FSA documents covering hormone treated beef: 1. VMD Briefing for CE 0420 To: Author: SCS clearance by: Subject: Emily Miles Enrique Vega Jane Clark Introductory meeting with VMD Logistics Teams meeting – 28 April at 10:00-11:00. Jane Clark is attending. Agenda 1. EU Exit • Growth Promotors 2. Post-exit relations – no briefing, will be an open discussion Enrique Vega Paul Cook Agenda item 1 - EU Exit (Residue testing, MRL setting, Growth promoters) Objectives • Residual testing - Discuss roles and responsibilities and how FSA and VMD work together (with Defra/DAs) in the context of UK exiting the EU. • MRL setting - Discuss future FSA involvement in MRL setting process for veterinary medicines • Growth Promoters – Confirm that FSA consider that growth promoters are a veterinary medicine with Defra/VMD as the policy owners and discuss how FSA engage and support food safety considerations during trade negotiations Top lines to take • Growth Promoters • Growth promoters are veterinary medicines for which Defra/VMD has policy lead • FSA has a vested interest in the safety of residues in foods and remains willing to provide input on food safety upon request • Some preliminary work has been done by COT to assess what further information is needed for a full RA of growth hormones Key Facts • MRL setting • • • • • MRL setting is currently undertaken at EU level. VMD have planned for assessments and decisions to be taken post exit using existing structures, namely SCISEC made up of officials and where needed VPC. Authorisation and MRL setting can be done administratively by DEFRA ministers, does not require an SI. VMD are assessing future methods for undertaking consumer exposure assessments using actual consumption data (as done by JECFA). VMD have asked for support from FSA for consumption data and exposure assessments to facilitate this. Growth Promoters • Growth promoters are prohibited from non-therapeutic use and include beta-agonists as well as hormones. • Hormones have metabolic and physiological actions, meaning they are veterinary medicines under definition in legislation (included in corresponding annex). • VMD generally has a purely national focus; consider that the focus for hormones has possible use in imported food. If the blanket ban on growth promoters is lifted, an evaluation and authorisation of individual substances is needed before they are permitted both domestically and in imported food. • Issues surrounding growth promotors are more extensive than purely food safety; due to the high level of consumer interest and a strong push from international partners likely on trade. Background • MRL setting • FSA currently has sight of papers submitted to SCISEC/VPC with ability to comment but lacks a formal route to flag any possible food safety concerns. • Exposure assessments for veterinary medicine residues have traditionally been relatively simplistic and use a ‘hypothetical basket’ approach but the trend is toward using actual consumption data in exposure assessments. FSA will occasionally use simplistic models where appropriate but we generally use advanced models in our assessments for all chemicals including veterinary medicine incidents and are happy to advise other departments. • Growth Promoters • Recent discussions in preparation for EU exit have unearthed uncertainty in where policy lead for growth promoting hormones in food production lies. Defra are leading on some policy mapping. Annexes Annex for EU Exit items: MRL testing Annex A: Current Processes in the UK A Maximum Residue Limit (MRL) is the maximum allowed concentration of a residue in foodstuffs obtained from an animal that has been exposed to veterinary medicine. Such limits are used to protect the consumer from unnecessary exposure to chemicals that may represent a hazard to health, whilst also promoting appropriate use of veterinary medicines through good animal husbandry. The lead on policy and authorisation of veterinary medicines is VMD. Applications for veterinary medicines are assessed by the VMD Scientific Secretariat (VMD peer review group, Pharmaceuticals) SCISEC. The Veterinary Products Committee (VPC) also have oversight of issues related to veterinary medicines. FSA (policy and science) are currently included in circulation of SCISEC papers and any additional food safety concerns can be raised as necessary on an ad hoc basis. It should be noted that both SCISEC and VPC are involved in both risk assessment and risk management. MRLs are currently set at EU level on the basis of advice from the European Medicines Agency (EMA). Current Processes within the EU The Committee for Medicinal Products for Veterinary Use (CVMP) plays a vital role in the authorisation of veterinary medicines in the European Union. In the centralised procedure, the CVMP is responsible for: • Conducting the initial assessment of EU-wide marketing authorisation applications as well as post-authorisation and maintenance activities e.g. modifications or extensions, safety monitoring and recommending changes to a medicine’s market authorisation • The CVMP also evaluates veterinary medicines authorised at national level referred to EMA for a harmonised position across the EU. • The CVMP recommends safe limits for residues of veterinary medicines used in food-producing animals and biocidal products used in animal husbandry, for the establishment of maximum residue limits by the European Commission. In addition, the CVMP and its working parties contribute to the development of veterinary medicines and medicine regulation, by: • • • Providing scientific advice to companies researching and developing new veterinary medicines Preparing scientific guidelines and regulatory guidance to help pharmaceutical companies prepare marketing authorisation applications for veterinary medicines Cooperate with international partners on the harmonisation of regulatory requirements Growth Promotors Annex A: Legislative Background (i) Defining a veterinary medicine: In legislation, “veterinary medicinal product” means: (a) Any substance or combination of substances presented as having properties for treating or preventing disease in animals; or (b) Any substance or combination of substances that may be used in or administered to animals with a view either to restoring, correcting or modifying physiological functions, by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. (ii) Legal ban on growth promoting hormones in food production Directive 96/22/EC maintains a prohibition on the use of substances having a hormonal or thyrostatic action and of beta agonists. The use of such substances for growth promotion is prohibited, whilst the directive allows very limited exemptions for specific substances to be used for therapeutic purposes. VMD have authorised hormones for this type of usage. The relevant elements of the Directive have been implemented into law by ‘The Animals and Animal Products (Examination for Residues and Maximum Residue Limits) (England and Scotland) Regulations 2015’ with similar provisions in Wales and Northern Ireland. Annex B: Further Information (i) Scientific background on growth promotors There are six growth promoting hormones under policy consideration which have not been authorised for use in food production. Two of these hormones are however authorised for other veterinary purposes. The six could be considered to fall in two groups: 1. Natural growth promoters: 17β-oestradiol, Testosterone, Progesterone 2. The synthetic substances: Zeranol (which has oestrogenic activity), Trenbelone acetate (which has androgenic activity), Melengestrol acetate (which has progestagenic activity). VPC concluded (2006/7) that evidence suggested likely exposure levels from treated meat wouldn’t induce measurable physiological effects; some evidential gaps however. (ii) WTO implications Whilst food safety is often quoted as the reason for the overall prohibition this was not necessarily what inspired the original measure in the 1980’s which was also about the acceptability of the use of growth promoters in general as well as possible food safety issues. Of the substances currently prohibited the quoted concerns are various including food safety, animal welfare and consumer acceptability in different combinations. The current EU blanket ban has been challenged and found wanting at WTO. The UK in maintaining this blanket ban will be open to challenge post exit. Whilst the current focus of relates to hormones the issue can be split into two elements. • • Firstly, the blanket prohibition which is a precautionary measure based on contested opinions from the European Commission’s former Scientific Committee on Veterinary Measures Related to Public Health (SCVPH) in addition to the wider issue of the acceptability of growth promoters. Secondly should the blanket ban be removed the individual substances should be assessed individually as veterinary medicines and a position taken based on the available evidence (as veterinary medicines normally there would be a greater onus on a requester to provide the necessary data in an application to allow a risk assessment to be undertaken). 2. FSA Future Involvement in MRL decisions The FSA has an interest from a food safety perspective in veterinary medicines and pesticides however the policy lead for their authorisation lies elsewhere. There are various elements related to these regimes ranging from the setting or MRLs, to authorising specific product formulations. In broad terms the MRL setting aspect is the most relevant for food safety and this is currently undertaken at EU level taking into account opinions by EMA and EFSA (thus subject to a degree of transparency and independence). After EU exit the responsibility for setting MRLs will fall to the relevant UK authorities. The sections below set out the current and future process for setting MRLs in these two areas with details of the formal and informal input for the FSA into these processes. It should be noted that the future scenarios are on the no deal basis. These may therefore be further adapted, reinforced in due course. However, it is not clear to what extent Defra will provide more formal input for FSA and to what extent issues in these areas could interplay with the FSA RA process. Veterinary medicines Current Situation The lead on policy and authorisation of veterinary medicines is VMD. Applications for veterinary medicines are assessed by the VMD Scientific Secretariat (VMD peer review group, Pharmaceuticals) SCISEC. The Veterinary Products Committee (VPC) also have oversight of issues related to veterinary medicines. FSA (policy and science) are currently included in circulation of SCISEC papers and any additional food safety concerns can be raised as necessary on an ad hoc basis. It should be noted that both SCISEC and VPC are involved in both risk assessment and risk management. MRLs are currently set at EU level on the basis of advice from the European Medicines Agency (EMA). Future approach (http://data.parliament.uk/DepositedPapers/Files/DEP20180962/Regulation_of_veterinary_medicines_if_theres_no_Brexit_deal.pdf) Existing EU MRLs would become UK law via the EU Withdrawal Act. This would ensure the UK can continue to trade animal food products with the EU and the majority of third countries that recognise the EU process. After this, the UK would need to set new MRLs and modify existing MRLs on a UK domestic basis. In order to assess MRL applications, the VMD would need to have access to supporting data. To maximise flexibility, the Secretary of State for Defra would have the power to set MRLs based on data from a range of sources, including other MRL setting bodies. UK exporters of products of animal origin to the EU would need to ensure they comply with EU MRLs, including those which may diverge from UK MRLs. The legislation is short on detail on the internal process for setting MRLs but gives the power to the appropriate authority to publish the assessment report that has been prepared on the MRL application and to maintain a publicly available register containing the MRLs. VMD envisage that SCISEC will take on the task of considering applications for MRLs post EU exit. VPC may have some form of oversight of the process and potentially looking in detail at particular cases. SCISEC meet on a monthly basis and VPC currently meets 3 times a year however that may change going forward as a result of the new work arising from EU exit. FSA (policy and science) routinely receive SCISEC papers and have the opportunity to comment on items as they are discussed. FSA has no formal position on VPC as with officials of other government departments with an interest in the issues under consideration FSA officials may attend meetings of, or provide written advice to the VPC or its sub-committees but they are not members. Note Enrique Vega is a member of VPC but that is in a personal capacity and he is not formally representing the FSA as such. 3. Hormone Policy Briefing_v3 Briefing Note: Agreeing a policy lead on the authorisation of hormones. Issue: Recent discussions in preparation for EU exit have unearthed some uncertainty in where policy lead for growth promoting hormones in food production lies. Specifically, in the frame of future trade negotiations who would be responsible for advising Ministers on whether the current EU prohibition should be maintained and on providing the evidence to defend any WTO challenge. Defra are considering this issue internally and this may be subject to future high-level engagement with FSA and VMD. Defra are in parallel preparing a submission to Defra Ministers setting out the background and current state of science around hormone treated beef and the potential WTO risks. FSA position DEFRA/VMD have the policy lead for veterinary medicines and since growth promoting hormones fall under the definition of veterinary medicine products ultimately, they also lead on growth promoting hormones. FSA however retains an interest in this issue to ensure that any residues of any veterinary medicine do not create unacceptable food safety risks. The COT (Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment) is an independent scientific committee that provides advice to the Food Standards Agency, the Department of Health and other Government Departments and Agencies on matters concerning the toxicity of chemicals. It does not however routinely undertake risk assessments on veterinary medicines although COT can provide advice on specific issues when requested. Whilst hormones are of high media interest fundamentally from a risk assessment perspective they are no different than any other veterinary medicine. Before being harmonised at EU level vet medicines would have been considered by the forerunner to the Veterinary Products Committee (VPC) and post exit (see separate briefing paper) will be considered by VPC and/or VMD scientists. Such evaluations of veterinary medicines will take into account numerous risks including to animal welfare, food safety, environment etc. VMD position Although VMD lead on all matters related to veterinary medicines they consider that since the issue at hand is most relevant for imported meat FSA would have the lead. Defensive line if needed: • • • Whilst FSA remain happy to advise on food safety aspects on request VMD are the lead for evaluating and authorising veterinary medicines that can be used on both animals domestically and on imported meat. The existence of the blanket ban on growth promoters should not change this approach and any relaxation of the ban may have to apply for imported and domestic production. The logical conclusion of the VMD position is that FSA should evaluate all individual veterinary medicines in relation to food safety although this aspect is already included in the overall risk assessment undertaken by VMD. Discussion Current EU legislation contains a cross cutting prohibition on use of various substances for growth promoting purposes. This prohibits hormones for nontherapeutic purposes but also beta agonists such as ractopamine and zilpaterol. Whilst food safety is often quoted as the reason for the overall prohibition this was not necessarily what inspired the original measure in the 1980’s which was more about the acceptability of the use of growth promoters in general as well as possible food safety issues. Of the substances currently prohibited the quoted concerns are various including food safety, animal welfare and consumer acceptability in different combinations. . Background That hormones are veterinary medicines Hormones have metabolic and physiological actions. In legislation, “veterinary medicinal product” means: (a) Any substance or combination of substances presented as having properties for treating or preventing disease in animals; or (b) Any substance or combination of substances that may be used in or administered to animals with a view either to restoring, correcting or modifying physiological functions, by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis. Legal ban on growth promoting hormones in food production Directive 96/22/EC maintains a prohibition on the use of substances having a hormonal or thyrostatic action and of beta agonists. The use of such substances for growth promotion is prohibited, whilst the directive allows very limited exemptions for specific substances to be used for therapeutic purposes. VMD have authorised hormones for this type of usage. This legislation applies to both domestic production and to imports from third countries. The relevant elements of the directive have been implemented into law by ‘The Animals and Animal Products (Examination for Residues and Maximum Residue Limits) (England and Scotland) Regulations 2015’ with similar provisions in Wales and Northern Ireland. FSA documents covering chlorinated chicken: 1. DOCUMENT – Parliamentary handling strategy Context of the following – It is FSA comments replying with reference to chlorinate washed chicken in relation to handling of an amendment (NC34) to the Agriculture Bill concerning substances to remove surface contamination. Extract one: An amendment worded as in NC34 would prohibit use of all substances other than potable water to remove surface contamination from animals and animal products. There may be initial support from farming stakeholders and parts of the food industry for the amendment as it applies to products of animal origin due to concerns that meat may be permitted to be imported from countries where as a result of using of using chlorinated wash lower welfare and hygiene standards are allowed compared to UK standards, and the imported meat is cheaper as a result of applying lower standards. However, farming and industry stakeholders will find re-assurance, and may question the need for the amendment, as there is already a robust legislative basis under retained EU food hygiene legislation to regulate what substances can be used to remove surface contamination from products of animal origin for human consumption. This prohibits the use of unapproved substances and has the effect of prohibiting the use of chlorinated wash on meat. Any proposals to approve a new substance to remove surface contamination will be subject to a rigorous approval process, which after the UK leaves the EU will include an evidence-based risk analysis and will be required to by authorised by Ministers and the SI subject to Parliamentary scrutiny. The approval process under current legislation allows for technological development so that substances which are assessed as safe and effective can be considered for approval. Also, other implications of the amendment are likely to raise farming and industry concerns about the amendment: Farming interests are likely to oppose the amendment as it applies to live animals, for example as regards use of chemicals in sheep dips. The UK fishery products and live bivalve mollusc Industries will be concerned that the amendment has the effect of prohibiting the use of clean water and clean seawater to remove surface contamination. The milk and dairy industry may be concerned as the use of authorised/registered teat dips and teat sprays would no longer be permitted by the amendment. Food businesses which use the currently approved substances, lactic acid on bovine carcases and recycled hot water on domestic ungulates and farmed game carcases, will find these substances prohibited and need to change their business practices. The industry may be concerned that the amendment does not allow for innovation or the development of safe substances for handling animal products, as the approval would need to be by means of primary legislation. Importers of meat from Canada may be concerned, as the Canadian industry uses lactic acid which is permitted under current EU food law, but which would not be permitted under the amendment. Similarly, exporters to Canada will be concerned that such as change has implications for trade with Canada. Extract two: Assurances should be given that there is already a robust legislative basis under retained EU food hygiene legislation (Regulation (EC) No 853/2004) to regulate what substances can be used to remove surface contamination from POAO. Only approved substances can be used to remove surface contamination from POAO. Chlorinated wash is not approved and is therefore not permitted to be used to remove surface contamination from chicken carcases. Any proposal to approve a new substance to remove surface contamination from POAO will be subject to the FSA’s/FSS’s independent, rigorous and transparent evidencebased risk analysis process where outputs and advice to Ministers will be publicly available. Any decision on whether to approve a substance for this purpose will be made by Ministers. A statutory instrument will be required allowing for the usual Parliamentary scrutiny. It could be flagged up that proposing an amendment to the Agriculture Bill similar to NC34 would mean that two separate legislative measures are in place risking confusion as to which legislation applies and divergence between the legislation. For example, if an amendment to the Ag Bill was worded as in NC34 it would prohibit the use of certain substances which are approved under 853/2004 such as clean water (see above). NC34 also could have had consequential effects of allowing the use of potable water to wash faecal contamination from carcases of domestic ungulates in abattoirs, which is not permitted under retained EU hygiene law. 853/2004 requires faecal material be trimmed of ungulate carcases. If an amendment similar to NC34 is proposed there needs to clarity as whether it is intended to apply only in England or more widely across the UK. Food hygiene is a devolved area and there would need to be consultation with Devolved Administrations. If the amendment were only to apply in some parts of the UK, this could have implications for trade within the internal UK market. 2. DOCUMENT – Specific Hygiene amendment HoL BRIEFING PACK FINAL Regulations to be considered The Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019 16 October 2019 CONTENTS Opening Speech 3 Closing remarks 10 Crib Sheet 11 Key points 21 Urgent Procedure Made-Affirmative Q+A 24 Questions concerning EU Exit and the SI programme 26 Questions concerning the consultation and impact on industry 39 Questions concerning devolved administrations and territorial application 41 Transfer of powers 47 Questions concerning issues specific to the SI 49 • Questions concerning RASFF 55 Questions concerning the risk analysis process 61 Questions concerning Trade 73 Questions concerning consequences of not proceeding with this legislation 74 PQs 76 Press coverage 78 Speech INTRODUCTION • My Lords, I thank the noble Lords for their consideration of: The Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019. • • My Lords, I am confident that we have the shared intention to ensure that the high standards of food and feed safety and consumer protection we enjoy in this country are maintained when the UK leaves the European Union. This instrument, and the original instrument that it amends, only seek to protect and maintain these standards. Changes are limited to minor drafting amendments to ensure that the legislation is operable on exit day. No policy changes are made through these instruments and we do not have any intention of making any at this point. • • This amends a previous EU Exit SI, The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019. Further clarity was required in setting out the authorisation process for products which can be used to remove surface contamination from products of animal origin. The clarification will ensure that the process is robust and can be applied clearly in assessing the risk of new products This instrument was made on 9 September under the urgent, made-affirmative procedure, which was considered appropriate to meet the deadline for the European Commission’s Third Country Listing vote on 11 October. It needed to be in place to support the UK’s application for third country listed status with the EU. Third country listed status guarantees that the UK can continue to export animals and animal products to the EU after exit. The application was voted on by the European Commission on 11 October, and I am pleased to report to my Lords that the vote was indeed in favour of accepting the UK’s application for third country listed status for products of animal origin. No Deal Planning • As my noble Lords know, the government has made clear that its priority is to seek a negotiated deal with the EU, but we are taking responsible action to ensure we prepare for every eventuality. Purpose of this instrument • • • I will now expand on the specific detail of the minor and technical changes made by this Instrument. The new instrument makes clear that the responsibility to approve substances which may be used to remove surface contamination from products of animal origin rests with the Secretary of State for Health and Social Care, and the appropriate Minister in each of the Devolved Administrations. Lack of clarity may affect implementation and has the potential to undermine the responsibilities for authorisation; this instrument rectifies this. This measure introduces no substantive policy changes to what has already been successfully passed and made in Parliament in March 2019. Main Changes • • Food Business Operators are not permitted to use any substance other than potable water, or where permitted clean water, to remove surface contamination from products of animal origin unless this has been approved. This relates to business establishments that handle products such as meat, eggs, fish, cheese and milk and which do not supply to final consumers. Currently, approval for such substances is given by the European Commission but after EU exit this responsibility will be carried out by Ministers. The amendment to Regulation (EC) 853/2004 made by the Specific Food Hygiene SI, is being further amended to make it absolutely clear that Ministers will be responsible for prescribing the use of any other substances and the process of consulting the Food Safety Authority is retained. That decision will be made based on independent food safety advice from the Food Standards Agency (the FSA)/ Food Standards Scotland (FSS). • If, after EU exit, any additional substances are proposed to be approved for this purpose, they will be subject to risk analysis by the FSA which has established a rigorous and transparent risk analysis process for assessment and approval of any such new substances. Any requests for substance approval would be subject to thorough scientific risk assessment and risk management before being put to Ministers for final decision. Impact on industry • Let me be clear that neither this instrument, nor the instrument it amends, introduce any changes for food businesses in how they are regulated and how they are run, nor does it introduce extra burden. • The overall changes to the food hygiene regulations will ensure a robust system of controls which will underpin UK businesses’ ability to trade both domestically and internationally. Devolved Administrations • It is also important to note that we have engaged positively with the devolved administrations throughout the development of this instrument. Furthermore, this ongoing engagement has been warmly welcomed. • • The devolved administrations in Wales and Northern Ireland have provided their consent for this instrument. The Scottish Government has been made aware of these Regulations but has not yet had the opportunity to scrutinise them. I would like to stress that we would not normally make EU Exit Regulations under this Act without the agreement of all the Devolved Administrations where the policy area is devolved in competence. However, as I have explained, this is a very minor drafting change to a Regulation which the Scottish Parliament has previously agreed. Communications with the Joint Committee on Statutory Instruments • Finally, I would like to draw my Lords’ attention to the fact that, in line with informal communications which the Food Standards Agency has had with the Joint Committee on Statutory Instruments, the Agency will, in accordance with the terms of the free-issue procedure, be making this Instrument available free of charge to those who purchased the earlier Exit SI, namely the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019. • • The government accepts that this Instrument should have been made available under the free issue procedure at the time it was first made, but that did not happen due to an oversight. I should like to apologise to my Lords for that oversight and confirm that it will be corrected. The Food Standards Agency will, together with colleagues in the National Archives, be taking action to ensure that anyone entitled to free copy of the Instrument under that procedure will, where appropriate, be able to apply for a refund, or otherwise obtain a copy of this Instrument for free on request, in accordance with the usual terms of that procedure. Conclusion • My Lords, this instrument constitutes a necessary measure to ensure that our food legislation relating to food safety continues to work effectively after Exit day. • I urge my Lords to support the amendment proposed to ensure the continuation of effective food safety and public health controls. I beg to move. CRIB SHEET 1. Purpose of the SI • The importance of food safety is paramount, and the amended minor and technical wording of this Instrument ensures that safety is maintained in the event of a ‘no deal’ scenario. • We have not tried to hide this minor provision on meat washes within a larger SI but have been open and transparent in publishing and debating as an Instrument in its own right. • This SI provides flexibility for Ministers to approve new substances as washes for products of animal origin (including carcass washes), which means that we can respond to new advances in technology on food safety to advance food safety. 2)Standards after Brexit •Leaving the EU doesn’t change our top priority of ensuring that UK food remains safe and what it says it is. The FSA is working hard to ensure that the high standard of food safety and hygiene, and consumer protection we enjoy in this country is maintained when the UK leaves the European Union. •From day one, we are committed to having in place a robust and effective regulatory regime which will mean business can continue as normal. For most food businesses, there will be no change in how they are regulated and how they are managed. •Currently, Food Business Operators are not permitted to use any substance other than potable water, or where permitted clean water, to remove surface contamination from products of animal origin unless this has been approved. Any such approval would be subject to a robust risk assessment and risk management considerations and would require a statutory instrument with usual parliamentary scrutiny. 3)Chlorine-washed chicken •Any substance to be used to remove surface contamination from chicken carcases must be specifically approved; chlorine has not been approved and so cannot be used. Therefore, chicken that has been washed with chlorine cannot be placed on the UK market •No substances other than potable water are approved to remove surface contamination from chicken carcases. There is no intention currently to change this when we leave the EU. •Any such change would have to be subject to a robust risk assessment and risk management considerations and would require a statutory instrument with usual parliamentary scrutiny. •If necessary: As you will be aware, there have been concerns expressed by some Members of this House, industry representatives and also speculative coverage in the media that the USA may press the UK that as part of a future free trade agreement the UK accept imports of chicken on which chlorine and other chemical washes and decontaminants have been used to remove surface contamination. While the use of such chlorinated and chemical washes is allowed for this purpose in the US, as I mentioned, they are not permitted by the UK or the EU. There is no intention currently to change this when we leave the EU. Maintaining the high standards of food fety • Leaving the EU doesn’t change our top priority of ensuring that UK food remains safe and what it says it is. The FSA is working hard to ensure that the high standard of food safety and hygiene, and consumer protection we enjoy in this country is maintained when the UK leaves the European Union. • From day one we are committed to having in place a robust and effective regulatory regime which will mean business can continue as normal. For most food businesses, there will be no change in how they are regulated and how they are managed. • Food Business Operators are not permitted to use any substance other than potable water, or where permitted clean water, to remove surface contamination from products of animal origin unless this has been approved. Any such approval would be subject to a robust risk assessment and risk management considerations and would require a statutory instrument with usual parliamentary scrutiny. 6. Why is the SI being laid when SIs relating to this area has already been through the debate process?  7. What is the government’s stance on chicken washed with chlorine? Is the Government intending to approve the use of chlorinated wash or similar substance to remove surface contamination from chicken carcases after EU exit? Any substance to be used to remove surface contamination from chicken carcases must be specifically approved; chlorine has not been approved and so cannot be used. Therefore, chicken that has been washed with chlorine cannot be placed on the UK market No substances other than potable water are approved to remove surface contamination from chicken carcases. There is no • This SI provides clarity on the process for approval of substances which may be used to remove surface contamination from products of animal origin. Any lack of clarity has the potential to place existing levels of food safety protection for consumers at risk.   • The original Specific Food Hygiene SI was insufficiently clear in describing the approval process for surface contaminants on products of animal origin. ntention currently to change this when we eave the EU. Any such change would have to be subject to a robust risk assessment and risk management considerations and would require a statutory instrument with usual parliamentary scrutiny. If necessary: As you will be aware, there have been concerns expressed by some Members of this House, industry representatives and also speculative coverage in the media that the USA may press the UK that as part of a future free trade agreement the UK accept imports of chicken on which chlorine and other chemical washes and decontaminants have been used to remove surface contamination. While the use of such chlorinated and chemical washes s allowed for this purpose in the US, as I mentioned, they are not permitted by the UK or the EU. There is no intention currently to change this when we leave the EU. 9. What it is the current process for approval of substances used to remove surface contamination products of animal origin? • 10. What will be the situation should Ministers in the devolved administrations take a different decision on the approval of a substance intended to remove surface contamination from carcasses? Currently, an applicant will make a request to the European Commission The Government is committed to which, following agreement with securing a deal that works for the entire representatives from Member United Kingdom - for Scotland, Wales, States, will refer the application to EFSA. EFSA will carry out a scientific Northern Ireland and all parts of England. The Scottish and Welsh evaluation on both the safety of the Governments have already recognised substance and efficacy of its use. that common frameworks may be needed in some areas including food and feed • • Following the issue of EFSA’s Opinion, Member States vote whether the substance will be approved at the European Commission’s Standing Committee meeting. After EU exit, if approval is sought for any further substances to be used, they will be subject to risk analysis by the FSA/FSS which has established a rigorous and transparent risk analysis process for assessment and approval of any such new substances.  Any requests for substance approval would be subject to thorough scientific risk assessment and risk management before being put to Ministers for final decision and would require a statutory instrument with usual parliamentary scrutiny. • • • safety and hygiene law, and discussions on this have begun via the Joint Ministerial Committee on EU Negotiations. • Whilst these high-level discussions are taking place, the FSA continues to have close working relationships with the administrations in Scotland, Wales, and Northern Ireland. We are therefore confident that in practice it will be possible to make arrangements to operate a framework for food safety regulation across the UK. Key points and top lines This instrument is being made for a no deal and negotiated scenario. The primary purpose of this instrument is to ensure legislation which allows for the protection of the public. The SI refines an amendment to retained EU law made by the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 and provides minor corrections to that SI to provide greater clarity in describing the process for approval of substances which may be used to remove surface contamination from products of animal origin. • • • o o o • • • The amendments proposed in this instrument are critical to ensure there is minimal impact on food safety regulation and the UK has the necessary powers to prevent contaminated food from being placed on the UK market. This instrument will maintain the current standard of food safety and hygiene on exit day and enable updates to be made. These changes would not affect the safety, quality or supply of food in the UK as the current standards of food safety and hygiene would be maintained. Our approach to EU Exit is underpinned by three key principles; the FSA has been working hard to ensure that UK food remains safe and what it says it is. the high standard of food safety and consumer protection we enjoy in this country is maintained when the UK leaves the European Union. from day one a robust and effective regulatory regime will be in place which will mean business can continue as normal. This instrument is subject to Parliamentary scrutiny through the affirmative resolution procedure and requires formal approval of the Commons and Lords. If the UK reaches a deal with the EU, the Food Standards Agency will revoke or amend this instrument. After exit day this domestic legislation will remain in force to enable the enforcement of the retained EU law as corrected by this instrument. Questions specific to the SI: The Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019 (the SI) What is the purpose of this SI? • The SI fixes an inoperability of Regulation (EC) No. 853/2004 that lays down specific hygiene measures for the production and processing of certain food products of animal origin. • The primary purpose of this SI is to refine an amendment to retained EU law previously made by the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019. That amendment is now considered to be insufficiently clear to describe the process for approval of substances which may be used to remove surface contamination from products of animal origin. • It amends Article 3(2) of Regulation (EC) No. 853/2004, to make it clearer that Ministers (the appropriate authority) will be responsible for deciding whether or not any alternative substance will be authorised to remove surface contamination from products of animal origin. • Ministers must take account of advice from the Food Safety Authority (the Food Standards Agency and Food Standards Scotland). What procedures will apply to the approval of substances for washing contaminants off the surface of products of animal origin? • The SI retains the requirement for substances used for removing surface contamination from products of animal origin to be approved. The Food Standards Agency and Food Standards Scotland will be responsible for analysing the risks associated with the use of a substance and for providing advice to Ministers. Ministers in England, Wales, Scotland, and the devolved authority in Northern Ireland will have responsibility for approving the use of the substance and a statutory instrument would be required with the usual parliamentary scrutiny. Will the Food Safety Authority be responsible for deciding what substances can be used for removing surface contamination from animal products? • No. Ministers will hold decision making responsibility. Decisions will be based on recommendations from the food safety authorities (Food Standards Agency and Food Standards Scotland). • The Food Safety Authority will analyse the risks associated with the use of a substance in accordance with the risk analysis process agreed by the Food Standards Agency Board and provide advice to Ministers on possible approval, and on the conditions of its use. Which body will be responsible for deciding whether or not the use of chlorinated wash is to be permitted for washing surface contamination off chicken meat? • Ministers will decide whether or not any application for use of chlorinated wash to remove surface contamination from chicken carcases is to be approved. This decision will be based on recommendations from the food safety authority (Food Standards Agency and Food Standards Scotland). A statutory instrument would be required with the usual parliamentary scrutiny. Will the Food Safety Authority’s risk assessment and advice to Ministers on use of substance be publicly available? • The risk analysis process must be open and transparent. When advising decision-makers, the Food Standards Agency and Food Standards Scotland will observe the relevant principles and provisions in their longstanding Code of practice on openness. The food safety authorities will publish the advice provided to others and the analysis and evidence on which that advice was based. What substances are approved to decontaminate poultry carcases / chicken carcases? • Potable water is the only substance approved to remove surface contamination from poultry meat / chicken meat. What substances are currently approved to remove surface contamination from meat and other products of animal origin? • Potable water is approved to remove surface contamination from meat and other products of animal origin. • Clean water, including clean seawater, is approved to remove surface contamination where permitted by hygiene legislation, for example for fishery products and live bivalve molluscs. • Lactic acid is approved to remove surface contamination from bovine carcases only. • Recycled hot water is approved to remove surface contaminations from carcases of domestic ungulates (e.g. cattle, sheep, pigs) and farmed game carcases only. What is the government’s stance on chicken washed with chlorine? Any substance to be used to remove surface contamination from chicken carcases must be specifically approved; chlorine has not been approved and so cannot be used. Therefore, chicken meat that has been washed with chlorine cannot be placed on the UK market. Is the Government intending to approve the use of chlorinated wash or similar substance to remove surface contamination from chicken carcases after EU exit? No substances other than potable water are approved to remove surface contamination from chicken carcases. There is no intention currently to change this when we leave the EU. General: Q: Why were these issues not identified sooner (i.e. when the main amendment SI was made)? • The amendment to retained EU law previously made by the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 is now considered to be insufficiently clear to describe the process for approval of substances which may be used to remove surface contamination from products of animal origin. • This instrument provides minor corrections to that SI to provide greater clarity in describing the process for approval of substances. It makes it absolutely clear that Ministers will be responsible for allowing the use of any other substances. • The amendments proposed in this instrument are critical to ensure there is minimal impact on food safety regulation and the UK has the necessary powers to prevent contaminated food from being placed on the UK market. • The Food Standards Agency together with colleagues in the National Archives, will ensure that anyone entitled to free copy of this revised Instrument will be able to apply for a refund, or otherwise obtain a copy of this Instrument for free, on request, in accordance with the terms of the free-issue procedure. Consequences of not proceeding with this legislation What would happen if this legislation does not pass? • The SI ensures that the retained EU law remains operable and enforceable within the UK regulatory framework after exit without compromising existing levels of public health protection and food safety. • The SI provides minor corrections to retained EU Law to provide greater clarity in describing the process for approval of substances which may be used to remove surface contamination from products of animal origin. Therefore, there is a risk that the functions transferring to the UK from the EU Commission via the European Union (Withdrawal) Act 2018 may not be clear and not transferred to the appropriate UK authorities rendering the current system of food safety protection inoperable. This is likely to damage consumer confidence and business and trading partner confidence in the UK. • The importance of food safety is paramount, and the wording of the retained legislation as amended by this instrument ensures that this is maintained in the event of a “no deal” scenario. Any agreements during exit negotiations that impact the food regulatory regime will be factored in to any future amendments to this instrument. • Food safety affects everyone and as we leave the EU it is important to maintain the current high standard of legal protection for UK consumers in relation to food in the UK. • Food safety regulations have a huge impact on the economy. These SIs enable that to happen. There are around 214,175 businesses active in the agri-food sector and approximately 419 Local Authorities (LAs) and 35 Port Health Authorities (PHAs) in the UK, which enforce existing food and feed law and will continue to enforce the retained EU law after the UK’s EU Exit. From day one we are committed to having in place a robust and effective regulatory regime which will mean business can continue as normal. • Food safety risk also has a high profile in the media, and so it risks raising its profile in a negative way, possibly leading to concerns by consumers and businesses which produce products of animal origin who export to the remaining members of the European Union.Page Break Background • The changes contained within this instrument are simply designed to fix inoperabilities in retained EU legislation relating to food safety to reflect the status of the UK outside the EU. This instrument delivers this for a single aspect of Regulation (EC) No. 853/2004. • The instrument is subject to Parliamentary scrutiny through the affirmative resolution procedure and requires formal approval of the Commons and the Lords. The SI has been laid before Parliament by Ministers from DHSC as the FSA is a non-ministerial department. • The amendments are being made to the following UK legislation: o • The Specific Food Hygiene (Amendment) (EU Exit) Regulations 2019. To ensure continuing operability of the retained EU law, the most significant function of this SI will be to provide suitable replacements for: o the risk management function currently undertaken by the European Commission and o the risk assessment function currently undertaken by the European Food Safety Authority (EFSA). • These functions feature throughout the EU legislation, most notably for the authorisation of substances to remove contamination from products of animal origin (POAO) is currently carried out by the European Commission. Following EU Exit, this function will be carried out by Ministers. • The amendment made to Article 3(2) by the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019, is further refined by this SI to make clearer that Ministers will hold responsibility for authorising the use of any additional substances to remove surface contamination from POAO. • This instrument provides that tertiary powers of the EU Commission pass to Ministers in accordance with the devolution settlements. This means that Ministers in the devolved administrations may make regulations in their respective territories and the Secretary of State will not be able to make Regulations for those territories. Related Parliamentary Questions UK Campy and Chlorine Chicken (February 2019) Lord Rooker To ask Her Majesty's Government what research they have carried out on the food safety effects of chlorine washing of (1) salad, and (2) meat, products. HL13759 “Answer:  I am advised by the Food Standards Agency (FSA) that chlorine washes can be used on fresh produce, including salad, but are legally not permitted on products of animal origin or meat. Past research commissioned by the FSA looked at ‘Reducing Campylobacter cross-contamination during poultry processing.’ The researchers tested some substances, including, chlorine dioxide, and compared their effect with steam treatment. The results indicated that none of the treatments eliminated Campylobacter entirely. The FSA is continuing to review the literature and monitor the latest developments on the topic. Press coverage: Chicken washed with chlorine There continues to be national media coverage about whether chlorine-washed chicken might be allowed on the UK market as part of a post-EU Exit US trade deal. This issue is regularly used to illustrate concerns about a lowering of food standards post-Brexit. The most recent coverage on the subject was generated by comments from Sir Ian Boyd, chief scientific adviser at Defra, who said there was no 'scientific' reason to ban chlorinated chicken or hormone beef in a post-Brexit trade deal, citing a lack of evidence the treatments would cause harm to British consumers. 3. DOCUMENT – Handling Plan - Made affirmative specific hygiene amended FINAL DRAFT PARLIAMENTARY HANDLING STRATEGY DEPARTMENTAL CLEARANCE Lead Department Food Standards Agency Secretary of State and Y SI Minister Signed Off SI SRO sign off Have Special Advisers cleared the Y handling plans? Departmental Whip Y been consulted? Y If there is significant cost or No significant cost economic implications implications. HMT with this SI or not consulted. No significant negative negative DUP DUP interest have HMT interest been consulted? INTRODUCTION Title: The Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019 Planned laying date: 9 September 2019 Lead Minister responsible: Commons only procedure? No Jo Churchill RISK AND CONTROVERSY Summarise the purpose of the SI and the effects of bringing in this piece of legislation. Food and feed safety legislation is laid down in directly applicable EU law. This protects public health and underpins UK businesses’ ability to trade domestically and internationally. UK Government intends to bring forward the above-named Regulations under powers in the European Union (Withdrawal) Act 2018. The Food Standards Agency (FSA) is working to correct deficiencies in retained EU law relating to food and animal feed. To achieve this, the FSA began a programme of EU Exit SIs in 2019 to fix inoperabilities in retained EU law. These have made no change in the level of protection given to human (or animal) health or to the high standards of food and feed that consumers expect from both domestically produced and imported products. The FSA has worked closely with Devolved Administrations throughout and this SI will take forward provisions on a UK basis. This SI will be laid before Parliament (under the made affirmative resolution procedure) by DHSC on behalf of the FSA. The purpose of this SI (The Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019) is to make clearer that Ministers will have responsibility for authorisation of substances to remove surface contamination from products of animal origin (POAO). This SI will provide this clarification by amending the provisions of retained EU legislation (Regulation (EC) No. 853/2004) on specific hygiene rules for handling certain POAO. These are establishments that handle products such as meat, eggs, fish, cheese and milk and which do not carry out retail activities (i.e. they do not supply to final consumers). The provisions of Article 3(2) of Regulation (EC) No. 853/2004 provides that food business operators are not permitted to use any substance other than potable water, or where permitted clean water to remove surface contamination from POAO unless this has been approved by the European Commission. Following EU Exit, the existing ban on the use of chemical decontaminants and washes on animal products other than those already approved, will be brought onto the UK statute book by the European Union (Withdrawal) Act 2018 and amended (without any change in policy) so that it functions properly by this instrument. Article 3(2) provided that the use of any other substance for this purpose must be approved by the European Commission. This was amended by the original Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 to remove the references to the Commission. The amendment provided for approval of any further substances by the Food Safety Authority and that measures would be prescribed by the appropriate authority. Article 3(2) of Regulation 853/2004 was amended by the Specific Food Hygiene SI as debated in Parliament on 5th March 2019 and agreed with the Devolved Administrations. The amendment to Article 3(2), made by the Specific Food Hygiene SI, is being further amended to make clearer that Ministers (the appropriate authority) will be responsible for prescribing the use of any other substances. As the role of the Food Safety Authority in this context is akin to that of the European Food Safety Authority and as EFSA is not specifically referred to in Article 3(2), in order to more closely follow the wording of Article 3(2) the amendment will no longer additionally refer to the Food Safety Authority. The drafting in the Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019 SI intentionally follows closely the drafting provision in the EU Regulation to make clear that no policy changes are being made to the text of the EU Regulation. The FSA was clear on its approach to fixing inoperabilities in the EU legislation and in the public consultation it issued was only to correct deficiencies, and not make further policy changes through the EU Exit SIs. During debates Ministers assured Parliament that only the essential changes had been made to provide operability of retained EU legislation on EU exit. If any additional substances are to be approved for this purpose: • The Food Safety Authority will undertake analysis of the risks associated with the use of a substance and provide advice to Ministers on possible approval, and on the conditions of its use. • The Appropriate Authority will prescribe use of the substance, and • The authorisation of the substance will be made by means of an SI (negative procedure). The FSA has established a rigorous and transparent process for assessment and approval of any new substance. As set out in the FSA publications, any requests for approval would be subject to thorough scientific risk assessment and risk management including analysis of other legitimate factors, following which independent food safety advice would be put to Ministers. This process provides an appropriate mechanism for decision-making on chemical de-contaminants and washes for animal products. It would be highly beneficial for the legislation to be in place for Exit Day, however, the Specific Food Hygiene SI will continue to provide basic food safety protection for consumers in that enforcement action could be taken against the placing of unsafe food on the market. Furthermore, the FSA considers that businesses marketing these products would want to continue current practices and maintain safety standards to maintain confidence in the food industry. The purpose of these regulations is to maintain the status quo in terms of regulation. To mitigate potential problems, the FSA would advise local authorities of the implications of the regulations, so that they can advise businesses of the required standards. Existing preventative safeguards e.g. the manufacture, storage, handling and sale of products would be covered under the general hygiene provisions of 852/2004. In addition to the above, the 15 earlier FSA UK EU Exit SIs to fix inoperabilities in retained EU Law have also been made and are operable. This further mitigates any risks presented by this further SI as the provision it is concerned with is comparatively minor. What is the risk rating? (Low, Medium or High) What are the reasons for this? Medium. This instrument does not make policy changes. However, it is appropriate for the measure covered by this SI to be in force before exit in order that Regulation (EC) No 853/2004 is fully at day one readiness. As with the previous FSA UK EU Exit SIs, if this SI is not made it may mean that there will be partially defective or unclear legislation on UK statute books, but administrative procedures and reliance on the key elements in food law may be used in the short term to mitigate any consequences that may arise until the inoperabilities can be addressed. There is political, farm, food industry and media concern that the USA may press the UK that as part of a future free trade agreement the UK accept imports of chicken on which chlorine and other chemical washes and decontaminants have been used to remove surface contamination. The use of such chlorinated and chemical washes for this purpose are allowed in the USA but are not permitted by the UK/EU and chicken that has been washed with chlorine or chemical washes cannot be placed on the UK/EU market. There are no current proposals to approve these substances for poultry carcases. The amendment SI may lead to wider questions whether the Government EU exit SIs have been introduced too quickly, about the robustness of EU exit legislation and that the process has not allowed time for proper Parliamentary scrutiny. The Specific Food Hygiene SI is only intended to clarify the authorisation process and does not make policy changes. What is the scope for debate? (Consider the most controversial issues that could arise) This instrument is subject to the made affirmative procedure and therefore will be subject to debate in both Houses. The instrument itself is not controversial as it does not implement substantive policy changes, and it seeks to maintain food/feed safety and protection and the requirements with which industry are fully familiar. However, there has been political and media interest in any potential future use of chlorine and other chemical washes and decontaminants to remove surface contamination from poultry carcases. The use of such chlorinated and chemical washes for this purpose is banned for poultry carcases and there are no current proposals to approve these for poultry carcases. George Eustice MP has proposed an amendment to the Agriculture Bill which if accepted would only permit the use of potable water to remove surface contamination from animal products. That would go beyond current EU legislation as it would prohibit the use of substances already approved in the EU under Article 3(2), such as clean water on fishery products, and prevent future approval of any alternative substances even if they were assessed as safe to use except by primary legislation. It is thought that the George Eustice amendment is intended to prevent the use of chlorine and chemical washes from being authorised for poultry carcases in order to facilitate a free trade agreement with the USA. If the George Eustice amendment were to be accepted this could have implications for trade with the EU27 as EU legislation allows other substances, such as clean water, to be used in certain circumstances. OTHER KEY ISSUES The debates will provide MPs/Peers with the opportunity to raise broader issues around food or feed safety, some of which have already been raised in Parliament and were responded to by DHSC Ministers and the FSA (see the parliamentary activity section for further detail). We anticipate the debates may also include issues such as the maintenance of existing food standards; the ‘loss’ of EFSA; technical notices; EU systems such as Rapid Alert System for Food and Feed (RASFF); and the enhanced role of the FSA after exit: Food Standards Protecting public health and consumer confidence in the safety and authenticity of food remains our key priority. The Government wishes to see the UK's globally leading food standards maintained after the UK leaves the EU. We have no plans to lower existing protections and principles that underpin food/feed safety and consumer interests in relation to food/feed. For example, this is especially important for chlorine-based decontaminants. Chlorine is not an authorised substance to remove surface contamination; chicken that has been washed with chlorine cannot be placed on the UK market. EFSA and other risk assessment bodies Risk-assessment and oversight of food and feed safety controls will be essential to ensure that food and feed remains safe, whether imported or produced here. Although our future relationship with EFSA is subject to UK-EU negotiations and remains to be determined at the time of submission of this handling plan. The UK already has risk assessment capacity and carries out routine risk assessment work and until recently has taken the lead on assessing risk in non-EU harmonised food issues. The Government’s contingency planning allows for a significant increase in the FSA’s capacity by building on existing independent scientific advisory structures to bridge any gap that might arise in risk assessment functions that were carried out by EFSA. FSA role After EU Exit, food and feed safety risk management functions now performed by EU institutions will return to the UK. Without prejudice to potential future arrangements between the UK and the EU, the UK will be responsible for decisions and legislation relating to food (and feed) safety. Food and feed safety risk management decisions are varied. Examples include: • Ministers already have a range of powers necessary to perform food and feed safety risk management functions under existing UK legislation. Similar provisions exist in the Devolved Administrations. The FSA is responsible for risk analysis (risk assessment, risk communication and policy development), with FSS performing a similar role in Scotland. Therefore, when we leave the EU there will be no gaps created affecting Government’s ability to make necessary risk management decisions, supported by FSA and FSS as appropriate. It is necessary to ensure that the retained EU laws reference the relevant UK risk managers and risk assessors so that the current rules will continue to function effectively on the day we leave the EU. Furthermore, discussions are ongoing across Government and with the Devolved Administrations as to how best to organise Risk Management and Risk Assessment for the UK after we have left the EU. The FSA's priority is to maintain the UK’s high-standards of food and feed safety, and to ensure we take a risk-based, proportionate approach to risk analysis. The UK is developing an alternative to some of the functions currently provided by EFSA, building on existing scientific advisory structures. Subject to negotiations, we will redefine and formalise a close working relationship with EFSA based on exchange of information and expertise, contribution to scientific networks, and cross-European collaboration. Other food and feed related issues It is possible that other food related concerns in the media may be raised in the debates, e.g. potential lowering of food and feed safety standards to facilitate trade with non-EU countries such as the USA. It is possible that issues falling within Defra’s remit, e.g. food stockpiling and food waste at the border may arise. Lines to take on these issues will be provided ahead of debates. Summarise the debate on the power/issue in the two Houses during the parent Act. Include any useful Hansard references. During the passage of the EU Withdrawal Bill through the House of Commons there were five amendments tabled that referenced this policy area: Amendment NC72 – regarding who should bear the costs on inspections of imported foods at Ports; Amendment 238 - Secretary of State asked to lay a report before Parliament setting out a strategy for seeking the maintenance of UK membership of the European Food Safety Authority on existing terms after withdrawal from the EU; Amendment 343 (Made by Jeremy Corbyn, Keir Starmer, Harriet Harman amongst others) Secretary of State asked to lay before Parliament a strategy for a food standards framework after withdrawal from the EU; Amendment 221 – Act should not come into force until a Minister of the Crown has published an assessment of the effect of the United Kingdom’s withdrawal from the EU on food and drink safety and quality standards, and has laid a copy of the assessment before Parliament; Amendment 8 – Regarding the transferring of powers from EU agencies back to the UK being set and administered by the Department of Health, the Food Standards Agency and any other public authority specified in regulations made by the Secretary of State. In the House of Lords there were two amendments tabled: Amendment 142 (Made by Lord Rooker former FSA Chair) - to require, as a minimum, maintenance of current regulations concerning food standards when the UK exits the EU; This amendment was agreed. Hansard ref https://hansard.parliament.uk/commons/2018-06-12/debates/3AC9EE4B-A84C-47D19519-80CEA3653807/EuropeanUnion(Withdrawal)Bill (col 839) Amendment 184 (Made by Lord Adonis) - No regulations may be made under this section until the Secretary of State has laid a report before Parliament setting out a strategy for seeking the maintenance of the United Kingdom's membership of the European Food Safety Authority on existing terms after withdrawal from the EU. This amendment was agreed. Hansard ref https://hansard.parliament.uk/Commons/2018-0613/division/BB6A6FDD-4B28-47B3-8D3720FFAA9B3B32/EuropeanUnion(Withdrawal)Bill?outputType=Names Has this policy area attracted any parliamentary activity e.g. PQs, Early Day Motions, debates or Lords oral questions? There has been parliamentary activity regarding the UK’s future risk assessment and risk management responsibilities to maintain food standards regulations. House of Commons In January 2018 Alex Cunningham (Lab) asked a question on future food safety regimes after EU Exit. In March 2018 Dr David Drew (Lab) asked a question in the House of Commons regarding additional funding for inspections on third party commercial assurance schemes and Bill Wiggin (Con) asked about the enforcement of rules on animal welfare in transport. In March, Jonathan Edwards (PC) also asked about whether lower standard foods would be allowed to be imported into the UK following our departure from the European Union. In June 2018 Caroline Lucas (Green) asked a question about the government’s plans to control imported food after our departure from the European Union. Alex Cunningham (Lab) also posed a question relating to future food safety and animal welfare standards in relation to trade deals in June. Priti Patel (Con) asked about the conduct of FSA inspectors in abattoirs. The use of substances to remove contamination from POAO was raised during the House of Commons debate on bundle 1 on 5 March 2019. A record the debate can be found here: https://hansard.parliament.uk/Commons/2019-03-05/debates/572fcd14-1a65-423e8aeeHouse of Lords In June 2018 we received a series of questions (HL8827, HL 8830, HL 8780, HL8782, HL8783) in the House of Lords from the Countess of Mar (CB) regarding official laboratories, local authorities and the Elliot Review. General food safety enquiries On 26th of April 2018, the House of Lords debated the role of the FSA after Brexit. Baroness Jones of Whitchurch (Lab) raised questions in the Lords regarding the future approach of the FSA to regulation after EU Exit. [HL OPQ 26 April 2018, Vol 790, Column 1654-1656] Baroness McIntosh of Pickering (Con), in the same debate, asked specifically about future statutory instruments. Lord Rooker (Lab) asked about future cooperation with other EU countries and access to the Rapid Alert System for Food and Feed. Baroness Bakewell of Hardington Mandeville (LD) also participated, asking about Meat Hygiene Controls. The Countess of Mar (CB) also raised a question about local authorities having suitable number of environmental health officers. Lord Bassam of Brighton asked an oral PQ on 4th September 2018: "To ask Her Majesty’s Government whether they will commit to putting before both Houses any proposals to amend the United Kingdom’s food standards regulations in the event of a “no deal” scenario when the United Kingdom leaves the European Union." [HL OPQ, 4 Sept 2018, Vol 792, Column 1694-1696]. This led to follow up questions from Lord Deben; Lord Rooker; Baroness Bakewell; The Countess of Mar; Baroness Jones of Whitchurch; Baroness McIntosh of Pickering; and Baroness Ludford. Lord O’Shaughnessy assured the House a programme of secondary legislation would be brought forward to make technical amendments to EU-derived and retained food safety and standards law to maintain the UK’s food standards and safety regime. He also highlighted additional funding for the FSA and local authority enforcement. Other key points were as follows: • there will be no lowering of food standards to accommodate products from outside the UK and before we consider revising/establishing any standards, a proper scientific and evidence-based assessment will be undertaken; • the Food Standards Agency will continue to fulfil its statutory duty to put consumers first in relation to food safety, but some technical changes to its role may be necessary to support this; • we will maintain the split between independent risk assessment and risk management, with decisions being made by Ministers; • we are planning for non-participation and are considering what other arrangements might be made to have access to food alerts and EU safety assessment data for food products. Heather Hancock, the Chair of the FSA gave oral evidence to the Lords EU Energy and Environment Sub Committee roundtable discussion which took place on 4 July 2018, and on 6 March 2019 and explored how food safety risk management decisions will be taken when the UK leaves the EU. The Chair described the current risk management functions and how they operate in an EU context. It has been proposed that the FSA should have the power to make risk management decisions, which are almost entirely technical. Questions also arose on RASFF and TRACES; The FSA is working to replicate, recreate and rebuild the necessary framework to operate effectively, and additional surveillance capability should we not have full access to those systems in future. It was highlighted that maintaining standards, public health and public trust were of the utmost importance. A record of the Committee can be found here: http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/euenergy-and-environment-subcommittee/food-safety-risk-managementpostbrexit/oral/86576.html Heather Hancock also gave oral evidence to the Commons Environment, Food and Rural Affairs Select Committee on 24 April 2019, to its one-off inquiry into the work of the FSA. A wide range of topics were discussed including: risk assessment post EU Exit; the independence and accountability to Parliament of the FSA; the safety of importing foods; and Rapid Alert System. A copy of the transcript can be found here: http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument /environment-food-and-rural-affairs-committee/work-of-the-food-standardsagency/oral/101349.pdf There was a PQ on the issue of chlorinated washed chicken in February 2019 – Lord Rooker: To ask Her Majesty’s Government what research they have carried out on the food safety effects of chlorine washing of; (1) salad, and (2) meat, products. (HL13759) A record of the Q&A can be found here: https://www.parliament.uk/business/publications/written-questions-answersstatements/written-question/Lords/2019-02-14/HL13759/ Jason Feeney, Chief Executive of the FSA was a witness before the Commons Public Bill Committee in relation to scrutiny of the Defra Agriculture Bill on 23 October 2018. The Committee sought assurance that food imported into the UK post-Brexit is produced to the equivalent standards. In an implementation period, we would expect a broad continuation of existing standards. In a no deal scenario, the EUWA will retain existing EU regulations, which will be amended through the FSA’s secondary legislation programme. Any future policy changes will be evidence-based, and the FSA would put its recommendations to Ministers accordingly. The Committee questioned what impact might arise on the devolved administrations. The Chief Executive explained that food safety is a devolved issue, the FSA (covering England, Wales and NI) is working with FSS to develop arrangements whereby emerging evidence will be considered in an advisory forum for food and feed, in which all four countries are represented and, as far as possible, a four-country conclusion is reached. A record of the Committee can be found here: https://hansard.parliament.uk/commons/2018-10-23/debates/480f10b5-dcf5-4772-bbb13f0701ff4725/AgricultureBill(SecondSitting) The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 was debated in the House of Lords as part of the bundle 1 of FSA’s SIs on 6 March 2019: https://hansard.parliament.uk/Lords/2019-03-06/debates/E124B43F-AE8B-43F7-8A34A5617C49638B/SpecificFoodHygiene(AmendmentEtc)(EUExit)Regulations2019 What are the consequences of not proceeding with this legislation? As with previous FSA UK EU Exit SI’s, if this instrument is not proceeded with, it may mean that there will be partially defective or unclear legislation on UK statute books, but administrative procedures and reliance on the key elements in food law may be used in the short term to mitigate any consequences that may arise until the inoperabilities can be addressed. HANDLING How are the DUP (also SNP/ PC) expected to react to this SI? *See also the Devolved Administrations section later in the Handling Plan. DUP As part of the Confidence and Supply Agreement, the DUP had agreed to support the Government on all legislation pertaining to the UK’s exit from the European Union. The DUP notes the importance of farming to the Northern Ireland economy, although there are no specific references to food safety, or to the food processing or retailing sectors. The DUP is keen to ensure a whole Ireland economy is maintained with a seamless frictionless border with the Republic of Ireland and have highlighted trade in food as a key element of this. A letter signed by key industry food trade bodies (FDF, BRC, NFU, BPC, BMPA) is supportive of this approach. The DUP supports strong protections for agrifood to guard against vulnerabilities to cheap inferior imports, as noted in their manifesto. It has expressed a desire to establish a marketing body to promote food from Northern Ireland, which could help support future trade deals and builds on their efforts to promote NI produced food in 2016. The DUP deputy leader, Nigel Dodds, has said preserving the "political, constitutional and economic integrity of the United Kingdom" was the "absolute priority for us". We anticipate support from the DUP as this SI preserves the effectiveness of existing food safety principles and does not introduce any policy changes. This will mean (subject to negotiations) that the NI food sector can continue operating to existing standards of safety, thereby facilitating current trading patterns. Agriculture makes up a greater proportion of the Northern Irish economy compared to the rest of the United Kingdom. As such, there may be heightened interest in legislation regarding control of the meat trade. SNP The Scottish Government supports continued membership of the EU Single Market and Customs Union – the views of SNP MPs at Westminster are highly likely to mirror this. https://www.gov.scot/Publications/2018/01/6407 On its website, the Scottish Government says there are concerns about the impact on the economy and that consultation with Scottish food stakeholders suggests concerns with attracting and retaining their workforce as well as ‘continuing questions about what kind of trading and regulatory relationship we will have with the EU after the UK leaves’. Concerns about impact on food standards and food safety however do not appear emphasized.https://news.gov.scot/news/brexit-impact-on-food-and-drink SNP MPs Alison Thewliss and David Linden spoke in June in the House of Commons regarding future food standards in relation to the EU and the USA so may have further interest in this topic. Additionally, in its publication ‘Scotland’s Place in Europe 2’ the Scottish Government notes concerns about the removal of the EU’s specialist agencies, such as those governing food, and so the SNP may raise this issue in regard to EFSA and participation in RASFF: https://www.gov.scot/Resource/0053/00530160.pdf (paragraph 114). PC In terms of Plaid Cymru, Jonathan Edwards (PC) has raised issues relating to food and feed regulation in the past. However, there is no suggestion that PC will object to these SIs. PC’s focus is that Wales must have its own distinct voice in any negotiations and does not consider there is a mandate for a ‘no deal Brexit’. PC has raised concerns about reductions / removal of farm payments (falling within Defra’s remit) after Exit but no specific concerns have been noted about food safety. Meetings with MPs and peers (add additional rows as applicable) – check which MPs/peers supported and opposed the delegated powers in the passage of the Bill. This engagement plan must include the DUP and where appropriate - SNP/ Plaid Cymru The Food Standards Agency is a non-ministerial government department and as such our engagement with parliamentarians is primarily led by our chairman Heather Hancock. She routinely meets with Ministers and Parliamentarians in both Houses, as part of our commitment to delivering on Parliamentary accountability for the FSA. Our other areas of activity include: giving written and oral evidence to parliamentary select committee enquiries; developing relationships with key select committee chairs and Oppositions spokespersons through 1-2-1 meetings; holding roundtables with peers; drop-in session for members of key select committees with our Board and Executive team; speaking at events organised by the relevant All-Party Parliamentary Groups. However, as a nonministerial department we are not able to operate in the same way that ministerial departments can, through PPS and the Government Whips, and so we need to work with colleagues in DHSC to access those sorts of political influence. A list of some of the kinds of meetings the FSA Chair has held over the last year include: 06.06.18 – Chair’s meeting with Sue Hayman MP, Shadow SoS for Environment, Food and Rural Affairs, and David Drew MP, Shadow Minister for Environment, Food and Rural Affairs. 25.06.18 – Chair’s attendance at the Annual Reception of the United Kingdom Accreditation Service (UKAS) 26.06.18 – Chair’s Meeting with Tim Smith, Adviser to Tesco CEO 02.07.18 – Chair’s Meeting with Sue Davies, Strategic Policy Partner, Which? 03.07.18 – Chair’s Visit to Deliveroo Editions site 04.07.18 – Cahir Gave evidence at EU Energy and Environment Sub-Committee, Food safety risk management post-Brexit House of Lords sub-committee 09.07.18 – Chair’s attendance at the Food and Drink Federation (FDF) Summer Reception 07.08.18 – Chair’s Visit to Compass Group 13.08.18 – Chair’s Meeting with National Trading Standards (NTS) 03.09.18 – Chair’s Meeting with Noel Lavery, Permanent Secretary, and Paul Grocott, Deputy Director of EU Trade Negotiations, at the Department for the Economy Northern reland 04.09.18 – Chair’s Meeting with industry stakeholders: NI Food and Drink Federation, Ulster Farmers Union, White’s Oats, Lough Neagh Fisherman’s Cooperative Society, Moy Park and Andrews Flour. 12.09.18 – Chair’s Meeting Simon Blackburn, Chair of Local Government Association Safer and Stronger Communities Board 12.09.18 - Chair’s Meeting with the Department for Environment, Food and Rural Affairs (Defra) and the Department for Exiting the European Union (DExEU). 18.09.18 – Chair’s Visit to R F Brookes 10/12/2018 – Chairs Meeting with Lord O’Shaughnessy, Parliamentary Under Secretary of Health and Social care. 10/12/2018 – Chairs Meeting with Neil Parish MP, Chair of the EFRA Committee 12/12/2018 – Chair’s Attendance at CENTRAL GOVERNMENT EMERGENCY RESPONSE TRAINING 18/12/2018 – Chairs Meeting with the RT. Hon Owen Paterson MP 18/12/2018 – Chairs Meeting with Lord Trees, Lord Cameron, Lord Gardiner, Parliamentary Under Secretary for the Department for Environment, Food and Rural Affairs, Baroness Pickering, Baroness Mcintosh, Baroness Bakewell, Countess Mar, Lord Krebs, Baroness Jones, Shadow Spokesperson of the Department for Environment, Food and Rural Affairs. 09/01/2019 – Chair’s Visit and Meeting with Martin Temple, Chair & Karne Russ, CEO of Health and Safety Executive, Buxton. 28/01/2019 – Chair’s Meeting with Tim Smith, Chair of Prets’ Food Advisory Panel. 30/01/2019 – Chair’s Meeting with Lord Gardiner of Kimble, Parliamentary Under Secretary for the Department for Environment, Food and Rural Affairs. 26/02/2019 – Chair’s Meeting with The RT. Hon Matt Hancock MP, Secretary of State for Health and Social Care & Steve Brine MP, Parliamentary Under Secretary of State for Public Health and Social Care for Department of Health and Social Care. 27/02/2019 – Chair’s Meeting with David Rutley MP, Parliamentary Under Secretary of State at the Department for the Environment, Food and Rural Affairs 05/03/2019 – Chair’s Meeting with Neil Parish MP, Chair of the EFRA Committee 06/03/2019 – Chair’s Meeting with EU Energy and Environmental Sub-Committee, Select Committee Hearing 24/04/2019 – Chair gave evidence at an EFRA Select Committee Evidence Session 30/04/2019 – Chair’s Meeting with Michael Gove, Secretary of State for the Department for the Environment, Food and Rural Affairs and David Rutley, Parliamentary Under Secretary of State at the Department for the Environment, Food and Rural Affairs01/05/2019 - Chair’s Meeting with Henry Dimbleby, Lead non-executive board member of the Department for the Environment, Food and Rural Affairs 01/05/2019 – Chair’s Meeting with Dame Lucy Neville-Rolfe, Chairman of Red Tractor Assurance 13/05/2019 – Chair’s Meeting with Seema Kennedy, Parliamentary Under Secretary of State for Public Health and Primary Care Heather Hancock also keeps in regular contact with Ministers in the Welsh Assembly Government (Vaughan Gething AM, Lesley Griffiths AM and Rebecca Evans AM), and senior stakeholders in Northern Ireland. This has helped to gain their confidence and buy-in to the principles the FSA has set for EU Exit, and we expect this also to reduce the risk of challenge to these SIs from Welsh or Northern Ireland MPs. Engagement already taken place When Outcome/ readout Who and why Both Lord Krebs and Lord Rooker sit on Lords EU Energy and Environmental the Sub Committee (both former Chairs of the Food Standards Agency) and have a keen interest in this area specifically. A follow-up session at this committee was held on the 6 March 2019. http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/euenergy-and-environment-subcommittee/food-safety-risk-managementpostbrexit/oral/86576.html Jason Feeney gave evidence at the Agricultural Bill Committee on 23rd October 2018. The FSA Chair has used the opportunities of 1:2:1 meeting, holding roundtables with peers; drop-in session for members and opportunities to brief parliamentarians on our SIs and seek their support.  Our Chairman has also written to the Shadow Secretaries of State for EFRA and Health, updating them on our plans and offering further information if they would like it. Engagement planned Who and why When Because of its sensitivity, the issue of chlorine washed chicken has featured regularly in discussions between the FSA Chair and senior officials and Ministers. The FSA will take opportunities to reiterate its brief to Ministers (including the DUP) as to its advice on this issue ahead of any debates on this SI. Courtesy letters will be sent from PS(PHPC) to Jim Shannon (health representative of the DUP), and Sharon Hodgson (Lab) introducing this SI before it is debated. How will this affect the devolved administrations? How might MPs representing constituencies in Scotland, Wales Northern Ireland react to it? The principles and rules set out in the retained legislation which this SI will correct are widely accepted as ensuring the same level of food safety protection throughout the UK and the free flow of trade within it. On this basis, we do not expect any particular challenges from the devolved administrations. Additionally, the Devolved Administrations have had sight of drafts of this SI as it has been worked upon, and the opportunity to input into the drafting. A formal Minister to Minister letter was sent to counterparts in Scotland and Wales on 15 July requesting agreement from Devolved Administrations to make this SI. Back in 2018, the FSA in England sought ‘agreement in principle’ from FSA Wales, FSA Northern Ireland and partners in Food Standards Scotland to take forward its programme of SIs on a UK wide basis. This agreement in principle was given under the commitment of FSA England to continue to share copies of the draft SIs as they are produced, so that the nature of the corrections can be identified and fully understood by colleagues in the devolved administrations, and no corrections will be made unless their substance is acceptable to all parties. This SI requires formal consent from the Devolved Administrations, as food safety is a devolved area of competence. Discussions with the devolved food safety bodies reached consensus (at official level) that common approaches to food and feed safety and hygiene are at least desirable across the UK. Detailed frameworks proposals have been developed collaboratively and will be tested with Ministers in the coming months. Do you expect this SI to be certified as EVEL? No. This SI will apply to the UK. Mobilising external stakeholders (add additional rows as applicable) Who and why It is not anticipated that the food industry, or bodies representing enforcers, consumers or the voluntary sector will oppose these SIs as they propose minimal viable change to seek continuity in the way food and feed law work. We issued a consultation from 4th September to 14th October 2018 https://www.food.gov.uk/sites/default/files/media/document/ euexit-regulations-consultation_0.pdf to seek the views of businesses, consumers, other stakeholders and the wider public on the corrections that ministers propose to make under the European Union (Withdrawal) Act 2018 (EUWA) to retained EU law relating to food and animal feed safety and hygiene, with particular regard to the functions of certain EU bodies and institutions. The consultation summary can be found on our website at https://www.food.gov.uk/news-alerts/consultations/proposed-approach-toretained-eu-law-for-food-and-feed-safety-and-hygiene When 4th Septemb er – 14th October 2018 Are there any concessions you could make ahead of laying which could ease the Parliamentary passage? No. All the provisions of the SI are required to correct retained EU law to ensure that it is operable in the UK after EU exit and food/feed safety is maintained. What alternatives/non-legislative options could you consider if you are not able to secure approval for the SI in its current form? None. This SI is necessary as this is the only way to correct retained EU law to ensure that it is operable in the UK after EU exit and food/feed safety is maintained in this area. There are no non-legislative options that could achieve that effect in the long term. LINES TO TAKE Please list the top three defensive Q&A you anticipate using in Parliamentary debates Q. Why does Article 3(2) need to be amended again? Article 3(2) is being amended to make clear that Ministers (the appropriate authority) will be responsible for deciding whether or not any alternative substance will be authorised. Ministers will take account of advice from the food safety authority. Q. Why does the amendment no longer require Food Standards Agency approval for the use of an alternative substance? The wording of Article 3(2) in the EU legislation does not provide an express role for the European Food Safety Authority, which provides risk analysis advice to the European Commission, for the approval of substances. This amendment makes the wording of Article 3(2) closer to that of the retained European Union legislation. The Food Standards Agency (the Food Safety Authority) will remain responsible for analysing the risks associated with the use of a substance and for providing advice to Ministers on whether any substance should be authorised. Q. Is the Government intending to approve the use of chlorinated wash or similar substance to remove surface contamination from chicken carcases after EU exit? No substances other than potable water are approved to remove surface contamination from chicken carcases.  There is no intention currently to change this when we leave the EU.  4. DOCUMENT – Specific Hygiene amendment HoC BRIEFING PACK FINAL 031019 Regulations to be considered The Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019 7 October 2019 CONTENTS Opening Speech 3 Closing remarks 10 Crib Sheet 11 Key points 19 Urgent Procedure Made-Affirmative Q+A 22 Questions concerning EU Exit and the SI programme 24 Questions concerning the consultation and impact on industry 37 Questions concerning devolved administrations and territorial application 39 Transfer of powers 45 Questions concerning issues specific to the SI 47 • Questions concerning RASFF 53 Questions concerning the risk analysis process 59 Questions concerning Trade 71 Questions concerning consequences of not proceeding with this legislation 72 PQs 74 Press coverage 76 Main Speech (1029 words) INTRODUCTION I beg to move, that the Committee has considered the: The Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019 It is a pleasure to serve under your chairmanship [Mr/Madam Chair name of chair] I am confident that we have the shared intention to ensure that the high standards of food and feed safety and consumer protection we enjoy in this country is maintained when the UK leaves the European Union. As my honourable friend, the Member for Winchester, stated previously, this instrument, and the original instrument that it amends only seek to protect and maintain these high public health and food safety standards; changes are limited to the necessary technical amendments to ensure that the legislation is operable on exit day. No policy changes are made through these instruments and we do not have any intention of making any at this point. This instrument amends a previous EU Exit SI, The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019. Further clarity was required in setting out the authorisation process for approving products which can be used to remove surface contamination from products of animal origin. The clarification will ensure that the process is robust and can be applied clearly in assessing the risk of new products. This instrument needed to be in place to support the UK’s application for third country listed status with the EU, so that the UK can continue to export animals and animal products to the EU which we anticipate is due to be voted on by the European Commission on 11 October. This instrument has been made using the powers in the European Union (Withdrawal) Act 2018, to make necessary amendments to UK Regulations to prevent, remedy or mitigate deficiencies in retained EU law that arise as a consequence of the UK’s withdrawal from the European Union. This instrument was made on 9 September under the urgent, made-affirmative procedure, which was considered appropriate to meet the deadline for the European Commission’s Third Country Listing vote on 11 October. No Deal Planning As Hon. Members know, the government has made clear that its priority is to seek a negotiated deal with the EU, but we are taking responsible action to ensure we prepare for every eventuality. The UK’s third country listing application was a particularly important part of our ‘no deal’ preparations. Third country listed status guaranteed that the export of animal products and most live animals from the UK to the EU could continue. This market is worth approximately £5 billion to the UK each year. Purpose and detail of the instrument [Mr/Madam Chairman], I will now expand on the specific detail of the minor and technical changes made by this Instrument. The primary purpose of this legislation is to refine an amendment to retained EU law made by the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019. We considered that this regulation would benefit from further clarity, in describing the authorisation process and the appropriate authority responsible for the process, to approve substances which may be used to remove surface contamination from products of animal origin. Lack of clarity may affect implementation and has the potential to undermine the responsibilities for authorisation; this instrument rectifies this. The new instrument makes clear that the responsibility for approval of substances which may be used to remove surface contamination from products of animal origin rests with the Secretary of State for Health and Social Care, and the appropriate minister in each of the Devolved Administrations. This measure introduces no substantive policy changes to what has already been successfully passed and made in Parliament in March 2019. Main Changes Food Business Operators are not permitted to use any substance other than potable water, or where permitted clean water, to remove surface contamination from products of animal origin unless this has been approved. This relates to business establishments that handle products such as meat, eggs, fish, cheese and milk and which do not supply to final consumers. Currently, approval for such substances is given by the European Commission but after EU exit this responsibility will be carried out by Ministers. The amendment to Regulation (EC) 853/2004 made by the Specific Food Hygiene SI, is being further amended to make it absolutely clear that Ministers will be responsible for prescribing the use of any other substances and the process of consulting the Food Safety Authority is retained. That decision will be made based on independent food safety advice from the Food Standards Agency (the FSA)/ Food Standards Scotland (FSS). If, after EU exit, any additional substances are proposed to be approved for this purpose, they will be subject to risk analysis by the FSA which has established a rigorous and transparent risk analysis process for assessment and approval of any such new substances. Any requests for substance approval would be subject to thorough scientific risk assessment and risk management before being put to Ministers for final decision. Impact on industry Let me be clear that neither this instrument, nor the instrument it amends, introduce any changes for food businesses in how they are regulated and how they are run, nor does it introduce extra burden. The overall changes to the food hygiene regulations will ensure a robust system of controls which will underpin UK businesses’ ability to trade both domestically and internationally. Devolved Administrations It is also important to note that we have engaged positively with the devolved administrations throughout the development of this instrument. Furthermore, this ongoing engagement has been warmly welcomed.  The devolved administrations in Wales and Northern Ireland have provided their consent for this instrument. The Scottish Government has been made aware of these Regulations but has not yet had the opportunity to scrutinise them. I would like to stress that we would not normally make EU Exit Regulations under this Act without the agreement of all the Devolved Administrations where the policy area is devolved in competence. However, as I have explained, this is a very minor drafting change to a Regulation which the Scottish Parliament has previously agreed. Regretfully, the potential impact should this instrument not be in place before 11 October on the Third Country Listing vote, does not constitute a normal situation, and could affect the farming industry across the whole of the UK. Communications with the Joint Committee on Statutory Instruments Finally, I would like to draw the Committee’s attention to the fact that, in line with informal communications which the Food Standards Agency has had with the Joint Committee on Statutory Instruments, the Agency will, in accordance with the terms of the free-issue procedure, be making this Instrument available free of charge to those who purchased the earlier Exit SI, namely the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019. The government accepts that this Instrument should have been made available under the free issue procedure at the time it was first made, but that did not happen due to an oversight. I should like to apologise for that oversight and confirm to the Committee that that oversight will be corrected, and that the Food Standards Agency will, together with colleagues in the National Archives, be taking action to ensure that anyone entitled to free copy of the Instrument under that procedure will, where appropriate, be able to apply for a refund, or otherwise obtain a copy of this Instrument for free, on request, in accordance with the usual terms of that procedure. Conclusion [Mr/Madam Chairman], this instrument constitutes a minor, technical but necessary measure to ensure that our food legislation relating to food safety continues to work effectively after Exit day. I urge honourable Members to support the amendment proposed to ensure the continuation of effective food safety and public health controls, and I thereby commend the Regulation to the Committee. Closing Note: • [Mr/Madam Chairman], I hope that I have answered all the questions raised by Hon Members. As I have said, the Government is working to agree a deal with the EU. But while we do that, and until we have final agreement, it is important that we prepare for the possibility that we will leave with no deal. • To reiterate, this instrument makes no changes to policy or to how food businesses are regulated and run. It is limited to drafting refinements which will ensure that regulatory controls for food continue to function effectively after exit day if the UK leaves the EU without a deal. CRIB SHEET 1. Purpose of the SI • The importance of food safety is paramount, and the amended minor and technical wording of this Instrument ensures that safety is maintained in the event of a ‘no deal’ scenario. • We have not tried to hide this minor provision on meat washes within a larger SI but have been open and transparent in publishing and debating as an Instrument in its own right. • This SI provides flexibility for Ministers to approve new substances as carcass washes, which means that we can respond to new advances in technology on food safety to advance food safety. 2)Standards after Brexit •Leaving the EU doesn’t change our top priority of ensuring that UK food remains safe and what it says it is. The FSA is working hard to ensure that the high standard of food safety and hygiene, and consumer protection we enjoy in this country is maintained when the UK leaves the European Union. •From day one, we are committed to having in place a robust and effective regulatory regime which will mean business can continue as normal. For most food businesses, there will be no change in how they are regulated and how they are managed. •Currently, no substances other than potable water or where permitted clean water, are approved to remove surface contamination from products of animal origin. Any such change would have to be subject to a robust risk assessment and risk management considerations and would require a statutory instrument with usual parliamentary scrutiny. 3)Chlorine chicken •Any substance to be used to remove surface contamination from chicken carcases must be specifically approved; chlorine has not been approved and so cannot be used. Therefore, chicken that has been washed with chlorine cannot be placed on the UK market •No substances other than potable water are approved to remove surface contamination from chicken carcases. There is no intention currently to change this when we leave the EU. •Any such change would have to be subject to a robust risk assessment and risk management considerations and would require a statutory instrument with usual parliamentary scrutiny. •If necessary: As you will be aware, there have been concerns expressed by some Members of this House, industry representatives and also speculative coverage in the media that the USA may press the UK that as part of a future free trade agreement the UK accept imports of chicken on which chlorine and other chemical washes and decontaminants have been used to remove surface contamination. While the use of such chlorinated and chemical washes is allowed for this purpose in the US, as I mentioned, they are not permitted by the UK or the EU. There is no intention currently to change this when we leave the EU. Maintaining the high standards of food fety • Leaving the EU doesn’t change our top priority of ensuring that UK food remains safe and what it says it is. The FSA is working hard to ensure that the high standard of food safety and hygiene, and consumer protection we enjoy in this country is maintained when the UK leaves the European Union. • From day one we are committed to having in place a robust and effective regulatory regime which will mean business can continue as normal. For most food businesses, there will be no change in how they are regulated and how they are managed. • Currently, no substances other than potable water or where permitted clean water, are approved to remove surface contamination from products of animal origin. Any such change would have to be subject to a robust risk assessment and risk management considerations and would require a statutory instrument with usual parliamentary scrutiny. 6. Why is the SI being laid when SIs relating to this area has already been through the debate process?  7. What is the government’s stance on chicken washed with chlorine? Is the Government intending to approve the use of chlorinated wash or similar substance to remove surface contamination from chicken carcases after EU exit? • Any substance to be used to remove surface contamination from chicken carcases must be specifically approved; chlorine has not been approved and so cannot be used. Therefore, chicken that has been washed with chlorine cannot be placed on the UK market • No substances other than potable water are approved to remove surface contamination from chicken carcases. There is no intention currently to change this when we leave the EU. • This SI provides clarity on the process for approval of substances which may be used to remove surface contamination from products of animal origin. Any lack of clarity has the potential to place existing levels of food safety protection for consumers at risk.   • The original Specific Food Hygiene SI was insufficiently clear in describing the approval process for surface contaminants on products of animal origin. • Any such change would have to be subject to a robust risk assessment and risk management considerations and would require a statutory instrument with usual parliamentary scrutiny. • If necessary: As you will be aware, there have been concerns expressed by some Members of this House, industry representatives and also speculative coverage in the media that the USA may press the UK that as part of a future free trade agreement the UK accept imports of chicken on which chlorine and other chemical washes and decontaminants have been used to remove surface contamination. While the use of such chlorinated and chemical washes is allowed for this purpose in the US, as I mentioned, they are not permitted by the UK or the EU. There is no intention currently to change this when we leave the EU. 9.. What it is the current process for 10. What will be the situation should approval of substances used to Ministers in the devolved remove surface contamination products administrations take a different of animal origin? decision on the approval of a substance intended to remove surface • Currently, an applicant will make a contamination from carcasses? request to the European Commission The Government is committed to which, following agreement with securing a deal that works for the entire representatives from Member United Kingdom - for Scotland, Wales, States, will refer the application to EFSA. EFSA will carry out a scientific Northern Ireland and all parts of England. The Scottish and Welsh evaluation on both the safety of the Governments have already recognised substance and efficacy of its use. that common frameworks may be needed • Following the issue of EFSA’s in some areas including food and feed Opinion, Member States vote whether safety and hygiene law, and discussions the substance will be approved at the on this have begun via the Joint European Commission’s Standing Ministerial Committee on EU Committee meeting. Negotiations. • After EU exit, if approval is sought for any further substances to be used, they will be subject to risk analysis by the FSA/FSS which has established a rigorous and transparent risk analysis process for assessment and approval of any such new substances.  Any requests for substance approval would be subject to thorough scientific risk assessment and risk management before being put to Ministers for final decision.  • • • • • • Whilst these high-level discussions are taking place, the FSA continues to have close working relationships with the administrations in Scotland, Wales, and Northern Ireland. We are therefore confident that in practice it will be possible to make arrangements to operate a framework for food safety regulation across the UK. Key points and top lines This instrument is being made for a no deal and negotiated scenario. The primary purpose of this instrument is to ensure legislation which allows for the protection of the public. The SI refines an amendment to retained EU law made by the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 and provides minor corrections to that SI to provide greater clarity in describing the process for approval of substances which may be used to remove surface contamination from products of animal origin. The amendments proposed in this instrument are critical to ensure there is minimal impact on food safety regulation and the UK has the necessary powers to prevent contaminated food from being placed on the UK market. This instrument will maintain the current standard of food safety and hygiene on exit day and enable updates to be made. These changes would not affect the safety, quality or supply of food in the UK as the current standards of food safety and hygiene would be maintained. • o o o • • • Our approach to EU Exit is underpinned by three key principles; the FSA has been working hard to ensure that UK food remains safe and what it says it is. the high standard of food safety and consumer protection we enjoy in this country is maintained when the UK leaves the European Union. from day one a robust and effective regulatory regime will be in place which will mean business can continue as normal. This instrument is subject to Parliamentary scrutiny through the affirmative resolution procedure and requires formal approval of the Commons and Lords. If the UK reaches a deal with the EU, the Food Standards Agency will revoke or amend this instrument. After exit day this domestic legislation will remain in force to enable the enforcement of the retained EU law as corrected by this instrument. Transfer of powers: • This instrument clarifies that these powers are transferred from the Commission, in terms of authorised substances to remove surface contamination from products of animal origin to Ministers in England, Scotland, Wales and the devolved authority in Northern Ireland. It should be noted that all powers in this category relate to technical, scientific and administrative adjustments which may be necessary to respond to changing circumstances. Questions specific to the SI: The Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019 (the SI) What is the purpose of this SI? • The SI fixes an inoperability of Regulation (EC) No. 853/2004 that lays down specific hygiene measures for the production and processing of certain food products of animal origin. • The primary purpose of this SI is to refine an amendment to retained EU law previously made by the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019. That amendment is now considered to be insufficiently clear to describe the process for approval of substances which may be used to remove surface contamination from products of animal origin. • It amends Article 3(2) of Regulation (EC) No. 853/2004, to make it clearer that Ministers (the appropriate authority) will be responsible for deciding whether or not any alternative substance will be authorised to remove surface contamination from products of animal origin. • Ministers must take account of advice from the Food Standards Agency (the Food Safety Authority) as outlined in the SI. Why does the amendment no longer require the Food Standards Agency to have responsibility for decision making on approval for the use of an alternative substance? • The wording of Article 3(2) of Regulation (EC) No. 853/2004 does not provide an express role for the European Food Safety Authority, which provides risk assessment advice to the European Commission, for the approval of substances. This amendment makes the wording of Article 3(2) closer to that of the retained European Union legislation. • The Food Safety Authority (Food Standards Agency and Food Standards Scotland) will remain responsible for analysing the risks associated with the use of a substance and for providing advice to Ministers on whether any substance should be authorised and its conditions of use. What procedures will apply to the approval of substances for washing contaminants off the surface of products of animal origin? • The SI retains the requirement for substances used for removing surface contamination from products of animal origin to be approved. Ministers in England, Wales, Scotland, and the devolved authority in Northern Ireland will in due course prescribe the measures that will apply for the approval of substances for washing contaminants off the surface of products of animal origin. Will the Food Safety Authority be responsible for deciding what substances can be used for removing surface contamination from animal products? • No. Ministers will hold decision making responsibility. Decisions will be based on recommendations from the food safety authorities (Food Standards Agency and Food Standards Scotland). • The Food Safety Authority will analyse the risks associated with the use of a substance in accordance with the risk analysis process agreed by the Food Standards Agency Board and provide advice to Ministers on possible approval, and on the conditions of its use. Which body will be responsible for deciding whether or not the use of chlorinated wash is to be permitted for washing surface contamination off chicken meat? • Ministers will decide whether or not any application for use of chlorinated wash to remove surface contamination from chicken carcases is to be approved. This decision will be based on recommendations from the food safety authority (Food Standards Agency and Food Standards Scotland). Will the Food Safety Authority’s risk assessment and advice to Ministers on use of substance be publicly available? • The risk analysis process must be open and transparent. When advising decision-makers, the Food Standards Agency and Food Standards Scotland will observe the relevant principles and provisions in their longstanding Code of practice on openness. The food safety authorities will publish the advice provided to others and the analysis and evidence on which that advice was based. What substances are approved to decontaminate poultry carcases / chicken carcases? • Potable water is the only substance approved to remove surface contamination from poultry meat / chicken meat. What substances are currently approved to remove surface contamination from meat and other products of animal origin? • Potable water is approved to remove surface contamination from meat and other products of animal origin. • Lactic acid is approved to remove surface contamination from bovine carcases only. • Recycled hot water is approved to remove surface contaminations from carcases of domestic ungulates (e.g. cattle, sheep, pigs) and wild game carcases only. • This Statutory instrument makes retained EU law on use of potable water, lactic acid and recycled hot water ready for the UK leaving the EU. What is the government’s stance on chicken washed with chlorine? Any substance to be used to remove surface contamination from chicken carcases must be specifically approved; chlorine has not been approved and so cannot be used. Therefore, chicken that has been washed with chlorine cannot be placed on the UK market. Is the Government intending to approve the use of chlorinated wash or similar substance to remove surface contamination from chicken carcases after EU exit? No substances other than potable water are approved to remove surface contamination from chicken carcases. There is no intention currently to change this when we leave the EU. General: Q: Why were these issues not identified sooner (i.e. when the main amendment SI was made)? • The amendment to retained EU law previously made by the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 is now considered to be insufficiently clear to describe the process for approval of substances which may be used to remove surface contamination from products of animal origin. • This instrument provides minor corrections to that SI to provide greater clarity in describing the process for approval of substances. It makes it absolutely clear that Ministers will be responsible for allowing the use of any other substances. • The amendments proposed in this instrument are critical to ensure there is minimal impact on food safety regulation and the UK has the necessary powers to prevent contaminated food from being placed on the UK market. • The Food Standards Agency together with colleagues in the National Archives, will ensure that anyone entitled to free copy of this revised Instrument will be able to apply for a refund, or otherwise obtain a copy of this Instrument for free, on request, in accordance with the terms of the free-issue procedure. • Page Break Consequences of not proceeding with this legislation What would happen if this legislation does not pass? • The SI ensures that the retained EU law remains operable and enforceable within the UK regulatory framework after exit without compromising existing levels of public health protection and food safety. • The SI provides minor corrections to retained EU Law to provide greater clarity in describing the process for approval of substances which may be used to remove surface contamination from products of animal origin. Therefore, there is a risk that the functions transferring to the UK from the EU Commission via the European Union (Withdrawal) Act 2018 may not be clear and not transferred to the appropriate UK authorities rendering the current system of food safety protection inoperable. This is likely to damage consumer confidence and business and trading partner confidence in the UK. • The importance of food safety is paramount, and the wording of the retained legislation as amended by this instrument ensures that this is maintained in the event of a “no deal” scenario. Any agreements during exit negotiations that impact the food regulatory regime will be factored in to any future amendments to this instrument. • Food safety affects everyone and as we leave the EU it is important to maintain the current high standard of legal protection for UK consumers in relation to food in the UK. • Food safety regulations have a huge impact on the economy. These SIs enable that to happen. There are around 214,175 businesses active in the agri-food sector and approximately 419 Local Authorities (LAs) and 35 Port Health Authorities (PHAs) in the UK, which enforce existing food and feed law and will continue to enforce the retained EU law after the UK’s EU Exit. From day one we are committed to having in place a robust and effective regulatory regime which will mean business can continue as normal. • Food safety risk also has a high profile in the media, and so it risks raising its profile in a negative way, possibly leading to concerns by consumers and businesses which produce products of animal origin who export to the remaining members of the European Union.Page Break Background • The changes contained within this instrument are simply designed to fix inoperabilities in retained EU legislation relating to food safety to reflect the status of the UK outside the EU. This instrument delivers this for a single aspect of Regulation (EC) No. 853/2004. • The instrument is subject to Parliamentary scrutiny through the affirmative resolution procedure and requires formal approval of the Commons and the Lords. The SI has been laid before Parliament by Ministers from DHSC as the FSA is a non-ministerial department. • The amendments are being made to the following UK legislation: o • The Specific Food Hygiene (Amendment) (EU Exit) Regulations 2019. To ensure continuing operability of the retained EU law, the most significant function of this SI will be to provide suitable replacements for: o the risk management function currently undertaken by the European Commission and o the risk assessment function currently undertaken by the European Food Safety Authority (EFSA). • These functions feature throughout the EU legislation, most notably for the authorisation of substances to remove contamination from products of animal origin (POAO) is currently carried out by the European Commission. Following EU Exit, this function will be carried out by Ministers. • The amendment made to Article 3(2) by the Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019, is further refined by this SI to make clearer that ministers will hold responsibility for authorising the use of any additional substances to remove surface contamination from POAO. • • This instrument provides that tertiary powers of the EU Commission pass to Ministers in accordance with the devolution settlements. This means that Ministers in the devolved administrations may make regulations in their respective territories and the Secretary of State will not be able to make Regulations for those territories. Page Break Related Parliamentary Questions UK Campy and Chlorine Chicken (February 2019) Lord Rooker To ask Her Majesty's Government what research they have carried out on the food safety effects of chlorine washing of (1) salad, and (2) meat, products. HL13759 “Answer:  I am advised by the Food Standards Agency (FSA) that chlorine washes can be used on fresh produce, including salad, but are legally not permitted on products of animal origin or meat. Past research commissioned by the FSA looked at ‘Reducing Campylobacter cross-contamination during poultry processing.’ The researchers tested some substances, including, chlorine dioxide, and compared their effect with steam treatment. The results indicated that none of the treatments eliminated Campylobacter entirely. The FSA is continuing to review the literature and monitor the latest developments on the topic. Press coverage: Chicken washed with chlorine There continues to be national media coverage about whether chlorine-washed chicken might be allowed on the UK market as part of a post-EU Exit US trade deal. This issue is regularly used to illustrate concerns about a lowering of food standards post-Brexit. The most recent coverage on the subject was generated by comments from Sir Ian Boyd, chief scientific adviser at Defra, who said there was no 'scientific' reason to ban chlorinated chicken or hormone beef in a post-Brexit trade deal, citing a lack of evidence the treatments would cause harm to British consumers. 5. DOCUMENT – Northern Ireland and approval of substances – revised Context: This formed part of the briefing for Ministers for the passage of the following EU exit statutory instrument (SI) through the House of Commons. The SI which concerned Article 3(2) of Regulation (EC) No 853/2004 on substances for removal of surface contamination from products of animal origin. The Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019. What approval process would apply in Northern Ireland for use of substances to remove surface contamination, if it is agreed under a UK/EU withdrawal agreement that Northern Ireland will continue to apply EU food safety Regulations? • The high standard of food safety and consumer protection we enjoy in this country will be maintained when the UK leaves the EU. • This will be true in any scenario, and for every part of the United Kingdom. ONLY if pressed - As the Prime Minister set out in his letter to President Juncker earlier this month, the UK's proposals for a revised Protocol include the potential for an all-island regulatory zone, including for agri-food. - Any such zone must and would make sure that food safety continues to be maintained to the high standard that people rightly expect. 6. DOCUMENT – Approval procedure for substances – removal of surface contamination Context: This formed part of the briefing for Ministers for the passage of the following EU exit statutory instrument (SI) through the House of Commons. The SI which concerned Article 3(2) of Regulation (EC) No 853/2004 on substances for removal of surface contamination from products of animal origin. The Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019. What procedure will apply for the approval of an alternative substance to remove surface contamination? • Applications for approval of a new substance to remove surface contamination from products of animal origin will need to be accompanied with evidence to support the safety and effectiveness of the proposed substance. • Substances being considered for approval will be subject to a rigorous risk analysis process by the food safety authority (Food Standards Agency (FSA) and Food Standards Scotland (FSS)), and will be subject to thorough scientific risk assessment and risk management before a recommendation is put to Ministers for final decision. • Ministers will hold decision making responsibility. Decisions will be based on recommendations from the food safety authorities (FSA and FSS). • All decisions to approve the use of substances to remove surface contamination from products of animal origin will require a statutory instrument, providing for parliamentary scrutiny. • The advice provided to Ministers, and the analysis and evidence on which that advice was based, will be publicly available. 7. DOCUMENT – Food safety standards watered down_(002) Context: This formed part of the briefing for Ministers for the passage of the following EU exit statutory instrument (SI) through the House of Commons. There had been media reports at the time around the matters referred to. The SI concerned Article 3(2) of Regulation (EC) No 853/2004 on substances for removal of surface contamination from products of animal origin. The SI is The Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019. Lines to take on – DIT/Liz Truss pushing for new Trade Deals / not watering down standards; etc Will food safety standards be watered down in the bid to get new trade deals through? • Leaving the EU doesn’t change our top priority of ensuring that UK food remains safe and what it says it is. The Government has worked hard to ensure that the high standard of food safety and hygiene, and consumer protection we enjoy in this country is maintained when the UK leaves the European Union. • There will be no lowering of food standards to accommodate products from outside the UK. • Currently, Food Business Operators are not permitted to use any substance other than potable water, or where permitted clean water, to remove surface contamination from products of animal origin unless this has been approved. Approval for any other substances would be subject to a robust scientific and evidence-based risk assessment and risk management considerations by the Food Safety Authority (FSA and FSS) before being put to Ministers for final decision. The advice provided to Ministers, and the analysis and evidence on which that advice was based, will be published and the decision to approve will be implemented by means of a statutory instrument, thus providing for parliamentary scrutiny. • If necessary: As you will be aware, there have been concerns expressed by some Members of this House, industry representatives and also speculative coverage in the media that the USA may press the UK that as part of a future free trade agreement the UK accept imports of chicken on which chlorine and other chemical washes and decontaminants have been used to remove surface contamination. While the use of such chlorinated and chemical washes is allowed for this purpose in the US, as I mentioned, they are not permitted by the UK or the EU. There is no intention currently to change this when we leave the EU. 8. DOCUMENT – Handling Plan - specific hygiene amended FINAL DRAFT PARLIAMENTARY HANDLING STRATEGY DEPARTMENTAL CLEARANCE Lead Department Food Standards Agency Secretary of State and Y SI Minister Signed Off SI SRO sign off Y Have Special Advisers cleared the Y handling plans? Departmental Whip Y been consulted? If there is significant cost or No significant cost economic implications implications. HMT with this SI or not consulted. No significant negative negative DUP DUP interest have HMT interest been consulted? INTRODUCTION Title: The Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019 Planned laying date: 3 Lead Minister September 2019 responsible: Commons only procedure? No Seema Kennedy RISK AND CONTROVERSY Summarise the purpose of the SI and the effects of bringing in this piece of legislation. Food and feed safety legislation is laid down in directly applicable EU law. This protects public health and underpins UK businesses’ ability to trade domestically and internationally. UK Government intends to bring forward the above-named Regulations under powers in the European Union (Withdrawal) Act 2018. The Food Standards Agency (FSA) is working to correct deficiencies in retained EU law relating to food and animal feed. To achieve this, the FSA began a programme of EU Exit SIs in 2019 to fix inoperabilities in retained EU law. These have made no change in the level of protection given to human (or animal) health or to the high standards of food and feed that consumers expect from both domestically produced and imported products. The FSA has worked closely with Devolved Administrations throughout and this SI will take forward provisions on a UK basis. This draft SI will be laid before Parliament (under the affirmative resolution procedure) by DHSC on behalf of the FSA. The purpose of this SI (The Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019) is to make clearer that Ministers will have responsibility for authorisation of substances to remove surface contamination from products of animal origin (POAO). This SI will provide this clarification by amending the provisions of retained EU legislation (Regulation (EC) No. 853/2004) on specific hygiene rules for handling certain POAO. These are establishments that handle products such as meat, eggs, fish, cheese and milk and which do not carry out retail activities (i.e. they do not supply to final consumers). The provisions of Article 3(2) of Regulation (EC) No. 853/2004 provides that food business operators are not permitted to use any substance other than potable water, or where permitted clean water to remove surface contamination from POAO unless this has been approved by the European Commission. Following EU Exit, the existing ban on the use of chemical decontaminants and washes on animal products other than those already approved, will be brought onto the UK statute book by the European Union (Withdrawal) Act 2018 and amended (without any change in policy) so that it functions properly by this instrument. Article 3(2) provided that the use of any other substance for this purpose must be approved by the European Commission. This was amended by the original Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 to remove the references to the Commission. The amendment provided for approval of any further substances by the Food Safety Authority and that measures would be prescribed by the appropriate authority. Article 3(2) of Regulation 853/2004 was amended by the Specific Food Hygiene SI as debated in Parliament on 5th March 2019 and agreed with the Devolved Administrations. The amendment to Article 3(2), made by the Specific Food Hygiene SI, is being further amended to make clearer that Ministers (the appropriate authority) will be responsible for prescribing the use of any other substances. As the role of the Food Safety Authority in this context is akin to that of the European Food Safety Authority and as EFSA is not specifically referred to in Article 3(2), in order to more closely follow the wording of Article 3(2) the amendment will no longer additionally refer to the Food Safety Authority. The drafting in the Specific Food Hygiene (Regulation (EC) No. 853/2004) (Amendment) (EU Exit) Regulations 2019 SI intentionally follows closely the drafting provision in the EU Regulation to make clear that no policy changes are being made to the text of the EU Regulation. The FSA was clear on its approach to fixing inoperabilities in the EU legislation and in the public consultation it issued was only to correct deficiencies, and not make further policy changes through the EU Exit SIs. During debates Ministers assured Parliament that only the essential changes had been made to provide operability of retained EU legislation on EU exit. If any additional substances are to be approved for this purpose: • The Food Safety Authority will undertake analysis of the risks associated with the use of a substance and provide advice to Ministers on possible approval, and on the conditions of its use. • The Appropriate Authority will prescribe use of the substance, and • The authorisation of the substance will be made by means of an SI (negative procedure). The FSA has established a rigorous and transparent process for assessment and approval of any new substance. As set out in the FSA publications, any requests for approval would be subject to thorough scientific risk assessment and risk management including analysis of other legitimate factors, following which independent food safety advice would be put to Ministers. This process provides an appropriate mechanism for decision-making on chemical de-contaminants and washes for animal products. It would be highly beneficial for the legislation to be in place for Exit Day, however, the Specific Food Hygiene SI will continue to provide basic food safety protection for consumers in that enforcement action could be taken against the placing of unsafe food on the market. Furthermore, the FSA considers that businesses marketing these products would want to continue current practices and maintain safety standards to maintain confidence in the food industry. The purpose of these regulations is to maintain the status quo in terms of regulation. To mitigate potential problems, the FSA would advise local authorities of the implications of the regulations, so that they can advise businesses of the required standards. Existing preventative safeguards e.g. the manufacture, storage, handling and sale of products would be covered under the general hygiene provisions of 852/2004. In addition to the above, the 15 earlier FSA UK EU Exit SIs to fix inoperabilities in retained EU Law have also been made and are operable. This further mitigates any risks presented by this further SI as the provision it is concerned with is comparatively minor. What is the risk rating? (Low, Medium or High) What are the reasons for this? Medium. This instrument does not make policy changes. However, it is appropriate for the measure covered by this SI to be in force before exit in order that Regulation (EC) No 853/2004 is fully at day one readiness. As with the previous FSA UK EU Exit SIs, if this SI is not made it may mean that there will be partially defective or unclear legislation on UK statute books, but administrative procedures and reliance on the key elements in food law may be used in the short term to mitigate any consequences that may arise until the inoperabilities can be addressed. There is political, farm, food industry and media concern that the USA may press the UK that as part of a future free trade agreement the UK accept imports of chicken on which chlorine and other chemical washes and decontaminants have been used to remove surface contamination. The use of such chlorinated and chemical washes for this purpose are allowed in the USA but are not permitted by the UK/EU and chicken that has been washed with chlorine or chemical washes cannot be placed on the UK/EU market. There are no current proposals to approve these substances for poultry carcases. The amendment SI may lead to wider questions whether the Government EU exit SIs have been introduced too quickly, about the robustness of EU exit legislation and that the process has not allowed time for proper Parliamentary scrutiny. The Specific Food Hygiene SI is only intended to clarify the authorisation process and does not make policy changes. What is the scope for debate? (Consider the most controversial issues that could arise) This instrument is subject to the affirmative procedure and therefore will be subject to debate in both Houses. The instrument itself is not controversial as it does not implement substantive policy changes, and it seeks to maintain food/feed safety and protection and the requirements with which industry are fully familiar. However, there has been political and media interest in any potential future use of chlorine and other chemical washes and decontaminants to remove surface contamination from poultry carcases. The use of such chlorinated and chemical washes for this purpose is banned for poultry carcases and there are no current proposals to approve these for poultry carcases. George Eustice MP has proposed an amendment to the Agriculture Bill which if accepted would only permit the use of potable water to remove surface contamination from animal products. That would go beyond current EU legislation as it would prohibit the use of substances already approved in the EU under Article 3(2), such as clean water on fishery products, and prevent future approval of any alternative substances even if they were assessed as safe to use except by primary legislation. It is thought that the George Eustice amendment is intended to prevent the use of chlorine and chemical washes from being authorised for poultry carcases in order to facilitate a free trade agreement with the USA. If the George Eustice amendment were to be accepted this could have implications for trade with the EU27 as EU legislation allows other substances, such as clean water, to be used in certain circumstances. OTHER KEY ISSUES The debates will provide MPs/Peers with the opportunity to raise broader issues around food or feed safety, some of which have already been raised in Parliament and were responded to by DHSC Ministers and the FSA (see the parliamentary activity section for further detail). We anticipate the debates may also include issues such as the maintenance of existing food standards; the ‘loss’ of EFSA; technical notices; EU systems such as Rapid Alert System for Food and Feed (RASFF); and the enhanced role of the FSA after exit: Food Standards Protecting public health and consumer confidence in the safety and authenticity of food remains our key priority. The Government wishes to see the UK's globally leading food standards maintained after the UK leaves the EU. We have no plans to lower existing protections and principles that underpin food/feed safety and consumer interests in relation to food/feed. For example, this is especially important for chlorine-based decontaminants. Chlorine is not an authorised substance to remove surface contamination; chicken that has been washed with chlorine cannot be placed on the UK market. EFSA and other risk assessment bodies Risk-assessment and oversight of food and feed safety controls will be essential to ensure that food and feed remains safe, whether imported or produced here. Although our future relationship with EFSA is subject to UK-EU negotiations and remains to be determined at the time of submission of this handling plan. The UK already has risk assessment capacity and carries out routine risk assessment work and until recently has taken the lead on assessing risk in non-EU harmonised food issues. The Government’s contingency planning allows for a significant increase in the FSA’s capacity by building on existing independent scientific advisory structures to bridge any gap that might arise in risk assessment functions that were carried out by EFSA. FSA role After EU Exit, food and feed safety risk management functions now performed by EU institutions will return to the UK. Without prejudice to potential future arrangements between the UK and the EU, the UK will be responsible for decisions and legislation relating to food (and feed) safety. Ministers already have a range of powers necessary to perform food and feed safety risk management functions under existing UK legislation. Similar provisions exist in the Devolved Administrations. The FSA is responsible for risk analysis (risk assessment, risk communication and policy development), with FSS performing a similar role in Scotland. Therefore, when we leave the EU there will be no gaps created affecting Government’s ability to make necessary risk management decisions, supported by FSA and FSS as appropriate. It is necessary to ensure that the retained EU laws reference the relevant UK risk managers and risk assessors so that the current rules will continue to function effectively on the day we leave the EU. Furthermore, discussions are ongoing across Government and with the Devolved Administrations as to how best to organise Risk Management and Risk Assessment for the UK after we have left the EU. The FSA's priority is to maintain the UK’s high-standards of food and feed safety, and to ensure we take a risk-based, proportionate approach to risk analysis. The UK is developing an alternative to some of the functions currently provided by EFSA, building on existing scientific advisory structures. Subject to negotiations, we will redefine and formalise a close working relationship with EFSA based on exchange of information and expertise, contribution to scientific networks, and cross-European collaboration. Other food and feed related issues It is possible that other food related concerns in the media may be raised in the debates, e.g. potential lowering of food and feed safety standards to facilitate trade with non-EU countries such as the USA. It is possible that issues falling within Defra’s remit, e.g. food stockpiling and food waste at the border may arise. Lines to take on these issues will be provided ahead of debates. Summarise the debate on the power/issue in the two Houses during the parent Act. Include any useful Hansard references. During the passage of the EU Withdrawal Bill through the House of Commons there were five amendments tabled that referenced this policy area: Amendment NC72 – regarding who should bear the costs on inspections of imported foods at Ports; Amendment 238 - Secretary of State asked to lay a report before Parliament setting out a strategy for seeking the maintenance of UK membership of the European Food Safety Authority on existing terms after withdrawal from the EU; Amendment 343 (Made by Jeremy Corbyn, Keir Starmer, Harriet Harman amongst others) Secretary of State asked to lay before Parliament a strategy for a food standards framework after withdrawal from the EU; Amendment 221 – Act should not come into force until a Minister of the Crown has published an assessment of the effect of the United Kingdom’s withdrawal from the EU on food and drink safety and quality standards, and has laid a copy of the assessment before Parliament; Amendment 8 – Regarding the transferring of powers from EU agencies back to the UK being set and administered by the Department of Health, the Food Standards Agency and any other public authority specified in regulations made by the Secretary of State. In the House of Lords there were two amendments tabled: Amendment 142 (Made by Lord Rooker former FSA Chair) - to require, as a minimum, maintenance of current regulations concerning food standards when the UK exits the EU; This amendment was agreed. Hansard ref https://hansard.parliament.uk/commons/2018-06-12/debates/3AC9EE4B-A84C-47D19519-80CEA3653807/EuropeanUnion(Withdrawal)Bill (col 839) Amendment 184 (Made by Lord Adonis) - No regulations may be made under this section until the Secretary of State has laid a report before Parliament setting out a strategy for seeking the maintenance of the United Kingdom's membership of the European Food Safety Authority on existing terms after withdrawal from the EU. This amendment was agreed. Hansard ref https://hansard.parliament.uk/Commons/2018-0613/division/BB6A6FDD-4B28-47B3-8D3720FFAA9B3B32/EuropeanUnion(Withdrawal)Bill?outputType=Names Has this policy area attracted any parliamentary activity e.g. PQs, Early Day Motions, debates or Lords oral questions? There has been parliamentary activity regarding the UK’s future risk assessment and risk management responsibilities to maintain food standards regulations. House of Commons In January 2018 Alex Cunningham (Lab) asked a question on future food safety regimes after EU Exit. In March 2018 Dr David Drew (Lab) asked a question in the House of Commons regarding additional funding for inspections on third party commercial assurance schemes and Bill Wiggin (Con) asked about the enforcement of rules on animal welfare in transport. In March, Jonathan Edwards (PC) also asked about whether lower standard foods would be allowed to be imported into the UK following our departure from the European Union. In June 2018 Caroline Lucas (Green) asked a question about the government’s plans to control imported food after our departure from the European Union. Alex Cunningham (Lab) also posed a question relating to future food safety and animal welfare standards in relation to trade deals in June. Priti Patel (Con) asked about the conduct of FSA inspectors in abattoirs. The use of substances to remove contamination from POAO was raised during the House of Commons debate on bundle 1 on 5 March 2019. A record the debate can be found here: https://hansard.parliament.uk/Commons/2019-03-05/debates/572fcd14-1a65-423e8aeeHouse of Lords In June 2018 we received a series of questions (HL8827, HL 8830, HL 8780, HL8782, HL8783) in the House of Lords from the Countess of Mar (CB) regarding official laboratories, local authorities and the Elliot Review. General food safety enquiries On 26th of April 2018, the House of Lords debated the role of the FSA after Brexit. Baroness Jones of Whitchurch (Lab) raised questions in the Lords regarding the future approach of the FSA to regulation after EU Exit. [HL OPQ 26 April 2018, Vol 790, Column 1654-1656] Baroness McIntosh of Pickering (Con), in the same debate, asked specifically about future statutory instruments. Lord Rooker (Lab) asked about future cooperation with other EU countries and access to the Rapid Alert System for Food and Feed. Baroness Bakewell of Hardington Mandeville (LD) also participated, asking about Meat Hygiene Controls. The Countess of Mar (CB) also raised a question about local authorities having suitable number of environmental health officers. Lord Bassam of Brighton asked an oral PQ on 4th September 2018: "To ask Her Majesty’s Government whether they will commit to putting before both Houses any proposals to amend the United Kingdom’s food standards regulations in the event of a “no deal” scenario when the United Kingdom leaves the European Union." [HL OPQ, 4 Sept 2018, Vol 792, Column 1694-1696]. This led to follow up questions from Lord Deben; Lord Rooker; Baroness Bakewell; The Countess of Mar; Baroness Jones of Whitchurch; Baroness McIntosh of Pickering; and Baroness Ludford. Lord O’Shaughnessy assured the House a programme of secondary legislation would be brought forward to make technical amendments to EU-derived and retained food safety and standards law to maintain the UK’s food standards and safety regime. He also highlighted additional funding for the FSA and local authority enforcement. Other key points were as follows: • there will be no lowering of food standards to accommodate products from outside the UK and before we consider revising/establishing any standards, a proper scientific and evidence-based assessment will be undertaken; • the Food Standards Agency will continue to fulfil its statutory duty to put consumers first in relation to food safety, but some technical changes to its role may be necessary to support this; • we will maintain the split between independent risk assessment and risk management, with decisions being made by Ministers; • we are planning for non-participation and are considering what other arrangements might be made to have access to food alerts and EU safety assessment data for food products. Heather Hancock, the Chair of the FSA gave oral evidence to the Lords EU Energy and Environment Sub Committee roundtable discussion which took place on 4 July 2018, and on 6 March 2019 and explored how food safety risk management decisions will be taken when the UK leaves the EU. The Chair described the current risk management functions and how they operate in an EU context. It has been proposed that the FSA should have the power to make risk management decisions, which are almost entirely technical. Questions also arose on RASFF and TRACES; The FSA is working to replicate, recreate and rebuild the necessary framework to operate effectively, and additional surveillance capability should we not have full access to those systems in future. It was highlighted that maintaining standards, public health and public trust were of the utmost importance. A record of the Committee can be found here: http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/euenergy-and-environment-subcommittee/food-safety-risk-managementpostbrexit/oral/86576.html Heather Hancock also gave oral evidence to the Commons Environment, Food and Rural Affairs Select Committee on 24 April 2019, to its one-off inquiry into the work of the FSA. A wide range of topics were discussed including: risk assessment post EU Exit; the independence and accountability to Parliament of the FSA; the safety of importing foods; and Rapid Alert System. A copy of the transcript can be found here: http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument /environment-food-and-rural-affairs-committee/work-of-the-food-standardsagency/oral/101349.pdf There was a PQ on the issue of chlorinated washed chicken in February 2019 – Lord Rooker: To ask Her Majesty’s Government what research they have carried out on the food safety effects of chlorine washing of; (1) salad, and (2) meat, products. (HL13759) A record of the Q&A can be found here: https://www.parliament.uk/business/publications/written-questions-answersstatements/written-question/Lords/2019-02-14/HL13759/ Jason Feeney, Chief Executive of the FSA was a witness before the Commons Public Bill Committee in relation to scrutiny of the Defra Agriculture Bill on 23 October 2018. The Committee sought assurance that food imported into the UK post-Brexit is produced to the equivalent standards. In an implementation period, we would expect a broad continuation of existing standards. In a no deal scenario, the EUWA will retain existing EU regulations, which will be amended through the FSA’s secondary legislation programme. Any future policy changes will be evidence-based, and the FSA would put its recommendations to Ministers accordingly. The Committee questioned what impact might arise on the devolved administrations. The Chief Executive explained that food safety is a devolved issue, the FSA (covering England, Wales and NI) is working with FSS to develop arrangements whereby emerging evidence will be considered in an advisory forum for food and feed, in which all four countries are represented and, as far as possible, a four-country conclusion is reached. A record of the Committee can be found here: https://hansard.parliament.uk/commons/2018-10-23/debates/480f10b5-dcf5-4772-bbb13f0701ff4725/AgricultureBill(SecondSitting) The Specific Food Hygiene (Amendment etc.) (EU Exit) Regulations 2019 was debated in the House of Lords as part of the bundle 1 of FSA’s SIs on 6 March 2019: https://hansard.parliament.uk/Lords/2019-03-06/debates/E124B43F-AE8B-43F7-8A34A5617C49638B/SpecificFoodHygiene(AmendmentEtc)(EUExit)Regulations2019 What are the consequences of not proceeding with this legislation? As with previous FSA UK EU Exit SI’s, if this instrument is not proceeded with, it may mean that there will be partially defective or unclear legislation on UK statute books, but administrative procedures and reliance on the key elements in food law may be used in the short term to mitigate any consequences that may arise until the inoperabilities can be addressed. HANDLING How are the DUP (also SNP/ PC) expected to react to this SI? *See also the Devolved Administrations section later in the Handling Plan. DUP As part of the Confidence and Supply Agreement, the DUP had agreed to support the Government on all legislation pertaining to the UK’s exit from the European Union. The DUP notes the importance of farming to the Northern Ireland economy, although there are no specific references to food safety, or to the food processing or retailing sectors. The DUP is keen to ensure a whole Ireland economy is maintained with a seamless frictionless border with the Republic of Ireland and have highlighted trade in food as a key element of this. A letter signed by key industry food trade bodies (FDF, BRC, NFU, BPC, BMPA) is supportive of this approach. The DUP supports strong protections for agrifood to guard against vulnerabilities to cheap inferior imports, as noted in their manifesto. It has expressed a desire to establish a marketing body to promote food from Northern Ireland, which could help support future trade deals and builds on their efforts to promote NI produced food in 2016. The DUP deputy leader, Nigel Dodds, has said preserving the "political, constitutional and economic integrity of the United Kingdom" was the "absolute priority for us". We anticipate support from the DUP as this SI preserves the effectiveness of existing food safety principles and does not introduce any policy changes. This will mean (subject to negotiations) that the NI food sector can continue operating to existing standards of safety, thereby facilitating current trading patterns. Agriculture makes up a greater proportion of the Northern Irish economy compared to the rest of the United Kingdom. As such, there may be heightened interest in legislation regarding control of the meat trade. SNP The Scottish Government supports continued membership of the EU Single Market and Customs Union – the views of SNP MPs at Westminster are highly likely to mirror this. https://www.gov.scot/Publications/2018/01/6407 On its website, the Scottish Government says there are concerns about the impact on the economy and that consultation with Scottish food stakeholders suggests concerns with attracting and retaining their workforce as well as ‘continuing questions about what kind of trading and regulatory relationship we will have with the EU after the UK leaves’. Concerns about impact on food standards and food safety however do not appear emphasized.https://news.gov.scot/news/brexit-impact-on-food-and-drink SNP MPs Alison Thewliss and David Linden spoke in June in the House of Commons regarding future food standards in relation to the EU and the USA so may have further interest in this topic. Additionally, in its publication ‘Scotland’s Place in Europe 2’ the Scottish Government notes concerns about the removal of the EU’s specialist agencies, such as those governing food, and so the SNP may raise this issue in regard to EFSA and participation in RASFF: https://www.gov.scot/Resource/0053/00530160.pdf (paragraph 114). PC In terms of Plaid Cymru, Jonathan Edwards (PC) has raised issues relating to food and feed regulation in the past. However, there is no suggestion that PC will object to these SIs. PC’s focus is that Wales must have its own distinct voice in any negotiations and does not consider there is a mandate for a ‘no deal Brexit’. PC has raised concerns about reductions / removal of farm payments (falling within Defra’s remit) after Exit but no specific concerns have been noted about food safety. Meetings with MPs and peers (add additional rows as applicable) – check which MPs/peers supported and opposed the delegated powers in the passage of the Bill. This engagement plan must include the DUP and where appropriate - SNP/ Plaid Cymru The Food Standards Agency is a non-ministerial government department and as such our engagement with parliamentarians is primarily led by our chairman Heather Hancock. She routinely meets with Ministers and Parliamentarians in both Houses, as part of our commitment to delivering on Parliamentary accountability for the FSA. Our other areas of activity include: giving written and oral evidence to parliamentary select committee enquiries; developing relationships with key select committee chairs and Oppositions spokespersons through 1-2-1 meetings; holding roundtables with peers; drop-in session for members of key select committees with our Board and Executive team; speaking at events organised by the relevant All-Party Parliamentary Groups. However, as a nonministerial department we are not able to operate in the same way that ministerial departments can, through PPS and the Government Whips, and so we need to work with colleagues in DHSC to access those sorts of political influence. A list of some of the kinds of meetings the FSA Chair has held over the last year include: 06.06.18 – Chair’s meeting with Sue Hayman MP, Shadow SoS for Environment, Food and Rural Affairs, and David Drew MP, Shadow Minister for Environment, Food and Rural Affairs. 25.06.18 – Chair’s attendance at the Annual Reception of the United Kingdom Accreditation Service (UKAS) 26.06.18 – Chair’s Meeting with Tim Smith, Adviser to Tesco CEO 02.07.18 – Chair’s Meeting with Sue Davies, Strategic Policy Partner, Which? 03.07.18 – Chair’s Visit to Deliveroo Editions site 04.07.18 – Cahir Gave evidence at EU Energy and Environment Sub-Committee, Food safety risk management post-Brexit House of Lords sub-committee 09.07.18 – Chair’s attendance at the Food and Drink Federation (FDF) Summer Reception 07.08.18 – Chair’s Visit to Compass Group 13.08.18 – Chair’s Meeting with National Trading Standards (NTS) 03.09.18 – Chair’s Meeting with Noel Lavery, Permanent Secretary, and Paul Grocott, Deputy Director of EU Trade Negotiations, at the Department for the Economy Northern reland 04.09.18 – Chair’s Meeting with industry stakeholders: NI Food and Drink Federation, Ulster Farmers Union, White’s Oats, Lough Neagh Fisherman’s Cooperative Society, Moy Park and Andrews Flour. 12.09.18 – Chair’s Meeting Simon Blackburn, Chair of Local Government Association Safer and Stronger Communities Board 12.09.18 - Chair’s Meeting with the Department for Environment, Food and Rural Affairs (Defra) and the Department for Exiting the European Union (DExEU). 18.09.18 – Chair’s Visit to R F Brookes 10/12/2018 – Chairs Meeting with Lord O’Shaughnessy, Parliamentary Under Secretary of Health and Social care. 10/12/2018 – Chairs Meeting with Neil Parish MP, Chair of the EFRA Committee 12/12/2018 – Chair’s Attendance at CENTRAL GOVERNMENT EMERGENCY RESPONSE TRAINING 18/12/2018 – Chairs Meeting with the RT. Hon Owen Paterson MP 18/12/2018 – Chairs Meeting with Lord Trees, Lord Cameron, Lord Gardiner, Parliamentary Under Secretary for the Department for Environment, Food and Rural Affairs, Baroness Pickering, Baroness Mcintosh, Baroness Bakewell, Countess Mar, Lord Krebs, Baroness Jones, Shadow Spokesperson of the Department for Environment, Food and Rural Affairs. 09/01/2019 – Chair’s Visit and Meeting with Martin Temple, Chair & Karne Russ, CEO of Health and Safety Executive, Buxton. 28/01/2019 – Chair’s Meeting with Tim Smith, Chair of Prets’ Food Advisory Panel. 30/01/2019 – Chair’s Meeting with Lord Gardiner of Kimble, Parliamentary Under Secretary for the Department for Environment, Food and Rural Affairs. 26/02/2019 – Chair’s Meeting with The RT. Hon Matt Hancock MP, Secretary of State for Health and Social Care & Steve Brine MP, Parliamentary Under Secretary of State for Public Health and Social Care for Department of Health and Social Care. 27/02/2019 – Chair’s Meeting with David Rutley MP, Parliamentary Under Secretary of State at the Department for the Environment, Food and Rural Affairs 05/03/2019 – Chair’s Meeting with Neil Parish MP, Chair of the EFRA Committee 06/03/2019 – Chair’s Meeting with EU Energy and Environmental Sub-Committee, Select Committee Hearing 24/04/2019 – Chair gave evidence at an EFRA Select Committee Evidence Session 30/04/2019 – Chair’s Meeting with Michael Gove, Secretary of State for the Department for the Environment, Food and Rural Affairs and David Rutley, Parliamentary Under Secretary of State at the Department for the Environment, Food and Rural Affairs01/05/2019 - Chair’s Meeting with Henry Dimbleby, Lead non-executive board member of the Department for the Environment, Food and Rural Affairs 01/05/2019 – Chair’s Meeting with Dame Lucy Neville-Rolfe, Chairman of Red Tractor Assurance 13/05/2019 – Chair’s Meeting with Seema Kennedy, Parliamentary Under Secretary of State for Public Health and Primary Care Heather Hancock also keeps in regular contact with Ministers in the Welsh Assembly Government (Vaughan Gething AM, Lesley Griffiths AM and Rebecca Evans AM), and senior stakeholders in Northern Ireland. This has helped to gain their confidence and buy-in to the principles the FSA has set for EU Exit, and we expect this also to reduce the risk of challenge to these SIs from Welsh or Northern Ireland MPs. Engagement already taken place When Outcome/ readout Who and why Both Lord Krebs and Lord Rooker sit on Lords EU Energy and Environmental the Sub Committee (both former Chairs of the Food Standards Agency) and have a keen interest in this area specifically. A follow-up session at this committee was held on the 6 March 2019. http://data.parliament.uk/writtenevidence/committeeevidence.svc/evidencedocument/euenergy-and-environment-subcommittee/food-safety-risk-managementpostbrexit/oral/86576.html Jason Feeney gave evidence at the Agricultural Bill Committee on 23rd October 2018. The FSA Chair has used the opportunities of 1:2:1 meeting, holding roundtables with peers; drop-in session for members and opportunities to brief parliamentarians on our SIs and seek their support.  Our Chairman has also written to the Shadow Secretaries of State for EFRA and Health, updating them on our plans and offering further information if they would like it. Engagement planned Who and why When Because of its sensitivity, the issue of chlorine washed chicken has featured regularly in discussions between the FSA Chair and senior officials and Ministers. The FSA will take opportunities to reiterate its brief to Ministers (including the DUP) as to its advice on this issue ahead of any debates on this SI. Courtesy letters will be sent from PS(PHPC) to Jim Shannon (health representative of the DUP), and Sharon Hodgson (Lab) introducing this SI before it is debated. How will this affect the devolved administrations? How might MPs representing constituencies in Scotland, Wales Northern Ireland react to it? The principles and rules set out in the retained legislation which this SI will correct are widely accepted as ensuring the same level of food safety protection throughout the UK and the free flow of trade within it. On this basis, we do not expect any particular challenges from the devolved administrations. Additionally, the Devolved Administrations have had sight of drafts of this SI as it has been worked upon, and the opportunity to input into the drafting. A formal Minister to Minister letter was sent to counterparts in Scotland and Wales on 15 July requesting agreement from Devolved Administrations to make this SI. Back in 2018, the FSA in England sought ‘agreement in principle’ from FSA Wales, FSA Northern Ireland and partners in Food Standards Scotland to take forward its programme of SIs on a UK wide basis. This agreement in principle was given under the commitment of FSA England to continue to share copies of the draft SIs as they are produced, so that the nature of the corrections can be identified and fully understood by colleagues in the devolved administrations, and no corrections will be made unless their substance is acceptable to all parties. This SI requires formal consent from the Devolved Administrations, as food safety is a devolved area of competence. Discussions with the devolved food safety bodies reached consensus (at official level) that common approaches to food and feed safety and hygiene are at least desirable across the UK. Detailed frameworks proposals have been developed collaboratively and will be tested with Ministers in the coming months. Do you expect this SI to be certified as EVEL? No. This SI will apply to the UK. Mobilising external stakeholders (add additional rows as applicable) Who and why It is not anticipated that the food industry, or bodies representing enforcers, consumers or the voluntary sector will oppose these SIs as they propose minimal viable change to seek continuity in the way food and feed law work. We issued a consultation from 4th September to 14th October 2018 https://www.food.gov.uk/sites/default/files/media/document/ euexit-regulations-consultation_0.pdf to seek the views of businesses, consumers, other stakeholders and the wider public on the corrections that ministers propose to make under the European Union (Withdrawal) Act 2018 (EUWA) to retained EU law relating to food and animal feed safety and hygiene, with particular regard to the functions of certain EU bodies and institutions. The consultation summary can be found on our website at https://www.food.gov.uk/news-alerts/consultations/proposed-approach-toretained-eu-law-for-food-and-feed-safety-and-hygiene When 4th Septemb er – 14th October 2018 Are there any concessions you could make ahead of laying which could ease the Parliamentary passage? No. All the provisions of the SI are required to correct retained EU law to ensure that it is operable in the UK after EU exit and food/feed safety is maintained. What alternatives/non-legislative options could you consider if you are not able to secure approval for the SI in its current form? None. This SI is necessary as this is the only way to correct retained EU law to ensure that it is operable in the UK after EU exit and food/feed safety is maintained in this area. There are no non-legislative options that could achieve that effect in the long term. LINES TO TAKE Please list the top three defensive Q&A you anticipate using in Parliamentary debates Q. Why does Article 3(2) need to be amended again? Article 3(2) is being amended to make clear that Ministers (the appropriate authority) will be responsible for deciding whether or not any alternative substance will be authorised. Ministers will take account of advice from the food safety authority. Q. Why does the amendment no longer require Food Standards Agency approval for the use of an alternative substance? The wording of Article 3(2) in the EU legislation does not provide an express role for the European Food Safety Authority, which provides risk analysis advice to the European Commission, for the approval of substances. This amendment makes the wording of Article 3(2) closer to that of the retained European Union legislation. The Food Standards Agency (the Food Safety Authority) will remain responsible for analysing the risks associated with the use of a substance and for providing advice to Ministers on whether any substance should be authorised. Q. Is the Government intending to approve the use of chlorinated wash or similar substance to remove surface contamination from chicken carcases after EU exit? No substances other than potable water are approved to remove surface contamination from chicken carcases.  There is no intention currently to change this when we leave the EU.  FSA documents covering both hormone treated beef and chlorinated chicken: 1. PAC Hearing Reactive Lines for CEO – FSA and Trade, Oct 2019 On chlorine chicken: The most recent coverage on the subject was generated by comments from Sir Ian Boyd, Chief Scientific Adviser at Defra, who said there was no 'scientific' reason to ban chlorinated chicken or hormone beef in a post-Brexit trade deal, citing a lack of evidence the treatments would cause harm to British consumers. • The legislation is clear that any substance to be used to remove surface contamination from chicken carcases must be specifically approved [following rigorous risk assessment]; chlorine has not been approved and so chicken that has been washed with chlorine cannot be placed on the UK market. • No substances other than potable water are approved to remove surface contamination from chicken carcases. There is no intention currently to change this when we leave the EU. The legislation provides for new substances to be authorised for use, only after rigorous risk analysis. On Hormone beef • The UK has transposed the EU legislation which prohibits the use of betaagonists in both domestic production and imported products. This protection will continue after we exit the EU. 2. Oxford Farming Conference meeting, Jan 2020 Defensive lines: • The legislation is clear that any substance to be used to remove surface contamination from chicken carcases must be specifically approved; chlorine has not been approved and so chicken that has been washed with chlorine cannot be placed on the UK market. • No substances other than potable water are approved to remove surface contamination from chicken carcases. There is no intention currently to change this when we leave the EU. The legislation provides for new substances to be authorised for use, but only after rigorous risk analysis. • Our scientists have started to think about how to approach possible future questions, but this work is still under early development. • Regardless, any future requests to authorise use of a new substance would require information from an applicant for FSA to assess and this would be subject to robust risk assessment and risk management through ministers, with Parliamentary scrutiny. Hormone-treated beef • We are not aware of any intention from Defra ministers to review the current ban. 3. Briefing for CEO meeting with Defra and VMD on food standards and trade, April 2020 On sensitive SPS issues: Hormone-treated beef In relation to hormone-treated beef, the FSA maintains that whilst we remain happy to advise on the food safety aspects of veterinary (and plant protection) residues in foods on request, VMD is the lead (and has the expertise) for evaluating and authorising veterinary medicines that can be used on animals domestically and on animals reared in other countries for import. Lifting of the blanket ban on the use of hormones and beta-agonists and the subsequent evaluations and authorisations that would be needed, would therefore rest with VMD, in our view, with input from FSA as appropriate. You are due to meet Peter Borriello on 28th April to discuss various issues of interest between FSA and VMD. This may be a more suitable forum for more detailed discussion. 4. Briefing for CEO meeting with DIT, April 2020 On sensitive SPS issues: Antimicrobial Treatments (Chlorine washes, Pathogen reduction treatments) There is no ‘ban’ in place to prevent applicants from applying to the UK after the TP to authorise a new substance for decontamination of animal products. Any application would have to go through the UK’s risk analysis process and be supported by a full dossier of information and data. Hormone-treated beef • Growth promoters are veterinary medicines for which Defra/VMD has policy lead. • VMD are responsible for evaluating and authorising veterinary medicines that can be used on animals domestically and on animals reared in other countries for import. • Lifting of the blanket ban on the use of hormones and beta-agonists and the subsequent evaluations and authorisations that would be needed, would therefore rest with VMD. • FSA would input as appropriate on the food safety aspects of residues in foods and remains willing to provide input on request. • We understand that Defra is in the process of seeking a ministerial steer on this issue. 5. CEO briefing on Defra meeting on sensitive SPS issues, May 2020 Current state of play, Pathogen Reduction Treatments (Chlorine chicken) The UK/FSA will be obliged to accept applications for authorisation of new substances to decontaminate carcases after the Transition Period. An application would require submission of a dossier by the competent authority in the applicant country. The FSA has draft guidance on the application process, which has been developed in reference to EFSA guidance. It is intended that the Regulated Products (RPs) portal also be used for Pathogen Reduction Treatments (PRT) applications, though we would not expect the same numbers of applications as we would for RPs and there are no legal timelines laid down in legislation for the authorisation process for PRTs as there are for RPs. Under WTO rules, trading partner applications should be considered without undue delay. Risk Managers have estimated that it would take a minimum of twelve months for this to go through the Risk Analysis process. 6. FSA answers to GE questions on PRTs, May 2020 Answers to Defra SoS technical questions on pathogen reduction treatments. 1. What % of poultry production in the US uses chlorine washes? Taking “chlorine washes” to be a reference to use of pathogen reduction treatments (PRTs) on poultry carcases in general, according to an information chart https://www.ers.usda.gov/data-products/chart-gallery/gallery/chartdetail/?chartId=77863 produced by the United States Department of Agriculture (USDA)’s Economic Research Service: “PRTs are approved for use in the United States and are used by virtually all U.S. processors.” Although this text is dated December 2014, other charts at the following link are dated to 2019 which suggests the information may be current: https://www.ers.usda.gov/data-products/charts-of-note/charts-ofnote/?topicId=14845 If almost all US processors use PRTs not permitted in the EU, then exports of US poultry meat to the EU would be very low. A USDA report in November 2015 on “Estimating the Effects of Selected Sanitary and Phytosanitary Measures and Technical Barriers to Trade on U.S.-EU Agricultural Trade” commented that: “restrictions on PRTs have reduced U.S. poultry exports to the EU to negligible amounts.” https://www.ers.usda.gov/webdocs/publications/45459/54377_err199.pdf? v=0 The above-mentioned chart includes the following graph which, for the years covered, shows exports of US broiler meat to the EU as follows: 2. Has the prevalence of the use of chlorine washes changed over the past 20/30 years i.e. is there a downward trend in usage? See question 1. We do not have access to US industry data on practices to allow us to make an evidence-based estimate of trends over time, however, current USDA guidance documents for HACCP controls recommend the use of chemical interventions during the poultry production process. List of PRTs approved by the USDA: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/directives/7000series/safe-suitable-ingredients-related-document 3. What other processes are used to ensure safety of poultry carcasses e.g. UV light and flash freezing? US approved PRTs for poultry carcasses include: • chlorine dioxide • trisodium phosphate • acidified sodium chlorite • peroxyacids • organic acid • chlorine • ozone • ionising radiation (UV) • cetylpyridinium chloride The first four of these were the focus of the European Commission and EFSA opinions. Anecdotally, veterinary advice is that chlorine is usually only added to the water in the spin chiller to prevent cross contamination rather than to eliminate pathogens from the carcase. Acids such as peroxyacetic acid are used in the form of sprays prior to chilling to achieve the pathogen reducing effect. Other treatments: There are a number of Campylobacter reduction interventions that are used by UK industry, more often used by bigger plants and major food groups. There are interventions which combine to specifically target Campylobacter, including: • Double scalding, sono steam or steam vacuuming; • Surface blast chilling (not ‘flash’ or ‘blast’ freezing which would damage the carcass); • Good hygiene practices (GHP) which include: • cleaning and disinfection controls • Higher scalding temperature • Correctly adjusted carcase washing air jets • Cross-contamination controls • Correctly adjusted automatic evisceration machinery Most of the bigger UK players on the market have no problem complying with the current legislative requirement on Campylobacter levels and frequently achieve levels well below the ones prescribed by the legislation. The UK poultry industry have spent a substantial amount of money on reducing the levels of Campylobacter and they have recently informed us that supermarkets will only accept 5% of samples tested for Campylobacter to be above 1000cfu/g. Industry complies with this target. All broilers and hens intended for slaughter for human consumption in the UK are tested for absence of Salmonella at farm level. Those positive to highly pathogenic strains are not permitted to enter the food chain, unless the meat is heat treated 7. DOCUMENT – OFFSEN CEO brief on Defra meeting on controversial SPS issues_cleared Key policy areas for consideration set out in paper: • Growth promoters (hormone treated beef and ractopamine) (Defra/VMD lead with FSA/FSS interest on food safety) Pathogen Reduction Treatments (chlorinated chicken) (FSA/FSS lead, Defra interest in animal welfare) • The Annexes set out background for the first 3 issues from an FSA perspective. Meeting Q&A The paper sets out a series of questions which will be considered in the meeting. FSA suggested answers added in blue. • Does this capture the main issues? A. Yes • When will decisions need to be taken on each area? A. For issues on which the FSA/FSS lead, risk management decisions will be taken through the risk analysis process on receipt of an application from a trading partner. For hormone treated beef and certain other growth promoters where there is a blanket prohibition in place, an earlier decision may need to be taken about whether the ban remains justifiable and what evidence is needed to support it. Note that Annex 1 provides lines to take should a discussion develop about which department has the policy lead on the blanket prohibition. • What evidence and other material will Ministers need to support any decision across Whitehall? A. Risk management advice from the Food Authorities will be presented to Ministers on the basis of science and evidence. Applications will be supported by a full dossier which meets certain criteria laid down by the Food Authorities about safety and efficacy. What is the role of FSA Board, Defra Ministers and DHSC Ministers in these decisions? • A. The FSA Board is responsible for the statutory duties carried out by the FSA in England, Wales and NI (as is the FSS Board in Scotland) and will provide an opinion to risk managers on controversial / sensitive issues. All food and feed safety risk management decisions will be taken by Health Ministers (the ‘appropriate authorities’ in the devolved administrations and Secretary of State in England, as defined in the legislation), in consultation with other Ministers as appropriate. For controversial issues, we would expect a write-round to take place. Ministers will take decisions based on independent food safety advice and risk management recommendations provided by the FSA and FSS. This will include the FSA’s views on consumer’s interests in relation to food. • Which decisions will other Ministers be consulted on? A. Health ministers (‘appropriate authorities’ in the devolved administrations and Secretary of State in England, as defined in the legislation) will consult other government departments ministers as appropriate, on issues which fall within the other government departments’ policy remit. For example, Agriculture Ministers will be consulted on issues which have implications for animal health and welfare and/or the agri-food trade. Health ministers will follow usual processes to secure collective agreement as required. • How best do our teams work together to provide coherent advice? A. In developing any policy the FSA will continue cross departmental and Devolved Administration engagement. This will be done through the FSA’s risk analysis process to ensure all relevant issues and interests of other government departments with responsibilities for food and agriculture, health and trade are considered. Outside of the risk analysis process, on issues where other Depts lead but FSA has an interest we would expect to be involved. Defra and VMD have been engaging with FSA officials at a working level to discuss issues around animal welfare and other Defra interests. We will continue to have regular contact, and recognise the importance of good, rapid communication on these issues should there be developments of interest to OGDs.