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

3/15/17

Food Safety Management System : Beyond HACCP

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

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

OUTLINE •  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

Ratih Dewanti-Hariyadi/IPB/2017

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Perkembangan Sistem Manajemen Keamanan Pangan Safety Management* 1900

1920

1940

1960

1980

2020

2000

Process Criteria Testing HACCP (Q)RA FSO Bogor Agricultural University Perkembangan

Peraturan

*adopted from Zwittering 2013

Hazard Analysis Critical Control Point (HACCP) •  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 *Codex Alimentarius General Principles of Food Hygiene) Bogor Agricultural University


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HACCP 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 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 Control (HARPC, FSMA) Bogor Agricultural University


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Tantangan Keamanan Pangan Global •  •  •  • 

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 Bogor Agricultural University

PERTAHANAN PANGAN (FOOD DEFENSE) Niat untuk menyebabkan celaka/kematian TERRORISM

Niat untuk menyebabkan kerugian ekonomi

SABOTASE

ECONOMICALLY MOTIVATED ADULTERATION

Pertikaian Pribadi

Bogor Agricultural University


From : FoodProtection.UMN.EDU, 2016

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FOOD DEFENSE

MOTIVASI Niat lawan untuk mencelakai

KEMAMPUAN

ANCAMAN FOOD DEFENSE

Pengetahuan lawan tentang adulteran, taktik

KERENTANAN Kondisi aksesibilitas dan peluang menyebabkan dampak Dari: FoodProtection.UMN.EDU, 2016 Bogor Agricultural University

ISTILAH TERKAIT FOOD DEFENSE 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


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FOOD DEFENSE – AS FD Ad A F ult SM era A tio Inte n R nt ule iona

l

D 9 FD A Ma E int sta en bli a n sh m ce of ent Re an FS co d I S rds Dis / po FD sa A G la nd uide De lin co es nta for mi na FD tio As A V n se uln ss er me ab i nt lity To ol FS I Sla S G ug uid hte el r & ines Pr fo DH oc r SP es sin PD g 8

8

SP SH

2009

2011

2013

2016

21

ct

2008

SP PD

2005 2006

DH

2004

Fo Mo od S de af rn ety iza tio nA

DH

DH

S

HS

PD

ce an

Gu id

2003

FS for IS S Fo ecu od rit Pr y G oc es uide so lin D HS rs es FS HS Gu IS S PD ide ec lin urit 7 es y -T r a FD ns po De A A rta ten dm tio n tio inis n tra tiv e FD Fo A R od eg Fa istr cili atio tie s n of FS Fo IS – od D De eve fen lop se ing Pla a n FD Of A P Im rior po rt S Noti hip ce me nts

2002

FD A

FD A

Bi

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Evolusi Kebijakan Food Defense AS


FOOD SAFETY MODERNIZATION ACT Latar Belakang FSMA •  Dokumentasi mengenai kontaminasi dan recall di industri pangan AS

•  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 Bogor Agricultural University


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FSMA– US


FSMA– US Rules the 7 rules oF FsMA

preventive controls huMAn Food

preventive controls – AniMAl Food

Foreign supplier veriFicAtion progrAM

produce sAFety

3rd pArty AccreditAtion

intentionAl AdulterAtion

sAnitAry trAnsport

rule

FinAl rule

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

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

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

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

Preventive Controls: Bogor Agricultural University Animal Food

Produce Safety

Ratih Dewanti-Hariyadi/IPB/2017 Intentional Adulteration

requireMents

deAdline For coMpliAnce

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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


Peraturan tentang Intentional Adulteration (IA) •  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 Bogor Agricultural University


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Persyaratan untuk Peraturan IA •  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


Vulnerability Assessment •  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



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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 Bogor Agricultural University

Skala Accessibility (Dapatkah saya mencapai target?) CRITERIA Easily Accessible (e.g., target is outside building and no perimeter fence).

SCALE 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 human observation to prevent reaching the target).

1–2



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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


Skala Criticality (Jika saya dapat meng”adulterate” apa dampaknya?) CRITERIA Very Large Volume Impact (e.g., a single instance of contamination at this point would contaminate multiple days of the production of this line). Large Volume Impact (e.g., a single instance of contamination at this point would contaminate multiple shifts of the production of this line). 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). 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). 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).

SCALE 9 – 10 7–8 5–6 3–4 1–2



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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.” Bogor Agricultural University

Elemen Vulnerability Assessment Untuk Fasilitas •  •  •  • 

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 Bogor Agricultural University


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Strategi Mitigasi •  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 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


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Rencana Food Defense Rencana Food Defense tertulis mencakup : •  Vulnerability Assessment •  Actionable process steps •  Mitigation strategies Monitoring Corrective actions Verification Training •  Recordkeeping Bogor Agricultural University

FOOD DEFENCE UK : PAS 96 2014

2014: The British Standards Institution (BSI) : PAS 96 2014 Guide to protecting and defending food and drink from deliberate attack Bogor Agricultural University


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PAS 96 2014 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 Bogor Agricultural University

Threat Assessment Critical Control Point (TACCP) 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



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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)


Memahami Ancaman •  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? Bogor Agricultural University


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Memahami Ancaman •  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) Bogor Agricultural University

TACCP 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


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Proses dalam TACCP •  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. Bogor Agricultural University


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Proses dalam TACCP 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 Bogor Agricultural University

Proses dalam TACCP Form TACCP team

15. Monitor horizon scans and emerging risks

1. Assess new information

2. Identify and assess threat to organization

14. Review and revise

11. Likelihood v. impact : priority

10. Determine if control procedures will detect the threats

3. Identify and assess threat to operation

13. Decide and implement necessary controls

12. Who could carry it out 9. Identify which supply points are most critical 8. Consider impact of threats identified

4. Select product 5. Identify and assess threat to product

6. Device flowchart of product supply chain

7. Identify key staff and vulnerable points



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Asesmen Ancaman dalam TACCP 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? Bogor Agricultural University

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 dalam TACCP 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 Vulnerability dalam TACCP 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)?



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Asesmen Vulnerability dalam TACCP 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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Asesmen Risiko dalam TACCP Contoh Matriks untuk Skoring Risiko Likelihood of threat happening

Score

Impact

Very High Chance High Chance Some Chance

5 4 3

Catastrophic Major Significant

May Happen Unlikely to Happen

2 1

Some Minor


Asesmen Risiko dalam TACCP Contoh Matriks untuk Skoring Risiko Likelihood of threat happening

Catastrophic

Very High Chance

Threat 1

High Chance Some Chance May Happen Unlikely to Happen

Major

Impact Significan Some t

Minor

Threat 3

Threat 2



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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 •  Food Defense Training Materials. FoodProtection.UMN.Edu



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Thank You

Thank You [email protected]



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

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