Aug 22, 2012
By Debbie Phillips-Donaldson
The US Food Safety Modernization Act (FSMA) is seemingly becoming a classic case of "hurry up and wait." When the act was signed into law by President Obama in January 2011, many players in the human food, petfood and animal feed industries began making an urgent case that food producers in all three industries needed to prepare, and fast, for new rules and regulations emanating from the law. Some experts even sounded notes of doom and gloom over concern that the new regulations would prove costly and onerous, especially for smaller manufacturers.
So, here we are, 19 months later and still waiting for many of the new FSMA rules and regulations to take effect -- or even be developed and communicated. While the US Food and Drug Administration, charged with implementing FSMA, did issue two new rules regarding import of ingredients into the US that took effect about a year ago (July 3, 2011) and have released a smattering of other new FSMA-related policies and documents this year -- an interim record-keeping rule, high-risk food facility criteria, new (and surprisingly lower) inspection fees -- many of the key provisions of the new food safety act are yet to be issued.
For example, any US food or petfood producer that imports ingredients or products into the US will need to verify that foreign suppliers produce these ingredients or food at the same level of public health protection required of domestic producers. Under this FSMA provision, the Foreign Supplier Verification Program (FSVP), proving imported products are safe may be difficult if a manufacturer sources from countries with weak food safety laws and inspection programs, says Stephen F. Sundlof, DVM, PhD, former director of FDA's Center for Veterinary Medicine and Center for Food Safety and Applied Nutrition. "It is likely that many products that currently enter freely into the US will not be able to meet the rigorous demands that would qualify them for the verification program," he adds. He advises petfood companies to evaluate their supply chains to ensure all imported products comply with FSVP even before new regulations take effect. "Otherwise, you risk shortages and market disruptions."
Sound advice, though there's no word from FDA when those regulations will be forthcoming. According to David W.K. Acheson, MD (also formerly with FDA, as associate commissioner for foods), in an opinion piece posted on FoodSafetyNews.com, the FSVP rules are "stuck in OMB (US Office of Management and Budget) for a variety of reasons." Dr. Acheson's point in discussing FSVP was that at the recent meeting of the International Association for Food Protection, a representative of the European Union expressed concern about some of these forthcoming rules, causing Dr. Acheson to speculate that potential trade issues were at least one of the reasons for the holdup by OMB.
Dr. Acheson also reported on a presentation at the meeting by Jenny Scott, FDA senior adviser, on Section 103 of FSMA, which deals with preventive controls -- a key area that will apply to all producers, whether for human food, petfood and animal feed. From her remarks (as reported by Dr. Acheson), it appears FDA might even be unsure of how to develop some of the rules and regulations for preventive controls because of several aspects of FSMA that are not clear, such as environmental monitoring programs, training and recall plans.
Perhaps it's good to know that FDA itself is delving so deeply into those areas, because they are certainly raising concerns within the affected industries. Recently the American Feed Industry Association, National Grain and Feed Association and Oilseed Processors Association sent a letter to Michael Taylor, deputy commissioner of foods for FDA, requesting that the agency exercise discretion in enforcing provisions of FSMA regarding conducting hazard analyses and implementing preventive controls, since final regulations have yet to be issued and no implementation period has been provided.
Taylor responded that FDA will "expect to enforce compliance" with the provisions within the "timeframes that will be described in the final rules." (Again, no notice of when those final rules might be forthcoming, despite the fact that they were supposed to be effective by July 3, 2012.) He also reminded the associations that compliance with good manufacturing practice (GMP) regulations and other food and feed safety-related provisions of the Federal Food, Drug and Cosmetic Act remained in effect.
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