q&a · antonio gallegos. attorney. ... • fda will not expect perfection ... • “we’ve...
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Q&A
Today’s Presenters
Antonio GallegosAttorneyGreenberg Traurig, LLP
Gary NowackiCEOTraceGains
Charles BreenSenior ConsultantCM Breen LLC
G R E E N B E R G T R A U R I G , L L P | A T T O R N E Y S A T L A W | W W W . G T L A W . C O M
©2013 Greenberg Traurig, LLP. All rights reserved.
FDA’s Re-Proposed FSMA Regulations for Product Testing and Supplier Verification
October 16, 2014
Antonio Gallegos| gallegosa@gtlaw.com| (303) 685-7489
Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
FOUR “RE-PROPOSED” FSMA REGULATIONS
Human Food Animal Food
Produce Foreign Suppliers
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Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
HAZARD ANALYSIS AND PREVENTATIVE CONTROLSFOR HUMAN FOOD
Product Testing & Supplier Verification
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Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
FDA RESPONDS TO 8,000+ PUBLIC COMMENTS
January 2013 Proposed Rule FDA discussed and requested comments on both issues
Not addressed in the proposed regulations
Re-Proposed Regulations FDA attempts to make them “more flexible practical and
targeted”
Public comments through December 12, 2014
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Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
THE FSMA FRAMEWORK
Key Requirements
Identify and Evaluate Hazards
Identify and Implement Preventative Controls
VERIFY EFFECTIVENESS
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Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
PRODUCT TESTING
Verification of Preventive Control Effectiveness
You must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing to preventing significant hazards. To do so, you must conduct activities that include the following, as appropriate to the facility, the food and the nature of the preventative control ….
Product testing, for a pathogen (or other appropriate indicator organism)
21 CFR 117.165 (Proposed)
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Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
TESTING PROCEDURE REQUIREMENTS
Scientifically valid
Identify the test microorganism(s)
Sample identification, number and frequency
Test identification, including analytic methods
Laboratory identification
Corrective action procedures
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Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
REGULATORY FLEXIBILITYPublic comments to FDA stressed
differences in facilities, foods, processes
Finished Products
Raw Materials
Considerations for foods that go through a “kill step” or have short shelf life
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Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
FDA REQUEST FOR COMMENTS
When and how testing is an appropriate means of implementing FSMA
Modifications to the proposed regulatory text
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Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
SUPPLIER VERIFICATION
The receiving facility must establish a risk-based supplier program for those raw materials and ingredients for which the receiving facility has identified a significant hazard when the hazard is controlled before receipt of the raw material or ingredient
21 CFR 117.36 (proposed)
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Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
EXCEPTIONS No significant hazards
Preventative controls at receiving facility are adequate
Reliance on supplier and annual written assurance from supplier that identifies its preventative controls
Be Prepared with Supporting Documents!
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Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
VERIFICATION ACTIVITIES & DOCUMENTATION
“As appropriate” to: Significantly minimize or prevent hazards
Ensure incoming raw materials and ingredients are not adulterated and they comply with applicable FDA food safety regulations
Similar regulatory flexibility as Product Testing
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Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
PUBLIC COMMENTS
Supplier approval and audits
Verification of immediate suppliers only
Documentation
Alignment with FSVP requirements
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Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
LEGAL CONSIDERATIONS
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Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
THE TWO SIDES OF REGULATORY FLEXIBILITY
FREEDOM to design for your products and systems
RESPONSIBILITY to decide what is “appropriate”
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Bioterrorism, Legal Considerations for Food CompaniesGreenberg Traurig, LLP | gtlaw.com
INDEMNIFICATION FROM SUPPLIERS AND CO-PACKERS
Clearly define responsibilities in contracts with co-packers and suppliers
Recovery of costs for claims based on the other party’s acts or omissions
Cannot “pass the buck” on liability
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FDA Strategy to Implement & Enforce the Food Safety
Modernization ActCharles M. Breen
Senior Consultant
CMBreen LLC
Charles.Breen@outlook.com
TraceGains Webinar Oct. 16, 2014
How Will FDA Implement FSMA?
•Training is High Priority for FDA• FDA Investigators,• States and other food safety agencies contracted to
make inspections, and• Industry Outreach.
CMBREEN LLC Charles.Breen@outlook.com 21
How Will FDA Implement FSMA?
•Emphasis on risk-based resource allocation• History of problems,• RTE and other high risk foods,• New scientific knowledge, and• Public issue, such as arsenic in apple juice.
CMBREEN LLC Charles.Breen@outlook.com 22
How Will FDA Implement FSMA?
• Guidance Documents• Industry and/or crop specific
• Real-time Subject Matter Experts• Recruitment underway
• Official FDA Recognition of Other Regulatory Agencies• MOU with New Zealand MPI• FDA-CFIA may be next
CMBREEN LLC Charles.Breen@outlook.com 23
• Reduced Reliance on Traditional Regulatory Activities• Seizures• Injunctions
• 1st year - no Warning Letters for FSMA deficiencies• “Information Letters” used for seafood and juice HACCP rollout• 2nd year, Warning Letters likely to increase over current frequency
• Much greater use of administrative actions• Administrative detention – think 30 day embargo• Facility registration suspension – effectively an injunction without
going to Court• Mandatory recall authority
CMBREEN LLC Charles.Breen@outlook.com 24
How Will FDA Implement FSMA?
• Food Manufacturing Inspections:• FSMA mandated frequency
• High risk, once every three years• Non-high risk, once every five years• Doubling or foreign inspections for each of five years
• Domestic frequency will be achieved• FDA and States making contract inspections will meet FSMA frequency
mandate• Foreign frequency will not be achieved
• FDA doubled 1st year number to exceed 2nd year mandate of 1200• No more than marginal increases for 3rd year going forward• Congress unlikely to fully fund its own mandates
CMBREEN LLC Charles.Breen@outlook.com 25
How Will FDA Implement FSMA?
How Will FDA Implement FSMA?
•You Will See Inspections That:•Follow “Train the trainer” model,•Have more done by teams, two, three, or four,•Are sector specific survey programs,•Are component, not full inspections, or•Are occasionally in-depth root cause investigations.
CMBREEN LLC Charles.Breen@outlook.com 26
How Will FDA Implement FSMA?
•Much faster FDA action following:• Outbreaks,• Class 1 recalls,• Observations of unsafe practices, and• Perceived health risk
CMBREEN LLC Charles.Breen@outlook.com 27
How Will FDA Implement FSMA?
•What FSMA does for FDA• Frees agency from initial reliance on Courts before
taking action,• FDA’s announced goal is to prevent illnesses, not
just follow up afterwards, • And,
CMBREEN LLC Charles.Breen@outlook.com 28
CMBREEN LLC Charles.Breen@outlook.com 29
• FSMA reduces internal FDA regulatory friction
How Will FDA Implement FSMA?
When Will It Happen?
• Timing of Final Rules:• Preventive Controls for Human Food, and Preventive Controls for
Animal Food August 30, 2015; • Foreign Supplier Verification Program, Produce Safety Standards,
and Accreditation of Third Party Auditors October 31, 2015; • Sanitary Transport of Food and Feed March 31, 2016; and • Mitigation of Risk for Intentional Contamination May 31, 2016.
• Enforcement begins 12 months after final rule, or later for small and very small firms.
CMBREEN LLC Charles.Breen@outlook.com 30
How to Show FDA You Comply With FSMA?
• Short version –DOCUMENTATION
• Longer version –• Corporate commitment to food
safety • Training• Facility specific food safety
analysis• Hazard identification
• Controls• Monitoring• Validation• Verification• Equipment calibration• Records review• Plan review at three years or
more often if needed
CMBREEN LLC Charles.Breen@outlook.com 31
How to Show FDA You Comply With FSMA?
•Suggested outline• Where to begin?
• With Qualified Individual(s)• Defined in rule as possessing training or experience• Standardized curriculum under development by FDA
• Conduct hazard analysis• Note current controls – would hazard exist without them?• Validation – What make makes a control effective?
CMBREEN LLC Charles.Breen@outlook.com 32
How to Show FDA You Comply With FSMA?
• Write the Facility Specific Food Safety Plan, Then Follow It to the Letter
• Any plan is better than no plan (APBTNP)• Follow the plan• Update as you learn what works and what doesn’t• Document each piece of the plan, implementation, monitoring
and review. • Document• Document• Document!
CMBREEN LLC Charles.Breen@outlook.com 33
How to Show FDA You Comply With FSMA?
• Recently Proposed Items That FDA Will Look For:• Supplier qualification program (APBTNP)• Economically motivated adulteration
• Other Likely Areas for Significant Early Attention:• Recall plan for high risk food• Timely review of records• Allergen cross-contact controls
CMBREEN LLC Charles.Breen@outlook.com 34
How to Show FDA You Comply With FSMA?
• FDA will rely on education and outreach more than ever• FDA will not expect perfection• FDA will expect major effort for firms to know how and why
food made or grown is safe• “We’ve always done it this way” is 100% inadequate
CMBREEN LLC Charles.Breen@outlook.com 35
Seven Key FSVP Requirements
Typical
24/7 Detection& Compliance
TraceGains
TraceGainsDynamic
Information
PerformanceScorecarding
Difficult to search, analyze, andtake action
Instant Alerts
Extract & AutomateStatic Data
HazardAnalysis
Supplier Documents
COAsCorrective
ActionsCompliance
Status
HazardAnalysis
SupplierVerification
PeriodicReassessment
CorrectiveActions
ComplianceStatus
Recordkeeping
ImporterIdentification
TraceGains Automation Solves Many Problems
GFSI
Labeling
FSMA
Audits
Q&A
Gary Nowacki
gary.nowacki@tracegains.com
Charles Breen
charles.breen@outlook.com
Antonio Gallegos
gallegosa@gtlaw.com
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