The Committee gratefully acknowledges the joint efforts of the Bureau of Animal and Plant Health Inspection and Quarantine (BAPHIQ) and the Taiwan Agricultural Chemicals and Toxic Substances Research Institute (TACTRI), both under the Council of Agriculture (COA), in simplifying crop-extension procedures for products with the same active ingredients but different dosages. These efforts have greatly reduced the resource burden on manufacturers when applying for crop extensions, as well as providing increased convenience for farmers.
The new-product registration system for agricultural chemicals is now into its eighth year. Due to proactive and attentive assistance from both BAPHIQ and TACTRI, manufacturers gradually made progress in getting their new products registered. However, since cancellation of the registration for the pesticide Fluopyram in March 2017, the Ministry of Health and Welfare (MOHW) has put new guidelines into place in line with three stipulations set by the Legislative Yuan’s Social Welfare and Environmental Hygiene Committee. The result has been cessation in the establishment of maximum residue levels (MRLs) for 618 pesticides submitted to MOHW by the COA between March and December 2017.
Although on January 16 this year the COA announced MRLs for 253 pesticides out of the 351 products applied for the previous March, decisions on several hundred additional items are still pending. Such indecision has caused a severe delay in the approval of many new-product applications for registration, expanded registration, extension, and import tolerance. Furthermore, a high degree of uncertainty remains regarding the handling of future new applications.
If this predicament is not resolved soon, a number of severe consequences will follow: safer and more effective new pesticides will be unable to be launched in Taiwan, pesticides will be unavailable for many crops of small quantities, various kinds of foreign produce will be blocked from import because import residue tolerances have not been set, and major overseas manufacturers will suspend plans for any additional investment in Taiwan.
This year the first three suggestions we would like to make are new issues, while two others are carried over from last year. The Committee sincerely hopes that the governing bodies give these recommendations serious consideration. Their adoption would make it possible for safer and greener new products to be introduced to Taiwan for the benefit of both consumers and farmers, and in the interest of strengthened environmental protection, food safety, and public health, while also promoting Taiwan’s agricultural development protecting the legal rights of companies operating in this market.
Suggestion 1: Follow international practice and use reasonable guidelines in setting pesticide residue tolerance standards.
On June 29 2017, the MOHW’s Taiwan Food and Drug Administration announced cancellation of the MRL for the pesticide Fluopyram for use on tea plants. This step violated the existing guidelines for pesticide registration procedures, which is not to require that pesticides be applied on crops in other markets before being allowed to do so in Taiwan, as well as the scientific spirit of respecting expert opinion. This new pesticide that has come under question has obtained approval for use on other crops from both the EU and the Codex Alimentarius Commission (CAC), and in Taiwan has been assigned MRLs for other crops. After a product has been legitimately registered in Taiwan, it is extremely unreasonable and troubling for an MRL to be revoked. Besides creating a high degree of uncertainty in the market about future new-pesticide registrations, it also raises the prospect of much broader unfavorable impact, including decreased industry trust in the government and concern within the international community regarding Taiwan’s regulatory process and investment environment, with consequent serious damage to Taiwan’s international image.
In brief, the resolution requested MRL items of the following three situations should be reviewed by MOHW expert panel again:
1. ADI above 70%
2. Additional review requests raised by expert panel
3. MRL not yet set by other country
With regard to the first resolution, each country has a different climate, environment, and approach to pesticide use; there is no fixed international standard for pesticide residue tolerance. Taiwan and advanced countries like the United States and EU adopt total volume control as the management approach, meaning that the pesticide residue in all foods consumed during a given day may not exceed the control level.
Considering the variation in eating habits and daily intake of the same crop in different countries, it is impossible to set a completely consistent residue tolerance that would be applicable for every country. Thus, the amount of residue tolerance assigned to individual crops does not directly reflect the daily total volume that might be consumed.
Instead, it would be more reasonable to make a comparison based on the total control volume. As a result, for the Legislative Yuan committee to demand that the MRL not exceed the “international standard” is essentially disregarding current international scientific practice.
As to the second resolution, certain crops common in Taiwan such as mesona, mugwort, wax apple, sugar apple, and bitter gourd are not grown in EU countries, the United States, and Japan. The demand that only pesticides used internationally may be used in Taiwan will lead to an absence of available pesticides for many domestic crops.
Concerning the third resolution, the international safety standard for MRLs is 80% of the ADI. For Taiwan to adopt its own standard of 70% would mean that it is no longer in line with the rest of the international community. The likely result is reduced willingness by major overseas manufacturers to engage in further investment in Taiwan since the fewer number of registered crops will mean less market potential.
The Committee therefore calls on SWEHC to withdraw its resolution as unfounded, and also reminds MOHW that the Legislative Yuan committee’s stipulations are in the form of a non-binding resolution, which an executive-branch agency should not be obliged to accept blindly if it is based on erroneous assumptions and is likely to cause harm to Taiwan’s agriculture and international reputation.
Suggestion 2: Simplify the requirement for physical-chemical property tests and data for pesticides.
Among the physical-chemical property tests required for pesticide registration, the data requirement regarding the manufacturing process is more complicated than in other countries, even though no specific standard has been set. In what is a very time-consuming and inefficient process, manufacturers are often asked to provide various supplementary documents but frequently have difficulty obtaining the documents from overseas factories due to a lack of clarity as to what is required.
The Committee therefore urges the relevant authorities to refer to international standards and be more specific in stipulating the nature of the needed documents. While we support the governing bodies’ proactive approach to verifying factories’ authenticity and quality, inspections conducted based on documents and photographs alone cannot completely deter fraudulent activity in manufacturing. They should be supplemented by random on-site factory inspections.
Suggestion 3: As soon as possible, announce what toxicity-study documents must be resubmitted for pesticides reaching their 15th year of registration.
According to Article 16 of the Pesticides Management Act, as of five years from the implementation day of the clause amended on December 9, 2014, pesticides reaching the 15th year since their approved registration may apply for permit renewal, reattaching their toxicity tests results. As this provision will be effective as of December 9, 2019 – less than a year and a half away – the Committee urges BAPHIQ to ensure that manufacturers have ample time to prepare their applications.
Article 16 states that it does not cover pesticides for which toxicity-study documents were submitted at the time of their registration. For many products, however, the registration period has already exceeded 15 years, and to prove their right to a waiver, manufacturers will need to spend a great deal of time going through old files and will spend even more time reproducing needed documents if any are missing. To enable manufacturers to proceed with the smooth preparation of the necessary documents, the Committee requests that BAPHIQ to disclose, as soon as possible, a list of the specific documents required for the process.
Suggestion 4: Establish a mechanism to ensure that both imported and domestic products with the same registered active ingredients are approved for use in domestic crops.
This is an issue continued from last year. As the documents required for residue-tolerance import applications (including medication efficacy reports) are all identical with those required for domestic expansion registration, we recommend that when products are approved for import residue tolerance, domestic products with the same active ingredients should also receive approval for use on domestic crops. Creating such a mechanism would help remove the current confusion among farmers as to whether certain products are legal for them to use.
Suggestion 5: Extend the protectation period for registered data from 8 to 10 years and encourage manufacturers to register products for crops of small quantities.
5.1 Extend data protection for pesticides from 8 to 10 years.
The Committee thanks BAPHIQ for having included this recommendation in the draft amendment to the Pesticides Management Act submitted to the the Legislative Yuan for review on July 22, 2016. As there has been no further news since then, we urge the COA to liaise with the Legislative Yuan to complete the legislative process as soon as possible. Promulgation of an extended protection period will increase manufacturers’ willingness to invest in this market, enabling more new products with lower risks and higher efficacy to be imported into Taiwan to the benefit of domestic agriculture.
5.2 Encourage manufacturers to register products for small-volume crops by offering a longer period of registered data protection.
This issue also appeared in last year’s paper. The current practice in the United States is to provide new pesticides with 10 years of registered data protection, but the protection period for products to be used on small-volume crops can be extended for up to three additional years. We recommend that Taiwan also adopt this practice as a way to encourage manufacturers to register products aimed at crops of small quantities.