Difference between revisions of "Team:Glasgow/HP/Gold Integrated/PolicyBrief"

Brexit

Implications on our project

On the 23rd June 2016, the UK voted to leave the European Union through a national referendum. This year, on March 29th 2017, the UK gave formal notice to the European Council under Article 50 of the Treaty on European Union (the TEU) of the UK's intention to leave the EU. This marks a decisive change for national and international policies since most current British legislation was reliant on EU-derived law.

Article 50 provides for a two-year period for the withdrawal to take effect. Even if the UK formally leaves the EU after 2 years, it is possible that much of the more detailed negotiation will need to be dealt with over a longer timeframe. This is the first time Article 50 has been used, so the UK would be setting a new precedent and this is likely to bring its own challenges for all parties involved, as there is a clear legal framework of negotiations which has never been defined before. ^[1]

The most important piece of UK legislation that would need to be repealed is the European Communities Act 1972 (ECA), which provides for the supremacy of EU law. Repealing the ECA will bring an end to the constitutional relationship that exists between EU and UK law. Moreover, the vast amounts of secondary legislation that have been passed with the objective and justification of implementing EU law would have to be considered by the Government. It has been announced that the Government intends to repeal the ECA with a ‘Great Repeal Bill’, which will convert all existing EU-derived law into domestic law allowing the UK to decide over time what laws it wishes to retain. This approach is intended to avoid the significant gaps and consequent uncertainty if all EU-derived law was repealed without replacement. ^[2]

The Government’s Great Repeal Bill White Paper proposes wide-ranging powers to amend EU-derived law by secondary legislation. In the Government’s view, these powers will give sufficient scope to correct or remove laws that would otherwise not function properly after Brexit, although the White Paper makes clear that the powers will not be able to be used to create ‘new policy’. A House of Lords committee has described Brexit it as a "unique challenge", with EU law having accumulated over decades. ^[3]

GMO legislation

In terms of legislation governing the use of GMOs within the European Union, we have considered an extensive amount of regulations that could pose a challenge to our ability to use our biosensor outside of our lab at the University of Glasgow. Since we were mainly concerned about the ethical, legal, political issues governing our project within the European Union, we have found out that the central issue is the use of live genetically modified organisms outside a contained and properly registered laboratory. This is covered in the EU by 2009/41/EC for contained use and 2001/18/EC for deliberate release into the environment, or in the UK, the Genetically Modified Organisms (Contained Use) Regulations 2014. With the crucial help provided by academic collaboration, we have created a draft listing the essential points covered by such regulations, which can be appropriately referred to when adopting different approaches on the engineering of a biosensor. We thought the following list could provide a useful guidance for future iGEM teams wishing to create a biosensor within the European Union:

• If a biosensor organism is not genetically modified, it is not covered by these regulations, but may be covered by other safety regulations.

• If a biosensor organism is modified but does not contain any DNA from an organism of a different genus (e.g. it only has 'self' genes inserted, rearranged, deleted etc.) then its status is unclear at the moment, since the EU has still not clarified the nature of the regulations regarding 'gene edited' organisms.

• If, like in our current case, an organism is modified and contains inserted genes from a different organism, as in most cases, it is covered under these regulations and can only be used inside a properly licensed laboratory. However, it might still be very useful in the food industry or clinical setting in a central test laboratory, just could not be used by consumers at home.

• If a biosensor does not contain any live organisms, e.g. is based on a cell-free transcription-translation system, then it is not regulated and can be used by anyone unless it contains toxic components, or requires culture of the target pathogen in a pre-enrichment step, in which case it must comply with the appropriate safety regulations.

Food Safety legislation

In terms of food safety in the UK, much of the detailed legislation on food standards is generated in the European Union. This year at Glasgow iGEM, we have considered extensive legislation generated in the European Union regarding food safety policies and controls. We have found that most legislation covers issues such as food hygiene and controls, however none of the regulations are specific for foodborne diseases and on how to prevent them, which will of course include infections caused by Campylobacter. Here we provide a summary of the legislation generated in the European Union on food standards. In addition, the Food Standards Agency provides a page for updates on rapidly changing EU policy. ^[4]

EC Standing Committee on the Food Chain and Animal Health

This committee was established following the adoption of Regulation (EC) 178/2002, which set out the general principles and requirements of food law in the EU. There is a continual flow of technical measures arising from meetings of the animal nutrition section of the Standing Committee on the Food Chain and Animal Health. These mainly concern new or revised authorisations for feed additives, which cannot be used in feed unless they have been specifically authorised, and reviews of the maximum permitted levels of various contaminants. Feed additives are authorised by EC Regulations which apply directly in Member States. ^[5]

Microbiological criteria for foodstuffs: Guidance for food business operators

EU Regulation No. 2073/2005 on microbiological criteria for foods (as amended by EU Regulation No. 1441/2007) complements the food hygiene legislation and applies to all food businesses involved in the production and handling of food. It should be stressed that the regulation is flexible in its approach, in that sampling and testing plans should be determined on the basis of risk (e.g. size and type of business). The microbiological criteria can be used by the food business to validate and verify their food safety management procedures and when assessing the acceptability of foodstuffs or their manufacturing, handling and distribution processes. This regulation does not introduce a general requirement for routine end product testing or the need to await results before placing a product on the market (positive release). Trade organisations, such as the British Retail Consortium and Chilled Food Association, have produced guidance on complying with the regulation that may also be helpful. ^[6]

Official feed and food controls regulation

EU Regulation 882/2004 on official controls for feed and food law (and animal health and animal welfare) sets out the approach that competent authorities of member states must adopt for official controls. Essentially, how they should monitor and enforce businesses' compliance with feed and food law (and with animal health and welfare rules). The European Commission believes that the legislation has been broadly successful in setting out a framework for feed and food controls throughout Europe, but has identified opportunities to strengthen 882/2004. The Commission published proposals to change the current legislation on 6 May 2013. Information on the proposed changes can be found at the link below. In the UK the Agency has overall responsibility for application of the feed and food elements of 882/2004. Defra and the devolved agriculture/rural affairs departments have responsibility for application in the areas of animal health and animal welfare. ^[7]

Enforcement of food hygiene in butchers' shops

Information for local authorities on enforcement at butchers' shops selling raw meat and ready-to-eat foods. The Food Law Code of Practice recognises that food businesses manufacturing high-risk ready-to-eat foods present a greater inherent risk. Butchers selling raw meat and producing ready-to-eat foods on-site would fall within this category. The fact that the ready-to-eat foods are often sold and consumed a number of days after production is one factor that leads to this greater inherent risk, alongside the potential for cross-contamination after production and before consumption. Consequently, bespoke and more detailed food safety management procedures are required in such establishments to ensure the production of safe food, and to comply with food law. Safer food better business is not considered to provide appropriate procedures in such establishments. Local authorities should carefully evaluate whether any such establishments under their control require their input over and above that determined by the Food Law Code of Practice. It is acknowledged that the same course of action will not be appropriate for all such establishments and that any additional input will relate to the confidence that the authority’s officers have in the controls in place at such businesses. The precise nature of any visit will vary and will be influenced by the business’s history of compliance, particularly with Article 5 of EC regulation 852/2004. ^[8] If any additional visits are considered appropriate or necessary, they may include:

• a focused visit to ensure the appropriateness and implementation of documented food safety management procedures, and include an audit element
• an assessment of the business’s adherence to the FSA’s guidance on controlling the risk of cross-contamination by E.coli O157
• follow up action to address issues of non compliance

References