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Concern over speed of regulatory action: US and Europe

Following an internal review, the Office of the Inspector General (OIG) in the US Department of Health and Human Services has issued a statement online on 22nd December 2017 titled:

"The Food and Drug Administration's Food-Recall Process Did Not Always Ensure the Safety of the Nation's Food Supply"

These are very strong words. They reviewed documentation for 30 voluntary food recalls selected from the 1,557 food recalls reported to FDA between October 1, 2012, and May 4, 2015. They stated

The FDA did not always have an efficient and effective food-recall process that ensured the safety of the Nation's food supply. We identified deficiencies in FDA's oversight of recall initiation, monitoring of recalls, and the recall information captured and maintained in FDA's electronic recall data system, the Recall Enterprise System (RES).  

Specifically, we found that FDA could not always ensure that firms initiated recalls promptly and that FDA did not always (1) evaluate health hazards in a timely manner, (2) issue audit check assignments at the appropriate level, (3) complete audit checks in accordance with its procedures, (4) collect timely and complete status reports from firms that have issued recalls, (5) track key recall data in the RES, and (6) maintain accurate recall data in the RES....   

We recommended that FDA use its Strategic Coordinated Oversight of Recall Execution (SCORE) initiative to establish set timeframes, expedite decision-making and move recall cases forward, and improve electronic recall data. We also made other procedural recommendations, which are listed in the report.  


Click on the links to download the complete report or the Report in Brief.

The FDA has not been alone in 2017 as a food regulator brought to task regarding their risk communication. Europe was hit in 2017 with the fipronil incident and the ripples of the incident continue on into 2018. The European Union published "Conclusions from the Ministerial Conference on the follow up of the fipronil incident Brussels, 26 September 2017" There were nineteen points raised by the Commission and the Member States taking part in the Ministerial Conference for action. Follow the link to read them all in full, but the Member States and the Commission exchanged views on lessons learned from the fipronil issue and agreed on several strategic and systemic actions needed at Member States and EU levels to prevent, detect as early as possible, and improve the handling of such incidents or crisis. These included:

4. Cooperation and communication is needed in order to prioritize coordinated efforts that will ensure trust and a harmonised approach during incidents or crises. The Commission is invited to develop a management plan for food and feed incidents (in line with the crisis management plan). In doing so the Commission should pay attention to reinforce its early coordinating role, including defining the criteria when the coordination at EU level should be triggered by Member States; 

5. Risk communication should be improved via upstream coordination between Member States and the Commission on the basis of a common factual and accurate information line to be used through the appropriate channels (in particular social media and press) to ensure it reaches the general public in a harmonized and prompt way; 

6. Provisions will be considered to strengthen the existing flexibility in residue monitoring at EU level, evaluate the existing risk based monitoring programs and adapt these in order to enable early detection of possible use of illegal substances or misuse of substances to enable Member States to respond without delay to emerging risks; 

7. Member States will encourage the food business operators and branch organisation representing these food business operators in their country to implement or improve existing self-monitoring programs on sectoral level; 

13. The way of establishing a ‘food safety officer’ acting as an experienced and trustworthy contact person in relation to food and feed safety issues should be considered.  

 19. Procedures should be put in place, with due regard to the need to not jeopardise potential criminal proceedings, to enable a rapid transfer of information, at Member State level between judicial authorities and public health authorities, and at Commission level between EUROJUST, EUROPOL and the RASFF-AAC-Food Fraud networks.

Both reports highlight weaknesses in food safety and food fraud regulatory governance that need to be addressed. Food for thought.

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