The Canadian Chemical Producers' Association Codes of Practice: Research and Development

Purpose

The member companies of the Canadian Chemical Producers' Association (CCPA) are committed, as a condition of membership, to the policy of "Responsible Care". This code governs member company actions in meeting the guiding principles of that policy as they relate to all aspects of the research and development, and initial use of new chemicals, chemical products, processes and equipment, as well as the development of new applications for existing chemicals and chemical products.

"Research and development" means technical work of an investigative nature which occurs at all stages of development of new chemicals, chemical products, processes, equipment and uses. It extends from initial approval of scientific research, through experimental development to the first full-scale operation of the process, or production of the chemical or chemical product and its introduction to the market. It is equally applicable when some of the stages are omitted; for example, experimental process change or development done on a full-scale plant, which is often not categorized as research.

Practice of this code is intended to result in:

* the protection of people and the environment through responsible management of all research and development operations, and the introduction of new chemicals, chemical products, processes, equipment and uses that minimize risk to people and the environment;
* the assurance that the management systems necessary for responsible research and development operations are in place and functioning effectively;
* public and employee confidence in research and development as a result of the effectiveness of the above.

Guiding Prinicples

The guiding principles of this code as they reflect those of the "Statement of Policy on Responsible Care" are:

i) make Responsible Care an early and integral part of the planning process leading to new chemicals, chemical products, processes, equipment or uses;
ii) increase the understanding of the hazards and associated risks of existing chemicals, chemical products, processes, equipment and their uses, and ensure that a thorough level of understanding of new chemicals, chemical products, processes, equipment and their uses and their potential hazards is achieved prior to and throughout commercial development;
iii) manage research and development operations in a manner which protects people and the environment from hazards;
iv) provide information about the hazards and associated risks of new chemicals, chemical products, processes and uses to customers, enabling them to use these and manage associated wastes in a responsible manner;
v) provide information about the hazards and associated risks of research and development operations to employees and other people on site, to contract laboratories, and to those in the community who have an interest;
vi) know the laws and regulations applicable to research and development, and meet or exceed them in letter and in spirit;
vii) be sensitive and responsive to community concerns about research and development operations;
viii) work actively to assist governments in developing public policies, legislation and regulations governing research and development operations.

Code of Practice

1. General
Each member company shall have written policies, and protocols and methodologies which govern all aspects of the research and development of new chemicals, chemical products, process, equipment and uses. Responsibility shall be clearly defined for generating, implementing, auditing and updating them, and for taking corrective action. These policies, protocols and methodologies shall meet or exceed all applicable laws and regulations in letter and in spirit.

Each member company shall have hiring standards and training criteria commensurate with responsible research and development requirements, take action to maintain employee competence and include code compliance in regular performance assessments.

The manager of a research and development site shall adhere to the requirements of the CAER code of practice.

Each member company shall site stand-alone facilities in a manner that conforms to the applicable requirements of section 3 of the manufacturing code of practice.

Each member company shall put in place security procedures and systems which protect the facilities and address possible security threats.

Each member company shall work actively, alone or through selected organizations, and, if possible, in consultation with other affected stakeholders, to assist governments in developing public policies, legislation and regulations governing research and development operations.

Each member company engaged in research and development agrees that responsibility and accountability for adhering to this code will be clearly assigned. Research and development operations will not occur unless they can be done in accordance with this code.

2. R&D Project Approval
Prior to initiating an R&D project, every member company conducting research and development of new chemicals and chemical products, processes, equipment or applications shall require that:

2.1 protocols and methodology are in place to ensure that health, safety and environmental hazards are identified and evaluated as early as possible, and standards for operations are defined. This procedure applies not only to the research phase but also to pilot plant operations, manufacturing and marketing as they progress. Particular attention is given early to long-term health and environmental effects related to chemicals, chemical products, processes and new uses and the management of associated wastes;
2.2 periodic reviews and checkpoints are established which dictate project continuance or termination dependent on performance versus such standards;
2.3 potential applications are defined and analysed for hazards both initially and as work proceeds;
2.4 the above principles apply wherever the work is done, including plants or contract laboratories.

3. Good Laboratory Practice
Member companies undertaking product, process or application research and development, whether performed in-house or by contract laboratories, shall establish written policies and standards to ensure good laboratory practice. These shall cover:

3.1 general laboratory health and safety;
3.2 hazard identification and communication, including regular employee training and education;
3.3 proper management of laboratory waste;
3.4 documentation and reporting of results in a scientifically accurate and ethical manner;
3.5 preparation of a data package on every new chemical, chemical product, process and application which clearly identifies potential hazards, including those of associated wastes.

Laboratory practice shall be audited and updated on a regular basis.

4. Transfer to Manufacturing
Every member company transferring a new chemical or chemical product, a new process or new equipment from research and development to manufacturing shall ensure that:

4.1 hazard and operability studies, or their equivalent, are an integral part of the design process;
4.2 standards for health and safety and environmental protection in the new process are clearly spelled out, and that it is the responsibility of the process design team to achieve them;
4.3 all operators are fully trained in the new or revised process before start-up, including procedures to be followed in an emergency;
4.4 material safety data sheets (MSDS) are available for all input, in-process and output materials, and proper procedures for packaging, handling and disposing of these materials, including by-products, are clearly identified;
4.5 the above principles are applied also to pilot or less-than-commercial scale plants, except that in this case certain standards, eg. those for durability of process equipment, may be less rigorous.

5. Market Introduction
Every member company introducing a new chemical, chemical product, process or application to the marketplace shall:

5.1 ensure that the requirements of all relevant legal and government regulations are met or exceeded in letter and in spirit;
5.2 educate employees and contract personnel to ensure responsible product handling and transportation;
5.3 provide potential customers with information about hazards and associated risks, and assistance to ensure responsible handling, use and waste management, including reduction/recycling/recovery/reuse opportunities where feasible;
5.4 subsequently check back to confirm that customers are following responsible handling, use and waste management practices. Each member company shall require, with due diligence, that customers follow responsible handling, use and waste management practice, if special requirements are determined to apply;
5.5 ensure that even for small-scale test marketing, the first three items in section 5 up to and including "waste management" in item three are in place before proceeding.

Typical Elapsed Time from Start

1. Coordinator appointed and aware of code requirements.

3 months

2. Management aware of code requirements.

6 months

3. Management assessment of action and resource needs completed.

12 months

4. Assessment results communicated to those who will be involved in planning and implementing action.

15 months

5. Plans developed.

18 months

6. Plans implemented.

36 months