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U.S. Department of Health and Human Services

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Preventive Standards

Information available related to Preventive Standards under the FDA Food Safety Modernization Act (FSMA).

Prevention as Cornerstone of FDA Food Safety Modernization Act

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.


The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.

Building a new food safety system based on prevention will take time, and FDA is creating a process for getting this work done. Congress has established specific implementation dates in the legislation. The funding the Agency gets each year, which affects staffing and vital operations, will affect how quickly FDA can put this legislation into effect. FDA is committed to implementing the requirements through an open process with opportunity for input from all stakeholders.

The following are among FDA’s key new prevention authorities and mandates. Specific implementation dates specified in the law are noted in parentheses:

For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. This mandate includes:

  • Mandatory preventive controls for food facilities: Food facilities are required to implement a written preventive controls plan. This involves: (1) evaluating the hazards that could affect food safety, (2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards, (3) specifying how the facility will monitor these controls to ensure they are working, (4) maintaining routine records of the monitoring, and (5) specifying what actions the facility will take to correct problems that arise. (Final rule due 18 months following enactment)
  • Mandatory produce safety standards: FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables. Those standards must consider naturally occurring hazards, as well as those that may be introduced either unintentionally or intentionally, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area and water. (Final regulation due about 2 years following enactment)
    Authority to prevent intentional contamination: FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points. (Final rule due 18 months following enactment)

  
Frequently Asked Questions on Prevention

P.1 What are preventive controls? 

Preventive controls are scientifically- and risk based-based practices that facilities use to address hazards that their products might be exposed to. Once preventive controls are in place, facilities should monitor them to make sure they are working as they were designed.

P.2 Will facilities that manufacture, process, pack, or hold food be required under FSMA to write and implement a preventive controls plan?
FDA’s intention is that all covered facilities would need to develop a plan; identify the hazards, identify and implement preventive controls; and then monitor to make certain that the controls work. However, not every facility will have the same hazards or preventive controls. Each plan should be tailored to fit the facility and the risks associated with the facility's food.

P.3 Is this requirement in the statute for creating and implementing these plans effective now and should facilities continue to follow the current good manufacturing practices (CGMPs)? 

The requirement is not effective now and will not be effective before FDA issues a final rule implementing the requirements. Firms need to continue to comply with CGMPs. Further, FDA does not anticipate that the new preventive control requirements will replace CGMPs. Rather, CGMPs will form the foundation for preventive controls.

P.4 Will all of the requirements for preventive controls apply to all facilities? 

FSMA provides for exemptions or modified requirements in certain circumstances, such as when a facility is already required to comply and is in compliance with seafood or juice HACCP, or if a facility is very small. FDA will address and explain these aspects of the law as part of the rulemaking process to implement the preventive controls provision. There will be guidance and a proposed and final rule issued with ample opportunity for public comment.

P.5. Will food in compliance with the mandatory juice or seafood HACCP requirements be subject to the new preventive control requirements for facilities? 

No. FSMA contains an exemption for a facility with regard to food subject to and in compliance with FDA's juice or seafood HACCP regulations.

P.6 What is the scope of the exemption for food subject to the low-acid canned foods (LACF) regulations? 

The exemption for LACF is limited to microbiological hazards. The preventive control requirements will apply as to other hazards.

P.7 For mandatory certification of high risk products, how will “high risk” foods be determined? Is this by product or firm? Who is to conduct this certification?
This is a decision still to be made.

P.8 Prior to passage of FSMA, were there requirements for farm inspections?
Prior to FSMA, FDA conducted farm inspections as part of investigations into outbreaks of foodborne illness and the associated tracebacks.

P.9 In Section 103 of the FSMA, the Agency is required to publish a proposed rule to address certain circumstances involving 1) activities that constitute on-farm packing or holding of food and 2) activities that constitute on-farm manufacturing or processing of food. This rulemaking is to clarify the activities that are included as part of the definition of the term "facility." When can we expect this rule to publish? 
The rule to clarify activities that are included as part of the definition of the term “facility” will be proposed as part of the rulemaking for the preventive controls regulation. This proposal will be published in the Federal Register when it is issued, and there will be an opportunity for public comment.

P.10 Is there an official checklist for manufacturers to prepare for compliance with section 418 of the FD&C Act (Hazard Analysis and Preventive Controls), added to the FD&C Act by FSMA? 
FDA is promulgating regulations to implement new section 418 of the FD&C Act, as required by FSMA, for both human foods and animal foods. Once those regulations are finalized, we will prepare guidance documents as appropriate to assist manufacturers in complying with the requirements. 

P.11 What are the estimated costs of a new inspection system – new inspectors, new processing, additional labs and reporting to Congress? What will the cost impact be on the farmer and consumer?
It is too soon to know what the costs will be; FDA anticipates there will be some initial costs with the implementation of two rules that FDA anticipates releasing soon, the preventive controls and produce regulations.

 

Full Text of the Law Relating to Prevention

   

Listen to FDA Expert Talk about Preventive Controls

http://www.fda.gov/Food/FoodSafety/FSMA/ucm249243.htm#preventive

 

Training

Food Safety Preventive Controls Alliance
FDA, in cooperation with the Institute for Food Safety and Health, has created the Food Safety Preventive Controls Alliance to develop training courses and materials to help industry, particularly small- and medium-sized companies, comply with the upcoming preventive control rules. 

   
Public Meeting

FDA hosted an all-day public meeting entitled FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities to provide interested persons an opportunity to discuss implementation of the preventive controls for facilities provisions of the recently enacted FDA Food Safety Modernization Act (FSMA).

  

Speeches and Statements

Prevention and Food Safety: Two Lenses, Common Vision
Remarks at the George Washington University School of Public Health
Washington, D.C.
May 19, 2011
   

Guidance and Rules

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