Food Safety Modernization Act (FSMA) and Food Imports

It took 73 years to update the Food, Drug, and Cosmetic Act of 1938, but when the Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011, the changes were dramatic and in some cases radical. The reasons for updating the law are well known and represent a combination of factors. Among these are:

• The continuing high level of adverse health effects, including 3,000 deaths, some 275,000 hospitalizations, and 40 million cases of diarrhea per year.
• Much longer and more complicated worldwide food supply chains.
• An increasing number of foreign food manufacturing facilities which export to the U.S. Today there are some 300,000 food plants which produce and export foods to the U.S.
• A greater dependence on a few countries for key food groups such as seafood and perishables (grains, fruits, vegetables).
• An FDA hamstrung by outdated laws and regulations.
• While the regulations are being published, consulted, and finalized with a final implementation date of June 15, 2015, the changes, additions, and enhancements to improve food safety in the supply chain are pretty obvious, especially for imported foods and beverages.
   

FSMA was structured under four titles:

• Title I – Improving Capacity to Prevent Food Safety Problems, containing sections 101 through 116 that apply to domestic and foreign facilities and are aimed at preventing unintentional and intentional adulteration.
• Title II – Improving the Capacity to Detect and Respond to Food Safety Problems, containing sections 201 through 211 that enhance the FDA’s statutory authority to be more proactive in detecting and responding to potential and real food safety problems. This section applies to foreign and domestic food producers.
• Title III – Improving the Safety of Imported Foods, containing sections 301 through 307 that apply to foreign manufacturing facilities which produce and export food products to the U.S., as well as the U.S. importers of these foreign-made food products.
• Title IV – Miscellaneous Provisions, section 402 on employee protections.
   

From the above, it is clear that only foreign food suppliers and U.S. importers are subject to Title III. This article explores the significance and implications of certain sections in Titles I, II, and III for both the foreign suppliers and importers in the U.S.

Under FSMA, an importer can be one of three options: the person in the U.S. who purchased the food being offered for import; if there is no such purchaser at the moment of import, it will be the consignee of the imported food; and in the absence of such consignee, it will be the agent or legal representative of the eligible entity which exported the food to the U.S.

The foreign supplier or eligible entity in the foreign country is the establishment which raised the animal, harvested the food, or manufactured/processed the food product to be exported to the U.S.

Certain sections of FSMA have profound implications for foreign suppliers and importers of food.
 

Title III – Section 301. Foreign Supplier Verification Program

Unless specifically exempt or subject to modified requirements, Section 301 “would require importers to implement a Foreign Supplier Verification Program (FSVP) that provides adequate assurances that the importer’s foreign suppliers produce food in compliance with processes and procedures, including risk-based preventive controls, that provide the same level of public health protection as those required under sections 418 (hazard analysis and preventive controls), 419 (produce safety), 402 (adulteration), and 403(w) (misbranding regarding allergen labeling) of the FD&C Act.”

This is a fundamental shift in oversight of imported foods from one relying on inspection of imported foods at the port of entry to a system which places the responsibility for food safety on the foreign supplier and the importer. This shift helps overcome the reliance on a very limited amount of food products being inspected at the entry point which, today, is less than 2% of all food products imported.

In order to demonstrate such assurances, importers will be required to develop, maintain, and follow a written FSVP which contains the following elements:

1. Hazard Analysis and Risk-Based Preventive Controls (Title I, Section 103).
Prior to importation and for each food product to be imported, the importer will have to undertake a hazard analysis or review and evaluate one undertaken by the foreign supplier, in order to assure that the product is manufactured under conditions which meet Sections 418, 419, 402, and 403(w) of the FD&C Act. This initial evaluation and subsequent periodic follow-up verification activities must be done by a “qualified individual.”

2. Supplier Verification Activities.
Before importing food products from a foreign supplier, the importer must review the compliance status of the food(s) and the potential foreign supplier, including whether the FDA has issued warning letters or import alerts on the food(s) or the supplier, or whether a certification (Title III - Section 303; high risk products) is required by the FDA as related to the safety of the food intended for export to the U.S. This information is available at www.fda.gov.

After the initial hazard analysis and compliance status review of the food and the foreign supplier the importer will have to carry certain verification activities to assure continued adequate controls are being maintained and documented by the foreign supplier, of the hazards identified as reasonably likely to occur in the food they are importing. FDA has proposed two options:

• Option #1 would require on-site audits of the foreign supplier by a qualified individual when exposure to identified hazards has a reasonable probability to result in serious adverse health consequences or death to humans and animals (SAHCODHA). For lesser hazards, the importer could rely on other verification activities such as periodic review of supplier’s records, product sampling and testing, and even audits.
• Option #2 would require the importer to “consider the risk presented by the hazard, the probability that exposure to the hazard would result in serious harm and the food and foreign supplier’s compliance with United States food safety regulations” to decide which verification activities will be carried out periodically to assess compliance. These verification activities are the same as in Option #1. The basic difference is that Option #1 makes an on-site visit mandatory for hazards which can result in serious adverse health consequences or death to humans and animals, while Option #2 makes it optional.
   

There could be situations where the hazard is not controlled by the foreign supplier, but is controlled by the importer or the client(s) of the importer. In these cases, if the importer controls the hazard he or she will have to develop, implement, and document effective preventive hazard controls; if the hazard is controlled by the client(s) of the importer, the importer must annually obtain written documentation from client(s) regarding the preventive control measures taken.

Other verification activities to be carried out by the importer include:

• Review complaints, investigate adulteration or misbranding (with respect to allergen labeling), and take (documented) corrective actions in the case of supplier noncompliance.
• Reassess the effectiveness of the FSVP when the importer becomes aware of new information about potential hazards associated with the food or otherwise every three years.
• Assure that the importer’s name and Dun and Bradstreet Data Universal Numbering System (DUNS) number are provided for each line entry.
• Maintain records of FSVP activities.
  
  
  

3. Records.
The importer will have to keep all records in English, sign and date them, maintain them for at least two years after the records were created or obtained, and have them available to the FDA upon request.

4. Consequence of Failure to Comply.
Under Title III - Section 301, the importation of food without an appropriate FSVP is a prohibited act subject to injunction and criminal prosecution. So it benefits both foreign suppliers and importers to start, sooner rather than later, to assess their current compliance status with Section 301, identify gaps and weaknesses, and begin making plans to develop and implement necessary changes and additions to their current food safety program. A proactive and timely approach can go a long way in minimizing noncompliance issues once this regulation becomes effective on June 15, 2015.
 

Title II – Section 207. Administrative Detention of Food

The FDA has maintained the authority to detain (hold) food since the implementation of the Bioterrorism Act of 2002. However, under FSMA, the criteria now used by the FDA to decide whether or not to detain food has changed.

Prior to FSMA, the FDA had the authority to detain food if there was credible evidence that the food would cause serious adverse health consequences or death to humans and animals (SAHCODHA). Under FSMA, the new threshold to detain food is that there is reasonable belief that the food will cause SAHCODHA. In other words, the FDA has lessened the criteria used to decide whether a food product shall be detained.

What is the difference? One can think of “credible evidence” as something discernibly obvious, (e.g., an adulterated product or the lack of a food safety program in a processing facility), absence of needed food safety-related documentation, or an obvious violation of a regulation. On the other hand, the decision criteria of “reasonable belief” relies more on evidence obtained through appropriate verification activities which lead to the conclusion that the process and control measures are not robust enough or are not being maintained to assure effective preventive controls, and therefore a failure is likely to occur. Consequently, such failure could lead to a food adulteration that will cause SAHCODHA.

Finally, the FDA has the right to detain product for 30 days.

What implications can the “reasonable belief” decision criteria have for foreign suppliers and importers? Let us review some likely scenarios:

• The documentation related to food safety preventive controls is incomplete for a food product being imported. Could this lead to “reason to believe” that the product could cause SAHCODHA? If so, the product could be detained until acceptable documentation is provided. What happens if we are dealing with a perishable product or a product needing refrigeration?
• In another scenario, the same foreign supplier commits the same documentation mistake more than once. Could he or she now be in violation of Section 301 and have committed a prohibited act subject to injunction and criminal prosecution?
• In yet another scenario, a given supplier fails a regular FDA inspection and Form 483 clearly points out several noncompliance issues related to food sanitation and safety that need corrective actions. Should this foreign supplier and the importer implement and document appropriate corrective actions and discontinue exports of the food product to the U.S. until such activities have proven to be effective?
   

In other words, Administrative Detention of Food should not only be viewed as a regulatory tool to be applied by the FDA and U.S. Customs at the port of entry, but also as a preventive measure to be used by foreign suppliers and their importers in the U.S. when the effectiveness of the preventive controls and documentation become questionable, as a result of repeat failures, or as evidenced by verifications activities such as inspections and audits.
 

Title III – Section 304. Prior Notice of Imported Food Shipments

The requirements to provide advance notice to the FDA and customs before importing a food product went into effect under the Bioterrorism Act of 2002. The standard notification requirements include the name of the article, the manufacturer and shipper of the article, the grower of the article, the country from which the article originates, the country from which the article is shipped, and the anticipated port of entry for the article and date and time of arrival.

Under FSMA, another information requirement was added which states that FDA and customs must be informed of “any country to which the article has been refused entry.” This is an attempt to reduce or eliminate the practice of “port-hopping.” For example, if a food product was not allowed entry in port A, it will deter the importer from shipping it to port B to attempt another entry. So, in practice, “any country” includes the U.S. and all entry ports available to importers. Thus, if the first port of entry refuses entry to a product, offering it again at another port would be considered a criminal offense subject to appropriate legal sanctions.

FSMA represents a radical change for foreign food suppliers and importers in the U.S. Under several sections contained in Titles I, II, and III, the burden of proof for food safety and corresponding cost of compliance has been shifted to the private sector. While the FDA will continue to inspect foreign facilities that manufacture and export foods to the U.S., and customs will continue to inspect a very small portion of imported food, under Title III – Section 301, importers in the U.S. will now be liable for any noncompliance issues, should they occur.

The sooner that importers and their foreign suppliers understand the meaning and scope of the relevant sections of FSMA, begin to assess their existing levels of compliance, and start updating their preventive controls and documentation, the sooner fewer problems and costly nonconformance issues will be faced when the regulations become official.

The author is Global Manager, Food Safety Services Innovation, AIB International.