With the Food Safety Modernization Act Set to Become Law, Certain Provisions Will Take Immediate Effect

By Ricardo Carvajal - 

Although many of the Food Safety Modernization Act's ("FSMA's") major provisions have a delayed effective date (including the requirement to develop and implement a HACCP plan), some significant provisions will take immediate effect, including:  

• Stronger records access authority (FSMA § 101).  FDA gains authority under amended FDC Act § 414(a) to access and copy “all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation” of a food if FDA believes that there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.  The provision extends to any other food that FDA reasonably believes is likely to be affected in a similar manner.  FDA can access records that the agency needs to determine whether there is “a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.”  FDA’s access to records is contingent on “presentation of appropriate credentials and written notice.”

• Mandatory recall authority (FSMA § 206).  The FDA Commissioner gains authority to order a mandatory recall when the agency determines that there is a reasonable probability that a food other than infant formula is adulterated under FDC Act § 402 or misbranded under § 403(w), and that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.  FDA must first give the responsible party an opportunity to conduct a voluntary recall.  If the responsible party refuses to do so, and the Commissioner issues an order, FDA must give the responsible party an opportunity for an informal hearing within two days of the order’s issuance. 

• Whistleblower protection (FSMA § 402).  An employee is protected from retaliation by an employer when that employee (1) provides an employer, the U.S. government, or a state attorney general with information relating to any violation of the FDC Act, (2) testifies or is about to testify in a proceeding concerning such a violation, (3) assists, participates, or is about to assist or participate in such a proceeding, or (4) objects to or refuses to participate in any activity, policy, practice, or assigned task that the employee reasonably believes to be a violation.  An employer found to have engaged in retaliation is liable for relief needed to make the employee whole, as well as costs and expenses related to the complaint. 

• Foreign facilities and refusal of inspection (FSMA § 306).  An imported food will be refused admission if it is from a foreign establishment to which a U.S. inspector is refused entry for the purpose of conducting an inspection.  Entry is deemed refused if the inspector isn’t granted access within 24 hours of requesting entry. 

 Affected firms would do well to review these particular provisions, modify their SOP’s as needed, and train their personnel accordingly.