New Requirements Imposed As FDA Proposes Two New Rules

New Requirements Imposed As FDA Proposes Two New Rules

On Friday, January 4th, 2013, the U.S. Food and Drug Administration (FDA) proposed two new regulations aimed at preventing food contamination.

The New Food Safety Modernization Act Proposed Rules:

  1. Preventive Controls for Human Food - The first rule would require manufacturers of processed foods sold in the United States to come up with ways to reduce the risk of contamination.
  2. Standards for Produce Safety - The second rule would apply to the harvesting and production of fruits and vegetables in an effort to combat bacterial contamination.

According to the New York Times, "The proposed rules represent a sea change in the way the agency polices food", essentially implementing a proactive style that they hope will stop possible contamination outbreaks before they reach the food supply chain.

The FDA is responsible for 80% of the food Americans consume (the other 20% falls under U.S. Department of Agriculture), the primary focus will be on produce that is intended for raw consumption.

“These new rules really set the basic framework for a modern, science-based approach to food safety and shift us from a strategy of reacting to problems to a strategy for preventing problems,” Michael R. Taylor, deputy commissioner for foods and veterinary medicine, said in an interview.

According to, one in six Americans will suffer some form of food poisoning this year. The most common causes of food poisoning cases are the organisms known as Salmonella, E. coli O157 and Listeria resulting in serious long term effects.

Why Now?

Passed in 2010 by the 111th United States Congress and signed into law by President Obama in 2010 after a series of contamination breakouts, the Food Safety Modernization Act (FSMA) is "the most sweeping reform of our food safety laws in more than 70 years and aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it."

FDA Extends Food Facility Registration Deadline

So Why Did It Take Two Years?

One view on the delay is that such a sweeping overhaul of the current standards would understandably be complex and require extended periods of time for review and phased in implementations. Another view is that the new mandate was caught up in bi-partisan politics and rather than risk criticism, the Obama administration waited until after the election. Either way the push is on to implement the proposed changes.

The 680 page Proposed Rule is scheduled to be printed on Wednesday, January 16, 2013 and will be available at: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

The Current Good Manufacturing Practice (CGMT) proposal would implement the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls. Specifically, the proposed rule would establish requirements for:

  • A written food safety plan;
  • Hazard analysis;
  • Preventive controls for hazards that are reasonably likely to occur;
  • Monitoring;
  • Corrective actions;
  • Verification;
  • Associated records

The application of the preventive controls would be required only in cases where facilities determine that hazards are reasonably likely to occur. We do not expect that all possible preventive measures and verification procedures would be applied to all foods at all facilities."

How Do The New Rules Impact Importers?

With the FDA becoming more proactive in attempts to stave off food contamination, importers can expect an increase in inspections of their shipments, both physically and electronically. One future proposal of note is the requirement of importer's to be responsible for the safety of food products produced overseas as "15% of food eaten by Americans and even higher percentage of produce is imported".

Once the Proposed Rule is published, there will be a 120 day period for public comment before the rules are completed. You can review the published rules and comment here: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food

Pacific Customs Brokers will continue to monitor the FSMA Rules as they are implemented and will keep you informed. We can also assist you with food facility registration or renewal and U.S. Agent services. Our 24 hour, 7 days a week operation is available to provide immediate answers to your regulatory questions.  Please address your comments and questions to the team at Pacific Customs Brokers at or call us at 877.332.8534.

Do you have questions or need further clarification on the new FSMA Rules? What are your thoughts on FDA’s announcement? Your comments are most welcome below. 

Mandatory Re-registration With FDA Due Dec 31, 2012
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About Author
Gloria Terhaar
CCS (CA/US), CTCS, CBSA Prof. Designate

Gloria Terhaar began her career in Canadian customs brokerage 2007. She currently works in our Canadian division as a Trade Compliance Supervisor and Regulatory Compliance Specialist. Gloria has extensive experience in all aspects of documentation and regulatory requirements as they relate to importing products into Canada. Gloria is often called upon to train industry with some recent talks for MNP, the Surrey Board of Trade, TFO Canada and the BC Produce Marketing Association. In 2018, Gloria also participated in the Canadian Produce Marketing Association and the Canadian Horticultural Council advocacy event "Fall Harvest" in Ottawa where she participated in advocacy efforts for the Canadian produce industry.

While we strive for accuracy in all our communications, as the Importer of Record it is incumbent upon your company to ensure that you are aware of the requirements under the new regulations so that you maintain compliance as always.
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