Environmental aspects in a Stage-Gate® model for the chemical industry

Develop Gate criteria

There are six Stages and five Gates in the Stage-Gate® procedure used by Akzo Nobel Surfactants Europe and Akzo Nobel Ethylene Amines. The Stages and Gates in this procedure are presented below.

The project team develops criteria and appoints Gate keepers for each gate. In this example we focus on the Health, Safety and Environmental criteria.

Meeting the gate criteria

It is not always obvious how to meet the gate criteria. People with different competences are needed and different tools have to be used. The project manager have to consult people with specific competences within health, safety or environment. Guidelines on how to tackle this are useful to ensure the fulfilment of the criteria.

Three different environmental competences are useful to involve in the project and they are referred to in the examples below, namely:

1. A person working with the laws and regulations connected to HSE matters, such as transportation, storage, handling, Safety Data Sheets etc. (referred to as RA specialist). Sometimes a Safety engineer may also be needed.
2. A toxicologist and eco-toxicologist working with the human health and environmental effects of chemicals (hence referred to as toxicologist).
3. A person working with Product Stewardship or Life Cycle Assessment thereby looking at the whole life cycle of the product and taking into account resource use, air and water emissions, energy use and wastes (hence referred to as LCA specialist).

HSE criteria used in product development

The examples of Gate criteria presented below are used by Akzo Nobel Surface Chemistry, Surfactants Europe in their product development projects. Examples of how the project manager can tackle the Gate criteria are also described.

GATE 1

Criteria	Competence and comments
Has a search for toxicological and/or eco-toxicological properties been made?	Consult a toxicologist or RA specialist. Data are available e.g. from the European Chemicals Bureau at http://ecb.jrc.it/esis/ or at other free or commercial databases. Examples of databases on the internet is available at http://meso.spawar.navy.mil/toxicity.html
In case of new chemicals: are safety data sheets (SDS) available for these chemicals?	Consult an RA specialist. SDS are available from ESIS, mentioned above, and from the supplier of the chemical.
Are the perceived health and/or environmental risks high?	This question is very subjective and every person will give a different answer. It may therefore be advantageous to consult a toxicologist as well as an LCA specialist in order to get an overall view of the health and environmental risks. Examples of things to consider on a screening level: - Are any scarce resources used? - Are the risks for accidents high within the production, during handling or during transportation? - Is the energy consumption high compared to other chemical products? Compare to products delivering the same function if possible. - Is the product or the constituents carcinogenic/mutagenic, reprotoxic, toxic, persistent or bioaccumulating? If it is carcinogenic/mutagenic or detrimental to reproduction it may be very expensive and time consuming, if not impossible, to put on the market. A persistent chemical may also have difficulties depending on the application. If the chemical is bioaccumulating or toxic the risks may need to be strictly managed based on the Risk Assessment to be conducted later in the project.
Has a literature search on product safety characteristics been made?	Consult a RA-specialist.

GATE 2

Criteria	Competence and comments
Have any toxicity and/or eco-toxicity issues been identified and will testing be required?	A toxicologist have to be consulted in order to interpret the gathered information on toxicological or eco-toxicological properties. Issues may include: - high toxicity (rats, fish, daphnia, algae or microorganisms) - carcinogenicity or mutagenicity - persistent or not biodegradable - bioaccumulating - widespread use by or high exposure to man or the environment Consult the RA-specialist about what the authorities require. General guidance on the completion of a Base set notification can be found at the European Chemicals Bureau and in the SNIF Guidance. Consult the marketing manager on whether there are any demands from the market on the environmental performance or the risks to human health of the product. Such demands can imply that certain tests may be advantageous to conduct from a competitive point of view.
May renewable raw materials be used?	Research and Development and Manufacturing. The raw material alternatives may be investigated by the LCA specialist, whether they are renewable or not, in order to find the best alternative from an environmental point of view. Information about LCA is available here.
How will the product lead to an environmental improvement compared to existing alternatives?	Marketing and Research and Development can be consulted about the alternatives on the market and a toxicologist and an LCA specialist about the impact on health, safety and the environment of these alternatives. Examples of things to compare are presented in the third criteria in Gate 1 (the question about environmental risks). The LCALight tool can also be used to make a quick comparison from a life cycle perspective.
Have any safety issues been identified? If so, specify.	An RA specialist or Safety engineer will have to go through all of the handling, production and transportation of the product in order to give an opinion on the safety. Examples of things to consider: - risks of explosion or fire - risks during storage - risks during transportation - risks for malfunction in production, packaging or filling - new hazardous materials are introduced

GATE 3

Criteria	Competence and comments
Have initial toxicity and eco-toxicity studies been conducted?	Consult a toxicologist or a Contract Research Organisation (CRO) directly for making toxicity tests. This task may be co-ordinated with other tests that have to be made in order to fulfil the base set for notification.
Have a human and environmental risk assessment been started?	Consult a toxicologist. It may be beneficial to try to find risk assessments on similar chemicals first. Information about risk assessments being conducted in the EU is available in European chemical Substances Information System (ESIS). General information about Environmental Risk Assessment can be found here. The project manager may have to discuss the objectives and budget for the assessment with the risk assessment practitioner.
Has a base set notification been started?	Have all of the data needed for a Base set notification been collected and the Competent Authority contacted? A toxicologist can be appointed the responsibility to complete a base set notification. General guidance can be found at the European Chemicals Bureau and in the SNIF Guidance.
Have all the aspects of future environmental taxes, regulations and consumer demands linked to the product life cycle been considered?	An LCA expert in co-operation with marketing and maybe even a company lawyer may be needed to answer this complex question. The LCA expert can point to environmental concerns linked to the life cycle of the product and the marketer and lawyer may know whether there is a risk of taxes or regulations connected to these concerns. Marketing  may also know of any consumer demands concerning environmental performance. These demands may have arisen during testing the fit of the product with the market in Stage 2.

GATE 4

Criteria	Competence and comments
Have final risk assessments for human health and environment been completed?	Is there a need for further risk reduction measures? Can these be overcome by a refined risk assessment for certain applications, by further testing or by labelling, worker protection, information to customers or other low cost measures?
Is the base set notification completed?	Have a base set notification been completed and sent to the Competent Authority?
Have a review of the environmental aspects covering the whole life cycle of the product been performed?	A screening LCA may be performed by the LCA expert in order to find possible environmental hot spots in the life cycle and their relative importance. Here is more information about LCA and tools that can be used.
Have all safety issues been resolved?	These can be resolved e.g. through plans for information, safety routines, protection and training.

GATE 5

Criteria	Competence and comments
Has a reassessment of the risks been made?	Have all of the issues that have been found throughout the project been dealt with? Are there questions or comments from the Competent Authorities on the base set notification that need to be dealt with? The toxicologist can go through all of the available information that has been gathered throughout the project concerning risks to human health or the environment and decide whether there are any issues of concern left.
Is any further testing warranted?	Are there questions or comments from the Competent Authority on the base set notification that need to be dealt with?
Is any further environmental risk assessment monitoring required?	Do the Competent Authority require any additional monitoring based on the notification?

There is also a simplified version of the Stage-Gate® model used by Surfactants Europe, which is intended for smaller projects. Most of the HSE criteria above are also included in this version, but the analyses and assessments are not conducted to the same depth of detail.

Environmental criteria used in process development

Described below are examples of how the project manager can tackle the Gate criteria used by Akzo Nobel subsidiary Ethylene Amines in their process development projects. These criteria are to be met in Gate 2 - Project initiation.

There is often only one person responsible for HSE issues, called HSE manager, which is referred to below. The Safety engineer mentioned is a person responsible for safety issues at the production site and the Site manager is the person responsible for the whole operation of the site.

Experiences

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