Chapter 2: The Era of the Food Safety Modernization Act and Hazard Analysis
2.2 Preventive Controls Rule for Human Food
Preventive controls are defined in 21 CFR Part 117.3 as “risk-based, reasonably appropri- ate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of analysis.” Essentially, nearly all food manufacturers now will be required to follow hazard analysis and critical control point (HACCP)–like principles. A discussion of HACCP and its similarities to the new preventive control requirements is found in Section 2.3.
FSMA
Increasing rates of foodborne
illness
Import adulteraon
concerns
Post-9/11 naonal security concerns
Third-party Cerficaon Rule
Prevenve Controls for Animal Foods Rule
Sanitary Transportaon Rule
Intenonal Adulteraon Rule
Foreign Supplier Verificaon Programs for Importers Rule
Produce Safety Rule
Prevenve Controls for Human Foods Rule
Figure 2.1
Seven foundational rules emerging from Food Safety Modernization Act.
In addition to being the most comprehensive change for food companies to address, the new PCHF is the part of FSMA that arguably will have the most labor-intensive impact on the food industry. Even after a Food Safety Plan for a food product is developed, it will require continual monitoring (with associated documentation). The Food Safety Plan will need to be updated when any food process or product ingre- dient is changed, new risks are realized, and as new products are added to a company’s product line. For example, the continual request by retail buyers of their suppliers to source new ingredients and products to grow sales in their business will require suppliers to consider updates to their Food Safety Plans. The impact of PCHF’s changes was quickly recognized: as shown in Table 2.1, the number of public comments received on the proposed PCHF regulation is by far greater than for any other FSMA regulation. Unusually, foreign governments and businesses both weighed in on the proposed regulations, highlighting their far-reaching scope and impact (U.S. Food and Drug Administration, 2015c). The final publication of the Final Rule in the Federal Register, including the comments and FDA responses, encompasses a massive 260 pages.
The rulemaking process for the PCHF regulations took more than 4 years to complete. Implementation (publishing of the final regulations) in fact took longer than specified by law, at least partly because of the extensive and appropriate input FDA sought and received on the proposed regulations. FDA held approximately 600 engagements (public meetings, webinars, presentations, etc.) to communicate with stake- holders about FSMA during the rulemaking process (U.S.
Food and Drug Administration, 2015c).
The Center for Food Safety filed suit against the FDA because of delays in implementing the key FSMA regula- tions, and the FDA finished the Final Rules under court- order deadlines (which also were extended) (Johnson, 2015).
Fig. 2.2 outlines the key steps, dates, and notices leading to the Final Rule for Human Preventive Controls on September 17, 2015.
The Final Rule is entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods.” Putting the Final Rule into the Code
$381 million: Estimated total annual cost for food industry to comply with human preventive controls
157,000: Number of illnesses that would need to be prevented by the human preventive controls to break even in terms of domestic costs 46,685: FDA-estimated number of facilities subject to human preventive controls that will need to create a Food Safety Plan
110 hours: Average number of hours the FDA estimates it will take to create a Food Safety Plan
>50: Number of regulations, guidelines and studies for which FDA is responsible for under FSMA
Sources: Johnson, R., 2015.
Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353). U.S. Food and Drug Administration, 2015c.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods; Final Rule. 80 Fed. Reg. 55908 (September 17, 2015).
FSMA AND HUMAN PREVENTIVE CONTROLS:
BY THE NUMBERS
The Era of the Food Safety Modernization Act and Hazard Analysis 19 Table 2.1: Major Food Safety Modernization Act (FSMA) regulations (foundational rules).
FSMA Regulation Final Rule
Comments Received Through
May 6, 2016 Preventive Controls for Human Food Final Rule published September 17, 2015 71,386 Preventive Controls for Food for Animals Final Rule published September 17, 2015 2,269
Standards for Produce Safety Final Rule Final Rule published November 27, 2015 39,856 Foreign Supplier Verification Programs
(FSVP) for Importers of Food for Humans and Animals Final Rule
Final Rule published November 27, 2015 450
Accredited Third-Party Certification Final Rule
Final Rule published November 27, 2015 212 Sanitary Transportation of Human and
Animal Food Final Rule Final Rule published April 6, 2016 219 Mitigation Strategies to Protect Food
Against Intentional Adulteration Final Rule
Final Rule published May 27, 2016 228
Figure 2.2
Rulemaking process for human preventive controls regulations.
of Federal Regulations (CFR) required modification to 12 different parts of 21 CFR, including the creation of a new Part 117. The bulk of the new hazard analysis and preven- tive controls requirements are located in 21 CFR Part 117, Subpart C. The old cGMPs for food were moved from Part 110 (which has now been removed) to a revised cGMP section in 21 CFR Part 117 Subpart B. Additionally, the Final Rule also made modifica- tions to 21 CFR Part 1, which will change the definition of “farm.” This modification has implications for which food establishments are exempt from the preventive controls requirements; see Section 2.6.
Five subparts comprise new 21 CFR Part 117, as shown in Table 2.2.
Subpart A includes a large collection of useful definitions as well as detailed information about the types of facilities to which the Final Rule applies. The revised cGMPs are found in Subpart B, while the “meat” of the rule, the hazard analysis and preventive control requirements for human foods, is found in Subpart C. Subpart D describes the modified requirements for certain categories of food facilities, especially “qualified” facilities that are subject to fewer requirements, while Subpart E details circumstances under which qualified facilities may lose “qualified” status. Subpart F describes requirements for records and documentation that must be maintained. Finally, Subpart G discusses the supply-chain program that is required when a supply-chain control is used to prevent a raw material or ingredient hazard.
The Final Rule also indicates that it may be formally abbreviated as the “Human Preventive Controls Rule,” which again illustrates how important Subpart C is within the regulation. In practice, the regulation as codified in 21 CFR Part 117 has become widely known as “pre- ventive controls for human food” and abbreviated as PCHF. Within this book, the phrase
“preventive controls for human food” and the abbreviation PCHF should be understood to Table 2.2: Components of the final regulation on current good manufacturing practice, hazard
analysis, and risk-based preventive controls for human foods (21 CFR Part 117).
Subpart Title
A General Provisions
B Current Good Manufacturing Practice (cGMP)
C Hazard Analysis and Risk-Based Preventive Controls for Human Foods (PCHF)
D Modified Requirements
E Withdrawal of an Exemption Applicable to a Qualified Facility F Requirements Applying to Records that Must Be Established and Maintained
G Supply-Chain Program
From U.S. Food and Drug Administration, 2015c. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods; Final Rule. 80 Fed. Reg. 55908 (September 17, 2015).
The Era of the Food Safety Modernization Act and Hazard Analysis 21 encompass both the hazard analysis and the risk-based preventive controls as well as the related provisions of 21 CFR Part 117.
The PCHF regulations intentionally are written with much flexibility. There are few situations where exact ways of complying with the regulations are specified. The goal was to provide manufacturers with the ability to develop Food Safety Plans that would be most suitable for their products and their company’s previous experience and procedures. The regulations do not detail specific hazards that need to always be addressed, nor do they specify exactly how a company should address a particular hazard.
The focus of this book will be on PCHF (21 CFR Part 117). Within PCHF are requirements for the following:
• A written Food Safety Plan • Hazard analysis