AEBC 04/16

 

NON FOOD AGRICULTURE (NFA) BACKGROUND INFORMATION PAPER  ON CASE STUDIES AND REGULATORY REVIEW (DRAFT)

 

 

Introduction

 

The AEBC has decided to look at implications of the application of biotechnology to non-food agriculture.  We will look at a series of case studies and analyse the regulations that pertain to them producing a gap and redundancy analysis, the objective being informed and appropriate guidelines on any necessary new regulation and elimination of bad or irrelevant regulation. We will also explore public attitudes towards biotechnology in the non-food sector, where we believe the benefits are more obvious to people and the risks are less personal.

 

Issues to cover in project

 

In consultation with stakeholders the workstream has been designed to address the following aspects of non-food agriculture. This is not indented to be an exhaustive list as it expected that other issues will become apparent as the workstream progresses. 

 

Crops with food and non-food applications. This has been identified as an issue for a number of reasons. Firstly, if and when non-food uses of crops are commercialised the potential for tension between food supply and the supply of other commodities becomes an issue and potential trade-offs include balancing security of energy supply with security of food supply could arise. Secondly, many crops have varieties which have been bred for food and feed and other varieties for non-food uses (some of which are unpalatable or even toxic). For example oil seed rape is an important vegetable oil crop but varieties have also been bred for industrial use which are toxic. Many of these varieties are difficult to differentiate in the field, raising various concerns. Thirdly, given that food crops have been selectively bred to maximise yield and ease of cultivation they are obvious choices for genetic modification to produce new non-food crops – this immediately raises a large set of issues around co-existence of non-GM (food) crops and GM (non-food crops). 

 

The different issues airing from non-food use of exiting crops, new crops developed using non-GM biotechnology and GM crops.  This has been identified as being important because different issues are likely to arise for each of these three sub-sets.  The larger scale importance of non-food agriculture will have a number of effects even using exiting varieties (e.g. landscape impacts discussed below). Non-GM biotechnology has and will allow the development of crops with very different characteristics than current food-crops. GM could potentially play an important role in non-food agriculture and indeed maybe a requirement for certain applications but raises a particular set of issues and concerns.

 

Crops whose wide cultivation implies significant land use impacts. The current landscape is shape by the purpose to which it is put, currently largely food production. If non-food agriculture becomes more important the nature of the landscape will be impacted, perhaps by the increasing importance of certain existing crops (maybe oil-seed rape for biofuels) or the large-scale introduction of new crops (e.g. willow for biomass heat and power). This raised issues around what we want our countryside to look like.

 

Diverse scope of non-food applications, including crops and other agricultural organisms (i.e. microbes and animals). The range of products that could be potentially be produced using non-food agriculture is vast and not just limited to crops…

 

Different degrees of confinement. The issues raised by using a GM microbe in a digester/fermenter to process a non-GM feed stock that is converted into a non-food use product, are likely to be different to those raised by growing new varieties (perhaps GM) of crops in a closed greenhouse and different again to those raised growing new (GM) varieties in the open environment.

 

Environmental Remediation. The capacity of plants and microbes to be used in the bio-remediation of pollution, for example, cleaning up contaminated land was seen to be important both as an independent objective and as a complimentary objective to for example the production of biomass for energy. 

 

Geographical scope, production in UK and elsewhere. Where non-food crops will be grown was identified as a key issue. For many crops the climate in the UK is sub optimal and intrinsically biological productivity is lower in the temperate UK and Europe than, for example, the tropics. Also agriculture arguably more heavily regulated in Europe than anywhere else in the world making the cultivation of new, particularly new GM crops much more difficult and expensive than elsewhere.  This means that, depending on how the local economics, it may prove cheaper to produce non-food products from imported feedstocks rather than local ones (e.g. it may prove more economic to produce biodiesel from imported palm oil rather than indigenous oilseed rape). Similarly for environmental, economic, regulatory and political reasons it is unlikely that significant qualities of bio-pharmaceuticals will be grown in the UK in the near future.

 

Moral obligation.  Some stakeholders suggested that the developed world holds an obligation to help combat problems for example disease in the developing world. Modern biotechnology may provide an opportunity to produce pharmaceuticals cheaply and in large quantities for treatment of diseases (particularly) effecting developing countries e.g. HIV-Aids and Malaria.  

 

GMOs that are used to produce things like vaccines already. It is not generally realised that many non-food products available in the UK are already produced using GMOs these range from vaccines to vegetarian rennet for cheese making. Some products produced using GMOs in non-food agriculture are widely available in other countries but not marketed in the UK and Europe due to current legislation and public attitude to GM and GM derived products.

 

6. Introduction to Case Studies

 

Final selection of the case studies.  The case studies have been selected on the basis of what society/industry requires in terms of (agricultural) outputs rather than focussing on individual crops. Three sectors have been identified where agricultural products either are beginning to have or have the potential to substitute for “conventional production methods”.  These are:

 

·        Bio energy (Biofuels/forestry)

·        Packaging (Biomaterials/Bioplastics)

·        Pharmaceuticals (Biopharmaceuticals)

 

Where there are a large number of alternative agricultural production routes, a small number of the most likely routes representing the range will be described and mapped for each of these three areas, which would then serve as exemplars for the whole.

 

In February the Commission held a stakeholder dialog event at which aimed to engage with stakeholders in developing its future work programme. At this meeting stakeholders identified a set of issues around the non-food agriculture agenda, which they agreed should covered collectively by the case studies, these are:

 

i.                 Crops with food and non-food applications (co-existence of food and non-food varieties).

ii.               Non-food crops to include including things which are non-GM, and even non-biotech.

iii.             Crops whose wide cultivation implies significant land use impacts

iv.              Diverse scope of non-food applications, including crops and other agricultural organisms (i.e. microbes and animals).

v.                Different degrees of confinement

vi.              Environmental Remediation angle

vii.            Geographical scope, production in UK elsewhere

viii.          Moral obligation (e.g. to cure diseases in the developing world)

ix.              Examples that are Likely to be good tests of public opinion (e.g. a range of desirability: cure to cancer/AIDS through to energy crops)

x.                Cover the point that GMOs that are used to produce things like vaccines already.

 

Biofuels/Forestry

Non-food crops have a long history of use as a source of energy. In theory any plant or animal is a potential fuel, as is any organic product produced by or from a plant or animal.  The majority of biomass used for energy is plant derived,  although animal by-products from farming and food processing (animal waste, waste oil and fat) are locally important is some places.  

Plants grow (make biomass) by using energy derived from sunlight to combine water and carbon dioxide into sugars through photosynthesis. These sugars are then polymerised and/or combined with other chemicals to produce plant material. 

Biomass can be used for fuel directly by burning, via 'gasification' technologies, or through the extraction of oils.

The use of plant and animal materials for energy production can be categorised in two areas:

        i.            Solid fuels, which are generally used for heat and power (electricity).

      ii.            Liquid fuels which are generally used as transport fuels - biodiesel and bioethanol.

 

Drivers

 

·        Security of energy supply

·        Climate Change abatement

·        Rural Economy

·        High quality CHP initative

 

The use of biofuels is becoming of increasing importance for a number of reasons. Environmental concerns relating to climate change, depleting fossil fuel reserves, and reducing reliance on imports, are leading to international, national and regional focus upon alternative energy sources. The 1997 Kyoto Protocol to the UN Framework Convention on Climate Change aims to tackle the effects of climate change through 'quantified emission limitation and reduction', where signatories are committed to reducing their overall emissions of greenhouse gases towards a 5% global reduction against 1990 levels by 2012. The UK is committed to reducing greenhouse gas emissions by 12.5% by 2012.

 

·        The UK's Energy White Paper, produced in February 2003, sets out a strategy for renewable energy sources and as part of this, biomass for heat and power and biofuels for transport are both recognised as offering significant potential.

·        Since the 1997 Kyoto Protocol agreements, the UK Government set targets to generate 10% of electricity production from renewables by 2010, and 20% by 2020 (currently the figure stands at around 3%). Additionally, the Renewables Obligation Order 2002 places an obligation on all licensed electricity suppliers in England and Wales to source a growing percentage of their total sales from eligible renewable sources, in order to create demand for renewables. One of the largest contributors to these targets is anticipated to be electricity from biomass.

·        The EU has proposed indicative targets for biofuel substitution of 2% by 2005, rising by 0.75% each year to 5.75% by 2010 (Directive on the Promotion of the Use of Biofuels or other Renewable Fuels for Transport).

·        Transport accounts for approximately 25% UK green house gas (GHG) emission, the majority of which (~85%) is derived from road transport The Powering Future Vehicles Strategy published in 2001 sets out a strategy for reducing the emissions GHG and together with the UK Energy White Paper, published in February 2003, sets out a strategy for investment in 'clean' low carbon transport via duty cuts. The duty on biodiesel has been reduced to 20p/litre below the standard (ultra low sulphur) diesel rate, and the pre-budget report in November 2002 announced the proposal to introduce the same 20p/litre incentive for bioethanol, subject to EU agreement.

·        [Biofuels specific para on Sustainable farming and food CAP etc]

 

Issues

 

·        Scope – i.e. what is realistic?

·        How much bio-diesel could be produced in the UK/EU and what percentage of diesel would be replaced? Scope for biotech to increase this proportion?

·        How much bio-ethanol could be produced in the UK/EU and what percentage of petrol would be replaced? Scope for biotech to increase this proportion?

·        What percentage of the UK’s heat/power demand could be realistically be supplied by biomass?

 

Willow example:

 

Factor	Note	Figure used	Units
Yield from willow:	7-13 Dry tonnes per hectare per year (~10 tHa-1a-1)	10	tHa-1a-1
Calorific Value (dry matter):	5.4 kWh per kg, 5400 KWh per Ton	5,400	kWh t-1
Energy yield per Ha	54000 kWh Ha-1 a-1	54,000	kWh Ha-1 a-1
	Assume 43 % conversion of energy to electricity	0.43
Effective power yield per Ha		23,220	kWh Ha-1 a-1
UK electrical power demand	394,634 GWh (DTI Figures, 2002)	394,634,000,000	kWh a-1
Area required to produce total UK demand from willow alone.		16,995,435	Ha
Total Area of UK agricultural land.	(Defra figures, 2002)	17,154,000	Ha
Percentage of UK Agricultural land required		99	%

 

 

 

 

Examples

 

·        Wood/Forestry residues for bioethanol production (also requires biotech in digestion process).

·        Short Rotation Coppice (SRC) Willow/Poplar – energy crops (increase biological productivity)

·        SRC Willow/Poplar – enhancing potential for bioremediation

·        SRC Willow/Poplar – increasing disease resistance (rusts in willows).

·        Biodiesel – from OSR / imported palm oil.

·        Bioethanol – from grain / mazie / forestry residues / straw / wood etc.

·        Heritage Trees

·        Dutch Elm Disease – landscape preservation and restoration.

 

Case Study

 

Of these examples we have chosen to look at SRC Willow and poplar for the following reasons…

 

·        Near Term

·        Active Biotech Research GM and Non Gm (e.g. Defra’s project to double the yield of willow in 10 years)

·        Bioremediation angle        

·        Landscape issue

 

 

Bioplastics [Biomaterials]

 

Crop derived materials play an increasing role in many commercial production processes and products as diverse as carpet tiles, plastic packaging, apparel and personal care products can be produced. Increasing attention is being focused on making the crop material fit for its intended end use through techniques of precision breeding either with or without genetic modification. In some production procedures the crop product may be used as the substrate for micro organisms in a fermenter where the micro organisms have been genetically modified. This way you get the advantage of using the extra differentiation you can achieve using GM, but the GM organisms are totally contained. The bugs are engineered to produce a range of useful products from the substrate, where these products are either novel or are replacements for feedstock chemicals that would usually be derived from other sources, for example, the petrochemical industry.

 

 

 

Drivers

 

·        Heavy reliance on non-renewable resources, particularly petrochemicals. I can’t see the relevance of this, or am I missing something?Energy Usage / GHG emissions

·        IPPC

·        Increasing cost of conventional fossil feed-stocks

·        Need  for low-environmental impact production methods for chemicals etc.

·        EU Waste Directive

 

Issues

 

·        Play-off between biofuels and biomaterial production – which saves the most green house gas? Perhaps emphasise that it is self defeating to use material from a renewable resources if the production process requires the input of more energy than when produced from the non-renewable resource.

 

Examples

 

[Bioplastics]

 

·         Starch-derived packaging

·        Polylactic acid plastics

·        1,3, propandiol, Dow-Cargill are developing plant derived 1,3, propandiol produced in a fermentation process using a corn feedstock by from corn marketed as Sorona[1]

 

[Biorefineries]

 

·        Do it all in one (GM) plant or feedstock then ferment?

 

§         Feedstocks

·        Conventional/biotech/GM:

o       Corn (Maize)

o       Straw

o       Wood

o       Grain

o       Oils

·        Closed / open growth

§         Microbes for bioreactor

·        Conventional (e.g. brewers yeast)/biotech/GM

o       Fungi

o       Bacteria

 

Case Study

 

To be selected at York Meeting

 

 

Bio-pharmaceuticals

 

Drivers

 

·        Cheaper drugs: Plants ability to produce large amounts of specific proteins cheaply.  Production costs using plant-based systems potentially 10-100 times lower than conventional production.

·        Providing drugs, and vaccines for poor countries.

·        Technology transfer from developed to developing countries

 

Issues

 

·        Delivery mechanisms: edible vaccines

·        Storage Issues: seeds are incredibly good at storing proteins etc.

·        Transportation – plants/plant material /seeds easy to transport – does not need refrigeration.

·        Contained (bio-reactor), Semi Contained (green houses) or open (field) cultivation.

·        The preference will be to go with plants in which the desired protein products are expressed in high quantities in the seeds, which are easily harvestable. 10’000 years of breeding has go into producing easily harvestable crops most of these are food crops – so there will be pressure to modify existing food crops.

·        Arguments for need to produce drugs in plants – using plants to do things you cant do industrially – scalability of agriculture.

·        Likely to require a sophisticated debate between stakeholders.

 

Examples

 

• Hepatatitis B Vaccine [See below]

·        Secretory antibodies (e.g. to treat Tooth Decay) [See below]

·        Rabies Vaccines [See below]

• Microbicides (e.g. for HIV/AIDS prevention) [See below]
• TB Vaccines/Treatment

 

Hepatitis B Vaccine

 

·        In the 70’s produced from blood of infected individuals, with AIDs and CJD this source dried up.

·        Hepatitis B vaccine was then one of the first to be produced from GM yeast. Now widely available in west, but the production of the vaccine and subsequent extraction is costly so it is not cheap.

·        In order for it to be viable to produce the large quantities cheaply need for developing countries a much cheaper production methord is needed GM plants could provide this.

·        Work being done in this field used same gene that is used in yeast.

 

 

Secretory antibodies (Tooth Decay)

 

·        Plants could be the only way to produce certain molecules e.g. Secretory antibodies such as immunoglobulins.

·        Applications of these include the production of antibodies to treat dental caries (tooth decay) which work by targeting the main adhesion protein of the pathogen Streptococcus Mutans (S. Mutans).

 

Rabies

 

·        Rabies particularly nasty disease, but no longer a serious problem in the west.

·        Major issue for the far east e.g. the streets of Bangkok, here high proportion of dog population is infected and dog bites are common.

·        Not economically possible to vaccinate whole population so strategy is to vaccinate immediately after any bite.

·        However vaccine takes two weeks to work so the wound also needs to be treated directly with antibodies.

·        These have historically been sourced from horses. However there is inerasably low profits have caused all the main producer to pull out of this market. Clinics are no increasingly keeping their own horses to produce antibodies.

·        World Health Organisation (WHO) has recognised this problem and is funding research to develop rabies antibody production in plants.

 

 

 

Microbicides (antivirals) against HIV

 

·        Some promising developments e.g. drug called Cyanoviron

·        Currently producible using conventional fermentation technologies 

·        But, can’t make anything like enough – scope for development using GM plants.

·        As it is unlikely there would be no vaccine for HIV in the foreseeable future, a female-controlled alternative to the prevention of viral transmission could be through the use of topical HIV microbicides.

·        There is currently  a five-year programme to put HIV antibodies into a plant and then take that product all the way through the regulatory trail.

·        Producing HIV antibodies in maize would be advantageous because maize can be produced all year round and there is good knowledge of the genetics of maize.

 

Case Study

 

The group decided that they would like to explore the HIV Microbicide topic as the case study for Biopharmaceuticals.

 

 

 

 

Regulatory Review

 

For each case study

 

1.                  Identify specific representative case studies

 

2.                  Create clear documentation of expected product and the process related to it for:

a.                 Research

b.                 Development

c.                  Production

d.                 Use

e.                 Disposal/Waste management/Recycling

 

3.                  Review and document expected/actual timescales for each stage, assuming technical/biological drivers for the timelines (unhindered by regulatory track)

 

4.                  Evidence-taking session with individuals who are working to develop these technologies to gage an understanding of the practical difficulties and the problems they are encountering. 

 

5.                  Recruit a legal trainee to assemble a flow chart of any and all regulatory processes that could be argued as applicable to the product/processes , at a national, EU and international level, and the indicative timescale to pass through them.  Lawyer will need some input from an appropriate expert e.g. an agronomist to ensure the principle practical implications are covered. The process for this review and the work product should be signed off by a qualified lawyer or lawyers (note that several legal fields could be relevant).

 

6.      Draw out strategic elements from 5 and analyze arising implications.

 

7.      Create and resource ‘gap’ and ‘redundancy’ sub-groups consisting of stakeholders supported by a moderator and appropriate experts to consider the implications of the legal analysis and answer

 

a.                         Where do the regulations fail to meet expectations of specific interest groups (e.g., will some feel they neglect certain parameters that could lead to risk or affect social acceptance? Will others feel they waste tax payers money, or make the replacement of a less desirable alternative slower than is optimally desirable?)

b.                         Where are the regulations irrelevant, unwieldy and where do they create logistical, economic or other barriers to the potential availability of the product, that could result in it failing to reach UK consumers