Clause 15: Meaning of 'enforcement authority' and related expressions.

Subsection (1) defines the legislation covered by the enforcement monitoring powers.

Subsection (2) defines an enforcement authority for the purposes of the above provisions. "Food authorities" in the Food Safety Act 1990 are, unless otherwise specified, the bodies responsible for enforcing or executing the provision of the Act or legislation made under it. They are defined in the Act as normally being local authorities (metropolitan borough, district or county councils in England and Wales; island or district councils in Scotland) or, where appropriate, port health authorities. Under Part IV of the Agriculture Act 1970, "enforcement authorities" are county, metropolitan district and London borough councils, and the Port of London Health Authority in England; and county and county borough councils in Wales.

Clause 16: Offences relating to sections 13 and 14.

This clause makes it an offence for anyone to refuse entry to the Agency's authorised officer or knowingly to provide false or misleading information or to withhold information required under clauses 13 and 14. The current maximum value of a level 5 fine is £5,000.

Clause 17: Delegation of powers to make emergency orders.

Under sections 1 and 2 of the Food and Environment Protection Act 1985 and section 13 of the Food Safety Act 1990 Ministers may make emergency orders in response to circumstances or incidents which pose a threat to public health in relation to food. The Secretary of State will retain this power, and in addition the Agency may be empowered by him to make these emergency orders itself on his behalf. This power does not give the Agency the ability to make legislation itself in other areas, and in practice it is envisaged that the Agency will only make orders in emergency situations where the Secretary of State is not available.

Subsection (3) makes it clear that it is the Secretary of State who is ultimately answerable for emergency legislation made by the Agency on his behalf, and that anything done by the Agency is in law done by the Secretary of State.

Responsibility for orders under the two Acts is devolved to the appropriate authorities in Scotland, Wales and Northern Ireland. Subsection (5) provides the devolved authorities with the power to delegate their powers to make emergency orders under the two Acts to the Agency within their own devolved competence.

Clause 18: Functions under other Acts.

This clause introduces Schedule 3, concerning amendments to other Acts which confer functions on the Agency.

Much of the legislation which is amended by Schedule 3 has been devolved to Scotland. This means that many functions of Ministers of the Crown (i.e. the Secretary of State and Minister of Agriculture, Fisheries and Food) under the legislation have transferred to Scottish Ministers, and Parliament's role in relation to secondary legislation to the Scottish Parliament.

However, the provisions of the Scotland Act 1998 and orders made under it which give effect to the transfer, do not generally amend the text of Acts of Parliament to show what has been done. Thus when this Bill amends Acts which have been subject to devolution, it does not attempt to alter the text of those Acts to reflect post-devolution responsibilities. Instead, the amendments are deemed to date from before the enactment of the Scotland Act, so that the provisions of that Act automatically transfer functions to the relevant parties in Scotland. This ensures that all the powers under the Scotland Act to make further provisions flowing from devolution are available.

Clause 19: Publication etc. by the Agency of advice and information.

This clause empowers the Agency to publish advice given by it in accordance with its general functions under clauses 6 (development of food policy and provision of advice, etc. to public authorities) and 7 (provision of advice, information and assistance to other persons) or information obtained by it as a result of its observations or enforcement monitoring (clauses 10 and 12). It also enables the Agency to publish any other information it holds.

The Agency's express ability to publish any of its advice to Ministers will be an important factor in its influence and independence: although Ministers would not be obliged to accept the Agency's advice, they would normally be expected to explain their reasons for not doing so.

It is envisaged that the Agency will normally wish to publish much of its advice and information. There are however certain limited circumstances in which publication would be inappropriate. These are specified in subsection (2), which makes clear that the Agency's power to publish information does not automatically override prohibitions on publication in existing legislation or EU obligation that prohibits the publication of certain kinds of information. For example, the provisions of the Data Protection Act 1998 will continue to apply in relation to personal information. Clause 25 nevertheless empowers the Secretary of State to make regulations relaxing or lifting statutory prohibitions where these prevent the Agency from carrying out its functions effectively or from publishing information that is clearly in the public interest.

Subsection (3) provides that in deciding to disclose, the Agency will not be bound by non-statutory confidentiality requirements (such as personal privacy or commercial confidence). Nonetheless, it will have to consider, before disclosure, whether the public interest in disclosure (for example, in terms of promoting openness or in making people aware of health risks) is outweighed by the confidence.

Subsection (4) provides that the duty to take account of any consideration of confidentiality under subsection (3) does not apply to information relating to the performance of enforcement authorities or people acting on behalf of enforcement authorities. However, in respect of information on, for example, the activities of a business that was obtained by the Agency while monitoring a local authority's enforcement work, the test in subsection (3) would apply.

Subsection (6) makes clear that the Agency's power to publish is limited only by those duties and considerations that are set down in subsections (2) and (3).

Subsection (9) provides for the Agency to disclose information to another public authority, subject to the same considerations as set out in this clause. Therefore, for example, the Agency could pass on confidential information to enforcement authorities to assist them in carrying out their enforcement functions.

Clause 20: Power to issue guidance on control of food-borne diseases.

This clause expands on the Agency's general function to give advice, information and assistance to provide it with the specific function of providing guidance to local authorities and other public authorities, including health authorities, on the management and control of outbreaks of food-borne illness (for example, salmonella, E.coli 0157, or campylobacter). Such guidance might, for example, include guidance on tracing the food-related source of any outbreak, or on the speed with which action needs to be taken to limit the spread of food poisoning.

Clause 21: Supplementary powers.

This clause gives the Agency power to take action which will help it to discharge its functions (subject to other provisions in the Bill which constrain the manner in which the Agency may act). This clause, although very general, does not give the Agency any power to act outside the area of its functions.

Subsection (2) makes clear that the Agency's powers include the ability to provide education or training. Specific reference is also made to the provision of financial support, the acquisition or disposal of property and the institution of criminal proceedings (in England, Wales and Northern Ireland - prosecutions in Scotland are the sole responsibility of the Procurator Fiscal). Other relevant action might include entering into contracts.

Subsection (3) allows the Agency to charge for any facilities or services it provides. Such charges would be made in accordance with the usual Government guidance on fees and charges.

Clause 22: Statement of general objectives and practices.

This clause requires the Agency to publish (with the approval of the appropriate authorities) a statement of its general objectives and practices. This statement will be formulated within the general framework of the Agency's main objective, in clause 1(2).

Subsection (2) specifies that, among any other general objectives it wishes to include in the statement, the Agency must address three in particular. These relate to

• consulting with interested parties on the Agency's activities,

• facilitating proper consultation between the Agency and other Departments of Government, local authorities and other public authorities on matters of mutual interest, and

• ensuring that the Agency's activities and decisions are transparent to the public.

It also provides for the appropriate authorities acting jointly to ask for the inclusion of particular objectives in the Statement. Subsections (4), (5) and (6) require that the statement should be approved by the Secretary of State and the devolved authorities, acting jointly, and published. The Secretary of State and the other appropriate authorities may amend the draft proposed by the Agency, but must consult the Agency before doing so.

Clause 23: Consideration of objectives, risks, costs and benefits, etc.

This clause requires the Agency, in carrying out its functions, to have due regard to its statement of general objectives and practice (clause 22) and take account of relevant advice from advisory committees and certain other considerations, as follows.

Subsection (2) requires the Agency to take account in its decision-making process of:

a)     the nature and magnitude of the risk which the action under consideration is designed to address. Risk to health is highlighted as of particular importance but other risks in relation to consumer protection (for example where labelling may mislead consumers) may also be relevant. The Agency is also required to take account of any uncertainty in the evidence. For example, where it is taking decisions in relation to a risk which is potentially very serious, but about which there is very little evidence, the Agency is likely to want to take a precautionary approach; and

b)      the likely costs and benefits associated with the course of action under consideration. This would mean that the Agency must balance obvious compliance costs, as well as matters such as restriction of consumer choice, against the benefits of reduced risk to health etc. arising from any action.

Subsection (3) provides that the duty under the clause does not apply where it is unreasonable or impracticable. For example, some of the Agency's actions may raise no concerns about risk, or an analysis of costs and benefits may not be appropriate. Decisions on appointments would be examples of this kind.

Clause 24: Directions relating to breach of duty or international obligations.

The clause permits the Secretary of State (subsection (1)) to give the Agency directions in cases where it appears to him that the Agency has failed seriously to fulfil the duty to comply with its statement of objectives and practice, take account of the advice of advisory committees, or consider risks, costs and benefits; or where it has failed in any other duty that he considers it should have performed. The power of direction relates only to significant failures by the Agency. The Secretary of State must consult the other appropriate authorities before issuing such directions.

Subsection (2) gives similar powers of direction to the devolved authorities to the extent that it is within their devolved competence. This means that they will generally be able to direct in relation to the Agency's activities in Scotland, Wales and Northern Ireland, as appropriate.

Subsection (3) allows the Secretary of State to give the Agency directions to do anything the UK is obliged to do under EU or international law. These are reserve powers, for use if the Agency has not already taken steps to fulfil the UK's obligations.

This power to issue directions is also vested in the devolved authorities (see subsection (4)) where the directions relate to the implementation of EU or other international obligations which is the responsibility of that authority (in general, this will be the case for matters within devolved competence).

Subsection (5) requires that an authority proposing to give directions must consult the Agency and the other appropriate authorities before doing so.

If the Agency fails to follow directions given under subsection (1), the Secretary of State or the devolved authorities may give effect to them, or the Secretary of State may take the steps outlined in subsection (7) with the agreement of the other appropriate authorities. Such powers, however, would only be used in the last resort and where normal processes of dialogue had failed to secure the necessary changes.

Clause 25: Power to modify enactments about disclosure of information.

This clause enables the Secretary of State to make orders for the purpose of relaxing or overriding any prohibitions on disclosure of information contained in other legislation that would otherwise prevent the Agency from obtaining or publishing information in carrying out its functions under the Bill. While clause 19 requires the Agency to observe statutory bars on disclosure in exercising its power to publish, this clause provides a means for dealing with those that would unnecessarily limit the Agency's ability to carry out its functions effectively. Some specific bars to disclosure are already dealt with directly in this Bill (for example, by over-riding the limitation on disclosure of information about veterinary medicines in the Medicines Act 1968). This clause provides the power to respond to any further barriers to disclosure identified in the light of experience.

Subsection (1) provides the basic order-making power.

Subsection (2) makes clear that the Secretary of State's powers in subsection (1) cannot be used in relation to legislation that falls under the devolved authority of the Scottish Parliament. A parallel enabling power exercisable by Scottish Ministers is accordingly provided in subsection (3). Subsection (4) similarly prevents Scottish Ministers from exercising their parallel powers in relation to legislation that lies outside their devolved competence. Subsection (5) makes similar provision for Northern Ireland.

Subsection (6) specifies the circumstances in which the enabling powers may be used to modify legislation i.e. where it prevents the disclosure of information relevant to the Agency's functions, or prevents the Agency from publishing some information which would otherwise be published in accordance with clause 19.

Clause 26: Statutory functions ceasing to be exercisable by the Minister of Agriculture, Fisheries and Food.

Under this Bill, the Minister of Agriculture, Fisheries and Food will cease to have any functions in relation to most matters within the Agency's remit.

This clause removes that Minister's statutory responsibilities in relation to emergencies which are likely to create a hazard to human health through the contamination of food stuffs (under Part I of the Food and Environment Protection Act 1985); food safety and standards (under the Food Safety Act 1990); and radioactive substances and waste (under the Radioactive Substances Act 1993).

The detailed transfer of responsibilities to the Secretary of State for Health and devolved authorities and/or the Agency is dealt with in Schedules 3 and 4.

Clause 27: Notification of tests for food-borne disease.

This clause enables the Secretary of State for Health and his equivalents in the devolved administrations to make regulations to set up a notification scheme for the results of laboratory tests for food borne organisms. This means that if a laboratory finds evidence that indicates a person may have been exposed to certain pathogens (which will be specified in any regulations) that are capable of causing illness and are commonly transmitted through food, they will be required to report it to the central authorities ('commonly' here means that when the disease occurs it is often food-borne; it does not mean the disease itself has to be common). This information will improve data collection on types of food-borne disease. It will enable the Agency better to understand patterns of the incidence and prevalence of food borne disease. The pathogens initially expected to be covered by a notification scheme are salmonella, E.coli O157 and campylobacter.

Subsection (3) allows the scheme to be set up to assist the work both of the Agency and of other bodies with public health responsibilities, such as the Department of Health and the Public Health Laboratory Service.

Subsection (4) sets out what must be included in the regulations, which includes the type and form of notification required for each organism specified, and to whom it is to be notified. Subsection (5) sets out further detail which may be included in regulations. The regulations may create an offence of failure to notify. The regulations can set the maximum fine for this offence at any level up to 5 on the standard scale (currently £5,000).

Under subsection (6), the Health Departments must consult representatives of interested parties before making any regulations.

Clause 28: Arrangements for sharing information about food-borne zoonoses.

This clause makes it a duty of the Minister of Agriculture, Fisheries and Food and the devolved authorities on the one hand and the Agency on the other to make administrative arrangements for sharing relevant information on food-borne zoonoses (as defined in subsection (5): this would include, for example, salmonella, campylobacter and E.coli).

Clause 29: Consultation on veterinary products.

Subsection (1) requires that Ministers who have responsibility for regulating veterinary products (principally, the Minister of Agriculture, Fisheries and Food acting through the Veterinary Medicines Directorate, an executive agency of MAFF) will consult the Agency on general policy matters relating to this work.

Subsection (3) lifts, so far as the Agency is concerned, a general restriction in the Medicines Act 1968 on disclosures of information relating to veterinary products (provided, for example, by businesses in connection with a licence application) so that the Agency can be fully consulted on the policy matters referred to in subsection (1).

Subsection (3) allows the Secretary of State and the Minister to disclose any information they have on matters connected with veterinary products to the Agency, even if it was obtained by them pursuant to any enactment (in particular, this applies to information obtained under the Medicines Act 1968 and the Marketing Authorisations for Veterinary Medicinal Products Regulations 1994 (SI 1994/3142)).

The further disclosure or publication of the information provided to the Agency under this sub-section is not prohibited by any statutory provision, and thus, subject to clause 19(3) of the Bill, the Agency may publish it or disclose it to other public authorities.

Clause 30: Animal feedingstuffs: Great Britain.

The Agency has a general function of providing advice etc. to Ministers in relation to animal feed. This is provided by clauses 6 and 7 (by virtue of the effect feedingstuffs can have on food safety), and by clause 9 in relation to the general safety of animal feed and the interests of users of feed.

At present, feedingstuffs are regulated under Part IV of the Agriculture Act 1970, and by regulations and Orders made under that Act, the European Communities Act 1972 and the Animal Health Act 1981.

This clause allows Ministers to establish by Order new provisions for the regulation of feed, based on the Food Safety Act 1990. Such an Order, which would have the effect of updating the primary powers available for the regulation of feedingstuffs, could cover areas such as the composition, processing, treatment, manufacturing conditions and labelling of feedingstuffs.

The Order would probably establish a general requirement for the safety of feedingstuffs (similar to the "food safety requirements" set out in section 8 of the Food Safety Act 1990), and allow further subordinate legislation to deal with more detailed requirements.

An Order under this clause can make incidental amendments and repeals to existing legislation - in practice, it would probably repeal Part IV of the Agriculture Act as it applies to feed. The application of Part IV to fertilisers would be unaffected.

The control of feedingstuffs is fully devolved to NI and Scotland, and thus the Order-making power is conferred on Scottish Ministers in relation to Scotland, and the DHSS (NI) in relation to NI.

Subsection (1) enables the Ministers to regulate feedingstuffs along the lines described above.

Subsection (2) provides that an Order made under these powers can be used to apply to animal feedingstuffs provisions which match those contained in the Food Safety Act 1990, so that food and feed may be dealt with in a similar manner. It will also allow EC requirements to be readily transposed into UK provisions under a single set of powers. This will give a more coherent body of legislation than at present where provisions are implemented under both the Agriculture Act 1970 and the European Communities Act 1972.

Subsection (3) provides that the power can also be used in relation to provisions of the Food Safety Act 1990, as amended by the Food Standards Bill.

Subsection (4)(a) provides for orders made under this clause to address the needs of animal health or human health and is necessary because the scope of the powers in this Act would not otherwise extend to animal health.

Subsection (4)(b) and (c) contain standard provisions but additionally provide power to amend or revoke inconsistent primary legislation.

Subsections (7) provides for the Order to be made jointly by the Secretary of State and the Minister of Agriculture, Fisheries and Food for England and Wales, and by the Scottish Ministers for Scotland. Orders made under this clause must be subject to the affirmative resolution procedure - i.e. approved in draft by each House of Parliament or by the Scottish Parliament as appropriate before being made (as required by clause 37).

A general definition of 'animal feedingstuffs' is given in clause 37, although this may be refined in any Orders to cover specific areas.

Clause 31: Animal feedingstuffs: Northern Ireland.

This clause makes provision parallel to that in clause 30 in relation to Northern Ireland.

Clause 32: Modification of this Act.

This clause provides powers to modify the provisions of the Act and is intended to deal with circumstances where the need for change arises from experience of operating a UK body in the area of food safety and standards, where responsibility has been devolved.

The Agency is being established with powers in relation to policy areas which have been wholly devolved to Scotland, Wales and Northern Ireland, and is therefore appropriate that it is the shared responsibility of the three devolved authorities and the UK Government (which also effectively represents the English interest). Its establishment coincides with the coming into operation of the devolved authorities and legislatures and there is therefore inevitably a degree of uncertainty about how they will chose to exercise their devolved powers in this area. Although Scottish Ministers and the Scottish Parliament and the National Assembly for Wales are being consulted formally on the principle of a UK Agency, it is possible that experience will show a need for some adjustment to the constitution or functions of the UK body. As such, alterations to the constitution or functions of the Agency could in principle concern all four of the authorities and it is therefore necessary to have procedures whereby all four bodies are associated with such changes. This clause and clause 33 provide for such arrangements. They follow the model established in sections 89 and 90 of the Scotland Act 1998 which are concerned with the adaptation and transfer of property for cross-border public authorities (except that the Scotland Act 1998 is concerned here only with the relationship between the body concerned and the Scottish and UK administrations).

Subsection (1) provides for modification to be made to the Food Standards Act by Order in Council where it is necessary to amend functions exercised by the appropriate authorities (i.e. the Secretary of State and the devolved administrations), Parliament, the Scottish Parliament or the Northern Ireland Assembly, or to amend the provisions on the establishment and constitution of the Agency (in particular clauses 2 to 4 and Schedule 1). For example it might, in the light of experience, be necessary to change the arrangements for the Scottish, Welsh and Northern Ireland advisory committees as established by clause 5, or to change the number of members of the Agency or the experiences which between them they must have.

The Order in Council route is chosen because it is clear that for the Agency to function successfully as a UK body it will depend on co-operation between the four authorities. Thus any amendments to its constitution and function will need to be jointly agreed in each part of the UK. The Order in Council procedure is the most appropriate procedure for allowing each legislature formally to consider and consent to such changes.

Subsection (3) elaborates on the matters which can be included in an Order in Council made under this provision.

Subsection (4) provides for the Agency to be consulted before any amendments are made, and for the Order to be approved by affirmative resolution of each of the four legislatures.

It should be noted that while clause 32 provides a procedure for altering the Agency's constitution, it would not prevent Parliament making changes by a further Act. To the extent it is within their competence under the Scotland and NI Acts, the Scottish Parliament and NI Assembly will also be able to make changes to the arrangements in the Bill using Acts of the Scottish Parliament and NI Acts.

Clause 33: Consequences of Agency losing certain functions.

Although the Food Standards Agency is being established as a UK body, the Scottish Parliament and the Northern Ireland Assembly have the competence, under devolution, to withdraw from the UK arrangements or any part of them, by means of an Act of the Scottish Parliament or Northern Ireland Assembly. This clause provides for amendments to the Food Standards Act to be made to deal with the consequences for the Agency of any such decision. As with clause 32, the Order in Council route is chosen since it provides a suitable procedure for use in all four legislatures. This clause does not apply to the National Assembly for Wales which does not have primary legislative powers.

Subsection (1) provides that this section has effect where the Scottish Parliament or NI Assembly pass an Act which has the effect of withdrawing from any of the functions of the Agency. For example, the Scottish Parliament might in future decide that it wished to set up a separate agency for Scotland, or that it wished some other body to carry out some of the Agency's functions, such as enforcement monitoring, without withdrawing Scotland from the Agency completely.

Subsection (2) goes on to specify the provisions which may be included in an Order in Council to make any consequential adjustments to the Agency. These include provisions to deal with the transfer of any property, rights and liabilities (property includes rights and interests of any description). The effect of the sub-section, read with sub-sections (3) and (4), is to allow the Order to transfer property and liabilities which were used (or arose) in relation to the functions which the Agency is to cease to have, to be transferred to whatever body appears appropriate.