1. FINAL RULE OVERVIEW Prepared By: Danielle Bauer
FOOD SAFETY MODERNIZATION ACT: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
FINAL RULE OVERVIEW
Prepared By: Danielle Bauer

2. What was updated and what does this rule mean for industry?
Overview
Current Good Manufacturing Practices
Education and training required
Management commitment
Written Food Safety Plan
Hazard Analysis
Preventive Controls
Written Recall Plan
Reanalyze Plan every 3 years
Preventive Controls Qualified Individual (PCQI)
Supply Chain Program
Human Food By-Product for use in Animal Food
Farm Exemptions/Definitions
What was updated and what does this rule mean for industry?
Proactive approach to preventing food safety, rather than reactive

3. WHAT SIGNIFICANT ISSUES WERE CONSIDERED FROM PROPOSED RULE COMMENTS?
Many small farmers raised concern over the financial burden of increased government regulation over their small business
Define the difference between a farm and a facility
“If it ain’t broke don’t fix it”
On-farm vs off-farm produce packing
Intrastate commerce should not be regulated
FARMS
Replace the term “reasonably likely to occur”
Facilities should determine product testing requirements
Define product categories for required environmental monitoring
Economically motivated hazards do not need a separate analysis
Recall plans should be plant specific, not product specific
INDUSTRY
Many requested guidance to the rule
Requested support and outreach programs
Foreign versus domestic oversight to compliance
GENERAL
WHAT SIGNIFICANT ISSUES WERE CONSIDERED FROM PROPOSED RULE COMMENTS?
Public and Industry Comments
Docket: FDA-2011-N-0920
21 CFR Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Final Rule

4. Before We Begin: Why Invest in Food Safety?
$15.5 billion burden annually
Before We Begin: Why Invest in Food Safety?
48 million (1 in 6!) Americans become ill every year
128,000 hospitalized
3,000 deaths
(CDC 2011) (Hoffman 2015)

5. CURRENT GOOD MANUFACTURING PRACTICES UPDATES
cGMPS: 21 CFR 117 (b)
Training and Education
Required to ensure all employees involved in the handling and manufacturing of food are adequately equipped to perform their job while ensuring food safety
Consider turn-over, new employees, and language barriers
Management commitment: Food Safety Culture
Record Keeping
Allergen Cross-Contact Control – Facilities must take adequate preventive precautions
Do not handle unprotected allergens in receiving, loading, or shipping areas simultaneously
Protect food traveling by conveyer throughout the facility
Human food used in animal food
Holding and distribution requirements
CURRENT GOOD MANUFACTURING PRACTICES UPDATES
(FDA 2016 Small Entity Compliance Guide)

6. What are the Main Components of a Food Safety Plan?
Hazard Analysis
Identify biological, chemical, and physical hazards possible at each step in the production process and for all incoming raw materials
Includes all steps under control of the food processor
Identify Significant Hazards
Use scientific sources and historical data to determine hazards reasonably likely to occur
Preventive Controls
Allergen: Control cross-contact and labeling
Sanitation: Environmental monitoring
Process: control during manufacturing
Supply Chain
Oversight and Management of Preventive Controls
Monitoring
Corrective Actions
Verification
Validation
Record Keeping
Supply Chain Program
Required to implement risk- based controls for raw materials identified as hazardous
Approved supplier programs
Not required when controlled elsewhere in the facilities food safety program
Written Recall Plan
All food safety plans that identify preventive controls are required to have a written plan in place in the event of a product recall
(FDA Preventive Controls Fact Sheet)

7. What is a PCQI and why do I need one?
The Preventive Controls Qualified Individual has completed training in risk-based preventive controls or has acquired considerable experience through their career
Oversee the preparation of the food safety plan
Validation of preventive controls
Record review
Not required for each manufacturing facility
21 CFR Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Final Rule)

8. Oversight and Management of Preventive Controls
Monitoring: Activities performed to ensure preventive control meets critical limits
Corrective Action: Steps taken to correct problems, identify the root cause, and prevent reoccurrence
Product must be evaluated for safety prior to release
Verification: Proof that preventive controls are properly implemented
Process validation
Record review
Product testing
Validation: Proof that the preventive controls/food safety plan adequately controls the hazards
Scientific basis for the plan
Oversight and Management of Preventive Controls
RECORD KEEPING REQUIRED
(FDA Preventive Controls Fact Sheet)

9. When and Why is Product Testing Required?
VERIFICATION: Companies are required to verify that their food safety plan is effective in preventing the identified hazards through activities such as:
Environmental Monitoring: If your food safety plan includes a preventive control for contamination of a ready-to eat (RTE) food product, this verification activity is required
Product Testing
Companies should consider more frequent testing for:
RTE Foods
Foods frequently associated with outbreaks
(FDA Preventive Controls Fact Sheet)

10. Supply Chain Program 21 CFR 117(b) and 21 CFR 507 Supplier approval
Only use materials that come from approved suppliers per company standards
Supplier verification
Determine and conduct appropriate activities such as supplier audits
Sampling/testing raw materials
Supply Chain Program
Q: When is it required?
A: If a preventive control is identified for raw material/ingredients prior to receiving AND the supplier is responsible for controlling the hazard
(FDA 2017 Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry )

11. What are the Rules for Human Food Intended for use in Animal Food?
Food and food byproducts must be safe for intended use
Generally recognized as Safe (GRAS)
Food additive approval for animal food
* Remember, human food additives are not always safe for animal food. Ex: Xylitol
Holding and Distribution cGMPs
Comply with human cGMPs and regulations
Facility may not further process the food, with a few exceptions
Food must be held in conditions that prevent contamination and held in clean and sanitary containers/equipment
Labeling
Clearly label if by-product is intended or not intended for use in animal food
Label with common or usual name
Sanitary shipping
Evaluate human food by-product rejected for food safety reasons prior to release
“Animal producers and animal food manufacturers are able to use by- products from the production of human food and beneficial and economical animal food that would otherwise be wasted.”
- US FDA Guidance for Industry Human Food By-Products for Use as Animal Food
(FDA 2016 Human Food By-Products for Use as Animal Food Draft Guidance)

12. Farm Definitions: FDA’s Response to Stakeholders
Primary production farm
Secondary activities farm
“An operation under one management in one general (but not necessarily contiguous) physical location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood),or any combination of these activities. A farm packs and holds raw agricultural commodities and may conduct certain manufacturing/processing activities (i.e., drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/ dehydrating grapes to produce raisins), treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling).”
“…An operation, not located on a primary production farm, devoted to the key farming operations of harvesting, packing, and/ or holding of raw agricultural commodities, provided that the primary production farm(s) that grow, harvest, and/or raise the majority of the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm. A secondary activities farm may also conduct those additional activities allowed on a primary production farm.”
(21 CFR Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Final Rule)
* FARMS ARE NOT REQUIRED TO REGISTER AS FACILITES AND THUS ARE NOT SUBJECT TO THIS RULE

13. Compliance Dates Sep. 1 2016 Sep. 18 2017 Sep. 17 2018
Businesses with > $1 million in sales
Sep
Small Businesses with < 500 full time employees
Sep
Very small businesses with an average of < $1million sales per year
Sep
Facilities subject to the Pasteurized Milk Ordinance
Compliance Dates
(FDA Preventive Controls Fact Sheet)

14. CREATE A CULTURE OF FOOD SAFETY THAT ALL EMPLOYEES ARE PROUD TO BE A PART OF!

15. REFERENCES
Centers for Disease Control CDC Estimates of Foodborne Illness in the United States Factsheet.
Department of Health and Human Services. Federal Register. Title 21 Parts 1, 11,16, 106, 110 et al. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Fuman Food: Final Rule. Volume 80. No September 2015
Hoffman, S. Machulloch, B. and Batz, M Economic Burden of Major Foodborne Illnesses Acquired in the United States.
United States Food and Drug Administration. Key Facts about Preventive Controls for Human Food. Retreived14 June 2018 from
U.S. Department of Health and Human Services Food and Drug Administration Supply-Chain Program Requirement and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry. Retrieved 16 June 2018 from
U.S. Department of Health and Human Services Food and Drug Administration Guidance for Industry Human Food By-Products for Use as Animal Food. Retrieved 15 June 2018 from
U.S. Department of Health and Human Services Food and Drug Administration What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food (21 CFR Part 117): Guidance for Industry Small Entity Compliance Guide. Retrieved 16 June 2018 from