Five Years to Safer Center for Science in the Imports Public - - PowerPoint PPT Presentation

Caroline Smith DeWaal Center for Science in the Public Interest July 20, 2011

FDA Food Safety Modernization Act

Five Years to Safer Imports

CSPI/SFI and IACFO

• The Center for Science in the Public Interest

(CSPI) is a bi-national NGO representing over 850,000 consumers in both the U.S. and Canada.

• Safe Food International (SFI), a CSPI project,

partners with consumer organizations in other regions of the world on food safety issues.

• The International Association of Consumer Food

Organizations provides representation in Codex for consumer organizations on five continents.

FDA Food Safety Modernization Act

 Foreign facilities:

• Register biennially
• May be suspended
• Prevention programs

 Inspection mandate  Foreign offices  Foreign Supplier Verification Program  Voluntary Qualified Importer Program  Capacity building programs  Certification of high-risk foods

President Obama signs FSMA Jan. 4, 2011

Timeline

20 2011 11 2012 2013 2014 20 2015 15

600 600 1, 1,20 200 2, 2,40 400 4, 4,80 800 9, 9,60 600 Small Very Small 2nd

nd Re

Re-registr trati tion 1st

st Re

Re-registr trati tion

Regis gistrati tion In Inspections Foreign O Office ces Prevention FSVP VQIP Capacity ty B Bld ldg Certification

Authority Accreditation 3rd Party Auditors

Year 1: Registration (and Suspension)

20,000-29,999 10,000-19,999 5,000-9,999 3,000-4,999

21 Countries with 3,000 or more Registered Facilities

191,000 o 0 of 252,000 00 F Foreign gn Facilities ( (70 p percent) are located i in thes ese 2 e 21 countries es. 16 166,00 000

Year 1: Foreign Facility Inspection

 New mandate to inspect foreign facilities

• Double foreign facility inspections every year for five

years

• Can refuse products from facilities that refuse inspection
• Interagency agreements on inspection of seafood

Year 1: Foreign Offices

Beijing Shanghai Guangzhou New Delhi Mumbai San Jose Santiago Mexico City Brussels London Parma

Year 1: Border Inspection

 Changes to border inspections

• Interagency agreements on inspection of seafood
• Risk-based border inspection

Timeline

20 2011 11 2012 2013 2014 20 2015 15

600 1,200 2,400 4,800 9,600 Sm Small Very S Small 2nd Re-registration 1st Re-registration

Regis gistrati tion In Inspections Foreign O Office ces Prevention FSVP VQIP Capacity ty B Bld ldg Certification

Authority Accreditation 3rd Party Auditors

18 Months: Prevention

• Foreign and domestic facilities must implement

a food safety plan that includes:

• Hazard analysis
• Preventive controls
• Sanitation
• Employee training
• Food allergen control
• Supplier Verification
• GMPs
• Recall plan
• Environmental monitoring
• Monitoring and records
• Verification steps
• Corrective action plan
• Records of corrective actions
• Recall plan

Year 2: Foreign Supplier Verification Program

 Importers must implement FSVP that includes:

• Assurance that foreign supplier has risk-

based preventive controls.

• Verification steps such as --
• Monitoring records for shipments,
• Lot-by-lot certification,
• Annual on-sight inspection,
• Checking foreign supplier’s HACCP plan, or
• Verification testing.
• Records that must be accessible

for inspection.

FSVP Introduces “Look-Back” to Enhance Import Safety

 Importer is accountable for product’s safety.

 FSVP required regardless of risk.

18 Months: Voluntary Qualified Importer Program  Importers may obtain expedited review

• Application (notice of intent to participate in

VQIP)

• Certified facility is source for food
• FDA reviews application for risk factors

VQIP Lets Importers Jump to Head of Line

 Contribution to safety

• Assesses safety before product reaches border.
• Reduces number of import lines needing review,

improving risk-based targeting of border inspections.

Timeline

20 2011 11 2012 2013 2014 20 2015 15

600 1,200 2,400 4,800 9,600 Small Very Small 2nd Re-registration 1st Re-registration

Regis gistrati tion In Inspections Foreign O Office ces Prevention FSVP VQIP Capacity ty B Bld ldg Certification

Auth thority Accr creditation 3rd Party ty A Audito tors

Capacity Building

 Foreign Governments can be “trusted partners” for ensuring import safety

• Mutual recognition of foreign inspection reports,
• Training of foreign governments and producers,
• Acceptance of lab methods/testing.

Certification

Certification assures

• High-risk imported food meets U.S. requirements
• Food is eligible for VQIP.

Certification may be from government or qualified 3rd party auditor.  3rd party auditors -- accredited by recognized accrediting bodies – may be:

• Foreign governments,
• Foreign cooperatives, or
• Private parties

Mandatory Certification of High-Risk Foods

 FDA may require certifications of high-risk foods if there are:

• Known safety risks associated with the food
• Known safety risks associated with the place food
• riginates from
• A finding by Secretary that foreign food safety

system is inadequate

• A finding by Secretary that certification would assist

border inspections

Certification: Final Check for High-Risk Food

1 Secreta tary d design ignates food o

• r

regi gion a as hig igh-risk an k and requires c certification. 2 Forei eign g gover ernmen ent or accred edited ed 3 3rd pa party a audi dits facility f for c compliance w with U.S. r req equiremen ents. 3 Based ed o

• n findings,

aud uditor i iss ssue ues certification. 3A 3A Impo porter’s F s FSVP includes es c chec eck f for certification. 3B 3B Certification i is commu mmunicated t to FDA w wit ith s ship ipment t

• r by o
• ther s

specified met ethod.

Registration

Beijing Shanghai Guangzhou New Delhi Mumbai San Jose Santiago Mexico City Brussels London Parma

Foreign Inspection Foreign Offices Capacity Building Importer Programs Border Inspection Foreign Supplier Verification Program Voluntary Qualified Importer Program

Thank you!

Caroline S

• line Smit

ith h DeWaa aal

Food S

• d Safet

ety Direc ector

• r

Cen Center f for

• r Science in the

e Pu Public I Inter erest 1220 220 L Street, NW, Su Suite 300 300 Was ashington, D DC 20005 20005

Ph Phone: (2 (202) 7 777-8366 Fax: ( (202) 2 265-4954 E-mai mail: : cdewaal aal@cspinet.or .org On On the i e int nter ernet: www.csp spinet. t.org and d www.s .saf afefood

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ation

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al.or .org