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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

Proposed Rule for Preventive Controls for Human Food

See Questions & Answers on the Proposed Rule for Preventive Controls for Human Food (PDF: 246KB).

Sanitary Transportation of Human and Animal Food 

ST1. Why is the FDA proposing this rule?
Due to past incidents of unsanitary transportation practices for human and animal food, there have been frequent concerns about the potential for food to become contaminated during transportation. The goal of the proposed rule is to prevent practices that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food during transportation.     

ST2. How frequent are incidents of unsanitary transportation of food?
The risk of contamination from transportation is low. However, the FDA continues to receive reports of food transported under unsanitary conditions. Additionally, findings from two recent studies of the food transportation industry identified several areas of concern, including improper refrigeration, transport of food and non-food items in the same load in a manner that could result in cross-contamination, improper sanitation, and low driver awareness of food safety. One of the larger detected outbreaks of foodborne illness happened in 1994, caused by the contamination of an ice cream mix with Salmonella during bulk transport to the packing facility. This outbreak was estimated to have affected more than 224,000 persons nationwide.

ST3. If the risk of contamination from transportation is so low, is this placing too great a burden on industry?
Although it is difficult to attribute foodborne illness to contamination during transportation, the FDA does receive reports of unsanitary food transportation practices that could lead to contamination. Furthermore, the proposed rule builds on current food transportation best practices concerning cleaning, inspection, maintaining, loading and unloading, and operating vehicles and transportation equipment.

ST4. What action has the FDA taken to date to ensure the safety of food during transportation?
In 1990, Congress passed the Sanitary Food Transportation Act of 1990 and delegated primary authority to implement the law to the Department of Transportation (DOT). Upon the passage of the 2005 SFTA, the 1990 SFTA was withdrawn, and the FDA now has the lead role among federal agencies in regulating the safety of food during transport. However, both DOT and the U.S. Department of Agriculture (USDA) have a role as partners with the FDA in the broad federal food safety structure. With the update of SFTA in 2005, Congress directed the FDA to establish regulations on sanitary transportation practices for food. As part of the implementation of the 2005 SFTA, the FDA has collected information on current best practices in the food transportation industry through an Advance Notice of Proposed Rulemaking and a study commissioned to characterize current baseline practices and to identify current areas where food is at risk. This proposed rule will implement the 2005 SFTA as well as the requirement in section 111 of FSMA to issue these regulations. In April of 2010 FDA also issued guidance to provide the industry with broadly applicable recommendations for controls to prevent food safety problems during transport. This guidance and other information about regulations and guidance applicable to food transportation are available on FDA's Sanitation & Transportation Guidance Documents & Regulatory Information page. The FDA will continue to work with its federal, state, local, and territorial and tribal partners to respond to reports of food transportation under unsanitary conditions. 

ST5. What are some examples of sanitary transportation practices that would be required under this rule?
This proposed rule establishes requirements for vehicles and transportation equipment, transportation operations, training, and recordkeeping. For example, shippers would be required to inspect a vehicle for cleanliness or contamination prior to loading food that is not completely enclosed by its container. Operators of motor vehicles, railcars, and other equipment used in food transportation would be required to establish written procedures, subject to record keeping requirements, for cleaning their vehicles and transportation equipment. The FDA would be entitled to review these procedures and records. It also requires individuals who transport foods that require time/temperature control for safety to ensure the maintenance of the transportation cold chain during operations. This includes pre-cooling the vehicle, loading and unloading operations, and the transportation phase. The proposed rule would also establish procedures for the exchange of information about prior cargos, cleaning of transportation equipment, and temperature control between the shipper, carrier and receiver, as appropriate to the situation. Shippers would need this information to ensure adequate sanitation practices were used that would help prevent adulteration of transported products. For example, a carrier transporting bulk liquid non-dairy foods would want to ensure that vehicles that have previously hauled milk will not introduce allergens into non-dairy foods through cross contact.  

ST6. Does this rule apply to international motor and rail shipments?
Yes, it would apply to the transportation operations of food that will be directly transported into the United States by motor or rail vehicle and consumed or distributed in the United States. For example, the requirements of this proposed rule would apply to a person outside of the United States, such as an exporter, who ships food to the United States in an international freight container by oceangoing vessel or in an air freight container, and arranges for the transfer of the intact container in the United States onto a motor vehicle or rail vehicle for transportation in U.S. commerce, if that food will be consumed or distributed in the United States.  We would consider this person to be a shipper under this proposed rule because he would be initiating a shipment of food by motor vehicle or rail vehicle, even if doing so from abroad, that would be entering U.S. commerce. The requirements of this proposal would not apply to the transportation operations of food that may ultimately be intended for U.S. commerce, but will not be directly transported into the United States by motor or rail vehicle. 

ST7. How will the FDA pay to oversee and enforce this rule?
The FDA currently has resources to issue the rules required by FSMA but requires additional funding to fully implement the modernized food safety system envisioned by Congress.

ST8. How will the FDA enforce this new rule?
In addition to inspections the FDA will carry out itself, under the 2005 SFTA, the Department of Transportation will also establish procedures for transportation safety inspections to be conducted by DOT or state personnel. The FDA will also work with its state, local, territorial and tribal partners to help industry come into compliance with the rule. Once the proposed rule is finalized and implemented, compliance tools may include administrative actions (e.g. warning letters) and, in some instances, could include legal actions such as injunction and criminal prosecution.

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

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. 

Proposed Rule for Preventive Controls for Animal Food 

PCAR.1 What is FDA announcing on October 25, 2013?
The proposed rule would establish regulations regarding the manufacturing, processing, packing, or holding of food for animals in two ways. First, it would create new current good manufacturing practice (CGMP) regulations that specifically address the manufacturing, processing, packing, and holding of animal food. The proposed CGMPs would establish procedures in areas such as buildings and facilities, design and layout, cleaning and maintenance, pest control, and personnel hygiene. Second, it would include new preventive control provisions intended to implement section 103 of the FDA Food Safety Modernization Act (FSMA) for animal food. These preventive controls would include requirements for covered facilities to maintain a food safety plan, perform a hazard analysis, and implement preventive controls to minimize or prevent those hazards. Facilities would also be required to monitor their controls, verify that they were effective, take any appropriate corrective actions, and maintain records documenting these actions.

PCAR.2 Why is this proposed rule important to public health?
This proposed rule has important public health impacts for both animals and people. It would primarily impact animal health by helping prevent foodborne illness, including from nutrient imbalances, in animals. Many animals consume one food as their sole source of nutrition, and nutrient deficiencies or excesses can raise safety concerns. This rule would include nutrient imbalances in the food safety plan required by facilities. It would also help prevent foodborne illness in individuals handling pet food. Agents causing foodborne illness, like Salmonella, can be transmitted through pet food. There is risk to individuals who handle contaminated pet food products, especially if they have not thoroughly washed their hands after having contact with the food products or any surfaces exposed to these products.

PCAR.3 Who is covered by this rule?
This proposed rule would apply to animal facilities required to register under the FD&C Act that manufacture, process, pack, and hold ingredients and finished products that are intended to be fed to animals, including livestock, pets, and other animals. This includes renderers, pet food manufacturers, as well as biofuel manufacturers that supply distillers grain for animal food, and manufacturers of animal feed minerals and mineral mixes. This proposed rule would not apply to farms. However, if the farm operates an animal food manufacturing, packing, or holding business (in addition to its traditional farm activities), that food manufacturing, packing, or holding business, with certain exceptions, would likely need to comply with this proposed rule. The proposed rule would establish a series of exemptions (including modified requirements in some cases) from the requirements for hazard analysis and preventive controls for small, on-farm facilities with low risk activity/animal food combinations. For more information, see Fact Sheet: CGMPs and Preventive Controls for Food for Animals.

PCAR.4 How is this rule different from the FSMA preventive controls for human food rule?
This proposed rule is similar but not identical to the proposed rule for preventive controls for human food. For example, the animal food preventive controls provisions would not include certain requirements that don’t pertain to animal food, such as identifying allergens as a hazard. Also, the proposed definitions for “very small business” are different for facilities manufacturing food for animals.

PCAR.5 What are the specific requirements under this proposed rule?
Specifically, the proposed rule would establish requirements for a written food safety plan; hazard analysis; preventive controls for hazards that are reasonably likely to occur; recall plan for animal food with a hazard that is reasonably likely to occur; monitoring; corrective actions; verification; and associated records. The proposed rule also would establish CGMPs for animal food.

PCAR.6 Under what circumstances will preventive controls be required under this new rule?
The application of the preventive controls would be required only in cases where facilities determine that hazards are reasonably likely to occur. FDA does not expect that all possible preventive measures and verification procedures would be applied to all animal foods at all facilities.

PCAR.7 How can I comment on the proposed rule?
Comments on the proposed rule “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals,” which publishes in the Federal Register on October 29, 2013, are due by 120 days after the publication date.  

     

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 Meetings

   

Speeches and Statements

Reports