In its guidance document, the European Food Safety Authority (EFSA) outlines specific data requirements and the methodology to be followed for risk assessment should applications for food and feed derived from GM animals be submitted for market authorisation in the European Union (EU). The risk assessment approach compares GM animals and derived food and feed with their respective conventional counterparts integrating both food and feed safety as well as animal health and welfare aspects. All stakeholders and interested parties are invited to provide their comments through an online public consultation that runs until 30 September 2011.
At present, no applications for market approval of food and feed derived from GM animals have been submitted in the EU. The technology has advanced rapidly in recent years and in some countries outside the EU regulators are already evaluating the safety of GM animal products developed for food and feed purposes. In this context and as a proactive measure in anticipation of potential future applications, the European Commission requested EFSA in 2007 to develop comprehensive guidance for the risk assessment of food and feed derived from GM animals and in 2010 requested the inclusion of related aspects of animal health and welfare. The draft guidance document, developed by scientific experts from EFSA’s Panel on Genetically Modified Organisms (GMO) and Panel on Animal Health and Welfare (AHAW), integrates the risk assessment of food and feed from GM animals with related aspects of animal health and welfare. A separate EFSA guidance document, due to be launched for public consultation in 2012, will address the environmental risk assessment of GM animals.
The present draft guidance document outlines a risk assessment approach to compare GM animals and derived food and feed with their respective conventional counterparts. The basic assumption of this type of comparative assessment is that food and feed from conventionally-bred animals have a history of safe use and therefore can serve as a baseline for the risk assessment of food and feed derived from GM animals. The document outlines specific data requirements for the comparative analysis of different components of the food and feed risk assessment. Important components of the risk assessment include molecular characterisation, compositional analysis and assessment of toxicity, nutritional aspects and potential allergenicity. For example, experts can assess whether food and feed from GM animals are as nutritious to humans and animals as those from conventionally-bred animals.
The draft guidance document also outlines the methodology required for the comparative assessment of health and welfare aspects of GM animals. This assessment is applied in two ways: firstly, in relation to the GM animal itself, where the assessment should focus on the effective functioning of the animal’s body systems (e.g. disease resistance); and secondly, in relation to the food and feed risk assessment, as the health and welfare status of animals is seen as an important indicator of the safety of animal-derived products. The draft guidance highlights the need for extensive comparative analysis of the characteristics and traits of GM animals, including physiological parameters, with those of their conventional counterparts. It also proposes that health and welfare should be assessed at all stages of development of the GM animal, up to the point at which it would receive authorisation, should this be granted. The recommended three-stage assessment strategy covers the laboratory setting where the GM animal is initially developed, experimental field trials outside the laboratory involving a higher number of animals and trials with large numbers of animals carried out in a commercial setting (prior to authorisation).
In the final chapter of the draft guidance document, recommendations are made for the post-market monitoring and surveillance (PMM) of GM animals and derived food and feed, which seeks to identify any potential unintended effects related to the genetic modification which might arise after the product has been authorised for placement on the market.
In the case of food and feed safety, PMM is not a substitute for but rather a complement to a thorough pre-marketing toxicological testing programme. PMM should be required in specific cases such as for GM food and feed with altered nutritional composition and/or for food and feed genetically modified to achieve specific health benefits.
In regard to animal health and welfare PMM is required to determine possible long-term unexpected effects with low incidence. The monitoring takes into account the breeding of large numbers of GM animals for food and feed purposes in more varied commercial conditions than those established during stage three of the proposed assessment strategy for animal health and welfare (i.e. trials carried out in a commercial setting).
EFSA invites stakeholders and all interested parties to comment on its draft guidance through a public consultation available on the EFSA website until 30 September 2011. Following the public consultation, EFSA will assess all comments made and, where relevant, these will be incorporated in a revised guidance document to be adopted by EFSA’s GMO and AHAW Panels at the end of 2011.
The risk assessment of GM animals proposed in the draft guidance follows a comparative approach similar to that required by EFSA for the risk assessment of GM plants.
Although no applications for market approval of GM animals have been submitted in the EU, in the US, the Food and Drug Administration (FDA) is currently considering an application from industry for placement on the market of a GM salmon.
The development of EFSA’s draft guidance on food and feed risk assessment of GM animals and animal health and welfare aspects followed a programme of work that began in 2009. At the beginning of that year, EFSA set up a Working Group of its GMO Panel to address the molecular characterisation and food and feed safety assessment of products derived from GM animals. In 2010, EFSA set up a Working Group of the AHAW Panel to address animal health and welfare aspects. The draft guidance was also informed by existing guidance on the subject of GM animals, namely the Codex Alimentarius “Guideline for the conduct of food safety assessment of foods derived from recombinant-DNA animals”. In 2008, EFSA provided scientific and technical advice to the European Commission related to the preparation of this Codex Alimentarius guidance.