President Obama has signed into law a new act that includes several changes to the United States' food safety rules. Significantly, the law – the FDA Food Safety Modernization Act – includes new rules that will apply to foreign food exporters and also to importers to the United States of food products.

I. Introduction

This new law puts prevention up front for the U.S. Food and Drug Administration (FDA). For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. Under the Act, implementation of mandatory preventive controls for food facilities and compliance with mandatory produce safety standards will be required. Food facilities will be required to implement a written preventive control plan, provide for the monitoring of the performance of those controls, and specify the corrective actions the facility will take when necessary.

The following are the key areas of the law:

  • Preventive Controls. For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply;
  • Inspection and Compliance. The legislation recognizes that inspection is an important means of holding an industry accountable for its responsibility to produce safe food; the new law specifies how often FDA should inspect food producers. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches;
  • Imported Food Safety -- New Requirements for Foreign Food Producers and Their Importers. FDA has new tools to ensure that those imported foods meet U.S. standards and are safe for consumers. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety. FDA will be able to accredit qualified third-party auditors to certify that foreign food facilities are complying with U.S. food safety standards; and
  • Recalls. For the first time, FDA will have mandatory recall authority for all food products. FDA expects to invoke this authority infrequently since the food industry largely honors requests for voluntary recalls.

II. Summary Of Key Aspects For Foreign Food Companies, Exporters And U.S. Importers

The key aspects of the program, as it relates to foreign food companies and their importers, are as follows:

  1. Authorizes the U.S. Government to inspect company records related to food. Records include all information relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of food held "at any location." The law requires the government to inspect not fewer than 600 foreign facilities in the first year; 1,200 in the second year; 2,400 in the third year; 4,800 in the fourth year; 9,600 in the fifth year; and 19,200 in the sixth year. The likelihood of inspection increases with time.
  2. Requires each owner, operator, or agent in charge of a food facility (including foreign food facilities) to identify and implement preventive controls to significantly minimize or prevent hazards that could affect food manufactured, processed, packed, or held by such facility. Preventive controls are defined as procedures, practices and processes that may include the following:

    1. Sanitation procedures for food-contact surfaces and utensils, and food-contact surfaces of equipment;
    2. Supervisor, manager and employee hygiene training;
    3. An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a good is exposed to a potential contaminant in the environment;
    4. A food allergen control program;
    5. A recall plan; and
    6. Supplier verification activities that relate to the safety of food.

  3. Requires U.S. importers to perform risk-based foreign supplier verification activities to verify that imported food is produced in compliance with applicable requirements related to hazard analysis and is not adulterated or misbranded. The Government will issue regulations within one year (i.e., by January 4, 2012) to provide importers with further guidance on these verification activities. The law, however, notes that verification activities of a U.S. importer may include "monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments." The importer must maintain records related to these activities for a minimum of two years.
  4. Requires a certification that an article of food imported or offered for import complies with applicable requirements of the law.
  5. Requires food to be refused admission to the United States if permission to inspect the food facility is denied by the facility owner, operator, or agent of the foreign country.
  6. Establishes a voluntary qualified importer program. Participants will be charged a fee to cover administrative costs of this program each year. According to the law, the benefit of registering as a voluntary qualified importer is that it provides "for the expedited review and importation of food offered for importation." Although there is nothing in the law stating why failure to participate in the "voluntary qualified importer program" should necessarily lead to longer (that is, unexpedited) reviews, the whole purpose of the voluntary program is to give preference to those companies who participate voluntarily.
  7. Establishes minimum standards for the safe production and harvesting of fruits and vegetables based on known safety risks, whether foreign or domestically farmed.
  8. Requires farms, including foreign farms, to keep records to help the government trace recalled foods. Additionally, we note that there are no new labeling requirements associated with this law.

The provisions of the law will take effect no later than July 3, 2011 (potentially earlier, if regulations are finalized prior to that date).

III. Next Steps

The next step will be for the FDA to issue draft regulations; it will provide interested parties an opportunity to submit comments. Foreign food companies, exporters and U.S. importers will have the right to submit comments. Because foreign food companies and their importers are affected by the new rules, they should begin to review their business practices to ensure their ability to comply with the new procedures. We can assist foreign food companies, exporters and importers to submit comments once the FDA issues proposed regulations. In addition, we can assist foreign food companies, exporters and importers in complying with the new requirements -- including establishing compliance plans.

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