Import Alert 99-48
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 99-48
Published Date: 03/19/2024
Type: DWPE
Import Alert Name:
Detention without Physical Examination of Foods Due to Chemical Contamination
Reason for Alert:
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 posed by these chemicals.
For example, Per- and polyfluoroalkyl substances (PFAS) are a diverse group of human-made chemicals used in a wide range of consumer and industrial products. PFAS do not easily breakdown and some types have been shown to accumulate in the environment and in our bodies. Exposure to some types of PFAS have been linked to serious health effects.
The FDA has not set levels for most chemical contaminants in food, including PFAS. However, the FDA generally has taken the approach of assessing, on a case-by-case basis, whether the type and level of the contaminant found in the food may pose a health concern, such that the food is considered to be adulterated in that the levels may render the food injurious to health.
This Import Alert covers specific firms and their food products with levels of chemical contaminants that may render a product 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.
When the FDA finds detectable levels of a chemical contaminant in food, the agency conducts a safety assessment to evaluate whether the levels present a possible human health concern and warrant further FDA action. The FDA's approach considers a number of factors, including, but not limited to, whether there is an established action level or tolerance, how much of the food people typically eat, the level of the contaminant detected in that food, and the toxicity of the specific contaminant(s). As part of the FDA's ongoing effort to use the best available current science to assess the safety of exposure to PFAS from foods, the agency monitors the scientific literature and available toxicological reference values for PFAS and updates the values we use in our evaluations as warranted.
In 2022, FDA conducted a targeted survey for PFAS analytes in 81 seafood samples collected at retail consisting of clams, cod, crab, pollock, salmon, shrimp, tuna, and tilapia, most of which were imported to the United States. The FDA determined that the estimated exposure to perfluorooctanoic acid (PFOA), a type of PFAS, from the samples of canned clams from China, is likely a health concern.
Note: This alert does not cover hazards/products addressed by other import alerts, such as:
- Pesticides in Raw Agricultural Products covered by Import Alert 99-05.
- Pesticides in Processed Foods covered by Import Alert 99-08.
- Countrywide DWPE of Raw Agricultural Products for Pesticides covered by Import Alert 99-14.
- Countrywide DWPE of Processed Foods for Pesticides covered by Import Alert 99-15.
- Food Products Due to the Presence of Melamine or Melamine Analogs covered by Import Alert 99-31;
- Foods Due to Heavy Metal (Toxic Element) Contamination covered by import alert 99-42.
- Foods containing Unsafe Food Additives covered by import alert 99-45.
For example, Per- and polyfluoroalkyl substances (PFAS) are a diverse group of human-made chemicals used in a wide range of consumer and industrial products. PFAS do not easily breakdown and some types have been shown to accumulate in the environment and in our bodies. Exposure to some types of PFAS have been linked to serious health effects.
The FDA has not set levels for most chemical contaminants in food, including PFAS. However, the FDA generally has taken the approach of assessing, on a case-by-case basis, whether the type and level of the contaminant found in the food may pose a health concern, such that the food is considered to be adulterated in that the levels may render the food injurious to health.
This Import Alert covers specific firms and their food products with levels of chemical contaminants that may render a product 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.
When the FDA finds detectable levels of a chemical contaminant in food, the agency conducts a safety assessment to evaluate whether the levels present a possible human health concern and warrant further FDA action. The FDA's approach considers a number of factors, including, but not limited to, whether there is an established action level or tolerance, how much of the food people typically eat, the level of the contaminant detected in that food, and the toxicity of the specific contaminant(s). As part of the FDA's ongoing effort to use the best available current science to assess the safety of exposure to PFAS from foods, the agency monitors the scientific literature and available toxicological reference values for PFAS and updates the values we use in our evaluations as warranted.
In 2022, FDA conducted a targeted survey for PFAS analytes in 81 seafood samples collected at retail consisting of clams, cod, crab, pollock, salmon, shrimp, tuna, and tilapia, most of which were imported to the United States. The FDA determined that the estimated exposure to perfluorooctanoic acid (PFOA), a type of PFAS, from the samples of canned clams from China, is likely a health concern.
Note: This alert does not cover hazards/products addressed by other import alerts, such as:
- Pesticides in Raw Agricultural Products covered by Import Alert 99-05.
- Pesticides in Processed Foods covered by Import Alert 99-08.
- Countrywide DWPE of Raw Agricultural Products for Pesticides covered by Import Alert 99-14.
- Countrywide DWPE of Processed Foods for Pesticides covered by Import Alert 99-15.
- Food Products Due to the Presence of Melamine or Melamine Analogs covered by Import Alert 99-31;
- Foods Due to Heavy Metal (Toxic Element) Contamination covered by import alert 99-42.
- Foods containing Unsafe Food Additives covered by import alert 99-45.
Guidance:
Divisions may detain without physical examination shipments of identified products from firms identified on the Red List of this Alert.
Recommendations for additions to the Red List may be forwarded to the Division of Import Operations (DIO). DIO and FDA's Center for Food Safety and Applied Nutrition (CFSAN) may evaluate regulatory packages on a case-by-case basis.
Release of Articles Subject to Detention without Physical Examination under This Import Alert:
In order to secure release of an individual shipment subject to detention without physical examination under this alert, the owner, consignee, and/or another responsible party to the shipment may provide evidence to FDA that the shipment is not adulterated. Such evidence may include the results of private laboratory analysis of a representative sample of the shipment, which demonstrates that the product does not bear or contain levels of chemical contaminants which may render it injurious to health.
Evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze an audit sample before rendering a final decision on the admissibility of the article.
Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm/product from DWPE, information should be provided to the FDA to adequately demonstrate that the firm in question has resolved the conditions that gave rise to the appearance of the violation, so that the Agency will have confidence that future entries will be in compliance. For guidance on removal from DWPE, refer to FDA's 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 detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov.
Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
Recommendations for additions to the Red List may be forwarded to the Division of Import Operations (DIO). DIO and FDA's Center for Food Safety and Applied Nutrition (CFSAN) may evaluate regulatory packages on a case-by-case basis.
Release of Articles Subject to Detention without Physical Examination under This Import Alert:
In order to secure release of an individual shipment subject to detention without physical examination under this alert, the owner, consignee, and/or another responsible party to the shipment may provide evidence to FDA that the shipment is not adulterated. Such evidence may include the results of private laboratory analysis of a representative sample of the shipment, which demonstrates that the product does not bear or contain levels of chemical contaminants which may render it injurious to health.
Evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, Volume III, Section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze an audit sample before rendering a final decision on the admissibility of the article.
Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm/product from DWPE, information should be provided to the FDA to adequately demonstrate that the firm in question has resolved the conditions that gave rise to the appearance of the violation, so that the Agency will have confidence that future entries will be in compliance. For guidance on removal from DWPE, refer to FDA's 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 detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov.
Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
Product Description:
Various Food Products
Charge:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains: [Adulteration, Section 402(a)(1)]
OASIS charge code - POISONOUS
OASIS charge code - POISONOUS