0. Webinar: Food Safety Modernization Act – What You Need to Know
Host:
Jessica McCune
Marketing & Communications Manager, MAMTC
Webinar: Food Safety Modernization Act – What You Need to Know
Thursday, August 24th, am-12pm
Presenter:
Kathy Hardee, JD, PCQI
Co-Chair Food & Ag Group
Polsinelli PC
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1. MAMTC (Mid-America Manufacturing Technology Center) helps Kansas manufacturers address challenges and achieve success.
We do this by:
Connecting manufacturing enterprises with vetted and trusted resources;
Providing information and education to manufacturers and affiliated industries;
Advocating for critical local and global manufacturing issues throughout Kansas and beyond.
Our mission is to promote manufacturing growth in the state of Kansas. We do this by connecting and convening manufacturing enterprises with vetted and trusted resources when needed; providing education and information to and about manufacturing; and advocating critical issues for manufacturers throughout the state and beyond.
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2. Kathy Hardee, JD, PCQI
Kathy is certified as a Preventative Controls Qualified Individual (PCQI) under FSMA.
Kathy Hardee’s litigation experience spans more than 25 years, representing clients in the food industry, toxic and mass tort litigation, product liability issues, business disputes and transportation disputes.
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3. The Food Safety Modernization Act (FSMA)
Preventative Control Rules for Human Food & Preventative Control Rules for Animal Food
Kathy Hardee, JD, PCQI
Co-Chair Food & Ag Group
Polsinelli PC
The Food Safety Modernization Act (FSMA)
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4. Food Safety Modernization Act (“FSMA”)
The goal of FSMA is to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.
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5. 7 Pillars of FSMA
1. Preventive Controls for Human Food, 2. Preventative Controls for Animal Food, 3. Produce Safety, 4. Foreign Supplier Verification, 5. Third Party Accreditation, 6. Sanitary Transportation, and 7. Food Defense From Intentional Adulteration.
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6. Components of Preventative Control Rules:
Preventative Control Rules for Human Food & Preventative Control Rules for Animal Food
Components of Preventative Control Rules:
1. Hazard Analysis and Risk-Based Preventative Controls Program – more simply referred to as a Written Food Safety Plan.
2. Current Good Manufacturing Practices (cGMPs) for both the manufacture of human food and animal food.
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7. Preventative Control Rules for Human Food & Preventative Control Rules for Animal Food
Who is Subject: Establishments, both domestic and foreign, who are required to register with the FDA as a food “facility.”
Not Included: Those not subject to FDA oversight: meat, poultry or egg processors (if that is their only product), retail food establishments, etc.
Complex and Narrow Exemptions: Those subject to FDA oversight but exempted:
Certain facilities which meet the definition of “farm”
Qualified facilities
Low-risk on-farm activities by small businesses
Certain activities relating to seafood, canned juice or “low-acid canned food”
Dietary supplements
Activities subject to the Produce Safety Rule
Alcoholic beverages
Misc. other exemptions
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8. Construction of Written Food Safety Plan Hazard Analysis
Hazard Analysis and Risk-Based Preventative Controls Program – Written Food Safety Plan
Construction of Written Food Safety Plan
Hazard Analysis
Preventive Controls
Procedures for monitoring, corrective action and verification
Documentation
All performed or overseen by a Preventative Controls Qualified Individual (PCQI)
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9. Construction of Written Food Safety Plan
1. Conduct Hazard Analysis – Identify hazards which are: a. Hazards known or reasonably foreseeable i. Including biological, chemical and physical hazards ii. Present in or around food because they occur naturally, are unintentionally introduced or are intentionally introduced for purposes of adulterating the food for an economic gain b. Reasonable probability that exposure to the hazard will result in serious adverse health consequences or death
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10. Construction of Written Food Safety Plan
Design Preventive Controls –
a. May Include:
i. Process Preventative Controls
ii. Allergen Preventative Controls
iii. Sanitation Preventative Controls
iv. Supply Chain Preventative Controls
v. Other Preventative Controls
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11. Construction of Written Food Safety Plan
Design Preventative Controls (cont’)
b. Intended to:
i. Eliminate or significantly minimize the risk of identified hazards
ii. Be consistent with current scientific understanding
iii. Be flexible
iv. Must include a written recall plan
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12. Recall Plans Recall Plan Summary
Required when a hazard requiring a preventative control is identified.
Must be in writing
Must describe steps and assign responsibilities
Identify scope of the recall
External notifications (regulators, customers, public)
Conduct effectiveness checks
Execute disposition of the food
Corrective actions
Mock recalls
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13. A Comparing Food Safety Plans to HACCP Plans
Requirements
PC Rule
NACMCF HACCP Guidelines
Written plan
Yes
Who is responsible for preparing the plan?
The owner, operator or agent in charge of a facility must prepare, or have prepared, and implement a written food safety plan. The food safety plan must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals.
A HACCP team may need assistance from outside experts knowledgeable in the hazards associated with the product and process.
What does the plan contain?
Written hazard analysis.
Written preventive controls.
Written supply-chain program.
Written recall plan.
Written procedures for monitoring the implementation of the preventive controls.
Written corrective action procedures.
Written verification procedures.
Written hazard analysis
Must include the hazard, the CCPs, and critical limits.
Must include monitoring procedures.
Must include corrective actions.
Must include verification procedures.
Must include recordkeeping procedures.
Is oversight required by a person qualified by training and experience?
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14. Location of Preventative Controls for Identified Hazards
Control Within the Facility
Control Within the Supply Chain (Upstream by Ingredient Suppliers)
Assure Control in the Distribution Chain (Downstream by Customers)
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15. Supply Chain Preventative Controls
Identified Hazards Not Preventable by the Facility. Hazards in the Supply Chain (Upstream)– Identified potential hazards in an ingredient or a raw material component. Facility must create a Supply Chain Program instead of creating a preventative control to protect against that hazard: a. Use of approved suppliers b. Determination of appropriate supplier verification activities c. Conducting supplier verification activities d. Documenting supplier verification activities Exclusion – An importer in compliance with the foreign supplier verification program for the ingredient.
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16. Distribution Chain Preventative Controls
Identified hazards not prevented by facility or suppliers. Hazards in the Distribution Chain – Identified potential hazard which may develop with the food down-stream with the facility’s customer or subsequent purchaser. a. Facility provides documentation to its direct customer that the food is “not processed to control for [identified hazard]”, and b. Facility must get written assurances from its direct customer regarding the appropriate procedures and processes the food will receive to control for the identified hazard.
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17. Management of the Food Safety Plan and Its Components
1. Monitoring Activities 2. Corrective Actions 3. Verification
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18. Management of the Food Safety Plan Thru Monitoring Activities
Safety Plan must include written monitoring activities
Underlying goal is to simply confirm that the preventive controls are properly implemented and are consistently performed
Selection of monitoring activities is flexible
Monitoring usually includes observations and/or measurements of the preventative controls at planned sequences
All monitoring activities must be documented and are subject to verification activities and records review.
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19. Management of the Food Safety Plan Thru Corrective Actions
WHEN must corrective actions be taken:
Corrective action must be taken whenever it is determined that the preventive controls are not being consistently performed.
Corrective action must be taken whenever a preventative control, a combination of preventative controls or the food safety plan as a whole is found to be ineffective.
Review of records finds that the records are incomplete, that certain activities did not occur in accordance with the food safety plan, or appropriate decisions were not made about corrective actions.
When any unanticipated problem occurs relating to the food product.
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20. Management of the Food Safety Plan Thru Corrective Actions
WHAT corrective actions must be taken:
Corrective actions depend upon the nature of the hazard and the nature of the preventative control.
Appropriate action is taken to identify and correct a problem that has occurred with the implementation of a preventative control.
Appropriate action is taken to reduce the likelihood that the problem will recur.
All affected food is evaluated for safety.
All affected food is prevented from entering into commerce if you cannot insure that the affected food is not adulterated.
If potentially adulterated food enters into commerce – initiate recall.
When appropriate, a corrective action may consist of a full re-analysis of the food safety plan to determine whether a modification of the plan is warranted.
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21. Management of the Food Safety Plan Thru Verification Activities
Validation
Verification of Monitoring Activities
Verification of Corrective Actions
Verification of Implementation and Effectiveness
Documentation of Verification Activities
Validation activities may result in need to re-evaluate the food safety plan.
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22. Preventative Controls Qualified Individual (“PCQI”)
Needed to:
Create or oversee the creation of a Food Safety Plan
Manage or oversee the management of a Food Safety Plan and its Component Parts
Training:
Successfully complete an FDA-approved standardized curriculum or have equivalent experience.
Food Safety Preventative Controls Alliance (FSPCA)
Curriculum/Equivalent:
Food Safety Preventive Controls Alliance
The curriculum is available through various formats
The Alliance is also establishing a technical assistance network to provide assistance, especially for small and medium-sized businesses.
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23. Current Good Manufacturing Practices
Current Good Manufacturing Practices (cGMPs) For Human Food Manufacturers
vs.
Current Good Manufacturing Practices (cGMPs) For Animal Food Manufacturers
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24. cGMPs for Human Food
Education and training of employees in the area of food hygiene, food protection, employee health and personal hygiene, as those may impact the safety of food products. Specific record keeping is required to document the training.
and
Precautions to protect against allergen cross-contact and against contamination of food, food-contact surfaces or food-packaging materials with microorganisms or foreign substances.
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25. cGMPs for Animal Food
First baseline cGMPs for facilities that manufacture, process, package and/or hold food for animals.
Personnel – All reasonable measures must be taken to ensure that personnel who come in contact with animal food, animal food-contact surfaces and animal food-packaging materials follow Good Hygiene Practices.
Plant and grounds – A facility’s buildings and surrounding grounds must receive appropriate maintenance and pest control, and a plant’s construction, size and design must be adequate.
Sanitation – Operations must insure clean and sanitary conditions of facilities and fixtures. In addition, there are restrictions on the use and storage of certain toxic materials.
Water supply and plumbing – Facilities must have appropriate water supplies, plumbing, sewage and hand-washing facilities.
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26. cGMPs for Animal Food
Equipment and utensils – Equipment, utensils and food-contact surfaces must be designed, constructed and maintained to protect against contamination of the food product.
Plant operations – Management must ensure that all processing, packaging, holding and distribution of animal food is conducted according to CGMPs.
Holding and distribution – Conditions must protect against contamination and deterioration of animal food in the storage and distribution processes.
Holding and distribution of human food by-products for use in animal food – Manufacturers of human foods whose by-products are sold as ingredients for use in animal foods will not be required to comply with animal food preventative controls or cGMPs when they sell by-products unless they perform additional processing before sale. Animal food manufacturers are responsible for insuring the safety of those by-products as ingredients in their products.
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27. Compliance Dates for Human Food Preventative Controls Rules
Human Food Preventative Controls Deadlines:
Very small businesses (averaging less than less than $1 million per year in both annual sales of human food plus the market value of human food manufactured, processed, packed and held without sale) – 9/17/2018.
Businesses subject to the Pasteurized Milk Ordinance – 9/17/2018.
Small businesses (fewer than 500 full-time equivalent employees) – 9/17/2017
All other businesses – 9/17/2016
Supply Chain Program deadlines are separate.
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28. Compliance Dates for Human Food Supply Chain Program
Human Food Supply Chain Program Deadlines (if required):
Receiving facility is a small business and its supplier will not be subject to the human preventative controls rule or the produce safety rule – 9/17/2017.
Receiving facility is a small business and its supplier will be subject to the preventative controls rule or the produce safety rule – 9/17/2017 OR six months after the supplier is required to comply with the applicable rule, whichever is later.
Receiving facility is not a small or very small business and its supplier will not be subject to the human preventative controls rule or the produce safety rule – 3/17/2017
Receiving facility is not a small or very small business and its supplier will be subject to the human preventative controls rule or the produce safety rule – 6 months after the supplier is required to comply with the applicable rule.
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29. Compliance Dates for Animal Food Rules
Very small businesses (averaging less than less than $2,500,000 per year in both annual sales of food for animals)
September 17, 2018 for cGMPs
September 17, 2019 for Preventive Controls
Small businesses (fewer than 500 full-time equivalent employees)
September 18, 2017 for cGMPs
September 17, 2018 for Preventive Controls
All other businesses
September 19, 2016 for cGMPs
September 18, 2017 for Preventive Controls.
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30. Compliance Dates for FSMA Rules Generally
Preventative Controls for Human Food – beginning 9/17/2016
Preventative Controls for Animal Food – beginning 9/17/2016
Produce Safety – beginning 11/27/2017
Foreign Supplier Verification – beginning 5/27/2017
Third Party Accreditation – beginning 6/2017
Sanitary Transportation – beginning 4/6/2017
Food Defense From Intentional Adulteration – beginning 5/27/2019
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31. Final Questions?
Kathy Hardee Co-Chair Food & Ag Group Polsinelli PC
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