Vantage Point: Another food scare! What's to be done?

Public Law 111-353, the "FDA Food Safety Modernization Act" became law on January 4, 2011. The law consists of eighty-eight pages and four titles that are destined to affect every nation, virtually all food products and practically any company engaged in the growing, processing, manufacture, distribution and selling of food products.

 

The Food Safety Modernization Act (FSMA), grants the FDA new authorities that allow the agency to better ensure the safety of food. The FDA has an expanded legislative mandate to require comprehensive prevention-based controls across the food supply and new tools to hold all players in the supply chain accountable, including mandatory recall authority and the administrative detention of food. The law covers both domestic and foreign producers. Further, the law represents a significant shift in the area of imports.

 

Importers will now have the explicit responsibility to verify that their foreign supplies have adequate preventative controls in place and that the food they ship to the United States is safe. U.S. producers will have to know that their vendors are in compliance. The FDA has the power to establish a third-party program for certifying that foreign food facilities comply with U.S. standards, to require certification as a condition of entry of certain high-risk foods, and to reject entry of food if the foreign facility or country refuses an inspection by FDA or its designee. The FSMA also encourages arrangements with foreign governments to leverage resources, provide for mutual recognition and capacity building.

 

The 'globalization' of the food and drug supply chain is evident when you consider that between 10% and 15% of all food consumed by U.S. households is imported. Nearly two-thirds of the fruits and vegetables and 80% of seafood consumed in the United States come from outside the U.S. Half of all medical devices and nearly 80% of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere. The FDA calculates that imports to the U.S. currently arrive from more than 300,000 facilities in 150 different countries and that shipments will triple by 2015.

 

Even U.S. based companies face the probability that some ingredient and some point in time will be imported or exported. Producers and manufacturers face intense pressure to lower costs, improve productivity and insure an uninterrupted supply chain. The rise of emerging markets, the scarcity of natural resources, and the increased flow of capital, information and goods across borders means the distinction between foreign and domestic products will continue to blur while increasing the complexity for regulators.

 

Goods entering the U.S will come from new and different markets, flowing through long multi-step processes to convert globally sourced materials into finished goods. The shift will make it difficult to identify the source of a product and to ensure that all players along the supply chain meet their safety and quality responsibilities. Additionally the FDA must contend with even more sophisticated threats of fraud, product adulteration and even terrorism. In order to cope with the fundamental shifts in the market, the FDA has committed to substantially and fundamentally revising its approach to global product safety and quality. Over the next decade, the FDA will transform itself from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders.

The FDA plans to achieve this transformation by developing an international operating model that relies on enhanced intelligence, information sharing, data-driven risk analytics, and the smart allocation of resources through partnerships.

 

The FDA’s approach is based on four core building blocks, where the department will:

What we know is:

 

Globalization is moving from 'business trend' to enforceable regulatory law. The regulatory foundation is moving from blueprint to construction. Compliance is not optional! What's next…what’s after next, is implementation.

Implementation starts with one simple question that is the same for C-level and general management: "How is my organization going to ensure that business-critical information is available, reliable, consistent, and borderless?"

 

First, an organization has to brace and prepare itself for an information deluge. Second, an organization has to be able to make sense of the facts pouring in through easily accessible decision support systems and actionable reporting capabilities. Third, an organization has to understand that available, reliable, consistent and borderless business critical information is no longer a 'want', it is an operational requirement.

 

The nuts and bolts: Master Data Management! MDM is a powerful equation comprised of people, processes, and technology.

 

The objective is a single, common network that allows trading and regulatory partners at all levels of sophistication to participate to the degree that is most prudent or required for their needs, and in the media that is best aligned to their capabilities.

 

Four 'streams' must converge to enable trading and regulatory partners to deliver accurate, essential product information through all channels, including: 

A Master Data Management strategy and capability for most is yet to be known. Over the next ten years, its development will be mandatory. MDM is not a onetime effort, but rather one that is regularly redefined, refined and updated. MDM requires organizational awareness and commitment. The value of MDM is about improving, sustaining and protecting your business through a continuous stream of available, near real-time, accurate, actionable, regulatory compliant information.

 

We already know the answer to 'What's next?'… tough new regulatory requirements. Now we need to work on 'What's next, after what's next?' … It’s MDM.