1. Zero-Tolerances: Pros and Cons Caroline Smith DeWaal Director of Food Safety IAFP July 10-15, 2009

2. Zero tolerance: based on science or emotion? A zero tolerance is appropriate for a pathogen if it can cause death and severe illnesses when present at low levels in a product as commonly consumed. As used today, zero tolerances are an enforcement tool applied to hazards based on demonstrated need and signaling the highest level of public health protection.

3. Simply stated Zero tolerance is a performance standard, or a statement of what the government determines is adulterated under the law. Necessarily dependent on the sampling strategy, with inherent confidence factors. BUT it communicates that the government will apply the toughest standard “zero” to the most hazardous pathogens

4. Current policies: Listeria & E.coli O157:H7 Historically used for chemical hazards like drug residues A zero tolerance was adopted for Listeria around 1990 to address problems in both the FDA and USDA regulated products. Zero tolerance was established for E. coli O157:H7 in ground beef in 1994; zero tolerance in meat destined for grinding (2004)

5. Effectiveness of Current Policies: Listeria Healthy People 2010 goals have not been met – Lowest rates (2002) have not been repeated Rates in Europe on the rise (100 cfu/g standard) Consumers indicate a lack of understanding about the risk– even pregnant women At least 30 products recalled last year… so far in 2009, 13 FDA-regulated products and 4 USDA-regulated products

6. Possible changes to the Listeria standard Listeria – FDA is considering a change that would allow 100 cfu/g in foods that do not support growth – There are concerns that an inconsistent standard for some products could lead to cross contamination at retail (ex. deli cases) and contaminate USDA products 83% of Listeria-contaminated deli meat is contaminated at retail

7. Effectiveness of Current Policies: E. coli O157:H7 Great strides since the 1990s, but the last several years have seen significant problems – between June and November 2007 alone, at least 30 million pounds of beef were recalled by 20 different companies – Between February and August 2008, almost 1.5 billion pounds of ground beef were recalled by 8 different companies 5 recalls so far in 2009

8. Arguments against zero tolerance If zero tolerance was not the standard, would industry be more likely to test for the pathogens? – European experience belies this. EU standard is 100 cfu/g, but rates are rising, especially among the elderly. Should the industry be held to a standard that it can’t always meet?

9. Do other hazards require zero tolerance? E. coli O157:H7? – Produce Salmonella? – Already under zero tolerance for RTE foods – A rising issue: salmonella in frozen, non-RTE products Vibrio vulnificus? – Deadly pathogen for consumers with liver disease, diabetics, and others who are immune compromised. – FDA uses consumer warnings but no microcriteria that would compel industry to use available treatment options

10. What could replace zero tolerance? Either government can mandate detailed technical systems (i.e. low acid canned food, milk code) or utilize performance standards Performance standards allow for innovation But we must recognize, the definition of “zero” will change as sampling strategies evolve and enforcement tools are modernized.

11. Questions? Contact Information: Caroline Smith DeWaal Food Safety Director CSPI csmithdewaal@cspinet.org (202)777-8366