178.Paragraph 15: Section 4 of the Medicines Act 1968 provides for the establishment of committees to advise on various aspects of the licensing of medicines (including veterinary medicines). Subparagraph (2) amends this provision to provide for the Agency to nominate a member of any committee established under it dealing with veterinary medicinal products for appointment by the Secretary of State.
179.This provision will in practice apply to the Veterinary Products Committee, which considers applications for authorisation of new veterinary medicines and related products. (It should be noted that, as with the Advisory Committee on Pesticides, it is expected that the Agency will also provide an adviser to this committee and its sub-committee.)
180.Section 129 of the Medicines Act 1968 provides the general procedure for the making of regulations and orders under that Act. Subparagraph (3) amends section 129 to specify that the Agency must be consulted on any new regulations concerning veterinary drugs or medicated feedingstuffs.
181.Paragraph 16, subparagraphs (1) and (2) set out the Agency’s functions in relation to emergency control orders made under the Food and Environment Protection Act 1985 (FEPA 1985), conferred by amendments to sections 2 and 3 of that Act. Consequential amendments are set out in more detail in Schedule 5.
182.Subparagraphs (3) to (5) amend Parts II and III of FEPA 1985, which relate respectively to the licensing of deposits at sea and of pesticides. The amendments introduce a requirement for the Agency to be consulted on licensing matters under Part II (dumping at sea), and a more general requirement for consultation of the Agency on matters covered by Part III (pesticides).
183.Powers are available under Part II of the Food and Environment Protection Act 1985 for Ministers to license the deposit of substances and articles in the sea and the loading of vessels with materials destined for incineration at sea. For these purposes, ‘licensing authority’ means the Minister of Agriculture, Fisheries and Food and the Secretary of State (in practice the Secretary of State for the Environment, Transport and the Regions) acting jointly in relation to England and Wales; and the Scottish Ministers in relation to Scotland. They may also make orders which specify types of operation which do not need a licence or which specify the conditions under which they may be exempt.
184.The purpose of such powers is primarily to protect the marine environment and to prevent interference with legitimate uses of the sea, and it is proposed that the powers should remain with Ministers as defined. However, in view of the potential effects of dumping at sea on the safety of food obtained from it, subparagraph (3) amends the powers to grant exemption from the requirement for licences to require that the Agency be consulted before any exemptions are made or conditions for exemptions set down in law.
185.Subparagraph (4) requires the licensing authority to consult on specific applications and on the general way in which food safety should be addressed when considering licence applications. The licensing authority is obliged to take the Agency’s advice into account.
186.Part III of FEPA 1985 concerns the licensing of pesticides and related products for the purposes of protecting human, animal and plant health, safeguarding the environment and securing safe, efficient and humane methods of controlling pests. Primary responsibility for such licensing lies with Agriculture, Health and Environment Ministers. Section 16 of the Act relates to the requirement on Ministers to consult the Advisory Committee on Pesticides (ACP) on proposals:
	for regulations;
	for giving, revoking or suspending approvals of pesticide products;
	for conditions to which they are considering making approvals subject.
187.Subparagraph (5) amends this provision to require Ministers to consult the Agency as well as the ACP on proposals for regulations, and from time to time on the general policy towards pesticides approvals. These are similar to the provisions concerning veterinary products outlined in the notes to section 29 and Schedule 3, paragraph 15 above.
188.In practice, the amendment means that the Agency will be formally consulted by officials from the Pesticides Safety Directorate on policy advice that they intend to submit to Ministers on any of the above three matters. It will also be achieved through the provision by the Agency of an assessor to the ACP and its sub-committee (the assessor’s duty is to contribute to the assessment and authorisation of pesticides). This supplements the provision in subparagraph (6) below.
189.Subparagraph (6) amends FEPA 1985 to provide for the Agency to nominate a member of the Advisory Committee on Pesticides.
190.Paragraphs 17 and 18 amend Part VI of the Environmental Protection Act 1990 (EPA 1990), which is concerned with preventing or minimising any damage to the environment which may result from the escape or release of genetically modified organisms (GMOs). Lead responsibility for this area of policy lies with the Secretary of State for the Environment, Transport and the Regions. However, the Secretary of State for Health could (through normal machinery of government arrangements) take part in the decision-making process where appropriate.
191.The amendments are designed to give the Agency a role in relation to regulations controlling the import, acquisition, release or marketing of any GMO and related matters. Paragraph 17 provides a new option allowing such regulations to specify that the Agency may act jointly with the Secretary of State in addition to the Secretary of State acting alone in considering any exemptions from the risk assessment or notification requirements for the matters mentioned above (section 108(7)) and exempting from the consent requirements relating to the same actions (section 111(7)).
192.Paragraph 18 modifies section 126 of the EPA 1990, which provides more generally for regulations under Part VI to be made jointly by the Secretary of State and the Minister of Agriculture, Fisheries and Food, where the regulations concern any matter with which the latter is concerned. The amendment made by this section does not alter this requirement, since MAFF will retain an interest in the economic and environmental implications of GMOs for the farming and food industries after the Agency comes into being.
193.It does however introduce mechanisms to ensure that the Agency can exercise the same degree of influence as MAFF does now. In particular, the Agency must be consulted before any regulations on the deliberate release of GMOs are made where these relate to matters with which the Agency is concerned.
194.The amendment to section 126 would have the following effect.
	Subsection (1) of this new section continues the Minister of Agriculture, Fisheries and Food’s role in relation to regulations under Part VI of the EPA 1990. It does however exclude him from the power to make regulations relating to fees and charges under section 113 of that Act (but see subsection (6) below).
	Subsection (2) preserves the Minister of Agriculture, Fisheries and Food’s role in all the functions under Part VI (other than the power to make regulations, which is dealt with under subparagraph (1) above).
	Subsection (3) applies in relation to the powers (other than powers to make regulations):under section 108(8), to require certain persons to apply for authorisation to release, market, import or acquire GMOs;under section 110, to prohibit certain persons from releasing, marketing, importing or acquiring GMOs if it is believed they risk damaging the environment.
	The effect of the amendment is that these powers must now be exercised jointly by the Secretary of State, the Agency, in relation to matters connected with food safety and other interests of consumers in relation to food, and the Minister of Agriculture, Fisheries and Food where he is also concerned with the matter in question.
	Subsection (5) introduces a new requirement for the Agency to be consulted:before any regulations under Part VI of EPA 1990 are made, other than regulations relating to fees and charges under section 113;before any consent relating to deliberate releases is issued (under section 111) or the conditions and limitations on the granting of a consent are varied (under section 112).
	Subsection (6) requires the Secretary of State to take account of costs incurred by the Minister of Agriculture, Fisheries and Food and the Agency in drawing up charging scheme under section 113 of the EPA 1990.
	Subsection (7) qualifies the subsections of this section that deal with joint action and consultation. Essentially, it provides that any regulatory power or function exercised under this subsection is not rendered invalid if there is subsequently any question as to whether it should have been done (or not done) jointly with the Minister of Agriculture, Fisheries and Food or the Agency (or both), rather than by the Secretary of State acting alone.
195.Paragraphs 19 and 20 amend the Genetically Modified Organisms (Northern Ireland) Order 1991 to make corresponding provision for Northern Ireland to that made by the amendments to the Environment Protection Act 1990 in paragraphs 17 and 18.
196.Paragraph 21 sets out the Agency’s right to be consulted on authorisations to dispose of radioactive waste. The detailed amendments to the Radioactive Substances Act 1993 are made in Schedule 5.
Schedule 3: The Agency’s functions under other enactments Part III: Other functions