FDA Releases Compliance Guide for Small Businesses under FSMA Intentional Adulteration Rule (Food defense)

Small Entity Compliance Guides (SECGs) are designed to help small businesses meet federal standards. They are among the resources that the FDA is providing to support compliance with the new FDA Food Safety Modernization Act (FSMA) standards.

The FDA announced today the availability of an SECG to help small businesses comply with the Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (or Intentional Adulteration Rule), mandated by FSMA.

The SECG was prepared in accordance with the Small Business Regulatory Enforcement and Fairness Act. It provides nonbinding recommendations on such topics as developing a food defense plan and records management.

The compliance date for small businesses under the Intentional Adulteration Rule is July 27, 2020. Very small businesses are exempt from the rule, except for a documentation requirement described in the SECG, which has a compliance date of July 26, 2021.

Here you can find also an FDA fact sheet on the final rule on food defense.

The FDA Food Safety Modernization Act (FSMA) final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, economic disruption of the food supply absent mitigation strategies.

Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.

The proposed rule was issued in December 2013. The changes in the final rule are largely designed to provide either more information, where stakeholders requested it, or greater flexibility for food facilities in determining how they will assess their facilities, implement mitigation strategies, and ensure that the mitigation strategies are working as intended.

In developing the rule, FDA interacted with the intelligence community and considered vulnerability assessments conducted in collaboration with the food industry.
While acts of intentional adulteration may many other forms, including acts of disgruntled employees or economically motivated adulteration, the goal of this rule is to prevent acts intended to cause wide-scale harm. Economic adulteration, on the contrary,  is addressed in the final preventive controls rules for human and animal foods.

We already treated food defense topic in a previous post regarding EU situation.

UK – Global food law challenges and opportunities seminar (19th September 2017)

On 19th September 2017 I have been invited as speaker to a very interesting one-day-seminar that will touch several key topics of the UK/EU food law, including food fraud prevention.

The seminar is organised by Campden BRI and will be held in their HQ in Chipping Campden, Gloucestershire.

Here you can see the full program and the speaker’s list, including Klaudyna Terlicka, Noelia Rodrigo and Jonathan Coleman from Campden BRI and Andrew Iveson (Amivet Ltd Veterinary Exports).

Summary

Maintaining an awareness of current food and drink legislation, understanding its implications and remaining alert to changes is increasingly challenging. Although progress has been made to harmonize legislation and enforcement and many food–related matters are regulated at the level of the European Union, Eurasian Economic Union, Gulf Cooperation Council (GCC) or Codex Alimentarius, national disparities can still be seen. A ‘one size fits all’ approach for the creation of products that comply with each market is not possible.

A further challenge is the UK’s movement towards independence from the European Union and what this might mean for the UK’s food industry.

For this seminar, Campden BRI assembled an expert team to give us their perspectives and cover emerging international food regulatory topics as they may well become more important as the regulatory landscape changes. This seminar will also provide a unique opportunity to discuss the most recent regulatory updates and trends from global perspective.

Key areas to be covered

  • Global food law trends.
  • Key export challenges, including case studies.
  • Food fraud: international perspective.
  • Global labelling differences, with particular focus on allergens, country of origin, nutrition labelling and claims.
  • Brexit and potential implications for international trade.

Key benefits of attending

  • A unique opportunity to discuss most recent updates and trends from global perspective.
  • Global regulatory awareness might become increasingly important as the UK moves on and it would be instructive to hear what is going on outside of the EU.
  • Case studies, practical applications and tools to understand and overcome export challenges.
  • Interactive discussions and great networking opportunities.

I will travel around UK for few days, so if you will participate to the seminar or would like to meet for a coffee, please drop me a not at foodlawlatest@gmail.com