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Antonio GallegosAttorneyGreenberg Traurig, LLP

Gary NowackiCEOTraceGains

Charles BreenSenior ConsultantCM Breen LLC

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FDA’s Re-Proposed FSMA Regulations for Product Testing and Supplier Verification

October 16, 2014

Antonio Gallegos| [email protected]| (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

5


HAZARD ANALYSIS AND PREVENTATIVE CONTROLSFOR HUMAN FOOD

Product Testing & Supplier Verification

6


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

7


THE FSMA FRAMEWORK

Key Requirements

Identify and Evaluate Hazards

Identify and Implement Preventative Controls

VERIFY EFFECTIVENESS

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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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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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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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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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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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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!

14


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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PUBLIC COMMENTS

Supplier approval and audits

Verification of immediate suppliers only

Documentation

Alignment with FSVP requirements

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LEGAL CONSIDERATIONS

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THE TWO SIDES OF REGULATORY FLEXIBILITY

FREEDOM to design for your products and systems

RESPONSIBILITY to decide what is “appropriate”

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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

19

FDA Strategy to Implement & Enforce the Food Safety

Modernization ActCharles M. Breen

Senior Consultant

CMBreen LLC

[email protected]

TraceGains Webinar Oct. 16, 2014

mailto:[email protected]

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 [email protected] 21


•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.



• 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


• 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



• 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




•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.



•Much faster FDA action following:• Outbreaks,• Class 1 recalls,• Observations of unsafe practices, and• Perceived health risk



•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,



• FSMA reduces internal FDA regulatory friction


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.


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



•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?



• 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!



• 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



• 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


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

[email protected]

Charles Breen

[email protected]

Antonio Gallegos

[email protected]