Food Safety Reform The Impact of One Small Company

Transcription

1 Food Safety Reform The Impact of One Small Company Jenny Scott Vice President of Science Policy, Food Protection Presented at the Western NY IFT Meeting Rochester, NY, March 31, 2009

2 Results of One Company s Actions November 10, 2008 PulseNet identified a dispersed multistate cluster of 13 Salmonella Typhimurium isolates with an unusual PFGE pattern Illnesses linked to peanut butter and peanut butter/peanut paste-containing ingredients from a facility in Blakely, Georgia owned by Peanut Corporation of America Additional illnesses linked to in-store ground peanut butter made with peanuts from Plainview, TX facility owned by PCA

3 Illnesses and Death 691 illnesses in 46 states (plus one in Canada), 9 possible deaths (as of March 15, 2009) Median age 16 years 21% < 5 years old; 17% > 59 years old Illness onset dates September 1, 2008 February 24, 2009 One laboratory-confirmed case in a dog

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6 Results of One Company s Actions January 10 Company A recalled peanut butter packed under its label by PCA January 13 PCA recalled 21 lots of peanut butter in 5-50 lb containers January 14 Company B placed precautionary hold on peanut butter crackers January 16 PCA expanded recall and Company B recalled peanut butter crackers

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8 Results of One Company s Actions January 28, 2009 PCA recalled all peanuts and peanut products processed in its Blakely, Georgia facility since Jan. 1, 2007 Ultimately this expanded to all products produced at its Plainview, TX facility 3863 products recalled (as of March 26, 2009) Brownies, cakes, pies, cookies, ice cream, candy, cereal, crackers, doughnuts, dressings, toppings, fruits and vegetables, pet foods, suet, meals, snack bars, snack mixes Recalls continue to date

9 The Fallout Major financial losses Loss of consumer confidence Food supply and the industry providing it CDC FDA and state regulators Negative impact on 3 rd party auditing Spurs Congress and States to fix the problem Spurs industry to fix the problem

10 Financial Losses This incident could cost the peanut producers $1 billion Weakened pricing Limited ability to sell products Company A - $ 0.5 million (before lawsuits) Company B - $65-70 million (before lawsuits) Losses for restaurants, grocers, candy, ice cream manufacturers, and other small businesses - TBD

11 Public Perceptions about the Foods That Have Been Recalled % who think that each food is involved in the recall, among the 93% who heard about the recall Peanut butter crackers 70% Some snack bars 49% Some cakes, brownies or cookies 45% Some pet treats 43% Some candy 39% Some pre-packaged meals Some ice cream Major national brands of peanut butter 27% 25% 36% Foods involved in recall Foods not involved in recall Jars or cans of dry-roasted peanuts 23% Harvard Opinion Research Program, Harvard School of Public Health, February 4-8, 2009.

12 Company Defense Companies such as ConAgra, Hershey, Smuckers and others NOT involved Issue press releases and take out newspaper ads that their products were not associated with the investigation Post information on their websites to that effect Promote sales with coupons

13 Financial Losses Significant losses for jarred peanut butter (not involved in the recall) For the 4 weeks ending 1/24/09, sales down 11.5% from previous 4 week period Lbs of jarred peanut butter down 22% from same period a year ago Nielsen Co.

14 PCA Losses PCA filed for Chapter 7 bankruptcy February 13 Insurance company has questioned its obligation to pay recall costs Civil lawsuits against the company have been filed in a number of states CEO called before Congress FDA has opened a criminal investigation

15 PCA Impact Beyond Recalls Forward Foods, LLC, Minden, NV filed for Chapter 11 bankruptcy February 16 Forced to recall several brands of energy bars Sales of these accounted for 75% of all the company s protein bar sales

16 FDA, 2009

17 Loss of Consumer Confidence FMI s annual US Grocery Shopper Trends Report shows consumer confidence fluctuates % completely or somewhat confident in supermarket food * Only 11% are completely confident *

18 Loss of Consumer Confidence 2/3 of Americans believe instances of food contamination have increased the last 5 years (although 87% agree US has one of strongest food safety systems in the world). 49% of mothers are avoiding products with peanut butter ingredients, even if not on the FDA recall list. 65% report changing short-term buying habits during a food contamination outbreak but not their long-term behavior. 23% said the most recent food scare will change their long-term food purchasing habits. Burson-Marsteller and Penn Schoen & Berland Associates 2/09

19 American Society for Quality Survey on Food Safety State of the Economy Energy costs Quality of the education system Safety of the food supply War on terror % Very concerned/concerned /09

20 Negative Impact on 3 rd Party Auditing March 6, 2009 Food Safety Problems Slip Past Private Inspectors Companies are increasingly requiring suppliers to undergo [3 rd party audits] as a way to ensure safety and minimize liability Rigor of audits vary widely Many companies choose the cheapest Auditors are usually paid by the food plants they inspect It is up to the discretion of food companies to fix problems found by auditors

21 Food Safety Problems Slip Past Private Inspectors Mr. X an expert in fresh produce, was not aware that peanuts were readily susceptible to salmonella poisoning. I never thought that this bacteria would survive in the peanut butter type environment, Mr. X wrote to a food safety expert on Jan. 20, after the deadly salmonella outbreak was made public, according to a copy of his message. What the heck is going on?? March 6, 2009

22 Negative Impact on 3 rd Party Auditing The contributions of third-party audits to food safety is the same as the contribution of mail-order diploma mills to education. Mansour Samadpour, President, CEO, IEH Laboratories & Consulting Group

23 Negative Impact on 3 rd Party Auditing The retail giant Costco, which had already limited Audit Company A s audits to bakery vendors, has now told suppliers to stop using the group altogether.

24 Negative Impact for Regulatory Inspections State inspectors also found only minor problems at the PCA Blakely plant (NY Times, March 6, 2009). Few of the 60 inspectors who oversee 16,000 Georgia food processors have backgrounds in food safety, or in any other science (AJC, March 8, 2009).

25 Peanut Inspection System Filled with Holes Inspector Y last inspected Peanut Corp. on Oct. 23. No one had made the connection at the time, but by then, federal authorities say, hundreds of people in more than 40 states already were ill from the plant s contaminated products. PCA was cited for two violations: mildew and dust on the ceiling of a peanut butter storeroom and a black buildup on shipping containers. The Atlanta Journal and Constitution March 8, 2009

26 Peanut Inspection System Filled with Holes Three inspectors who visited the plant from 2006 through 2008 documented such unsanitary conditions as standing water that could breed bacteria, mildew on walls of food production areas, and gaps where rodents could enter. But they never recognized patterns persistent moisture inside the plant, a leaky roof that would have predicted the extensive contamination the U.S. Food and Drug Administration has now documented. The Atlanta Journal and Constitution March 8, 2009

27 Congressional Fixes Mandatory recall authority Mandatory GAPs/produce standards Mandatory traceability (EACH article of food in commerce, farm to fork) Preventive control plans Performance standards Plant registration/suspension Specific inspection frequencies Civil penalties Re-inspection fees Use of third-party auditors

28 Key Legislative Proposals House Dingell, Pallone, Stupak H.R. 759, Food and Drug Administration Globalization Act of 2009 DeLauro H.R. 7143, Food Safety Modernization Act [of 2009] DeGette H.R. 814, Tracing and Recalling Agricultural Contamination Everywhere (TRACE) Act of 2009 DeGette H.R. 815, Safe and Fair Enforcement and Recall for Meat, Poultry, and Food Act of 2009 Costa, Putnam H.R. 1332, The Safe FEAST Act of 2009

29 Key Legislative Proposals Senate Brown S.425, Food Safety and Tracing Improvement Act Durbin, Gregg, Burr S. 510, Food Safety Modernization Act of 2009

30 Dingell & DeLauro Bills GMA Concerns: Requires mandatory third party certification for all imports: Congress should focus domestic and foreign inspections on facilities that pose the greatest risk of contamination that could result in foodborne illness or injury. To focus scarce resources, FDA should permit expedited to entry for imports that pose no meaningful risk. To support such efforts, FDA should encourage the use of voluntary third-party auditors but should not require all imports regardless of risk to be subject to a third-party audit.

31 Dingell & DeLauro Bills GMA Concerns: Contains significant user fees that would attach to the bill s requirement that all food facilities register annually with FDA. Specifically contains a complicated fee structure that would allow FDA to set the registration fee as necessary to generate revenues for increases in activities related to FDA inspections and other related activities. There would be an exemption for small companies thereby placing the burden on large companies. The bill also includes a $10,000 importer fee. At a time of volatile food prices, Congress and the Administration should use general revenue -- and reject broad food taxes or fees -- to finance essential FDA functions. Although we support user fees that provide clear benefits to industry, we oppose broad food taxes or fees to finance basic FDA functions.

32 Dingell & DeLauro Bills GMA Concerns: Broad traceability requirements. Would impose a one size fits all approach to traceability that will increase the cost of food production. FDA should work with fruit and vegetable growers to demonstrate a variety of traceability systems for produce as a prelude to rulemaking. Administrative Detention. If the scope is to be expanded to include misbranded products, that should be limited to misbranding under 403(w) which covers undeclared allergens. Country-of-Origin- Labeling. Would require country-of-originlabeling on the product label for a finished food and on the company s website for all ingredients.

33 Dingell & DeLauro Bills GMA Concerns: Civil Money Penalties. A penalty up to $100,000 for an individual, and up to $500,000 for a company, could be triggered for any violation of the Act. Food companies have powerful incentives to ensure the safety of food products and ingredients. In addition to the cost of recalling contaminated foods, food companies risk the loss of market share and the diminished value of their brands as well as litigation in state courts. Current law provides a wide range of enforcement tools, including seizure, injunction, and criminal penalties. Dramatically increasing civil penalties will not provide any new incentives to produce food safely, but will instead divert resources and/or result in higher food costs.

34 DeLauro HR 7143 Create a separate Food Safety Agency within HHS. Rep. DeLauro bill would take an interim step towards the creation of a single food agency by establishing a Food Safety Administration with in HHS. reorganization would take a tremendous amount of time and money. steps Congress can take right now that would have a more immediate and direct impact on improving food safety.

35 The Bottom Line We will see a food safety bill from this Congress. We probably won t everything we see in it. FDA will get new authorities. Companies will see more inspections. Companies will be required to share more information during inspections.

36 State Fixes Georgia Commissioner to establish requirements for testing foods for contaminants, mandatory reporting of positives Texas Requirement to report positive tests for contaminants in food and raw materials; requirement to test for certain contaminants; requirement to provide isolates

37 Industry Fixes Support extensive additional funding for FDA Support new authorities for FDA Shift our focus from detection to implementing preventive controls

38 GMA Supports: Risk-based preventive controls Identify and evaluate potential biological, chemical, and physical hazards that may reasonably be associated with processing and packaging Implement reasonable and appropriate preventive controls for the identified hazards Prepare a written plan identifying the preventive controls Document that the plan is being implemented Durbin; Dingell; Costa

39 GMA Supports: Supply Chain Management KNOW YOUR SUPPLIER Have supplier approval programs Having controls for the immediate previous supplier will not be adequate in many cases.

40 GMA Supports: Mandatory standards for produce safety Procedures, processes, and practices for safe production, harvesting, and packaging of specific fruits and vegetables for which mandatory standards are necessary to minimize the risk of serious adverse health consequences or death Durbin; Dingell; Costa

41 GMA Supports: Mandatory foreign supplier safety assurance program to confirm that imported food complies with the same requirements as apply to food produced domestically Durbin; Costa

42 GMA Supports: Voluntary qualified importer program To provide for the expedited review and importation of food products offered for importation by U.S. importers of record who have voluntarily agreed to participate in such program Durbin; Dingell; Costa

43 GMA Supports: Building the capacity of foreign governments expand the technical, scientific, and regulatory capacity of foreign governments, and their respective food industries, from which foods are exported to the United States Durbin; Costa

44 GMA Supports: Mandatory recall authority where a company refuses to do so voluntarily and there is a significant risk of adverse health consequences or death to humans or animals Durbin; Dingell; Costa

45 GMA Supports: Modernizing FDA s good manufacturing practice regulations to include requirements for Written sanitation plans Allergen controls Environmental monitoring programs for certain production facilities Supervisor, manager, and employee training in hygiene and food safety control measures

46 GMA Supports: One-step forward, one step backward traceability

47 Traceability Core Elements Each raw material/ingredient should have a batch/lot code and records that tie it to the immediate previous source Each finished product that leaves a facility should have a batch/lot code and records that tie it back to the specific raw materials/ingredients used to manufacture the product and to the manufacturing facility Distributors (including manufacturers) should have batch/lot code records of receipt and distribution for each product. The systems used for data capture and transfer should be interoperable.

48 GMA Supports: A simple means of rapid, uniform notification of safety-related recalls of consumer products to retailers who need to remove these products from the shelf. A greater role for industry during foodborne illness outbreak investigations

49 Industry Role in Multi-Jurisdictional Investigations Industry can provide information on where ingredients are used, distribution patterns Processing info can eliminate the need to consider certain products Early warning about potentially implicated products and brands can allow affected industry/company to implement product withdrawal or recall early

50 NOT the Way To FIX the Problem! FDA Approves Salmonella Calling it "perfectly safe for the most part," and "not nearly as destructive or fatal as previously thought," the Food and Drug Administration approved the enterobacteria salmonella for human consumption this week. The Onion, March 10, 2009

51 Conclusions Industry takes its responsibility for food safety seriously. The impact of a small company can be very farreaching. Small companies must use the same food safety practices as large companies. Food safety in the US can be improved, but not by knee-jerk reactions. We need well thought-out approaches that are developed collaboratively and broadly applied.

52 Conclusions Industry wants to play a key role in developing solutions to problems, not be a roadblock.

53 Conclusions What will really make a difference?* Require risk-based preventive controls Mandatory produce standards More regulatory oversight (inspection) More supplier oversight by food companies More microbial testing by food companies Industry working together with regulatory officials to develop guidance for industry segments. * Reflects the views of Jenny Scott, not necessarily GMA

54 Thank you!