FSMA Preventive Controls Exemptions and Modifications: Do They Apply to You?

Departments - Legislation

April 9, 2013

In January, FDA published the proposed Preventive Controls rule of FSMA requiring that food facilities prepare, implement, and document comprehensive food safety plans. Understanding, however, that implementing the plans can be a very time-consuming activity, FDA also proposed to reduce the burden on the food industry through several exemptions and modifications to the general rule.

To determine if any of these exemptions or modifications apply to your facility, you could read through the entire 680 pages of the proposed rule. But to make it a bit easier, the following provides a guide to help food facilities determine which parts of the proposed rule will apply to you.

The easiest way to determine whether your facility and/or activities within your facility are subject to or exempt from the rule is by walking through the requirements and exemptions step by step.


1. Food Facility Registration.
The first and overarching check is the food facility registration requirement of the Bioterrorism Act. Food facilities have had to register since 2005. FSMA did not fundamentally change who has to register, however not all those who have to register are impacted by the Preventive Controls rules. But there are a few changes to registration (see #2). In general, domestic and foreign facilities must be registered with FDA if they manufacture, process, pack, or hold food for consumption in the U.S., regardless of size or extent of distribution (i.e., even facilities that only sell FDA-regulated food within a state do need to register). Thus, if you are required to register, you may be subject to the mandates of the Preventive Controls rule; if you are not required to register, this rule does not apply to you.


2. Registration Exemptions.There are various exemptions for registration based primarily on the activity within the facility:

a. If a foreign food facility processes a food, then sends it to another foreign facility for further manufacturing/processing or packaging (not simply labeling, or other de minimis activity), and the food is then exported to the U.S., only the second foreign facility is required to register. Additionally, a foreign facility that packs or holds product after it is processed also must register.

b. Farm exemptions are significantly expanded, with those exempted from registering/adhering to Preventive Controls subject, instead, to the rules of the proposed Produce Safety Standards. Some of the expanded exempted on-farm activities are: harvesting, some packing and holding, and manufacturing/processing if and only if the product is consumed only on farm.

c. Retail and restaurant establishments continue to be exempt from registration and the rule. Other exemptions include Non-profit/501(c)(3) entities, fishing vessels (except on-vessel processing), and facilities wholly regulated by USDA.

It is important to note that in a mixed-type facility (having exempt and non-exempt activities), the exemption applies only to the exempt activities. The non-exempt activities need to comply with the proposed rule.


3. Facility Exemptions.
The following facilities are completely exempt from the preventive control rule: dietary supplement facilities, raw agricultural commodity storage facilities, facilities solely engaged in the storage of packaged food that does not rely on temperature control.


4. Qualified Facility Exemption. Smaller food facilities that may have trouble complying with the more onerous requirements of the proposed rule must instead comply with modified requirements. A qualified facility is one that fits the category of one or both the following:

a. Very small business. Annual food sales of the entire business (not just the facility in question) are below $250,000, $500,000, or $1 million. (The proposed rule requests comment on which of the three figures should be used to determine very small.)

b. Qualified end-user. Annual food sales (averaged over the preceding three years) must be less than $500K, and food sales made directly to consumers or to a restaurant or retail establishment in the same state or within 275 miles of the facility, must be greater than the value of all food sales to other customers.


To qualify for Modified Requirements, a facility must submit documents to FDA showing that it meets the qualified-facility requirements and that it has sufficient food-safety planning. Documenting food-safety planning requires that the owner, operator, or agent in charge submit a statement certifying that the facility either has identified potential food safety hazards, is implementing preventive controls to address the hazards, and is monitoring the preventive controls to ensure that such controls are effective; or is in compliance with state, local, county, or foreign food safety laws. It is not necessary to provide documentation supporting these self-certified statements.

However, if the facility is ever involved in an active investigation of a foodborne illness outbreak directly linked to the facility, or if FDA deems it necessary to prevent an outbreak, the exemption may be withdrawn.


Activity Exemptions.
Certain activities in a facility may qualify for an activity-level exemption, however the non-qualifying activities remain subject to the Preventive Controls rule.

a. Food-specific activity-level exemptions include those subject to Seafood and Juice HACCP Programs, Low Acid Canned Food Standards in relation to microbiological controls, or U.S. Treasury Department Alcoholic Beverage Registration.

b. Low risk, on-farm packing, manufacturing, or processing, or holding activities of small or very small businesses. Activities considered to be low risk are listed in the rule.

If none of the above exemptions apply to your facility or specific activities within your facility, then you are subject to the Preventive Controls rule. The one exception where there may be a partial exemption is in relation to warehouses. In this situation, the warehouse is exempt for goods that do not require time/temperature control to mitigate food safety hazards (which are obviously microbiological). However, the warehouse will have to comply with Preventive Controls rules for time/temperature control of hazards in foods for which this is needed to manage risk, e.g. produce.

Because the Preventive Controls rule is intended to be flexible and adaptable to each facility’s capacity and level of risk and to prevent situations where a facility might have to perform duplicative compliance activities, there are many ways that a facility may be exempt from some, or all, the rules. However, it is important to remember that many of the exemptions are targeted to specific foods and specific processing activities. Thus, exemption of an activity may not exempt your entire facility, it may just exempt one portion of what you do.


This column provides a general overview and step-by-step guide to determining whether your facility and/or activities are subject to the rule. Further detail and a listing of low-risk activities are available in the white paper, “The Proposed Preventive Control Rule Are You In or Out?” at http://leavittpartners.com/fsma.


FSMA Two Years Later

With the Food Safety Modernization Act (FSMA) having been signed on January 4, 2011, by President Obama, we are well into year three. When the first two years showed little movement on publication of regulation, many expected that the reelection of President Obama would help to speed things along. The expectation seemed valid at first as two proposed rules—Preventive Controls and Produce Safety—finally came off the desk of the Office of Management and Budget on January 4, 2013, but the Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Section 103) and the Foreign Supplier Verification Program (Section 301) rules continue to lag at OMB, despite their having been submitted at the same time as Preventive Controls and Produce Safety—in December 2011. So what has happened since the signing? Following are some highlights from the years:


2011. FDA:

  • issued interim final rules on criteria for administrative detention and used this authority three times; issued interim final rules on prior notice of imported food.
  • issued guidance to the seafood industry on food safety hazards and to the dietary supplement industry regarding new dietary ingredients.
  • conducted domestic and foreign outreach for input on the preventive control rules.
  • established the Produce Safety Alliance and the Food Safety Preventive Controls Alliance.
  • met the FSMA mandate for foreign inspections; did over 20,000 domestic inspections.
  • began using its new authority to administratively detain food products that it has reason to believe are adulterated or misbranded.
  • launched two Product Tracing Pilots, by the Institute of Food Technologists (IFT), to enhance the ability to trace products responsible for foodborne illness outbreaks.
  • submitted proposed rules to the Office of Management and Budget for
    • the Produce Safety Regulation (Section 105)
    • Hazard Analysis and Risk-Based Preventive Controls (Section 103);
    • Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Section 103)
    • the Foreign Supplier Verification Program (Section 301).
  • conducted and/or participated in a number of communication, outreach, and technical assistance programs and meetings on FSMA, and established a FSMA webpage.



2012. FDA:

  • established the Sprouts Safety Alliance, housed at the Illinois Institute of Technology’s Institute for Food Safety and Health, to develop a core curriculum. training and outreach programs.
  • issued the Interim Final Rule and Guidance on FDA’s Access to Records.
  • published documents on how it identifies a high-risk facility and how it will be updated.
  • released updated draft guidance on Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories and Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories.
  • rolled out an updated, electronic food facility registration system.



2013. FDA:

  • published the proposed rule for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (Preventative Controls).
  • published the proposed rule for Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety) .



More information and FSMA updates is available at www.fda.gov/fsma.