FDAs Implementation of FSMA Presents Opportunities and Challenges for Industry

By James William ("Will") Woodlee

Almost two years have passed since President Obama signed the FDA Food Safety Modernization Act (FSMA") into law. Widely recognized as the first major overhaul of the U.S. food safety laws in over 70 years, FSMA shifts FDAs approach to combating foodborne illness from one of reaction and response to a prevention-focused paradigm. 

The law places new, more demanding responsibilities on those involved in the business of bringing food to Americas tables. While it also gives FDA new tools to evaluate and enforce compliance with federal law, FSMA imposes significant implementation obligations on the agency. Whether due to challenging legal or scientific questions, resource limitations, election-year politics, or some combination of all three, FDA has failed to meet some of these obligations within the timeframes prescribed by FSMA.

For example, months have passed since the deadline for final regulations implementing what is perhaps FSMAs signature provision, which requires each facility to conduct a hazard analysis and implement preventive controls designed to assure that the foods manufactured, processed, packed, or held there are not adulterated or misbranded. These requirements technically took effect without FDAs having issued even a proposed rule.  However, the agency announced in a trio of June letters that it would not enforce them until final regulations are in place.

FSMAs delayed implementation has unquestionably hindered the laws ability to deliver on its promise of preventing the kinds of illness outbreaks that sparked Congressional action and led to FSMAs passage. Salmonella-contaminated peanut butter caused a February 2007 outbreak that, among other incidents, kick-started FSMAs development. In September, FDAand those in Congress responsible for its fundingreceived an unfortunate reminder of the potential costs of delaying FSMA implementation in the form of an outbreak of Salmonella Bredeney, again involving peanut butter. 

FDA now finds itself in the midst of a multi-agency investigation that has traced the outbreak back to a New Mexico firm that processes peanuts and manufactures nut and seed spreads. The Centers for Disease Control has confirmed nearly 40 infections in 20 states. What began as a recall of a single peanut butter product sold in one national chain has snowballed into recalls of approximately 311 seed and nut products processed or manufactured at the facility as well as related" recalls of approximately 137 products by 37 other firms to which the New Mexico facility supplied affected products.

The news is not all bad. After a brief delay, FDA recently began accepting food facility re-registrations as required under FSMA. Facilities must renew their registrations with FDA before the year ends. A key feature of FSMA, the enhanced registration program authorizes FDA to suspend a facilitys registration upon finding that food manufactured, processed, packed, or held there has a reasonable probability of causing serious adverse health consequences or death."
 
A facilitys registration thus functions as a sort of federal license that FDA may revoke due to serious safety concerns. FSMA requires FDA to issue regulations implementing these provisions, which it has not yet done. FDA has issued an updated guidance document related to the identification of the categories of food in which the registering facility deals, but questions remain.

Like a number of other self-executing FSMA provisions, the biannual re-registration requirement and FDAs suspension authority took effect automatically.  Incorporating FSMAs requirements into a compliance program without needed instruction from FDA, however, presents considerable challenges. Even where FDA has confirmed it will not enforce a requirement pending issuance of delayed implementing regulations, companies may understandably wish to modernize their safety programs and come into compliance" early.

Will Woodlee is an associate lawyer with Kleinfeld, Kaplan & Becker LLP, a law firm focused on the regulation of products subject to the jurisdiction of the FDA. His practice focuses primarily on counseling and advocating on behalf of food, cosmetic, pharmaceutical, medical device, dietary supplement, and tobacco companies on matters involving FDA law, USDA law, and related federal and state laws.

Editor's Note: Food Product Design is proud to sponsor a series of FSMA-related educational programs during next weeks SupplySide West Global Expo and Conference. Don't miss them!