FSMA Proposed Rule to Protect Intentional
Adulteration of Food
FDA’s proposed rule, published on December 24, 2013,
on food defense would require domestic and foreign facilities to address
vulnerable processes in their operations to prevent acts on the food supply
intended to cause large-scale public harm. The proposed rule, mandated by the
FDA Food Safety Modernization Act (FSMA), would require the largest food
businesses to have a written food defense plan that addresses significant vulnerabilities
in a food operation. Comments are invited by March 31, 2014.
The FDA is proposing that requirements be
effective 60 days after the final rule is published in the Federal Register.
Recognizing that small and very small businesses may need more time to comply
with the requirements, the FDA is proposing tiered compliance dates based on
facility size. The FDA will hold a public meeting on February 20, 2014, to
explain the proposal and provide additional opportunity for input.
The FDA Food Safety Modernization Act (FSMA) was
signed into law on January 4, 2011, to better protect human and animal health
by helping to ensure the safety and security of the modern food and feed supply
and recognizes the need for global approach food and feed safety as well.
Acts of intentional adulteration may take several
forms, such as the intentional large-scale public health harm; acts of
disgruntled employees, consumers, or competitors; and economically motivated
While intentional adulteration of the food supply
is unlikely to occur; however, it could have catastrophic results including
human illness and death, loss of public confidence in the safety of food, and
significant adverse economic impacts, including trade disruption, all of which
can lead to widespread public fear.
Efforts to protect against intentional adulteration
require a shift in perspective; FDA proposes targeting vulnerable processes
rather than targeting specific foods or hazards.
With some exceptions, this proposed rule would apply
to both domestic and foreign facilities that manufacture, process, pack, or
hold food and are required to register as a food facility. This rule would
not apply to farms or other food facilities not required to register.
The FDA has identified four key activities within
the food system that are most vulnerable. They include:
- Bulk liquid receiving and loading
- Liquid storage and handling
- Secondary ingredient handling (the step where
ingredients other than the primary ingredient of the food are handled before
being combined with the primary ingredient)
- Mixing and similar activities.
Each facility covered by this rule would be
required to prepare and implement a written food defense plan, which would
include the following:
- Actionable process steps
- Focused mitigation
- Corrective actions
The cost of the proposed rule to both domestic and
foreign firms (annualized over 10 years at a 7 percent discount rate) is
between $260 million and $470 million. The first-year cost is between $520
million and $860 million. The expected benefit of preventing a catastrophic
terrorist attack on the US food supply is about $130 billion, such that the
benefits of this rule outweigh the costs to Americans if the rule has a 1 in
730 or better annual chance of preventing such an attack.
Labels: California Ag News, FDA Invites Comment on Food Adulteration Policy, FSMA Proposed Rule to Protect Intentional Adulteration of Food