Import Alert 99-51

Import Alert # 99-51

Published Date: 09/18/2025

Type: DWPE

Detention Without Physical Examination of Human Food Products That Appear To Have Been Prepared, Packed Or Held Under Insanitary Conditions Resulting in Chemical Contamination

The FDA oversees the safety of the U.S. food supply (domestic and imports) by monitoring for chemical contaminants in food and assessing the potential exposure and safety concerns posed by these chemicals.

For example, radionuclides such as Cesium-137 (Cs-137), a radioisotope of cesium, can be present in many places around the world as a result of contamination produced high in the atmosphere during nuclear testing. Cs-137 is created via nuclear reactions, such as occurring in nuclear power plants and is also commonly used in medical and other industrial applications. Elevated amounts of Cs-137 can be present at locations where contamination settled from accidents such as Chernobyl in 1986 and Fukushima in 2011.

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.”

Divisions may detain without physical examination shipments of identified products from firms on the Red List of this Alert.

The evidence to support recommendations for addition to the Red List of this Import Alert will be evaluated by the Human Foods Program (HFP) on a case-by-case basis. Recommendations for addition to the Red List require documentation of HFP concurrence. Final recommendations for DWPE additions to the Red List will be reviewed by the Division of Import Operations (DIO).

NOTE:
In cases where it appears that a product has been prepared, packed, or held under insanitary conditions, the appearance of a violation may not be resolved by reconditioning. If a firm is considering pursuing reconditioning, please contact the appropriate FDA Division compliance office listed in the FDA Notice of Action. Due to the heterogenous nature and distribution of some chemical contaminants, such as Cs-137, within food product, the FDA generally considers submission of only analytical results to be insufficient to overcome the appearance of the product having been prepared, packed, or held under insanitary conditions.

Removal from Detention Without Physical Examination (REMOVAL FROM THE RED LIST):

In order to remove a firms' product(s) from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).

Examples of such documentation may include:

1. Documentation of a root cause analysis to identify potential sources and routes of contamination such as a detailed evaluation of all aspects of their operations to identify potential sources, routes of contamination, and corresponding corrective actions. For example, documentation of a root cause analysis to identify potential sources and routes of contamination, as well as corrections that have been made to avoid future occurrence. Such evidence may include, but is not limited to, environmental and product testing, as well other evidence that demonstrates adequate control of the chemical hazard; AND

2. A written Food Safety Plan or HACCP plan, as applicable, that includes a written hazard analysis identifying hazards requiring a preventive control; written preventive controls/Critical Control Points; written procedures for monitoring, corrective actions, and verification; evidence of implementation of the plan; validation of any process controls; written recall plan, if required; to prevent the food from becoming adulterated.

If an inspection was conducted by the FDA or competent authority:

Documentation to demonstrate that inspectional observations or deviations identified by the FDA (or competent authority) have been corrected. Firms whose food products appear to be adulterated based on inspectional evidence should submit documentation demonstrating that corrections have been made to address the violations. This should include detailed descriptions of the specific steps taken to identify and correct deviations and/or the cause of the contamination, to reduce the likelihood that the problem will recur.

In addition, after reviewing these submissions outlined above, an FDA, foreign competent authority, or third-party inspection of the manufacturing facility may be necessary to verify the validity of the information submitted to the FDA, before considering removal of the firm from the Red List.

For further guidance on removal from detention without physical examination, refer to the FDA Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from DWPE under the Red List of this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov

Requests for removal from detention without physical examination under the Red List of this alert will be referred by DIO to HFP/Import Enforcement Branch for evaluation.
Questions or issues involving import operations, contact OII, Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov.

Questions or issues with regard to human food on policy, sample collection recommendations, or any other additional questions not directly related to a detained entry, should be addressed to HFP/Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov.

                                                                                                                                                                  

Various Human Food products

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that such article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4)]

OASIS CHARGE CODE: MFR INJ

AND

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions. [INSANITARY MANUFACTURING, PROCESSING, OR PACKING, Section 801(a)(1)]

OASIS CHARGE CODE: MFR INSAN

Desc: All Spice Products

Desc: All Spice Products

Desc: All Shrimp Products