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Keeping your dawn raid guidance current
Unannounced inspections or ‘dawn raids’ are used by antitrust authorities to obtain evidence when there are suspicions that individuals or businesses have infringed the antitrust rules.
Global | Publication | June 2016
The 7th and final Food Safety Modernization Act (FSMA) implementing rule is finally here and most companies will have three years to comply. On May 26, 2016, the FDA finalized the Mitigation Strategies to Protect Food Against Intentional Adulteration rule. The effective date of the rule is May 27, 2016, the date of the rule’s publication in the Federal Register. The rule implements the “food defense” provisions of the FSMA and aims to protect the public health from intentional adulteration acts, such as acts of terrorism targeting the food supply.
The proposed rule was issued in December 2013 and the final rule primarily provides more information to stakeholders and greater flexibility for facilities in how they can mitigate these risks. The rule does not focus on specific foods or hazards but instead the rule mandates risk-reducing strategies for processes in certain food facilities.
The rule applies to domestic and foreign companies that are required to register with the FDA as food facilities under the Food, Drug, and Cosmetic Act (FDCA). Primarily, the rule is targeted at large companies whose products reach many people, while smaller companies may be exempt. Also, the rule does not cover farms. The FDA estimated that there are 3,400 covered firms under the rule that operate 9,800 food facilities.
The FDA is providing a longer timeline than expected for facilities to comply with the final rule. Very small businesses will have to comply with modified requirements within five years after the publication of the final rule. Small businesses[ will have to comply four years after the publication of the final rule. Finally, all other businesses will have to comply three years after the publication of the final rule. Facilities should begin to determine if they are exempt from the rule’s requirements or have to meet modified requirements. While the deadlines are a few years away, affected facilities should begin efforts now to ensure that all of the rule’s requirements are met by the compliance start date.
Exemptions from the final rule include
Key provisions of the final rule include
Due to the novelty of the rule, the FDA is providing education and outreach tools to affected food facilities. The FDA established an Intentional Adulteration Subcommittee with the Food Safety Preventive Controls Alliance to develop food defense training resources for industry and regulators alike. Additionally, the FDA intends to publish guidance documents to provide information about the final rule requirements, such as conducting a vulnerability assessment, identifying and implementing mitigation strategies, and writing procedures for food defense monitoring, corrective actions, and verification. The Mitigation Strategies Database is also available for covered facilities and provides a searchable list of mitigation strategies that can be used during different times in a food operation to mitigate intentional adulteration risks. Lastly, the FDA FSMA Food Safety Technical Assistance Network is a central source of information to help the industry understand and implement FSMA.
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Unannounced inspections or ‘dawn raids’ are used by antitrust authorities to obtain evidence when there are suspicions that individuals or businesses have infringed the antitrust rules.
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The EU Foreign Subsidies Regulation, or FSR, is intended to prevent or remedy distortions of the EU internal market caused by “foreign” – meaning non-EU – subsidies benefitting companies active in the EU.
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In July 2024, the English High Court handed down a judgment on whether or not the insurers under a charterer’s liability policy were obliged to indemnify third parties, where the insured went insolvent and had not paid the underlying claim to the third parties.
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