Federal agency finds recordkeeping lacking in food bought at retail

May 13, 2009

Recent foodborne outbreaks have brought into question the ability of FDA to track down the source of a contaminated product due to inadequate recordkeeping. The U.S. Department of Health and Human Services Office of Inspector General released a report March 26 that identified areas of improvement for the food supply, and specifically for the fresh-cut produce industry.

The report was issued the same day Tom Stenzel, president of United Fresh Produce Association, and Craig Henry, senior vice president for science and regulatory affairs for the Grocery Manufacturers Association, testified before the House of Representatives Committee on Appropriations, Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, chaired by Rep. Rosa DeLauro (D-Conn.)

The Inspector General’s report was a traceability exercise that tracked 40 items from four categories from retail purchase back to the farm. Of those items, four were bagged salads and four were whole fresh tomatoes – two products implicated in foodborne outbreaks within the last few years. Other items in the report included bottled water, bagged ice, flour, oatmeal, fruit juice, eggs and yogurt. One item from each category was purchased in each of four cities: New York, Chicago, San Francisco and Washington, D.C.

After purchase, the Office of Inspector General contacted the retailer and provided the store with a description of the product and whatever relevant information was on the package, if any. The retailer was then asked to provide the contact information of the transporter and source of the product, the date the retailer received the product, the quantity of product the retailer received and a description of the product as it was received at the store.

The agency then contacted the companies provided by the retailer, and continued backtracking until the farm or first site of production was found. In all, 220 facilities were involved in the production or handling of the 40 items purchased at retail. There were the 40 stores where the 40 items were purchased; 45 distribution, wholesale or storage facilities; 45 processing or packing facilities; 6 brokers and 84 farms. Excluding farms, 118 of the facilities are required by FDA to have records least a step forward and step back.

The part of the report that concerns FDA and the Inspector General is the finding that almost 60 percent of the facilities that handled the products were unable to provide the information required by FDA.

Of the 40 retail items purchased, only five could be traced all the way through the production and supply chain, according to the report. Three of the five were cartons of eggs, which went to the retailer directly from the farm. The other complete tracebacks were one bottle of water and one container of yogurt, which was traced through four facilities and four farms. Thirty-one of the 40 products were traced back to facilities that “likely” handled the product, but the traceback wasn’t complete because the facilities either didn’t have specific lot codes or couldn’t produce the exact arrival of raw product or departure of finished product. The final four products –a tomato, a bag of ice, a bottle of fruit juice and a bottle of water – could not be traced to any facilities because at least one company in the supply chain had no information about the product.

“In a food emergency, there could be serious health consequences if FDA cannot – at a minimum – identify the facilities that potentially handled a contaminated food product,” according to the Inspector General report.

The agency identified four factors that significantly affected whether a traceback could be completed. First, processors, packers and distributors were not always keeping lot-specific information as required. Second, intermediary handlers did not record lot-specific information because it wasn’t required of them. Third, products received at retail did not have lot-specific information on the label, and lastly, there was mixing of product from several different farms.

Of the 118 facilities that were required to keep records, 59 percent did not provide all of the necessary information, according to the report. Six facilities provided no information, and 64 provided some but not all of the required information.

Recordkeeping requirements include contact information – name, address and telephone number – for sources of food goods, and 20 percent of the 118 facilities had incomplete contact information. Six of those facilities had no contact information, one being a produce distributor that purchased tomatoes from various vendors and did not record those transactions, according to the report.

More than half of the facilities in the traceback study did not have complete information on the recipients of food goods. Forty-one facilities had incomplete information about where the products were going, and the same six facilities that had no source information also had no recipient information. The report indicated that the facilities typically sold to various customers, and even if records were complete they were often on paper or kept in different databases. That slowed down the response time for the traceback.

In follow-up interviews with the companies that were part of the mock recall, the investigators found there was a lack of knowledge about FDA recordkeeping requirements. In total, one out of four managers were unaware FDA’s requirements – half of retail managers, 21 percent of storage, distribution or warehouse facilities, and 13 percent of managers at processing, packing or manufacturing facilities.

Based on the findings of the mock recall situation, the Office of Inspector General issued six recommendations to FDA:

1. Strengthen existing recordkeeping requirements regarding lot-specific information.

2. Consider seeking statutory authorization to improve traceability, including requirements for facilities to have a list of every farm that supplied raw material and requiring facilities to use a uniform tracking system.

3. Work with the food industry to develop additional guidance to improve traceablility.

4. Develop standards for mixing product from a large number of farms.

5. Seek statutory authority to request recordkeeping documents at any time, not only when there is reason to suspect a problem with the food.

6. Conduct education and outreach to the food industry about recordkeeping requirements.

Grocery Manufacturers Association supports more funding for FDA

Craig Henry, senior vice president for science and regulatory affairs for the Grocery Manufacturers Association (GMA), testified March 26 before the Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, following the presentation of the report from the Inspector General’s office.

Henry said GMA supports increasing the safety of the U.S. food supply, and the association recognized that more steps need to be taken.

“Ensuring the safety of our products – and maintaining the confidence of consumers – is the single most important goal of the food and beverage industry. Product safety is the foundation of consumer trust, and our industry devotes enormous resources to ensure that our products are safe,” Henry said.

Henry, on behalf of GMA, presented the subcommittee with the following recommendations for improving food safety.

1. Increase FDA food-related spending.

2. Require food manufacturers to have a food safety plan that documents risks and potential sources for contamination and identifies the risk prevention measures needed.

3. Require foreign suppliers to have food safety plans and encourage importer nations to regulate their own food or agriculture industries.

4. Give FDA the authority to regulate and establish federal safety standards for certain fruits and vegetables, if risk and science deem it necessary.

5. Adopt a risk-based approach to inspections that focuses on facilities that pose the greatest risk for contamination, and expedites entry of products that pose little risk.

6. Improve traceability systems, which could be developed with industry and government collaboration throughout the supply chain.

7. Give FDA and the Department of Health and Human Services the authority to authorize recalls, specifically in cases where food manufacturers refuse to issue a recall and FDA cites serious health risk to the public.