Helping to make new, international-standard pesticides offering improved safety and efficacy available in Taiwan for the benefit of farmers and consumers.
The launch of the Pesticide Registration Inquiry System 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 Ministry of Health and Welfare (MOHW) for gradually resuming the setting of maximum residue limits (MRLs) on pesticides from January this year, and for establishing a “Pesticide MRL Inquiry System” for easier access of related information. However, the Committee notes that MOHW has not yet provided a definite schedule for the MRL review process.
The Committee would also like to emphasize the importance of aligning domestic pesticide-related laws and policies with international standards, as well as encouraging the steady introduction of new pesticides offering improved safety and efficiency. It is also important to clearly define the residue limits for domestic pesticide so as to ensure compliance, promote crop exports, and enhance the value of Taiwan agriculture.
We offer the following suggestions as ways to help protect the environment, food safety, and the health of both consumers and agricultural workers.
Suggestion I: Divulge the methodology and schedule for setting pesticide MRLs.
Pesticide maximal residue levels need to be set in accordance with scientific methods. The Committee found that the limit defined by the Taiwan Food and Drug Administration (TFDA) in many cases is inconsistent with the accepted method used for application of the pesticide on the crop. We urge TFDA to clarify the methodology and theoretical basis for their calculation, such as a formula based on the acceptable daily intake (ADI) value or any deviations from the standard formula.
Suggestion 2: Rely on international best practice to establish product specification validations.
A. Internationally, suspensibility tests conducted as part of the testing for pesticide quality are based on specifications set by the Collaborative International Pesticides Analytical Council. However, the suspensibility test method used in Taiwan is based on the CIPAC MT15 standard announced in 2000, whereas the current international standard is CIPAC MT184, resulting in disqualification. The committee strongly recommends updating the Taiwan method to align it with the latest standard, CIPAC MT181.4.
B. While the current test method for dispersion stability references CIPAC MT180, the sample volume of 5 grams is not consistent with that of international practice. The Committee suggests adjusting the sampling volume based on CIPAC MT180 plus the volume of usage registered.
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.”
The Committee urges the authorities to interpret this requirement as referring to products as they are manufactured or imported, but not to demand the recall of products already in the marketplace, which would constitute a waste of resources and involve the risky exposure of workers during the repacking operation.
Further, there is no need to recall products already on the market and repackage them with a new label, since the descriptions and instructions on the originally approved label still provide accurate information for use by farmers. Therefore, the authorities need only require that new labels are incorporated on the packaging of products entering the market six months after the change in indication.
Suggestion 4: Give parallel approval for use on domestic crops to imported and domestic pesticides with the same registered active ingredients.
As the Committee has pointed out in the past several years’ White Papers, the documents required for residue-tolerance import applications are identical to those required for domestic registration. We therefore 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. The efficacy study could be considered as an optional requirement. Creating such a mechanism would ensure that Taiwanese farmers have the same opportunity as farmers from other countries.
Suggestion 5: Implement the new active-ingredient test data protection period of 10 years as soon as possible.
The Committee wishes to express it gratitude to BAPHIQ for extending the new active-ingredient data protection period in the Agro-pesticides Management Act from 8 to 10 years on May 23, 2018. However, the Executive Yuan has yet to determine the schedule for this revision to become effective. The Committee suggests that the Legislative Yuan consider removing the requirement, written into the amended law, that the extended period would go into effect only upon Taiwan’s participation in the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP). The extension would benefit the domestic agricultural industry with more incoming investments as well as 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.