Transcript FDA Actions - Hogan Lovells
Food Safety Modernization Act: Are You Ready?
March 27, 2012 Gary Jay Kushner NPA Annual Meeting La Playa, Florida
Agenda
• Main Requirements of FSMA • FDA Implementation So Far • Provisions Already in Effect • What’s Next • Inspections and Records Access • Preparation www.hoganlovells.com
2
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
3
Main Elements of FSMA
1. New Responsibilities on Food Companies 2. New Controls over Imported Food 3. New Powers for the FDA 4. New Fees on Food Companies and Importers www.hoganlovells.com
4
New Responsibilities for Food Companies
• Affecting 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 www.hoganlovells.com
5
Not To Be Forgotten
• Bi-annual registration • Safety standards for fruits and vegetables • Traceability • Records access under Bioterrorism Act • Performance standards www.hoganlovells.com
6
New Controls Over Imported Food
• Supply chain verification procedures • Foreign facilities subject to same requirements as domestic 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
7
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
8
New Fees on Food Companies and Importers
• Reimbursement to FDA – Reinspections – Recall (very limited) • Export certificates • Fast lane for imports • Fees already in effect for facility reinspections www.hoganlovells.com
9
Implementation Timetable
• Various effective dates for different provisions • Basic timeline (set by statute) – 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 • Enforcement discretion www.hoganlovells.com
10
FDA Outreach
• 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
11
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 www.hoganlovells.com
12
FDA Actions – Reinspection Fees
• 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 published notice of
reinspection fee
costs – Rates: $224/hour; $325/hour if foreign travel required (per person) www.hoganlovells.com
13
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
14
FDA Actions
• Selected IFT to conduct
traceability
– Produce; packaged food pilots – Stakeholder meetings on pilot scope – Completion and report expected late spring 2012 • Updated
website
for recalls with improved search capability • 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) www.hoganlovells.com
15
Provisions Already in Effect
• Mandatory recall • Suspension of registration • Administrative detention (enhanced version) • Prior notice of imports (enhanced version) • Emergency access to records (enhanced version) • Reinspection fees (but not for imports) www.hoganlovells.com
16
What’s Next
• Proposed rules expected soon • FDA priorities are: – Preventive controls – Fresh produce – Foreign supplier verification – Third-party accreditation standards • Comment periods likely to be short (60 days), with no extensions • FDA will try to issue final rules by January 2013 (end of Obama’s first term) • Enforcement dates to be specified in final rules www.hoganlovells.com
17
FDA Culture is Changing
• More aggressive and enforcement-minded • For example, FDA is: – Conducting many more inspections (with the states) – Issuing many more Warning Letters for food GMPs – Increasing oversight of imports, especially ingredients, and conducting foreign on-site inspections – Testing more, both environment and product – Expanding working definition of “high risk” • Nut-containing products • Dairy/cheese www.hoganlovells.com
18
Inspections - What to Do Now
• FDA will not have routine access to food safety records until July 2012, at the earliest • But, 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 to take photographs even without express legal authority – Inspections involve comprehensive environmental sampling (“swab-a-thon”) www.hoganlovells.com
19
Inspections – Changes to Come
• Historically, FDA has inspected food processing facilities for basic sanitation and to detect visible problems with the facility or the product produced • Under FSMA, FDA also will focus on whether facilities are implementing effective food safety systems – This “systems-based” approach is aimed at preventing problems on a continuing basis, not just when the inspector is in the facility • This change is consistent with a main theme of FSMA: Move from reaction to prevention www.hoganlovells.com
20
Inspections – Changes to Come
•
• As soon as July 2012, FDA will have increased access to a broad range of records, including food safety plans and implementation documents • FDA will likely start with the hazard analysis in the Food Safety (HACCP) Plan and related controls – Are all the hazards addressed?
– Are there adequate controls, especially CCPs?
– Is there scientific validation for CCPs/kill steps?
Complete documentation will be critical!
www.hoganlovells.com
21
Inspections – Changes to Come
• FDA will carefully review production records, focusing on monitoring for CCPs and documentation of corrective actions – Plant personnel should work with inspectors to narrow the scope of their request – It’s okay to ask questions about what they are looking for to narrow the focus • • Having good records to document corrective actions is best way to show FDA company is acting responsibly
Remember: If you didn’t document it, it didn’t happen!
www.hoganlovells.com
22
Records Access Will be Central Feature of FSMA Inspections
• Records you will need to have ready: – Hazard Analysis – Food Safety Plan (with designated controls) – Scientific basis for preventive controls – Monitoring records – Corrective actions – Verification, including environmental and product testing – Consumer complaints related to food safety – Supply chain oversight (domestic and foreign) – Recall plan and records of any recalls conducted www.hoganlovells.com
23
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 – Records maintenance procedures • Work with NPA to file comments www.hoganlovells.com
24
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 • Inspections will change significantly, so preparation is key www.hoganlovells.com
25
Contact Information
Gary Jay Kushner Hogan Lovells US LLP (202) 637-5856 [email protected]
www.hoganlovells.com
26
www.hoganlovells.com
Hogan Lovells has offices in: Abu Dhabi Alicante Amsterdam Baltimore Beijing Berlin Boulder Brussels Budapest* Caracas Chicago Colorado Springs Denver Dubai Dusseldorf Frankfurt Hamburg Hanoi Ho Chi Minh City Hong Kong Houston Jeddah* London Los Angeles Madrid Miami Milan Moscow Munich New York Northern Virginia Paris Philadelphia Prague Riyadh* Rome San Francisco Shanghai Silicon Valley Singapore Tokyo Warsaw Washington DC Zagreb* "Hogan Lovells" or the "firm" refers to the international legal practice comprising Hogan Lovells International LLP, Hogan Lo vells 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 dir ectories 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 www.hoganlovells.com
27