Import Alert 99-51: Detention without physical examination of human food products that appear to have been prepared, packed or held under insanitary conditions resulting in chemical contamination

Cs-137 emits beta particles and gamma radiation that are associated with adverse health effects. Potential for health concerns following Cs-137 exposure depends on the dose and the duration of exposure. High doses lead to acute radiation syndrome. However, exposure to low doses spread out over a period of time may not cause immediate apparent adverse effects but may still be harmful. The primary health effect of concern following longer term, repeated low dose exposure (e.g., through consumption of contaminated food or water over time) is cancer, resulting from damage to DNA within living cells of the body.

The FDA considers the totality of the circumstances, on a case-by-case basis, to determine whether a food appears to have been prepared, packed, or held under insanitary conditions whereby it has become contaminated with a chemical contaminant that may have rendered it injurious to health. Evidence may be obtained through analytical results and/or other information available to the Agency that demonstrates the environment associated with the food or the circumstances involved in producing the food may have caused the food to be contaminated with chemical contaminants. These findings and/or conditions may necessitate the need for documentation demonstrating corrective actions identifying and addressing the root cause of the contamination; the establishment of controls to ensure future shipments are not adulterated to overcome the appearance of adulteration; and verification that the controls are effective at preventing contamination.

This Import Alert covers specific firms and their food products that appear to have been prepared, packed, or held under insanitary conditions in which chemical contamination may have rendered the article of food injurious to health and that may be detained without physical examination in accordance with the guidance in FDA's Regulatory Procedures Manual (RPM) Chapter 9-8.

Note: This alert does not cover hazards/products addressed by other import alerts, such as:

- Import Alert 99-05,"Detention Without Physical Examination Of Raw Agricultural Products for Pesticides." - Import Alert 99-08, "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides.” - Import Alert 99-14, "Countrywide Detention Without Physical Examination Of Raw Agricultural Products for Pesticides.” - Import Alert 99-15, "Countrywide Detention Without Physical Examination of Processed Foods for Pesticides.” - Import Alert 99-31,"Detention Without Physical Examination of Food Products Due to the Presence of Melamine and/or Melamine Analogs." - Import Alert 99-42, “DETENTION WITHOUT PHYSICAL EXAMINATION OF FOODS DUE TO HEAVY METAL (TOXIC ELEMENT) CONTAMINATION.” - Import Alert 99-45, “Detention Without Physical Examination of Food Products That Are or Contain an Unsafe Food Additive.” -Foods Due to Chemical Contamination covered by Import Alert 99-48, “Detention without Physical Examination of Foods Due to Chemical Contamination.”