High lysine corn gazetted

High lysine corn is being gazetted today at 1pm. This corn is used as an animal feed, but it has had its safety assessed as if for human consumption. Food containing this GM variety can now be imported and sold in New Zealand, although such products would have to adhere to GM labelling requirements, says NZFSA Director (Joint Food Standards), Carole Inkster.

"Although the corn was assessed as safe some time ago, and was approved by the Australia New Zealand Food Regulation Ministerial Council in July, the previous Minister for Food Safety (Minister King) delayed its gazettal in New Zealand while she sought advice as to whether approvals for varieties not intended for human food use are within the scope of the Food Treaty New Zealand shares with Australia. NZFSA has worked through this issue and advice on this legal matter has now been received. It confirms that approvals for this type of variety are within the scope of the Food Treaty."

Carole Inkster says that the delays are not, contrary to some media reports, because of safety concerns.

"The Food Standards Australia New Zealand (FSANZ) assessment process was thorough and included two rounds of public consultation. The final safety assessment was externally peer-reviewed and, to ensure the assessment took into account the New Zealand context, NZFSA commissioned ESR to analyse the science. We are satisfied that this corn is as safe as conventional corn should it ever enter the human food chain."

High lysine corn has been approved as safe by every country asked to assess it as far as NZFSA is aware. It is a high-value animal feed and its use as a human food is allowed in the United States, Japan, Canada, Australia and the Philippines. The FSANZ approval for use of high lysine corn as an animal feed does not allow it to be grown in New Zealand. This would require assessment and approval by the New Zealand Risk Management Authority (ERMA) and further public consultation.


High lysine corn – questions and answers

What is high lysine corn?

High lysine corn has been genetically modified to produce higher than usual levels of an amino acid called lysine. Pigs and chickens fed conventional corn-based diets need to have lysine added to their feed for optimal animal growth and performance. Animals fed with high lysine corn don't need additional lysine.

Has high lysine corn been approved for human consumption in other countries?

Yes. High lysine corn is approved for use as food in the United States, Canada, Japan, the Philippines, Australia and New Zealand. To the best of NZFSA's knowledge high lysine corn has been found to be safe for human consumption by every food regulatory agency that has assessed its safety.

Are there human health risks with consumption of high lysine corn?

The FSANZ safety assessment did not find any potential public health and safety concerns with the consumption of food derived from high lysine corn. FSANZ concluded that high lysine corn is as safe and wholesome as food derived from other corn varieties.

The FSANZ safety assessment was externally reviewed by two independent experts. Both reviewers considered that the safety of high lysine corn was adequately demonstrated by the FSANZ safety assessment.

The New Zealand Food Safety Authority (NZFSA) also reviewed the FSANZ safety assessment and agreed with its conclusions. In addition, NZFSA commissioned Environmental Science and Research Ltd (ESR) to provide an expert opinion on the safety assessment. ESR also agreed with the FSANZ conclusions.

Are there any safety concerns?

Some people say that high lysine corn has the potential to form advanced glycation endproducts (AGEs) and toxic by-products, as well as presenting risks associated with potential allergens.

These issues were well canvassed during the FSANZ safety assessment process. FSANZ made a detailed response to 94 recommendations made by the Centre for Integrated Research in Biosafety (INBI). FSANZ also re-examined the evidence on which its decision was based during a review and it remained satisfied that high lysine corn is as safe as food derived from other corn varieties and upheld its recommendation.

AGEs are a class of chemicals that form when amino acids (such as those that make up lysine) and sugars react together. AGEs can occur naturally in the body through normal metabolism and aging; form during prolonged food storage; and occur in many foods, such as bread crusts, chocolate, roasted meats and fried foods during cooking. The particular range of AGEs in any food is influenced by the composition of proteins, sugars and fat of the food and also by the cooking method and duration. The formation of AGEs is not unique to high lysine corn or any other GM food.

Further information can be found on the FSANZ website at:
http://www.foodstandards.gov.au/standardsdevelopment/applications/applicationa549foodd2801.cfm  

Is high lysine corn likely to get into human food?

High lysine corn will not be grown in New Zealand and will not be used in breeding programmes for other types of corn, such as sweet corn, that are used as human food. However, there is the potential for the imported product to co-mingle with conventional corn and enter the human food chain. A system called 'identity preservation methods' is used to minimise this possibility, but co-mingling of commercial grains can occur. This is why FSANZ has assessed high lysine corn as if it were intended for human consumption.

The main product produced from imported corn is high fructose corn syrup which would contain very little, if any, protein, including lysine.

Can high lysine corn be imported into New Zealand?

Yes. FSANZ has assessed high lysine corn as if it were intended for use as a human food. Any high lysine corn imported into New Zealand cannot be in a form that could germinate, and foods containing DNA and/or protein from this variety would need to be labelled accordingly.

Will food products containing high lysine corn be labelled?

All food sold in New Zealand must be labelled as GM if it contains novel DNA and/or protein, or the food has altered characteristics as a result of a genetic modification process. This applies to high lysine corn. Any food containing its DNA and/or protein would need to be labelled to indicate both genetic modification and increased levels of lysine.

There is an allowance for the unintentional presence of approved GM foods of up to 1% before an ingredient must be labelled. This recognises that occasionally some cross-contamination of different foods can occur. Food produced from animals fed on high lysine corn does not need to be labelled.

Is the Food Standards Australia New Zealand safety assessment process international best practice?
The FSANZ pre-market safety assessment is based on international guidelines developed by the Food and Agricultural Organization of the United Nations (FAO), World Health Organization (WHO), the Organisation for Economic Cooperation and Development (OECD) and Codex Alimentarius Commission.

What is the FSANZ Safety Assessment Process?
Before any GM food can be sold in New Zealand, it must first be assessed for safety by FSANZ, approved by the FSANZ Board and then cleared by all Australian and New Zealand ministers responsible for food regulation.

Standard 1.5.2 of the Australia New Zealand Food Standards Code sets out a general prohibition on the sale and use of food produced using gene technology, unless specific permission is given under that Standard.

When assessing the safety of a GM food, FSANZ requires a wide range of information from an applicant. This includes the nature of the genetic modification, the presence of any antibiotic resistance genes, a characterisation of the novel protein, characterisation of any other novel substances (including acute oral toxicological studies and assessment of potential allergenicity), compositional analyses, information on the nutritional impact, and information on overseas approvals (or refusals to approve). A statutory declaration is also required with all applications.

The high lysine corn assessment took place over a two and a half year period, involved two rounds of public consultation and was reviewed at the Ministers' request.

Why does FSANZ assess GM products not intended for human consumption?

In mid 2000, GM StarLink corn was found in food products in the United States, and then in food products in several other countries. StarLink corn had been approved for animal feed use, but not for human food use, on the grounds that it had one characteristic of a potential allergen.

As a consequence, many regulatory authorities, including FSANZ, now require GM products intended for non-food use to also gain approval for use as a human food. In such cases, the safety assessment conducted by FSANZ is no different to the rigorous scientific assessment conducted on any GM food. If a risk to human health was identified, the variety would not be allowed to be used for either purpose. This approach ensures the protection of public health and safety should the product ever enter human food.

Can high lysine corn be grown in New Zealand?

No. The FSANZ approval for food derived from high lysine corn does not constitute an approval allowing it to be grown in New Zealand. Before high lysine corn could be grown in New Zealand it would need to be assessed and approved by the New Zealand Risk Management Authority (ERMA). This would involve public consultation. ERMA has not received any application for the environmental release of high lysine corn.

Did FSANZ compare high lysine corn to another GM Variety?

When assessing the safety of high lysine corn, FSANZ used a negative segregant as a comparator. A negative segregant is an individual that has been subjected to the application of GM techniques, but has not take up the novel gene introduced into the GM variety commercialised. In this case the negative segregant does not contain the gene introduced into high lysine corn that results in that variety having higher levels of lysine.

Opponents of high lysine corn claimed that by using a negative segregant FSANZ departed from International Guidelines. These people cite a footnote in the relevant International Guideline that states "it is recognised that for the foreseeable future, foods derived from modern biotechnology will not be used as conventional counterparts".

The Task Force who developed this Guideline had extensive discussion on this issue and specifically decided not to limit the definition of conventional counterpart to non-GM organisms. In addition, a FAO/WHO Expert Consultation, that was established to advise the Task Force, was of the opinion that the comparator used in a safety assessment should ideally be the "near isogenic parental line grown under identical conditions". They did not state that it could not be a GM variety.

Why didn't FSANZ use the non-GM parental line as the comparator?

Often the breeding steps involved in the development of a GM variety result in the genetic background of the variety commercialised being quite different to that of the original parental line. When conducting a safety assessment, the closer the comparator is in genetic background to the line commercialised, the more sensitive the comparison will be in detecting unintended effects directly related to the introduced gene/s. Using a distantly related parental line is likely to result in differences being identified that are not attributable to the novel gene, but are purely the result of the two lines being distantly related.