Food Science & Food Safety · silver), Nano-Carbones and Nano-Zinc Oxides (commercial uses:...

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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

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

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

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

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

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

Today’s lecture

Ensuring food safety & security in three regulatory

contexts

Nanomaterials and Consumer Safety

Sustainable, Responsible R&D

Ecology & Biodiversity

Introduction

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

1. EU/US: Nanotech & Food Safety

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

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

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?)

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)

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

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)

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.

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?

“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???

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.

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.

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

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

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

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)

manufacture

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)

monitoring

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

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

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!

Dilemma no. 2

How To Intervene???

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

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

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

American and European Environmental & Safety Policies:

An Ocean Apart?

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

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!

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)

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

Questions? Opinions?

Nanotechnology and Food Safety

2. EU: Bio-invasions impact on Food Security

Sir Horatio Thomas Austin

(1801-1865)

European wild rabbit

(Oryctolagus cuniculus)

After 7 years…

14,253 )!(

1859 - 24 individuals

“After habitat destruction, introduced species are the

second greatest cause of species endangerment and

decline worldwide”.

(Schmitz & Simberloff, 1997)

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.

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!

How Do They Get to a New Place?

Variety of pathways: 3 types of introductions

Random introduction Intentional introduction

Directly to nature Captivation No specific purpose

Forestry

Nursery plants, food

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

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

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?

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

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”

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

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)

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

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)

Go & Learn: Biodiversity, Food Security &

Regulation on Alien Invasive Species

Questions? Opinions?

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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