Food Safety Modernization Act

The Food Safety Modernization Act is a United States federal statute enacted in 2011 to ensure the safety of the U.S. food supply and prevent food contamination. The main features of the FSMA include expanding... more +
The Food Safety Modernization Act is a United States federal statute enacted in 2011 to ensure the safety of the U.S. food supply and prevent food contamination. The main features of the FSMA include expanding the FDA's inspection of food processing facilities and imported food products, requiring all food processors, manufactures and handlers to register with HHS and maintain food safety records, and shifting the government's focus away from responding to food contamination and towards preventing food contamination.  less -
News & Analysis as of

The UK Contractual Recognition Of Bail-In Rules: Partial Delay To Implementation

On 25 November 2015, the Prudential Regulation Authority (PRA) published a ‘waiver by consent’ in relation to the contractual recognition of bail-in requirements. To the extent that it would be impracticable for firms to...more

Tribunal awards costs in Burns case

The Tribunal has awarded £100,000 in respect of legal costs to Angela Burns in respect of her dispute with FCA over her alleged misuse of her non-executive director position. The Tribunal awarded the amount because of FCA’s...more

Proposed Guidance for Firms Outsourcing to the "Cloud" and Other Third-Party IT Services: FCA Guidance Consultation 15/6 -...

The FCA Guidance Consultation 15/6 consults on proposed guidance to clarify various requirements imposed on firms, when outsourcing to the 'cloud.' The proposed guidance is the FCA's response to uncertainty on how the FCA...more

Blog: ILS Provisions Added To The Bank Of England & Financial Services Bill, As It Makes Its Way Through The House Of Lords

The UK government has proposed amendments to the Bank of England and Financial Services Bill (the Bill), which if enacted, would pave the way for Insurance Linked Securities (ILS) and collateralised reinsurance business...more

Treasury gives FCA AIFMR disciplinary powers

Treasury has given FCA new disciplinary powers via the Financial Services and Markets Act 2000 (Misconduct and Appropriate Regulator) Order 2015. The order amends section 66A of the Financial Services and Markets Act 2000...more

Treasury corrects MCD Orders

Treasury has made the FSMA (Regulated Activities) (Amendment) (No. 3) Order 2015. It amends the FSMA (Regulated Activities) Order 2001 to clarify the correct regulatory treatment under FSMA for a small number of first charge...more

Treasury increases SMR scope

The FSMA (Relevant Authorised Persons) Order 2015 came into force on 9 November. It provides that persons falling within either of two categories of non-UK institution are “relevant authorised persons” for the purposes of...more

Three More FSMA Rules Finalized As the Year Comes to a Close

Although not quite meeting the deadline of October 31 established in a legal settlement last year, FDA has released a set of three more “foundational” Final Rules mandated by the Food Safety Modernization Act (FSMA or the...more

Investment Funds Update - Europe: Legal and regulatory updates for the funds industry from the key asset management centres and...

HM Treasury proposes to extend Senior Managers and Certification Regime to all FCA firms - HM Treasury published a policy paper on 15 October 2015, in which it proposes to extend the senior managers and certification...more

UK Financial Conduct Authority Signals Significant Changes to the FCA Handbook arising from EU Market Abuse Regulation

Removal of the Model Code and Disclosure Rules are among the important modifications. On 5 November 2015, the UK Financial Conduct Authority (FCA) published its consultation paper addressing the changes it proposes to...more

FCA consults on EU MAR

FCA is consulting on the changes it will need to make to its Handbook to support the implementation of the new market abuse regime under the Market Abuse Regulation (EU MAR). UK primary legislation and FCA’s rules will need...more

Implementation Issues Arising from the Revised UK Senior Manager and Certification Regime

The UK Government recently announced that it would introduce a new statutory duty of responsibility on senior managers in all financial institutions and repeal the presumption of responsibility that would have applied to...more

Complaints Commissioner criticises FCA handling

OCC published its final decision with regards to a complaint against FCA’s handling of a change in control application. The complainant said the FCA set extremely short deadlines for them to respond to issues FCA had raised....more

Upper Tribunal grants extension to refer

The Upper Tribunal has granted an application to extend the timeframe in which an applicant could refer their notice to the Tribunal. Whilst acknowledging that the case was borderline, the Tribunal granted the application due...more

Food Recall Events: The Importance of Evaluating Your Insurance Coverage Before a Voluntary and Mandatory Food Recall

Food recalls are on the rise as consumer protection regulations become more stringent, and they can be costly events. There can be significant expenses associated with removing impacted products from stores; reimbursing...more

FDA promotes safety, control by veterinarians in new Rule: Veterinary Feed Directive

The U.S. Food and Drug Administration (FDA) continues to publish new Rules as part of its implementation of the Food Safety and Modernization Act (FSMA). In addition to new animal feed and food safety rules, the FDA recently...more

Treasury makes Transparency Regulations

Treasury has made the Transparency Regulations 2015, which amend the Financial Services and Markets Act 2000 (FSMA) in line with the Transparency Directive. The Regulations make changes in respect of...more

"The UK Softens Its Approach to Senior Banker Regulatory Liability"

The aftermath of the financial crisis saw regulators worldwide tighten rules and launch large-scale enforcement investigations, particularly directed at the banking sector. The U.K., notwithstanding the importance to it of...more

Wrap-Up of Federal and State Chemical Regulatory Developments, October 2015

On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) issued a report, "The DNA of the U.S. Regulatory System: Are We Getting It Right For Synthetic...more

Treasury introduces BoE Bill

Treasury has published the responses to the Government’s technical consultation on proposed changes to the governance of BoE (see FReD 24 July). It also introduced the Bank of England and Financial Services Bill (the BoE...more

Long-awaited overhaul of FDA food safety rules arrives – Part II: A roadmap for food manufacturers on FDA’s changes to cGMPs

The new FDA Rule revamping cGMPs and implementing new rules referred to as HARPC will impact the food industry greatly. In this second in a three-part series, we will discuss the FDA’s changes to cGMPs, noting the changes...more

Food and Beverage Alert (US) - October 2015

FSMA will have major impact on dietary ingredient suppliers, expert says. The biggest change in food regulation in the US in the past 75 years will have a major effect on the suppliers of dietary ingredients, a food-quality...more

Food Safety Does Not Exist In A Vacuum, and Neither Do the FSMA’s Rules: What the New Rules on Preventive Controls for Human and...

On September 17, 2015 the FDA published the first two of its seven rules in conjunction with the Food Safety Modernization Act’s (the “FSMA”) regulatory scheme. The rules, which focus on Current Good Manufacturing Practices...more

Long-awaited overhaul of FDA food safety rules arrives – Part I: Introducing HARPC, changes to cGMP

Since the passage of the Food Safety Modernization Act in 2011, the FDA has promulgated proposed rules that overhaul the old Good Manufacturing Practice (cGMP) rule and create new Hazard Analysis and Risk-Based Preventative...more

FDA Releases Two Final Food Safety Rules: What You Need to Know

Progress on Final Rules implementing the Food Safety Modernization Act (FSMA) took a significant step forward last week when FDA released its first two, comprising the final rules on Current Good Manufacturing Practice and...more

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