fsma – one year plus: where we are now and where...

FSMA – One Year Plus: Where We Are Now and Where We Are GoingMay 11, 2012

Maile Gradison HermidaPresentation to the Green Coffee Association, 2012 Convention

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Agenda

• Main Requirements of FSMA• FDA Activities So Far• Provisions Already in Effect• What’s Next• How to Prepare


Overview

• Law signed on January 4, 2011• FDA has conducted extensive outreach• FDA has already completed some actions• Some provisions already in effect• Messaging from FDA mostly positive, but issues

may surface in proposed rules• Activity will accelerate during 2012• Food companies have started to prepare


Main Elements of FSMA

1. New Responsibilities on Food Companies2. New Controls over Imported Food3. New Powers for the FDA4. New Fees on Food Companies and Importers


New Responsibilities for Food Companies• Impacting daily operations

– Food Safety Plans/Preventive Controls– Supply Chain Management– Records Maintenance and Access– Food Defense Plans

• Applies to all Registered Facilities– Including warehouses– Including foreign facilities that produce

food for sale in the U.S.


Food Safety Plans

• Conduct hazard analysis of hazards of known or reasonably foreseeable hazards

• Put into place controls designed to significantly minimize or prevent those hazards

• Implement preventive controls through monitoring, corrective actions, and verification activities

• Verification activities include environmental and product testing

• Reanalysis required every 3 years• Food safety plan and all related records available to

FDA during inspection


Not To Be Forgotten

• Bi-annual registration• Safety standards for fruits and vegetables• Traceability• Records access under Bioterrorism Act• Performance standards


New Controls Over Imported Food• Supply chain verification procedures• Foreign facilities subject to all the same requirements as

U.S-based facilities• FDA authority to require third party certification for food

safety-related reason• Accredited laboratory must be used for certain testing• Expedited entry at border if safety and security guidelines

met


Foreign Supplier Verification Program

• Each importer must perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer is:– Produced in compliance with the Food Safety

Plan requirements– Produced in compliance with produce safety

regulations to be promulgated by FDA– Not adulterated or misbranded under 403(w)

(undeclared allergens)



• Importer: – “…the United States owner or consignee of the

article of food at the time of entry of such article into the United States” or

– If there is no such owner or consignee, the U.S. agent or representative of a foreign owner or consignee.



Verification activities may include (but are not limited to):• Monitoring records for shipments• Lot-by-lot certification of compliance• Annual on-site inspections• Checking the Food Safety Plan of the foreign supplier• Periodically testing and sampling shipments

Obligations apply to both food and packaging materials.



• FDA is required to take action to flesh out the foreign supplier verification program– FDA will promulgate regulations – FDA will issue guidance documents to assist importers in

developing their foreign supplier verification programs• Statutory effective date: January 4, 2013

– Proposed rule currently undergoing review by OMB– FDA expected not to enforce FSVP until after final regulations

are issued• Records must be maintained for at least 2 years and

made available to FDA upon request

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Voluntary Qualified Importer Program

• Provides for expedited review and importation by qualified importers

• Participation is voluntary and will be limited to eligible importers – fee-based program

• Participation requires: – (1) Facility certification by accredited third party auditor – (2) FDA will determine whether an importer is eligible for

VQIP based on statutory factors

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New or Enhanced Enforcement Powers for FDA• Increased inspection frequency

– High Risk Domestic – every 3 years– Low Risk Domestic – every 5 years– Ramp up Foreign inspections

(600 to 19,200 over 6 years)• Suspension of registration• Mandatory recall• Expanded administrative detention

authority


New Fees on Food Companies and Importers

• Reimbursement to FDA – Reinspections– Recall (very limited)

• Export certificates• Fast lane for imports

• Note that fees are currently in effect for facility reinspections


Implementation Timetable• Various effective dates for different provisions• Basic timeline

– 18 months – food safety plans– 24 months – foreign supplier

verification– Longer for traceability– Bi-annual registration begins 2012

• Detailed schedule for FDA regulations and guidance• Longer implementation time for small and very small

businesses


FDA Outreach

• FDA outreach has been extensive• Agency conducted 3 public meetings in spring 2011

– Import provisions– Preventive controls– Inspections and enforcement Each meeting followed by open public docket

• Additional docket opened for guidance documents to support preventive controls rulemaking

• Meetings held with subject matter experts and trade associations


FDA Actions• Published interim final rule for administrative

detention – Trigger is: “reason to believe” an article of food is

“adulterated or misbranded”– Tied to seizure and injunction actions

• Published interim final rule for prior notice of imports– Requires prior notice for an imported food to identify any

country to which the article of food has been shipped, but refused entry

• Published interim final rule and draft guidance for emergency records access authority


FDA Actions – Reinspection Fees

• FDA published notice of reinspection fee costs– Rates: $224/hour; $325/hour if foreign travel required (per

person)

• FDA can assess reinspection fees against:1. Domestic facilities to cover reinspection-related costs

• Reinspection: previous inspection was “Official Action Indicated” and the noncompliance was materially related to food safety

2. Domestic facilities to cover recall-related activities performed by FDA if the facility refuses to comply with a mandatory recall order


FDA Actions – Reinspection Fees

3. Importers to cover reinspection-related costs • Imports: reconditioning of imported food; importers seeking

admission of an article that has been detained; entities requesting removal from an import alert for detention without physical examination; and destruction of food that has been refused admission

• FDA has curtailed plans to implement the reinspection fees. Currently:– Reinspection fees will only be assessed if the initial

inspection occurred after October 1, 2011– Import reinspection fees are not being implemented yet– Mandatory recall fees are in effect


FDA Actions – “High Risk” Definition • Inspection frequency for domestic facilities depends

on whether a facility is “high risk” • FDA defines a facility as “high risk” for inspection

purposes if any of the following apply: 1) History of Class I recalls and foodborne illness outbreaks

for any food in the product category2) History of Class I recalls or foodborne illness outbreaks

for the product category and no FDA inspection for previous 5 years

3) Single inspection classified as OAI (i.e., resulting in Warning Letter) or 3 inspections classified as VAI (i.e., resulting in 483s) in the last 5 years

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FDA Actions

• Selected IFT to conduct traceability pilots– Produce; packaged food– Stakeholder meetings on pilot scope– Completion and report expected late spring 2012

• Updated website with improved search capability for recalls

• Issued anti-smuggling strategy• Issued series of Q & A documents• Met other statutory deadlines (reports to Congress,

updating Seafood HACCP Guidance, issuing guidance on new dietary ingredient notifications)

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Provisions Already in Effect

• Mandatory recall• Suspension of registration• Administrative detention (expanded version)• Prior notice of imports (expanded version)• Emergency access to records (expanded version)• Reinspection fees (but not yet for imports)


What’s Next• FDA priorities are:

– Preventive controls for food and feed– Fresh produce– Foreign supplier verification – Third-party accreditation standards

• Proposed rules under review by OMB• Comment periods likely to be 90 days (or longer)• FDA will hold public meetings across the country and

internationally


Key Issues for the Coffee Industry

• Requirements triggered by registration• Requirements apply to foreign facilities producing

food for export to the U.S. • FDA can exempt storage facilities for raw

agricultural commodities intended for further distribution or processing

• Emphasis on imports


Preparing Now• Initial briefings of senior management • Initial trainings:

– Quality staff and plant managers– Co-manufacturers and suppliers

• Review/update:– HACCP plans– Supplier qualification procedures (domestic and foreign)– Records maintenance procedures

• Consider seeking exemption from preventive controls for the storage of raw agricultural commodities; warehouses for packaged goods


Conclusion

• FDA has been very open so far• FDA appears driven to complete required actions

and implement the law in a timely manner– Election year– Budget

• Although there have been some delays, implementation/enforcement is just around the corner


Contact Information

Maile HermidaHogan Lovells US LLP(202) [email protected]



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