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.

Summer Academy in Global Food Law and Policy 2017

The Summer Academy in Global Food Law & Policy is an established one-week summer programme that brings together practitioners, policymakers, industry representatives and leading academics working in the field of food law and policy.

It offers intensive training on the most innovative developments in global food regulation and provides a unique opportunity for professional development and networking in an informal and inter-disciplinary setting.

By talking, studying and interacting with food experts from all over the world, participants are able to gain new perspectives into both their own sectors and international regulatory issues.

This is achieved by combining traditional classroom instruction with experiential learning opportunities offered by dedicated and distinguished international experts.

The Academy will take place from Monday, 17 July, to Thursday, 20 July, 2017 in Bilbao, Spain.

The choice of this vibrant city will enable participants to benefit from the world renowned Basque cuisine, its privileged geographical location between the Atlantic sea and the Rioja region, as well as its distinctive architectural landscapes (with the Guggenheim Museum, Norman Foster’s Undergroud, the towers by Arata Isozaki and César Pelli and the Calatrava’s airport).

2017’s edition keynote speaker will be Dr. Ala Alwan, the former Assistant Director General for non-communicable diseases and mental health at the World Health Organization and regional director for the WHO Eastern Mediterranean Region.

Also this year I will be there, leading a panel which will explore risks and opportunities of the application of new technologies and internet of things in the food sector.

You can apply until 31st May 2017 to the following link and here you can download the full program.

Here’s a preview:

The International Trade Regime of Food: a WTO Perspective

Erik Wijkström, Trade and Environment Division, Secretary of the WTO Committee on Technical Barriers to Trade at the World Health Organization

Food Labeling: Can Labels Reshape the World?

Melissa M. Card, J.D., Institute for Food Laws and Regulations, Michigan State University College of Law

What Role for the Law in the Prevention of Non-Communicable Diseases? Focus on the Obesity Challenge

Alberto Alemanno, Jean Monnet Professor of EU Law at HEC Paris and Global Clinical Professor of Law at NYU School of Law

Unlocking the Mindful Consumer: Where Business Performance and Public Policy Goals Meet

Francesco Tramontin, Chair of the AIM/Nudge Task Force and Director Public Affairs Mondelez International

Bridging the Gap between Behavioural Policymaking and Obesity: Unleashing the Power of Peers for Healthy Nutrition

Pelle Guldborg Hansen, University of Roskilde

Business and Human Rights: Opportunities and Challenges for a Food Company Embarking on the Social Sustainability Journey

Virginie Mahin, External Communications Manager at Mondelez Europe

Chile’s Super 8 Front-of-Package Food Labelling Law and its Interactions with the Global Health, Trade, and Investment Architecture

Paul Mertenskoetter, Institute for International Law and Justice at NYU School of Law

The Consumer Information Paradigm: A Critical, European Perspective

Caoimhin Mac Maolain, Trinity College Dublin

Taxing Food and Beverage Products: A Public Health Perspective

Jennifer Pomeranz, Assistant Professor at NYU College of Public Health

A Global Perspective through the Lenses of the Latin American Experience

Oscar Cabrera, Executive Director of the O’Neill Institute for National and Global Health Law and Visiting Professor of Law at Georgetown University Law Center

The Application of New Technologies and Internet of Things in the Food Sector: Risks and Opportunities

Cesare Varallo, Food Lawyer, foodlawtest.com founder, and Vice President at INSCATECH