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Impacts of the Food Safety Modernization Act (FSMA)

April 22, 2015 - Kestrel Food Safety

Called the (complete) rewrite of the existing FDA food laws, the Food Safety Modernization Act (FSMA) of January 4, 2011 is really an enhancement focused on key requirements and, more importantly, expanding the authority of the FDA to unprecedented levels.

With FSMA, other areas of existing statutes (i.e., 21 CFR FDA Section 110.XXX) or any probable cause that the food safety laws are being broken possibly endangering the public, as determined by the FDA or its agents, remain fully enforceable. These are unchanged with regard to compliance but now fall under the direct enforcement authority of the FDA.

FSMA Rules

The first five FSMA rules were passed into law January 4, 2011, while the sixth rule (Sanitary Transportation of Human and Animal Feed) was passed in January 2014. The rulemaking and rule issue date will vary for the first five rules and the lagging rule number six. Once the rulemaking periods are complete, there will be a grace period announced for implementation by affected companies. This will likely be 60-90 days but is yet to be confirmed.

Since the passing of the FSMA rules, all issues related to the processing and, more importantly, distribution of safe food are completely enforceable by the FDA. This authority can also include the use of other agencies as enforcement. This broad authority has eliminated the need for the FDA or its agents to require judicial approval for investigations, access to information (previously required by subpoena), the right to recall, ordering detention of product, suspending business registrations, levying fines and penalties, and controlling the food supply chain, as determined for the safety of food and the general public.


Based on the complexity and broad nature of the FSMA rules, it is recommended that companies move forward with updates to their food safety management systems, which can then be adjusted when the final rules are issued. Certification to FSSC22000 and other GFSI schemes will help to ensure compliance with many of the new overall requirements.


FSMA Clarification

Preventive Controls (Rule 2) – Final Rules due by August 2015

Biannual registration

Each food processor or distributor now must complete biannual FDA registration.

Food Safety Plan

Each site’s operating locations must have a Food Safety Plan, including hazard analysis and GMPs, to ensure product against adulteration. There is a grace period for implementation (estimated 60 days) after the rule is finalized.

Historically, companies have required records for FDA compliance; however, now the FDA or its agents have full authority to request and receive any information they deem in the interest of food safety. An inspection for cause or request (demand) for records can occur at any time.

FSMA provides that the FDA has full access to all compliance records for food safety (active upon the signing of FSMA on January 4, 2011). This includes any and all records that a company must have to ensure food safety and recall. Records and information must be provided upon the request of the FDA without any Justice Department oversight or court order.

Inspections are mandated by the FSMA law according to an established schedule or condition. This does not preclude the FDA from determining inspections for other reasons they deem are in the best interest of food safety.

A key issue is records for products received from any supplier and the qualification of the supplier providing materials that are unadulterated and meet the specifications of the customer receiving the materials.

Mandatory inspection rules are being finalized and will require an inspection every three years for high-risk locations and every five years for low-risk locations. Any site that has not been previously inspected will be considered high risk. Inspections can be conducted at any time based on FDA or agents’ decision-making latitude. This is especially true where recall, complaints, or probable cause exists.

FDA can determine how and when to fine, charge, or penalize individuals or organizations for violations associated with food safety compliance.

The broad level of authority that is included with FSMA has given the FDA the authority to issue fines, charges, and criminal penalties, including incarceration.

Foreign Supplier Verifications (Rule 3) – Final Rules due by August 2015

All foreign suppliers must be registered and certified through a third-party inspection prior to shipping food product to their customers in the U.S. This holds true for the export of food product from the U.S., as well, and the detention of any questionable product by the FDA or its agents.


  • Registration of foreign suppliers
  • Process of approval of foreign suppliers
  • Reporting of shipments by foreign suppliers
  • Management of foreign suppliers by their U.S. customers
  • Reporting of non-conforming product from foreign suppliers by U.S. companies to the FDA
  • Process of certification for foreign suppliers to meet U.S. laws and the specification requirements of their U.S. customers

Preventive Controls (Rule 4) – Final Rules due by August 2015

FSMA requires that companies under the statute complete a process of science-based risk assessment and preventive controls.

This differs from HACCP, as the requirement is to use industry and company information based on broad assessments and statistical methods for preventive controls that might not be included in the accepted HACCP process. This process is also known as HARPC (Hazard Analysis Risk-Based Preventative Controls) and is based on science-based information outside of the company risk flows. A common HARPC is radiological contamination or other environmental risks outside of the established HACCP.

Accredited Third-Party Certifications (Rule 5)

FSMA establishes a program for accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods that they produce.

Depending on the final rule, this rule may lead to a higher level of acceptance of third-party audited food safety management systems. Not all of the general public focused on food safety regulations accepts this concept; however, it does appear that acceptance is growing.

Sanitary Transportation of Human and Animal Food (Rule 6)

The sixth FSMA rule was passed on January 6, 2014, and will likely be implemented in 2016 (following the rulemaking period). Currently, all food distribution must meet food safety requirements and shipping and storage instructions for the product.

To a food processor and distributor, a transportation service or warehouse is just like any other supplier based on the food exposure risk. This rule will require all aspects of the transportation process (e.g., short haul, long haul, some rail, ocean going, parcel, holding, warehousing, cross-docking, and delivery) to ensure food safety. This includes personal (driver) hygiene, transport inspection prior to loading and delivery, HACCP, GMPs, food facility and training, and more.

*Not included/not applicable “Produce Safety Standards” (Rule No. 1)
**Other aspects of FSMA to be addressed include Laboratory Accreditation, Protection for Whistleblowers, etc. (other aspects of the law TBD).

Submitted by: Steve McPherson

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