fsma – one year plus: where we are now and where...
TRANSCRIPT
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
www.hoganlovells.com 2
Agenda
• Main Requirements of FSMA• FDA Activities So Far• Provisions Already in Effect• What’s Next• How to Prepare
www.hoganlovells.com 3
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
www.hoganlovells.com 4
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
www.hoganlovells.com 5
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.
www.hoganlovells.com 6
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
www.hoganlovells.com 7
Not To Be Forgotten
• Bi-annual registration• Safety standards for fruits and vegetables• Traceability• Records access under Bioterrorism Act• Performance standards
www.hoganlovells.com 8
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
www.hoganlovells.com 9
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)
www.hoganlovells.com 10
Foreign Supplier Verification Program
• 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.
www.hoganlovells.com 11
Foreign Supplier Verification Program
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.
www.hoganlovells.com 12
Foreign Supplier Verification Program
• 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
www.hoganlovells.com
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
13
www.hoganlovells.com 14
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
www.hoganlovells.com 15
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
www.hoganlovells.com 16
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
www.hoganlovells.com 17
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
www.hoganlovells.com 18
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
www.hoganlovells.com 19
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
www.hoganlovells.com 20
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
www.hoganlovells.com
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
21
www.hoganlovells.com
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)
22
www.hoganlovells.com 23
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)
www.hoganlovells.com 24
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
www.hoganlovells.com
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
www.hoganlovells.com 26
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
www.hoganlovells.com 27
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
www.hoganlovells.com 28
Contact Information
Maile HermidaHogan Lovells US LLP(202) [email protected]
www.hoganlovells.com 29
www.hoganlovells.com
Hogan Lovells has offices in:
Abu DhabiAlicanteAmsterdamBaltimoreBeijingBerlinBoulderBrusselsBudapest*
CaracasChicagoColorado SpringsDenverDubaiDusseldorfFrankfurtHamburgHanoi
Ho Chi Minh CityHong KongHoustonJeddah*LondonLos AngelesMadridMiamiMilan
MoscowMunichNew YorkNorthern VirginiaParisPhiladelphiaPragueRiyadh*Rome
San FranciscoShanghaiSilicon ValleySingaporeTokyoWarsawWashington DCZagreb*
"Hogan Lovells" or the "firm" refers to the international legal practice comprising Hogan Lovells International LLP, Hogan Lovells US LLP, Hogan Lovells Worldwide Group (a Swiss Verein), and their affiliated businesses, each of which is a separate legal entity. Hogan Lovells International LLP is a limited liability partnership registered in England and Wales with registered number OC323639. Registered office and principal place of business: Atlantic House, Holborn Viaduct, London EC1A 2FG. Hogan Lovells US LLP is a limited liability partnership registered in the District of Columbia.
The word "partner" is used to refer to a member of Hogan Lovells International LLP or a partner of Hogan Lovells US LLP, or an employee or consultant with equivalent standing and qualifications, and to a partner, member, employee or consultant in any of their affiliated businesses who has equivalent standing. Rankings and quotes from legal directories and other sources may refer to the former firms of Hogan & Hartson LLP and Lovells LLP. Where case studies are included, results achieved do not guarantee similar outcomes for other clients. New York State Notice: Attorney Advertising.
© Copyright Hogan Lovells 2010. All rights reserved.
* Associated offices