FDA releases International Food Safety Capacity-Building Plan

The Food Safety Modernization Act directs the U.S. Food and Drug Administration “to develop a comprehensive plan to increase the technical, scientific, and regulatory food safety capacity of foreign governments and their respective food industries, from which foods are exported to the U.S.” This emphasis on enhancing the safety of food products imported into the U.S. is a reflection of the global marketplace for food, particularly fresh fruits and vegetables. Approximately 20 percent of fresh vegetables, 50 percent of fresh fruit, and 80 percent of seafood that are consumed in the US are imported.
The Food Safety Modernization Act calls for numerous enhanced international collaborations as well as the development of the International Food Safety Capacity-Building Plan. According to an FDA statement, the recently released plan sets forth a strategic framework for how the FDA will develop international food safety capacity. The agency reports that it may develop a more specific, detailed operational document for implementing its capacity-building strategies at a later date.

FDA issues interim final rules for Food Safety Modernization Act

The Food and Drug Administration has published two interim final rules in the Federal Register, regarding the FDA's administrative detention authority and advanced notice of rejected imports, connected to the Food Safety Modernization Act.
The first interim final rule relates to the FDA’s administrative detention authority. Currently, the FDA has the authority to detain products deemed to have “credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals.” Under the FSMA, the criteria level has been modified to the more general definition “reason to believe that the article of food is adulterated or misbranded.” This change in administrative detention authority widens the FDA’s scope of products acceptable for detention to products that would normally be considered as part of a Class II recall.
The second interim final rule relates to importers giving advanced notice of imports that were refused entry into another country. Presently, importers must give the FDA advanced notice of imports electronically through a Customs and Border Protection or FDA system. This interim final rule implements an FSMA-mandated requirement that this prior notice include the identity of any country to which an article of food has been refused entry.
The requirements in both interim final rules will be effective July 3, 2011. Comments will be accepted on both interim final rules and reviewed by the American Feed Industry Association's FSMA work groups.

Food Safety Modernization Act focus at feed mill forum

Vice President of Feed Regulation and Nutrition for the American Feed Industry Association Richard Sellers addressed feed mill managers at a recent seminar, focusing on the Food Safety Modernization Act and its ramifications on the industry.
During the event, sponsored by the U.S. Poultry & Egg Association’s Poultry & Egg Institute, Sellers said that the industry is experiencing some of the most significant changes in the Food and Drug Administration's regulation of feed since 1958. “You need to know what is in the Food Safety Modernization Act in order to comply,” said Sellers. “You will not see anything like this law in the history of the Food and Drug Administration and probably will not see anything to the magnitude of this bill in the future.”  
The new law applies to all ingredient processing, feed manufacturing, pet food, feed and ingredient imports and transportation. Sellers discussed some of the new facets of the law that he said need to be addressed by all companies:

• Determining each company’s risk level
• Foreign supplier compliance to ensure they comply with the FSMA
• User fees for re-inspections
• Implementation timelines

Other talks at the event included Jim Norris, senior safety administrator of Bunge North America, presenting “Safe Entry and Reclaim from Flat Storage Spaces;" Andy Yersin of Kemin Industries presenting "Salmonella Control and Prevention;" and Don Holman of Tyson Foods discussing "Transportation Guidelines — Comprehensive Safety Analysis 2010."

FDA seeks increase in funding

The U.S. Food and Drug Administration has requested a 33% increase in their FY 2011 budget allowance over the previous allocation of $4.3 billion.
In supporting the request, Margaret A. Hamberg MD, Commissioner of the Food and Drug Agency stated, “The breadth of this mandate means that FDA responsibilities continue to grow.” She was referring to the recently enacted but as yet unfunded Food Safety Modernization Act. The critical initiatives that will require an increase in budget include:

• Transforming the Food Safety and Nutrition Initiative: The $324 million requested will be devoted to the Food Safety Modernization Act and to activities which will encourage citizens to make healthier food choices. Prevention of food-borne diseases will be carried out in cooperation with state and local partners.
• Advancing the Medical Counter Measure Initiative: The $70 million will be required to develop medical countermeasures to respond to national security threats. The legal, regulatory and policy framework of the program will be updated.
• Expanding the Protecting Patients Initiative: Funded at $124 million this program will establish approval for “biosimilars” (analogous to generics) similar in clinical action to existing FDA-approved biological products.
• Intensifying the Regulatory Science Facility Initiative: The $49 million requested would be applied to strengthen the regulatory scientific capacity required to support FDA missions.

Given the current opposition by the House to budget increases, the FDA will be hard pressed to justify increased funding and it is possible that many of the provisions of the Food Safety Modernization Act will not be realized in the foreseeable future.