down starches) and chymosin (used in cheese)
• veterinary chemicals such as porcine somatotropin (pig growth hormone) and bovine somatotropin (beef growth hormone).

Group B consists of less well-defined substances such as oils, fats, starch and protein where the composition may or may not be slightly altered.

Examples include:

• vegetable oil from pesticide-resistant seed plants
• sugar from insect-resistant sugar cane
• starch from insect-resistant maize
• vegetable oils with a modified fat composition from modified seed plants
• mycoprotein (fungal protein) from genetically-modified yeast.

Group C consists of foods produced using GMOs (usually microorganisms) where the GMO has been removed from the final product, such as beer and wine.

Examples include:

• beer produced using yeast modified to ferment at a colder temperature
• wine or beer produced using yeast modified to result in an altered flavour profile.

Group D consists of transgenic plants or animals (those that contain new or altered genetic material).

Examples include:

• tomatoes or cotton plants containing the gene for Bt toxin
• soybeans containing a gene which confers herbicide resistance
• potatoes in which genes have been altered to result in higher protein content
• pigs with altered growth characteristics
• sheep resistant to blowfly strike.

Group E consists of foods such as yoghurt where the genetically-modified microorganism remains in the food.

Examples include:

• yoghurt containing a fermentation organism with increased phage (bacterial virus) resistance
• yoghurt containing a modified fermentation organism that leads to increased vitamin content

Concerns about safety

The approval procedures of FSANZ ensure that any new foods released onto the market are assessed for safety by answering questions such as:

• Is the genetic material transferred unchanged from its source, and does it work in the same way in its new location?
• Is any of this genetic material present in the food product derived from the GM plant or animal?
• Could any of this genetic material cause harm if it was transferred to human cells?
• Are new proteins produced in the plant or animal as a result of genetic modification?
• Are these proteins present in the food product derived from the GM plant or animal?
• Are any new proteins in the food product likely to be poisonous or cause allergies?
• Is the composition of the food product derived from the genetically modified plant or animal different from the non-GM form of the food?

The safety assessment process undertaken for GM foods is a more thorough process than that undertaken for all other foods, and the level of safety associated with GM foods is at least as high as that of all other available foods.

Tempting debate with beer

A Swedish brewer has created a new light lager that’s produced with the usual hops and barley — and a touch of GM corn. The purpose of this beer is to encourage the public to become more involved in the biotech debate. Apart from protests by Greenpeace, the beer is being fairly well accepted across the country.

Labelling of GM foods

The new food labelling standard required the labelling of GM food and food ingredients – additive or processing aid - where new DNA and/or new protein is present in the final food or where the food has altered characteristics

Certain GM foods are exempt from labelling as a GM product:

• highly refined foods where the effect of the refining process is to remove novel DNA and/or novel protein
• processing aids or food additives where novel DNA and/or novel protein is not present in the final food
• flavours which are present in the food in a concentration of no more than 1g/kg (0.1%)
• foods, ingredients or processing aids in which the genetically modified food is unintentionally present in a quantity of no more than 10g/kg (1%) per ingredient
  • this tolerance level only applies where the manufacturer has sought to source non-genetically modified foods or ingredients
• food intended for immediate consumption that is prepared and sold from food premises and vending vehicles, including restaurants, take away outlets, caterers or self-catering institutions
  • in these situations, consumers have the right to ask the proprietor what is in the food being purchased and whether it is from a GM source.

Concerns about labelling of GM foods

For example, the refining process used to make canola oil removes all DNA and protein. The end result does not contain any genetic material and does not require labelling. Labelling according to process would state that canola oil came from a plant that had been genetically modified.