From Blue Sky to Field: Regulatory Drivers for the Development of

New Methodology

Dr David N Mortimer Policy lead, environmental contaminants Food Standards Agency

Food Standards Agency • Non-ministerial Government Department responsible for food safety

and hygiene across the UK (excl Scotland from 1 April) • Independent of direct Government control • Run by a Board and Chief Executive • Set up by Labour following BSE crisis

Food Standards Act 1999

Article 6. Development of food policy and provision of advice, etc. to public authorities. Article 7. Provision of advice, information and assistance to other persons (i.e. anyone who asks). Article 8. Acquisition and review of information. (1) … obtain, compile and review information … (2a) … monitor developments in science, technology etc … (2b) … carry out, co-ordinate, commission research … (3) … ensure sufficient information for informed decisions …

Food Standards Agency

• Follows 5-year strategies 2015 – 2020 draft

We will put the consumer first in everything we do. • Consumers have the right to be protected.

• Consumers have the right to make choices knowing the facts

• Consumers have the right to the best food future* we can deliver * Impacts of: shortages; climate change; population movement; industrial development; novel foods and processes; other emerging risks.

Food Standards Agency

Policy and Science Directorate Food Safety Policy Division

Science & Evidence Division

Chemical Safety Unit

Chemical Risk Assessment, Microbiological Safety & Risk Assessment, Exposure, Analytical Standards, Statistics, Chief Scientist’s Team

Additives & FCMs

Microbiology & Hygiene

Allergens

Contaminants (Agricultural, process & environmental; residues)

Novel Foods & Processes

Environmental Contaminants Research Programme

Information sources

‘Baseline’ projects

Emerging risks Pathways

Targeted investigations (food)

Targeted investigations (determinand)

Outcomes (Policy)

Environmental contaminants • Dioxins & furans (chlorinated, brominated, mixed) • Halogenated biphenyls • Polycyclic aromatic hydrocarbons • Brominated flame retardants • Other FR classes (chlorinated, organophosphates) • Perfluorinated compounds • Other Stockholm POPs / candidates • Legacy pesticides • Other dioxin-like compounds • Nanoparticles • Microplastics • Endocrine disruptors

Environmental Contaminants Programme Drivers

Information sources: Symposia / networking; literature RASFF / Intelligence hub Regulatory changes

‘Baseline’ Science & Evidence projects: Total Diet Studies Marine survey

Emerging risks: New Stockholm compounds Dechloranes OPFRs Nanoparticles Microplastics Endocrine disruptors

Pathways: Waste uptakes BFRs in kitchens FRs in production plants FRs in transport

Targeted investigations (food): Infant foods & formulae Bovine meat & liver Free range/organic eggs Duck eggs

Targeted investigations (determinand): Novel & existing BFRs Dioxin-like compounds

Outcomes: Consumer protection/advice Food chain protection EU position / negotiation Data sharing (EFSA) Scientific dissemination Further research

Analytical needs

Emerging risks Screening methods (presence in food?) Validated methods for new determinands Methods for new matrices

Pathways: Dependent on type of investigation New matrices ‘In-line’methods

Targeted investigations (food) Robust, accredited* Lower cost Rapid turnaround** *especially for enforcement ** especially for incidents

Targeted investigations (determinand) Screening methods (including bioassays) Very high sensitivity Fractionations Identification of ‘unknowns’

Emerging risks • New / candidate Stockholm compounds (current)

– Pentachlorobenzene (listed 2009) – Hexachlorobutadiene (candidate) – Pentachlorophenol (candidate – dioxin source) – Polychlorinated naphthalenes (candidate – already studied) – Short chain chlorinated paraffins (complex analysis)

Future • Organophosphorus flame retardants • Dechloranes • Nanomaterials • Microplastics

Dechlorane 604

Targeted investigations Dioxin-like compounds • Advice from COT to look at dioxin-like activity • Use of bioassay(s) to determine total dioxin-like activity (Ah-receptor

binding potency) • Measure known Cl/Br/Mixed dioxins & BPs; PCNs • Select samples with ‘gaps’ • Fractionate and isolate unaccounted dioxin-like activity • Attempted ID of dioxin-like components

BFRs • Measurement of total bromine (400 samples) • Analysis for known BFRs (200 highest across all food/feed groups) • Mass balance & ID of novel BFRs • Data available for EFSA

2

3

4

1

5

6

7

8Cl

Cl

Cl

Cl

ClPCN-52

Br

Cl Cl

Cl

Cl

(PXB-118)

Horizon scanning (Symposia, literature, intelligence, research)

Discussion at Working Group

Call for data

Risk assessment

Risk management options

Official Control methodology

Finalisation of limits, S&A

National monitoring

Review of effectiveness

Policy leads/experts

COM, MS experts

COM, EFSA

Coordinated monitoring

Policy leads/experts

EFSA, COT

COM, MS experts

EURL, NRLs

Policy leads/experts

COM, MS experts

All

A policy & science cycle

Vote at SCoPAFF

Brominated Flame Retardants - call

For the emerging and novel brominated flame retardants: tris(2,3-dibromopropyl) phosphate (TDBPP, CAS No 126-72-7); N,N'-ethylenebis(tetrabromophthalimide) (EBTEBPI, CAS No 32588-76-4) en hexabromocyclodecane (HBCYD, CAS No 25495-98-1); bis(2-ethylhexyl) tetrabromophthalate (BEH-TEBP, CAS No 26040-51-7) and 2-ethylhexyl 2,3,4,5-tetrabromobenzoate (EH-TBB, CAS No 183658-27-7) and dibromoneopentyl glycol (DBNPG, CAS No 3296-90-0) in fish & other seafood, meat and meat products (including edible offal), animal and vegetable fats and oils, milk and dairy products, eggs and egg products, food for infants and small children and feed for food producing animals.

For the class of polybrominated diphenyl ethers (PBDEs): 2,2’,4-tribromodiphenyl ether (BDE-28, CAS No 41318-75-6); 2,2’,4,4’-tetrabromodiphenyl ether (BDE-47, CAS No 5436-43-1); 2,2',4,4',5-pentabromodiphenyl ether (BDE-99, CAS No 60348-60-9); 2,2’,4,4’,6-pentabromodiphenyl ether (BDE-100, CAS No 189084-64-8); 2,2’,4,4’,5,5’-hexabromodiphenyl ether (BDE-153, CAS No 68631-49-2); 2,2’,4,4’,5,6’-hexabromodiphenyl ether (BDE-154, CAS No 207122-15-4); 2,2’,3,4,4’,5’,6-heptabromodiphenyl ether (BDE-183, CAS No 207122-16-5); 2,2’,3,3’,4,4’,5,5’,6,6’-decabromodiphenyl ether (BDE-209, CAS No 1163-19-5), in eggs and egg products, milk and dairy products, meat and meat products, animal and vegetable fats and oils, fish and other seafood, products for specific nutritional uses, and food for infants and small children

For the class of hexabromocyclododecanes (HBCDDs): (+/-)-α-HBCD (1,2,5,6,9,10-hexabromo-(1R,2R,5S,6R,9R,10S)-rel-cyclododecane; CAS No 134237-50-6), (+/-)-β-HBCD (1,2,5,6,9,10-hexabromo-(1R,2S,5R,6R,9R,10S)-rel-cyclododecane; CAS No 134237-51-7) and (+/-)-γ-HBCD (1,2,5,6,9,10-hexabromo-(1R,2R,5R,6S,9S, 10R)-rel-cyclododecane; CAS No 134237-52-8) in fish and other seafood, meat and meat products, milk and dairy products, eggs and egg products, and infant formula & follow-up formula

For the class of tetrabromobisphenol A and its derivatives: tetrabromobisphenol A (TBBPA, CAS No 79-94-7) and possibly TBBPA bismethyl ether (TBBPA-bME, CAS No 70156-79-5), TBBPA bis(2-hydroxyethyl) ether (TBBPA-bOHEE, CAS No 4162-45-2), TBBPA bisallyl ether (TBBPA-bAE, CAS No 25327-89-3), Tetrabromobisphenol A bis(glycidyl ether) (TBBPA-bGE, CAS No 3072-84-2) and TBBPA bis(2,3-dibromopropyl)ether (TBBPA-bDiBPrE, CAS No 21850-44-2) in fish and other seafood, meat and meat products, milk and dairy products, eggs and egg products.

Horizon scanning (Symposia, literature, intelligence, research)

Discussion at Working Group

Call for data

Risk assessment

Risk management options

Official Control methodology

Finalisation of limits, S&A

National monitoring

Review of effectiveness

Policy leads/experts

COM, MS experts

COM, EFSA

Coordinated monitoring

Policy leads/experts

EFSA, COT

COM, MS experts

EURL, NRLs

Policy leads/experts

COM, MS experts

All

A policy & science cycle

Vote at SCoPAFF

Official Controls Work by EURL/NRL network

Horizon scanning (Symposia, literature, intelligence, research)

Discussion at Working Group

Call for data

Risk assessment

Risk management options

Official Control methodology

Finalisation of limits, S&A

National monitoring

Review of effectiveness

Policy leads/experts

COM, MS experts

COM, EFSA

Coordinated monitoring

Policy leads/experts

EFSA, COT

COM, MS experts

EURL, NRLs

Policy leads/experts

COM, MS experts

All

A policy & science cycle

Vote at SCoPAFF

Wish list Future needs: Methods for chlorinated paraffins (1 Mte/a POP) Dip-stick test for dioxins (blood, milk …) Rapid identification of unknowns Faster, cheaper, more sensitive … Simplified extraction MIPs – bespoke antibodies

Thank you

Questions?

Contact details David.mortimer@foodstandards.gsi.gov.uk Tel. +44 (0)20 7276 8731 Mob. +44 (0)7732 687159