The launch of the Pesticide Registration Inquiry System in January 2018 has helped improve administrative efficiency by making all applications and submissions available online. We appreciate the efforts of the Council of Agriculture’s Bureau of Animal and Plant Health Inspection and Quarantine (BAPHIQ) and its Taiwan Agricultural Chemicals and Toxic Substances Research Institute (TACTRI) in developing the Inquiry System.
The Committee also wishes to express its gratitude to the Taiwan Food and Drug Administration (TFDA) for updating the pesticide import tolerance application to bring it in line with international standards. However, the Committee notes that TFDA has not yet provided a definite schedule for the maximum residue level (MRL) review process.
The Committee recommends that domestic pesticide-related laws and policies be regularly updated to enhance the value of Taiwan agriculture by encouraging the steady import of advanced pesticides offering improved safety and efficacy.
This year, we offer the following specific suggestions as ways to help protect the environment, food safety, and the health of both consumers and agricultural workers.
Suggestion 1: Update the methodology for calculating the ADI risk cup and divulge the schedule for setting pesticide MRLs.
The Committee looks forward to the JMPR (Joint FAO/WHO Meeting on Pesticide Residues) announcement regarding the Acceptable Daily Intake (ADI) per active ingredient in order to have a transparent means to calculate the ADI “risk cup” or acceptable exposure level. The Committee has found that in many cases when the ADI “risk cup” exceeds 70%, a further assessment by age group may be requested. If the calculation for any age group exceeds 80%, the crop residue tolerance cannot be increased.
We would like to urge the Council of Agriculture (COA) to change the method of calculating the ADI risk cup from Theoretical Maximum Daily Intake (TMDI) to Estimated Daily Intake (EDI), which would provide a more accurate assessment of the actual intake by consumers in Taiwan.
In addition, despite a COA committee’s review of the schedule for setting MRLs for pesticides, the schedule has not yet been announced. We urge the TFDA to adhere to a schedule of publishing the timetable for residual tolerance cases within six months of completion of the COA review – which had been the predictable timeline before 2017. The current delay is impacting farmers’ ability to use the latest pesticides.
Suggestion 2: Rely on international best practice to establish product specification validations.
Internationally, suspensibility tests conducted as part of the testing for pesticide quality are based on specifications set by the Collaborative International Pesticides Analytical Council (CIPAC). However, the suspensibility test method used in Taiwan is based on the CIPAC MT15 standard announced in 2000, whereas the most updated CIPAC method based on new formulations is CIPAC MT 184.1 released in 2019.
The outdated standard is no longer applied in the pesticide manufacturing process, making it difficult to ask manufacturers to conduct individual testing to meet Taiwan’s requirement. The Committee urges COA to adopt the latest methods published by CIPAC.
Suggestion 3: Amend the “Replacement Rules Concerning Pesticides Indication” for the Agro-pesticides Management Act.
Article 14 of the Act says: “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.”
But there is no need to recall products already on the market and repackage them with new labels when the original descriptions and instructions still provide accurate relevant information for use by farmers. For example, a change in the location of the manufacturing plant, extension of the expiry date, or revised label design should not be sufficient cause for the product to be withdrawn and relabeled.
The Committee recommends that pesticides continue to be permitted to be sold until the expiry date if the changes in indications are not related to product safety.
This issue was presented in last year’s Taiwan White Paper but did not result in any change in policy. The Committee respectfully requests that BAPHIQ give our request full consideration.
Suggestion 4: Permit use of the residue-tolerance data for imports for evaluating new uses for domestic pesticides.
Although the requirement for efficacy trials as part of the application for import tolerance has been canceled, such reports are still an optional condition for registration of a new active ingredient or label expansion. We recommend simultaneous use of the same dossiers for applications for import tolerance and for registration of a new active ingredient or label expansion.
Creating such a system would ensure that Taiwanese farmers have the same opportunity as farmers from other countries. It would also save time in the evaluation and registration process.
If the efficacy trial data submitted is in line with Taiwan’s regulations, the import residue tolerance data for given crops could also be used in evaluating new uses for domestic products.
Suggestion 5: Implement the new active ingredient test data protection period of 10 years as soon as possible.
In May 2018, BAPHIQ extended the new active-ingredient data protection period under the Agro-pesticides Management Act from 8 to 10 years. However, as pointed out in the 2019 Taiwan White Paper a year ago, the Executive Yuan has been unable to put this revision into effect due to a requirement in the amended law that the change would take place only upon Taiwan’s accession to the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP).
The Committee urges the Legislative Yuan to remove this requirement as soon as possible. Extending the protection period would benefit the domestic agricultural sector by encouraging more new investment in the pesticide market, particularly the registration of new low-risk, high-efficiency products.
Those benefits should not be made contingent on Taiwan’s entry into a multilateral agreement – something that is beyond its control. At the same time, the legislature should extend the data protection period further to cover minor crops.