Ministry of Health, Labour and Welfare (MHLW) has conducted food safety assessment of the genetically modified (GM) plants generated by conventional breeding among approved GM plants (hereinafter called “stacked trait products”). Food safety assessment procedure of stacked trait products was revised in 2014. The safety assessment policies will continue to be updated, based on the collected knowledge and experience.
FSCJ conducted a risk assessment of monepantel (CAS No.887148-69-8), a parasiticide based on results from various studies. Data on pharmacokinetics (cattle) and residues (cattle) were newly submitted. Negative results were obtained in all genotoxicity and carcinogenicity studies. The no-observed-adverse-effect level (NOAEL) obtained in all studies was 100 ppm (equivalent to 3 mg/kg bw per day for both sexes). In the 52-week chronic toxicity study in dogs, FSCJ specified an ADI for monepantel at 0.03 mg/kg bw per day based on NOAEL of 3 mg/kg bw per day, by applying a safety factor of 100.
FSCJ conducted the risk assessment of a fungicide, dichlobentiazox (CAS No.957144-77-3), having benzoisothiazole and isothiazole rings, based on results from various studies.The data used in the assessment include fate in animals (rats) and in livestock (goats), fate in plants (paddy rice), residues in crops, subacute toxicity (rats, mice and dogs), chronic toxicity (dogs), carcinogenicity (rats and mice) and other relevant study results. This chemical showed none of carcinogenicity, reproductive toxicity, teratogenicity and genotoxicity. The lowest no-observed-adverse-effect level (NOAEL) obtained in all studies was 5.03 mg/kg bw per day in a two-year chronic toxicity/carcinogenicity study in rats. FSCJ specified an acceptable daily intake (ADI) of 0.05 mg/kg bw per day by applying a safety factor of 100 to the NOAEL.
FSCJ conducted a risk assessment of an antimicrobial, flumequine (CAS No. 42835-25-6), based on reports of JECFA (Joint FAO/WHO Expert Committee on Food Additives) and EMEA (European Medicines Agency) and other documents including the mechanism for liver tumor. Data used in the assessment include pharmacokinetics, acute toxicity, subacute toxicity, chronic toxicity/carcinogenicity, reproductive toxicity, genotoxicity, and microbiological effects. FSCJ specified the ADI of flumenquine as 0.071 mg/kg bw per day, that is the microbiological ADI calculated using the equation for VICH.
FSCJ conducted a risk assessment of fluxametamide (CAS No. 928783-29-3), an isoxazoline insecticide, based on results from various studies. The data used in the assessment include the fate in animals, fate in plants, residues in crops, subacute toxicity, subacute neurotoxicity, chronic toxicity, combined chronic toxicity/carcinogenicity, carcinogenicity, two-generation reproductive toxicity, developmental toxicity, and genotoxicity. Alveolar macrophage accumulation, vacuolated epithelial cells in the small intestine, and hepatocellular vacuolation are observed in various toxicity studies. Increased incidences of thyroid follicular cell adenoma in male rats and of hepatocellular adenoma in male mice were observed in carcinogenicity studies. However, a genotoxic mechanism was unlikely to be involved in the tumor increases. FSCJ specified an acceptable daily intake (ADI) of 0.0085 mg/kg bw per day, applying a safety factor of 100 to the NOAEL, 0.85 mg/kg bw per day, that was derived from the two-year combined chronic toxicity/carcinogenicity study in rats.