Food Safety
FSMA Proposed Rule for Hazard Analysis and Risk-Based
Preventative Controls for Human Food
UVM Extension Fact Sheet- January 2013
More information, including the complete text of the Produce Safety and the Preventative Controls proposed
rules, how to comment, etc. is available from: www.fda.gov/food/foodsafety/fsma/default.htm
What is the intent of the rule? Prevent problems that can cause foodborne illness
Who does it apply to? Domestic and foreign firms that manufacture, process, pack or hold human food.
Am I exempted? See back side for details on exemptions.
What would be required? Written food safety plans that: a) identify hazards, b) specify the steps
(preventative controls) that will be put in place to minimize or prevent those hazards, c) identify monitoring
procedures, d) record monitoring results and e) specify what actions will be taken to correct problems that
arise. Facilities would also need to comply with the updated Good Manufacturing Practices (see UVM
Extension Fact Sheet on GMPs).
How does a “preventative controls plan” compare to a HACCP plan? The general concepts are very similar.
However, these “preventative controls plans” also cover monitoring, records, and corrective actions for items
that are considered pre-requisite programs in HACCP, including food allergen controls, sanitation controls, and
a recall plan. Preventative controls plans do NOT have a requirement for a Critical Limit as in HACCP plans.
What oversight will the FDA have of my plan? FDA would evaluate the plans and continue to inspect facilities
to make sure the plans are being implemented properly.
When would I need to comply (if I am not exempted)?
*Large businesses (> 500 employees): 1 year after the FINAL rule is published
*Small businesses (<500 employees): 2 years after the FINAL rule is published
*Very small businesses (3 definitions proposed: <$250,000 or <$500,000 or <$1,000,000 total annual
sales of food): 3 years after the FINAL rule is published
How can I comment on the proposed rule? Comment online through the FSMA website or share your
comments with UVM Extension or relevant state officials. Comments due by May 16, 2013
1
Exemptions and Modified Requirements for Preventive Controls for Human Food*
Hazard Analysis and Risk Based
Preventive Control Requirements
Current Good Manufacturing
Practices (CGMP)
Exempt
Must comply
Exempt
Must comply
A facility that has a) food sales
averaging less than $500,000/ year in
the last three years AND b) sales to
qualified end users1 exceed sales to
others.
Facility must certify that it is
implementing and monitoring
preventive controls or complying with
state laws.
Must comply
A very small business. Three definitions
are being proposed: <$250,000,
<$500,000, or <$1,000,000 in total
annual sales of food.
Facility must certify that it is
implementing and monitoring
preventive controls or complying with
state laws.
Must comply
Type of facility or operation
On-farm processing of jams and jellies
and manufacturing honey and maple
syrup
Foods subject to FDA HACCP regulations
(seafood and juice)
Exempt from Preventative Controls.
Activities within the definition of “farm”
May be covered by Produce Safety
(production of food)
rule
Warehouses only storing packaged
foods that are not exposed to the
environment
Warehouses that store raw fruits and
vegetables intended for further
distribution or processing.
If refrigeration is not required for
safety: exempt.
If refrigeration is required:
temperature control records are
required.
Must comply*
Exempt
Must comply
Exempt
* Adapted from the FDA FSMA Chart. More information is available in the proposed rule available at:
www.fda.gov/food/foodsafety/fsma/default.htm
Note: your facility will lose its exempt status if it is determined that it was the source of a foodborne illness outbreak.
Fact sheet prepared by Dr. Londa Nwadike, UVM Extension Food Safety Specialist,
londa.nwadike@uvm.edu; tel: 802-223-2389; 617 Comstock Road, Berlin, VT 05602
Fact sheet reviewed by Dr. Ginger Nickerson, UVM Extension Center for Sustainable
Agriculture GAPS/Produce Safety Outreach Coordinator
UVM Extension helps
individuals and communities
put research-based knowledge
to work.
Issued in furtherance of Cooperative Extension work, Acts of May 8 and June 30, 1914, in cooperation with the United States Department of
Agriculture. University of Vermont Extension, Burlington, Vermont. University of Vermont Extension, and U.S. Department of Agriculture,
cooperating, offer education and employment to everyone without regard to race, color, national origin, gender, religion, age, disability, political
beliefs, sexual orientation, and marital or familial status.
1
A qualified end-user is either a consumer (in any location), or a restaurant or retail food establishment purchasing the food for sale
directly to consumers that is located in the same State or not more than 275 miles away.
2