FSVP and VQIP Statutory Requirements GMA Science Forum

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1 FSVP and VQIP Statutory Requirements GMA Science Forum Maile Gradison Hermida Elizabeth Barr Fawell April 5, 2012

2 FSMA Overview New controls over imported food are a key component of FSMA Volume of imports has increased exponentially 250,000+ registered foreign facilities 10 million+ food import shipments annually Foreign facilities that export to the U.S. are subject to all the same requirements as U.S.-based facilities New import requirements include: Supply chain verification procedures (FSVP) Voluntary expedited entry at border if safety and security guidelines met (VQIP) 2

3 FSVP FSMA 301 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) 3

4 FSVP FSMA 301 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 4

5 FSVP FSMA 301 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 5

6 FSVP FSMA 301 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 6

7 FSVP FSMA 301 Exemptions: Small quantities imported for research and evaluation purposes Food imported for personal consumption Requirements do not apply to facilities that are subject to FDA s seafood, juice, or low-acid canned food products (microbial hazards only) requirements 7

8 VQIP FSMA 302 Provides for expedited review and importation by qualified importers FDA required work with the Department of Homeland Security in establishing the program Participation is voluntary and will be limited to eligible importers fee-based program 8

9 VQIP FSMA 302 Participation requires: (1) Facility certification by accredited third party auditor FDA must first establish a process for accrediting third party auditors 9

10 VQIP FSMA 302 (2) FDA will determine whether an importer is eligible for VQIP based on factors that include: Known safety risks of the food Compliance history of foreign suppliers used by the importer Capability of the regulatory system of the country of export to ensure compliance with US food safety standards Importer compliance with FSVP requirements Recordkeeping, testing, inspections, and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer Potential risk for intentional adulteration of the food 10

11 Conclusion FSVP shifts the burden to importers to ensure that they import safe food All importers are covered by the FSVP (not just registered facilities) Forthcoming regulations should answer many open questions about how FSVP will work VQIP is a narrower, voluntary, fee-based program VQIP cannot be implemented until FDA establishes a system for third party accreditations 11

12 Maile Gradison Hermida, Associate Hogan Lovells US LLP (202) Elizabeth Barr Fawell, Associate Hogan Lovells US LLP (202) 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 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 OC 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 All rights reserved. * Associated offices 12