Preparing for New FSMA Preventive Controls for Human Food RegulationsPerspective Webinar

August 25, 2015Dr. Donna Garren, AFFI | Jeff Chilton, Alchemy Systems

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Today’s Speakers

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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

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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

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• 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!

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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

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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)

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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

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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

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“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

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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

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Implications of Records Access

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• 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

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• Web site: http://www.fda.gov/fsma • Subscription feature available• Send questions to FSMA@fda.hhs.gov

For More Information

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Transitioning from HACCP to HARPC

HACCP and HARPC Comparison

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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)

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Food Safety Plan

5 HARPC Mandates

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• 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

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• 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

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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

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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

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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

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• 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

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• 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

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• 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

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Tools for Compliance

FDA Resources

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• 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

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• 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

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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

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Q & A

Upcoming Events

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• 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

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