FDA Releases New FSMA Draft Guidance on
Food Defense and Adulteration
The U.S. Food and Drug Administration (FDA)’s Food Safety Modernization Act (FSMA)
added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) several new sections that
reference intentional adulteration (IA). For example, Section 418 of the FD&C Act ( 21 U.S.C.
350g) addresses IA in the context of facilities that manufacture, process, pack, or hold food
and that are required to register under Section 415 ( 21 U.S.C.
350d). Section 420 of the FD&C Act ( 21 U.S.C. 350i) addresses
IA in the context of high-risk foods and exempts farms except for
those that produce milk.
FDA implemented these IA provisions through a rule entitled
“Mitigation Strategies to Protect Food Against Intentional Adul-
teration” (IA rule) and published the final rule in the Federal
Register of May 27, 2016. The rule, which includes the
requirements for food defense measures against IA, and
related requirements can be found in 21 C.F.R. Part 121.
The IA rule applies to the owner, operator, or agent in
charge of a domestic or foreign food facility that manufac-tures/processes, packs, or holds food for consumption in the
U.S. and is required to register under Section 415 of the FD&C
Act, unless one of the exemptions provided in 21 C.F.R.
This document is directed to those persons who are
subject to the IA rule. Identifying significant vulner-abilities at a company’s facilities and implementing mitigation strategies and mitigation strategy
management components enable a company to
apply a proactive and systematic approach to its
food defense program to protect its food from IA
intended to cause wide-scale public health harm.
Download the draft guidance for industry from
Stubbs Joins FSM Board
Tim Stubbs, CFS, is vice president, product research and food
safety, at Dairy Management Inc. (DMI). He leads the Innovation
Center for U.S. Dairy Food Safety Committee, a very active group of
food safety experts from dairy companies and co-ops. Tim also leads
National Dairy Council research programs at universities to drive dairy
innovation and sales on behalf of America’s dairy farmers.
Prior to joining DMI, Tim worked with Kraft Foods and Sara Lee/
Hillshire Brands. He has a broad background in food science and
engineering, new product innovation, formulation, process research,
thermal processing, and food safety across a wide variety of products,
including cheese, milk, salad dressings, sauces, chilled foods, fresh pasta, bakery products,
processed meats, and frozen ready-to-eat meals.
Tim is on the board of the Chicagoland Food Science Foundation and is a member of the
Institute of Food Technologists. Tim holds a B.Sc. in chemical engineering from the University
New Reports on
in European Food
The European Food Safety Authority (EFSA) has announced the publication
of two new reports that
demonstrate how whole-genome sequencing (WGS)
can be used in food safety
and how it is currently being
applied in Europe.
The first report is
Outcome of EC/EFSA Questionnaire (2016) on Use of Whole
Genome Sequencing (WGS) for
Food and Waterborne Pathogens
Isolated from Animals, Food,
Feed, and Related Environmental Samples in EU/EFTA
Countries. The report explains
the extent by which WGS
is being utilized in Europe,
why—in some cases—WGS is
not an option, and the main
uses for WGS.
The other report is Es-
tablishing Next Generation
Sequencing Ability for Genomic
Analysis in Europe. It in-
cludes a description of all
milestones achieved, such
as public release of bacterial
sequences, scientific publica-
tions, benchmarking exer-
cises, workshops, trainings,
and learning materials.
The aim of the project was to boost scientific cooperation among
to use WGS in food
safety and public health
protection. All materials
produced can be found in
the reports and at