Updated: Jul 23, 2020
By Sarah Everhart
Today we will continue our look at the Food Safety Modernization Act (FSMA) with a detailed explanation of the provisions of the law related to imported food safety. To date, we have previously looked at the preventive controls rule, the produce safety rule, inspection and compliance and response and enhanced relationships. Hopefully, the FSMA blog post series has given you an introduction to the important elements of the law.
Imported Food Safety
The FSMA provides the Food and Drug Administration (FDA) with new and powerful authority to make certain imported foods meet the same safety standards as foods produced in the U.S. Imported food is responsible for a disproportionate number of food-borne illnesses in the U.S. According to the food safety program at the Pew Charitable Trusts, eight of the 19 reported multi-state food-borne illness outbreaks linked to FDA-regulated products since 2011 were from imports. The foods included pomegranate seeds, tahini sesame paste, cucumbers, ricotta salata cheese, mangoes, raw tuna, pine nuts and papayas. The current food safety system in the U.S. relies on FDA inspectors at ports of entry around the country physically inspecting food and detaining items that may pose a hazard to the American public. But inspectors can only physically examine 2% of the nation’s incoming food supply, according to the agency, leaving the other 98% unchecked.
Pursuant to regulations promulgated by the FDA, importers will have the legal responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. This program is referred to as the Foreign Supplier Verification Program. The FSMA also mandates the creation of a program of accreditation for third party auditors to conduct safety inspections of foreign food facilities to ensure that the facilities comply with U.S. food safety standards.  By the authority granted in The FSMA, the FDA may require that certain high-risk imported foods, such as the ones described above, not be imported into the U.S. without a credible third party certification of food safety. In an effort to encourage compliance with U.S. food safety laws, the FSMA directs the FDA to create the Voluntary Qualified Importer Program which allows for the expedited review and entry of foods after an importer has received a certification of their facility. Finally, the FSMA grants the FDA the right to deny entry of foreign food into the U.S. if the FDA has been denied access to the foreign facility from which the food originated.
Response and Food Recalls
The FSMA equips the FDA with the necessary tools to respond effectively when food safety problems arise. Specifically, the FSMA increases the FDA’s power to recall a product. Under the prior law, food recalls were voluntary and usually prompted by the FDA threatening to issue or issuing a press release regarding a product. Under the FSMA, the FDA may still request a voluntary recall but it is further authorized to order a mandatory recall, after the opportunity for an informal hearing, if the FDA determines that the removal of the product is necessary. Further, before the FSMA the FDA could only administratively detain food if it had reason to believe that food presented a “threat of serious adverse health consequences or death to human or animals” and now the standard has been lowered and FDA can detain food if it has reason to believe that such article is “adulterated or misbranded.”
One way in which the FSMA has improved the FDA’s ability to respond to food safety issues is that the FDA now has the ability to suspend the registration of a facility if it determines that food poses a reasonable probability of serious adverse health consequences or death. A suspension of a registration means a facility is prohibited from distributing any food. Another way that the FSMA increases the ability of the government to respond to food safety concerns is the improved ability of the FDA to track and trace domestic and imported processed and raw agricultural foods. The FSMA directs the FDA to establish pilot projects to evaluate the methods that food can be tracked in an effort to prevent or control a foodborne illness outbreak.
In an effort to improve food safety, the FSMA creates a network of collaboration with other governmental agencies both domestic and foreign to integrate food systems and protect public health. The FSMA mandates a formal system of collaboration by charging the FDA with the development of strategies, through a multi-year grant program, to enhance the capacity of individual states to more efficiently achieve national food safety goals. Further, the law directs FDA to develop a comprehensive plan to train foreign governments and food producers on U.S. food safety requirements. Another example of an enhanced partnership created by the FSMA, is the ability of the FDA to rely on inspections of Federal, state and local agencies to meet its increased inspection mandates.
 Weise, Elizabeth, “FDA Issues New Safety Standards for Imported Food”, USA Today, July 26, 2013, Retrieved at: http://www.usatoday.com/story/news/nation/2013/07/26/fda-new-safety-rules-imported-food/2587391/
 Sloane, Matt, “FDA imposes new safety rules on imported food”, CNN online, July 6, 2013, Retrieved at: http://www.cnn.com/2013/07/26/health/fda-food-safety-rules/index.html
 21 U.S.C. § 384a, Draft regulations can be found at 78 FR 45729
 21 U.S.C. § 384d, Draft regulations can be found at 78 FR 69603
 21 U.S.C. § 381
 21 U.S.C. § 384b
 21 U.S.C. § 384c
 21 U.S.C. § 350l
 21 U.S.C. §334(h)(1)(A)
 21 U.S.C. §350d(b)
 21 U.S.C. §2223
 21 U.S.C. §399c(b)
 21 U.S.C. §399c(a)
 21 U.S.C. §350j