AmCham Special Luncheon: Meet the Deputy Minister of Health and Welfare Lin Ching-yi
AmCham Special Luncheon: Meet the Deputy Minister of Health and Welfare Lin Ching-yi
AmCham Special Events & Luncheons
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the change has no impact on farmers’ safe use of pesticides, there is no need for a product already on the market to be withdrawn for relabeling.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:
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:
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:
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.
農化委員會非常感謝衛生福利部食品藥物管理署及農業部的支持並重視本委員會所提出的建議。為因應氣候變遷及維持糧食安全等需求,祈請各主管機關能考量以下建言,持續精進相關管理政策,以期能加速引進高安全性、高效率且用量少的新型農藥產品及有助育種創新的新技術,得以減少環境危害並促進農業環境永續發展,進一步加快農藥管理法修訂進度。
建議一:加速修訂《農藥管理法》第14條及相關規定
本委員會自2019年起不斷提出本項訴求,迄今未觀察到任何實質性作為。《農藥管理法》第14條第1項及相關子法《農藥標示管理辦法》明列:標示經核准後「原標示應於六個月內更換之」,對於可能影響產品安全性的變更,這樣的要求是合理的;但若不影響農民使用安全之內容,已上市產品則應無需撤回重新貼標。
標示核准變更後,市售產品回收或更換標示程序繁瑣及困難,造成大幅增加額外處理成本。此外,法規明訂「更換之標示,不得以塗改、貼紙修正、重複黏貼方式為之」,部分產品標示需要整個拆除包裝後再重新分裝(例如鋁袋),增加作業人員重複暴露這類產品的職業衛生安全疑慮。
另外,主管機關對於個別產品的登記使用範圍或注意事項等變更的零星公告,導致辦理許可證登記相關事項時,將強制依最新公告內容要求進行標示修正,已造成資源的浪費及額外成本,例如:銷毀已印製之原核准標示、回收及重新分裝市場上尚未銷售完畢之產品等。
【建議 】
建議二:加速新有效成分、新劑型產品之審查登記
因應農業部動植物防疫檢疫署「化學農藥十年減半行動方案」,主管機關鼓勵業者登記安全性高、用量少、具專一性農藥,以降低農民用藥暴露及環境影響風險,建請將主要審查與行政量能投入在於新有效成分、新劑型含量等創新產品,以加速該類產品加速上市以汰換高危害或是高風險之成品農藥。
農藥登記、展延、重新評估,審查類型種類繁多,但主管機關對新有效成分及新劑型產品之審查通過占比相當微量。依農藥資訊服務網公開資訊統計,2023年成品農藥進口證與製造證共發證229張,其中僅3張屬於新有效成分;2022年成品農藥進口證與製造證共發證296張,其中僅9張屬於新有效成分。另外參考登記屆滿15年農藥有效成分審查通過清單,2023年通過20個有效成分,2022年通過34個有效成分。
【建議 】
建請農委會加速對新有效成分、新劑型產品之審查與核可,有助於汰換高風險之產品。
建議三:加速農藥殘留容許量訂定之行政程序
感謝食藥署及衛福部近年已改善農藥殘留容許量標準 (以下簡稱容許量)公告頻度,目前已可觀察到每年至少3次容許量之正式公告,使各相關產業有明確的法源依據而受益匪淺。雖已觀察到公告頻度的改善,但農藥登記的程序中仍有諸多不明確之行政流程,導致延宕產品登記及影響申請人投資意願,以下幾點之不確定性造成申請人難以預測登記的核准時間:
【建議 】
建請農業部及衛生福利部轄下各機關明確訂定部會間及部會內所需之各項行政程序及所需時程並公諸於眾。澄清這些程序將有助於簡化行政流程,使產、官雙方受益;此外,我們希望相關程序可以公開透明化,各部會間可以改善或加強跨部會之橫向溝通,增加協調性及提高行政效率。
建議四:正視農藥學名藥(成品)要求登記的合理性,以確保農民用藥之安全性及有效性
委員會已第四年提出此議題,至今尚未觀察到農藥主管機關對於學名藥成品有任何精進管制作為。
綜觀其他各國之學名藥登記,僅有台灣對於學名藥登記之資料要求最簡要(僅需繳交物理及化學數據資料),這種作法僅確認學名藥有效成分、劑型與原廠藥劑相同。然而,其他成分皆與最初、受充分審查之原廠藥劑不同。這種成分上的差異,引起了藥效以及產品安全上的擔憂,因為配方不能確認與原廠產品完全匹配。因此,易造成農民可能會無意中過度使用這些產品,並悖離農藥減量政策。
故,委員會建議主管機關修法:
建議五:敦促主管機關針對基因編輯產品建立透明的監管架構和可預期的時程,並採取與貿易夥伴一致、依產品為導向的監管方式
農業創新在提高產量和生產力上發揮了至關重要的作用,進而得以支持日益繁榮的文明。此外,鑑於世界人口的迅速增長、氣候變遷以及可耕地和水等自然資源的日益稀缺,植物育種的進展更是前所未有的重要。產量高、營養價值提升且資源利用效率更佳的作物日漸成為永續又高產量之農業的基石。再者,作物需要更能夠抵抗病蟲害,並對逆境如乾旱、高溫、淹水和鹽害等不利的種植條件更具耐受性。因此,需要基因編輯等精準生物技術之創新來提升植物育種的速度、可預測性、精確性和成功率。
如2023年白皮書中所強調的,世界貿易組織(WTO)於2018年發布由十個會員國共同簽署的《國際精準生物技術農業應用聲明(International Statement on Agricultural Applications of Precision Biotechnology)》,該聲明敦促各國政府實施基於科學且全球調和的精準生物技術相關政策。為了支持農業創新,許多台灣的主要貿易夥伴,包括美國、日本、澳洲、阿根廷、巴西、菲律賓和印度均已經訂定實施運作良好且合宜的監管制度,並將特定類型的基因編輯產品從基因改造的管理範疇中排除。政府主管機關可經由預先諮商的方式,根據產品的特性進行評估,來確認其是否符合豁免範疇。
在過去的12個月中,部分地區和國家對基因編輯產品管理政策制定取得了顯著的進展。舉例來說,歐盟執委會於2023年7月5日發布了新基因體技術(New Genomic Techniques, NGT)提案,對利用新基因體技術(例如基因編輯技術)開發的植物提出新的法規,並提議第一類NGT植物可從基因改造生物法條的要求中豁免排除,據此確認歐盟執委會的立場,認同源自這些技術的植物具有與傳統植物相當的安全性,並且能有助於歐盟主張的「從農場到餐桌策略」和環境永續性,其與2021年4月29日歐盟執委會發布的NGT研究所得到的結論一致。
2023年12月20日,新加坡食品局提出一份政策文件,就食品和飼料用基因編輯作物的監管架構進行公眾諮商,這份文件提議,不含外源DNA的植物可免除上市前的安全評估。此外,2024年1月18日,泰國的技術性生物安全委員會(Technical Biosafety Committee)核准其「基因編輯技術研發生物之評估指引(Guideline for Determination of Organisms Developed by Genome Editing Technology)」,認定不含新穎基因組合或外源基因序列的產品可免除基因改造法規的監管。最近的這些政策發展都證明精準生物技術(如基因編輯)對於解決農業生產挑戰以及支持糧食自給自足和實現永續發展目標的重要性。
台灣身為農產品(包括種子/植物產品)上重要的全球貿易夥伴,為了協助台灣維持競爭力並確保充足的糧食和飼料原料供應,我們敦促食品藥物管理署和農業部能對基因編輯產品建立透明的監管架構和可預期的時程,並採取與台灣主要貿易夥伴一致、依產品為導向的監管方式。