U.S. FOOD AND DRUG ADMINISTRATION REGULATIONS (FDA)

Dr. DONALD A. PRATER, DVMDeputy Director (Foods), US FDA Europe Office

Presented at: How to do business in the USA

May 24, 2011, Thessaloniki, Greece

Organized by the American-Hellenic Chamber of Commerce

FDA’s Mission

• Protect public health by assuring the safety and efficacy of – human drugs– biological products– medical devices and products that emit radiation– animal feed and veterinary drugs– food and cosmetics

• Advance public health by facilitating innovations that make medicines and foods more effective, safer and more affordable

• Provide the public with accurate, science-based information on medicines and foods

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Challenges of Globalization

Globalization has fundamentally changed the environment for regulating food and medical products and has created unique regulatory challenges for FDA:– More foreign facilities supplying the U.S.– Increasing volume of FDA-regulated imported products– $2 Trillion worth of products enters the U.S. from more than

150 countries, with 130,000 importers of record, and from

more than 300,000 foreign facilities

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1,282

1,507

1,780

2,046

2,323

2,595

2,820

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Foreign Facilities Foreign Facilities Inspections

Number of Foreign Sites Making FDA-Regulated Drugs Has More Than Doubled Since 2001

Official FDA Data – ORA/DIOP

Note: Number of foreign facilities inspections are scaled in fiscal year. Number of foreign facilities are scaled in calendar year. Numbers approximate due to data limitations.

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FDA Foreign Offices

U.S. Food Safety SystemDepartment of Health and Human Services (HHS)

– Food and Drug Administration (FDA)– Centers for Disease Control and Prevention (CDC)

Department of Agriculture (USDA)– Food Safety and Inspection Service (FSIS)– Animal and Plant Health Inspection Service (APHIS) – Foreign Agricultural Service (FAS)

Environmental Protection Agency (EPA)Department of Commerce – (NOAA NMFS)Bureau of Customs and Border Protection (CBP)Alcohol and Tobacco Tax and Trade Bureau (TTB)State and local health and agricultural agencies

Bioterrorism Act Regulations

• Took effect December 12, 2003• FDA and Border Patrol/Customs collaboration• Facility Registration (foreign 226,373; total 382,866)

– Domestic and foreign facilities engaged in manufacturing, processing, packing and holding of food

– Greece has 1,166 registered facilities– The EU has 54,181 registered facilities

• Prior Notification of imported foods– 2 hours by land– 4 hours by air or by rail– 8 hours by sea

Major FDA Center for Food Safety and Applied Nutrition (CFSAN) Programs- Food facility registration and prior notice for imports

– Minimization of health risks due to chemical and biological contamination

– Safety of dietary supplements, infant formulas and medical foods

– Pre-market safety of substances added to food, including colors

– Safety of food and ingredients developed through biotechnology

Major CFSAN Programs

– Food and allergen labeling, health claims

– Seafood and juice HACCP regulatory programs

– Low Acid Canned Food/Acidified Food (LACF) process registration

– Post-market surveillance and compliance

– International food standard and safety harmonization (Codex, WTO)

– Technical cooperation and assistance

Reportable Food Registry

• Portal opened September 2009• All registered food facilities (domestic and

foreign) required to report in 24 hours• When there is reasonable probability that food

or feed will produce serious adverse health consequences to humans or animals (equivalent to Type 1 Recall)

• Served by HHS Safety Reporting Portal

Food Defense Approach

• Detect and identify harmful organisms and toxins in food (Awareness)

• Train industry and state officials on “CARVER” vulnerability assessments (Prevention)– Criticality– Accessibility– Recuperability– Vulnerability– Effect– Reconcilability

• Develop effective strategies to protect the food supply from terrorist threats (Protection)

• ALERT, FIRST

How to Export Food to the U.S.• Register facility with FDA• Register process for canning/aseptic packaging of Low

Acid/Acidified Canned Foods (LACF)• Give “Prior Notice”• Use good practices in food production

– Agricultural– Aquacultural– Manufacturing– HACCP

• Assure that the product is safe, wholesome, sanitary, properly packaged and labeled

FDA Food Safety Modernization Act

Main Themes of the Legislation

Prevention Standards

Inspections, Compliance, and Response

Import Safety

Enhanced Partnerships

Import Safety: Most groundbreaking shift

• Current reliance on port-of-entry inspection cannot handle increase in imported food.

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

• Requires food from abroad to be as safe as domestic

Import Safety Mandates

Sec. 301. Foreign supplier verification program• Requires importers to verify their suppliers use risk-based

preventive controls that provide same level of protection as U.S. requirements.

Sec. 302. Voluntary qualified importer program• Allows for expedited review and entry; facility certification

requiredSec. 303. Certification for high-risk food imports• FDA has discretionary authority to require assurances of

compliance for high-risk foods

Import Safety Mandates

Sec. 304. Prior notice of imported food shipments• Requires information on prior refusals to be added to prior notice

submissionSec. 305. Capacity building• FDA mandate to work with foreign governments to build food safety capacitySec. 306. Inspection of foreign food facilities• Can deny entry if FDA access for inspection is deniedSec. 201. Targeting of inspection resources • Increased inspection of foreign as well as domestic facilities

Import Safety Mandates

Sec. 307. Accreditation of third-party auditors• FDA can rely on accredited third parties to certify that foreign food

facilities meet U.S. requirementsSec. 308. Foreign Offices of the Food and Drug Administration. • Establish offices in foreign countries to provide assistance on food

safety measures for food exported to the U.S.Sec. 309. Smuggled Food• In coordination with DHS, better identify and prevent entry of

smuggled food

Role of Third-Party Certification Programs

• Tool for importers to obtain needed assurances to meet their obligations for the foreign supplier verification program (sec. 301)

• A way for importers to participate in the voluntary qualified importer program to expedite movement of food through the import process (sec. 302)

• Can be required by FDA to accompany high-risk foods (sec. 303)

Import Projects Completed(as of May 2011)

Sec. 304. Prior notice of imported food shipments– Requires information on prior refusals to be added to

prior notice submission – Effective July 3, 2011

Enhanced Partnerships: Vital to Success

International capacity building– FDA has mandate to work with foreign governments

to build their food safety capacity– Allows FDA to rely more heavily on foreign

government oversight– Capacity building helps to prevent problems before

products reach the U.S. port of entry.

Implementation: FDA is prepared

• Experience in preventive controls • Implementation process in place• Much work already underway• Projects completed can be found on

www.fda.gov/fsma

But, many 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

Implementation Approach

• Coalition needed • Transparency a priority• Focus on public health protection • Engage with stakeholders to help determine

reasonable and practical ways to do so

Priorities• Prevention

– Mandatory preventive controls for facilities (FR 18 months)

– Produce safety standards (FR 2 years)

– Intentional contamination (FR 18 months)

• Inspection, Compliance, and Response

– Administrative detention (IFR 120 days)

– Recall (Upon enactment)

– Suspension of registration (180 days)

• Imports

– Foreign supplier verification program (Guidance and FR 1 year)

– Accredited third-party certification program (FR 2 years)

– Mandatory certification for high risk foods (Upon enactment)

For more information

www.fda.gov/fsma

(Subscription feature available)

Contact Information

Donald A. Prater, DVMDeputy Director (Foods)FDA Europe Office

Based at the European Food Safety AuthorityParma, Italy

Telephone: 39 0521 036582Email: donald.prater@fda.hhs.gov