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Food Science & Food Safety: Global Regulatory Challenges, New Directions
Ronit Justo-Hanani Adv. LL.B, MSc, PhD
2016 Food Safety & Security Summer Institute, Manna Center, TAU
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Jun 14th 2007
'NATURE is full of surprises’
Biology's Big Bang: What physics was to the
20th century, biology will be to the 21st
The challenge of policymaking for the new Life Sciences
Introduction
3
21st century Policymaking for Food Safety & Security: New Challenges and New Dynamics
How to keep pace with rapidly-evolving S&T? (stem cells, nanotechnologies, molecular biology, synthetic genomics)
High degree of complexity, scientific uncertainty
From Lab to Market: stimulating safe, effective innovation
Good evidence base for policy decisions
Introduction
4
Introduction
5
Utilizing S&T for Food Safety & Security
“End hunger, achieve food security and improved nutrition and promote sustainable agriculture targets”
‘Food security exists when all people, at all times, have physical and economic access to sufficient, safe and nutritious food to meet their dietary needs and food preferences for an active and healthy life’ (FAO)
Introduction
6
What Role for Governments?
‘Assuring food safety and quality’
Stimulating innovation: The regulation/innovation interface
Building blocks:
1. R&D policy for emerging technologies
2. Environmental, health and safety risk regulation
Getting the balance right: innovation, trust, and regulation
Introduction
7
Food safety & Security: Why Policy is Important?
Promises and threats:
Securing the promise of science and technology
↓
Sustainable, responsible technology development
Ensuring food safety
↓
Tackling threats to food production
Policy: a law, regulation, procedure or administrative action to
advance a desired outcome
WHAT DOES IT MEAN IN PRACTICE?
Introduction
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Today’s lecture
Ensuring food safety & security in three regulatory
contexts
Nanomaterials and Consumer Safety
Sustainable, Responsible R&D
Ecology & Biodiversity
Introduction
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How governments organize their long term policies and regulation for food safety & security?
2 cases:
1. EU and US: Nanomaterials and food safety
2. EU: Bio-invasions and food security
Introduction
10
1. EU/US: Nanotech & Food Safety
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Nanotechnology and nanomaterials
Richard P. Feynman 1918-1988
There's Plenty of Room at the Bottom
December 29th 1959
American Physical Society
Kim Eric Drexler 1955-
From scientific vision to industrial technology
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Nanotechnology and Nanomaterials: complexity and scope
A basic definition:
Material with one or more external dimensions, or an internal structure, at nanoscale
And which could exhibit novel characteristics compared to the same material at a larger scale (SCENIEIR, EU Scientific
committee)
The size range of nanoparticle – 1-100nm
1 meter = billion nanometer
or
1 nanometer = 1/1,000,000,000 or 1x10^-9 m
The most important elements for technology implementation
Better understanding of physical and chemical reactions at the nanometric scale
An effective process for creating a new and/or improved characteristics
Databases to implement the technology (risks? adverse effects? proven benefits?)
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Nanotechnology in the food industry
using nanotechnology to improve food production, packaging, and quality
Major commercial applications: [suspensions, crystals, powders] Nanomaterials in food packaging Nanomaterials changing food characteristics Nanotechnology in agriculture
Nano-encapsulation for
nutrient delivery
Nano-sensors and
dispensers - food crops
pesticides encapsulated in
nanoparticles 14
Nanotechnology is not small Government Nanotechnology R&D Expenditures
“Nanotechnology R&D continues to grow in priority on national science agendas in OECD
countries, both in terms of public and private funding.” (OECD, Observer)
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Nanomaterials:
Challenging scientific basic assumptions
What do we know about risks?
Evidence of toxicity caused by the release of atoms and molecules (Nano-Silver)
Clinical trials: exposure of workers in the industry involves high risk
The incidence of lung, similar to asbestos (Carbon nanotubes(
Unlike ‘normal’ chemical pollution: release of toxic molecules and atoms
Septic blood vessel cells, inflammation and cell death (nano-zinc oxide)
Laboratory experiments: health injury of rats, fish gills and nervous system of mice (titanium dioxide).
[Gilbert, 2009; Wijnhoven et al. 2009 ; Song, Y., X. Li, and X. Du. 2009]
Early-stage eco-toxicity and toxicology research 16
Sounds familiar?
Much scarier than nanotechnology
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Nanomaterials raise concerns about food regulation
Nanotechnology Environmental and Safety Aspects
Potential Environmental Effects (EU SCENIHR 2009; DG Health and Consumers Protection) Means through which products containing nanomaterials may end up in releases to the
environment (wastewater treatment streams, landfill and combustion of products)
Fate and effects in aquatic environment: The behavior of nanoparticles is expected to depend not only on the physical and chemical character of the nanomaterial, but also and perhaps predominantly on the characteristics of the receiving environment (Chen et al. 2008; Chen and Elimelech 2008)
Upon entry into the environment, nanoparticles may undergo one or more of the following: aggregation in soil and sediments; presence in air; aggregation in aquatic systems etc.
Experimental studies: uptake by biota via respiratory or digestive tracts in animals, or via plant’s root system;
verification methods on ‘what makes nanomaterials active after release’ are limited in scope (e.g. aquatic ecotoxicological fate)
Potential for transfer across food chain levels, depends on material type and food chain (as is the case for bulk materials) (Fortner et al. 2005; Holbrook et al. 2008)
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Nanotechnology Environmental and Safety Risks: Particular Interest Occupational Exposure to Carbon Nanotubes (CNT) and Nanofibers (CNF) (NIOSH 2010) concerns arises mainly from results of laboratory animal studies
laboratory studies shows a consistent toxicological response (pulmonary inflammation, fibrosis) independent of the study design (i.e., intratracheal, aspiration, and inhalation)
workplace exposure measurements indicate the potential for worker exposure
Food Containing Carbon Nanoparticles, Food Packaging materials (FDA 2012)
Products already on the market that contain CNPs; Many are not labeled as containing nano particles
CNT’s for specific applications and existing products are largely untested for their human health effects.
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Bio-and-Nanotechnologies R&D policy challenges on food production
■ what?
The problem of scientific uncertainty:
Are current risk assessment criteria relevant?
How to define materials and manufacturing processes?
How to obtain market-data (manufacturing, trading-volumes)?
How to obtain data on toxicological effects?
■ how?
Government activity
R&D policy, design regulation, supervision, enforcement
Degree of supervision:
Expansion? tightening industry regulation?
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“The regulation of nanotechnology risks and uncertainties is lagging behind technological innovation”
(Greenpeace, environmental defense fund )
The regulatory challenge: addressing issues of scientific and regulatory uncertainty [Accepted definitions; Material Characterization; Risk assessment; Material Safety Date Sheets]
Dilemma no. 1
Global Powers: To Intervene or Not to Intervene???
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A widespread Understanding: Governance Without Governments Two faces of power:
Regulatory Capacity (related to financial sources; knowledge)
lack of a genuine regulatory capacity that would enable state authorities to govern nanotechnology risks through their own regulatory means independently of the market
Regulatory sovereignty (related to rulemaking, standard-setting)
Reliance on private-rulemaking and voluntary regulation; consequently, private actors retain substantial regulatory autonomy, while state power decreases
Examples: Bowman & Hodge 2008, 2009; Abbott et al.2010; Bowman & Van-Calster 2010; Marchant et al. 2012; Falkner & Jaspers 2012.
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The paper’s question Does government regulation expand in international nano -policies? The paper’s argument Significant Expansion of Government Rulemaking The argument presented via a series of claims Global private actors still have considerable regulatory power, but the EU and the
US strive to determine the shape and the level of nanochemicals risk regulation.
Regulatory activity in the EU and US takes a new turn not only towards empowerment of their regulatory systems, but also constrains private actors' power to regulate (a highly political issue of power allocation).
Initial comparison: the EU's governance modes are 'more robust' than those of the US federal government.
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The global Nanochemicals Market
Defining Features:
Total Market-size: unknown
Risks: contested;
limited
observations
Empirical Case
Nanochemical I.D.
▪ a material of nano-size (in the range of 1–100 nm)
▪ displays different physical and chemical characteristics compares to regular chemical
▪ spans many industrial sectors (e.g. food, lubricants, health care, electronics and pharmaceuticals)
▪ particular concern: Nano-Metals (titanium, silver), Nano-Carbones and Nano-Zinc Oxides (commercial uses: textile, UV protection, antibacterial functions (OECD 2008)
▪ Partial estimations of production volumes:
2010: 21,500 tons 2016:~50,000 tons
Among the fastest growing products of the global nanotechnology industry
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The EU and US in Nanochemicals Risk Regulation Case studies: US: Data-reporting regulation (EPA under TSCA*)
EU: Market-entry regulation (EC under REACH**)
Rationales:
Hotly contested global policy fields
Significant change in the role of the EU and US rulemaking
The limits of privatization; the most likely path towards government rulemaking
Major themes: 1) state sovereignty; 2) power-constrained non-state actors
*Toxic Substances Control Act, 1976
** Registration, Evaluation, Authorisation and Restriction of Chemical substances, 2007
Empirical Case
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the State of Play in Data-Reporting Regulation: Developments by the EPA under TSCA regulatory system
Three trends: 1. Policy shift: power-sharing → reduction of delegated enforcement 2. Scope: expands 3. Variety: voluntarism → coercion; stewardship program → decisions, administrative orders, standards
The extent and nature of state-centric
market-constrained rulemaking
Policy tool Regulatory instrument Regulatory
issue area
year
increasing governmental regulatory scrutiny
on the private market
Proposed lower thresholds for reporting
requirements of 'new' chemicals Regulatory review: Premanufacture notification (PMN) (TSCA
section 5)
Pre-
manufacture
2010
2011 embedding governance mechanisms in
private activity
identify priority for review and
assessment: the 2 most commonly used
nano-chemicals has listed as chemicals
of concern
Administrative order: the Significant New Use Rules (SNURs)
(TSCA section 5(a)(2)).
embedding governance mechanisms in
private activity
more stringent reporting requirements
for additional commonly used nano-
chemicals
Administrative order: Significant New Use Rules (SNURs)
(TSCA section 5(a)(2)).
diminishing power-sharing with the private
sector; increasing independence of the
federal government from private sector
withdrawing the voluntary data-
reporting agreement with industry
Program
Nanoscale Materials Stewardship Program
(2008)
Post-
monitoring
2009
2011 Enhancing the agency monitoring authority expanding the frequency and scope of
reporting requirements Rule:
the Chemical Data Reporting (CDR) rule
(Modification to IUR rule)
decreasing the high bargaining power of the
private sector
replacing the "not readily obtainable"
regulatory loophole
Standard/guiding principle:
the "not reasonably ascertainable” reporting
principle
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the State of Play in Market-Entry Regulation: Developments by the EC under REACH
The extent and nature of state-centric
market-constrained rulemaking
Policy tool Regulatory instrument Regulatory issue area Year Market entry
policy area
a constrain to the collective power of
ISO and other private actors in
defining and enforcing global criteria
for market ID
supranational definition of a
'nanomaterial' for regulatory
purposes
EC Recommendation:
(2011/696/EU)
Defining 'nano-
material'
2011 Substance
identification
expanding the role of administrative
agency (ECHA)
development of nano-
identification system
(inventory/database) by ECHA
C&L inventory
(under (EC) No
1272/2008)
substance detection 2011
defining specific objects for active
regulatory scrutiny over the global
market
remove 'registration exemption'
status of carbon and graphite
Rule Amendment:
(EC No 987/2008)
Registration
Exemptions
2008 Registration
Reservation of decision-making
power on market-entry policy at the
EU level
'No-data no market' guiding
principle to apply under REACH
EP resolution
(2008/2208(INI))
Information
requirements
2009
Enhancing regulatory implementation
and compliance over the global
market
-Calls for 1) a change of criteria
to trigger registration ( threshold
values); 2) a request for safety
report for all registered nano
materials
EP resolution
(2008/2208(INI))
Registration trigger 2009
Three trends:
1. Scope: expands
2. Revoking delegation of rulemaking (ISO, BSI, ATSM and other standards organizations alike)
3. objectives: improving regulatory capacity and market integration 27
Conclusions
Common denominators in governments behavior:
acting decisively to gain more power over the global market
empowerment of regulatory systems
constraining industry power to shape regulation
Findings are not consistent with the common understanding
Findings suggest for the strengthening of governments' regulation
Law at the end of the day!
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Dilemma no. 2
How To Intervene???
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The Challenge: Addressing Scientific and Regulatory Uncertainties
Scientific Uncertainty: Material Characterization; Material Safety, Risk assessment; Risk prediction, Environmental Fate, Mammalian Toxicology
Regulatory Uncertainty: The ‘appropriateness’ of existing regulatory frameworks
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What explains current dynamics? 1. Domestic Environmental Politics: Green Political Parties
European Commission, 2004 'Safe, Integrated, and Responsible' approach
European Commission, 2005-2006 Review of existing legislation
European Commission, 2007, 2008 ‘existing legislation is adequate’
passive, laisser-faire attitude
European Parliament, 2009 'those rules are about as effective in addressing nanotechnology as trying to catch
plankton with a cod fishing net' (Swedish green MEP, Schlyter)
2010 – labelling requirements (food and cosmetics products)
2011 – scientific ‘nanomaterials’ definition – OUT; Accepted political definition - IN
2012-2016 – ongoing review & adjustments (Chemicals, Electric equipment, food, cosmetics, biocidal products regulations); nano-specific risk assessments
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Justo-Hanani & Dayan. Research Policy 2015
2. EU: Domestic Environmental Politics
Go it alone with nano risk regulation….
Germany 2010: ban all consumer products using nanosilver
French Environmental Code 2010: compulsory reporting
Netherlands 2012: call for urgent regulatory action on nanomaterials
Belgian Presidency 2009-2010: call for compulsory nanomaterials database
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American and European Environmental & Safety Policies:
An Ocean Apart?
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Nanotechnology EHS Risk regulation in Europe and the United States: a comparative analysis
Sub – queries:
Differences/similarities in state-centric patterns ?
What explains transatlantic policy divergence?
The politics of environmental, health and safety risk regulation in the EU and the US
Nano-Risk Regulation & Governance; Nano-Risk Perceptions
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Nano-Risk Policies: Convergence or Divergence?
United States • existing regulatory frameworks +
adjustments
• no labeling requirements
• patch-work at the national-federal level
• some risk assessment and management activities (e.g. FDA Regulatory science program)
• Lack of Congress support or leadership
European Union • existing regulatory frameworks +
adjustments
• labeling requirements (food, cosmetics)
• unified EU-level regulation: no data-no market
• intensive capacity –building: risk assessment and management (e.g.,FP7), NMs definition for regulatory purposes, regulatory frameworks revisited
• Parliament: ‘blueprint’ for regulatory
initiatives
Emerging Transatlantic Divergence!
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What explains transatlantic policy divergence? Leading Theoretical Explanations
Economic interests?
(US competitiveness vs. EU sustainability)
Environmental NGOs?
(e.g. GMOs)
Domestic Environmental Politics & Policymaking Patterns
(Vogel, 2003, 2012)
(Justo-Hanani & Dayan. Global Environmental Politics 2016)
‘Alarm bells’?
(cultural risk perceptions? media pressure)
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The precautionary approach (European Parliament 2009)
‘applying the Precautionary Principle is
about EHS research and regulating nano-
products before their release into the
market, as opposed to applying it after
release in the event that realistic and
serious risks are identified”.
Risk-based, case-by-case approach (White House memo, 2011)
‘regulation should be grounded in the
best available science and able to evolve
as scientific insights mature and the
body of evidence grows and evolves.
Consistent with current law, regulatory
agencies should take a science-based
approach to risk management.”
≠
Risk vs. Precaution
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Questions? Opinions?
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Nanotechnology and Food Safety
2. EU: Bio-invasions impact on Food Security
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Sir Horatio Thomas Austin
(1801-1865)
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European wild rabbit
(Oryctolagus cuniculus)
After 7 years…
14,253 )!(
1859 - 24 individuals
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Today
“After habitat destruction, introduced species are the
second greatest cause of species endangerment and
decline worldwide”.
(Schmitz & Simberloff, 1997)
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Definitions
Alien Species A species, subspecies, or lower taxon occurring outside of its natural range and dispersal potential, including any part, gametes or propagule of such species that might survive and subsequently reproduce.
Invasive Species An alien species which becomes established in natural or semi-natural ecosystems or habitat, is an agent of change, and threatens native biological diversity
Introduction
The movement, by human agency, of a species, subspecies, or lower taxon outside its natural range. This movement can be either within a country or between countries.
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Frequency of Biological Invasions
The Tens Rule, Williamson 1996
10% of alien species undergoing Introduction establish themselves in the new area
↓
Of which 10% have become pests
It is difficult to predict biological invasions -
Preventive approach is needed!
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How Do They Get to a New Place?
Variety of pathways: 3 types of introductions
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Random introduction Intentional introduction
Directly to nature Captivation No specific purpose
Forestry
Nursery plants, food
crops
Mariculture
Biological control
Zoos, Botanical gardens
Research labs
Pet industry
Culture, ornamental plants
Private collections
"Stowaways "
Shipments of goods
Vehicles
Animals as vector
Tourism
Commercial Activity
Primary source for biological invasions
A significant portion of intentional introduction: pet industry, biological control, research
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psittacula krameri Trachemys scripta Oncorhynchus
mykiss
The impact of Invasive species on
global food production Negative impact on functioning of ecosystems and
biodiversity change
Water depletion, soil fertility, interactions with native species (e.g. predation, parasitism, competition for pollination)
Plant pests and plant diseases
Yield losses
Economic costs (USA: $120 billion annually)
Public health
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Lates niloticus Xanthomonas oryzae pv. oryzae Aphis craccivora
Dendroctonus ponderosae
Ophiostoma
What should be done to stop invasive
species?
1. Prevention and early detection
2. Eradication
3. Control and management
48 (Simberloff et al, 2005)
“Prevention is better than cure”
How can we produce sufficient, safe and nutritious food?
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Israel: Invasive species impact in a nutshell
Agricultural damages
Fields and crops pests
Damages to agricultural
infrastructures
Control and eradication costs
Examples (NIS millions)
Ambrosia 1.2 (2006-8)
The red palm weevil (-1999 )1
The little fire ant (2006-9 )1.2
Ecosystems functioning
Species extinction
Competitive exclusion
Establishment in ecosystems
Threat to ecosystem functioning
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100 of the World’s Worst Invasive Species )IUCN/ISSG(
blue-leafed wattle
Acacia saligna
Camphorweed
Heterotheca subaxillaris Kochia indica Wight
Bassia Indica
Lantana
Lantana camara
Rose-ringed Parakeet
Psittacula krameri
nutria, river rat
Myocastor coypus
Little fire ant
Wasmannia auropunctata
The common myna
Acridotheres tristis
Mosquitofish
Gambusia affinis
Indian silverbill
Lonchura malabarica
Legal and Institutional Framework
Convention on Biological Diversity, 1992
“Each contracting Party shall, as far as possible and as appropriate,
prevent the introduction of, control or eradicate those alien species
which threaten ecosystems, habitats or species”. Article 8 (h)
COP 6 Decision VI/23
“Invites the Food and Agriculture Organization of the United Nations,
the World Health Organization, the United Nations Development
Programme, the United Nations Environment Programme, the World
Bank and other development agencies to take this matter into account
when considering the impacts of land-use change, agriculture,
aquaculture, forestry, health and development policies and activities”
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The European Union – Policy Innovation
New, regional dedicated regulation
Regulation on the prevention and management of the
introduction and spread of invasive alien species
(Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014
What is innovative?
Union list – species of Union concern (open list, inclusion of
taxonomic groups of species )
Common criteria for risk assessment; research, monitoring
and surveillance by all relevant sectors and stakeholders
Core policy principles - prevention, eradication, management
55
The EU Food Security Policy Framework
‘The preservation of biodiversity is key for the production of food and
feed, and is therefore in the vested interest of farmers; ‘
‘Stresses the need to protect agricultural biodiversity in developing
countries in order to achieve food security; calls on the Commission,
therefore, to invest in agro-ecology in developing countries;’
‘Urges the Commission to establish, without delay and in accordance with
Article 4 of Regulation (EU) No 1143/2014, an accurate and
comprehensive list of invasive alien species which are of concern to the
Union’
Committee on the Environment, Public Health and Food Safety
EU’s Biodiversity Strategy, report (January 2016)
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Go & Learn: Biodiversity, Food Security &
Regulation on Alien Invasive Species
Australia
The Environment Protection and
Biodiversity Conservation
Act 1999 (the EPBC Act)
List of threats to biodiversity
Threat Abatement Plans – 14 TAP’s
Targeted, cooperative border inspection
(agriculture and environment)
Minnesota
Imposing personal liability in respect of
deliberate or negligent release
Risk assessment criteria set by law
Strict licensing system
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Britain
Wildlife and countryside Act, 1981
Minimizing introductions as a specific,
defined purpose
Illegal, Criminal planting: list of non-
native plants
Strategy for environmental risks.
Targeted, cooperative border inspection
(agriculture and environment)
58
Go & Learn: Biodiversity, Food Security &
Regulation on Alien Invasive Species
Questions? Opinions?
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Invasive Species and Food Security
Take-Home message
Legal instruments are currently being modified in accordance with
scientific knowledge on food safety & security
Cooperation is required between scientists and decision makers in
identifying gaps in legislation and policy;
More data is needed on the food safety & security challenges and
implications of ST&E
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