Appendix A - Regulatory Arrangements for GMOs and GM products in Australia and Australia's Major Export Markets for Canola and Cottonseed


Australia

Table A1: Australia - regulatory arrangements for GMOs and GM products

Experimental and commercial release into the environment

The Gene Technology Act (2000) (Cwlth) (the Act) and the Regulations and corresponding state and territory laws provide a nationally consistent system to regulate development and use of gene technology in Australia. Dealings with GMOs (including research, manufacture, production, transport, destruction, commercial release and import) are regulated by the Gene Technology Regulator (the Regulator) supported by the Office of the Gene Technology Regulator (OGTR) under the Act. The object of the Act is to protect human health and safety and the environment by identifying and managing potential risks posed by gene technology through regulating certain dealings with GMOs. Dealing with GMOs are illegal in Australia unless authorised under the Act.

Marketing approval

The Regulator has approved certain lines of GM cotton, canola and carnations for unrestricted commercial release into the environment. GM products (products which are derived from a GMO but that are not a GMO; for example a purified protein derived from a GM bacteria) are not regulated under the Act unless there is no existing product regulator (however, the GMO producing the product would need to be approved by the Regulator). The use of GM product is regulated by other regulatory agencies, for example Food Standards Australia New Zealand (FSANZ), the Therapeutic Goods Administration (TGA), and the Australian Pesticides and Veterinary Medicines Authority (APVMA).

FSANZ regulates food produced using gene technology, meaning a food which has been derived or developed from an organism which has been modified by gene technology. FSANZ is responsible for carrying out safety assessments of GM foods on behalf of the Australian Government, the state and territory governments of Australian and the Government of New Zealand (under Food Standard 1.5.2—Food Produced Using Gene Technology). As of July 2008, FSANZ has approved 35 GM foods/food ingredients from seven crops: soybean, canola, maize (corn), potato, sugar beet, lucerne and cotton.

Imports

GM seed-for-sowing and grain imported into Australia must be declared to the Australian Quarantine and Inspection Service (AQIS). AQIS provides quarantine inspection for (amongst other things) plants and plant products arriving in Australia in accordance with the Quarantine Act 1908 (Cwlth). The Quarantine Act 1908 (Cwlth) requires the importer to obtain prior approval (via an import permit) to import declared GM seeds and grain. In deciding whether to grant a permit to import a seed of a kind of plant that was produced through genetic manipulation, the Director of Quarantine must also take into account any risk assessment prepared, and any decision made, in relation to the seed by the Regulator under the Act.

The importation of GM seed-for-sowing to Australia intended for commercial release or for release in an open-environment field trial requires authorisation under the Act and actual release requires a licence from the Regulator.

To date, imports of GM grains for processing and use in food and/or feed but which have not been approved for commercial release, have been authorised under licences for ‘dealings not involving an intentional release’ (DNIR). The licences include conditions to prevent release of the GMO, including requiring containment during transport and storage, and devitalisation of the grain.

Labelling

Labelling of approved GM food is required to indicate that it is GM or contains GM ingredients. The purpose of labelling is for consumer choice, and not for food safety reasons. There are some instances where labelling of approved GM foods or ingredients is not required, for example in highly refined foods where the effect of the refining process is to remove novel DNA and/or novel protein, or where the approved GM food is unintentionally present in the food, ingredient or processing aid at a concentration of no more than 10g/kg (1 per cent) per ingredient.

The FSANZ Food Standard 1.5.2—Food Produced Using Gene Technology—and the labelling requirements under that Standard apply only to food for humans and do not apply to animal feed. Stockfeed legislation in Australia is the responsibility of State and Territory jurisdictions and jurisdictions each have their own stockfeed legislation. There are no labelling requirements in regard to animal feed that is a GM crop or contains feed ingredients derived from a GM crop. To date, for GM crops approved for commercial release the Regulator has concluded that they are as safe (for human health and the environment) as their conventional counterparts and may be used in the same manner, including for animal feed.

In Australia, industry has adopted threshold levels for the labelling of non-GM canola grain and seed-for-sowing which may contain the adventitious presence (AP) of GM canolas approved by the Regulator. The AP thresholds are 0.9 per cent GM canola in non-GM canola grain and 0.5 per cent GM canola in non-GM canola seed-for-sowing. Above these thresholds the canola must be labelled as GM canola.

Japan

Table A2: Japan - regulatory arrangements for GMOs and GM products

Experimental and commercial release into the environment

In Japan, commercialisation of GM crop plants requires environmental, food and feed approvals. Four Ministries are involved in the regulatory framework – the Ministry of Agriculture, Forestry and Fisheries (MAFF), the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Environment (MOE), and the Ministry of Education, Culture, Sports, Science and Technology (MEXT).

Marketing approval

Based on the Food Sanitation Law (FSL), the MHLW is responsible for the food safety of GM products. All GM foods must undergo a safety assessment prior to being awarded certification for distribution to the domestic market. The Food Safety Commission (FSC) performs food and feed safety risk assessments for MHLW and MAFF.

As of February 2008, Japan had approved 88 GM events in seven crops (potato, soybean, sugar beet, maize, canola, cotton and alfalfa)for use in food products; 52 GM events in six crops (canola, maize, soybean, cotton, sugar beet and alfalfa) for use in animal feed; and 14 GM events for use in producing six food additives (α-amylase, rennet, pullulanase, lipase, riboflavin and glucoamylase).

Imports

It is illegal to import GM products that have not been approved. To assure compliance, a sampling program is in place to test both import shipments and processed food products at the retail level. Testing of imported foods at ports is handled by the MHLW directly. All testing is performed according to sampling and testing criteria set by the MHLW. The testing is normally carried out by a Japanese Government Agency called FAMIC—Food and Agricultural Materials Inspection Center.

MAFF monitors quality and safety of imported feed ingredients at the ports.

Japan ratified the Cartagena Protocol on Biosafety in November 2003.

Labelling

Labelling of GM foods is legislated under two laws—the FSL and the Japan Agricultural Standards (JAS).

Under the FSL, if the GM content of the top three ingredients in these foods exceeds 5 per cent of the total weight of the foods, they must be labelled with either the phrase ‘Biotech Ingredients Used’ or ‘Biotech Ingredient Not Segregated’ if the raw material is not accompanied by certificates of identity preservation handling. In order to be labelled ‘Non-Biotech’, the processor must be able to show that the ingredient to be labelled was identity-preservation-handled from production through to processing.

Under the JAS law, Japan has set an informal tolerance of 5 per cent for GM ingredients in products that are labelled ‘Non-Biotech’. This tolerance only applies to events that have been approved in Japan. If MAFF or MHLW finds a product labelled ‘Non-Biotech’ that has a GM content of greater that five per cent, it is determined that the identity preservation handling has not been carried out correctly and the product must be re-labelled as ‘Biotech Ingredients Used’.

United States Department of Agriculture - Foreign Agricultural Service (200f).

Pakistan

Table A3: Pakistan - regulatory arrangements for GMOs and GM products

Experimental and commercial release into the environment

The responsible government ministries are: Environment; Food, Agriculture and Livestock; Science and Technology; and Health and Education.

Marketing approval

National Biosafety Guidelines were approved in April 2005; however, to date no GM crop has been approved for cultivation on a commercial scale. The implementation and monitoring mechanisms of the proposed guidelines are built upon a three tier system comprising the National Biosafety Committee (NBC), a Technical Advisory Committee (TAC), and the Institutional Biosafety Committees (IBCs) at the level of distinct organisations. The Secretary of the Ministry of Environment heads the NBC and is responsible for overseeing all laboratory work and field trials, and authorising the commercial release of GM products.

Imports

Pakistan has signed the Cartagena Protocol on Biosafety. Biotechnology products are sold in all segments of society. Industry and consumers are using GM soybean, soybean oil and other processed food products.

Labelling

Pakistan does not have any labelling requirements for food or feed derived from GMOs.

United States Department of Agriculture - Foreign Agricultural Service (2007g).

China

Table A4: China - regulatory arrangements for GMOs and GM products

Experimental and commercial release into the environment

The Ministry of Agriculture (MOA) is China’s primary governingbody over agricultural biotechnology issues. The MOA Ministerial Decrees 8, 9 and 10 create the legal framework under which the GM products are regulated. Other government agencies, such as General Administration on Quality Supervisions Inspection and Quarantine (AQSIQ) and the State Environment Protection Administration (SEPA) are also involved.

Marketing approval

China has commercialised five GM plants domestically since 1997 (cotton, tomato, sweet pepper, petunia and papaya).

The MOA is chiefly responsible for import approval of GM crops forand domestic production. SEPA is the lead authority for negotiation of the Cartagena Protocol on Biosafety. AQSIQ is responsible for the nationwide management of the inspection and quarantine for entry and exit of all GM products; Ministerial Decree 62 governs the steps that importers or exporters of GM products need to take at customs.

The National Biosafety Committee (NBC) evaluates applications for safety certificates for GM products for different uses as submitted by both domestic and foreign seed developers.

The National Technical Committee for Standardisation of Biosafety Management of Agricultural GMOs is responsible for drafting and revising technical standards for agricultural GMOs including standards for safety assessment and sampling and testing.

Imports

China ratified the Cartagena Protocol on Biosafety in 2005.

The MOA must approve GM products that are intended for import into China. The approval process varies depending on the product’s intended use and the potential risk to human or animal health and the environment.

For importation of GM products as processing materials, a foreign seed developer must apply for an agricultural GMO safety certificate from MOA’s Agricultural GMO Biosafety Office. The regulations require applicants to have certification that the exporting country has allowed the use and sale of the GM products in its domestic market and that they have undergone tests there showing no harm to human or animal health or the environment. The MOA also requires environmental and food safety test conducted by Chinese institutions, to verify data provided by the seed developer. All these documents are reviewed by the National Biosafety Committee before the MOA can issue a safety certificate.

China has approved four GM crops for import as processing materials (soybean, maize, canola and cotton). The safety certificate of a food crop is valid for three years and that of a non-food crop is valid for five years.

Labelling

Governed by the MOA, China requires approved GM products be labelled and prohibits the importation and sale of any unlabelled or mislabelled products. The regulations spell out the type of labelling as well as the language required to be used.

United States Department of Agriculture - Foreign Agricultural Service (2007h).

Bangladesh

Table A5: Bangladesh - regulatory arrangements for GMOs and GM products

Experimental and commercial release into the environment

The Ministries of Agriculture (MOA), Science and Information technology (MOSICT) and Environment and Forest (MOEF) are jointly responsible for the development of a biotechnology policy and regulatory framework. MOSICT is the lead agency for biotechnology research and development, and MOEF is the lead agency for biosafety. In 2006 Bangladesh approved a National Biotechnology Policy that emphasises protection of indigenous knowledge, collective innovation and community rights.

The Secretary of the MOEF heads the National Technical Committees on Biosafety (NCB). The principal role of the NCB is to draft legislation and measures to ensure the environmentally safe management of modern biotechnology development.

The draft Biosafety Guidelines developed in 2000 under the leadership of the MOSICT, contain standards and codes of practice related to ‘risks’ associated with the environmental release of GMOs. They propose a decision-making framework that will allow experimental field-testing based on: the testing agency’s familiarity with the plant; and, the perceived environmental impact should the GM plant escape confinement.

Marketing approval

Bangladesh has yet to establish a regulatory framework for agricultural biotechnology, and as such no GM crop has yet been approved for commercial cultivation. Bangladesh does not differentiate between GM or non-GM agricultural commodities.

Imports

Banglasdesh is a signatory to the Cartagena Protocol on Biosafety. It ratified the Protocol in 2004, but rules to implement the protocol have not yet been formulated. There are no GM-specific barriers on imports.

Labelling

Bangladesh has no regulations governing the labelling of GM products.

United States Department of Agriculture - Foreign Agricultural Service (2007a).

EU-27

Table A6: EU-27 - Regulatory arrangements for GMOs and GM products

Experimental and commercial release into the environment

There are two EU laws under which technology providers can file an application for the authorisation of GM products – Regulation (EC) No 1829/2003 (under the control of the Directorate General for Health and Consumer Protection (SANCO)) and Directive 2001/18/EC (under the control of the Directorate General for the Environment).

Marketing approval

Under Regulation (EC) No 1829/2003 a company can file a single application for a GM event and all its uses by submitting it to the
competent authority of the Member State where the product will first be marketed. The Member State will then forward the application to the European Food Safety Authority (EFSA) for review. EFSA conducts a single risk assessment and may grant a single authorisation for a GM event and all its uses. The findings of the EFSA review apply to all EU Member States. If EFSA issues a positive risk assessment, the application is then forwarded to the European Commission (EC), which has responsibility for risk management. The EC will then present a proposal to Member States recommending they authorize the marketing of the product. The Member States then review and vote on the proposal in a regulatory committee. A qualified majority (QM) is required to approve the proposal. If the proposal fails to get a QM, it then goes to the Agriculture Council of Ministers for review. If the Council fails to make a decision within three months, the EC may then authorise the marketing of the product.

Under Directive 2001/18/EC, a company may file an application for the marketing of a GM event for cultivation, importation and processing into different products. This procedure differs from that under Regulation (EC) 1829/2003 in that when the application is submitted in the Member State, that country’s competent authority performs the safety assessment (as opposed to the EFSA). If a favourable assessment is issued, then the results are shared with EC and all other Member States who may approve the GM event for marketing within the EU or may raise objections. If objections are raised by other Member States, the EC will ask the EFSA to conduct a risk assessment. The approval procedure is then as for Regulation (EC) 1829/2003, except that the Environment Council of Ministers is responsible for reviewing EC proposals if Member States cannot reach an agreement.

Imports

The EU is a signatory to the Cartagena Protocol on Biosafety. See above for requirements for importing GMOs into the EU.

Labelling

All food and feed products containing GMOs and or producted from GMOs, including products that no longer contain detectable traces of GMOs, must be labelled. Before a product can be labelled as GM, the European Commission must review its safety and authorises its marketing. EFSA must also issue a positive risk assessment.

Labelling regulations for products containing or consisting of GMOs
are presented in Regulation (EC) No 1830/2003, article 4B. These
regulations apply to bulk agricultural commodities such as whole grains and oilseeds.

Labelling regulations for food and feed products that are produced from GMOs are presented in Regulation (EC) No 1829/2003—Articles 12–13 for food and Articles 24–25 for feed.

The adventitious presence level for EU-approved varieties of GMOs for use in food and feed is set at 0.9 per cent. Above this level, all products must be labelled.

For GMOs that are not formally approved but which have received a positive EU risk assessment, the adventitious presence level is set 0.5 per cent. Above this threshold, the product is not allowed on the EU market.

Meat, milk or eggs obtained from animals fed with GM feed or treated with GM medicinal products do not require GM labelling.

No threshold for the adventitious presence of GM seeds in conventional seed lots has been established, meaning any seed lot containing GM seed authorised for cultivation must be labelled as containing GMOs. Seed lots containing GM seed that is not authorised for cultivation cannot be marketed in the EU and must be returned to point of origin or destroyed.

Traceability

Under Regulation (EC) No 1830/2003, business operators must transmit and retain information about products that contain or are produced from GMOs at each stage of placing on the market. This information must be transmitted throughout the commercial chain and must be retained for five years. The regulation covers all products, included food and feed, containing or derived from GMOs that have received an EU authorisation.

For GMOs intended for deliberate release in to the environment operators must transmit specified information on the identity of the individual genetic modifications the product contains.

For GMOs intended for food, feed or processing operators may either transmit the specified information or transmit a declaration that the product shall be used only as food or feed or for processing together with the identity of the GMOs from which the product was derived.

For food and feed produced from GMOs, operators must inform the next operator in the chain that the product is produced from GMOs.

The EC has also established a system for the development and assignment of unique identifiers for GMOs (Commission Regulation 65/2004). Under this system, a unique identifier is assigned to each GMO as a means of tracking its presence and indicating the specific GM event covered by the authorisation for it to be marketed in the EU.

United States Department of Agriculture - Foreign Agricultural Services (2007c).

India

Table A7: India - regulatory arrangements for GMOs and GM products

Experimental and commercial release into the environment

The regulatory framework for GM events and products in India is governed under the Environmental Protection Act (EPA) 1986. This covers research, development, large-scale use as food or feed and imports. There are six competent authorities for handling the responsibilities under this Act.

Marketing approval

The Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment and Forest (MOEF) is the nodal agency responsible for implementing the ‘Rules for manufacture, use / import / export and storage of hazardous micro-organisms / genetically engineered organisms or cells, 1989’ (the ‘Biotech Rules’) under the EPA.

The Department of Biotechnology (DBT) under the Ministry of Science and Technology (MST) provides guidelines and technical support to the GEAC. The DBT also evaluates and approves the safety assessment of GM research and development in India.

The Ministry of Agriculture (MOA) evaluates and approves the commercial release of transgenic crop varieties through multi-location trials conducted for assessing agronomic performance.

The Ministry of Health and Family Welfare (MHFW) evaluates and approves the safety assessment of GM crops and products for human consumption.

Currently, there are no restrictions on the marketing of domestically produced GM cottonseed oil and meal for consumption.

Imports

India ratified the Cartagena Protocol on Biosafety in 2003.

India has approved imports of soybean oil derived from Roundup Ready® soybean for consumption after refining. No other food products are officially permitted for commercial import.

All imports containing GM events or products must receive prior approval from the GEAC and complete a mandatory declaration.

The import of GM seeds is regulated by the national Bureau of Plant Genetic Resources under the Plant Quarantine Order (PQO) 2003.

Labelling

India supports the mandatory labelling of GM foods in the Codex Alimentarius. It has not yet enacted a GM food labelling regulation(s).

United States Department of Agriculture - Foreign Agricultural Service (2007e).

United States of America

Table A8: USA - regulatory arrangements for GMOs and GM products

Experimental and commercial release into the environment

Established in 1986, the Coordinated Framework for Regulation of Biotechnology describes the Federal policy for regulating products developed using modern biotechnology. The USA Government Agencies responsible for implementing this Framework are:

  • The United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS);
  • The United States Environmental Protection Agency (USEPA);and
  • The Department of Health and Human Services’ Food and Drug Administration (FDA).

 

USDA-APHIS is the lead agency for ensuring the safety of release of GMOs into the environment, but shares with USEPA the responsibility for the release of GM crops modified to express pesticides (for example GM insect resistant cotton).

Marketing approval

The FDA is the lead agency for food safety assessment of GMOs.

Imports

The import of GMOs into the USA is permitted with the joint approval of all three agencies. The USA (like Australia) is not a signatory to the Cartagena Protocol on Biosafety.

Labelling

If the FDA rules that a GMO is ‘substantially equivalent’ to its conventional counterpart, labelling is not required. However, labelling would be required if the FDA considers consumers need to be alerted to a potential safety issue. There are no GMOs that require labelling currently on the market in the USA.

United States Regulatory Agencies Unified Biotechnology Website (n.d.) and Foster and French (2007).

Republic of Korea

Table A9: Republic of Korea - regulatory arrangements for GMOs and GM products

Experimental and commercial release into the environment

The Korean Ministry for Food, Agriculture, Forestry and Fisheries MiFAFF) regulates labelling of unprocessed GM products and is responsible for conducting environmental risk assessments (ERA) of GM crops. The Korean Food and Drug Administration (KFDA) is responsible for the food safety approval of GM crops and the labelling of processed food products that contain GM components. The Ministry of Knowledge Economy (MKE) is the responsible authority for implementation of Korea’s obligations under the Cartagena Protocol on Biosafety (CPB).

No GM crops have been commercialised in Korea and as a result, the process for crop and food approval has only been applied to imported products to date.

Marketing approval

Currently, food safety approvals for GM crops are mandatory but ERAs are voluntary. When Korea’s Act on Transboundary Movement of Living Modified Organisms (LMO Act) takes effect (expected in 2008), it will implement Korea’s obligations under the CPB and ERAs will become mandatory. The scope of Korea’s ERAs has so far been limited to approval of GM crops for unintentional release into the environment.

As of July 2007, 50 GM events had received food safety approval and 21 had completed ERAs. Food safety approval has been given to M varieties of soybean, maize, cotton, canola, potato and sugar beet.

Imports

Korea has ratified the CPB, and is expected to start implementing its provisions in 2008. Korea imports both GM crops and processed products derived from GM crops. Maize imported for human consumption is nearly all identity-preserved non-GM. Soybean imported for food processing (not vegetable oil), for example tofu, bean paste, bean sprouts, is nearly all identity-preserved non-GM.

The KFDA maintains a zero-tolerance policy for the unintended presence of GM events in organic produce.

Korea still requires a ‘Starlink-free’ certificate and ‘Starlink-free’ statement to accompany all maize imports intended for food use from the USA. Korea also requires multiple testing of all shipments of rice from the USA to confirm the absence of LibertyLink® rice. Korea’s MiFAFF requires that two separate tests be carried out prior to loading and the KFDA requires a third test upon arrival. Once the rice is released into the market, the MiFAFF conducts a fourth test to verify the absence of LibertyLink® rice.

Labelling

Unprocessed GM crops intended for human consumption that have been approved by the KFDA are required to carry GM labels. A 3 per cent adventitious presence of a GM event in a non-GM consignment is allowed and this tolerance level applies to 20 raw agricultural products approved by Korea including cottonseed, canola, soybean and maize. Vegetable oils and processed sugar are exempt from labelling requirements

For processing products, labelling for GM components is required for 27 different food categories if either of the following apply:
GM soybean or maize comprise one or more of the top five ingredients in the final product; or
Foreign protein or DNA inserted into the product using modern biotechnological methods is still present in the final product.

The KFDA has recently proposed expanding mandatory GM labelling to GM cotton, canola, canola and sugar beets (see note below).

In April 2007, MiFAFF introduced GMO labelling requirements for animan feed. Under these requirements, retail-packaged animal feed products are required to carry a GMO label on the packaging if GMO ingredients have been used.

United States Department of Agriculture - Foreign Agricultural Service (2007i).

Note: The recently proposed changes to the Republic of Korea’s KFDA GM labelling regime, which are yet to come into force, include:

  • processing foods that contain any GM agricultural ingredients must be labelled
  • previously exempt products (i.e. highly processed food such as soy sauce or cottonseed oiil) must be labelled (a three year grace period for this requirement is proposed)
  • GM-free labelling will be available but there will be zero tolerance for unintentional GM presence
  • GM-free labelling cannot be applied to products that can't be tested for GMOs (i.e. highly processed foods such as soy sauce or cottonseed oil)
  • GM labelling will also apply to alcoholic beverages.   

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