- 85 percent: The approximate percentage of its seafood the U.S. imports yearly
- 39 percent: The approximate percentage of its fruit the U.S. imports yearly
- 20 million: The number of import lines the FDA oversees
With these huge numbers, it’s no surprise that the federal government made new regulations for imports a large part of its Food Safety Modernization Act (FSMA) of 2011. According to a study released April 4 from the Institute of Medicine, it isn’t as simple as tracking where whole product imports come from. The majority of products use ingredients imported from a myriad of different countries, all with varying regulations. For its part, the federal government has shifted away from its traditional route of administering domestic regulation and now is taking a more global approach. According to the report, the FDA will work with similar regulatory agencies globally to create a “coalitions of regulators” worldwide, which includes expanding intelligence and data sharing systems and increased collaboration with private parties and industry.
Although regulations stemming from FSMA are being worked out, the aim is to increase the FDA’s ability to issue mandatory recalls and requiring importers to prove their overseas facilities follow U.S. regulatory standards. FSMA also calls for the number of foreign inspections to increase dramatically.
In addition to being extremely interesting and valuable reading, the study provides a roadmap to help the FDA work through the changes by “identifying the core elements needed” by those in food, pharmaceutical, and medical device industries in developing countries and how the FDA can be involved.
The study also highlights several examples of instance the FSMA is supposed to prevent, including an adulterated ingredient in a blood thinner that caused allergic reactions in patients and melamine contamination of pet food and Chinese milk. The melamine contamination caused illness in 300,000 children and led to an FDA recall of 60 million packages of pet food, according to the report.
So what are some of the key issues highlighted by the report? There are quite a few:
- Controlling and monitoring supply chain
- Adhering to a set of international standards
- Infrastructure to perform testing and maintain traceability
- Enforcement of regulations
- Appropriate and effective staffing levels
What does the report suggest as pathways for moving forward? The first is a risk assessment to determine which areas need to be bulked up and other considerations. Given the global economic state, the report suggests using existing channels to build partnerships, which would be more cost effective than forging new networks. The report also suggests the FDA strengthen ties with regulatory agencies in other countries and increase “pharmacovigilence and foodborne diseases surveillance systems in developing countries.” Other recommendations include encouraging more research into fraud management and tracking, taking a leadership role in developing international standards and overhauling the FDA’s informatics system.
Read the Ensuring Safe Foods and Medical Products through Stronger Regulatory Systems Abroad in its entirety here.