Watch the replat here: Presentation Abstract: The FDA has finally released an update to the Preventive Controls/Human Foods Rule draft guidance, including a revised Appendix 1: Known or reasonably foreseeable hazards. This means clearer steps to identify potential dangers in your food products. But what's changed? The new Appendix 1 now includes a listing of potential biological and chemical hazards for 16 different food types. Plus, it clarifies the importance of considering process-related hazards too. Think of it as your personalized starting point for the Hazard Analysis process, a crucial step in ensuring food safety. Presented by Dr. Ruth Petran, Sr. Advisor of Food Safety for The Acheson Group See more FSMA Friday episodes at https://safetychain.com/resources/webinars

1. FSMA Fridays Webinar Series
Monthly Industry News, Updates & Trends for Food, Beverage, & CPG Manufacturers
Dr. Ruth Petran
Sr. Advisor, Food Safety
Impact and Implementation:
Understanding the New PCHF Analysis Guidance

2. ✔Monthly FSMA Related News
✔Regulation Changes & Updates
✔Industry Trends
✔Q&A with TAG
What is FSMA Fridays?
FSMA FRIDAYS
A global food safety and public
health consulting group made up
of seasoned industry experts
Award-winning digital plant
management platform to visualize
plant-wide performance and
better control quality, yield &
production optimization.
Brought to you by:

3. Meet Your FSMA Friday Speaker
FSMA FRIDAYS
Dr. Ruth Petran
Sr. Advisor, Food Safety
Dr. Petran has held technical food safety and public health leadership
roles at Ecolab, Pillsbury, and General Mills. She is skilled at tactical
application of technical food safety risk management strategies
spanning the global farm-to-fork supply chain and has focused on
managing safety and quality concerns of microbiologically sensitive
foods and systems. She has led food safety assessments at food
manufacturing facilities worldwide, focusing on applied HACCP
systems and regulatory compliance.

4. FSMA FRIDAYS
What We’ll Cover
• Recent Regulatory Developments
• Refresher on PCHF rule requirements
• Guidance from FDA
• What’s newly published?
• How to use it

5. FSMA FRIDAYS
FSMA FRIDAYS
FSMA: Regulatory Updates
● The USDA intends to renew the committee for the National Advisory
Committee on Microbiological Criteria for Foods & its charter
● Recent notice that the FDA has approved the first medication to help
reduce allergic reactions to multiple foods
○ NOT a cure for food allergies
○ Continuing avoidance to allergenic foods is needed

6. FSMA FRIDAYS
PCHF Rule Requirements
FSMA Preventive Controls for Human Foods (PCHF)
Rule Expectations, 21 CFR Part 117
• GMP compliance
• Food Safety Plan
• Hazard Analysis
• Risk-based Preventive Controls
• Records
• Supply Chain program

7. FSMA FRIDAYS
PCHF Rule Requirements
FSMA Preventive Controls for Human Foods (PCHF)
Rule Expectations, 21 CFR Part 117
• GMP compliance
• Food Safety Plan
• Hazard Analysis
• Risk-based Preventive Controls
• Records
• Supply Chain program
• Final Rule Published, Sept 2015
• Staggered compliance dates based
on size of operation and activities
• Sept 2018 = date by which all were to comply
These are NOT new requirements

8. FSMA FRIDAYS
Required elements of a food safety plan
FSMA FRIDAYS
• A hazard analysis
• Preventative controls
• Risk-based supply chain program, if appropriate
• Recall plan, if there are any identified hazards
• Monitoring procedures and corrective actions for
the implementation of the preventive controls
• Verification procedures to ensure that preventive
controls are consistently implemented & effectively
minimize or prevent identified hazards
21 CFR, Part 117, Subpart C

9. FSMA FRIDAYS
Any biological, chemical (including radiological), or physical agent that
has the potential to cause illness or injury.
Relevant Definitions
The process of collecting and evaluating information on hazards and
the conditions leading to their presence to determine which hazards
are significant for food safety and therefore should be addressed in a
HACCP plan or food safety plan.
• Hazard Analysis:
• Hazard:

10. FSMA FRIDAYS
1. List raw materials or other ingredients and process steps
2. Identify known or reasonably foreseeable (i.e., potential) food
safety hazards for the raw materials or other ingredients and
finished product manufacturing process steps
3. Evaluate to determine if the hazard requires a preventive
control (i.e., is significant)
a. Severity and probability in the absence of control
4. Justify the decision
5. Identify preventive controls for significant hazards
Hazard Analysis Steps

11. FSMA FRIDAYS
1. Must be accurate
2. Must be complete
3. Don’t miss any hazards!
It All Starts With the Hazard Analysis
The good news…
You’re not alone here…

12. FSMA FRIDAYS
• To inform domestic and foreign food facilities about the
PCHF regulation
• Enable better understanding of the requirements of the rule
• FDA’s guidance documents do not establish legally enforceable
responsibilities
• Guidances describe FDA’s current thinking on a topic
• Should be viewed only as recommendation, unless specific regulatory
or statutory requirements are cited
Many Guidance Documents Published

13. FSMA FRIDAYS
Many Guidance Documents Published
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-industry#Guidance

15. FSMA FRIDAYS
• Food Group A: Bakery Items
• Food Group B: Beverage items
• Food Group C: Food Additives, Color Additives,
and GRAS Substances
• Food Group D: Chocolate and Candy
• Food Group E: Dairy
• Food Group F: Dressings, Condiments, and Dips
• Food Group G: Egg and Egg Products
• Food Group H: Fruits and Vegetables
Appendix 1 Food Categories
• Food Group I: Game Meat Products
• Food Group J: Grains, Pulses, Flours,
and Starches
• Food Group K: Nuts and Seeds
• Food Group L: Oils and Oil Products
• Food Group M: Snack Foods
• Food Group N: Soups and Sauces
• Food Group O: Spices and Herbs
• Food Group P: Food Sweeteners
(Nutritive and Non-Nutritive)

16. FSMA FRIDAYS
How to Apply the Hazard Analysis Process
1. Identify Potential Ingredient-Related Hazards (inherent hazards):
• Biological Hazards (using Appendix 1 Table 1)
• Chemical Hazards (using Appendix Table 2)
2. Identify Potential Supplier Process-Related hazards
(using Chapters 2 & 3)
3. Identify Potential Facility-Related | Process-Related hazards
(using Chapters 2 & 3)

17. Using the
Guidance

18. Example: Biological hazards in Bakery Items

19. Example: Chemical hazards in Beverages

20. FSMA FRIDAYS
Some Categories don’t have a table 2…
This Appendix does not include a Table of known or reasonably foreseeable
(“potential”) food-related chemical hazards for Bakery Items. Instead, for
known or reasonably foreseeable (“potential”) food-related chemical
hazards for Bakery Items, you should see the Table(s) associated with the
ingredients in your Bakery Item.
Example:
Consider chocolate, eggs, wheat flour, fruit in their respective tables.
Food Group 2A: Known or reasonably foreseeable (“potential”) food-related
chemical hazards for Bakery Items

21. FSMA FRIDAYS
Example: Baked Chocolate Croissant
Ingredients:
Enriched Wheat Flour [Wheat Flour, Niacin, Reduced Iron, Ascorbic Acid, Thiamine
Mononitrate, Riboflavin, Folic Acid, Enzyme], Butter [Cream (Milk), Natural Flavor],
Water, Semisweet Chocolate [Sugar, Chocolate Liquor, Cocoa Butter, Soy Lecithin,
Natural Flavor], Sugar, Eggs, Dry Whole Milk, Yeast, Sea Salt, Sourdough [Water,
Fermented Wheat Flour], Dough Conditioner [Wheat Gluten, Xanthan Gum, Ascorbic
Acid, Salt, Enzymes], Contains Bioengineered Food Ingredients.
Separately consider the ingredients to determine potential hazards.

22. FSMA FRIDAYS
Example: Multi Component Foods
Separately consider the ingredients to determine potential hazards.
Frozen Entree Ingredients:
SKIM MILK, COOKED PASTA (WATER, SEMOLINA WHEAT FLOUR), WATER, CARROTS, PART-SKIM
MOZZARELLA CHEESE AND MODIFIED CORNSTARCH (PART-SKIM MOZZARELLA CHEESE [CULTURED MILK,
SALT, ENZYMES], MODIFIED CORNSTARCH, SKIM MILK, FLAVORS), BROCCOLI, LOW-MOISTURE PART-SKIM
MOZZARELLA CHEESE (CULTURED PART-SKIM MILK, SALT, ENZYMES), PARMESAN CHEESE (CULTURED MILK,
SALT, ENZYMES), SPINACH, ONIONS, 2% OR LESS OF WHEAT FLOUR, SOYBEAN OIL, MODIFIED
CORNSTARCH, SUGAR, SALT, ROMANO CHEESE MADE FROM COW'S MILK (CULTURED MILK, SALT,
ENZYMES), POTASSIUM CHLORIDE, GARLIC PUREE, SPICES, ONION POWDER, YEAST.

24. FSMA FRIDAYS
Chapter 2: Conducting a Hazard Analysis
• Provides recommendations for step-
by-step approach to conducting the
hazard identification and hazard
evaluation phases of the hazard
analysis.
• Consider the biological, chemical,
and physical hazards that are
commonly of concern in food plants
and that should be addressed in a
hazard analysis.

25. FSMA FRIDAYS
Chapter 3: Potential Hazards Associated with the
Manufacturing, Processing, Packing, and Holding of Human Food
• Addresses ingredient-related hazards, process-related hazards,
and hazards that may be introduced from the food-production
environment (facility-related hazards)
• In-depth resource that provides background info about the most
relevant biological, chemical, and physical hazards that could be
associated with a facility or a food – “Quick Reference Guides”

26. FSMA FRIDAYS
How to Apply to the Hazard Analysis Process
• Identify Potential Ingredient-Related Hazards (inherent hazards):
• Biological Hazards (using Appendix 1 Table 1)
• Chemical Hazards (using Appendix Table 2)
• Identify Potential Supplier-Related Process-related hazards
(using Chapters 2 & 3)
• Identify Potential Facility-Related Process-Related hazards
(using Chapters 2 & 3)

27. FSMA FRIDAYS
Examples:
Supplier or Manufacturer Process-Related Biological Hazards
• Presence/growth/toxin production due to survival of a lethal treatment.
• Listeria monocytogenes in milk not pasteurized properly at the dairy supplying
the milk as an ingredient
• Growth and/or toxin production due to poor time/temperature control.
• C. perfringens in gravy cooled too slowly
• Staph aureus in batter exposed to warm temperatures
• Growth and/or toxin production due to poor formulation control.
• Acidified vegetable that did not achieve pH <4.6 allowing Salmonella growth
• Growth and/or toxin production due to reduced oxygen packaging.
• C. botulinum toxin production in vacuum packaged pasta

28. FSMA FRIDAYS
Examples:
Supplier or Manufacturer Process-Related Biological Hazards
• Presence due to ingredients added after process controls.
• Salmonella in cocoa from the supplier that is used as a dusting on a baked cake
• Seasonings added to cracker after baking step
• Presence, growth, or growth with toxin production due to recontamination due
to lack of container integrity.
• RTE food pasteurized in a jar, then submerged in cooling water. If pathogens are in
the cooling water, they could be drawn in.
• Environmental Pathogens – Presence due to recontamination from the
processing environment.
• Salmonella, L. monocytogenes
• Food exposed to the environment after a lethality step - e.g., baked goods

29. FSMA FRIDAYS
Examples:
Supplier or Manufacturer Process-Related Chemical Hazards
• Undeclared food allergens due to incorrect labelling.
• Printing error in verbiage on label
• Placing the wrong label on package
• Unintended food allergen presence caused by cross-contact.
• Residual allergen soil left on shared equipment due to insufficient cleaning
• Chemical hazards due to mis-formulation
• Adding sulfite to a product not intended to have sulfite
• Over-addition of ingredient with a maximum use level - e.g., niacin
• Process-contaminant hazards in certain plant-based foods
• Acrylamide formation in certain plant-based food (e.g., potato chips)

30. FSMA FRIDAYS
Examples:
Supplier or Manufacturer Process-Related Physical Hazards
• Metal
• A process with a metal chopping blade could
introduce metal fragments if the blade breaks
• Glass
• From a product packed in glass containers
• Hard plastic
• From equipment guard wear, utensils, etc.

31. FSMA FRIDAYS
Be aware that there may be other
process related hazards that must
to be considered for particular
foods & manufacturing settings…

32. FSMA FRIDAYS
Systematically applying this information in the
Hazard Identification Process…
• Start at the Supplier level
• Identify inherent hazards in ingredients
• Identify Potential Process-Related & Facility-Related hazards
• Move to the Manufacturing level, using a step-by-step approach…
• Identify Potential Process-Related & Facility-Related hazards

33. FSMA FRIDAYS
Next Step = Hazard Evaluation
• Severity
• Likelihood of occurrence
Considerations:
Remember to refer to Chapters 2 and 3!

34. FSMA FRIDAYS
Evaluating Severity of Food Safety Hazards
Consider certain factors, including:
• Susceptibility of intended consumers to
foodborne illness (e.g., children versus adults)
• Potential magnitude and duration of the illness
or injury
• Length of illness
• Hospitalizations, deaths
• Possible impact of secondary problems
(chronic sequelae)
FDA Hazard Guide (2.4.2.1)

35. FSMA FRIDAYS
Evaluating Likelihood of Food Safety Hazards
Consider certain factors, including:
• Frequency of association of the hazard with
the food or facility
• Effectiveness of facility programs such as GMPs
• Method of preparation in the establishment
• Conditions during transportation
• Expected storage conditions
• Likely preparation and handling steps before
consumption
FDA Hazard Guide (2.4.2.1)

36. FSMA FRIDAYS
Next Step is Identification of
Preventive Controls for Potential Hazards
where Indicated

37. FSMA FRIDAYS
Wrap Up
• Hazard Analysis is a KEY STEP to food safety assurance
• Expectation is that this is robustly done
• FDA will be looking for this…
• Guidance will help you to do this

38. FSMA FRIDAY
Questions?
Dr. Ruth Petran
Sr. Advisor, Food Safety
Impact and Implementation:
Understanding the New PCHF Analysis Guidance

39. FSMA FRIDAYS
Industry eGuides
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Success Stories
Solution Consultation
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