Fluralaner can be used for mite control in poultry farming; the Food and Drug Administration has announced a draft residue tolerance limit
The Food and Drug Administration under the Ministry of Health and Welfare has announced a draft amendment to Article 3 of the "Standards for Veterinary Drug Residues," setting residue standards for Fluralaner used in chicken meat and eggs and other products. Fluralaner can be used as an antiparasitic and is a medication for lice and mite control. The Food and Drug Administration, referencing regulations from the European Union and New Zealand, has announced draft residue standards for Fluralaner in chicken meat, eggs, chicken skin, and chicken offal, with a 60-day announcement period; meanwhile, the Bureau of Animal and Plant Health Inspection and Quarantine under the Council of Agriculture stated that another drug technical review meeting will be convened to discuss the withdrawal period.
The incident of fipronil pesticide residues in eggs dealt a blow to consumers' confidence in egg food safety. Chicken lice are a problem in poultry farming, which is the reason a very small number of poultry farmers resort to fipronil when disinfecting chicken coops. Domestic poultry farmers indeed face the difficulty of having no available medication when dealing with chicken lice. The Council of Agriculture revealed in February this year that alternative medications to fipronil were under review. A drug technical review meeting was recently convened and approved the manufacturer's application, meaning the Council of Agriculture has planned to approve Fluralaner for treating red mite infections in chickens. The Food and Drug Administration has established testing methods and announced draft residue standards. Next, the Council of Agriculture will convene another drug technical review meeting to discuss withdrawal period regulations.
Hsu Jung-pin, head of the Animal Epidemic Prevention Division at the Bureau of Animal and Plant Health Inspection and Quarantine under the Council of Agriculture, stated that fipronil cannot be used for deworming and lice removal in chickens, but chicken lice are sometimes encountered in poultry farming. The pharmaceutical company applied to the Council of Agriculture for approval to use Fluralaner. After review by the Council of Agriculture's technical review committee, it was deemed usable. Therefore, the Food and Drug Administration formulated our country's Fluralaner residue tolerance limits by referencing the residue standards of the European Union and New Zealand.
The trade name of the Fluralaner product for which the manufacturer applied for approval is Exzolt. It is administered by mixing with water and giving it to chickens to drink. This is an antiparasitic treatment course, administered only when deworming is needed. The dosage is calculated according to the chicken's body weight, at 0.5 mg per 1 kg. The withdrawal period still needs to be confirmed.
According to the announced draft amendment to the veterinary drug residue tolerance limits, Fluralaner can only be used in chickens. The residue tolerances for each part are as follows: muscle 0.06 ppm, liver 0.6 ppm, kidney 0.4 ppm, fat and skin 0.6 ppm, eggs 1 ppm. The residue parts and residue tolerance limits all follow the New Zealand standards.
The Food and Drug Administration explained the reasons for the amendment and the reference basis: since the Council of Agriculture has planned to approve Fluralaner for treating red mite infections in chickens, the residue tolerance limits are being added accordingly to meet practical and management needs. After discussion by the Ministry of Health and Welfare's Food Safety and Nutrition Advisory Council, the Fluralaner residue tolerance limits were established based on the drug's animal toxicological data, residue trials, and the results of exposure assessments based on the population's dietary intake. The draft amendment has a 60-day announcement period. If there are other opinions, they can be stated during the announcement period on the "Health and Welfare Laws and Regulations Retrieval System" or the "Public Policy Participation Platform -- Join the Discussion" webpage. The Food and Drug Administration will reference all parties' opinions before the official announcement.