Food Safety

The FDA’s Role in Food Safety of Imported Foods


The FDA Food Safety Modernization Act (FSMA) was created to ensure a safe food supply in the United States using specific measures which include the FDA’s authority to mandate additional preventive controls to this end.  Such preventative standards are applicable to both foreign and domestic food growers, manufacturers, processors, and packers.  For example, the preventive control rules for human and animal food production require manufacturers, processors, packers, and holders of foods to broadly institute current good manufacturing practices and, as appropriate, to apply preventive controls, including supply chain controls as appropriate.

“In addition to establishing food safety standards, FSMA grants FDA new and supplementary oversight and enforcement authorities to ensure industry is meeting these standards. While inspectional oversight remains the primary tool for domestic food producers and is an important tool for foreign producers, the U.S. Congress determined that more was needed to control the food safety risks associated with imported foods. Thus, FSMA creates a multilayered safety net with respect to imported food, specifying distinct roles for manufacturers, importers, third-party auditors, foreign regulatory bodies, FDA, and other stakeholders. FSMA provides FDA significant new tools and, more fundamentally, it mandates an agency shift in perspective; FDA is charged with creating an oversight system designed primarily to prevent food safety problems from occurring, preferably before the food arrives at our border or reaches the plates of U.S. consumers”.

One area of particular importance is the role of the FDA in border surveillance at the more than 300 active U.S. ports of entry to prevent the importation of unsafe foods.  Generally, the tools used are screening, examination, sampling and testing, and even more refined testing methods in this area are under development.  The FDA will utilize relationships with domestic and international food safety regulatory and public health partners to further identify food safety issues at points of entry and feedback loops will be developed for the intelligence gathered from multiple sources.

The FDAs Import Screening & Entry Review Processes

FDA electronically screens every one of the millions of shipments of food offered for import into the United States every year. Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) is FDA’s automated import screening tool. FDA uses PREDICT to identify higher-risk shipments of food offered for import. PREDICT screens all regulated shipments, considering multiple factors about each import shipment – everything from compliance history of the facility that produced the imported product to the level of risk associated with that product.

With that current intelligence, PREDICT assigns a risk score 1 to every imported food shipment, identifying higher-risk shipments for potential examination and expediting the clearance of lower-risk cargo.

FDA continues to assess opportunities to optimize import screening by incorporating new sources of intelligence with its current data. By optimizing import screening in this fashion, FDA is better able to identify and hold food offered for import when food poses a risk to public health.

Physical Examination & Screening of Imported Foods

Reviewing entry documents and conducting physical examination of the contents of food shipments offered for import is valuable, but resource intensive. Sampling and testing food before admitting it into the country can be an effective method for detecting contamination; however, it is labor-intensive and costly to industry as well as to the agency. FDA will use an approach to examination and sampling that targets the highest-risk products, allows regular monitoring and surveillance of imported products, facilitates targeted assignments to collect data that informs oversight activities, and assists with verification of other related programs. Smart work planning — using all available intelligence — is essential, as is the ability to adjust work plans when information supports reallocation of resources.

Use of Import Alerts & Certifications

Import alerts (IAs) are used to provide information to field staff when the agency has reason to believe that future shipments of a product offered for entry may appear to violate FDA laws or regulations. The agency uses a variety of data to determine if future shipments are likely to appear violative. IAs are incorporated into the electronic system that screens food shipments being offered for import, and this helps FDA communicate with field staff across all ports of entry.

After FDA detains a shipment that is listed on an IA, the importer has the opportunity to prove that the product it wants to import into the U.S. is safe. This helps FDA efficiently allocate oversight resources toward products warranting increased monitoring. IAs are usually specific to a manufacturer, importer, product, facility, or farm, and, if there is sufficient evidence, they may apply world-wide, country-wide, or area-wide. FDA may also list an entity on an IA when a foreign facility refuses inspection or when an importer is in violation of FSVP requirements.

FDA has the authority to make a risk-based determination to require, as a condition of admissibility, that a food imported or offered for import into the United States be accompanied by a certification or other assurance that the food meets the applicable requirements of the FD&C Act. The authority to mandate import certification for food, based on risk, is one of the tools we can use to help prevent potentially harmful food from reaching U.S. consumers. When FDA has determined that a food import is subject to such certification, FDA will require, as a condition of entry, a certification issued either by an accredited third- party certification body or by an agency or representative of the government of the country from which the food at issue originated, as designated by FDA.

Using Improved Testing Methods & Tools to Determine Admissibility

FDA scientists use hundreds of established, validated tests and screening methods to detect pathogens or contaminants in different types of food and food presentations. For example, FDA uses one method to test for the presence of E. coli on fresh leafy green vegetables and another method to test for the presence of drug residues in seafood. In cases where there is no satisfactory method to test for a pathogen or contaminant in a type of human food offered for import, FDA scientists are working to develop and validate new methods.

Scientists also are working to improve and expand our rapid screening analytical capabilities by developing methods and devices that produce results more quickly and that detect more than one kind of contaminant. Using rapid screening methods and devices when examining shipments of food offered for import makes FDA border operations more efficient and allows the agency to make quicker admission decisions.

Border Surveillance Through Partnerships

Under certain circumstances, states conduct sampling and analyses of higher-risk imported foods — once they have entered commerce in their jurisdictions — and they share findings with FDA that may indicate significant food safety problems. FDA will continue to support collaborations and shared communications with state regulatory partners. This is a foundational element of our nation’s strategy for supporting and ensuring an effective and efficient Integrated Food Safety System by leveraging the work, expertise, resources, and authorities of partner agencies with food safety responsibilities. FDA also will continue to encourage participation in organizations and networks that support the speed and accuracy of signal detection and response by providing platforms for sharing scientific evidence of food safety problems internationally.

Determining the best way to use the full range of available tools across the different segments of the international food-supply chain — in ways that decrease public health risks while maintaining a level playing field for domestic and foreign producers — requires both dexterity and pragmatism.

The above information describes the FDA’s strategic approach to imported food safety specifically at U.S. border crossings.  To read the entire strategy, please refer to the FDA Strategy for the Safety of Imported Foods which can be found at


USDA: FDA Strategy for the Safety of Imported Foods,

米国の食品安全強化法(FSMA)は、具体的な方策を使用して米国の食品供給の安全性を向上させるために制定されました。その方策のひとつとして含まれていたのが、追加的な予防統制を義務付ける権限を食品医薬品局(FDA)に与えたことです。その種の予防的な基準は、食品を栽培、製造、加工、梱包する国内外の事業体に適用されます。例えば、ヒト向け・動物向け食品のための予防的コントロール規則では、製造、加工、梱包を手がける事業体、および食品を貯蔵する事業体に対して、最新のGMPGood Manufacturing Practice)を幅広く導入し、またサプライチェーンのコントロールをはじめ適切な予防的コントロールを適宜運用することを義務付けています。





FDAは、米国に入ってくる年間数百万件に上る輸入食品の積荷を逐一、電子的に審査しています。「ダイナミック輸入コンプライアンス・ターゲッティングのための予測的リスクベース評価(Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting)」、略して「PREDICT」と呼ばれる自動化ツールを使用して、輸入時の審査を行っています。PREDICTを使用する目的は、相対的に高リスクな食品の積荷を特定することです。規制下にあるすべての積荷を審査して、その輸入食品を製造した工場の過去のコンプライアンス履歴から、その食品自体に関連付けられたリスクのレベルまで、あらゆる要因を積荷ひとつずつ対して確認します。PREDICTは、その最新情報を基に、すべての輸入食品の積荷にリスクスコアを付け(、リスクが高いものは検査の候補、リスクが低いものは迅速通関の候補としてマークします。














今回紹介した情報は、輸入食品の安全性を特に米国に入る時点で統制するためのFDAの戦略的アプローチです。戦略の全文は、www.fda.govにある「FDA Strategy for the Safety of Imported Foods(輸入食品の安全性ためのFDAの戦略)」をご覧ください。



USDA: FDA Strategy for the Safety of Imported Foods(米農務省:輸入食品の安全性のためのFDAの戦略)、


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