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FSMA CLUB: Preventative Controls for Animal Food Are No Joke! Marc Sanchez, FDA Attorney & Founder Contract In-House Counsel & Consultants, LLC and Gary Nowacki, CEO TraceGains, Inc.
| Date post: | 11-Feb-2017 |
| Category: |
Food |
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FSMA CLUB:Preventative Controls for Animal Food Are No Joke!
Marc Sanchez, FDA Attorney & FounderContract In-House Counsel & Consultants, LLC
andGary Nowacki, CEO
TraceGains, Inc.
Gary NowackiCEOTraceGains
Marc Sanchez, Esq.FounderContract In-House Counsel & Consultants LLC
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Preventative Controls for Animal Food are No Joke!
Marc C. Sanchez, Esq.www.fdaatty.com
The Bare BonesThe Rule Can be Broken into Two Parts
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GMP (cGMP)
This will be the FIRST mandatory adoption
of Good Manufacturing Practices (GMPs;
cGMPs)
Baseline safety standards
Byproduct used for animal feed?
Preventative Controls
Food Safety Plan - reasonably foreseeable
hazards
Preventative Controls
Oversight - monitoring, verification, and
corrective actions
Recall Plan
Who Me?Coverage and Effective Dates
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Animal Rule Applies iffacility manufactures, process, packs or holds animal feed/food, EXCEPT
for retailers and “farms”**
Byproduct OnlyQ. Already Subject to HARPC? Then no additional requirements.Q. Processing byproduct (drying, pelleting, etc.)? Then yes Animal rule applies.
Farm DefinitionPrimary Production vs Secondary Production Guidance forthcoming to explain the nuance.Activities known to fall outside the “farm” definition: pitting fruit, producing a product (e.g. bean chips), or roasting peanuts/tree nuts.
01
02
Not Small or Very Small, then 1 year for GMP compliance, 2 years for PC compliance
A small business will have 2 years on GMP and 3 years on PC compliance
03A very small business will have 3 years on GMP and 4 years on PC compliance (except records supporting status!!!)
Receiving Facility? Effective dates vary.
**
?
Feed MillsA subcategory of the “farm” question
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Primary Production Farm Feed Mill vs
Secondary Production Farm Feed Mill
Nuanced distinction that may partly be resolved by a rule under consideration that would extent
GMPs to exempt feed mills.
A farm that raises beef cattle may own and operate a feed mill. Considered part of the farm and exempt as a “farm” IF same management, same general location AND feed for animals on
the farm ONLY
A poultry processor may own a feed mill but contract the raising of the poultry to a third-party farmer. Different management means the feed mill owned by the poultry processor does not
qualify as a farm and is NOT exempt
Same Food Safety Plan…But Different Hazards
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Salmonella Risk in Feed Additive
Hazards Unique to
a Species?
Risks Unique to a Hazard?
Multiplicity of Hazards
Hazards are Species Specific
Swine and Poultry?
Same Hazard Different RiskHazard Analysis for Animals Multifaceted
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Dairy CowsIs there a risk posed to
human consumption?
SwineDoes risk vary by level consumed?
Take Corn as an Example
In Corn Aflatoxin is a Hazard
Other Ways Hazard Analysis Varies
Hazard analysis must account for hazards and risks reasonably likely to occur to human handlers.
Animal welfare depends on appropriate levels of feed additives and nutrition
Risks to Human Handlers
Nutrition Imbalances
Allergens a uniquely human hazardAllergens
Qualified SplitIn the Final Rule Two “Qualifications” Emerge
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Qualified IndividualThis is the term used in the Proposed
Human and Animal HARPC
Preventative Controls Qualified Individual
This is the new term, but the old one is still in use too.
QI
PCQ
I
Automating Supplier and
Quality Management
TraceGains Products
Specification Publishing
Create, maintain, and publish your company’s unique specifications to ensure compliance on incoming ingredients.
Supplier Compliance
Automate lot-by-lot compliance across purchasing, COAs,
receiving, testing, and plant floor.
Finished Goods COAs
Generate finished goods COAs, manage
customer-specific formats, and send to
customers on demand.
Supplier Management
Automatically manage supplier qualification,
documents, and relationships.
Quality Management
Automate HACCP / HARPC and comply with GFSI, FSMA, safety, and quality.
Supplier Analysis& Scorecarding
TraceGains Supplier Management
To-do Lists,Corrective Actions
Access Anywhere,Anytime
Allergens OrganicAudits KosherNutritionSupplier Qualification
FSMA, GFSI, 365 Audit Ready™
C.O.O.L. Specifications
24/7 Monitoring
eNotifications
Labeling(e.g., Genesis)
TraceGains Quality Management
To-do Lists, Alerts,Corrective Actions
Trends & Graphs
Access Anywhere,Anytime
CCPsPre-op Sanitize, Calibrate, etc.
Verify CCPs Automate FSMA, GFSI Audits & Records
GFSI Documents
FSMA, GFSI, 365 Audit Ready™
Pre-ShipmentCheckoff
Staff Training
Automation Solves Many Problems
GFSI
Labeling
FSMA
Audits
• Mar. 9 – Sneak Peak at SQF Edition 8
• Mar. 18 – FSMA Club: What You Need to Know About Allergens and Intentional Adulteration
• Apr. 21 – FSMA Club: Sanitary Food Transportation Final Rule
Register for free at www.tracegains.com/events.
Gary [email protected]
720-465-9400www.tracegains.com
Marc Sanchez, [email protected]
202.765.4491www.fdaatty.com
