Principles For Chemical Management Systems

In announcing our 2015 Product Safety Commitment goal, Dow has committed to publicly share its views on the principles on which product safety legislation or regulation should be based. This is consistent with our commitment to the principles of Responsible Care to lead in the development of responsible laws, regulations, standards, practices and procedures that safeguard the community, workplace and environment.

We believe that there needs to be a sufficient knowledge base to assess health, safety and environmental effects of chemicals and there is a need to assist users and governments in managing their risks. The provision of this knowledge base and continuous improvement in the safe use of chemicals is a shared responsibility among producers, distributors, users, and other stakeholders at each stage of the supply chain, and there is a legitimate role for government regulation.

We recognize that regulatory systems vary by country. As governments select specific legislative or regulatory approaches to product safety or chemical control policies, we believe that certain principles should be adhered to, and we present them here. We will base our behavior on these principles, and they will guide our interactions with others in the supply chain, as well as shape our advocacy with governments and other external stakeholders.

PROPOSED OBJECTIVES: The proper implementation of a chemical management system should enable the safe management of chemicals, while maintaining the benefits for society associated with the use of chemical products and ensuring a competitive industry.

1.  Assure that public health and the environment are protected from unreasonable risk resulting from exposure to chemicals through the application of appropriate risk management measures
2.  Assure that the risks of chemical manufacture, distribution, use, disposal and recycle are adequately characterized and managed
3.  Apply appropriate chemical control management systems that meet the needs for health and environmental protection while sustaining a global competitive chemical industry
4.  Increase public confidence about the safety of chemicals
5.  Provide timely responses to public concerns about chemical risks

1.  PRINCIPLE: A chemical management system must be RISK-BASED.

Risk-based approaches consider both the intrinsic hazard of a substance, as well as the potential for exposure and the implementation of appropriate risk management strategies to reduce or control exposure. Regulatory approaches based solely on hazard or exposure are overly conservative and may lead to the loss of beneficial chemicals. Risk-based approaches would allow continued safe use of some high hazard chemicals, as long as their applications and uses are controlled to restrict or prevent exposure.

1.1.  Decisions must be based on a consistent scientific evaluation of risk.
1.2.  Chemicals should be managed so that they do not pose significant adverse risk.
1.3.  All segments of the population at risk should be considered when implementing risk management strategies.
1.4.  Assessment decisions should be made in a timely fashion.
1.5.  Cost/benefit analysis should have a key role in risk management decisions.
 
1.5.1.  Substitution, if warranted, should be considered after a comparison of substances based on performance, health, environmental and socio-economic aspects in the relevant applications.
 
1.5.2.  Precautionary action to protect human health and the environment, as set out in Principle 15 of the Rio Declaration on Environment and Development, and as amended at Johannesburg and agreed at Dubai, should be proportional to the objective being pursued, provisional, and the least burdensome option to provide adequate protection from the risk.

2.  PRINCIPLE:  The system should SCREEN all chemicals (new and existing) to determine further information needs in a TIERED, risk-based approach.

An approach that focuses on initial screening for all chemicals and a tiered approach to additional information needs will allow the development of necessary and appropriate risk (hazard and exposure) information in a way that informs risk management actions and conserves resources.

2.1.  The system should provide a basis for quickly and efficiently screening chemicals to evaluate the need for further hazard or exposure information to reduce uncertainty and improve risk characterizations.
2.2.  Decisions on whether chemicals need further evaluation or additional information gathering/generation must be based on a set of defined criteria that are based on a firm scientific foundation.
2.3.  Chemicals and other products of innovation in the development stage may initially require less comprehensive information packages (due to low volume, sophisticated users, more limited end uses, fewer users) but should be subject to appropriate controls to reduce the chance for human exposure and environmental release.
2.4.  Chemicals that have strict controls and have limited exposure and environmental release potential (e.g., intermediates in a chemical process) or limited potential to enter commerce may require information packages tailored to their potential for human exposure or environmental release.
2.5.  Waste streams should have information packages tailored to the regulatory regimes under which they would be handled.
2.6.  There should be a clear communication of the results, rankings, priorities and uncertainties associated with chemical screening categorizations.
2.7.  Chemicals already regulated by government agencies should have information packages tailored to meet the regulatory regimes under which they would be handled.


3.  PRINCIPLE: The system should initially leverage AVAILABLE INFORMATION

An approach that encourages the identification and use of available information prior to initiating new testing will conserve resources, appropriately inform the design and execution of new testing, and help reduce animal use.

3.1.  All valid information should be used (including data from manufacturers and users) in chemical management decisions in a weight-of-the-evidence approach.
3.2.  There should be a systematic gathering of available valid hazard and exposure information to be used in chemical management decisions. This includes utilizing information gathered on similar chemicals though the use of validated non-animal test methods, computer modeling and/or quantitative structure-activity relationship (QSAR) activities.
  3.2.1.  If new information generation is unavoidable, an effort should be made to minimize animal testing where other accepted valid study methods will provide the same answer and level of confidence.

4.  PRINCIPLE: The system should recognize the SHARED RESPONSIBILITIES of each party within the VALUE CHAIN

All producers and downstream users, in addition to regulatory authorities, have a role to play in ensuring the safe management of chemicals.

4.1.  There should be a transparent flow of relevant and necessary information along the chain of commerce, so that manufacturers and users can evaluate and manage risks, and provide meaningful and relevant information to their respective stakeholders.
4.2.  There should be a cooperative effort among producers, distributors and users of chemicals (e.g., appropriate data sharing/data compensation system) that ensures that data and information necessary in chemical risk characterization are developed, shared as appropriate, and applied.
4.3.  The framework should provide incentives that encourage producers, distributors and users to take voluntary measures that further promote the safe use of chemical products.
4.4.  If any party within the value chain identifies improper practices involving a product, it should work to improve those practices and, if, in the party’s independent judgment, improvement is not evident, then the party should take further measures up to and including termination of product sale or use.
4.5.  There should be industry, non-governmental organization and governmental support for the development of risk assessment and risk management capabilities in jurisdictions that need to build their chemicals management framework to support the protection of human health and environment and the development of their economies based on the principles for the safe management of chemicals.

5.  PRINCIPLE: The system should promote TRANSPARENCY

Information is essential to assist chemical users in making sound decisions about the safe management of chemicals. Government agencies and chemical manufacturers should ensure that their processes for conducting risk assessments are transparent.

5.1.  Information that is used to make a determination of risk should be made accessible to the public.
  5.1.1.  Details that implicate proprietary interests, such as certain information on the ingredients in a product, should be protected as confidential business information.
  5.1.2.  The framework should develop and support means to share information with other governments, while protecting legitimate business interests in proprietary information.
  5.1.3.  If the information that is used to make a determination of risk is of commercial value, provisions should be made for protecting the commercial interest while ensuring public access to the information.
  5.1.4.  Companies that invest in the conduct of chemical, physical property or health and environmental safety testing should received compensation from other companies who choose not to participate in such studies, but wish to use the data generated. Health and safety information such as would appear on anMSDS should be make publicly available.
5.2.  There should be public access to information sufficient to allow downstream chemical users, consumers, or the public to evaluate the risk appropriate to their uses of chemicals and to take proper risk management actions.
5.3.  There should be appropriate opportunities for public input and feedback.

 

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