Product Stewardship founded in risk evaluation

The basis of a product stewardship program is a structured evaluation of the safety, risk and benefit profile of a product or portfolio. Ag Engagement Lab will facilitate this through:

A review of available data about the product or portfolio. This will include studies and input from those with the most in depth knowledge of the product.

Using our Product Stewardship Risk Evaluation & Mitigation tool, we work with your team to evaluate the risks in 9 different risk domains and determine those that are most significant.

Identify actions to mitigate risks and maximise opportunities for the elements identified as medium or high risk.

You then have the option of feeding the results of the Risk Evaluation & Mitigation into our Engagement Framework to define the farmer/product user facing elements of the Product Stewardship program.

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Frequently asked questions

Is the product stewardship risk evaluation just duplicating the regulatory risk assessment?

No. A stewardship risk evaluation starts where the regulatory risk assessment stops.

Regulatory risk assessments are completed to support pesticide registration decisions and periodic reviews. Their aim is to demonstrate, before a product goes on the market, that its use will stay within limits set by law.

The assessments assume that products will be used as specified, as reflected in approved label instructions and conditions of use. They draw on study data submitted by the registrant, together with exposure modelling. They also set the conditions under which a product may be used, such as label directions, maximum residue limits and re-entry intervals.

The stewardship risk evaluation uses these risk assessments and the studies behind them as an input, and moves beyond them. It does not revisit the regulator's safety conclusions. Instead, it asks whether the conditions those conclusions depend on hold in practice. That means looking at specific markets and market segments, and at how a product is typically moved, stored, used and disposed of. For example, a regulatory assessment may assume that operators wear chemical-resistant gloves when mixing a product. A stewardship risk evaluation asks whether suitable gloves are available, affordable and actually worn in that market.

Regulatory risk assessments focus on human health and the environment, and also require evidence of efficacy or value. Australia adds an explicit trade test. Stewardship risk evaluations take the regulator's conclusions as their starting point and cover a broader set of risks. Ag Engagement Lab's Solution Risk Assessment & Mitigation (SRAM) framework examines nine risk domains:

  • human health

  • environment and ecosystems

  • biology, efficacy and climate

  • application and handling

  • regulatory pathways

  • supply chain integrity

  • trade barriers

  • packaging

  • economic and reputational risks

Several of these sit largely outside a registration assessment, including supply chain integrity, packaging, residue requirements in export markets and supplier reputation. Stewardship risk evaluations also account for commercial considerations, such as optimization of on-farm value, product lifespan and how well registration conditions are followed in practice.

How long does a product stewardship risk evaluation take?

For a registered product already on the market, usually two to three weeks from kick-off to a completed evaluation. That covers preparation, a three hour workshop and a written output within a week of the workshop.

Most of the preparation sits with us. We populate the SRAM tool with what's already known about the product, so the workshop time goes into working through the risks and agreeing which ones are important, rather than gathering information.

What we need from you is the right people in the room, usually regulatory, commercial, technical and supply chain, and access beforehand to the registration documents, label, safety data sheet, and information on the markets and uses in question.

The evaluation is designed to be revisited. Risks change as a product moves into new markets or as use patterns shift, so the evaluation is updated rather than redone.

For new innovations, the evaluation is best run at each stage gate or decision point in the development cycle. Each pass takes about the same time as an evaluation for an established product; the difference is that you run it several times. Run early, it can shape which studies you commission, what tweaks need to be made and how you engage the value chain, before that spend is committed.