Dear Editor,
The Food and Drug Administration (FDA) was founded out of the need to use scientific principles to ensure the production of safe food. This is very well explained in the book “The Poison Squad” by Deborah Blum. The FDA continues to use science and logic in developing food safety laws. This resulted in several regulations tailored to specific product categories such as low-acid shelf-stable foods (21 CFR Part 113), seafood (21 CFR Part 123), and juices (21 CFR Part 120). The Food Safety Modernization Act (FSMA) created a rule that covers all FDA-regulated products. Under this rule (21 CFR Part 117 – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food), food processors are required to develop preventive controls for all hazards that are known or reasonably likely to occur, with some exceptions for hazards covered under existing regulations.
Another regulation developed in the late 1970s was the Acid Foods Regulation (21 CFR Part 114). This regulation was developed at the request of Pickle Packers International and is intended to control the possibility that manufacturers may not add enough acid up front during the pickling process, causing the pH after the pH equilibration time to exceed the specified microbiological food safety limit of 4.6.
FSMA excluded microbial hazard controls from the regulations for products produced under 21 CFR Parts 113, 123, and 120. There is no exclusion for products produced under the Acidified Foods regulation (Part 114). The potential microbial hazards for acidified pickle products covered in Part 114 are also covered in Part 117, Preventive Controls for Human Food (PCHF). Therefore, the Acidified Foods regulation, Part 114, is a redundant regulation.
FDA is developing guidance for implementing the PCHF rule, “Hazard Analysis and Risk-Based Preventive Controls for Food: Guidance for Industry,” which recently added draft guidance for “Chapter 16: Acidified Foods.” This chapter of the guidance is intended to help food processors blend the requirements of 21CFR Part 114 Acidified Foods with the PCHF rule. One thing that is very clear from this draft guidance is that the potential microbial hazards covered by the Acidified Foods rule can be adequately controlled by the PCHF rule alone.
Chapter 16 of the PCHF Draft Guidance contains a 33-page comparison of Parts 114 and 117, including subtle suggestions on how to consolidate the rules. This is more complicated than it needs to be. The logical solution would be to eliminate Part 114 as a rule and allow the microbiological hazards of acidified pickled foods to be addressed solely by the PCHF rule rather than two rules. This would simplify the preparation of the Food Safety Plans (FSPs) required by the PCHF rule and allow the focus to be on true food safety concerns rather than on the implications of the differences between the two rules.
In the Federal Register description of the Acidified Foods Rule and in the rule itself, acidification is a pickling process (FR 44 No 53 16205). The agency made the distinction between acidified pickles and fermented pickles based on the fact that no food safety incidents have been reported from fermented pickle products (FR 44 No 53 16204). Thus, the rule applies only to acidified pickle products. The Acidified Foods Rule defines acidified foods as “foods called or purporting to be ‘pickles’ or ‘pickles'” and all of the problematic examples of products used to justify the rule were acidified pickle products. All of the examples in the rule’s definition of acidified foods are pickled products. The determination of whether a product is acidic or acidified should be based on whether the product is pickled or pickled and therefore fits the definition of an acidified food.
Another, more compelling reason to repeal Part 114 is the fact that it is not being enforced in a manner consistent with the principles of regulation established in FSMA. FSMA promotes the use of scientific risk analysis to develop preventive controls to create safe foods. The current criteria that FDA uses to determine if a product is acidic or acidified strays significantly from this concept. The criteria are not based on the definition of an acidified food, nor are they related to the risks for which Part 114 was developed. This creates an entirely new category of food that does not fit the definition of an acidified food found in the Federal Register or other literature. Many of these foods designated as acidified foods are acidic foods that were never intended to be subject to the acidified foods regulation.
Furthermore, the limitations that FDA currently uses on the criteria for acid foods vs. acidified foods are completely arbitrary. At a recent food safety conference, an FDA presenter was asked how the limitations on one of the criteria for acid foods vs. acidified foods were determined. The regulator’s response was, “We had to draw the line somewhere.” This is an admission by the agency that the limitations on the criteria for distinguishing acid foods vs. acidified foods are completely arbitrary and have no bearing on food safety. These types of criteria are a significant departure from the food safety principles of FSMA and also from the principles of other food safety schemes.
Acid foods and acidified foods have an excellent safety record, and efforts to consolidate parts 117 and 114 are entirely unjustified because the implementation of part 114 would not improve food safety compared to regulating these products solely under part 117. The draft guidance goes a long way in demonstrating that the important food safety aspects of acidified foods are adequately addressed in the PCHF rule alone.
The acidity and acidification criteria used by the agency are unscientific, unrelated to food safety, and arbitrary, and thus completely contrary to the principles of FSMA. Repealing Part 114 would greatly assist FDA in promulgating the principles of FSMA and the agency in achieving its blueprint for future goals. Duplicate regulations only add confusion to the development of a robust food safety system. Repealing Part 114 would eliminate unnecessary duplication of regulatory oversight and help industry improve their food safety programs and practices to better protect public health.
Author: David Bresnahan, President, Bresnahan Thermal Processing Consultancy, Kenmore, Washington
