Reform of the U.S. Import System for FDA-Regulated Foods/Ingredients Overview of 2009 Legislation

Caroline Smith DeWaal Food Safety Director Center for Science in the Public Interest

October 2009

CSPI: Nearly Four Decades of Consumer Advocacy z

Bi-national consumer advocacy organization founded in 1971 by Michael Jacobson, Ph.D. – – –

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Focuses on nutrition and health, and food safety Publishes award-winning Nutrition Action Healthletter Maintains database of U.S. outbreaks and publishes annual Outbreak Alert! Report Represents 950,000 subscriber/members in the United States and Canada

Food Safety System Reform Overdue z

Foodborne disease causes 76 Million Illnesses, 325,000 Hospitalizations and 5,000 Deaths Annually – – –

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FDA operates under outdated laws – – –

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Strikes hardest at very old, very young, and those with weakened immune systems Can lead to chronic medical conditions May affect healthy food choices Federal Food and Drug Act – 1906 Federal Food, Drug, and Cosmetic Act – 1938 Public Health Service Act – 1944

Societal costs due to foodborne illnesses estimated to top $44 billion each year

Consumer Confidence Declines z

Consumers losing confidence in safety of food –

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78% believe that food is less safe today than a year ago

Consumers more skeptical of import safety –

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64% say government is doing too little to ensure that imported food is safe (compared to 48% expressing same concern for domestically produced food) 79% of CSPI members express concern over safety of imported food (compared to 52% expressing same concern over domestic food)

Sources: 2009 University of Minnesota, Hart Research, CSPI

National Food Safety Efforts Bearing Fruit in 111th Congress z

H.R. 2749, Food Safety Enhancement Act – –

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Approved in Energy and Commerce, June 17, 2009 Passed House July 30, 2009, with a strong bipartisan vote of 283-142

S. 510, FDA Food Safety Modernization Act – – – –

Introduced March 3, 2009 Pending Hearing and Mark up in Senate HELP Leadership’s commitment Bipartisan cosponsorship

Comparing House and Senate Bills z

Structurally H.R. 2749 and S. 510 are similar –

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Processors must re-register periodically, implement food safety plans, meet performance standards, and have program to verify food they import complies with U.S. law FDA must conduct risk-based inspections FDA can require high-risk imported food to be independently certified as complying with U.S. law FDA can order a recall of food likely to cause serious illness or death

But importers must know how substance of import provisions affect them

S. 510 Import Program FDA’s Role Write regulations and guidance for Foreign Supplier Verification Program List participating importers

Foreign Supplier Verification Program

Establish Voluntary Qualified Importer Program

Registration

Conduct risk determination for high risk foods/countries

Prior Notice

Establish accreditation program for certifying agents

Importer/U.S. Agent

Import Requirements And Options Equivalence Agreements

Certification*

* Mandatory High-risk products or countries * Voluntary Voluntary Qualified Importer Program

Imports Must Comply with U.S. Law z

H.R. 2749 – – –

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Processors must analyze hazards and implement food safety plans FDA may specify reasonably likely hazards, evaluate plans, and order a reanalysis of hazards to protect public health FDA may order reporting of positive test results from high-risk facilities

S. 510 – –

Processors must analyze hazards and implement food safety plans FDA may order a reanalysis of hazards in light of new science

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Processors must meet FDA defined performance Standards

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H.R. 2749 – –

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FDA to review data and establish performance standards for significant contaminants and list serious contaminants every 2 years FDA can recommend sampling programs to demonstrate compliance

S. 510 –

FDA to review data and establish performance standards for significant contaminants every 2 years

Inspection mandate covers foreign and domestic food z

H.R. 2749 – –

Foreign and domestic facilities, and importers must register annually and pay registration fee Mandatory inspection frequencies: z z z z

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FDA must inspect foreign and domestic facilities, High-risk facilities inspected every 6-12 months, Low-risk facilities inspected every 18 months to 3 years, and Warehouses inspected at least once every 5 years

Dedicated foreign inspectorate created at FDA

S. 510 – – –

Foreign and domestic facilities must register biennially FDA must inspect high-risk facilities at least annually and low risk facilities at least once every 4 years FDA must open 5 offices in foreign countries by Oct. 1, 2010

Import Facts • More than 10 million line items enter each year

Import Controls

• Imported food = 13% of average American’s diet • FDA rarely inspects foreign plants (96 in 2007) • Only 1.28% of imported food is inspected at border

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H.R. 2749 – – – –

Importers must follow good importer practices FDA must establish process for demonstrating foreign government controls are adequate (no certification necessary if controls are adequate) FDA can detain imported food if inspector has reasonable belief it is adulterated or misbranded FDA can require certification that high-risk imports comply with law z

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3rd party certifying agents okay

S. 510 – – – –

Importers must implement a Foreign Supplier Verification Program FDA may conduct audits to determine if foreign country has equivalent food safety system FDA can detain imported food if inspector has reasonable belief it is adulterated or misbranded FDA can require certification that high-risk imports comply with law z

Recognized accrediting bodies accredit governments and 3rd party certifying agents to perform certification audits

Farm import provisions z

H.R. 2749 – –

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FDA sets scientific and risk-based safety standards for high-risk raw agricultural commodities (fruit, vegetable, nut or fungus) Produce is adulterated if not grown, harvested, processed, packed, sorted, transported, or held under conditions that comply with standards

S. 510 –

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FDA to issue regulations establishing science-based minimum standards for safe production of high-risk raw agricultural commodities (fruits and vegetables) Variances allowed to accommodate conditions/practices in foreign country (must ensure food is not adulterated)

Questions?

Contact Information:

Caroline Smith DeWaal Food Safety Director Center for Science in the Public Interest

[email protected] (202) 777-8366