Data Transparency FAQ

General Questions Around Safety Studies

1 What are safety studies?

Safety studies are specially designed experiments that allow regulatory scientists to assess the potential of a crop protection product to adversely affect humans, animals, non-target organisms (insects and plants that are not pests) or the environment (e.g. soil and water and the organisms that live in them).

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2 How are safety studies conducted?

Regulatory agencies from around the world have designed and validated a whole package of safety studies (more than 150 per chemical) that are required by law to be performed by companies that want to register a crop protection product. The studies are designed to test exposures over different lengths of time and at different concentrations. There are studies that test a large single dose to assess what happens in an accidental exposure or spill. The studies also test all routes of exposure: by mouth, on the skin and by inhalation. Other studies test low and high doses over longer periods of time (days to months to years) to assess exposure to workers and consumers, as well as to the environment (e.g. beneficial insects, birds, mammals, fish, earthworms, soil microorganisms and plants).

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3 What do safety studies tell us?

Safety studies tell us a lot about a chemical. These studies show us how the chemical interacts with the environment and in the body. How does it enter a plant, bug, animal or human; where does it go; how much goes to different organs or parts of a plant; is it toxic and at what dose; how long does it stay; how is it broken down; is it still toxic when it is broken down; how much stays in the environment (soil, water, and air). For humans and animals, these studies test if the chemical is toxic to the immune system, reproduction and development of fetuses and young animals; all organ systems (liver, kidney, heart, brain, reproductive organs, eyes, nervous system, blood, spleen, bones, muscles, thyroid); and whether it is genotoxic (toxic to genetic material) or can cause cancer. For the environment, these test look at the toxicity to organisms that live in soil, sediment and water, as well as beneficial insects, birds, wild mammals and plants.

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4 Many of the safety studies show toxic effects, how are they considered safe?

Every chemical can be toxic including water, oxygen, salt and sugar. Our bodies are designed to take in chemicals, use what we need to be healthy and then get rid of everything we don’t need. Toxicity happens when the body can no longer get rid of chemicals effectively and a toxic effect happens. For example, when you drink alcohol faster than your body can break it down and eliminate it, the alcohol builds up in your body and causes toxicity (e.g. incoordination, dehydration, decreased body temperature, decreased breathing and heart rate, nausea, vomiting and death in extreme cases).

Many Crop protection products are designed to be toxic to pests, others to combat weeds or diseases. Safety studies are specifically designed to show toxicity. Because we cannot test in humans or in all wild animals or all beneficial insects, there is always uncertainty if humans or other non-target organisms might be more sensitive to the toxic effect of a chemical than the test species. Therefore, safety studies require a range of doses. The lowest dose should cause no observable adverse effect (called a NOAEL; like a small sip of beer). Higher doses are tested until a toxic effect is observed (called a lowest observable adverse effect level (LOAEL); like 2-3 bottles of beer for a non-drinker). The highest dose in the study should cause significant adverse effects (similar to passing out due to too much alcohol). By testing the full range of toxicity, regulators have better certainty that if the maximum exposure a human may have is still 100 times or more lower than the NOAEL in the safety studies, then the product is safe to use according to the approved label (e.g. NOAEL = 10 mg/kg/day and the maximum human exposure is 0,1 mg/kg/day, the product is considered safe)

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5 How do regulators use safety studies to assess crop protection products?

Regulators use the results from all of these studies to understand the safety profile of the chemical. They look at the toxic effects and the dose levels. Then they estimate how much exposure is likely to happen based on how the product will be used. If the exposure is well below (at least 100 times lower) doses that cause no adverse effects in the studies, the product is considered to be safe for use.

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6 Safety studies are funded by industry – can the results therefore be trusted?

Regulatory tests are performed according to internationally agreed guidance documents and have to be conducted following Good Laboratory Practice guidelines. They are also an integral part of the 1981 European Council Decision on the Mutual Acceptance of Data in the Assessment of Chemicals. The compliance with guidelines and GLP regulations is monitored internally, as well as externally by authority inspections and audits to guarantee that the conduct of studies and data generation is accurate and valid. Monitoring activities include audits of the facilities, ongoing work in the facilities (i.e. the observation of personnel in the laboratory to assure they are working in compliance with GLP and follow test guidelines), the inspection of documents (e.g. review of the study plan that outlines the work to be conducted, review of the report for accuracy of data generated) and also include regular authority visits. Raw data of studies are archived for at least 15 years. The high standards and importance which is attached to GLP-Studies is also reflected in the fact that study directors or other people falsifying, using falsified or fraudulently issuing inaccurate GLP-certificates may be potentially subject to criminal prosecution.

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7 How is industry committed to data transparency

In March 2018, CropLife International and its member companies launched their transparency commitment. With the initiative CropLife International and its member companies are developing straightforward ways to enable non-commercial access to safety information – see here an example from CropLife International member Bayer.

With this initiative, the industry takes its responsibility and goes one step further in making safety data more easily accessible. We believe that enhanced transparency of regulatory crop protection safety data can help maintain public confidence in the regulatory review process and thereby address the questions consumers may have about crop protection products.

CropLife International and its member companies are further committed to continue to proactively engage in conversations with all stakeholders to explain the existing regulatory process and the safety, efficacy and benefits of crop protection products.

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8 What information is already available?

All relevant health and environmental safety information is already made public through various channels, such as the product label, product brochures or company websites, peer reviewed scientific literature and regulatory summaries by competent authorities. In the EU, for example, the regulatory risk assessment and study summaries for all active ingredients, and sometimes also for the crop protection products, is online with links to review reports and decisions. Further, the active substance registration reports (done by a rapporteur member state and containing the study summaries and risk assessment, as well as summaries on scientific literature) are published on the EFSA website. EFSA also peer-reviews the registration reports and publishes their peer review.

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9 Why is dialogue important to industry?

Proactively engaging with stakeholders to explain safety measures, efficacy and benefits of our products is key to responsible and transparent industry behaviour. CropLife International and its member companies listen to diverse points of view and we hope that through our commitment to transparency we can start a constructive dialogue with stakeholders to help broaden our understanding of issues and concerns. It is in this context that our member companies are providing straightforward ways to enable non-commercial access to safety-relevant data.

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10 What is confidential business information and why is this important?

The crop protection industry is research intensive - investing around $3 billion every year in innovation to ensure sustainable products are continuously being created. CBI is information that, if disclosed, could cause harm to the developer’s commercial interests. Regulatory data are submitted to regulatory authorities with the understanding that CBI will be protected by confidentiality rules and will not be disclosed at any time. If disclosed without permission, it could be detrimental to a developer’s business interests or to the safety and privacy of researchers. Similar to the violation of patents and trademarks, disclosure of CBI can lead to the significant loss of potential revenue, and failure to adequately protect CBI discourages the research and development of innovative plant protection products. Protection of CBI is therefore a crucial incentive for innovators to create new technologies.

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11 Are the data requirements for crop protection product approvals in low income countries different to those in in OECD members, such as the EU and US?

The high cost, level of expertise and human resource required to evaluate crop protection product dossiers among OECD members is often hard for low income countries to match. This is why CropLife International members try to ensure their products are evaluated and registered in an OECD country before an application for commercial access in a low income country. However, local use conditions must still be taken into consideration by the applicant in support of local registration.

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