FDA Releases Final Preventive Controls Rule for Human Food under FSMA

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FDA released its final Preventive Controls Rule for Human Food, part of its implementation of FSMA. Registrar Corp reports on key points of the rule.

Registrar Corp Assists Companies with U.S. FDA Regulations
Covered facilities must create a written Food Safety Plan in which they identify likely biological, chemical, and physical hazards and preventive controls for those hazards.

On September 10, 2015, the U.S. Food and Drug Administration (FDA) released its final rule for Preventive Controls for Human Food. This rule is part FDA's implementation of the Food Safety Modernization Act (FSMA). The rule is scheduled to be officially published on September 17, 2015. Until then, the document is available in PDF format through the Federal Register.

Key requirements for Preventive Controls for Human Food:

Food Safety Plans

Covered facilities must create a written Food Safety Plan in which they identify likely biological, chemical, and physical hazards and determine whether these hazards require preventive controls. For those that do, facilities must establish preventive controls to minimize or prevent the occurrence of those hazards. FDA says preventive controls include "process, food allergen, and sanitation controls, as well as supply-chain controls and a recall plan."

Food Safety Plans must include methods to monitor and verify the consistency and effectiveness of the preventive controls put in place. Food Safety Plans must also include methods to correct problems that may arise in a timely, effective manner. Corrective actions must be recorded.

Possible monitoring and verification activities and the frequency in which they should be performed depend greatly on the preventive control at hand. Facilities must determine what is appropriate for their facility and controls.

Managing Suppliers

To ensure the safety of food where hazards are controlled in raw materials and other ingredients before receipt by a receiving facility, covered facilities are responsible for approving their raw material and ingredient suppliers and only receiving food from their approved suppliers (or, when necessary and appropriate, on a temporary basis from unapproved suppliers). When approving a supplier, facilities must conduct a hazard analysis of the food and assess the entity that will be controlling the hazards. Facilities must also consider supplier performance.

Employee Qualification

Management of covered facilities must ensure that all employees who manufacture, process, pack or hold food have the necessary education, training, and/or experience and ensure they receive training in the principles of food hygiene, food safety, and employee health and hygiene.

Who is covered?

All companies that are required to register with FDA as a food facility are required to comply with FDA's preventive controls rules unless covered by an exemption. Exemptions include, but are not limited to:

  • Very small businesses (businesses that have less than $1,000,000 in total annual sales of human food, adjusted for inflation)
  • Activities subject to seafood HACCP requirements of part 123
  • Activities subject to juice HACCP requirements of part 120
  • Activities that are subject to the "low acid canned food" requirements of part 113

For a list of all exemptions and modified requirements, see page 19 of the final rule.

Farms are not required to register with FDA or comply with the preventive control rules. The final rule expands the definition of a farm to cover two types of farm operations, and therefore expands the definitions of who is not required to comply. See the expanded definition here.

Compliance Dates

Most covered facilities will have only one year (until September 2016) to comply with FDA's Preventive Controls for Human Food. Compliance dates are as follows:

  • Very small businesses (businesses that have less than $1,000,000 in total annual sales of human food, adjusted for inflation) – Three years after publication of the final rule (September 2018)
  • Businesses subject to the Pasteurized Milk Ordinance: Three years after publication of the final rule (September 2018)
  • Small businesses (businesses with fewer than 500 full-time equivalent employees): Two years after publication of the final rule (September 2017)
  • All other businesses: One year after publication of the final rule (September 2016)

Compliance dates for supply chain programs differ and depend on the size of the facility and the status of its suppliers. See all compliance dates here.

Registrar Corp offers services to help food facilities comply with FDA's Preventive Controls for Human Foods. Registrar Corp can help facilities develop a Food Safety Plan and conduct a Mock FDA Inspection of a facility to ensure employees are following correct food hygiene, food safety, and employee health and hygiene practices. Registrar Corp also offers an FDA Compliance Monitor through which facilities can monitor the FDA compliance history of their raw material and ingredient suppliers.

Registrar Corp is an FDA consulting firm that helps companies comply with U.S. FDA regulations. For more information about FDA's Preventive Controls for Human Foods, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at http://www.registrarcorp.com/livehelp.

FDA also released its final rule for Preventive Controls for Animal Food. FDA is expected to publish final versions of its Foreign Supplier Verification Program (FSVP) and Produce Safety rules, two more FSMA implementation rules, by October 31, 2015.

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David Lennarz

Liviana Callahan
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