preparing for new fsma preventive controls regulations
Post on 11-Feb-2017
1.518 Views
Preview:
TRANSCRIPT
Preparing for New FSMA Preventive Controls for Human Food RegulationsPerspective Webinar
August 25, 2015Dr. Donna Garren, AFFI | Jeff Chilton, Alchemy Systems
Webinar Logistics
2
• Join audio:– Choose “Mic & Speakers” to
use VoIP– Choose “Telephone” to dial in
using info provided
• All lines are in listen-only mode
• Post your questions early and often!
• A link to the webinar recording will be emailed shortly after the event
Today’s Speakers
3
Jeff ChiltonAlchemy
Diana PeñaModerator
Dr. Donna GarrenAmerican Frozen
Food Institute
Agenda
• New Regulatory Requirements Overview
• Process of Transitioning From HACCP To HARPC
• Tools for Compliance
• Q & A
Confidential and Proprietary 5
New Regulatory Requirements Overview
FDA’s FSMA Implementation Plan – A Continuum
Phase 1: Set
standards
Phase 2Design
strategies to
implement standards
Phase 3: Monitor, evaluate, refresh
Stakeholder engagement throughout the process
Develop regulations, guidance, & protocols for new administrative enforcement tools
Fully develop & implement the standards
Regulation Proposal Final (consent decree)
Preventive Controls (Human Food)* Jan 16, 2013 Aug 30, 2015
Preventive Controls (Animal Food)* Oct 29, 2013 Aug 30, 2015
Produce Safety* Jan 16, 2013 Oct 31, 2015
Foreign Supplier Verification Program* Jul 29, 2013 Oct 31, 2015
Third Party Accreditation Jul 29, 2013 Oct 31, 2015
Sanitary Transport Feb 5, 2014 Mar 31, 2016
Intentional Adulteration Dec 24, 2013 May 31, 2016
*Supplemental proposals published September 2014
Phase I: Standard Setting
Transition to Phase 2: Implementation
• Teams continue rulemaking, guidance and other policy work until completed
• Concurrently, workgroups:
– Implement the final rules, programs established through guidance and other policy
– Design specific strategies, capacity building, training and operation plans needed to implement FSMA
• Steering Committee oversees 5 workgroups:
– Preventive Controls in Food and Feed Facilities, Produce Safety Standards, Import Oversight, Intentional Adulteration, and Training
Operations and Policy Working Together
High Level FDA Oversight
Internal Advisory Team
Internal Adulteration Import Controls
Preventive Controls (human & animal food)
Sanitary Transportation
Produce Safety
ORA, CFSAN, CVM, and State representation
Reduced Risk of Illness Attributed to Food From Facilities Subject to the PC Rule
8.2: More Effective Inspection & Enforcement
Program/ Protocol/Policy
Established
3: Increased Implementation by Industry of PC Rule Requirements
2: Reduced Contamination of Food From Facilities Subject to PC Rule
8.1: Increased Knowledge by Food
Safety Staff of PC Rule & Underlying Science
7: Increased Industry Understanding of PC Rule and
the Underlying Science
8: More Effective and Efficient Regulatory Activities Related to
the PC Rule
6: Expanded Voluntary
Compliance and non-
Enforcement Incentives
5: Increased Acceptance by Firms of their
Responsibility for Meeting PC
Standards (for Food Safety)
4: Increased Transparency/Info Exchange Related
to PC Rule for Emerging Issues
Between Regulatory Agencies, Public Health Orgs &
Industry 8.3: Expanded Risk-Based
Management of Regulatory Resources
8.3.2: Improved Analytics to Assess
Risk
8.3.1: Increased Capture, Analysis, Management, & Sharing of Enforcement & Voluntary Corrective Relevant Information
1: More Rapid and Effective Recall Actions by Facilities Subject to PC Rule
Draft Preventive Controls ResultsFramework
8/25/14
A: Improved IT
Infrastructure and Systems
F: Research Better Targeted to PC
Priorities
D: Improved Collaboration Between
FDA, Regulatory Partners & Industry
E: Increased Support for Preventive Approach by
Stakeholders
B: Change in Culture of FDA & Regulatory Partners from Response to Prevention &
Provide a Continuum to Achieve Voluntary Compliance
C: Expanded & Improved
Outreach and Education
5.1: Increased Availability of PC Training, Guidance Materials, and Technical Assistance for Food Safety Staff and Industry (learning resources)
Key Results
Industry
Regulatory
New FDA Culture
• FSMA implementation is occurring just as FDA culture is changing
• FDA is rapidly becoming:– More inspection-oriented– More enforcement-minded
11
Educate Before and While We Regulate
• Facilitate industry implementation of modern, preventive practices through:
– Commodity and sector-specific guidance– Education, outreach and technical assistance– Regulatory incentives for compliance
New FDA Strategies
13
• FDA to develop inspection cadre specially trained in and devoted to food inspections
• Closer integration of field inspections and CFSAN/ headquarters experts (in real time)
• Distinct types of inspections by staff with different technical expertise
• Two-tiered inspections and centralized records review
FDA is More Inspection-Oriented
• FDA is: – Conducting more domestic inspections (with the states)– More strategic about selecting inspection sites– Posting some 483s on website– Expanding definition of “high risk”– Testing more, especially environmental testing– Increasing oversight of imports, especially ingredients,
and conducting foreign on-site inspections – Much more forceful in demanding access to records
regardless of current legal authority
Enforcement is on the Rise
• FDA is more critical and more inclined to identify/find issues
• Increase in Warning Letters for food adulteration based on food inspections/GMPs
• Increase in court injunctions
• Heightened use of Import Alerts
• New authorities for mandatory recalls and suspension of registration are now in play
• Expanded use of Park Doctrine on the horizon
What Does This Mean?
• FDA’s expectations are changing
• Inspections are changing
• Testing has increased
• Imported ingredients will face particular scrutiny
• Crackdowns will increase in frequency
Food companies need to
1) Know their rights
2) Adapt to these changes and be prepared!
16
17
Know Your Rights
• The FFDCA and implementing regulations specifically address the records that FDA legally is entitled receive during an inspection
– When a general inspection, FDA currently has very limited access to records
– Once Bioterrorism is invoked, records access is almost unlimited • FDA must provide written notice that the inspection is under
the Bioterrorism statute
• FDA can ask (and frequently demands) it has the right to records when no such authority exists
• Companies should know their rights and then make informed decisions on whether they will voluntarily release additional information
What does this mean for your next inspection?
• Inspections have already changed: – FDA is energized and persistent and will note all possible violations as
inspectional observations– FDA will demand access to records the agency lacks the legal authority
to access– FDA will try hard to take photographs even without express legal
authority – Inspections involve comprehensive environmental sampling (“swab-a-
thon”)Note: Some states have additional legal authorities (e.g., records access), so know your local rules
18
19
Inspectional Observations
• 483 Inspectional Observations– A few years ago, investigators would note minor
observations orally but would not record them– Today, minor observations are included in the Form
483– Unusual for a company to escape an inspection
without receiving a 483
• FDA policy announced in August 2009 gives industry 15 business days to provide a response
• Absolutely essential to respond, in writing, to every 483 observation within the 15 period
Implications of FSMA for Inspections
New FDA culture
+New records access authority
+New tools
=New inspection paradigm
(Starting September 2016)
20
FSMA: Systems-Based Approach
• Historically, FDA has inspected food facilities for basic sanitation and to detect visible problems with the facility or the product produced
– FDA has assessed compliance based on this “snapshot” of the facility’s operations
• FSMA requires FDA to take a risk-based approach to facility inspections
– Shift from reaction to prevention
21
Systems-Based Approach
• To implement FSMA’s risk-based inspection mandate, FDA will focus on whether facilities are implementing the systems needed to make safe food
• The “systems-based” approach is aimed at preventing problems on a continuing basis, not just when the inspector is in the facility
22
“Culture of Food Safety”
• FDA provided flexibility in the regulations in exchange for facilities developing a “culture of food safety”
• FDA wants to assess whether a company has a “culture of food safety” as a barometer of competence
• How can you demonstrate a culture of food safety?– Employees understand their responsibilities and why– You can explain your programs, the rationale behind
decisions– With flexibility comes responsibility
23
Increased Records Access Authority
• FSMA provides FDA with greatly expanded access to records during routine inspections
• This new authority facilitates the systems-based inspection approach – Let’s FDA know how a company is operating when inspectors
aren’t present– FDA will know what happened not just today, but last week, last
month, and last year!
• Records review will be a central component of FDA inspections– Inspections will become more like an IRS audit
24
Implications of Records Access
25
• Companies decisions will be become much more exposed to scrutiny by inspectors
– Flexibility in FSMA proposed rules is double edged sword: with it comes responsibility
• If it isn’t documented, it didn’t happen!
– “You are what your records say you are”
What to Do NOW:
• Know your rights
• Start preparing for FSMA inspections– Update your inspection manual– Recordkeeping training -- apply good
record keeping practices– Review audits for areas of
improvement
26
• Web site: http://www.fda.gov/fsma • Subscription feature available• Send questions to FSMA@fda.hhs.gov
For More Information
27
28
Transitioning from HACCP to HARPC
HACCP and HARPC Comparison
29
HACCP HARPC
Hazard Analysis Critical Control Point Hazard Analysis Risk-Based Preventive Controls
Global standard U.S. standard incorporated into Food Safety Modernization Act (FSMA)
Applies to low-acid, canned food, juice, & seafood processors
Applies to almost all food processing facilities
Traditional HACCP plan based on 7 principles of HACCP
Food Safety Plan – A Qualified Individual Must Prepare and
Implement a Written Food Safety Plan (117.126(a))
HARPC Written Plan Requirements - 117.126(b)
30
Food Safety Plan
5 HARPC Mandates
31
• Hazard Analysis 117.130
• Preventive Controls 117.135
• Preventive Control Management Components 117.140
• Food Safety Plan Reanalysis 117.170
• Implementation Records Required 117.190
Hazard Analysis 117.130
32
• Identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held to determine whether there are significant hazards
• Hazard Identification (1)– Biological – Pathogens, Environmental Pathogens, Parasites– Chemical – Radiological, Pesticides and Drug Residues, Natural Toxins, Decomposition, Unapproved
Food or Color Additives and Food Allergens– Physical – Physical foreign materials
• Hazard Identification (2)(i) Hazards that occur naturally(ii) Hazards that may be unintentionally introduced(iii) Hazards that may be intentionally introduced for economic gain
• Hazard Evaluation (2c)(i) Hazards must be evaluated to assess severity of illness/injury and probability the hazard will
occur(ii) Environmental pathogens whenever a RTE food is exposed prior to packaging
Hazard Analysis 117.30
33
Formulation of the food
Condition, function and design of the facility and
equipment
Raw materials and ingredients
Transportation Practices
Manufacturing / Processing Procedures
Packaging and Labeling Activities
Storage and Distribution
Intended or Reasonably Foreseeable Use
Sanitation and Employee Hygiene
Other Relevant Factors
Hazard evaluation must consider the effect of the following:
Preventive Controls 117.135
34
Process
Controls
Food Allergen Controls
Sanitation Controls
Supplier
Controls
Recall Plan
Other
Controls
• Controls established at Critical Control Points (CCPs), if they have been identified
• Controls are also appropriate at non-CCPs
Control parameters and values for processes such as heat, refrigeration, acidifying, irradiating etc.
Protection and labeling
Sanitary condition for pathogen and allergen control
Risk based for significant hazard ingredient
For food with a significant hazard
Hygiene Training; GMP’s
Preventive Control Management Components 117.140
35
Validation
Verification of
Monitoring
Verification of Correctiv
e Actio
ns
Verification
of Implementation and
Effectivenes
s
Reanalysis
Monitoring: written procedures with adequate frequency documented on records
Corrective Action and Corrections: For pathogens, environmental pathogens and unanticipated food safety problem
Scientific or technical information prior to implementation or during first six weeks of production
Conducted as required
As required Calibration, product testing, environmental monitoring, and record reviews
3 years, changes, unanticipated events, FDA determination
Food Safety Plan Reanalysis 117.170
36
• Performed before change is operative or during first 6 weeks of production when necessary
• Revise the Food Safety Plan if a significant change made or document basis for no revisions
• Performed by a qualified individual
• FDA determines it is necessary to respond to new hazards or developments
Reanalysis
Once every 3 years
Significant change made
Aware of new info
Unanticipated food safety issue
Preventative control found ineffective
Implementation Records Required 117.190
37
• Food Safety Plan
• Preventive Control Monitoring Records
• Corrective Action Records
• Verification Records1. Validation records 5.
Product Testing2. Monitoring verification 6. Environmental
Monitoring3. Corrective Action verification 7. Records Review4. Calibration records 8.
Reanalysis records
• Training Records for Qualified Individuals who have had HACCP/HARPC training certification
HACCP to HARPC Reassessments – Major Changes
38
• Creation of Food Safety Plan with all required components
• Reassessment of the Hazard Analysis for:- Risk and severity evaluation of hazards- Inclusion of radiological hazards- Inclusion of unintentionally introduced hazards- Inclusion of intentionally introduced hazards for
economic gain
• Identification of Preventive Controls and control measures
• Verification of Implementation Effectiveness Procedures – product testing and environmental testing requirements
• Training requirement to be considered a qualified individual
39
Tools for Compliance
FDA Resources
40
• Web site: http://www.fda.gov/fsma
• FSMA Proposed Rule at a Glance– http://www.fda.gov/downloads/Food/GuidanceRegulation/
FSMA/UCM412922.pdf
• Food Safety Modernization Act – http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.ht
m
• FSMA Proposed Rule for Preventative Controls for Human Food Detail
– http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm
AFFI Resources
41
• FSMA Readiness Self Assessment Checklist
• Useful Industry Resource Available
• Available for purchase at www.affi.org
• http://www.affi.org/member-services/fsma-self-assessment-tool
• AFFI Forum – October 19-22, 2015 Lake Geneva, WI
• AFFI Regulatory and Technical Support Assistance
Alchemy Professional Services Offerings
42
Training
HARPC Workshop based on FDA recognized standardized curriculum• Public courses or on-site• On-line courses coming
soon
Gap Analysis
• On site review to evaluate existing programs, products and facility to new regulatory requirements
• Off site desk top review of existing HACCP Plans comparison to new regulatory requirements
Development
Creation of new Food Safety Plan documentation customized for your products and processes
Reanalysis
• Desk top review of client created Food Safety Plan
• On Site Reanalysis to validate food safety system and written program compliance
43
Q & A
Upcoming Events
44
• Network with industry leaders• Master best practices• Discover new technologies
http://www.alchemysystems.com/alchemy-conference/
Thank you!
Dr. Donna Garren– dgarren@affi.com– 703.821.0770
Jeff Chilton– jeff.chilton@alchemysystems.com– 706.483.4400
contactus@alchemysystems.com
www.alchemysystems.com/solutions/professional-services
The Feed: Alchemy Blog
top related