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Food Safety Modernization Act
(FSMA):
FDA Proposed Animal Feed
Rule
Florida Overview
Susan Caime Mardenborough
September 18, 2014
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Agenda
Background on FSMA
Highlights of Proposed Animal Feed Rule
Coverage and Definitions
Current Good Manufacturing Practices
Hazard Analysis & Risk-Based Controls
Florida’s FSMA Rules Response Program
Key Considerations
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Foundations of FSMA
To better protect human and
animal health
Prevention not reaction
Partnerships
Seven primary rules
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Proposed Rules
Standards for the Growing, Harvesting, Packing, and
Holding of Produce for Human Consumption
(Docket FDA-2011-N-0921) (Produce Safety)
Current Good Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive Controls for
Human Food (Docket FDA-2011-N-0920)
Foreign Supplier Verification Programs for
Importers of Food for Humans and Animals- (Docket
FDA-2011-N-0143)
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Proposed Rules Continued
Accreditation of Third-Party Auditors/
Certification Bodies to Conduct Food
Safety Audits and to Issue Certifications
(Docket FDA-2011-N-0146)
Current Good Manufacturing Practice and
Hazard Analysis and Risk-Based
Preventive Controls for Animal Food
(Docket FDA-2011-N-0922)
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Proposed Rules Continued
Focused Mitigation Strategies to Protect
Food Against Intentional Adulteration
(Docket FDA-2013-N-1425)
Sanitary Transportation of Human and
Animal Food (Docket FDA-2013-N-0013)
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History Of Animal Food Incidents
2005 contaminated corn
2007 melamine to elevate protein levels
2007 Salmonella in pet food and humans
Nutrient imbalances
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Animal Feed Rule- Coverage
Facilities required to register with FDA
under Section 415 of the FD&C Act-
facilities that manufacture, process, pack or
hold animal food
Domestic and foreign facilities
**Farms and some retail are exempt
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Definitions and Impact
Farm- Classical vs Current
Ownership- Raising of own
and other
Farm mixed-type facility
Raw Agricultural Commodities (RACs)
Business sizes and ‘Qualified’ components
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Current Good Manufacturing Practices
(CGMPs)
Personnel Practices and Training
Facility Operations, maintenance, and sanitation
Equipment & utensil design, use and maintenance
Processes and controls
Warehousing and Distribution
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Exemptions to CGMPs
Activities within farm
definition
Including those activities that
are covered by the Produce
Safety rule
Facilities that store RACs
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Hazard Analysis and Risk-Based
Preventive Controls (HARBPC)
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Hazard Analysis and Risk-Based
Preventive Controls (HARBPC)
Analysis of hazards
Preventive Controls of identified hazards
Mandatory recall plan
Monitoring procedures
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Hazard Analysis and Risk-
Based Preventive Controls
(HARBPC)
Corrective actions
Verification activities
Record keeping
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Hazard Analysis & Preventive Controls
Exemptions
Modified exemptions- must be qualified
facility and follow preventive controls
Animal food sales <$500K/ yr for last three
years & Qualified end-user sales exceed
sales to other
Very small business
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Hazard Analysis & Preventive Controls
Exemptions
Low-acid canned foods
Facilities that store animal food
Farm activities
Low- risk activities
Specified storage facilities
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Florida FSMA Rules Response
Research Impacted Parties
Gather input
Cross-pollination of ideas
Feedback to FDA
Issue comments
Continued communication
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Working Group Topics
Usage of Culls
Back grounding cattle
Aquaculture
Coverage for pet food vs livestock
Citrus processing
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Florida Citrus Discussion
Ten processing plants with mills
~58% juice weight, 42% excess
Pellets sold regionally/internationally
Existing safety programs
Landfill options are not viable/tonnage
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Citrus Cull Usage
Use of culls from packinghouses and
processing facilities
Historic and safe
Quality of fruit
Nutritious
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Florida Animal Feed
Tour March 2014
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Florida Animal Feed Tour
March 2014
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FDA Requests on Proposed
Rule
Finished product testing
Environmental testing
Review of customer
complaints
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Summary of Key Concerns
Current food system
Resource restrictions
Risk-based and science-based
Definition inconsistencies
Inequities in supply
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Summary of Key Concerns
Continued
Economic impact- funding
Education, research, training
Formal agreements
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Anticipated FDA Next Steps
Re-opening portions of rule
Creation of programs
Final rule issuance
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Further Information
http://www.fda.gov/fsma
http://www.fda.gov/Food/GuidanceRegulation/FSMA/u
cm366510.htm
http://www.gpo.gov/fdsys/pkg/FR-2013-10-29/pdf/2013-
25125.pdf
http://blogs.fda.gov/fdavoice/index.php/2014/04/getting
-it-right-on-spent-grains/
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Contact Information
Susan Caime Mardenborough
Florida Department of Agriculture and
Consumer Services
850.694.4911