U.S. FDA Rules Impacting Food Exporters

by register-FDA


Every year, about 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases in the United States. This is a significant public health burden that is largely preventable and are addressed in the FDA Food Safety Modernization Act (FSMA).

Several of the new rules to implement FSMA will have an impact on food exporters. We will discuss the main changes and how they will impact the food supply chain from farm to exporters and importers in more detail below.

Preventive Controls for Human Food Rule

This program requires that food facilities have safety plans in place that outline how they will identify and minimize hazards.

In general, all facilities that manufacture, process, pack or hold food and are registered as a food facility with the FDA are covered. Farms or retail food establishments are not covered.

Covered facilities must establish and implement a food safety system that includes the following areas:

Hazard analysis (HA): The first step is hazard identification, which must consider known or reasonably foreseeable biological, chemical, and physical hazards. These hazards could be present because they occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain (if they affect the safety of the food).

Preventive controls (PC): These measures are required to ensure that hazards requiring a preventive control will be minimized or prevented. They include process, food allergen, and sanitation controls, as well as supply-chain controls and a recall plan.

Oversight and management of preventive controls: The rules provide flexibility in the steps needed to ensure that preventive controls are effective and to correct problems that may arise.

Monitoring: These procedures must be designed to provide assurance that preventive controls are consistently performed. Monitoring is conducted as appropriate to the preventive control. For example, monitoring of a heat process to kill pathogens would include actual temperature values and be more frequent than monitoring preventive maintenance activities used to minimize metal hazards, which could be a simple record of the date on which the activity took place.

Corrective actions and corrections: Corrections are steps taken to timely identify and correct a minor, isolated problem that occurs during food production. Corrective actions include actions to identify a problem with preventive control implementation, to reduce the likelihood the problem will recur, evaluate affected food for safety, and prevent it from entering commerce. Corrective actions must be documented with records.

Verification: These activities are required to ensure that preventive controls are consistently implemented and effective. They include validating with scientific evidence that a preventive control is capable of effectively controlling an identified hazard; calibration (or accuracy checks) of process monitoring and verification instruments such as thermometers, and reviewing records to verify that monitoring and corrective actions (if necessary) are being conducted.

Manufacturing/processing facility also need to have a risk-based supply chain program in place for those raw material and other ingredients for which it has identified a hazard requiring a supply-chain applied control. They are responsible for ensuring that these foods are received only from approved suppliers.

Finally, as part of the Current Good Manufacturing Practices (CGMPs), facility management is required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties.

You can read more about the Preventative Controls for Human Food rules on the FDA website by clicking here.

Most food operations fall under the definition of “farm mixed-type facility” and must be registered as a Food Facility with the FDA. However, the same farms are sometimes not subject to the requirements for Hazard Analysis and Risk-based Preventative Controls (HA/PC), due to their farm activities. For example, farms that harvest raw agricultural commodities, such as cocoa beans or coffee beans, don’t need to comply with the preventative controls for human food rules.


Produce Safety Rule

Establishes science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms.

Although this is a very important part of FSMA and will impact many farms, cocoa beans and coffee beans are on the “rarely consumed raw” list and are exempt.

You can read more about the new Produce Safety rules on the FDA website, by clicking here.

Foreign Supplier Verification Program (FSVP) Rule

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.

For the purposes of FSVP, an importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent.

What is an FSVP? It is a program that importers must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate.

Modified FSVP requirements are established for very small importers and importers of food from certain small suppliers. (An example of these modified requirements is that certain importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances from their supplier.) The definition of very small importer is consistent with the definition of very small business in the preventive controls rules: a sales ceiling of $1 million for human food.

Importers of certain small foreign suppliers are also only subject to modified FSVP requirements. And farms that are not covered farms under the produce safety rule because they average $25,000 or less in annual produce sales or because they meet requirements for a qualified exemption.

Each of these types of producers is either exempt from their underlying FDA food safety regulations or subject to modified requirements, mostly, and in some cases entirely, because of the size of these firms.

You can read more about the new Foreign Supplier Verification Program on the FDA website, by clicking here.

Sanitary Transportation Rule

Requires those who transport food to use sanitary practices to ensure the safety of food.

The final rule applies to persons, e.g., shippers, in other countries who ship food to the United States directly by motor or rail vehicle (from Canada or Mexico), or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the U.S.

You can read more about the new Sanitary Transportation rules on the FDA website, by clicking here.


Small businesses (a business with fewer than 500 full-time equivalent employees):

September 16, 2017.
Very small businesses (averaging less than $1 million per year in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale):

September 16, 2018.

All other businesses:

September 16, 2016.


November 27, 2017
Importers of certain small foreign suppliers are subject to modified FSVP requirements.
Those small suppliers are:

Facilities subject to modified requirements under the preventive controls rules because they are qualified facilities, and
Farms that are not covered farms under the produce safety rule because they average $25,000 or less in annual produce sales or because they meet requirements for a qualified exemption

May 30, 2017

March 31, 2017

FSMA Training

fsmaOn September 17, 2015, the FDA published final rules for Preventive Controls for Human and Animal Food and, continuing into 2016, the FDA intends to finalize the remaining five rules it has proposed to implement FSMA.

There will be extensive outreach to industry to help ensure that everyone who seeks to comply with these rules, whether legally required to or not, understands the new requirements.
Continue reading, by clicking here.

2016 Food Facility Biennial Registration Renewal Required with new Updates

The Amendments to Registration of Food Facilities final rule updates FDA’s food facility registration requirements to better protect public health by requiring additional registration information that will improve the accuracy of the food facility registration database for facilities both in the United States and abroad.

This final rule will support the FDA’s efforts to act quickly in response to food-related emergencies and will help the FDA to use its inspectional resources more efficiently.
Continue reading, by clicking here.

Fast Facts


Of the 300,539 registered facilities in 2016, 212,183 or more than 70%, are non-US based facility registrations.

Please visit our FDA NEWS page for up to date information and updates on the FSMA rules.