RISK ASSOCIATED WITH PRODUCT

THE RISK CHARACTERIZATION PROCESS

Setting Priorities for Preparing Product Risk Characterizations

Below are factors to consider when categorizing chemicals as “high priority” for completing risk characterizations (and subsequently developing associated risk management recommendations). They should be applied in light of the circumstances of each individual company and region. This approach also provides companies flexibility so that they can make expert judgments about the appropriate criteria required for their product lines, based on the screening of relevant available hazard information as well as information on potential exposure and risk associated with the chemical and its use by the respective company and value chain. Companies can set their priorities from a comprehensive point of view, taking these factors and other business considerations into account.     

Primary Considerations For Categorizing Chemicals As “High Priority“

·         Chemicals with testing and/or risk evaluation work already completed or underway in response to current or impending regulatory scrutiny (e.g., Canadian DSL, EU Regulation of existing chemical substances, EU REACH); 

·         Categories of chemicals of particular concern under national or regional regulatory programs, such as those listed as known carcinogens, mutagens, or substances that are toxic to reproduction;

·         Chemicals listed as candidates under the Stockholm Convention (Persistent Organic Pollutants) or the Rotterdam Convention (Prior Informed Consent);

·         Chemicals restricted by other national or regional regulations or international conventions.

Other Relevant Factors That May Be Considered Include, But Are Not Limited To:

·         Whether the chemical could be classified as Persistent, Bioaccumulative and Toxic (PBT);

·         Whether and to what extent the chemical has potential for (significant) human exposure, especially when children and other sensitive subpopulations could be impacted.  For example, such chemicals might include those:

-        used in products used by children;

-        used in consumer products, medical devices, drugs or cosmetics, particularly where such products are not regulated under a separate legal regime;

·         Whether and to what extent the chemical has a potential for significant environmental exposure when these chemicals are not regulated under a specific regime;

·         Whether the chemical presents a significant acute hazard (e.g., highly flammable, corrosive, reactive, etc.);

·         Whether the chemical is a high production volume chemical (1,000 tons production per year);

·         Whether and to what extent the chemical is a focus of broader or increasing societal concern;

·         Whether there are attributes of the value chain for a particular chemical that could raise significant concern (e.g., customers are very numerous or generally lack sophistication and competency in managing chemicals, or they do not have adequate product stewardship practices in place);

·         Whether a company wants to make a chemical “high priority” for business or other purposes (e.g., a new product or an existing product in a new application).

Key Steps in Risk Characterization and Risk Management  

Gathering Product Information:

The first step is to gather available, relevant hazard and potential exposure information. This information is used to characterize risks that may occur during handling, transport and use.  The range of information sources can vary widely, including e.g., supplier (Material) Safety Data Sheets and labels, predefined regulatory criteria, and published reports. 

Relevant, available information on usage, hazard and exposure should be gathered to help understand the key health and environmental effects of the chemicals produced, distributed, used, recycled or disposed.  This includes hazard and possible exposure information adequate to conduct a product risk characterization. Such information may include:

·         Major components and/or impurities;

·         Physical and chemical characteristics;

·         Potential human health hazards;

·         Potential environmental hazards;

·         Uses, functions and applications of products;

·         Production volume ranges;

·         General descriptions of potential exposure pathways;

·         Potential misuses, as reasonably foreseeable, or as known from customers, consumers or authorities.

Sources of such information may include, although are not limited to:

·         (Material) Safety Data Sheets and labels for raw materials used to manufacture the product;

·         Dialogue with suppliers of raw materials;

·         Governmental regulatory/sources e.g. OECD/SIDS dossiers, ORATS (Online European Risk Assessment Tracking System);

·         Databases e.g. IRIS, ESIS (European Chemical Substance Information System);

·         Reference books. 

Chemical Definition—Identification of Chemical/Application

In the initial step, a company identifies its chemicals and their uses/applications in commerce.  Risk characterization results and risk management implementation may differ for the same chemical depending on its specific use/application. This provides a more flexible risk management approach in which actions to prevent or control risks should be tailored to an application rather than arbitrarily prescribed for a chemical in all applications.

Establish Knowledgebase

In the development of the knowledge base, existing relevant available information on the  chemical and its applications should be gathered. Items to consider may include:

·         Lifecycle;

·         Product characterization (including physicochemical properties);

·         Hazard and exposure information;

·         Current risk management/management measures;

·         Regulatory restrictions;

·         Public concern;

·         Identification of screening/priority-setting criteria (the criteria against which the outcomes of the risk characterization work will be measured.  There may be cases in which regulatory mandated criteria exist for certain endpoints).

Conduct Risk Characterization

Hazard Evaluation

Hazard is an intrinsic property of a chemical and can be assessed independent of its use or application. Hazard evaluation addresses the kinds of adverse health and environmental effects that have been observed, the level of certainty, the severity, the significance of the effect, and the quantitative relationship between exposure and effects (often expressed as “dose-response” curve).

Information may be derived from laboratory testing of physico-chemical, toxicological or   ecotoxicological properties, from data on similar chemicals, QSAR (Structure Activity Relationships), studies, literature, experience, etc.

Exposure Evaluation

Consider potential exposures to humans and the environment from the production, distribution, use, and disposal or recycling of a chemical.

Exposure is a determinant of chemical-induced human and ecological effects and is a key component of the risk characterization.  Exposure evaluation considers the magnitude, frequency, duration, and route of potential or actual human and environmental exposures.  It also considers the nature, size and constitution of the potentially exposed population.  Important factors in characterizing exposure include conditions of packaging, transportation, storage, use, reuse, and disposal. 

Information may be derived from known exposure categories or scenarios, workplace measurements, air and water sampling, etc.  

 

Is Information Sufficient to Complete a Risk Characterization?

This preliminary risk characterization should provide an understanding of the nature, magnitude and probability of a potential adverse health or environmental effect.  It should also include uncertainties associated with the exposure and hazard evaluations.  Additional risk characterization information may be obtained by comparing the chemical to a similar one. 

Results of the preliminary risk characterization should be weighed against the organization’s identified screening and/or priority criteria to determine if additional risk characterization is needed.  If so, resources should be directed first at those products or applications that had the highest risks identified through the preliminary characterization process. 

Decision Point

If there is sufficient information to complete a risk characterization, proceed to the Risk Management step under ‘DO’.

If there is insufficient information to complete a risk characterization, additional, relevant hazard or exposure information may be needed. This step should be repeated until you are satisfied that a meaningful product risk characterization can be undertaken.

 

Other Influences And Issues Affecting Product Stewardship Requirements 

·         Organization policies; 

·         Clear understanding (mapping) of the different value chains through which the organization’s chemicals pass;

·         Organization’s processes for procuring raw materials and marketing and selling its chemicals;    

·         Relevant technical standards;

·         Results of audits;

·         Constructive opinions and views of stakeholders which may include, but not be limited to, employee feedback, correspondence from the public or non-governmental environment organizations (NGOs), investors comments, requirements from customers, insurance audit reports and surveys and questionnaires.

Examples of Product Stewardship Practices And Possible Associated Internal Metrics

A.     Management – Setting Policies and Objectives and Planning

Practices

·         Written corporate policies that discuss the commitment of management to achieving the objectives of Responsible Care^®, including product stewardship, and the communication of those polices throughout the company;

·         Written corporate policies that address core values including a commitment to Responsible Care and product stewardship, and communication of those values in and outside the company;

·         A written set of objectives to be accomplished by the company under Responsible Care and product stewardship, as well as a plan to achieve those objectives;

·         An organizational infrastructure to achieve the objectives of product stewardship, i.e., employees that have product stewardship performance as part of their job responsibilities;

·         Involvement of high level management in the review and tracking of company performance toward implementation of Responsible Care and product stewardship.

Possible Internal Metrics or Milestones

·         Written corporate policies addressing a commitment to Responsible Care and product stewardship are in place;

·         Written objectives and plans for product stewardship implementation;

·         Company resources dedicated to implementing Responsible Care and product stewardship are in place;

·         A mechanism to track company performance toward implementing Responsible Care and product stewardship are in place.