Toxicity and Limitations in Systemic Use
- Nitrofurans require concentrations at or above the Minimum Inhibitory Concentration (MIC) to treat systemic infections, which also produce systemic toxicity.
- Toxic effects include central nervous system symptoms (excitement, tremors, convulsions, peripheral neuritis), gastrointestinal disturbances, poor weight gain, and depression of spermatogenesis.
- Sensitivity reactions may also occur.
Carcinogenicity and Mutagenic Concerns
- Furazolidone, a nitrofuran derivative, has been extensively studied and shown to be carcinogenic in laboratory and food animals.
- Tumor development, including mammary tumors, has been linked to Furazolidone use in dose-related studies.
- The United States Food and Drug Administration (FDA) has classified nitrofurans as mutagens and carcinogens and prohibited their use since 1991.
International Regulatory Responses
- Germany’s Federal Health Office has withdrawn approval of veterinary nitrofuran products except furazolidone for food-producing animals.
- European Commission regulations list nitrofurans among substances with no permissible maximum residue limits in food of animal origin, except for furazolidone.
- Nitrofurazone and Furazolidone are banned in the USA for food-producing animals and are no longer approved as feed additives.
Philippine Government's Ban and Rationale
- Based on scientific evidence and international regulatory actions, the Philippine Department of Health’s National Drug Committee Subcommittee on Veterinary Drugs recommends banning nitrofurans in food-producing animals.
- The ban addresses health risks posed by residues in animal products consumed by humans.
Joint Administrative Order Provisions
- Nitrofurans are banned for use in all food-producing animals, including aquaculture, irrespective of administration route.
- Registration of nitrofuran products for food-producing animals is withdrawn; new applications will be disapproved.
- Enforcement agencies and personnel shall implement the ban and conduct public education regarding health risks.
Phase-out and Implementation Timeline
- Importation of nitrofurans banned after 29 February 2000.
- Manufacturers allowed to produce existing products only until 31 May 2000.
- Use of nitrofurans in food-producing animals prohibited entirely after 31 August 2000.
Signatories and Effectivity
- The order is jointly signed by the Secretary of Agriculture and the Secretary of Health.
- It mandates nationwide compliance to protect public health and uphold food safety standards.