The Committee is grateful to the Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare (MOHW), and Ministry of Agriculture (MOA) for their recognition of and support for our previous suggestions. To effectively address climate change and maintain food security, we urge the authorities to consider our latest suggestions and continue to improve relevant management policies in accelerating the introduction of new pesticide products that are highly safe, efficient, and low-intensity, as well as new technologies for promoting breeding innovation. Doing so will help reduce environmental harm and enable agricultural sustainability. Further, we urge the MOA to accelerate the revision schedule for the Agro-pesticides Management Act.

Suggestion 1: Accelerate revision of Article 14 of the Agro-pesticides Management Act and related labeling regulations.

This suggestion has been brought up in every White Paper since 2019, but no progress has occurred. Article 14 of the Act provides that following the MOEA’s approval of changes in a pesticide label, all relevant products must be relabeled within six months. Such a requirement is reasonable for changes potentially affecting the safety of a product. However, if the change has no impact on farmers’ safe use of pesticides, there is no need for a product already on the market to be withdrawn for relabeling.

Following the approval of new labeling, the procedures for either recalling products from the market or replacing labels have become overly complicated and burdensome, leading to significant costs. Moreover, the requirement that labels cannot be updated by merely marking the change, modifying the adhesive label, or affixing a new adhesive label over the old one necessitates that products (such as those in aluminum sacks) be unpacked and then repacked, which in turn raises occupational safety concerns about the repeated exposure of workers to these products during the process.

Further complicating matters are sporadic announcements from the government regarding changes in the use pattern or cautionary notes about individual products, as these necessitate re-approval of the label if any license has been submitted for renewal or amendment. This requirement wastes resources and results in additional costs, including the destruction of existing inventory labels and the labor-intensive process of unpacking and repacking recalled products.

Recommendations:

1. Fast-track revisions to Article 14 of the Agro-pesticides Management Act. Since 2019, the Committee has been calling for amendments, such as removal of the mandate to recall products within six months due to minor label amendments that do not affect safety or manufacturing, but has yet to see any substantial action or even receive a formal reply. We urge the Animal and Plant Health Inspection Agency (APHIA) to confirm that our proposed amendment to Article 14 is among the prospective revisions. Furthermore, we urge APHIA to accelerate the drafting process, enabling a bill to be submitted for legislative approval without further delay.
2. Add a positive list in the Enforcement Rules of the Agro-pesticides Management Act specifying the types of changes that do not require relabeling. Changes such as the name of the manufacturer, extension of product shelf life, and modifications to packaging, labeling design, and barcodes have no impact on product safety. The practice of allowing such modifications without relabeling is already common in other industries. To avoid unnecessary costs and waste, and in consideration of industry practice, the sale of products should be allowed to continue until their expiry dates.

Suggestion 2: Expedite the review process for new active ingredients and products with new content or new formulations.

Under APHIA’s 10-year plan to reduce the volume of chemical pesticide usage by half, companies are encouraged to register pesticides with high safety, low dosage, and specificity to reduce the risks of pesticide exposure to farmers, as well as to mitigate negative environmental impact. Achieving that goal will require the approval of products with new active ingredients and new formulations.

Whether for pesticide registration, renewal, or re-registration, however, the proportion of application approvals for new active ingredients and new formulation products has been minimal. Statistics compiled by APHIA’s Agricultural Information Network show that of the 229 certificates issued in 2023, only 3 were for new active ingredients. In 2022, 296 certificates were issued, with a mere 9 dedicated to new active ingredients. Additionally, on the list of active ingredients that have passed the 15-year pesticide re-registration, 20 active ingredients were approved in 2023, much fewer than the 34 approved in 2022.

We urge APHIA to prioritize the allocation of its review and administrative capacities toward innovative products, such as those with new active ingredients and new formulations. This prioritization would spur the launch of innovative products and aid the elimination of high-hazard or high-risk formulation products.

Suggestion 3: Accelerate the administrative process for determining the maximum residue limits for pesticides.

We are grateful to the TFDA and the MOHW for their commendable efforts in increasing the frequency of announcements regarding the maximum residue limits (MRLs) of pesticides. The TFDA has consistently issued official announcements on MRLs at least three times annually, a practice that greatly benefits stakeholders by providing clearer regulatory guidance.

Despite these improvements, several aspects of the administrative procedures for pesticide registration remain unclear. These ambiguities have caused delays in the registration process, significantly impacting applicants who have made substantial investments in Taiwan. Uncertainty regarding the following points has made it challenging for applicants to predict the approval timeline for their applications:

• The timeline for sending cases to APHIA to schedule review by the Pesticide Advisory Committee under the MOA after the cases have passed review by the Agricultural Chemicals Research Institute.
• The timeline for sending cases to the TFDA after they have passed the Pesticide Advisory Committee’s review.
• The timeline for arranging document reviews by experts and comprehensive review by the Food Sanitation, Safety and Nutrition Advisory Committee after the TFDA has received a case.
• Following case reviews, the various required administrative procedures and joint actions involving some 20 functional offices or units. These procedures may take more than one month, not including the time required for subsequent pre-notification and official announcement of related regulations, which may take at least another four months.
• APHIA’s informal pre-notification procedure that, although officially optional, is being enforced as if mandatory. Completing this process can take up to two months. APHIA has advised the Committee that applicants are expected to initiate direct communication with the TFDA, requesting that it notify APHIA about the contents of any forthcoming announcement prior to its public disclosure. In practice, this procedure significantly delays APHIA’s ability to announce the approved use pattern of registration after the TFDA discloses the finalized MRLs. This extended timeline for procedural compliance not only complicates the registration process but also affects the timely introduction and use of registered products, hindering the efficient management and implementation of agricultural practices.
• The requirement that companies await an official announcement from APHIA before proceeding with applications for permits or changes in labeling. This administrative procedure alone can take at least one month.

We urge departments within the MOA and the MOHW to establish and clearly define the procedures and precise timings of administrative processes at both the ministerial and departmental levels. Clarifying these procedures would help streamline the administrative process to the benefit of all stakeholders.

Additionally, we ask that these procedural details be made available to the public. Such transparency could significantly enhance horizontal communication across different ministries and departments, leading to a more coordinated and efficient administrative process.

Suggestion 4: Reassess the reasonableness of data requirements for registering generic pesticides to ensure safe and effective use by farmers.

The Committee has raised this issue in the past four White Paper issues, but no progress has been made. Compared to the regulatory frameworks in other countries for registering generic agricultural products, the procedure in Taiwan stands out for its conciseness, requiring only the submission of physical and chemical data. This approach focuses on ensuring that the active ingredients and formulation type of the generic product match those of the originally registered product.

However, other ingredients in the product may differ from what was covered in the original comprehensively evaluated registration. This discrepancy in composition raises concerns about the efficacy of the generic products, as it cannot be guaranteed to fully match that of the original products. As a result, farmers may inadvertently overuse these products or use them in ways that deviate from the government’s pesticide reduction policy.

Recommendations:

1. Revise current legislation to mandate at least one field test assessing the efficacy of generic pesticides on the crops for which registration is sought.
2. Require the submission of comprehensive toxicological data for the registration of generic products. Data should include reports on oral-, dermal-, and inhalation-acute toxicity, as well as eye irritation tests, to unequivocally demonstrate the safety of the generic products for users.
3. Formalize the registration process for generic pesticides. This process should include evaluation by the MOA’s Pesticide Advisory Committee for the generic product’s necessity, efficacy, and safety before approval is granted. Such measures will ensure that generic pesticides introduced into the market meet the expected high standards of performance and safety, thereby protecting users and supporting the goals of pesticide reduction and sustainable agriculture practices.

Suggestion 5: Set up a transparent regulatory frame-work with a predictable timeline and adopt a product-based regulatory approach harmonized with Taiwan’s major trading partners for genome-edited products.

Agricultural innovation has played an essential role in increasing yields and productivity in support of growing, prosperous civilizations. Moreover, considering the rapidly growing world population, climate change, and increasing scarcity of natural resources such as arable land and water, progress in plant propagation has gained unprecedented importance.

High-yielding crops of superior nutritional value that can be grown more resource-efficiently are increasingly becoming the cornerstone of sustainable yet highly productive agriculture. In addition, there is a need to make crops more pest- and disease-resistant as well as more tolerant to adverse conditions such as drought, heat, submergence, and salinity. Innovations in precision biotechnology, such as gene editing, are therefore required to enhance the speed, predictability, precision, and success rate of plant breeding.

As highlighted in the 2023 White Paper, the World Trade Organization released the joint International Statement on Agricultural Applications of Precision Biotechnology, supported by 10 members, urging governments to implement science-based and globally harmonized policies for precision biotechnology. To support agricultural innovation, many of Taiwan’s key trading partners – including Argentina, Australia, Brazil, India, Japan, the Philippines, and the United States – have since implemented well-functioning and proportionate regulatory systems. These markets have exemptions granted certain types of gene-edited crops from their GMO regulations. Furthermore, the exemption by some government agencies can be evaluated and confirmed through a pre-consultation mechanism.

Over the past 12 months, some countries and regions have made further noteworthy progress in developing policies for the management of genome-edited products. For example, the European Commission released its New Genomic Techniques (NGT) proposal for new regulation on plants produced by certain new genomic techniques (for example, gene-editing technology) on July 5, 2023. The Commission also proposed that Category 1 NGT plants should be exempted from the requirements of GMO legislation, affirming the Commission’s position that plants derived from these technologies have safety profiles comparable to conventional counterparts and may contribute to sustainable agriculture and the European Union’s Farm to Fork Strategy, as concluded in the NGT study published on April 29, 2021.

On December 20, 2023, the Singapore Food Agency released a policy document for public consultation on the regulatory framework for genome-edited crops for food and feed. This document proposed that plants that do not contain foreign DNA should be exempted from pre-market safety assessment. On January 18, 2024, Thailand’s Technical Biosafety Committee approved the Guidelines for Consideration of Genome Editing, stipulating that products lacking novel genetic combinations or foreign genetic sequences should be exempt from GMO regulation.

These recent policy developments have demonstrated the importance of precision biotechnology such as gene editing to address challenges in agricultural production as well as to support food sufficiency and achieve sustainability goals.

Taiwan is a key global trading partner for agricultural products, including seed and plant products. To help Taiwan maintain a competitive and secure food and feed supply, we urge the government to establish a transparent regulatory framework with predictable timelines and adopt a product-based regulatory approach for gene-edited products to ensure harmonization with Taiwan’s major trading partners.