One of the main challenges facing U.S. food safety officials involves the process of thoroughly checking imported foods for safe consumption. Part of the reason why this can be so challenging is due to the sheer volume of food that enters the country.

fishThe United States imports foodstuffs from a global marketplace that is comprised of over 170 countries. The United States Department of Agriculture (USDA) estimates that the U.S. imported approximately 60 million metric tons of food in 2013. Meanwhile, exports comprised approximately 67 million metric tons.

With a population of citizens who are increasingly concerned about foodborne illness outbreaks, the U.S. government drafted and passed the FDA Food Safety Modernization Act (FSMA), the most sweeping changes to food safety laws in more than 70 years. The legislation was signed into law by President Barack Obama on January 4, 2011.

Foreign Supplier Verification Programs

CFSAN LogoRecently, the Food and Drug Administration (FDA) finalized the FSMA rules pertaining to Foreign Supplier Verification Programs (FSVP). These sections of the FSMA focus on the “importers of food for humans and animals,” which requires importers to “perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.”

In July 2013, the FDA proposed the rule, which was subsequently amended in the FSMA. The FDA notes that this particular statute is “the product of a significant level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, tribal and international regulatory counterparts, academia and other stakeholders.”

Following a series of communications between various stakeholders, which included speaking engagements, webinars and public meetings, the FDA proposed its initial legislative recommendations in September 2014.

FSVP Statutes

Under FSVP statutes, obligated parties include importers who either own or who are authorized to import goods in the United States for sale. They include foreign companies that have designated a U.S. consignee for imported products.

Importers are required by FSVP to verify that a safety framework is in place in order to demonstrate that foods are produced in a way that is safe for public consumption. Acceptable documentation of preventive controls and produce safety standards, as well as proof that food is not adulterated or misbranded in any way, is a requirement under the law.

In addition, importers are required to determine known or potential safety hazards for each food that is brought into the United States. In order to accomplish this, imported foodstuffs must undergo a risk and hazard analysis that is comparable to domestically produced goods, producing documentation of such activities. Furthermore, a foreign food supplier’s safety performance record may determine whether or not additional documentation or proof of safety and hazard compliance is required.

Importers must comply with FSVP requirements

canned foodAn importer is determined to be in compliance with most FSVP requirements when certain measurable conditions are met:

  1. Importers must establish and maintain compliance with supply-chain program requirements.
  2. Importers must implement controls of a preventative nature in order to accommodate potential food hazards.

In order to determine the potential hazards of food, importers must “identify and evaluate—based on experience, illness data, scientific reports and other information—the known or reasonably foreseeable hazards for each type of food it imports.” Among the hazards that must be identified and evaluated are:

  1. Biological hazards, such as parasites and disease-causing bacteria
  2. Chemical hazards, such as natural toxins, decomposition of food, radiological hazards, food additives, and allergens
  3. Physical hazards, such as glass or debris

Appropriate documentation and literature

All analysis and evaluation required under FSVP must be accompanied by appropriate documentation and literature. The documentation requirements of analysis and evaluation include: how the food is formulated, the condition and functionality of the food manufacturing facilities and equipment, transportation mechanisms, raw materials, and additional ingredients; procedures of raising, harvesting, manufacturing, processing, and packaging; storage and distribution and sanitation conditions. Importers have the option of designating another entity to perform such analysis provided that certain conditions are met.

The remaining FSVP statutes encompass supplier verification and corrective actions. Supplier verification includes ensuring that only approved foreign suppliers are used in the importation of food. Importers are authorized under FSVP to take action to ensure compliance with a foreign supplier, which includes conducting on-site audits, sampling and testing food, and reviewing a suppliers’ food safety record.

Importers are required to take immediate action if a determination is made that a supplier is out of compliance with any FSVP-mandated processes and procedures. Punitive actions may be taken against foreign suppliers, which could include discontinuing services until the causes of noncompliance have been investigated and corrected.