"Globalization I: How Should the FDA Ensure the Safety of Imported Foods?" Panel

Remarks of Heather Klinkhamer
Program Director, S.T.O.P. - Safe Tables Our Priority

Public Voice for Food and Health Policy
21st Annual National Food Policy Conference
Washington, DC
March 24, 2025

Before addressing import issues and food safety, I'd like to explain who S.T.O.P. - Safe Tables Our Priority is and the focus of our concern. S.T.O.P. was formed in the summer of 1993 by victims of foodborne illness. Most of our founders were parents of children maimed or killed by E. coli O157:H7 in meat. The organization's membership has grown to include adult survivors of debilitating foodborne illnesses, and victims of a variety of foodborne pathogens from a variety of sources. S.T.O.P. provides victim support, consumer education, and advocates improved food safety policies. Our concern is pathogens in foods, regardless of the source.

The Problems

Foodborne illness is a domestic and international problem. The Council for Agricultural Science and Technology (CAST) estimates there are between 6.5 and 81 million illnesses and 9,000 deaths attributed to foodborne illness each year in the U.S. The World Health Organization (WHO) estimates that there are 1.5 billion episodes of diarrheal illness annually worldwide resulting in 3 million deaths of children under the age of five. Foodborne illness is frequently under-reported. The WHO estimates foodborne illness incidents my be 300-350 times what is reported. Unfortunately, the risk and incidence of foodborne illness is expected to rise.

While some incidences of illness may be linked to imported food products, S.T.O.P. does not believe that the U.S. is solely importing its food safety woes. Recent foodborne illnesses linked to Food and Drug Administration (FDA) regulated products domestically grown and processed include:

• Salmonella in fresh squeezed Florida orange juice (1995)
• E. coli O157:H7 in fresh apple juice (1996, 1997)
• E. coli O157:H7 in lettuce grown in Montana (1995) and California (1996)

Imports, however, are a risk factor. Several speakers yesterday recognized that product imported from other countries my introduce new pathogens to the U.S. Sometimes, the U.S. imports products from countries with less sophisticated public health and sanitation infrastructures than we enjoy in the U.S. Foodborne illness incidents linked to imported produce include:

• Shigella in onions (1994)
• Cyclospora in raspberries (1996, 1997)

The amount of FDA inspected imports has doubled over the past five years. FDA only inspects 1-2% of imported food shipments, which is a documented problem.

A California based committee of FDA officials, industry representatives, and consumers is addressing the problem of importers intentionally overloading an understaffed Los Angeles port. As products pile up for inspection, fewer inspections get performed and product is passed without any inspection whatsoever.

Imports are required to meet the same standards as domestic goods: be pure, wholesome, safe, and produced under sanitary conditions. Due to severe resource strains at FDA, inspections are not occurring as frequently as they should. Here are some facts to illustrate FDA's resource problem:

• There are approximately 800 inspectors assigned to an estimated 53,000 U.S. plants
• Under the current structure, a plant is inspected approximately once every 10 years
• In 1981 FDA conducted approximately 21,000 inspections annually, but by 1996 the number of inspections dropped to approximately 5,000 per year.

For the purposes of this panel discussion, I am going to limit my remarks to produce -- the FDA regulated product of concern to S.T.O.P. members. Produce linked foodborne illnesses are increasing. Between 1973 and 1987 approximately 2% of foodborne illnesses were linked to produce, but this number jumped to approximately 5-8% between 1988 and 1991. According to recent information released by the Minnesota Department of Health, 27% of MN foodborne illness outbreaks between 1990 and 1996 were linked to produce.

Produce contamination is a major concern because these products are often intended to be eaten raw and there is very little consumers can do to reduce or eliminate contamination. How do consumers eliminate the risks of E. coli O157:H7 in lettuce or Cyclospora in raspberries?

Expanding FDA powers

S.T.O.P. supports efforts to grant FDA the authority to prevent imports of products that do not meet U.S. standards. We support the draft Good Manufacturing Practices (GMPs) and Good Agricultural Practices (GAPs) developed at the urging of the President under the Food Safety Initiative.

The proposed GAPs and GMPs make common sense: reduce product contact with contaminated water and manure, give food handlers adequate bathroom and hand washing facilities, and keep equipment clean. Unfortunately, guidelines do not have the force of law, and it is unclear to S.T.O.P. how adoption of these guidelines will give FDA the authority to demand similar common sense measures from importers.

A key component of the President's Food Safety Initiative should be a more aggressive enforcement approach. We recommend adopting the GAPs and GMPs as law and implementing regular farm level inspections. Currently, FDA only inspects farms in the course of outbreak investigation. Voluntary measures don't work and are not accountable to tax payers.

Labeling

S.T.O.P. supports farm of origin labeling. We believe the proposed country of origin labeling has limited value to consumers in cases of foodborne illness. Country of origin labeling is required for meat, poultry and cheese, but hasn't proven to be a substantial help in facilitating traceback.

Farm of origin labeling provides accountability, which will breed precaution in growers. This type of labeling pinpoints where problems arise so that foodborne illness incidents can be better contained and fewer people will suffer. It also would help the industry by implicating the culprit rather than an entire class of products. It will save money spent searching for the source of outbreaks by providing needed information upfront.

This concept is not new. The 1997 Food Code urges retailers to observe similar labels on molluscan shellfish. The identification of the harvester, date of harvest, and location of harvest are required. The California Strawberry Commission and the California-based Apple Hill Growers Association have implemented traceback to the farm. USDA requires processing plant identification numbers on meat and poultry products, which facilitates trackback to that level of production.

Thank you for your attention. I look forward to the discussion.