Date: Jan 19, 2011
A number of provisions in the "FDA Food Safety Modernization Act" (FSMA), Public Law No. 111-353, are directly applicable to food-contact substances. In particular, the recordkeeping requirements, sanitary transportation provisions, expanded recall authority, new imported food requirements, and whistleblower protections will affect the food packaging industry.
The legislation (H.R. 2751) was signed into law by President Barak Obama on January 4, 2011 and constitutes the most significant overhaul of the Federal Foods, Drug, and Cosmetic Act provisions in 15 years. Following is a summary of the legislation's potential impact on the food packaging industry.
Recordkeeping and Inspection of Records: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) added recordkeeping requirements to Section 414 of the Federal Food, Drug, and Cosmetic Act (FFDCA), which do apply to food-contact materials. The FSMA amends Section 414 to permit FDA "at reasonable times and within reasonable limits and in a reasonable manner" to access and copy all records of each person who manufactures, processes, receives, holds, or imports food (or any article of food reasonably believed to be affected in the same manner), if FDA believes there is a reasonable probability that exposure to an article of food will cause serious adverse health consequences or death. Thus, FDA's records access authority is expanded to allow the Agency to access records of products—including food packaging—related to the food product at issue.
Sanitary Transportation of Food: The FSMA requires that regulations on sanitary food transportation practices be issued within 18 months of enactment. In April 2010, FDA published an Advance Notice of Proposed Rulemaking (75 Fed. Reg. 22713, April 30, 2010) to obtain data and information about food transportation issues. Potentially, FDA's proposed regulations could impact requirements for the transportation of food-contact materials, as well as regulations on coatings and articles used in vehicles, tank cars and the like for hauling food.
Recall Authority and Administrative Detention: Under current law, FDA is permitted to administratively detain adulterated food if it has "credible evidence or information indicating" that the food "presents a threat of serious adverse health consequences or death to humans or animals." The FSMA broadens this authority and allows FDA to detain any article of food that the Agency has "reason to believe" is "adulterated or misbranded." Relaxing the standard for detention of product as adulterated will make it easier for FDA to justify its action if challenged. Although it is unclear how FDA will implement this provision in practice, it is unlikely that FDA will exercise this authority unless it has reason to believe that there is a serious public health concern. This provision is effective 180 days after enactment, and FDA must issue an interim final rule to implement this provision within 120 days of enactment.
Imported Food: The FMSA requires a Foreign Supplier Verification Program to be established for imported food. Imported food could be interpreted as including packaging materials and may, in practice, require third party certifications and, possibly, introduce the need for food-contact substance manufacturers to develop and maintain a HAACP program to satisfy the requirements of the potential verification program. Noncompliance is a violation of the adulteration provisions of the FFDCA. This issue can be sorted out when FDA promulgates regulations to implement this provision of the law.
Whistleblower Protections: Employees of food-contact substance manufacturers may take advantage of the Whistleblower protections available under the FSMA. Food-contact material manufacturers should be aware of the impacts of these whistleblower protections, and should consider implementing a whistleblower policy and compliance plan.
Many of the other requirements established by the FSMA only apply to a "food facility" that is required to register with FDA pursuant to Section 415 of the FFDCA. FDA regulations implementing the Section 415 registration requirements for food, facilities explicitly exclude food-contact substances from the definition of food. Therefore, facilities that manufacture food-contact substances are excluded from the registration and related requirements. (For more information on registrations and other requirements of the Bioterrorism Act, see the PackagingLaw.com article, FDA Completes Implementation of the Bioterrorism Act's Provisions.)