Food

Frequently Asked Questions on FSMA

Questions & Answers on the Food Safety Modernization Act

General 

G.1 How big a problem is foodborne illness in this country?
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.

G.2 What are the major elements of the FDA Food Safety Modernization Act?
The elements can be divided into five key areas:

  • Preventive controls - For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply to prevent or significantly minimize the likelihood of problems occurring.
  • Inspection and Compliance - The legislation recognizes that inspection is an important means of holding industry accountable for its responsibility to produce safe food. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches.
  • Imported Food Safety - FDA has new tools to ensure that imported foods meet U.S. standards and are safe for our consumers. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards.
  • Response - For the first time, FDA has mandatory recall authority for all food products. FDA expects that it will only need to invoke this authority infrequently since the food industry largely honors our requests for voluntary recalls. The agency has other new authorities that are also in effect: expanded administrative detention of products that are potentially in violation of the law, and suspension of a food facility’s registration.
  • Enhanced Partnerships - The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, state, local, territorial, tribal and foreign--to achieve our public health goals. For example, it directs FDA to improve training of state, local, territorial and tribal food safety officials.

G.3 How will FDA implement FSMA?
Since January 2013, FDA has proposed seven foundational rules to implement FSMA. Those rules become final in 2015 and 2016:

  • Preventive Controls for Human Food: Requires that food facilities have safety plans that set forth how they will identify and minimize hazards. Original rule proposed January 2013; supplemental rule to add specific language for important provisions proposed September 2014. Final rule issued: Sept. 10, 2015.
  • Preventive Controls for Animal Food: Establishes Current Good Manufacturing Practices and preventive controls for food for animals. Original rule proposed October 2013; supplemental rule to add provisions geared specifically to animal foods proposed September 2014. Final rule issued: Sept. 10, 2015.
  • Produce Safety: Establishes science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. Original rule proposed January 2013; supplemental rule to amend key areas proposed September 2014. Final rule issued: Nov. 13, 2015.
  • Foreign Supplier Verification Program: Importers will be required to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of U.S. food producers. Original rule proposed July 2013; supplemental rule to provide, among other provisions, more flexibility in determining appropriate verification measures proposed September 2014. Final rule issued: Nov. 13, 2015.
  • Third Party Certification: Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals. Proposed July 2013. Final rule issued: Nov. 13, 2015.
  • Sanitary Transportation: Requires those who transport food to use sanitary practices to ensure the safety of food. Proposed January 2014. Final rule issued: Apr. 5, 2016.
  • Intentional Adulteration: Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large-scale public harm. Proposed December 2013. Final rule deadline: May 31, 2016.

G.4 Does the legislation apply to restaurants and food retailers?
Some but not all provisions of the law exclude restaurants and food retailers. For example, restaurants and retail food establishments are not required to register with FDA, so they are not subject to requirements for registered facilities, such as preventive controls. Other provisions could apply to restaurants and food retailers, such as the foreign supplier verification program, which applies to importers.

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Preventive Controls Rules: Human Food and Animal Food 

PC.1 Why are the final rules on preventive controls important for public health?
These rules will be important for the health of both people and animals. High-profile outbreaks of foodborne illness over the last decade, and data showing that such illnesses strike one in six Americans each year, have caused a widespread recognition that we need to prevent food safety problems, not merely react once they happen. Requiring preventive measures at facilities that produce human food is an important step in reducing foodborne illness for humans. In addition, requiring good manufacturing practices and preventive controls in animal food facilities will result in fewer instances of contaminated animal food, reducing the risk to animals, to humans handling the food, and to humans consuming food products of animal origin. 

PC.2 What are the major requirements under the final preventive controls rules?
They can be found in two fact sheets:

PC.3 Product testing and environmental monitoring are in the final rules. When would companies need to apply these activities?
The preventive controls final rules require that a facility verify that hazards are being controlled and take corrective action to prevent contamination; and product testing and environmental monitoring are examples of steps a firm may take. A facility’s decision to conduct product testing, and to establish the frequency of such testing, will reflect a risk-based approach consistent with its hazard analysis. Consequently, the FDA expects that facilities that produce foods that have frequently been associated with outbreaks of foodborne illness or pathogen contamination, or produce ready-to-eat foods for which an effective preventive control cannot be implemented, would establish product testing programs more often than facilities that do not produce such foods.

Similarly, a facility that identifies an environmental pathogen as a hazard requiring a preventive control, for example, sanitation controls, would conduct environmental monitoring. Such a facility would decide what, if any, role product testing would play as a verification activity or as part of a corrective action as a result of positive findings from environmental monitoring, based on the facility, the food, the nature of the preventive control, and the role of the preventive control in the facility’s food safety system. 

PC.4 The rule requires food facilities to have a written food safety plan that includes a hazard analysis and preventive controls. How often must that plan be reanalyzed?
At least once every three years. The facility must also review portions of the food safety plan under certain circumstances, such as when a preventive control is found to be ineffective.

PC.5 What is a preventive controls qualified individual?
This is a new term in the final rule. A preventive controls qualified individual is someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system. The written food safety plan required of food facilities must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals. And the preventive controls qualified individual is charged with overseeing the validation that preventive controls are capable of controlling identified hazards and the records review. 

PC.6 Does the final rule include provisions to appeal the withdrawal of a qualified facility exemption?
Yes. The final rule provides procedures for a facility to appeal the withdrawal order and request an informal hearing. And there is a procedure for reinstating an exemption that was withdrawn. 

PC. 7 How are the preventive controls rules different from the Hazard Analysis and Critical Control Points (HACCP) system?
The Hazard Analysis and Critical Control Points systems that many FDA-regulated manufacturers have in place are the foundation of the preventive controls regulations. Although there are similarities between the FSMA preventive controls requirements and the HACCP system, not every provision is identical. For example, in HACCP systems, controls are applied at critical control points (CCPs), whereas preventive controls include controls at CCPs or controls other than those at CCPs that are appropriate for food safety.   

PC.8 What are the manufacturing/processing activities allowed under the farm definition?
Drying/dehydrating raw agricultural commodities that creates a distinct commodity, such as producing raisins and prunes from grapes and plums, and packaging and labeling such commodities, without additional manufacturing/processing are allowed under the farm definition. Treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling raw agricultural commodities, when these activities do not involve additional manufacturing/processing, are other examples of manufacturing/processing activities that can be conducted under the farm definition. 

PC.9 What does this final rule specifically require human food facilities to do when providing a by-product for use as animal food?
Processors already implementing human food safety requirements, such as brewers, would not need to implement additional preventive controls or Current Good Manufacturing Practice (CGMP) regulations when supplying a by-product (e.g., wet spent grains, fruit or vegetable peels, liquid whey) for animal food, except to prevent physical and chemical contamination when holding and distributing the by-product. This regulation applies to human food facilities that both donate or sell a by-product for use in animal food. Labeling that identifies the by-product by the common or usual name must be affixed to or accompany human food by-products for use as animal food when distributed.

Further processing a by-product for use as animal food (e.g., drying, pelleting, heat-treatment) would require compliance with CGMPs to ensure the animal food’s safety and to make sure that the processing does not introduce hazards to the animal food. The company can choose to follow either the human food or animal food CGMPs when further processing the by-product. In addition, unless they are a qualified facility or otherwise exempt from subpart C (hazard analysis and preventive controls) the facility would need to assess its processing and determine whether there are any hazards that would require a preventive control. A facility that appropriately determines through its hazard analysis that there are no hazards requiring a preventive control would document such a determination in its hazard analysis but would not need to establish preventive controls. 

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

PMO.1. Do facilities operating under the PMO meet the requirements of the final preventive controls rule?
The preventive controls provision of FSMA (section 103) does not exempt dairy facilities that are required to register with the FDA. The 2013 PMO does not address all of the FSMA requirements, such as a written hazard analysis, those relevant to food allergens, or the potential presence of environmental pathogens in the food processing environment. Such provisions in the Preventive Controls rule could help prevent food safety problems from the consumption of food produced in PMO facilities. At its biennial conference in April 2015, the National Conference on Interstate Milk Shipments (NCIMS) initiated work to modify the PMO; therefore we are extending the compliance date for PMO-regulated facilities to comply with the rule in order to make use of the existing system of state regulatory oversight for Grade “A” milk and milk products provided through the NCIMS and the food safety requirements of the PMO.

PMO.2. Does the preventive controls rule apply to dairy farms?
Establishments that meet the definition of a farm are not required to register under section 415 of the Food, Drugs, and Cosmetics (FD&C) Act. However, farms, including dairy farms, that conduct manufacturing/processing activities beyond those included in the farm definition in the Preventive Controls rule are subject to registration and would be subject to requirements of the Preventive Controls Rule unless a specific exemption applies.

PMO.3. What environmental and product testing for milk and dairy products is required under FSMA and the preventive controls rule?
The Preventive Controls Rule includes requirements for environmental monitoring and finished product testing as verification activities that would be applied as appropriate to the food, the facility, and the preventive control. Such testing would be appropriate for certain ready-to-eat dairy products, e.g., environmental monitoring for Listeria spp. in facilities making soft cheeses that are exposed to the environment.

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Produce Safety Rule

PSR.1 Why is this rule necessary for public health?
Produce is an essential component of a healthy diet, and the safe production and harvesting of fruits and vegetables helps consumers to maintain healthy diets. Foodborne illness outbreaks associated with contaminated produce have caused a widespread recognition of the need for a modern food safety system that focuses on preventing food safety problems in the first place—rather than on reacting once they happen. Therefore, the produce rule focuses on setting enforceable standards that are reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and that provide reasonable assurances that produce is not adulterated on account of these hazards. FDA estimates that about 332,000 illnesses per year are expected to be prevented by the provisions of this rule.

PSR.2 What are the key requirements and compliance dates?
More information about the final rule can be found in the Produce Safety At-a-Glance fact sheet.

PSR.3 What produce is covered by this rule, and what produce is not covered?
All types of produce are covered by the rule except as provided by specific exemptions from the rule. Exemptions include produce that:

  • is grown for personal or on-farm consumption
  • Is not a “raw agricultural commodity.” (A raw agricultural commodity is any food in its raw or natural state
  • will receive commercial processing that adequately reduces microorganisms of public health concern (e.g., through use of a “kill step”) is eligible for exemption under certain conditions (including keeping certain documentation).
  • is on the “rarely consumed raw” list. The “rarely consumed raw” list is exhaustive and contains the following fruits and vegetables: asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts.
    • The content of this list in the final rule is somewhat different from the proposed version. These changes were made in response to public comments and based on FDA’s analysis of available data. For example, Brussels sprouts and kale were removed from the proposed list, and pecans were added to the final list.

PSR. 4 Are vegetables intended to be frozen prior to sale eligible for exemption?
Not necessarily. Produce that receives commercial processing that adequately reduces the presence of pathogens of public health significance is eligible for exemption if other relevant requirements are met. Blanching and/or freezing processes may qualify if they are validated to ensure that the specific procedures followed adequately reduce pathogens in the food.  

PSR.5. Why does the final rule contain additional requirements for sprout production?
Sprouts are vulnerable to bacterial contamination because of the warm, moist and nutrient-rich conditions in which they grow. They have frequently been associated with outbreaks of foodborne illness. The Produce Safety final rule includes specific requirements in Subpart M for most sprouts. This subpart does not cover sprouts that are soil- or substrate-grown and are harvested without their roots. All sprouts, including those not covered under Subpart M, are covered produce subject to the other provisions of the produce rule as applicable.

PSR.6 Is extra time allowed for smaller farms to come into compliance with the requirements?
The FDA has staggered the compliance dates, based on the size of farms, to provide additional time for small and very small farms to come into compliance with the requirements, and is providing extended time for almost all farms to meet certain water requirements in Subpart E. Because of their history of outbreaks, operations growing sprouts have less time to come into compliance than other farms and do not get additional time to come into compliance with any of the water requirements. Farms with an average annual value of produce sold of $25,000 or less during the previous three year period are not covered by the rule. 

PSR. 7 What if farmers need help meeting these new requirements?
The FDA has been working with the U.S. Department of Agriculture (USDA), state agriculture departments, the Produce Safety Alliance and the Sprouts Safety Alliance, as well as others, to make sure there are numerous resources available for training, education and technical assistance to aid farmers with implementation of the Produce Safety rule. The agency is planning to use a number of approaches, including guidance documents, to give farmers the tools they need to comply with the new regulations. The agency recently released a training strategy to support compliance with the FSMA rules.

PSR.8 How does the FDA plan to determine how much time should be required between the application of raw manure and the harvest of produce covered by the rule?
The FDA is deferring its decision on an appropriate time interval between the application of untreated biological soil amendments of animal origin, including manure, and harvest of covered produce until we pursue a risk assessment and research to supplement the science on an appropriate interval. We anticipate that these efforts will take five to 10 years to complete. Following the completion of the risk assessment and research work, we expect to: (1) provide stakeholders with data and information gathered from scientific investigations and risk assessment; (2) consider such new data and information to develop tentative scientific conclusions; (3) provide an opportunity for public comment on our tentative decisions; and (4) consider public input to finalize the provision(s) establishing an appropriate minimum application interval(s). The final produce rule contains other requirements related to the safe use of biological soil amendments of animal origin, including raw manure, in Subpart F. For example, the rule establishes certain application method requirements for treated and untreated biological soil amendments of animal origin.

PSR.9 What were the primary findings of the Final Environmental Impact Statement (EIS) and Record of Decision (ROD)?
In developing the Final Environmental Impact Statement (EIS), the FDA considered any adverse impacts that implementation of the proposed Produce Safety rule provisions and various alternatives could potentially have on the environment. The agency is also required to prepare a public document, called the Record of Decision (ROD), to address how the EIS findings are incorporated into decisions about the final rule and the ROD further explains potential impacts on the environment that could result from the Produce Safety Rule, as finalized. In the ROD, the agency explains how the provisions in the final rule best meet FDA’s public health goals while minimizing environmental impacts as much as possible. The primary benefit of this rule is expected to be a significant decrease in the number of foodborne illnesses every year. The rule has the potential to significantly impact the environment as a result of groundwater drawdown. However, the flexibility that has been introduced into the rule is expected to minimize the likelihood that this will occur. 

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FSVP Rule

FSVP.1 Why are the Foreign Supplier Verification Program (FSVP) requirements important?
Importers will be required to perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of domestic food processors and produce farms, and is not adulterated or misbranded with respect to allergen labeling. This program serves an important purpose in the new import paradigm. Requiring importers to take responsibility for the safety of the food they import serves as an additional check on the system,

FSVP.2 What are the key requirements and compliance dates?
More information about the final rule can be found in the Foreign Supplier Verification Program At-a-Glance fact sheet.

FSVP.3 What are the final requirements for required supplier verification activities?
The final rule gives importers the flexibility to determine appropriate verification measures based on risks associated with the food and supplier performance, while acknowledging the greater risk to public health posed by the most serious hazards in foods. Depending on the circumstances, supplier verification activities could include audits, records review, sampling and testing, some combination of those, or other activities. When there is reason to believe that a hazard in a food that will be controlled by the foreign supplier is one for which there is a reasonable probability that it will cause serious adverse health consequences or deaths, a clear, rigorous verification standard is required in the form of annual on-site auditing of the supplier. However, importers have the flexibility to use a different approach if they can establish that it will be appropriate to provide adequate assurance that the foreign supplier is significantly minimizing or preventing the hazard.

FSVP.4 Will importers find themselves having to meet the provisions in the FSVP regulations and the regulations on preventive controls for human and animal foods?
Importers are only subject to the preventive controls rules if they are also facilities that manufacture, process, pack or hold food. An importer that is a facility can be deemed in compliance with most aspects of FSVP if it is:

  • in compliance with the supply-chain program requirements in the preventive controls rules;
  • itself implementing preventive controls to significantly minimize or prevent hazards in accordance with the requirements in the preventive controls rules; or 
  • not required to implement a preventive control under the preventive controls regulations in certain specified circumstances (for instance, because its customer will significantly minimize or prevent the identified hazard and the facility complies with the requirements related to relying on customers to significantly minimize or prevent hazards.)

FSVP.5 Who is subject to the FSVP rule?
When the FSVP requirements take effect, they will apply to all importers, unless there’s an exemption. The “importer” is:
(A) the United States owner or consignee of a food offered for import into the United States; or
(B) in the case when there is no United States owner or consignee at the time of U.S. entry, the importer is the U.S. agent or representative of a foreign owner or consignee of the food offered for import at the time of entry, as confirmed in a signed statement of consent.

FSVP.6 To what foods does the rule apply?
FSVP requirements will apply to all food imported by the importer or agent of the importer, unless there’s an exemption.

FSVP.7 What foods are exempt from the FSVP rule?

  • Fish and fishery products that are imported from a foreign supplier that is required to comply with, and is in compliance with, FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations for those products, as well as for certain raw materials or other ingredients for use in processing fish or fishery products in compliance with HACCP.
  • Juice products that are imported from a foreign supplier that is required to comply with, and is in compliance with, FDA’s HACCP regulation for those products, as well as for certain raw materials or other ingredients for use in processing juice in compliance with HACCP.
  • Food for research or evaluation
  • Food for personal consumption
  • Alcoholic beverages and certain raw materials and ingredients that are imported for use in alcoholic beverages
  • Food that is imported for processing and future export
  • Low-acid canned foods, such as canned vegetables, but only with respect to microbiological hazards
  • Certain meat, poultry and egg products
  • Food that is transshipped, meaning it stops in the U.S. en route to another country
  • U.S. food that is exported and returned without further manufacturing or processing in a foreign country.

FSVP.8 Are restaurant owners who serve foods from other countries subject to FSVP? Only if they meet the definition of importer (i.e. the owner or consignee of the food at the time of entry or the designated U.S. agent or representative). If the food is purchased from another U.S. entity, the restaurant would likely not be the importer with direct responsibility for meeting FSVP requirements.

FSVP.9. What if no hazards requiring a control are identified for a particular food? There may be many circumstances in which an importer evaluates the known and reasonably foreseeable hazards in a food and determines that there are no hazards requiring control. In these cases, the importer would not be required to conduct a supplier evaluation or determine what foreign supplier verification and related activities to conduct and would not be required to conduct such activities.
Examples of foods for which there might not be hazards requiring controls include salt, many kinds of crackers, many cookies and many types of candy (such as hard candy, fudge, maple candy, taffy and toffee), bread, dried pasta, honey, molasses, sugar, syrup, soft drinks and certain jams, jellies and preserves.

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Accredited Third-Party Certification

TPA.1 How will the third-party certification program work?
The final rule establishes a system for the FDA to recognize accreditation bodies that in turn accredit third-party certification bodies to perform food safety audits and issue certifications for foreign food facilities and the foods they produce. Such certifications will be required for participation in the Voluntary Qualified Importer Program (VQIP), which will allow for expedited review and entry of foods from importers in the program. In addition, to prevent potentially harmful food from reaching U.S. consumers, the FDA can require in specific circumstances that a food offered for import be accompanied by a certification from an accredited third-party certification body.

TPA.2 What are the key features of the program?
More information about the final rule can be found in the Third Party Accreditation At-a-Glance fact sheet.

TPA.3 Will certification bodies have to submit their audit reports to FDA?
For regulatory audits, in which a facility is examined for compliance with FDA food safety requirements for purposes of certification, an accredited third-party certification body must routinely submit an audit report to the FDA. For consultative audits, which are performed in preparation for regulatory audits and do not result in issuance of a certification, the audit report is generally intended for internal use. The FDA must be notified if a potential serious risk to public health is identified during a regulatory or consultative audit.

TPA.4 Can a foreign government serve as a third-party certification body?
Yes. Public and private agencies and organizations are eligible for accreditation as third-party certification bodies.

TPA.5 Can reports and notifications from participants in this program be submitted in their native language?
No, all reports and notifications required to be submitted to the FDA must be submitted in English to be properly and efficiently reviewed.

TPA.6 How long does recognition (i.e., qualification) last for recognized accreditation bodies?
The FDA may grant a period of recognition for an accreditation body of up to five years. The length of recognition granted will be determined on a case-by-case basis, depending on a number of factors, including the accreditation body’s experience conducting accreditation work in the food safety area.

TPA.7 How long does the accreditation last for certification bodies?
The maximum duration of accreditation for certification bodies is four years under the rule.

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Sanitary Transportation of Human and Animal Food 

ST1. 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 (SFTA) of 1990 and delegated primary authority to implement the law to the Department of Transportation (DOT). With the passage of the 2005 SFTA, Congress reallocated authority for food transportation safety to FDA, DOT, and U.S. Department of Agriculture (USDA), and the FDA now has the lead role among federal agencies in regulating the safety of food during transport. However, both DOT and the 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 April 2010 Advance Notice of Proposed Rulemaking published in Federal Register and a 2009 study commissioned to characterize current baseline practices and to identify current areas where food is at risk. This rule implements the 2005 SFTA as well as the requirement in section 111 of the FDA Food Safety Modernization Act (FSMA) that instructed FDA to issue SFTA regulations.

In April 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.

ST2. What are some examples of sanitary transportation practices that will be required under this rule?
This final rule establishes requirements for vehicles and transportation equipment, transportation operations, training, and recordkeeping. For example, prior to loading food that is not completely enclosed by its container, loaders are required to determine that a vehicle is in appropriate sanitary condition for the transport of the food, e.g., it is in adequate physical condition, and free of visible evidence of pest infestation and previous cargo that could cause the food to become unsafe during transportation. 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 and inspecting their vehicles and transportation equipment. The FDA can review these procedures and records.

Another example is the requirement for 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 rule also establishes procedures for the exchange of information about prior cargos transported in bulk vehicles such as tankers, that directly contact food, the intervening cleaning of the vehicles, and information about temperature control, between the shipper, carrier and receiver, as appropriate to the situation. Shippers need this information to ensure adequate sanitation practices are used to prevent adulteration of transported products. For example, a shipper of a bulk liquid non-dairy food product would want to obtain information from the carrier assuring that any vehicles that have previously hauled dairy based foods have been adequately cleaned and will not introduce allergens into the non-dairy food through cross contact.

ST3. Who is covered or not covered under this rule?
Please see the fact sheet for a list of those subject and not subject to the final rule.

ST4. How will the FDA implement and enforce this new rule?
As with the other FSMA rules, FDA is committed to developing training and technical assistance. Food industry training will be an important component of successful implementation of FSMA, as will be outreach to foreign trading partners. The agency will also use its partnerships with other Federal agencies (such as the U.S. Department of Transportation) and with state, local, and tribal entities to implement this rule.

FDA will carry out some inspections, and the Department of Transportation, under the 2005 SFTA, will also establish procedures for transportation safety inspections to be conducted by DOT or state personnel. FDA maintains its ability to take enforcement action when agency efforts to work with a company fail to achieve compliance, but promoting a strong food safety culture is FDA’s first priority.

ST5. How will FSMA regulations for sanitary transportation benefit public health?
While historically, there have been occurrences of illness due to contamination arising during the transportation of food, fortunately, major incidents have been infrequent. But they do occur. The goal of the 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.

ST6. What are the major differences between the proposed rule and the final rule?
Please see the fact sheet for a list of major changes from the proposed rule.

ST7. Does this rule place too great a burden on industry?
Although incidents of foodborne illness attributable to contamination during transportation have been infrequent, the FDA does receive reports of unsanitary food transportation practices that could lead to contamination. Furthermore, we have minimized the cost of this rule by building it upon current industry transportation best practices concerning cleaning, inspection, maintaining, loading and unloading, and operating vehicles and transportation equipment used to transport food, and by focusing the rule strictly on public health risks associated with transport.

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Intentional Adulteration

FD.1 What is Food Defense?
Food defense is the effort to protect the food supply against intentional contamination due to sabotage, terrorism, counterfeiting, or other illegal, intentionally harmful means. Potential contaminants include biological, chemical and radiological hazards that are generally not found in foods or their production environment. Food defense differs from food safety, which is the effort to prevent unintentional contamination of food products by agents reasonably likely to occur in the food supply (e.g., E. coli, Salmonella, Listeria).

FD.2 How will the Intentional Adulteration final rule change food defense?
The subject of this final rule is to, consistent with the statute, protect food from intentional adulteration when the intent is to cause wide scale public health harm. The final rule takes a HACCP-type approach to intentional adulteration, similar to the approach used in the preventive controls rule, as the most effective means of ensuring that mitigation strategies are consistently applied to areas of highest vulnerability in food production. The rule requires facilities to write and implement a food defense plan, train certain employees, and includes records requirements.

FD.3. What are food companies required to do?
Registered food facilities are required to complete a vulnerability assessment of their production system and identify actionable process steps, which are points, steps, or procedures in a food process that require mitigation strategies to reduce the risk of intentional adulteration. The vulnerability assessment, actionable process steps, mitigation strategies and procedures for food defense monitoring, corrective actions and verification need to be documented in a written food defense plan. Facilities also have to ensure that personnel assigned to the vulnerable areas receive appropriate training and maintain records for food defense monitoring, corrective actions, and verification activities.

FD.4. Do food carriers need a defense plan during transport?
No. The mitigation strategies are more appropriately implemented by food facilities, rather than by carriers. If a facility has identified a significant vulnerability related to transportation, the facility must take steps to reduce that vulnerability.

FD.5. Will FDA create an alliance to support implementation of the Intentional Adulteration final rule?
Yes, FDA has funded an Intentional Adulteration subcommittee disclaimer icon under the existing Food Safety Preventive Controls Alliance disclaimer icon. The agency intends to leverage the expertise of state and local public health professionals, state and local public health associations, and industry associations to develop the standardized curriculum needed to meet the training requirement.

FD.6 Prior to passage of FSMA, were there requirements for food defense?
There were no requirements that food facilities implement mitigation strategies or measures to protect against intentional contamination. FDA has guidance, tools, and resources for industry on food defense, and the agency will update this cadre of materials after the release of the final rule. For more information on the guidance, tools, and resources available to industry, visit the FDA Food Defense page.

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Recalls

RC.1 Under FSMA, FDA now has authority to order a mandatory recall. How will that work?
In order to issue such a mandatory recall order, FDA must first provide the responsible party with the opportunity to cease distribution and to conduct a voluntary recall of the article of food in question. If the responsible party refuses to, or does not voluntarily cease distribution or recall such food within the time and in the manner prescribed by FDA, the agency may proceed with a mandatory recall.  FDA anticipates that mandatory recall authority will be used in rare instances.

RC.2 Would a voluntary recall preclude an FDA mandated recall under FSMA?
Under FDCA section 423(a), FDA is required to first give a responsible party the opportunity to cease distribution and conduct a voluntary recall of an article of food. If the responsible party refuses to or does not voluntarily cease distribution or recall such food within the time and in the manner prescribed by FDA, FDA may proceed under the mandatory recall authority as set forth in FDCA section 423.

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Administrative Detention 

AD.1 For administrative detention, what is the process to detain food and what if the food is perishable and can spoil?
FSMA enhances FDA's administrative detention authority by authorizing FDA to administratively detain articles of food that FDA has a reason to believe may be adulterated or misbranded. FDA intends to revise its administrative detention regulations and other relevant documents to reflect this new standard.

AD.2 Is compensation available for those whose products are determined to have been recalled or detained without cause?
There is nothing in FSMA that changes existing rules regarding such matters, such as, for example, the Federal Tort Claims Act.

AD.3 What changes did FSMA make to FDA’s administrative detention authority?
The changes made by FSMA to the criteria for administrative detention in the FD&C Act further strengthened FDA’s ability to prevent potentially unsafe food from entering commerce. Under the new criteria, FDA can order an administrative detention if the agency has reason to believe that an article of food is adulterated or misbranded. Prior to FSMA, FDA could order an administrative detention if it had credible evidence or information that the food presented a threat of serious adverse health consequences or death to humans or animals.

AD.4 Has FDA used its expanded administrative detention authority since the IFR published in July 2011?
FDA has effectively implemented this expanded authority three times since the IFR became effective. One of these administrative detentions led to a request to recondition the goods under FDA supervision, while another resulted in a seizure, and another terminated when the owner voluntarily destroyed the suspect food.

Additional Questions & Answers Concerning Administrative Detention: Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide
This guidance document, updated March 2013, provides updated information pertaining to the FDA’s authority to order the administrative detention of human or animal food under section 304(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 334(h)]. Congress originally established this authority in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and amended it in January 2011 as part of the FDA Food Safety Modernization Act (FSMA). 

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Smuggled Food

SF.1 Will FDA be targeting all smuggled food, including those foods transported in luggage for personal use?
Section 309 of FSMA defines smuggled food as “any food that a person introduces into the United States through fraudulent means or with the intent to defraud or mislead.” While this could be interpreted to apply to a single undeclared low risk food item carried in personal luggage, FDA and the Department of Homeland Security will focus resources on imported food that poses the greatest risk to public health.

SF.2 How will FDA notify the public of potentially dangerous smuggled food?
FSMA provides for public notifications of harmful and dangerous smuggled food “reasonably believe[d] to [have] entered domestic commerce” and “likely to be consumed”. FDA intends to issue a press release and use other appropriate emergency communications or recall networks in order to warn consumers, distributors, and vendors about the threat.

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Federal/State Integration

FSI.1 Does FSMA change any of the authorities over food safety currently divided between FDA and USDA?
No. However, FSMA does provide for FDA and USDA and other federal and state/local food safety agencies to work together more closely. 

FSI.2 How will FSMA support the vision of an Integrated Food Safety System?
Congress recognized that the more than 3,000 state, local, and tribal government agencies involved in food safety must be fully integrated in FDA’s work to fulfill FSMA’s mandate that consumers be protected by a food safety system based on prevention and risk. This National Integrated Food Safety System will ensure the quality, consistency, and effectiveness of local, state, and federal efforts to protect the food supply. Successful implementation of FSMA’s new produce safety standards is especially dependent on partnership between FDA and the states, both to deliver education and technical assistance and to provide on-going compliance support and oversight. As part of its effort to build a long-term produce safety partnership with the states, FDA has entered into a five-year cooperative agreement with the National Association of State Departments of Agriculture (NASDA) that will bring together a range of state partners to collaboratively plan implementation of the produce safety rule from the ground up.

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Lab Accreditation

L.1 Will in-house laboratories (set up by a company for the testing of its own foods) be eligible for laboratory accreditation per FSMA?
Valid analytical results are essential to make informed decisions that impact public health. At its heart, laboratory accreditation is about laboratories’ consistently producing valid results by focusing on assuring 1) management requirements for the operation and effectiveness of the quality management system within the laboratory and 2) technical requirements that address the correctness and reliability of the tests and calibrations performed in laboratory. FDA supports laboratories' interests in pursuing accreditation but FDA has not yet fully developed its thinking or rulemaking with regard to FSMA implementation so any interpretations of requirements are premature at this time.

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Fees

F.1.1 Is there a registration fee required under FSMA?
FSMA does not require a registration fee to be paid by registered facilities.

F.1.2 Will there be any fees connected to the new recall authority FDA now has?
FDA has authority to assess and collect fees for food recall activities associated with a recall order when a domestic food facility or importer does not comply with such order.

F.1.3 What other fees are outlined in the new law?
There are also fees that can be collected for administrative costs of the Voluntary Qualified Importer program, for costs associated with issuing food export certifications, and for costs to establish and administer the third-party accreditation program.

F.1.4 What fees have been established?
For each fiscal year since FY2012, a fee schedule has been established for domestic and foreign facility reinspections, failure to comply with recall orders, and certain importer reinspections (please see section below). FDA publishes the fee schedule 60 days before the start of each fiscal year along with the methodology used to formulate those fees. The other fees (see F.1.4) will be established as the programs develop.

Domestic and Foreign Facility Reinspections, Failure to Comply with Recall Orders, and Certain Importer Reinspections User Fee Rates for Fiscal Year 2016

F.2.1 What is FDA announcing?
On July 31, 2015, FDA announced in a Federal Register notice the fiscal year FY 2016 fee schedule for certain domestic and foreign facility reinspections, importer reinspections, and failure to comply with recall orders.

F.2.2 Will importer reinspection fees be assessed and collected in FY 2016?
FDA is in the process of considering various issues associated with the assessment and collection of importer reinspection fees as stated in the Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act. Recognizing the particular complexities involved in these issues, FDA is not in a position to assess importer reinspection fees until the agency has resolved these issues and will not assess importer reinspection fees until the agency notifies the public. However, the fee rates set forth in the notice for FY 2016 will be used to determine any importer reinspection fees assessed in FY 2016 once the Agency begins to assess such fees.

F.2.3 What are the FY 2016 fees?
The rates are as follows: $221 an hour if no foreign travel is required and $315 an hour if foreign travel is required.

F.2.4 When do the FY 2016 fees go into effect?
The fees are effective October 1, 2015, and will remain in effect through September 30, 2016. As stated in FDA’s September 2011 Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act, because FDA recognizes that for some small businesses the full cost recovery of FDA reinspection or recall oversight could impose severe economic hardship, FDA intends to consider reducing certain fees for those firms.  FDA is currently developing a guidance document to outline the process through which firms may request such a reduction of fees. FDA does not intend to issue invoices for reinspection or recall order fees until this guidance document has been published. 

F.2.5 Who is affected by these fees?
Only those parties in the food and feed industry whose non-compliance results in the following activities: 

  • Facility reinspections – follow-up inspections conducted by FDA subsequent to a previous facility inspection that identified noncompliance materially related to a food safety requirement of the Federal Food, Drug, and Cosmetic Act (the Act). The reinspection must be conducted specifically to determine that compliance has been achieved.
  •  Recalls – food recall activities performed by FDA that are associated with a recall order with which a responsible party has not complied.
  • Importer reinspections -- follow-up inspections of a food offered for import conducted by FDA subsequent to a previous inspection that identified noncompliance materially related to a food safety requirement of the Act. The reinspection must be conducted specifically to determine that compliance has been achieved. As discussed in F.2.2., these fees will not be assessed until the agency has resolved issues associated with these fees and the public has been notified by the agency. 

F.2.6 Why are these fees important? 
FSMA represents a critical step in strengthening the U.S. food safety system.  However, there are challenges and costs associated with achieving the full implementation of FSMA. The fees allow FDA to recover costs associated with certain domestic and foreign facility reinspections, failure to comply with a recall order, and certain importer reinspections.  Prior to FSMA, FDA bore the entire burden of these costs.

F.2.7 How does FDA plan to charge these fees?
For facility reinspection fees, FDA will invoice theresponsible party for each domestic facility and the United States Agent for each foreign facility for the direct hours, including travel, spent to perform the reinspection at the appropriate hourly rate. For recall order fees, FDA will invoice the responsible party for each domestic facility or an importer who does not comply with a recall order under sections 423 or 412 of the Act for the hours spent to cover food recall activities associated with such order. For importer reinspection fees, FDA will invoice the importer for the direct hours spent to perform the reinspection including travel. Detailed payment information will be included in the invoice. 

F.2.8 Why is there only one foreign travel fee rate? Shouldn’t it be a different rate for each country depending on the distance from the U.S? For example, traveling to Canada or Mexico from the U.S. should cost less than traveling to China.
Fees are charged on an hourly basis, thus the cost of traveling to a country closer to the U.S. will take less travel time, and therefore, will account for the distance variations and costs associated. Please see the FY 2016 Fee Rate Federal Register notice for explanation of the methodology used to determine the fee rate for foreign travel. 

F.2.9 Which fiscal year rate will be charged if a reinspection occurs during one fiscal year and the invoice is sent out in the next fiscal year?
The fiscal year in which the reinspection occurs dictates the fee rate to be applied. For example, if a reinspection was conducted in September, 2014 and the invoice was issued in October, 2014, the fee rate to be applied would be the FY 2014 rate. The invoice clearly itemizes the fiscal year, hours and rate used to calculate the total invoice amount. 

F.2.10 Can small businesses have their fees waived?
The FY 2016 fee schedule does not contain any reduced fee rate for small business. However, as stated in F.2.4, FDA does not intend to issue invoices for reinspection or recall order fees until a guidance document to outline the process through which firms may request a reduction of fees has been published. Once published, invoices will be issued and firms can apply for reductions as outlined in the guidance.  

F.2.11 Will states conduct FSMA-related reinspections?
Generally, FDA intends to conduct all reinspections that could result in the assessment of fees under FSMA, even in the case where an initial inspection was conducted under state contract. 

F.2.12 How long does the responsible party have to pay the fees?
Payment must be made within 90 days of the invoice date. 

F.2.13 What happens if the responsible party or U.S. agent does not pay?
Any fee that is not paid within 30 days after it is due shall be treated as a claim of the United States government subject to provisions of subchapter II of Chapter 37 of Title 31, United States Code.

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Records and Records Access

RRA.1 For how long are records required under the new law’s “Hazard Analysis and Risk-Based Preventive Controls” provision (FSMA section 103/Food Drug and Cosmetic Act (the FD&C Act) section 418) required to be kept?
This section of the new law contains a provision (FD&C Act section 418(g)) requiring that certain records established under that section be kept for at least two years.

RRA.2 What records do I have to provide to FDA based on the FSMA amendments?
The manner in which you respond to a FDA records request remains unchanged. Similarly, the type of documents that you may have to provide to FDA in response to a records request remains unchanged. The FSMA amendment simply expands FDA’s former records access beyond records related to the specific suspect article of food for which FDA reasonably believes is adulterated and presents a threat of serious adverse health consequences or death to humans or animals to now include records relating to any article of food that is reasonably likely to be affected in a similar manner.

In addition, the FSMA amendment permits FDA to access records related to articles of food for which FDA believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animal.

Once either of the above mentioned circumstances is met, FDA may request all existing records needed to assist the agency in determining whether the circumstances, which gave rise to the records request, exist.

RRA.3 What constitutes a “reasonable belief” that food is affected in a similar manner in the context of FDA records access?
Decisions regarding whether FDA “reasonably believes” a food is affected in similar manner so as to either be adulterated and present a threat of serious adverse health consequences or death to humans or animals or to pose a reasonable probability that the use of or exposure to such food will cause serious adverse health consequences or death to humans or animals will be made on a case-by-case basis because such decisions are fact-specific. 

RRA.4 How does FDA identify a high-risk facility?  
See FSMA Domestic Facility Risk Categorization (FY 2012).

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Registration

R.1 Does FSMA require a food facility to submit additional registration information to FDA in order for the facility to receive a food facility registration number?
Yes. Section 102 of FSMA amends section 415(a)(2) of the FD&C Act by requiring food facilities to submit registrations to FDA containing additional information. Specifically, a registration for a domestic facility is required to contain the e-mail address for the contact person of the facility, or for a foreign facility, the email address of the United States agent for the facility. All food facility registrations are required to contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Additionally, if determined necessary by FDA, registrations are required to contain information regarding other applicable food categories, as determined appropriate by FDA, for foods manufactured/processed, packed, or held at registering facilities.

R.2 Will food facilities already registered with FDA under section 415 of the FD&C Act be required to renew their registrations?
Yes. All food facilities that are required to register with FDA under section 415 of the FD&C Act must renew their registrations with FDA, every other year, during the period of time beginning on October 1 and ending on December 31 of each even-numbered year.

R.3 Has the scope of who is required to register under section 415 of the FD&C Act changed?
At this time, the same types of food facilities that were required to register with FDA under section 415 of the FD&C Act before FSMA are required to register with FDA and renew such registrations. Those facilities are domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. Section 103(c) of FSMA directs FDA to conduct a rulemaking to “clarify the activities that are included as part of the definition of the term ‘facility’ under such section 415 [of the FD&C Act].” A clarification of activities included as part of the definition of the term “facility” is included in the rulemaking for preventive controls, as provided by section 103(c) of FSMA. For more information on preventive controls, please visit FDA’s Preventive Standards page.

R.4 Does the FSMA amendments final rule change who is subject to food facility registration?
Yes. The final rule amends the definition of a retail food establishment in a way that expands the number of establishments that are considered retail food establishments, and that are therefore not required to register. The expanded definition of a retail food establishment allows establishments located on a farm and “farm-operated businesses” may consider sales directly to consumers via roadside stands, farmers markets, Community Supported Agriculture (CSAs), and other such direct-to-consumer platforms in determining their primary function and whether they would meet the requirements to be considered retail food establishments. By “farm-operated business,” we mean a business that is managed by one or more farms and that conducts manufacturing/processing not on the farm(s). Entities that meet this expanded definition are exempt from food facility registration requirements.

R.5 When do I have to register or renew registration for my food facility?
The owner, operator, or agent in charge of a food facility that begins to manufacture, process, pack, or hold food for consumption in the United States must register before the facility begins such activities. Registration expires at the end of a two-year renewal cycle and renewal is required each even-numbered year between October 1 and December 31. The next registration renewal period will be October through December of 2016. The requirement for mandatory electronic registration will begin January 4, 2020, and the requirement for providing a unique facility identifier (UFI) will begin October 1, 2020.

R.6 If a foreign facility is already registered with FDA will it need to renew its registration?
Under FSMA, all food facilities that are required to register with FDA under section 415 of the FD&C Act, including foreign facilities, are required to submit registration renewals to FDA during the registration renewal period.

R.7 How can I complete registration for my food facility?
Food facilities can be registered here: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm2006831.htm.

Beginning January 4, 2020, facilities must submit registrations, registration renewals, updates, and cancellations to the FDA electronically, unless the FDA has granted a waiver. To obtain a waiver, facilities must submit a written request to the FDA that explains why it is not reasonable to use the electronic registration system (e.g., lack of Internet access). Facilities that have been granted waivers may submit registration through mail or fax.

R.8 What form do I use to renew a food facility registration?
Registrants must use Form 3537 to register, update, or renew a registration. Facilities may register online via the Internet at www.fda.gov/furls, which operates during business hours from 7:00 am to 11:00 pm U.S. Eastern Time. Facilities may also register by mail or fax or for multiple submissions, by CD-ROM.  

R.9 What information is required for food facility registration renewal?
All mandatory fields on the Form 3537 must be complete in order to renew a food facility registration. This includes new or updated fields described in question IC.3.1. If using the online renewal process, existing registration information will be displayed for review and can be edited as necessary. All information submitted, in both mandatory and optional fields, must be true and accurate, and the registrant will be required to certify that all information submitted is true and accurate at the end of the registration process. 

R.10 Am I required to renew a food facility registration online?
No. Registrants can renew food facility registrations online or submit the paper Form 3537 by mail or fax. A business with multiple facilities may also renew a registration on a CD-ROM by mail.  FDA encourages online registration renewal as a cost-effective, quick, and efficient means for food facility registration renewal. With online registration renewal, a registrant may review and edit existing registration information and add information. All of the mandatory data fields are required for the system to accept the renewal submission.  After all required information has been entered, a registrant will receive confirmation of registration renewal.

Paper registration renewal likely will be a more costly and less efficient process to supply FDA with registration information and to provide food facilities with their registration renewal confirmations than online registration. As with online submissions, for paper submissions, all mandatory data fields must be completed. However, if your paper registration form contains errors or omissions, FDA will return it for corrections, which may require additional time to complete the registration process. As a result it may take longer to receive confirmation for paper registration renewals. 

R.11 Is there a fee for registration, updating a registration, or renewal of registration?
No. There is no fee associated with initial registration, updating a registration, or renewing a registration. 

R.12 Do new food facilities need to wait until October 1st to register?
No. The owner, operator, or agent in charge of a facility that begins to manufacture/process, pack, or hold food for consumption in the U.S. on or after December 12, 2003 must register before the facility begins such activities (21 C.F.R. 1.230). An owner, operator, or agent in charge of a facility may authorize an individual to register the facility on its behalf (21 C.F.R. 1.230). If a facility registers before October 1 during an even-numbered year, the facility will still be required to renew its registration during the registration renewal period. 

R.13 I have changes to my registration information now. Must I amend or update it now, or can I wait until the beginning of the first biennial registration renewal period?
The owner, operator, or agent in charge of a facility is required to submit an update to a facility’s registration to FDA within 60 calendar days of a change to any of the required registration information previously submitted under 21 CFR 1.232, except for a change of the owner (21 CFR 1.234(a)).  If a facility has a new owner, the former owner must cancel the facility’s registration within 60 calendar days of the change and the new owner must re-register the facility (21 CFR 1.234(b)). If a change occurs to a facility’s previously submitted required registration information before the start of or during the next biennial registration renewal period, a registrant may submit an update for such change as part of the facility’s registration renewal by including the update information in the registration renewal, provided that such update is submitted within 60 calendar days of the change.  If a facility submits an update to FDA before the start of the next biennial registration renewal period, the facility will still be required to submit a registration renewal to FDA during the biennial registration renewal period.

R.14 Do I have to use a third-party registrar for the initial, update, renewal or cancellation of registration for my food facility?
No. FDA does not require a food facility to use a third-party registrar to submit an initial registration, update, renewal, or cancellation of a food facility registration to FDA. A food facility owner, operator, or agent in charge of the facility must register, update, renew, or cancel a registration (see section 415(a) of the FD&C Act; and 21 CFR 1.225, 1.234). The owner, operator, or agent in charge may authorize an individual to register, update, or cancel a registration on his or her behalf (except for cancellations caused by changes of ownership) (21 CFR 1.225, 1.234). The authorized individual may be, but is not required to be, the U.S. agent for a foreign facility. Foreign facilities should note that U.S. agents may charge a fee for their services, but this is solely controlled by the third-party, and there is no fee assessed by FDA for the initial, update, renewal or cancellation of registration of a food facility.

If a facility is cancelling its registration because it has a new owner, the former owner, or an individual authorized by the former owner, must cancel the facility’s registration as specified in 21 CFR 1.235 (21 CFR 1.234). 

R.15 What happens if a facility fails to register?
The failure to register your facility, update required elements, or cancel a registration in accordance with 21 CFR Part 1, Subpart H  is a prohibited act under the FD&C Act (see 21 C.F.R. 1.241).  If a foreign food facility is required to register with FDA, but fails to do so, food from that facility that is being imported or offered for import into the U.S. is subject to refusal under section 801(l) of the FD&C Act.  

R.16 Will a food facility be issued a new registration number during the biennial registration renewal process?
No. A food facility will not be issued a new registration number when it renews a current registration under the biennial registration renewal process.

R.17 When may FDA suspend the registration of a facility registered under section 415 of the FD&C Act?
Under section 415(b) of the FD&C Act, if FDA determines that food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that:

  • Created, caused or was otherwise responsible for such reasonable probability; OR
  • Knew of or had reason to know of such reasonable probability AND packed, received or held such food.

R.18 When are registered facilities subject to the suspension of registration provisions?
Registered facilities became subject to the suspension of registration provisions in section 415(b) of the Federal Food Drug and Cosmetic Act on July 3, 2011; 180 days after the date of enactment of FSMA (January 4, 2011).

R.19 What is the effect of such a suspension?
If the registration of a facility is suspended, no person can import or export food into the United States from such facility, offer to import or export food into the United States from such facility, or otherwise introduce food into interstate or intrastate commerce in the United States from such facility (section 415(b)(4) of the FD&C Act). This important authority will further help FDA ensure the safety and security of our nation’s food supply.

R.20 Who may issue an order to suspend a facility’s registration?
The authority to issue an order to suspend a registration or to vacate an order of suspension may not be delegated by the Secretary of Health and Human Services to any officer or employee other than the FDA Commissioner (section 415(b)(7) of the FD&C Act).

R.21 Is there an opportunity for an informal hearing on suspension of registration?
FDA will provide a registrant subject to a suspension of registration order with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 business days after the issuance of the suspension of registration order, unless an alternate time period is agreed upon by FDA and registrant. The registrant will have an opportunity for an informal hearing on actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated. FDA will reinstate a registration if it determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration (section 415(b)(2) of the FD&C Act).

R.22 What happens if it is determined that suspension remains necessary after the opportunity for the informal hearing?
If, after providing opportunity for an informal hearing, FDA determines that a suspension of registration remains necessary, FDA will require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by FDA (section 415(b)(3) of the FD&C Act).

R.23 How may a suspension of registration order be vacated or modified?
Upon a determination by FDA that adequate grounds do not exist to continue the suspension actions required by a suspension of registration order, or that such actions should be modified, FDA will vacate the order and reinstate the registration of the facility subject to the order, or modify the order, as appropriate (section 415(b)(3) of the FD&C Act).

R.24 Is FDA going to promulgate regulations on suspension of registration?
Yes. Section 415(b)(5) of the FD&C Act requires that FDA issue regulations to implement section 415(b) of the FD&C Act. However, food facilities became subject to the requirements of  section 415(b) of the FD&C Act, including the suspension of registration provisions, on July 3, 2011 (180 days after the date of enactment of FSMA).

R.25 What changes were made to the “Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities”?
FDA updated this guidance document to specify additional food product categories to be included as mandatory fields in the food facility registration form. The updated guidance notes that the list of additional food product categories includes food categories that were previously included on the food facility registration form as optional fields, including food product categories for animal consumption. This guidance also describes certain FSMA amendments to section 415(a) of the FD&C Act, which provide that, when determined necessary by FDA “through guidance,” a registrant must submit a registration to FDA containing information necessary to notify FDA of the general food category (as identified in 21 CFR 170.3 or any other food categories, as determined appropriate by FDA, including by guidance) of any food manufactured, processed, packed, or held at such facility. FDA believes that the additional food product categories are necessary and appropriate for food facility registration and has included such categories as mandatory fields in the food facility registration form.

R.26 Why did FDA make changes to “Guidance for Industry: Necessity of the Use of Food Product Categories in Registration of Food Facilities”?
FDA believes that information about the food product categories of foods manufactured, processed, packed or held at food facilities is a key element to allow for rapid communications between FDA and facilities directly impacted by actual or potential bioterrorist attacks, other food-related emergencies, or food safety incidents. Information about the categories of food a facility handles currently assists FDA in conducting investigations and surveillance operations in response to food-related emergencies. These categories also enable FDA to quickly alert facilities potentially affected by such an incident if FDA receives information indicating the type of food affected. The additional food product categories enhance the agency’s ability to respond quickly and accurately to an actual or potential bioterrorist incident or other food-related emergency. See the updated guidance, Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories, for more information.

R.27 Will FDA provide further outreach or guidance on how FSMA changed food facility registration?
Yes. FDA anticipates releasing updated registration guidance materials after a rule published in April 2015 to amend and update FDA’s registration regulation is finalized. Additionally, FDA intends to conduct outreach with stakeholders and make technical assistance available as this renewal period takes place.

R.28 If I create a new registration, will I retain my compliance history or shipping history associated with my facility?
Some facilities may create new registrations rather than renew existing registrations because they no longer have the PIN numbers that are needed to access their existing registrations in the online registration system. For such a facility, the Agency does not anticipate a loss of compliance history or shipping history, provided that the facility’s new registration includes the same information such as facility name and facility address. 

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Product Tracing

PT.1.1 What is product tracing and why is it important?
In general, a product tracing system involves documenting the production and distribution chain of products so that in the case of an outbreak or evidence of contaminated food, a product can be traced back to a common source or forward through distribution channels.

Product tracing systems enable government agencies and those who produce and sell food to take action more quickly when an outbreak of foodborne illness occurs or contaminated product is identified, thus preventing illnesses. Actions include removing a product from the marketplace and alerting the public if a product has already been distributed.

Many producers, manufacturers and retailers have product tracing systems in place but they vary depending on the amount of information the system records, how far forward or backwards in the supply chain the system tracks, technologies used to maintain records and the precision with which a system can pinpoint a product’s movement.

PT.1.2 What are the FSMA requirements for product tracing?
Sec. 204, Enhanced Tracking and Tracing of Food and Recordkeeping, has two major requirements. First, FDA, working with the U.S. Department of Agriculture (USDA) and State agencies, must establish pilot projects in coordination with the food industry to explore and evaluate methods and appropriate technologies for rapid and effective tracking and tracing of foods. Second, FDA must publish a notice of proposed rulemaking to establish recordkeeping requirements for high risk foods to help in tracing products.

PT.1.3 Where can I find the statutory language for the requirements?
The statutory language for FSMA SEC 204, Enhanced Tracking and Tracing of Food and Recordkeeping, can be found on the FSMA website.

Product Tracing Pilots

PT.2.1 What did the pilots involve?
FDA announced the pilots in September 2011. Information from the pilots will help to determine what data are most needed to trace a product that has been distributed widely in the marketplace back to a common source. Tracing product forward, such as in the case of an ingredient known to be contaminated, was also tested. Two pilots were required by FSMA—one with the processed food sector and one with processors or distributors of raw fruits and vegetables. FSMA required that the pilots reflect the diversity of the food supply, take into account practicality for small businesses and include at least three different types of foods that have been the subject of significant outbreaks during the five-year period preceding the enactment of FSMA in January 2011. FDA also was required to consider international product tracing practices and consult with a diverse and broad range of experts and stakeholders. A report to Congress on the findings of the pilot projects and FDA’s recommendations for improving product tracing is required.

PT.2.2 Does this mean that FDA carried out the pilot studies?
No; these two pilot projects were conducted through an existing contract with the Institute of Food Technologists (IFT). However, IFT carried out the pilots at the direction of FDA, and the Agency retained the ultimate decision making authority.

PT.2.3 Did IFT consult with stakeholders before and during the pilots?
Yes, IFT involved multiple stakeholders throughout the process. IFT obtained input from the processed food and produce industry sectors and consulted with USDA, state agencies and consumer groups on proposed foods and/or ingredients and product tracing technologies. IFT held three stakeholder input sessions in different geographical locations and offered opportunities for written input as well. Food industry representatives, trade associations, consumer groups, third party technology providers, academicians, and others responded to these requests.

PT.2.4 What types of industries were asked to participate in the pilot?
IFT solicited participation in the pilots. FDA indicated it wanted to include industries representing the entire supply chain—from growers to point of sale, such as a restaurant or grocery store. FSMA required that the pilots include at least three different types of foods that have been associated with significant outbreaks in the recent past.

PT.2.5 What foods were part of the pilots?
With input from a variety of stakeholders, the following types of foods were selected for the pilot projects:

  • Tomatoes, grown in fields and greenhouses; whole and sliced; and distributed to restaurants and other institutions like hospitals, schools and nursing homes, and through grocery stores. We looked at tomatoes because they have been involved in a number of significant and repeat outbreaks. Tomatoes represent a complex food supply chain and were identified by most industry associations as a top candidate for the produce related pilot;
  • Frozen Kung Pao-style dishes that contain peanut products, red pepper spice, and chicken were chosen because they contain multiple ingredients involved in significant outbreaks. They also offered a variety of supply chain distribution channels, and, like tomatoes, involved both domestic and imported products.
  • Jarred peanut butter and dry, packaged peanut/spice were added to the pilot projects to enhance the complexity of the pilots.

PT.2.6 What is the status of the product tracing pilots required by FSMA?
FDA released in a final report in March 2013, which can be found at this link: Pilot Projects for Improving Product Tracing along the Food Supply System – Final Report (PDF: 5.6MB).

PT.2.7 What does IFT’s report cover?
The IFT report covers baseline studies, pilot execution using trace scenarios, use of technology, cost and benefits, domestic and global practices, findings, recommendations and suggested next steps.

PT.2.8 In the pilots, what were some of the costs to industry to implement a product tracing system?
Available data to assess costs is limited. Within the context of the pilot projects, the report estimated the costs associated with improved recordkeeping and product tracing, and costs varied greatly based on a number of factors such as using a paper-based or electronic system, scanning labels, nomenclature standardization, and electronically linking supply chain partners.

PT.2.9 In the pilots, what were found to be some of the benefits to implementing a product tracing system?

  • Product tracing systems enable government agencies and those who produce and sell food to take action more quickly when an outbreak of foodborne illness occurs or contaminated product is identified, thus preventing illnesses.
  • As part of the overall project, cost savings, driven by reductions in illness, were estimated for reducing traceback duration by 25, 50, 75, and 100 percent. The range of public health benefit per outbreak ranged from $18,000 to $14 million, depending on the characteristics of the outbreak.
  • In addition to quickly discovering which food(s) may be causing an outbreak, we may also be able to determine what foods can be eliminated from consideration, reducing economic impact on the industry.
  • Product tracing also is helpful to industry for other functions, such as inventory control.

PT.2.10 In the pilots, what enhancements did technology provide to improve tracing?
The pilot projects found that technology was no substitute for quality data. Once challenges with data quality could be overcome, significant improvements in the speed and accuracy were achieved with the aid of technology. A variety of technology solutions were explored for data capture, visualization, and analysis. 

PT.2.12 What were the IFT recommendations?
IFT has 10 recommendations:

  1. From an overarching perspective, IFT recommends that FDA establish a uniform set of recordkeeping requirements for all FDA-regulated foods and not permit exemptions to recordkeeping requirements based on risk classification.
  2. FDA should require firms that manufacture, process, pack, transport, distribute, receive, hold, or import food to identify and maintain records of Critical Tracking Events (CTEs) and Key Data Elements (KDEs) as determined by FDA.
  3. Each member of the food supply chain should be required to develop, document, and exercise a product tracing plan.
  4. FDA should encourage current industry-led initiatives and issue an Advance Notice of Proposed Rulemaking or use other similar mechanisms to seek stakeholder input.
  5. FDA should clearly and more consistently articulate and communicate to industry the information it needs to conduct product tracing investigations.
  6. FDA should develop standardized electronic mechanisms for the reporting and acquiring of CTEs and KDEs during product tracing investigations.
  7. FDA should accept summarized CTEs and KDEs data that are submitted through standardized reporting mechanisms and initiate investigations based on such data.
  8. If available, FDA should request more than one level of tracing data.
  9. FDA should consider adopting a technology platform that would allow efficient aggregation and analysis of data submitted in response to a request from regulatory officials. The technology platform should be accessible to other regulatory entities.
  10. FDA should coordinate traceback investigations and develop response protocols between state and local health and regulatory agencies, using existing commissioning and credentialing processes. In addition, FDA should formalize the use of industry subject matter experts in product tracing investigations.

For more details on IFT’s recommendations and their report, please go to Pilot Projects for Improving Product Tracing along the Food Supply System – Final Report (PDF: 5.6MB).

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Recordkeeping Requirements for High Risk Foods

PT.3.1 What is the FSMA requirement related to recordkeeping for high-risk foods?
Under section 204 of FSMA, FDA is required to designate high-risk foods for which additional recordkeeping requirements are appropriate and necessary and to establish recordkeeping requirements for these foods. The requirement is designed to enable foods to be more rapidly and effectively tracked and traced during a foodborne illness outbreak or other event.

PT.3.2 Did Congress provide any specifics about the recordkeeping requirements FDA is to establish for high-risk foods?
Yes. Congress has established certain specifics about these recordkeeping requirements, including the following:

  • they must relate only to information that is reasonably available and appropriate;
  • they must be science-based;
  • they may not prescribe specific technologies to maintain records;
  • the public health benefits must outweigh the cost of complying with the requirements;
  • they must be practical for facilities of varying sizes and capabilities;
  • to the extent practical, they may not require a facility to change business systems to comply;
  • they must allow for the maintenance of records at a reasonably accessible location, provided that the records can be made available to FDA within 24 hours of a request; and
  • they may not require a full pedigree, or a record of the complete previous distribution history of the food from the point of origin.

PT.3.3 Did Congress provide specifics about how FDA should determine what foods are high risk under this section of FSMA?
Yes. FDA must consider these factors:

  • the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention;
  • the likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food;
  • the point in the manufacturing process of the food where contamination is most likely to occur;
  • the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;
  • the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and
  • the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

PT.3.4 Has FDA determined which foods are high risk?
No. In February 2014, we published a Federal Register Notice to seek comments and scientific data that will help us refine our draft methodological approach to identifying high-risk foods. After that approach is finalized, FDA will develop the list of high-risk foods.

PT.3.5 Will there be opportunity to comment on the foods FDA determines are high risk?
Yes. FDA plans to publish a list of high risk foods either before, or at the same time, that FDA issues a proposed rule. FDA will provide opportunity to comment on this list.

PT.3.6 When will FDA begin developing recordkeeping requirements for high-risk foods, as directed by FSMA?
Now that the pilot projects that were mandated by section 204(a) of FSMA have been completed, we are continuing to gather data and information as we begin to develop a proposed rule.

PT.3.7 Will FDA expand these additional recordkeeping requirements to apply to foods that are not designated as high risk?
No. FSMA specifies that additional recordkeeping requirements developed under section 204 must apply only to high-risk foods. FDA will be seeking input from stakeholders in considering whether to develop voluntary guidance for foods beyond those designated as high risk to enhance product tracing in the supply chain. 

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