RISK ASSESSMENT AND MONITORING FOR ENVIRONMENTAL

CHEMICALS-JAPAN GROUP TRAINING COURSE

MID-COURSE REPORT PRESENTATION

ZEPHANIA.O.OUMA-KENYA

1. My expected Achievements (Expectations)

in this training course

Expected Achievements/Expectations-1

• Understanding the concept of Risk Assessment-Risk Management and its application in Regulatory decision making

• Gain knowledge on sampling and monitoring techniques of pesticides and environmental chemicals in the environmental media

Expected Achievements/Expectations-2

• Acquire knowledge on other applicable Risk Management approaches critical to Risk Reduction

• Gain knowledge in explaining Risk-Based decisions so that the Regulatory Authority can demonstrate confident of wisdom of decision and to be able to articulate the sufficiently sound technical and policy issues to the public, interested and affected parties and to the courtroom.

2. What have I achieved so far?

An evaluation of my achievement

(2a) Understanding the concept of Risk Assessment-Hazard, Risk and Safety

• Hazard-determining the dangerous and harmful factor (toxicity) or anything that has a known potential to cause damage to life, property and/or the environment.

• The Hazard of a particular material or installation is constant or an intrinsic property; that is it would present the same hazard wherever it was.

• Risk is the probability of harm (health effect) or the likelihood of a significant impact.

• Safety is a condition of low risk in which the risk level is adequately protective.

• No risk is not practicable, however we should strive to seek less and less risk (more and more safety)

Risk=Hazard x Exposure

Exposure: time x concentration

If exposure is 0, risk is 0 (mathematically) even if

Hazard is very high

If exposure is high, risk might be High even if the hazard is low

The critical need to move from Hazard (toxicity) based Assessment

to Risk Based Assessment

(2a)From exposure to dose; dose to toxic effect: Dose-effect relationship

2. “All substances are poisons, there is none which is not poison.

The right dose differentiates a poison

from a remedy”-Paracelsus, a Swiss Physician 1493-1541

“Good for health but Bad for health, depending on the amount”-Yashuhiro YOGO

NIAES, Japan on May 29th 2007

(2a)-Risk Assessment-Definition

1.“Analytical framework to organize, evaluate and characterize available knowledge and its associated uncertainties regarding the nature and magnitude of threats to human health arising from the environment, including both the natural world and every type of human influence on it so as to guide policy decisions regarding the need to take actions to control or eliminate these threats so that human health is adequately protected”.

2. “scientific characterization of potential adverse effects of a chemical resulting from exposure”

Risk Assessment (RA)

• Description of potential adverse health effects based on evaluation of results of epidemiologic, clinical, toxicological and environmental research.

• Extrapolation of results to predict the type and estimate the extent of number and characteristics of persons exposed at various intensities and duration.

• Characterization of the uncertainties inherent in the process of inferring risk. Incorporation of uncertainty and safety factor into the risk assessment findings.

• Requirement for strict adherence to Good Laboratory Practice Guidelines/Regulations to avoid discrepancies.

• Manufactures burden to demonstrate safety and efficacy of a given chemical.

(2a)-Risk Management (RM)• Describes the process of evaluating

alternative regulatory actions and selecting among them-policy action

• RM is carried out by Regulatory agencies under various legislative mandates.

• Its an agency decision-making process that entails consideration of health, environmental, social estimation, economic estimation, policy judgment (political), engineering information and Risk-Benefit control.

• It requires the use of value judgment on issues such as acceptability of risk and the reasonableness of the cost of control

• Note that it is a trademark of environmentally enlightened corporations to also undertake their own management actions.

Risk

Benefit

“good things always bring bad things”RM is a balance or trade-off of Benefit

and Risk

(2a)-Risk Communication

• Risk communication to the Public, consumers and Interested parties on safety or risk of exposure to emissions and other products

• Securing opportunities to get the opinions of the citizens and the consumers

• Opportunity to address risk perception and provide public “Relief”.

• Role of Regulatory Authorities and the MEDIA• Role of the “close observers of the Regulatory scene”-

NGOs and other civil society groups.• Political involvement? Complicates the public perception

of Risk

Media and Risk Communication

• Media play a key role in disseminating well orchestrated scare campaigns; why? Sensational headlines sale!!

• The Regulatory Authority therefore has a critical role to communicate the real risk situation and feeding the media with the correct information

• A progress in building an informed public with more light being cast on contentious or poorly understood environmental issues and therefore less heat being generated

(2a)-Risk Assessment Framework

RESEARCH RISK ASSESSMENT RISK MGT

Epidemiological, clinical

and toxicologicalstudies

Data on levels of chemicals in the

environment and on rates of human contact with and

exposure to chemicals

Hazard identification

•What chemical?•What toxic effect?•What mechanism of toxic action?•Relevance to humans?

Dose response assessment

How does risk of toxic effect change with dose and exposure time?

Human exposure Assessment •What population?

•What doses and route of exposure?•Over what period of time?

Risk Characterization

•Risk to health?

•What is themagnitude?

•How well is it known?

Risk Management

•Are risk excessive?

•What are risk control options?

Risk- benefit analysis?

•What are the applicable legal standards?

•What is the optimal solution?

Reliance on epidemiological and

toxicological data available or liaise with concerned regulatory

body

Scientific uncertainties or lack of scientific

consensus? Default assumptions!!? Then adopt

“worst-case” exposure scenarios

•High degree of consistency•Systematic procedure

(2b)-Risk Assessment in compliance and Enforcement-

integrated management

Risk Assessment(Research & Dev-

Burden of manufacturers)

Risk Management(RegulatoryAuthorities)

Risk Communication(Regulatory

Authorities and the MEDIA) and Politicians?!

Integrated management

Determining the dangerous

or harmful factor

Making improving plans on the basis of the assessment and putting the improving plan

into practice

Communicate risk to the

public, consumers, affected and

interested parties

lack of integration-Asbestos example: Research had proved the carcinogenic risks of Asbestos in the early 70 but there was Lack of appropriate RM and RC this resulted in Disease, Death and Huge compensation

by the Governments

Monitoring, Compliancepromotion and

Enforcement Actions

Explaining adequacy of the Risk-basedDecisions to the

Public-

Strict Reliance on Scientific

and technical Information as a

guide

Risk Management (Education, advice,

Warnings and degree of Regulation)

(2c)-Approaches to Risk ManagementInputs from Risk Assessment, availability of cost effective risk control technology, a notice of judgment issued by country of

origin and development of screening guide for consistent

decision making

e.g. a) explaining to members of surrounding community why they need not fear the emissions from

a nearby manufacturing plant- technical and policy issues must

be sufficiently sound

Plant inspections and monitoring (sampling and analysis), GLP

laboratory inspections, Standards enforcement

(shutdowns, product recall etc) and court

procedures

b) Issuing of Cautionary notices by the Authority so

as to prevent further progress of environmental

pollution caused by the release of a product (case

of plastic bags)

2c. (i)-Sampling and Monitoring- an approach to Risk Management

2c. (ii) Environmental Monitoring-an approach to Risk Management

Portable Oil content analyzer (OCMA-

350)

2c. (iii) Multi water quality monitoring system

Portable Multi-water quality monitoring system-U-20XD Series with a multi probe with in-built sensors for about 10 parameters and optional sensors for

the common nutrients and metals

pH,,DO, TDS, Temp,Turb.,Cond,

Salinity,Depth,

2c (iv) .Inspection-an approach to Risk Management

Portable Motor Exhaust Gas

Analyzer(MEXA-324L)-CO, HC, NOx, PM

2c. (v) GLP Inspections-an approach to Risk Management

• GLP is a standard guideline that define conditions under which a safety test should be planned, conducted, monitored, reported and archived issued by OECD. This is critical for mutual acceptance of data/test results

• Adoption of new, improved and high sensitivity analytical techniques and setting up of Quality Control unit in the Laboratory.

• Highly technical and adequate staffing• Attempts to adopt Clean Analysis (avoid analytical

methods using toxic chemicals or materials)• Government inspection of the Laboratory at regular

interval e.g. Adoption of periodic experimental proficiency test programme for the accredited laboratories.

Elements of GLP-Technical expertise, adequate staff and state of the art and clean technology

Experimental proficiency Test Programme was carried out for 8 accredited laboratories in Japan (6 food inspection Labs and 2 quarantine stations).

Total performance in the 5-Round external proficiency test is shown below

No. of correctly detected pesticides

Laboratories

A B C D E F G HRound 1(10 Pesticides were added to sample)

Round 2 (10 Pesticides were added to sample)

Round 3 (13 Pesticides were added to sample)

Round 4(14 Pesticides were added to sample)

Round 1(2 Pesticides were added to sample)

8 6 9 8 8 10 10 10

5 8 10 5 10 10 10 9

7 11 13 8 11 13 12 13

11 11 14 9 12 14 14 14

1 2 2 2 2 2 2 2

It has been shown that there is a great difference in the ability of laboratories to screen multi residual pesticides due differences in Technical experts, number of technicians and equipments/machines and therefore the necessity to adhere to periodic GLP inspections

2c. (vi) Development of comprehensive Chemical Risk Information Platform (CHRIP) e.g., Screening

Information Data Sets (SIDS) of OECD-an approach to Risk Management

• Availability of toxicity evaluation data to guide on:

a) Safety to workers, distributors and field workers (acute toxicity data)

b) Safety to consumers-chronic toxicity (MRL, ADI)

c) Safety to the environment-ecotoxicity (pollution of surface and ground water, crops, soil, air and wildlife) and persistence of the chemical & metabolites in the environment (PNEC/PEC)

(2d)-Challenges to Risk Management

i. Risk Overestimationii. Risk Underestimationiii. Public perception (or anxiety) of risk-e.g. absence of

personal benefit contributes to the strange resistance of individuals to relatively small risks projects

iv. Media distortion of Risksv. POLITICAL interference and influencevi. The burden of providing evidence that individuals have

been exposed to harmful substances, and that they were exposed at sufficiently high level, for a sufficient period of time, to make it “more likely to be true than not true” that the injury or disease they have was caused by the particular exposure

3. List of interesting and beneficial subjects

• Risk Assessment of Pesticides and other chemicals for Human Health by N. Umetsu

• Ecological Risk Assessment of Environmental Contaminants by Masaru Nokata

• Pesticides Residue and Positive List System by HPTCAFF

• Introduction to Risk Assessment and Monitoring for Environmental Chemicals

• Japan’s effort to Reduce Environmental Emissions by Akira Hasegawa

• Environmental Toxicology-Science based Risk Assessment of Environmental Chemicals

• Waste Management System By T. Okazaki

List of interesting and beneficial subjects

• Safety Evaluation of Chemical Substances By Shigeki Miyachi

• Mechanism of Dioxin toxicity by H. Ashida• Occupational Diseases due to Chemical Substances and

Hazard Assessment in Occupational Health By Kawai Toshio

• Practical Operation of the Chemical Substance Control Law By Yohei Ohnishi

• Remediation and Bioremediation Technologies for Soil and Groundwater in Japan By Kazuhiro Iwasaki

• Project Cycle Management Method

4. List of further subjects to be followed-up in the second half

• Risk Assessment and the Courtroom. This lecture should give case studies regarding the nature of reliable scientific evidence and admissibility of scientific evidence and management decisions in courtroom proceedings.

5. THEME OF MY ACTION PLANDEVELOPMENT OF COMPREHENSIVE INSPECTION SYSTEM

FOR THE NATIONAL ENVIRONMENT MANAGEMENT AUTHORITYAS KEY TO EFFECTIVE ENVIRONMENTAL RISK MANAGEMENT

IN KENYA(AS MANDATED UNDER PART X-INSPECTION, ANALYSIS

AND RECORDS OF ENVIRONMENTAL MANAGEMENT AND COORDINATION ACT, 1999)

Development of Inspection Manual

Development/adoption of

Chemical Risk Information Platformto guide on toxicity

evaluation of chemicals

Requisition of Sampling, inspection,

on-site monitoring Equipments and Establishment of

Preparatory Laboratory

AppropriateTraining for

environmentalInspectors

A look aheadSignificant degree of worldwide

Movement to adopt the Risk AssessmentFramework as critical measure to manage

Risks

DOMO ARIGATOO GOZAIMASHITA