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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)

   

Guidance and Rules

      
Frequently Asked Questions

Questions & Answers on the FSMA Proposed Rule for Preventive Controls for Human Food: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (PDF: 246KB)

The Proposed Rule for Preventive Controls as it Relates to Dairy Products Produced under the Pasteurized Milk Ordinance (PMO) NEW

PCR.1 Do facilities operating under the PMO meet the requirements of the proposed preventive controls rule?
The preventive controls provision of FSMA (section 103) does not exempt dairy facilities that are required to register with FDA. FDA is interested in receiving comment on whether and how a facility complying with the PMO would be in compliance with the requirements of the proposed PC rule.

PCR.2 If a firm implements the PMO’s voluntary HACCP program, will the preventive controls requirements of FSMA be satisfied? If not, what are the additional requirements?
Beginning on page 3662 of the preamble of the proposed Preventive Controls Rule, FDA discusses the voluntary HACCP program of Appendix K in the PMO in relation to other HACCP programs. Beginning on page 3785, Section XVI. B discusses the comparison of hazard analysis and preventive controls standards; this comparison includes the PMO HACCP Appendix. The proposed rule would require a food safety plan, and outlines specific components that are very similar but not identical to the requirements for a HACCP plan in the PMO HACCP Appendix. FDA is interested in receiving comment on the comparison of requirements under the proposed Preventive Controls Rule and the PMO HACCP Annex and any specific differences, as well as whether and how the PMO voluntary HACCP program satisfies the proposed rule’s requirements. 

PCR.3 After the Preventive Controls Rule becomes effective, when FDA conducts a Grade A milk plant inspection, what inspection criteria will be used - Preventive Controls, PMO or both sets of rules?
Grade A milk plants currently inspected under the PMO would be required to meet any additional requirements of the Preventive Controls Rule. FDA would like to receive comments on how the requirements of the PMO and the Preventive Controls Rule can be implemented in a way that avoids duplication and makes sense with respect to ensuring food safety. 

PCR.4 Does the Preventive Controls Rule apply to dairy farms?
Dairy farms that conduct manufacturing/processing activities on food not consumed on that farm or that pack or hold food not grown, raised or consumed on that farm are subject to registration under section 415 of the FD&C Act and would be subject to requirements of the Preventive Controls Rule unless a specific exemption applies. 

PCR.5 What environmental and finished product testing for milk and dairy products is required under FSMA and the proposed Preventive Controls Rule?
The proposed Preventive Controls Rule did not include requirements for environmental monitoring or finished product testing. Instead, the proposed rule discusses FDA’s current thinking and poses a number of questions seeking input on when and how such testing is appropriate in verifying that hazards are being effectively controlled. We encourage the submission of comments on when it would be appropriate to use environmental monitoring and/or finished product testing for milk and dairy products. 

     

Full Text of the Law Relating to Prevention

   

Listen to FDA Expert Talk about Preventive Controls

 

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

   

Speeches and Statements

  

Reports

  

 

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