ARAC/SOP1

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ARAC Procedure No: 1

Title:

PRIORITISATION AND COMMISSIONING OF RISK ASSESSMENT

Version No: 1

Endorsed by: 10th Senior Officials Meeting on Health Development Date: 15th September 2015

ASEAN Risk Assessment Centre for Food Safety (ARAC),

Food Safety and Quality Division, Ministry of Health Malaysia,

Level 4, Menara Prisma, No 26, Persiaran Perdana, Presint 3,

62675 Putrajaya, Malaysia

Phone no: +603-88850797

Fax no: +603-88850798

Email: arac@moh.gov.my

Website: www.arac-asean.org

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TABLE OF CONTENTS

Abbreviation and acronyms

1 Introduction

2 Objective

3 Scope

4 Definitions

5 Procedure Details

5.1 Prioritisation of Risk Assessment Process

5.1.1 Request of Risk Assessment Output / Scientific Opinion

5.1.2 Evaluation and Prioritisation Risk Assessment Request

5.1.3 Establishment of Priority List for Risk Assessment

5.2 Commissioning of Risk Assessment Process

5.3 Summary of the Prioritisation and Commissioning of Risk Assessment

Process

6 References

7 Annexes

Annex I Term of Reference

Annex II Proposal for Risk Assessment Request on Food Safety for

ASEAN Risk Assessment Centre for Food Safety (ARAC)

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Abbreviation and acronyms

ACCSQ – ASEAN Consultative Committee on Standards and Quality

AEGFS – ASEAN Expert Group on Food Safety

AMS – ASEAN Member State

ARAC – ASEAN Risk Assessment Centre for Food Safety

FAO – Food and Agriculture Organisation

GEMS – Global Environment Monitoring System

INFOSAN – International Network of Food Safety Authorities

JECFA – The Joint FAO/WHO Expert Committee on Food Additives

JEMRA – The Joint FAO/WHO Expert Meetings on Microbiological Risk

JMPR – The Joint FAO/WHO Meeting on Pesticide Residues Assessment

PFPWG – Prepared Foodstuff Products Working Group

SOM-AMAF – Senior Officials Meeting of ASEAN Ministerial Meeting on Agriculture

and Forestry

SOM-HD – Senior Officials Meeting on Health Development

WHO – World Health Organisation

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1. INTRODUCTION

The establishment of the ASEAN Risk Assessment Centre for Food Safety (ARAC)

located in Malaysia is one (1) of the most important milestones of ASEAN Expert

Group on Food Safety (AEGFS) in the application of an integrated risk assessment

mechanism. The primary function of ARAC is to provide independent scientific input

by pooling and utilising scientific expertise across ASEAN in developing evidence-

based common food safety measures in ASEAN.

As the coordinating centre on risk assessment in the region, ARAC will serve to

provide independent risk assessment output and scientific opinion to all relevant

ASEAN sectoral bodies such as AEGFS under Senior Officials Meeting on Health

Development (SOM-HD), Prepared Foodstuff Products Working Group (PFPWG)

under ASEAN Consultative Committee on Standards and Quality (ACCSQ) and

ASEAN Sectoral Working Groups under Senior Officials Meeting of ASEAN

Ministerial Meeting on Agriculture and Forestry (SOM-AMAF).

These ASEAN sectoral bodies, as the Risk Manager(s), need to prioritise their risk

assessment request to ARAC for risk assessment output or scientific opinion based

on criteria for prioritisation as set out in this procedure.

This will facilitate AEGFS with the assistance of ARAC Secretariat to evaluate the

request from Risk Manager(s) against the criteria in this procedure in order to

establish priority list for risk assessment for ARAC by taking into account workload,

resources and information provided.

The prioritisation process is very important in order to rank the most urgent food

safety risk assessment work request by the Risk Manager(s). A defined prioritisation

process ensures transparency and repeatability, and facilitates re-evaluation when

new data are available without repeating all steps.

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2. OBJECTIVE

This procedure provides a systematic flow in prioritising and commissioning of food

safety risk assessment as further work by ARAC.

3. SCOPE

This procedure covers the procedures of requesting risk assessment output /

scientific opinion from Risk Manager(s), evaluation and prioritisation of risk

assessment, commission on the risk assessment work by closely consultation with

the Scientific Committee and Scientific Panel(s). Term of Reference is presented in

Annex I.

4. DEFINITIONS

Risk Manager is a group consists of ASEAN Sectoral Working Groups under SOM-

AMAF, AEGFS under SOM-HD, PFPWG under ACCSQ and AMSs (food safety

competent authorities) which will request for risk assessment output or scientific

opinion to ARAC.

Risk Assessment is a scientifically based process consisting of the following steps:

(i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and

(iv) risk characterization.

Risk Profile is a description of the food safety problem and its context. A typical risk

profile includes a brief description of the situation, product or commodity involved;

information on pathways by which consumers are exposed to the hazard; possible

risks associated with that exposure; consumer perceptions of the risks; and the

distribution of possible risks among different segments of the population.

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Scientific opinion is a scientific output prepared by Scientific Panel(s) and

adopted/endorsed by the Scientific Committee. An Opinion comprises a generic or

applications-specific risk assessment or an evaluation of a risk assessment.

5. PROCEDURE DETAILS

5.1 Prioritisation of Risk Assessment Process

5.1.1 Request of Risk Assessment Output / Scientific Opinion

ASEAN Secretariat will call for risk assessment request from the Risk

Manager(s), in good time for consideration in the AEGFS meeting.

Before submitting the risk assessment requests, the Risk Manager(s) shall

ensure that:

o The form of Proposal for Risk Assessment Request in Food Safety for

ASEAN Risk Assessment Centre for Food Safety (ARAC) has to be

completed. The form is in the Annex II.

o Additional available information should be provided:

Statistic report on the consumer health problem in AMSs;

Volume of production and consumption in AMSs;

Regulations of such hazard / commodity in AMSs;

Regulatory Monitoring / surveillance program/data in AMSs;

Scientific peer-reviewed publications, international scientific committees

such as JECFA, JMPR and JEMRA, international programs such as the

WHO Global Environment Monitoring System (GEMS/Food); the Joint

FAO/WHO International Food Safety Authorities Network (INFOSAN) and

other reliable rapid alert systems, and industry self-monitoring programs.

All requests shall be submitted to the AEGFS, through the ARAC Secretariat

with a copy to ASEAN Secretariat.

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AEGFS and ARAC Secretariat will coordinate the requests of risk assessment

which met the requirements needed for prioritisation of risk assessment.

5.1.2 Evaluation and Prioritisation of Risk Assessment Request

ARAC Secretariat will support and facilitate AEGFS to verify the completeness

of Proposal for Risk Assessment Request on Food Safety for ASEAN Risk

Assessment Centre (ARAC) for prioritisation purposes by AEGFS.

If the information in the proposal is incomplete, the ARAC Secretariat will

request the requesting Risk Manager for further information / clarification.

AEGFS acting as a governing body shall:

o Evaluate the Proposal for Risk Assessment Request in Food Safety for

ASEAN Risk Assessment Centre (ARAC) submitted by the Risk Manager(s);

o Consider the availability of the scientific information related to hazard for

conducting the risk assessment;

o Prioritise the risk assessment based on the information provided in proposal,

in order to establish the priority list for risk assessment;

o Report the result of evaluation and prioritisation of the risk assessment work

with rationale to the requesting risk manager via Chair of AEGFS; and

o Take into account the protection of confidential information and transparency

approach during the process of evaluation and prioritisation of the risk

assessment work.

5.1.3 Establishment of the Priority List for Risk Assessment

After evaluation and prioritisation of the risk assessment request, AEGFS shall

establish the priority list for risk assessment.

The priority list for risk assessment shall be updated by AEGFS and published

to Risk Manager(s) and AMSs.

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5.2 Commissioning of Risk Assessment Process

After prioritisation of risk assessment request, AEGFS will commission

Scientific Committee, under ARAC to conduct risk assessment. Scientific

Committee shall work consistently with the Standard Operating Procedure for

Scientific Committee of ARAC.

Scientific Committee, under the ARAC will review the work in terms of its clarity

and expected scientific output. Based on this review, the Scientific Committee

will identify and allocate the expertise required for the convening of the

Scientific Panel(s), with the assistance from the ARAC Secretariat, to carry out

the risk assessment work. The Scientific Panel(s) shall comply with the

Standard Operating Procedure for Scientific Panels of ARAC.

ARAC Secretariat will facilitate the work of Scientific Committee and Scientific

Panel(s).

The requesting Risk Manager can request for risk assessment output / scientific

opinion to be reviewed and/or revised from time to time based on new available

information or data. The request with complete new information or data can be

made through ARAC Secretariat with a copy to ASEAN Secretariat.

5.3 Summary of the Prioritisation and Commissioning of Risk Assessment

Process

The summary of prioritisation and commissioning of risk assessment process is

presented as below:

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Responsible body Step Input/output

Risk Manager(s) Request of risk

assessment output

/Scientific opinion

Proposal for Risk

Assessment Request on

Food Safety for ASEAN Risk

Assessment Centre for Food

Safety (ARAC)

Submit the proposal

ARAC Secretariat

copy to ASEAN

Secretariat

Receive and verify the

completeness of the

proposal

In case of incompleteness of

the proposal, request more

information from Risk

Manager(s)

AEGFS Receive the complete

proposal

Evaluation and

Prioritisation of the risk

assessment based on the

proposal

Result of the Evaluation

and Prioritisation

No

Report with rationale

submitted to Risk

Manager(s) via ASEAN

Secretariat

AEGFS

SC/SP

- SOP of Scientific

Committee

- SOP of Scientific Panels

Priority list for risk

assessment

Rejection

Commissioning of

risk assessment

Yes

Yes

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6. REFERENCES

Codex Alimentarius Commission Procedural Manual 21st Edition. World Health

Organisation Food and Agriculture Organisation of the United Nations. Rome 2013.

Food Safety Risk Analysis: A Guide for national Food Safety Authorities. FAO Food

and Nutrition Paper No 87. Rome 2006.

Guidelines on the Application of Risk Assessment for Feed (CAC/GL 80-2013).

2013.

S.B. Dennis and the FDA CFSAN.Prioritizing Food Safety Risk Assessments: A New

Approach. Risk Analysis Working Group. http://www.foodsafetymagazine.com/

Sherri B. Dennis. Risk Ranking and Risk Prioritization Tools. Workshop on Produce

Safety in Schools.FDA/CFSAN/OFDCER/RACT. October 28, 2009.

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7. ANNEXES

Annex 1: Term of Reference

ASEAN Expert Group on Food Safety (AEGFS)

i. Coordinate all requesting proposal for risk assessment / scientific opinion

from risk manager / requesting bodies through ASEAN Secretariat

ii. Establish risk management goal in order to decide whether a risk

assessment is necessary

iii. Prioritise risk assessment work based on request

iv. Establish risk assessment question for selected risk assessment work

v. Commission ARAC to conduct risk assessment

ARAC Secretariat

i) Facilitate the ASEAN Secretariat and AEGFS in order to commission risk

assessment in ASEAN

ii) Deliver risk management question to the Scientific Committee and

Scientific Panel to conduct risk assessment

ASEAN Secretariat

i) Circulate letter requesting proposal for risk assessment / scientific opinion

to all risk manager / requesting bodies prior to AEGFS Meeting

ii) Facilitate AEGFS and ARAC in order to commission risk assessment in

ASEAN

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Annex II: Proposal for Risk Assessment Request on Food Safety for ASEAN

Risk Assessment Centre for Food Safety (ARAC)

Email to: ARAC Secretariat (arac@moh.gov.my) with a copy to ASEAN Secretariat

(micheal.glen@asean.org), the Chair and vice chair of AEGFS.

1. Information on the Risk Manager (requesting body)

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

2. Purpose and Scope of the Proposed Risk Assessment Request

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

3. Relevance and Timeliness (Urgency)

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

4. Main Aspects to be Covered (Risk Management Question)

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

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5. Assessment against the Criteria for the Establishment of Risk Assessment

Request Priorities

This proposal for new work is consistent with the following criteria applicable

to the products:

a. Consumer protection from the point of view of health, food safety

including concentration data, ensuring fair practices in the food trade in

ASEAN and taking into account the identified needs of developing

countries

________________________________________________________

________________________________________________________

________________________________________________________

________________________________________________________

b. Volume of production and consumption in individual countries, and

volume and pattern of trade between countries

________________________________________________________

________________________________________________________

________________________________________________________

________________________________________________________

c. Diversification of national legislation and apparent resultant or potential

impediments to international trade

________________________________________________________

________________________________________________________

________________________________________________________

________________________________________________________

d. International or regional market potential

________________________________________________________

________________________________________________________

________________________________________________________

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e. Coverage of the main consumer protection and trade issues by existing

or proposed general standards

________________________________________________________

________________________________________________________

________________________________________________________

________________________________________________________

f. Work already undertaken by other international organisations in this

field and/or suggested by the relevant international intergovernmental

body(ies)

________________________________________________________

________________________________________________________

________________________________________________________

________________________________________________________

g. Impact of the risk assessment result to achieve ASEAN Community

(Economic and Socio-Social parts)

________________________________________________________

________________________________________________________

________________________________________________________

________________________________________________________

6. Proposed timeline for completion of the Risk Assessment Request

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

7. List of relevant documents

7.1 Risk Profile

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______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

7.2 Others

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

Date/time request form received: ________________________

Date/time all information received: _______________________

Note: Risk manager requesting the risk assessment commits to provide supporting

data for review in response to the Scientific Committee and/or Scientific Panel(s)

“data call-in”.