Food Labeling Compliance Seminar – September 24-25, 2018 in Kansas City, MO

Specializing in FDA Regulatory Matters

FDA Food Code 12th Edition – What’s New?

The FDA Food Code is used as the basis for food safety regulation of more than a million restaurants, retail food stores, institutional and other food operations in the US and around the world. It is updated every two years through a collaborative process with the Conference for Food Protection where all stakeholders have a voice in what is included in the next edition published by FDA. Allen Sayler, Senior Director for Food Consulting Services, in his March column in the EAS-e-News announced the release of the 2017 edition on February 12, 2018.

This article will focus on the 10 major changes in this 12th edition since the first modern risk- and the science-based code was issued by FDA in 1993. Twelve earlier editions had been published by FDA and the U.S. Public Health Service since 1934 that were more retail segment-specific guidance, i.e. food service, food store or food vending.

FDA Food Code only becomes a regulation when its requirements are adopted by local, state, and federal food programs for their segment of this vast industry. The new provisions also become the de facto standard of prudence for many companies, even before their operations are required by the local regulatory authorities to comply with it.

A summary of the 10 major updates in the 2017 edition of the FDA Food Code is provided below. This release also had many less significant changes and numerous editorial and clarification amendments.

Chapter 2 Management and Personnel
2-102

 

Certified Food Protection Manager

Required, for the first time, that the Person in Charge of the food establishment be a Certified Food Protection Manager. The program that awards this recognition must be accredited, meaning that it has been evaluated and listed by an accrediting agency, as conforming to national standards for organizations that certify individuals.

2-103 Monitoring of Food Temperatures

Added a new duty for the Person in Charge, ensuring employees are routinely monitoring food temperatures in hot and cold holding.

2-201 Salmonella Typhi and nontyphoidal Salmonella distinctions

Expanded on the changes begun in the 2013 Food Code in emphasizing the importance of nontyphoidal Salmonella (NTS), such as S. enterica serotypes, that cause more than one million domestically acquired foodborne illnesses in the United States each year.

2-401 Bandages, Finger Cots or Finger Stalls

Required the use of a single-use glove to cover a bandage, finger cot or finger stall used on the wrist, hand or finger.

2-501 Written Vomit and Diarrhea Clean-Up Procedures

Required that a written plan be provided for cleanup of these bodily fluid discharges by employees or customers. A very good detailed explanation for the plan elements is provided in Food Code’s Public Health Reasons Annex.

Chapter 3 Food
3-401 Changed Cooking Times

Raised the cooking temperature dwell time for foods like comminuted meats requiring a cooking temperature of 68°C (155°F) from 15 seconds to 17 seconds. Lowered the cooking temperature dwell time for foods like poultry requiring a cooking temperature of 74°C (165°F) or above to < 1 second (instantaneous).

3-502 ROP Frozen Fish Labelling

Added criteria for fish that is reduced oxygen packaged at retail to bear a label indicating that it is to be kept frozen until time of use.

Chapter 8 Compliance and Enforcement
8-201 HACCP Plan

When a Hazard Analysis and Critical Control Points plan is required by a jurisdiction for variances including those for specialized processing at retail, more detailed information is required to be submitted for the jurisdictions review and approval.

8-402 Regulatory Training

Added requirement for the Regulatory Authority to ensure that authorized representatives, who inspect food establishments or conduct plan reviews for compliance with Food Code, have access to training and continuing education, as needed, to properly identify violations and apply the Food Code. You will see in this month’s FSMA Perspective that employee training is also a requirement of FSMA and documentation of that training should be kept and provided to FDA upon request during an inspection.

8-404 Utility Interruption Contingency Plan

Allowed the regulatory authority to agree to continue operations during an extended water or electrical outage, if written operational plans have been approved by the regulatory authority.

 

As mentioned with the changes outlined in Section 2-501, the Public Health Reasons in Annex 3 provide excellent plain English descriptions of the science and other details behind the requirements of the changed, as well as the older sections of FDA Food Code. Additional information can be provided by the adopting regulatory authority or by the FDA National Retail Food Team. Questions of FDA on the Food Code may be directed to RetailFoodProtectionTeam@fda.hhs.govor should you have questions which you would like to direct to EAS, contact Allen Sayler at ASayler@easconsultinggroup.com