Food Safety Management System : Beyond HACCP. Presented in Seminar BUILDING PREVENTIVE FOOD SAFETY MEASURES Food Review Indonesia,Bogor March 15, 2017

Ratih Dewanti-Hariyadi/IPB/2017 1

Ratih Dewanti-Hariyadi

Department of Food Science and Technology and Southeast Asia Food Agric Sci & Technol. (SEAFAST) Center Bogor Agricultural University Bogor, Indonesia

Food Safety Management System :

Beyond HACCP

Presented in Seminar “ BUILDING PREVENTIVE FOOD SAFETY MEASURES” Food Review Indonesia,Bogor March 15, 2017

Bogor Agricultural University

• 

Perkembangan Sistem Manajemen Keamanan

Pangan

• 

Hazard Analysis Critical Control Point

(HACCP)

• 

Tantangan Keamanan Pangan Global

• 

Pertahanan Pangan (Food Defense)

• 

AS : - Intentional Adulteration (IA) Rule

- Vulnerability Assessment

- Food Defense Plan

• 

Inggris: - PAS 96 2014 (BSI)

- Threat Assessment Critical Control

Point (TACCP)

Bogor Agricultural University

Perkembangan Sistem Manajemen

Keamanan Pangan Safety Management*

Process Criteria Testing HACCP (Q)RA FSO 1900 1920 1940 1960 1980 2000 2020

*adopted from Zwittering 2013 Peraturan

Perkembangan

•  Sistem yang mengidentifikasi, mengevaluasi

dan mengendalikan bahaya (hazard) yang

penting untuk keamanan pangan *

•  Pertama kali dikembangkan tahun 1959 oleh

Pillsbury Co and US Natick Army untuk

menjamin keamanan makanan astronot

•  Dianggap sebagai pencegahan yang mampu

meningkatkan jaminan keamanan pangan

untuk industri pangan

Hazard Analysis Critical Control

Point (HACCP)

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Prinsip HACCP :

•  Analisis Bahaya (Hazard Analysis) •  Penetapan CCP

•  Penetapan Critical Limit

•  Penetapan Monitoring Procedures •  Penetapan Corrective Action

•  Penetapan Verification Procedures •  Penetapan Documentation System

Bahaya

•  Senyawa (biologi, kimia dan fisik) dalam pangan yang dapat menyebabkan ganggunan kesehatan kontaminasi alami, ketidaksengajaan, akibat

kekuranghatihatianatau ignorance orang yang terlibat

HACCP

Bogor Agricultural University

Perkembangan HACCP

•  Prinsip HACCP diadopsi dan diintegrasikan ke berbagai sistem manajemen keamanan pangan:

- Safe Quality Foods (SQF 2000) -  ISO 22000: 2005 Food Safety

Management System in Food Chain -  Food Safety System Certification (FSSC) -  British Retail Consortium (BRC)

-  GFSI (Global Food Safety Initiative) -  Hazard analysis Risk-Based Preventive

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•  Sistem pangan yang semakin kompleks

•  Kerentanan (Vulnerable)terhadap serangan

•  Interconnectedness, menyebar cepat, luas

•  Terjadi fraud/tampering yang tidak dapat

diprediksi atau dikendalikan melalui HACCP

- melamine dalam Powder Infant Formula

- S. Typhimurium sengaja ditambahkan ke

salad

•  Perlunya Food Defense

Tantangan Keamanan Pangan Global

Niat untuk menyebabkan

celaka/kematian

Niat untuk menyebabkan

kerugian ekonomi

TERRORISM SABOTASE ECONOMICALLY MOTIVATED ADULTERATION

Pertikaian Pribadi

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K E M A M P U A N K E R E N T A N A N M O T I V A S I N i a t l a w a n u n t u k m e n c e l a k a i P e n g e t a h u a n l a w a n t e n t a n g a d u l t e r a n , t a k t i k K o n d i s i a k s e s i b i l i t a s d a n p e l u a n g m e n y e b a b k a n d a m p a k ANCAMAN FOOD DEFENSE

FOOD DEFENSE

Dari: FoodProtection.UMN.EDU, 2016

Bogor Agricultural University

Food Protection

•  Prosedur yang dilakukan untuk menghalangi dan mendeteksi kecurangan/penipuan/pemalsuan pada pangan baik disengaja maupun tidak

Food Defence

•  Prosedur untuk menjamin keamanan makanan dan minuman dan rantai suplainya dari serangan bermotif

jahat dan ideologis yang mengakibatkan

kontaminasi atau gangguan suplai (BSI, 2014)

Food Defense

•  Upaya untuk melindungi pangan dari kegiatan pemalsuan (adulteration) yang disengaja (http:// www.fda.gov/food/fooddefense/).

Bogor Agricultural University

Evolusi Kebijakan Food Defense AS

FSI S / F DA G uide lines for Disp osa l and Deco ntami natio n FDA Biot erro rism Act 2002 FDA Gui dance 2003 DHS HSPD 7 DHS HSPD 8 DH S H SPD 9 FDA Est ablish ment and Ma inte nance of R eco rds FSI S Se curit y Gui delin es - T ransp ortat ion 2004 2005 FDA Reg istra tion of Food Faci litie s 2006 FSI S – Deve lopi ng a Food Def ense Plan 2008 FDA Vul nera bilit y Asse ssme nt T ool 2009 FDA Pri or N otice Of I mport Sh ipme nts FSI S G uide lines for Slau ghte r & Pro cessi ng 2011 Food Sa fety Mo dern izatio n A ct FSI S Se curit y G uide lines for F ood Pro cesso rs FDA Ad mini stra tive Detention 2013 DH S PPD 21 DH S PPD 8 2016 FDA FSMA Inte ntio nal Adul tera tion Rul e

FOOD DEFENSE – AS

FOOD SAFETY MODERNIZATION ACT

Latar Belakang FSMA

•  9.3 juta penyakit bawaan pangan (1 dalam 31) per tahun, 53,245 dirawat RS dan 2,377 kenmatian

•  Pergeseran fokus industri menuju strategi pencegahan bernasiskan “science-based standards”

•  Pangan impor harus memiliki persyaratan sama dengan pangan lokal

•  Ditandatangani 4 Januari 2011

•  Dokumentasi mengenai

kontaminasi dan recall di industri pangan AS

Ratih Dewanti-Hariyadi/IPB/2017 7

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FSMA– US

Bogor Agricultural University

the 7 rules oF FsMA

preventive controls -

huMAn Food produce sAFety

3rd pArty AccreditAtion preventive controls – AniMAl Food Foreign supplier veriFicAtion progrAM intentionAl AdulterAtion sAnitAry trAnsport

rule FinAl rule requireMents deAdline For coMpliAnce

Preventive Controls: Human Food

September 17, 2015 One year after final rule: general Two years after final rule: small business* Three years after final rule: very small business (<$1 million) plus PMO (Pasteurized Milk Ordinance) Supply chain: plus six month supplier’s compliance

September 19, 2016 September 18, 2017 September 17, 2018

Preventive Controls: Animal Food

September 17, 2015 CGMP compliance date One year after final rule: general Two years after final rule: small business* Three years after final rule: very small business (<$2.5 million)

Preventive controls compliance date: plus one year from above

Supply-chain: plus six months of supplier’s compliance

September 19, 2016 September 18, 2017 September 17, 2018

Produce Safety November 27, 2015 One year after final rule: general** Two years after final rule: small business ($250,000-$500,000)**

Three years after final rule: very small business ($25,000-$250,000) **

November 27, 2016 November 27, 2017 November 27, 2018

Intentional Adulteration May 27, 2016 Three years after final rule: general Four years after final rule: small business* Five years after final rule: very small business (<$10 million) General: July 26, 2019 Small businesses: July 27, 2020 Very small businesses: July 26, 2021 Foreign Supplier Verification Program

November 27, 2015 18 months after final rule

For produce sector: 18 months plus 6 months or 6 months after supplier’s compliance to PC/Produce rule

May 27, 2017 November 27, 2017

Third Party Accreditation November 27, 2015 ASAP after final fee rules Sanitary Transport April 6, 2016 One years after final rule: general**

Two years after final rule: small business* (carriers <$27.5 million)

April 6, 2017 April 6, 2018

4

* Small business : less than 500 employees business-wide

** Except for sprouts farms have + 1 year from listed plus additional 2 years to comply with water requirements

FSMA– US

Rules

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Final Rule: Protecting Food Against

Intentional Adulteration (IA)

http://www.fda.gov/fsma

Strategi Mitigasi untuk Melindungi Pangan dari

Adulterasi yang Disengaja (Mitigation Strategies to

Protect Food Against Intentional Adulteration)

•  Proposed on December 24, 2013

•  Public comments: More than 200 for the original proposal •  Final rule publication date: May 27, 2016

•  Menetapkan persyaratan untuk mencegah

atau meminimalkan secara signifikan

kegiatan yang bertujuan untuk

mengakibahkan bahaya kesehatan

masyarakat pada skala luas

•  Menggunakan pendekatan serupa HACCP,

dengan perbedaan pada “Preventive

Controls for Human Food”

•  Berbasiskan risiko dan fleksibel

Peraturan tentang Intentional

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•  Rencana Food Defense

– Vulnerability assessment

– Strategi Mitigasi

– Prosedur monitoring untuk food defense

– Prosedur corrective action untuk food defense

– Prosedur verifikasi untuk food defense

– Perekaman

•  Training

Persyaratan untuk Peraturan IA

Bogor Agricultural University

•  Proses mengidentifikasi dan prioritasisasi

titik-titik, langkah proses, prosedur, dalam

fasilitas pengolahan pangan yang rentan

terhadap adulteration yang disengaja

•  Dapat membantu mengidentifikasi:

– Actionable Process Steps

– Area operasi dimana Strategi Mitigasi

harus diaplikasikan

Bogor Agricultural University

Metode Vulnerable Assessment

Methodology

Tiga faktor paling penting untuk

dipertimbangkan :

•  Aksesibilitas: ukuran kemudahan bagi seorang penyerang dapat menjangkau secara fisik target yang ingin diserang

•  Vulnerabilitas: ukuran kemudahan bagi suatu

kontaminan dapat diletakkan dalam jumlah yang cukup untuk mencapai tujuan penyerang (setelah target

dijangkau)

•  Kritikalitas (impact) : apakah dampak kontaminan terhadap produksi/ gangguan kesehatan

Skala Accessibility

(Dapatkah saya mencapai target?)

CRITERIA SCALE

Easily Accessible (e.g., target is outside building and no

perimeter fence). 9 – 10

Accessible (e.g., target is inside building, but in unsecured part of

facility). 7 – 8

Partially Accessible (e.g. inside building, but in a relatively

unsecured, but busy, part of facility). 5 – 6

Hardly Accessible (e.g., inside building in a secured part of

facility). 3 – 4

Not Accessible (e.g., there are physical barriers, alarms, and

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Skala Vulnerability

(Setelah mencapai target, bisakan saya meng”adulterate” pangan)

CRITERIA SCALE

Highly Vulnerable (e.g., product is openly exposed and there is lots of

time to allow for easy introduction of contaminants without being seen).

9 – 10

Vulnerable (e.g., product has some open exposure and there is sufficient

time to almost always allow for introduction of contaminants without being seen).

7 – 8

Somewhat Vulnerable (e.g., product has limited exposure points and

limited times when contaminant can be added without being seen).

5 – 6

Barely Vulnerable (e.g., product has limited exposure points but is almost

always under observation while in production).

3 – 4

Not Vulnerable (e.g., product is in sealed vessels/pipes with no practical

exposure points or it is under full and controlled observation).

1 – 2

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Skala Criticality

(Jika saya dapat meng”adulterate” apa dampaknya?)

CRITERIA SCALE

Very Large Volume Impact (e.g., a single instance of contamination

at this point would contaminate multiple days of the production of this line).

9 – 10

Large Volume Impact (e.g., a single instance of contamination at

this point would contaminate multiple shifts of the production of this line).

7 – 8

Medium Volume Impact (e.g., a single instance of contamination at

this point would contaminate one shift or less of the production of this line).

5 – 6

Small Volume Impact (e.g., a single instance of contamination at

this point would contaminate two hours or less of the production of this line).

3 – 4

Low Volume Impact (e.g., a single instance of contamination at this

point would contaminate 30 minutes or less of the production of this line).

1 – 2

Bogor Agricultural University

Asesmen Vulnerability untuk Fasilitas

•  Lakukan vulnerability assessment dengan metode yang tepat dan qualified individual(s) •  Identifikasi da prioritaskan prioritize titik dalam

operasi pangan yang rentan (vulnerable) terhadap intentional adulteration

•  Identifikasi actionable process untuk vulnerability yang signifikan : a point, step, or procedure in a food

process at which food defense measures can be applied and are essential to prevent or eliminate a significant vulnerability or reduce such vulnerability to an acceptable level.”

•  Evaluasi senyawa yang dikhawatirkan •  Buat tim Vulnerability Assessment (VA) •  Menyusun diagram alir

•  Identifikasi Vulnerabilities yang signifikan: –  Public health impact

–  Volume of product impacted –  Downstream processing –  Physical access to product

–  Ability of aggressor to contaminate product •  Identifikasi Actionable Process Steps

Elemen Vulnerability Assessment

Untuk Fasilitas

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•  Strategi mitigasi harus diidentifikasi dan

diimplementasikan iuntuk tiap actionable process

step untuk memberi jaminan bahwa vulnerabilitas

diminimalkan atau dicegah

•  Strategi mitigasi harus disusun khusus (tailored ) untuk fasilitas dan prosedur-prosedur.

•  Contoh mitigasi : pagar disekeliling fasilitas untuk mencegah outsider, cara lain mungkin diperlukan untuk melindungi actionable process step dari serangan “insider”

Strategi Mitigasi

Bogor Agricultural University

Komponen Strategi Mitigasi

•  Monitoring: Establishing and implementing

procedures, including the frequency with which they are to be performed, for monitoring the mitigation strategies.

•  Corrective actions: The response if mitigation strategies are not properly implemented.

•  Verification: Verification activities would ensure that monitoring is being conducted and appropriate decisions about corrective actions are being made.

Bogor Agricultural University

Rencana Food Defense

Rencana Food Defense tertulis mencakup :

•  Vulnerability Assessment

•  Actionable process steps

•  Mitigation strategies

Monitoring

Corrective actions

Verification

Training

•  Recordkeeping

2014:

The British Standards

Institution (BSI) :

PAS 96 2014

Guide to protecting

and defending food

and drink from

deliberate attack

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Bogor Agricultural University

Background

•  HACCP tidak digunakan untuk mendeteksi atau mengurangi serangan yang disengaja dalam sistem pangan yang menyebabkan bahaya keamanan pangan maupun merusakn reputasi perusahaan(pemerasan dsb)) •  Faktor umum serangan disengaja: orang, motivasi

•  PAS 96 panduan bagi manajer industri pangan melalui pendekatan dan prosedur untuk meningkatkan ketahanan rantai pangan dari penipuan/bentuk serangan lain

•  Menekankan pada Threat Assessment Critical Control Points (TACCP),

•  Proses TACCP diasumsikan dan dibangun di atas HACCP

PAS 96 2014

Bogor Agricultural University

TACCP

Manajemen risiko secara sistematis melalui evaluasi ancaman (threats), identifikasi vulnerability, dan

penerapan pengendalian terhadap bahan dan produk, pembelian, proses, fasilitas, jaringan distribusi dan sistem bisnis dengan tim terpercaya dan berpengetahuan yang diberi otoritas untuk mengubah prosedur

Ancaman

Sesuatu yang dapat mengakibatkan kehilangan atau bahaya yang timbul karena orang yang berniat jahat

Threat Assessment Critical Control

Point (TACCP)

Bogor Agricultural University

Jenis Ancaman

•  Pemalsuan bermotif ekonomi (Economically

motivated adulteration/EMA)

•  Kontaminasi karena unsur kejahatan (Malicious

contamination)

•  Pemerasan (Extortion)

•  Spionase (Espionage)

•  Pemalsuan (Counterfeiting)

•  Kejahatan cyber (Cyber crime)

•  Keberhasilan serangan (attack) yang

disengaja terhadap pangan atau rantai

pangan tergantung dari :

a)  Apakah penyerang memiliki motivasi dan dorongan untuk mengatasi hambatan baik besar atau kecil b)  Apakah penyerang memiliki kemampuan untuk

melakukan serangan? c)  Apakah penyerang memiliki

kesempatan(=akses)untuk menjalankan serangan d)  Apakah penyerang akan mengurungkan niatnya jika

terdeteksi atau ana kemungkinan dihukum?

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•  Jenis Penyerang:

-  Pemeras (the extortionist)

-  Oportunis (the opportunis)

-  Ekstrimis (the extremist)

-  Perorangan yang tak rasional (the irrational

individual)

-  Perorangan yang tidak puas (the disgruntled

individual)

-  Hackivist dan penjahat cyber lainnya (the

hacktivist and other cyber criminals)

Memahami Ancaman

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Tujuan :

• mengurangi peluang serangan yang disengaja • mengurangi dampak serangan (jika terjadi) • melindungi reputasi organisasi

• menmberi jaminan pada konsumen. Pers, masyarakat bahwa langkah-langkah pencegahan telah disiapkan untuk melindungi pangan dari serangan yang disengaja • Memuaskna harapan international dan mendukung

trading partners

• Mendemonstrasikan bahwa pencegahjan telah dilakukan dan uji kelayakan telah dipraktekkan

Bogor Agricultural University

•  Dalam banyak kasus, TACCP seharusnya merupakan kerja tim. Untuk bisnis skala kecil yang tidak praktis untuk membuat tim, dapat menjadi tugas 1 orang

•  Tim TACCP harus melakukan exercise setidaknya 4 pertanyaan berikut :

a) Siapa yang mungkin ingin menyerang kita? b) Bagaimana mereka akan melakukannya? c) Dimana titik kerentanan (vulnerable) kita? d) Bagaimana kita dapat menghentikannya?

Proses dalam TACCP

Tim TACCP dapat terdiri dari orang yang menguasai :

• security;

• human resources; • food technology; • process engineering; • production and operations; • purchasing and supply; • distribution;

• communications; and • commercial/marketing.

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Bogor Agricultural University

Langkah

•  Mengidentifikasi ancaman spesifik terhadap bisnis perusahaan

•  mengases peluang suatu serangan dengan

mempertimbangkan : motivasi kandidat penyerang, vulnerability proses, kesempatan dan kemampuan untuk melakukan serangan,mengases dampak

•  Menimbang prioritas pada berbagai ancamandengan memperhatikan likelihood and impact

•  Menetapkan pengendalian yang tepat untuk menghalangi (discourage) penyerang dan membuat early warning •  Memelihara sistem informasi dan intelijen untuk merevisi

prioritas

Proses dalam TACCP

Bogor Agricultural University Form TACCP team 1. Assess new information 2. Identify and assess threat to organization 3. Identify and assess threat to operation 4. Select product 5. Identify and assess threat to

product 6. Device flowchart of product supply chain

7. Identify key staff and vulnerable points 8. Consider impact of threats identified 9. Identify which supply points are most critical 10. Determine if control

procedures will detect the threats 11. Likelihood v.

impact : priority 12. Who could carry it out 13. Decide and

implement necessary controls 14. Review and revise

15. Monitor horizon scans and emerging risks

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Ancaman terhadap tempat, misalnya:

•  Are the premises located in a politically or socially sensitive area? •  Do the premises share access or key services with controversial

neighbours?

•  Are new recruits, especially agency and seasonal staff, appropriately screened?

•  Are services to the premises adequately protected? •  Are external utilities adequately protected?

•  Are hazardous materials, which could be valuable to hostile groups, stored on site?

•  Are large numbers of people (including the general public) using the location?

•  Do any employees have reason to feel disgruntled or show signs of dissatisfaction?

•  Are internal audit arrangements independent?

Have key roles been occupied by staff for many years with little supervision?

Asesmen Ancaman dalam TACCP

Asesmen ancaman terhadap organisasi :

• Are we under foreign ownership by nations involved in

international conflict?

• Do we have a celebrity or high profile chief executive or proprietor?

• Do we have a reputation for having significant links, customers, suppliers, etc. with unstable regions of the world?

• Are our brands regarded as controversial by some? • Do we or our customers supply high profile customers or

events?

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Asesmen ancaman terhadap produk :

•  Have there been significant cost increases which have affected this product?

•  Does this product have particular religious, ethical or moral significance for some people?

•  Could this product be used as an ingredient in a wide range of popular foods?

•  Does the product contain ingredients or other material sourced from overseas?

Asesmen Ancaman dalam TACCP

Bogor Agricultural University

Untuk EMA:

•  Are low cost substitute materials available?

•  Have there been significant material cost increases? •  Has pressure increased on suppliers’ trading margins? •  Do you trust your suppliers’ managers, and their

suppliers’ managers?

•  Do key suppliers use personnel security practices? •  Do suppliers think that we monitor their operation •  and analyze their products?

•  Which suppliers are not routinely audited?

•  Are we supplied through remote, obscure chains? •  Are major materials becoming less available (e.g. from

crop failure) or alternatives plentiful (e.g. from overproduction)?

Bogor Agricultural University

Untuk EMA:

•  How do suppliers dispose of excessive amounts of waste materials?

•  Are we aware of shortcuts to the process which could affect us?

•  Are our staff and those of suppliers encouraged to report concerns (whistleblowing)?

•  Are accreditation records, certificates of

conformance and analyzes reports independent?

Asesmen Vulnerability dalam TACCP

Untuk Malicious Contamination:

•  Are food safety audits rigorous and up-to-date? •  Are personnel security procedures in use?

•  Is access to product restricted to those with a business need? •  Do storage containers have tamper-evident seals?

•  Is the organization involved with controversial trade? •  Is the organization owned by nationals from conflict areas? •  Is there opportunity for access by sympathizers of single issue

groups?

•  Do any employees bear a grudge against the organization? •  Is staff boredom, discipline, recruitment a problem?

•  Have business competitors been accused of espionage •  or sabotage?

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Likelihood of threat happening

Score Impact

Very High Chance 5 Catastrophic

High Chance 4 Major

Some Chance 3 Significant

May Happen 2 Some

Unlikely to Happen 1 Minor

Contoh Matriks untuk Skoring Risiko

Asesmen Risiko dalam TACCP

Bogor Agricultural University

Likelihood of threat happening Impact Catas-trophic Major Significan t Some Minor Very High Chance Threat 1

High Chance Threat 3

Some Chance May Happen Unlikely to Happen Threat 2

Contoh Matriks untuk Skoring Risiko

Bogor Agricultural University

Laporan TACCP

Bahan Bacaan

•  British Standard Institute. 2014. PAS 96 2014. Guide to protecting

and defending food and drink from deliberate attack

•  SGS. 2016. Understanding the US Food Safety Modernization Act (FSMA)

•  USFDA. 2011. Food Safety Modernization Act. https://www.fda.gov/Food/GuidanceRegulation/FSMA/ ucm253380.htm

•  USFDA. 2016. Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration (IA).

https://www.fda.gov/Food/GuidanceRegulation/FSMA/ ucm378628.htm

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Thank You

Thank You