Here is a quick introduction to some of the terms commonly used on our website and in our workshops.
The scientific information to be included in a data package is a mix of published scientific literature, scientific rationales, scientific bridges, monographs from other regulators and scientific studies. IDRG Plant Protection uses the refined data requirements from the regulators to identify the most cost and time efficient options in answering to the regulators’ requirements.
Prior to the authorization of a plant protection product (biological or chemical) and its uses, governments assess its safety and efficacy. They do this by reviewing scientific, technical, administrative and legal information that is provided to them by the owners of these products and their cooperators. A data package is a collection of these important scientific and technical data, and their interpretations. The data package consists of thousands of pages of text, tables, statistics, graphics and pictures that describe the chemistry, the biology, the physics, the toxicity, the efficacy and the manufacture of a plant protection product.
The type of information to be included in a data package, the scientific methods to be used and the structure of the data package are prescribed by government. IDRG plant protection uses the material that governments have jointly prepared under OECD.
The required content of a data package is prescribed by government and includes a great number of details about the plant protection product and its uses. It includes information on the physical, chemical and biological characteristics of the product and its ingredients. It includes all aspects of human and environmental health. It also describes safe product application methods, the efficacy and the crop safety of the product. Many countries have published the general list of their data requirements but this list can be further refined by providing the government with a preliminary description of the product and its purpose. The better the communication between industry and regulator, the better the quality of the resulting data package for assessment by the regulator.
Scientific studies must be conducted in a way that is up-to-date on the most recent scientific knowledge and methods. Regulators have therefore developed a set of general study protocols that industry can adjust to their particular product and its uses. This way government has set a scientific and technical standard that industry needs to follow.
When a scientific study is completed, detailed information on the methods, the results and their interpretation has to be documented in a report. Some study reports are hundreds of pages long and cover several years of research. Publishers of scientific articles have therefore developed clear guidelines on how to format a scientific article for publication in their journal. Regulators have followed that example and have created templates for study reports that ease the communication between regulators and industry. Under the leadership of OECD, governments have now generated templates for study reports that are accepted by most governments for workshares and joint reviews.
In most countries, the regulatory authorities are part of the civil service and their scientists are civil servants. Normally that means that the work of these scientists is paid for by tax dollars. However, as they provide a service to a specific industry sector most countries recover some of their costs associated to the assessment of plant protection products by charging a fee. The amount of money to be paid by industry varies greatly and is calculated in different ways. Some governments charge by time spent, some charge by type of information to be reviewed and some charge by type of approval requested. A relatively new factor in cost recovery are payments made by growers, food processors, food traders and other organizations who participate in covering the costs of government.
In agriculture, antagonists are organisms that inflict damage on cultivated plants (crops). These include:
Antagonists have the potential to hamper plant growth, to destroy the plant parts that form part of our diet, and may even render a plant toxic for human consumption. IDRG Plant Protection has included all types of antagonists on all crops into its activities and strategies.
Growers, from around the globe, produce over 10,000 different plant species including grains for food and feed, oil crops, fruits, vegetables, herbs & spices, animal feed, fibre crops, trees and ornamental plants. International trade has the potential to ensure that worldwide every person can be provided with a healthy diet. Which plant a grower can produce depends on the characteristics of his fields and the surrounding climate. Growers also have to protect their crops from damage of dozens of antagonists such as insects, mammals, pathogens or weeds, and have to prevent the introduction of invasive alien species. IDRG Plant Protection offers growers a world view of plant protection problems and their solutions for any crop.
The plant protection industry develops, manufacturers and commercialises biological and chemical substances that destroy or repel agricultural antagonists. Large amounts of research have to be conducted to select or design substances that harm the antagonists but not the planted crops, humans or the environment. IDRG Plant Protection works with all companies (SME and multinational) in all countries, builds business alliances and cooperation between companies, and partnerships with other industry sectors.
Worldwide, regulatory authorities receive technical and scientific information from industry, review this information for its validity and quality of data, conduct risk assessments and risk mitigations, and take regulatory decisions. When a regulatory decision is positive, the authorities approve a label that companies attach to their packaged product to inform growers and handlers of the products’ approved uses and use patterns. Required risk mitigation measures are communicated to the growers on the approved label. IDRG Plant Protection facilitates the communication among and between governments, industry, growers, Universities, international organizations and NGOs.
Starting in 1993, OECD engaged governments, academia, industry and growers in the development of agreements and tools that are necessary for all stakeholder groups to cooperate across international borders. At their annual meeting, the ‘Pesticide Stakeholder Group’ selects specific topics in plant protection that will be addressed during the next twelve months.
The work on a new topic begins with a survey of the current state of all OECD member states and observer countries to establish the status in the different countries. A survey report is then published and used as a working tool for an international conference on the topic to discuss and achieve agreements for future cooperation procedures.
Following the conference, OECD drafts agreements, guidelines, templates and updates. These are then shared with all the participating countries for approval, and subsequently published on the OECD website. IDRG Plant Protection develops win-win scenarios when national legislation seems to differ too widely between countries to overcome the gap.
A presubmission consultation is the request from industry to government to establish a product and use-specific list of data requirements based on the general requirements that are publicly available. While in the past, presubmission consultations took place in person, the majority of requests today, are processed electronically. Personal meetings are reserved for problems or clarifications that could not be resolved electronically. Considering the need for global cooperation, electronic presubmission consultations are therefore definitely preferable. IDRG Plant Protection conducts multinational presubmission consultations for its clients.
In a cooperative approach, people build a taskforce for a common purpose, while also pursuing their individual goals. All participants continue to do what they do best and do even better. The novelty compared to a competitive approach is the way in which transparency within the taskforce connects the ‘dots’, creates synergies and reduces duplication. IDRG Plant Protection uses cooperation when there is a benefit for all.
A Global Joint Review (GJR) is the cooperation between the regulatory authorities of several countries. It includes agreement on the data requirements, a split of the data package between the countries, an exchange of review documents, joint risk assessments and risk mitigations, but it allows separate regulatory decisions for every country. However, governments make all efforts to make their decisions compatible. A use that is not applicable to country’s agriculture can be approved as an acceptable residue for importation. A risk mitigation message might be put on the label in one country but on an accompanying leaflet in another. IDRG Plant Protection facilitates the joint agreements between and among governments and industry.
A workshare between the regulatory authorities in several countries is similar to the GJR but allows more flexibility in terms of workload, timelines, risk assessments and regulatory decision taking. Data requirements between countries might differ, only part of the data package might be reviewed jointly, the assessment of a report by one country might or might not be accepted by other countries, and risk assessments and risk mitigation might differ. IDRG Plant Protection facilitates communication, conflict resolution and compatibility of decisions.
In the European Union, a mandatory mutual recognition strategy encourages member states to accept the regulatory decisions that have been taken by other member states. For the application of plant protection products in open field settings, mutual recognition applies to the member states within the three European zones. For the application of plant protection products in greenhouses all 28 member states are considered as a single zone. IDRG Plant Protection either encourages governments to conduct workshares or facilitates communication among regulators before regulatory decisions are taken to ensure compatibility of decisions with national legislation.
The Global Needs Database (GND) is the collection of plant protection needs that growers from the around the world have identified for their crops and countries. The collection is open to all crops, all pests, all product types, and all companies in all countries. Currently there are two versions of the GND – a spreadsheet online and a database in development. Considering the hundreds of thousands of needs, the hope is that the spreadsheet will be transferred into the database rather sooner than later. IDRG Plant Protection encourages its clients to participate in publishing of this database and the use of the information it provides.
The Global Plant Protection Database (GPPD) is the collection of all approved plant protection products and their uses in almost 80 countries. The collection includes all crops, all pests, all product types and all companies. It lists different formulation types, use patterns, approval and expiry dates, maximum residue limits (MRL) and safety phrases. IDRG Plant Protection uses this database to ensure that our clients have a global view when taking a national, regional or global business decision.