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According to the CDC, “about 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases.” The FDA viewed this significant public health burden to be largely preventable and as a result, launched the Food Safety Modernization Act (FSMA)—the first major regulatory overhaul in 70 years. The regulations went into effect on Nov. 16, 2015 and are found in 21 CFR Part 117—current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF). The body of legislation defines a dramatic shift in the agency’s approach from reaction to prevention by requiring facilities to develop documented food safety plans that identify all potential hazards associated with the process or product and to implement risk-based preventive control measures that minimize or prevent the identified hazards. The FDA has also revised the requirements of the cGMPs, which have been relatively untouched for the last 30 years.
Compliance dates to FSMA are staggered over the next three years. On Sept. 19, 2016, larger companies with greater than 500 full-time employees were required to be in compliance with the PCHF Final Rules and revised cGMPs, and animal food facilities were required to be in compliance with the cGMPs. Small companies with fewer than 500 employees have until September 2017 to comply with the regulations. Businesses regulated by the Pasteurized Milk Ordinance and very small businesses averaging less than $1 million per year in sales have until September 2018 to implement the new rules.
FSMA encompasses the revised cGMPs and the body of the legislation contained in the seven foundational rules listed below.
- Preventive Controls for Human Food Final Rule
- Preventive Controls for Food for Animals Final Rule
- Accredited Third-Party Certification Final Rule
- Foreign Supplier Verification Programs (FSVP) Final Rule
- Produce Safety Final Rule and Environmental Impact Statement
- Sanitary Transportation of Human and Animal Food Final Rule
- Mitigation Strategies to Protect Food Against Intentional Adulteration Final Rule
Since 1986, the cGMPs in manufacturing, packing, or holding human food have been located in 21 CFR Part 110 Subparts A through G, which cover general provisions, buildings and facilities, equipment and utensils, production and process controls, and defect action levels.
The revised and expanded cGMPs are now found wholly in 21 CFR Part 117 Subpart B and include the below nine sections.
- 117.10 Personnel
- 117.20 Plant and Grounds
- 117.35 Sanitary Operations
- 117.37 Sanitary Facilities and Controls
- 117.40 Equipment and Utensils
- 117.80 Processes and Controls
- 117.93 Warehousing and Distribution
- 117.95 Holding and Distribution of Human Food By-Products for Use as Animal Food
- 117.110 Defect Action Levels
Significant changes to the modernized cGMPs include stricter requirements for allergen control, clarification of definitions, and the inclusion of requirements for section 117.95. Recommended practices have either become required practices or been removed (for basic safety practices that should already be in place). Production and sanitation processes must be explicitly designed to prevent the cross-contact of food products and food packaging with allergens. Since allergens are an inherent part of food and not a contaminant, the term “cross-contact” is used to define the unintentional transfer of allergenic proteins to foods that do not contain like proteins. “Cross-contamination” now refers to foods that have been intentionally or unintentionally adulterated with bacteria, chemicals, or foreign materials. The word “shall” has been replaced with “must,” and definitions of terms are now aligned with the definitions established by Codex and the National Advisory Committee on Microbiological Criteria for Foods.
Emphasis has been placed on food packaging as a food-contact surface and controls must be in place for its protection. The regulations no longer include recommended practices by use of the word “should” and some of the previously non-binding sections, including employee education and training, are now mandatory. In addition, section 117.95 Holding and Distribution of Human Food By-Products for Use as Animal Food specifies new requirements for proper labeling and handling of by-products to prevent cross-contamination of human foods. On Sept. 17, 2018, once compliance is implemented for food manufacturing operations of all sizes, the cGMPs in 21 CFR Part 110 will be removed from the legislation and will no longer be valid.
The PCHF, or Preventive Controls for Human Food, Final Rule is the cornerstone of FSMA and is contained in 21 CFR Part 117 Subpart C—Hazard Analysis and Risk-Based Preventive Controls. The rule requires facilities to develop comprehensive food safety systems that focus on prevention-based controls throughout the food chain with the intent to prevent or significantly minimize the likelihood of problems occurring. This involves the development and implementation of a documented food safety plan that includes an analysis of hazards and risk-based preventive controls.