Regulations Across Five Continents

Africa (Pukclai)

Top issues:

With multiple countries in Africa, one of the top issues is the national regulatory systems and the process of pesticide registrations. In many of those countries, regulatory authorities have limited capacities on toxicity and risk assessment.

Toxicity studies are very costly with the result that toxicity data used to register pesticides in Africa are often sourced from northern hemisphere countries.

Risk assessment requires toxicity assessment, environmental fate data, and the use of models for occupational, dietary, residential, and environmental exposure assessments.

Using exposure modeling results from the northern hemisphere is not an ideal approach. Authorities in African countries should generate the required data, despite these being very costly.

Authorities should also provide guidance on the type of models and standard scenarios for estimating predicted environmental concentrations in various environmental compartments. Another concern from agribusiness companies is how authorities reach the decision to register a specific pesticide.

What’s driving regulations:

Increasing resistance of pathogens to active ingredients, banning of some pesticides, food safety policy, and residue data.

How you can create change:

Manufacturers and distributors should coordinate and monitor the implementation of regulations, standards for mutual support, and the sharing of good practices with the authorities and policymakers. Though, compared to Asia and South America, where the incentives were stronger for multinationals to partner with government authorities, in Africa, it is more difficult to get and keep pesticide companies on board, alongside issues with access to pesticides, expertise, and other resources.

Asia (Pukclai)

Top issues:

The registration process takes a long time. During COVID-19, authorities from many Asian countries created a work-from-home policy and set new rules regarding dossier submission or meeting with the authority. Furthermore, due to the shortage of raw materials and products from China, and the transportation interruptions, importers and distributors that wanted to change or add the source of material meant the product registration documents required updates. Changing or adding a new source may take a few months or almost a year, before getting approval from any national authority.

In some countries where the bio-efficacy trials are required and must be conducted by an accredited institute or need to be inspected by the government officers, there is a delay that occurred due to the suspension of the operation or inspection of the authority. Delayed field trials or data generation also affected the registration dossier submission. In the case of delayed data, the registration process could not proceed.

What’s driving regulations:

The banning of some pesticides affects several domestic industries as the countries rely on the importation of several agricultural commodities. The international trading of fruit and vegetable products could face disruptions in their supply chains once the ban goes into effect.

Governments are trying to find alternatives to those banned pesticides so as to cushion the financial impact of the prohibition on farmers.

While the world is focusing on food safety, businesses and farmers are not yet ready for that change, and many are also adversely hit by the COVID-19 outbreak.

In Asia, the development of new active ingredients for pesticides to replace those banned pesticides remains difficult though several countries have a new procedure to evaluate the information of new active ingredients. The process still takes a long time to get approval and add the new active ingredient to the national list of pesticides that allows being registered.

How you can create change:

Manufacturers and distributors are required to coordinate and monitor the implementation of regulations, standards for mutual support, and the sharing of good practices with the authorities/ policymakers. Keep in contact with national authorities and request specific regulations for different categories when registering products.

Europe (Stephan and Kamilova)

Top issues:

Biocontrol products in the European Union are handled in the same regulatory framework as conventional active substances. This means that the products are assessed with the presumption that they are unsafe. As a consequence, more testing and data is required to register a biocontrol product in the EU than in any other country or region. Furthermore, the companies dealing with timelines for registration, which are very long to begin with, face a system delayed due to the lack of experts for evaluation in the EU member states. For these reasons a lot of capital is needed to register a biocontrol product in EU, which makes it especially hard for small companies to enter the market.

What’s driving regulations:

The EU has put the Farm-to-Fork strategy in place. The aim is to reduce the use of pesticides in the EU by 50% and increase organic farming by 2030. The goals of the Farm-to-Fork strategy are not legally binding. Therefore, the sustainable use directive is under revision and will be changed into a regulation that will put legally binding targets for EU member states in place. These goals are highly ambitious, and for this reason, the EU Commission is more focused on biocontrol products.

It is the belief of the Commission that it will accelerate the assessment process so it will comply with the timelines of Regulation (EC) 1107/2009. However, no measure has been put in place to prioritize the registration of biocontrol products, or to make market access for small companies easier. All of this shows that from a political perspective biocontrol products are wanted, but the regulatory system is lagging behind. Further revisions of the current system in the future will depend on the effects of the revisions the EU commission is currently putting in place.

How you can create change:

Manufacturers and distributors can be proactive within industry associations on national and international levels as well as in their contacts with NGOs to approach the EU Commission and competent authorities to create a fast track registration system for biocontrol products as well as to reduce and harmonize registration fees.

North America (Benmhend and Bahraini)

Top issues:

The most concerning issue is that there are cases where regulations may overlap. A fine line might result in a product being regulated under one regulation while not under another. For example, the labeling claims, application, and mode of action play a crucial role in defining the related regulatory statute.

The United States (U.S.) Environmental Protection Agency (EPA) regulates the sale and distribution of pesticide products in the U.S. under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including those imported into or exported from the U.S. EPA’s registration process would pose significant hurdles to ensuring public and environmental safety and adverse health effects. As a result, companies must submit proper data or justifications to meet EPA standards and requirements. EPA may reject the approval if a company cannot fulfill the registration data requirements.

What’s driving regulations:

The U.S. federal government has a coordinated, risk-based system to ensure that products are safe for the environment and human and animal health. Therefore, regulatory changes are driven by mostly new findings (or changes). For example, during the COVID-19 pandemic, the legislation made some changes to the regulations to help expedite approval on a case-by-case basis. Additionally, harmonization can be another driving source. For example, the legislation is trying to find approaches to harmonize the testing and data requirements between countries to help reduce animal testing and the review process, while ensuring the safety of humans and the environment.

According to the EPA: “Regulations are codified annually in the U.S. Code of Federal Regulations (CFR). Title 40: Protection of Environment is the section of the CFR that deals with EPA’s mission of protecting human health and the environment.”

How you can create change:

Manufacturers and distributors can participate in EPA regulatory rulemaking by sharing their experiences and providing comments. Generally, EPA researches issues and, if necessary, proposes a regulation, also known as a Notice of Proposed Rulemaking (NPRM). The proposal is listed in the Federal Register (FR) EPA website so that members of the public such as manufacturers and distributors can consider it and send their comments to EPA. EPA considers the comments received when the proposed regulation was issued, may revise the regulation accordingly, and then issue a final rule.

South America (Bejarano)

Top issues:

The structure of the South America’s agriculture is very diverse, as is the regulatory legislative framework (varying from country to country). Harmonization of regulatory legislative frameworks, as well as allowing the simultaneous registration in multiple countries and/or the application of mutual recognition of products, would prompt the transition of its regional agricultural (emerging) market into a developed market.

On the other hand, regulatory harmonization comes along with the implementation of stricter requirements.

This obligates manufacturers to take necessary measures so that the manufacturing process and its monitoring ensure compliance of the manufactured products. The implementation of tighter regulatory frameworks also entails that authorities, regulators, and subcontractors align with these stricter requirements (e.g., providing in-country infrastructures and services).

What’s driving regulations:

Climate change and increasing resistance of pathogens to active ingredients.

How you can create change:

Manufacturers and distributors should coordinate and monitor the implementation of regulations, standards for mutual support, and the sharing of good practices with the authorities and policymakers. In this context, it is important that they keep in contact with national authorities and request specific regulations for different categories when registering products. For example, through the participation in public commenting on draft regulations if available.