Over the past year, countries around the world have been greatly impacted by the COVID-19 pandemic. The Committee would like to thank the relevant Taiwan government agencies for defending the health and safety of the people of Taiwan by continuously revising old policies and promoting new ones to guard against the pandemic, making Taiwan a role model for the rest of the world.
At the same time, however, little progress has been achieved regarding the registration of new pesticides and establishment of pesticide residue tolerance levels, preventing Taiwan’s agricultural sector from becoming truly integrated with the rest of the world and severely limiting its access to global trade. The U.S. International Trade Commission, in the second volume of its report Global Economic Impact of Missing and Low Pesticide Maximum Residue Levels, referred to Taiwan’s slow progress in setting maximum residue levels (MRLs) for pesticides. Setting an MRL sometimes takes up to several years, which has steadily decreased Taiwan’s global competitiveness in this area.
Consequently, the Committee last year requested that the Taiwan Food and Drug Administration (TFDA) and the Council of Agriculture’s Bureau of Animal and Plant Health Inspection and Quarantine (BAPHIQ) collaborate to provide industry operators and the general public with a transparent schedule for the relevant registration and review procedures for agro-chemicals. But the progress has been disappointing. Since 2020, only one new pesticide active ingredient has been approved for sale in Taiwan, and only one new pesticide MRL has been announced.
This year, the Committee urges the TFDA and BAPHIQ to provide a clear review process for the registration of local pesticides and the establishment of crop pesticide residue levels. In addition, the agencies should review the specific schedule for each stage of the procedure and announce amendments within a certain period of time after the approval of each application. This approach would facilitate the introduction of low-risk pesticides into Taiwan, and would help boost agricultural output and ensure consumer safety, further bolstering the value and excellent image of Taiwan’s agricultural sector.
Suggestion 1: Update the methodology for calculating the ADI risk cup.
In the glossary for their joint publication Principles and Methods for the Risk Assessment of Chemicals in Food, the Food and Agriculture Organization (FAO) of the United Nations and the World Health Organization (WHO) define theoretical maximum daily intake (TMDI) as a “prediction of the maximum daily intake of, for example, a pesticide residue, assuming that residues are present at the maximum residue levels/limits and average daily consumption of foods per person.”
Instead of using TMDI to calculate the Acceptable Daily Intake (ADI) “risk cup” or acceptable exposure standards for each active ingredient the Committee recommends that the relevant authorities adopt the estimated daily intake (EDI) method in the interest of greater transparency and accuracy as suggested by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR). Whereas TMDI assumes the presence of residues at maximum levels, the FAO/WHO notes that EDI is “derived on the basis of all the known facts at the time of the evaluation.” For example, the process includes an evaluation of the total actual exposure to pesticides as a result of the general public’s actual intake of various foods. It also considers a number of other factors such as the effects on residue levels due to storage, processing, or cooking practices.
According to the JMPR, using the MRL to calculate TMDI can result in grossly overestimating the risk of pesticide exposure, potentially causing unnecessary consumer concern or overstatement of pesticide hazards. We therefore strongly recommend changing the method for calculating the ADI “risk cup” from TMDI to the more realistic EDI approach.
The Committee brought up this issue in the 2020 Taiwan White Paper. In the government response, the relevant authorities noted that each country makes its own determination of proper risk levels rather than necessarily following JMPR guidelines, but they left the door open to consider making the recommended change. We hope that this will be the year that Taiwan accepts the EDI methodology.
Suggestion 2: Make public the schedule for establishing pesticide MRLs.
In its 2020 White Paper, the Committee appealed to the TFDA to confirm a timetable for taking up residual tolerance cases within six months following the COA’s completion of its review of applications for new pesticides. That timeframe had been the practice prior to 2017. We were pleased with the positive written response we received to this suggestion from the TFDA, which estimated a timetable for such cases of six months following the COA’s review.
The TFDA reiterated its response at a White Paper meeting held last October at the National Development Council. It added that the Ministry of Health and Welfare (MOHW) would announce MRL standards once per quarter on average, a schedule that the MOHW later confirmed.
Over the past year, however, the TFDA has only announced one revised pesticide residue tolerance standard. The Committee is deeply disappointed by the large discrepancy between the responses to our 2020 White Paper, the statements made during our meetings with the TFDA and MOHW, and the actual situation. Such a disparity has the potential to greatly impact international trade and the rights and interests of domestic farmers seeking the legal use of new high-efficiency, low-risk pesticides. Furthermore, it contravenes national policies on food safety by delaying the market entry of new and safer pesticide products.
We therefore once again urge the TFDA to adhere to the pre-2017 timetable for pesticide review applications of announcing the pesticide residue tolerance within six months after completion of the COA’s review, and to maintain on average one announcement per quarter.
Suggestion 3: Amend the “Replacement Rules Concerning Pesticides Indication” for the Agro-pesticides Management Act.
Article 14 of the Act provides that “any use or modification of pesticides indication should be approved by the central administration. After an indication is revised, the original indication should be replaced within six months.”
However, if the change made to commercially available products does not affect their safe and legal use by farmers, there is no need for the withdrawal of such products from the market to be re-labeled, and they should be allowed to continue to be sold until their expiry date. Examples include change of manufacturer, contracted packaging plant, contracted processing plant, or label design; expansion of product applications; or extension of a product’s shelf life. Such changes do not materially affect the original information provided to farmers.
This issue was raised in both the 2019 and 2020 Taiwan White Papers, but so far no progress has been made on revising the policy and no meaningful response was received from the authorities. We urge the COA to fully consider industry needs and accelerate the process of amending the relevant articles of the Agro-pesticides Management Act.
Suggestion 4: Implement the 10-year protection period for new active-ingredient data.
The COA in May 2018 amended the Agro-pesticides Management Act and announced that it would extend the new active-ingredient data protection period from 8 to 10 years. However, as the Committee noted in the 2020 Taiwan White Paper, Article 59 of the Act provides that the enforcement date for the 2018 amendments shall be decided by the Executive Yuan. In its response to the Committee, the COA confirmed the government’s position that enforcement will commence only upon Taiwan’s accession to the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP). The COA also requested that industry members use their influence to help Taiwan join the CPTPP.
Taiwan’s participation in multilateral agreements is beyond the control of industry. Moreover, for the sake of the wellbeing of Taiwan’s consumers and farmers, it is important to encourage industry practitioners to continue introducing new safe and effective pesticides and retiring older high-risk pesticides. We call on the authorities to drop the tie-in to the CPTPP and implement the 2018 amendments as soon as possible to extend the data-protection period to 10 years.
Suggestion 5: Strengthen registration requirements for generic pesticides.
Research and development for new pesticides can take more than 10 years, and another five to eight years may be required for conducting various safety and efficacy tests before the pesticide can be approved for sale. Generic pesticides, although they contain the same active ingredients and content as the original registered formula – with the only difference being certain additives and formula compositions – are required to undergo registration as well.
However, due to the low threshold for registration, manufacturers of generic pesticides do not need to expend a lot of resources to register or introduce to market products that have not been as strictly evaluated as their name-brand counterparts. Farmers may therefore be able to purchase generic pesticides at low prices, but over the years the price-cutting competition between name-brand and generic pesticide producers has led to overuse. Media reports have cited higher than usual pesticide residues in crops.
Article 10, Paragraph 3, Item 1 of the Agro-pesticides Management Act provides that: “After the expiration of the period in the preceding paragraph, when applying for approval of registration with the same active ingredient, formulation, content or the scope of application of the registered agro-pesticide, all or a portion of the data of the field test and toxicological test may be exempted from submission.” We recommend that the COA strengthen its registration requirements by amending the Act to require that manufacturers of generic pesticides provide proof that their formulas are the same as those of the original manufacturers. If they cannot, the toxicology, safety, and efficacy reports for those products should be reassessed to ensure safe use by farmers, control performance, and enhance environmental sustainability. This approach would also ensure consumer food safety and help the government achieve its goal of reducing the use of pesticides in Taiwan by half within 10 years.
但是，與此同時，負責農藥登記與農藥殘留容許量制定之相關部門，政策與行動上進展甚微，造成農業經濟無法與國際接軌，全球貿易嚴重受阻。美國國際貿易委員會（United States International Trade Commission）甚至在其報告 Global Economic Impact of Missing and Low Pesticide Maximum Residue Levels Vol.2，當中提及台灣設定農藥最大殘留容許量進程緩慢，甚至耗費數年，顯然已降低台灣在該領域的全球競爭力。
委員會去年建議參考 JPMR（糧農組織/世界衛生組織農藥殘留聯合會議）對於每個農藥有效成分（AI）訂定每日可接受攝取量（ADI）並公告之以為依據，公開透明的計算 ADI Risk cup 或可接受暴露標準。並建議將計算 ADI Risk cup方法由最高每日容許攝取理論值 Theoretical maximum daily intake（TMDI）改為每日估計攝入量 Estimated daily intake （EDI），以國人估算之實際攝取量來進行攝食風險評估實為合理。
委員會同意衛福部《2020年白皮書》之回覆：有關 ADI risk cup 之計算，係依據國際評估指引，以國人於各類食物之實際攝取量，來評估農藥之總暴露量，但所代入農藥殘留值，應為田間實際偵測之最大值而非所訂之最大殘留容許量，如以最大容許量（MRL）來計算 TMDI 將高估了農藥攝入風險，此作法非但不科學，恐造成消費者恐慌或被有心人士操弄農藥危害議題。促請行政院農業委員會及衛生福利部將計算 ADI Risk cup 方法由TMDI 改為 EDI，以國人實際攝取量進行攝食風險評估。