The Food Safety Modernization Act:

Implications for Laboratory Accreditation Tim McGrath

Deputy Director, Food and Feed (acting) Office of Regulatory Science Office of Regulatory Affairs

FDA

FSMA “I thank the President and

members of Congress for recognizing that the burden that foodborne illness places on the American people is too great, and for taking this action.”

Margaret A. Hamburg, M.D.,

Commissioner of Food and Drugs

Outline of Presentation

• The public health impact • Additional drivers • Provisions of the law and significance

– Main Themes of Legislation • Important stuff - Laboratory Accreditation

– Regulations – Writing the Regs – Considerations

The Public Health Impact

• Foodborne illness is a significant burden – About 48 million (1 in 6 Americans) get sick each year – 128,000 are hospitalized – 3,000 die

• Immune-compromised individuals more susceptible – Infants and children, pregnant women, older individuals, those

on chemotherapy

• Foodborne illness can cause life-long chronic disease – Arthritis, kidney failure

Additional Drivers for Legislation

• Globalization – 15 percent of U.S. food supply is imported

• Food supply more high-tech and complex – More foods in the marketplace – New hazards in foods not previously seen

• Shifting demographics – Growing population (about 30%) of individuals are

especially “at risk” for foodborne illness

Broad Reaching Legislation • Involves creation of a new food safety system • Broad prevention mandate and accountability • New system of import oversight • Emphasizes partnerships • Emphasizes farm-to-table responsibility • Developed through broad coalition

Main Themes of the Legislation Prevention

Inspections, Compliance, and Response

Import Safety

Enhanced Partnerships

Prevention

• Comprehensive preventive controls for food facilities – Prevention is not new, but Congress has given FDA

explicit authority to use the tool more broadly – Strengthens accountability for prevention

• Produce safety standards • Intentional adulteration standards

Inspection, Compliance, and Response

• Mandated inspection frequency – Considering new ways to inspect

• New tools – Mandatory recall – Expanded records access – Expanded administrative detention – Suspension of registration – Enhanced product tracing – Third party laboratory testing

Import Safety

• Importers now responsible for ensuring that their foreign suppliers have adequate preventive controls in place

• FDA can rely on third parties to certify that foreign food facilities meet U.S. requirements

• Can require mandatory certification for high-risk foods • Voluntary qualified importer program--expedited review • Can deny entry if FDA access for inspection is denied • Requires food from abroad to be as safe as domestic

Enhanced Partnerships

• Reliance on inspections by other agencies that meet standards

• State/local and international capacity building • Improve foodborne illness surveillance • National agriculture and food defense strategy • Consortium of laboratory networks • Easier to find recall information

Challenges

• Enormous workload – 50 new rules, guidance documents, reports in 3 years

• Tight deadlines • Changes won’t appear overnight

– Building new system will be a long-range process • Resources

Priorities • Prevention

– Mandatory preventive controls for facilities – Produce safety standards – Intentional contamination

• Inspection, Compliance, and Response – Administrative detention – Recall (Upon enactment) – Suspension of registration

• Imports – Foreign supplier verification program – Accredited third-party certification program – Mandatory certification for high risk foods (Upon enactment)

For more information

• www.fda.gov • www.foodsafety.gov

Title II – Improving Capacity to Detect and Respond to Food Safety Problems

• Sec. 201. Targeting Inspection

Resources • Sec. 202. Laboratory

Accreditation • Sec. 203. Integrated Consortium

of Laboratory Networks • Sec. 204. Enhancing Tracking and

Tracing of Food and Recordkeeping

• Sec. 205. Surveillance • Sec. 206. Mandatory Recall

Authority

• Sec. 207. Administrative Detention • Sec. 208. Decontamination and

Disposal Standards and Plans • Sec. 209. Improving the training of

State, local, territorial, and tribal food safety officials

• Sec. 210. Enhancing Food Safety • Sec. 211. Improving the

Reportable Food Registry

Section 202 of FSMA Laboratory Accreditation for Analyses of Foods

202(a) – Recognition of Laboratory Accreditation • Establish an accreditation program NLT 2 yrs

– Criteria for recognition of accreditation bodies – Accredited labs to include Federal/State/Local labs and independent

private labs – Accreditation standards also applicable to foreign laboratories – Recognized ABs and ALs required to report any changes to FDA

• Establish a publicly available registry of recognized accreditation bodies and accredited laboratories

• Increase the number of qualified laboratories • Develop model laboratory standards • Periodic review of recognition (at least once in 5 y)

Section 202 of FSMA Laboratory Accreditation for Analyses of Foods

202(a)(6) – Model Laboratory Standards • FDA to develop model standards required to be met by laboratories

for accreditation for a specified sampling or analytical testing methodology

• FDA shall consult existing standards for guidance • Model standards requirements:

– Appropriate sampling, analytical procedures – Internal quality systems – Procedures to handle complaints – Qualified lab personnel – Any other appropriate criteria established by FDA

Section 202 of FSMA Laboratory Accreditation for Analyses of Foods

202(b) – Testing Procedures • Testing by accredited labs • Testing conducted “by or on behalf of an owner or consignee” in

cases of: – identified or suspected food safety problem – import alerts

• Results of testing to be reported to FDA – May be submitted by electronic means – By regulation, may exempt results from submission requirement

• Testing procedures may be waived for new validated methodologies as needed for food emergency/ outbreaks

Section 202 of FSMA Laboratory Accreditation for Analyses of Foods

202(c) – Review by Secretary • In cases of State recalls, review sampling and testing

results to determine need for national recall or other CE activities

Writing the Regulation

• While writing Regulations and Guidance – restrictions on information

• Research ongoing to look at utilization by those regulated

• FDA shall consult existing standards for guidance

• Regulations proposed in past – 2004 and 2009 language

• Model Standards and Guidance an opportunity to provide uniformity and clarifications (sample collections)

More Considerations

• Utilization of IT system for submissions, relaying packages, record keeping – accessible in some part to all parties involved

• Promotion of uniformity throughout process

• Known timeframes throughout process

• Consistency…

Section 202 of FSMA Laboratory Accreditation for Analyses of Foods

Summary Key Deliverables

• Establish lab accreditation program – Develop a process and criteria for recognition and accreditation – Develop a process and criteria for periodic review – Develop model standards for testing labs – Develop internal database to support program

• Establish public registry of recognized ABs and accredited labs

• Accredited labs to conduct food testing – Develop process for electronic submission of data

• Develop process for reviewing State/local labs results for purposes of recall, CE activities

FSMA Laboratory Accreditation Working Group

FSMA Information: • http://www.fda.gov/fsma • www.foodsafety.gov

Contact Information: • Tim McGrath (FDA/ORS) Timothy.mcgrath@fda.hhs.gov