Lost opportunity?

I was talking with David Plunkett, a lobbyist for the Center for Science in the Public Interest, earlier today about his perceptions of the produce industry position on traceability. (Find his powerpoint presentation here to the Oct. 16 FDA traceability meeting)

While commending the industry's recent push toward a more efficient traceability system, he said the industry was "feeling the pain" from the ineffectiveness of the 2002 bioterrorism law. Rather than have a efficient traceability system in place as a result of the 2002 law, he said what emerged from the regulatory process to implement that law was a weakened "one step up and one step back" approach. Likewise, instead of the entire industry of sharing the costs of an efficient traceability system starting in 2003, the costs and penalties for an ineffective system have shifted to subsets of the produce industry - namely leafy greens and tomatoes. He pointed to the July 31 testimony of William Hubbard (Coalition for a Stronger FDA) before the House Energy and Commerce, Oversight and Investigations subcommittee. From Hubbard's testimony on July 31:


As you know, after the September 11 attacks seven years ago, Congress was concerned that the food supply could be vulnerable to terrorism, and enacted the Bioterrorism Act of 2002 (formally titled the Public Health Security and Bioterrorism Preparedness and Response Act). One provision of that statute required food firms to establish and maintain records detailing the movement of food through the supply chain, with the intention of giving FDA the ability to rapidly trace sources of contamination; and thereby blunt the potentially devastating effects of intentionally contaminated food.
Unfortunately, the transition from what was believed needed right after 9/11 to what they agency actually got months later when it promulgated its regulations on recordkeeping is
a virtual case study in how to weaken a regulation to the point of being indistinguishable from the original intent. Indeed, if we were to consider the tomato/pepper salmonella search as a test of the recordkeeping rule, I think it’s fair to conclude that the grade would be a fairly clear “F.” Let me explain, and in so doing describe why the old axiom of not wanting to watch laws or sausages being made can also apply to implementing regulations.
Below is a brief “side-by-side” analysis of some of the key weak points introduced into the original legislation and regulation as it was being reviewed and considered by Administration reviewers:


What FDA wanted/needed Final Rule Provisions
Records by all sources/recipients Farms and restaurants excluded
Foreign firms as well as U.S. Foreign firms dropped
Complete record of a food’s movements Only “one forward, one back”
Lot numbers for each shipment Denied
Electronic records (for speed) Denied
Records access within 4 hours Extended to 24 hours
Consistent record format Denied
Authority to verify keeping of records Denied
Authority to enforce requirement Only (mostly enforceable) “prohibited act”


In sum, the theory after 9/11 was that the agency needed rapid access to complete and useable records of a food’s origins and movements, to deter and react to a terrorist attack.
What it ended up with was a requirement for partial records, made available in no particular hurry, from some people but not others, without a requirement that a given shipment be well identified, and in a format that could (and does) include the back of a plain brown paper bag. Further, the word quickly went out among the industry that FDA could only check on a firm’s adherence to the recordkeeping requirement if a food connected to the firm was the subject of a serious (“Class I”) recall and that the firm was unlikely to be punished if it ignored the recordkeeping requirement entirely.
One reason that the recordkeeping requirements were so watered down was the fear that they would be too costly for the food industry, with some estimates that the rules could cost processors $140 million per year. But, of course, the produce industry lost that much in the 2006 E Coli outbreak and is on track for similar losses in the ongoing Salmonella Saintpaul investigation. While our reluctance to impose regulatory costs is understandable, it may also be contributing to an ineffective regulatory structure and, in turn, the destruction of industries that rely on regulators to make rapid and accurate decisions about public health threats.


TK: Fast forward to next year; given the version of events prevented above - and the timeworn but true "you are only as strong as your weakest link" adage - it makes sense for the industry to agree to a deadline for mandatory supply chain implementation of the Produce Traceability Initiative.

Whole Foods: Rough patch?

This AP story reports that Whole Foods has been downgraded by one analyst to "underperform."

Given the challenging economic times, the analyst said the company may have trouble improving its profile in the months ahead. In fact, he said, maintaining even flat sales looks to be an uphill climb late this year and into next.

When the organic market sneezes, Whole Foods will catch a cold, and so this anticipated belt tightening by consumers shouldn't be surprising. The company is scheduled to report its quarterly earnings Nov. 5.

What may be surprising is that the most recent retail sales figures reflect continued double digit growth for the organic produce category.

The United Fresh Fresh Facts report showed second quarter 2008 sales of organic fruits and vegetables were up strongly, with weekly sales of organic fruit up 26% over last year in the second quarter and organic fruit volume up 16%. Likewise, organic vegetables showed a 22% gain in weekly sales per store and a 14% increase in weekly volume per store in the second quarter. Overall, Fresh Facts reported that the average price of organic fruit was $.371 per pound, up 17% from last year. The average price for organic vegetable was $3.46 per pound, up 8% from a year ago.

Fresh Facts said organic fruit contributed 7.2% to total produce sales in the second quarter, while vegetables accounted to 5.5% of total produce sales.

Looking ahead, it will be closely watched to see how much sales of organic produce decelerate from second quarter performance to the July through September third quarter.

Part 6 - WPPC-FDA Meeting Problems with traceback

More from John Guzewich, senior environmental health scientist in the Center for Food Safety and Applied Nutrition of the Food and Drug Administration, addressing WPPC attendees in the FDA auditorium on Sept. 11. He speaking about the salmonella Saintpaul traceback investigation.



Some of the problems that we had with traceback were the lack of adequate identifiers. All that we had in some cases was a pull date or an invoice and it may say case of tomatoes, it may say red rounds, it may say romas, it may say just tomatoes. But the terminology was quite variable. That was one our problems. The products go through the market place and the names referred to on the records often are changed. The same product can have multiple names through the system, and it makes it difficult to know if we are tracing the right product or not.

And we have the problem of repacking as well….

Chain restaurants ready for federal nutrition labeling standards

From the NRA this morning. Better to have one standard to comply with than a crazy patchwork quilt of state regs, no doubt....

A new coalition announced today that it will support federal legislation that provides consumers with detailed nutrition information in chain restaurants and other foodservice establishments using a uniform national standard. Legislation has been introduced by Senator Tom Carper (D-Del.), Senator Lisa Murkowski (R-Alaska), and Congressman Jim Matheson (D-Utah), which provides consumers across the country with nutrition information in a uniform, predictable way.

The Coalition for Responsible Nutrition Information (CRNI) was formed to ensure that consumers across the country will have access to detailed nutrition information when they dine out. Americans are becoming more health conscious and have a growing interest in the nutritional value of the food they eat. The Coalition (www.nationalnutritionstandards.com) is launching with more than thirty companies and associations that represent restaurant owners and franchisees, food manufacturers, distributors, suppliers, business organizations and health organizations.

“We believe consumers who visit chain restaurants should have access to detailed written nutrition information in a consistent and convenient manner. The only way to make sure this happens is by creating a uniform, national standard,” said Dawn Sweeney, President and CEO of the National Restaurant Association. “When different rules exist in various parts of the country, it makes it difficult for consumers to compare options. Consumers deserve a federal standard that provides access to the same nutrition information no matter where they are or where they live.”

“Consumers are increasingly looking for a variety of nutrition information to be available for their use in restaurants. The Coalition for Responsible Nutrition Information is working to create a nationwide standard that provides a significant amount of nutrition information in a manner that is efficient and effective for the wide variety of restaurants and dining occasions enjoyed by our guests,” said Joe Taylor, Vice President of Communication & Public Affairs for Brinker International.

Consumers understand that calories are only part of the information necessary to make smart food choices. The new coalition wants to provide consumers with a broad range of nutrition information including sodium, trans fat, saturated fat, cholesterol, carbohydrates, sugars and protein as well as calories to help them make appropriate decisions when eating at restaurants.

In fact, 79 percent of registered voters favor a law that would require restaurants to provide detailed nutrition information in writing, according to a recent national poll conducted by Peter D. Hart Research Associates.

“The majority of Americans, based on our findings, favor requiring restaurants to provide detailed nutrition information in writing, but not necessarily on the menu, as it seems to fulfill their desire to have access to nutrition information without intruding on their individual choice,” said Jay Campbell, Vice President of Peter D. Hart Research Associates.

Increasingly, restaurants are offering detailed information in convenient formats – including brochures, posters, in-store computer kiosks and Web sites. The approach should help consumers make smart food choices with comprehensive information like that found on packaged goods and groceries. Information would be available in writing in the restaurant - which is what customers want - and the Coalition for Responsible Nutrition Information is working with chain foodservice establishments and restaurants across the country to provide.

Recently, several cities, including New York and Seattle, passed menu labeling laws requiring restaurants to provide consumers with calories or a limited range of nutrition information. This approach will not provide all consumers with all of the detailed nutrition information they may want when they dine out. In addition, providing limited nutrition information on a city-by-city or state-by-state basis creates a patchwork quilt of confusing and contradictory local regulations.

For example, New York City requires just caloric information while Seattle requires calories, sodium, saturated fat and carbohydrates be listed on their menu. A uniform national nutrition standard, such as the one that has been proposed in the Carper-Murkowski and Matheson bills, would offer all consumers consistent detailed nutrition information in writing in chain restaurants and other foodservice establishments that goes beyond just calories.

In addition to numerous state restaurant associations and state retail associations, Coalition members include Auntie Anne’s Pretzels, Blue Cross Blue Shield of Florida, Brinker International, Burger King, Carlson Restaurants Worldwide, Darden Restaurants, Domino’s Pizza, Dunkin’ Brands, Grocery Manufacturers Association, International Dairy Queen, International Foodservice Distributors Association, International Franchise Association, McDonald’s, National Chicken Council, National Council of Chain Restaurants, National Fisheries Institute, National Franchisee Association, National Restaurant Association, National Turkey Foundation, OSI Restaurants LLC., Sonic, and White Castle.

The Coalition for Responsible Nutrition information is a broad based coalition of restaurants, industry organizations and companies that believe a uniform national nutrition standard for chain food service establishments will give consumers access to detailed nutrition information that meets their needs. For more information, visit our Web site at www.nationalnutritionstandards.com.

USDA analysis of FDA import refusals

Here is a link to the summary page of a USDA ERS study on FDA's refused food imports.Look for coverage of this in The Packer, and the author of the study promises future studies that will take a closer look at Chinese food import refusals and fruit and vegetable refusals. What did the study (link here to full report) find?


The study revealed recurring food safety risks and other problems (e.g., inadequate labeling) in certain types of imported foods. The findings, however, do not indicate the actual level or distribution of food safety risk that imports may pose to American consumers because FDA’s process for selecting shipments for inspection or other administrative actions is not random. Instead, FDA relies on risk-based criteria to guide its actions, including data on products and manufacturers with a history of violating U.S. import regulations. In essence, import refusals highlight food safety problems that appear to recur in trade and where the FDA has focused its import alerts and monitoring efforts. The top imported food categories refused due to food safety and other violations under FDA law were:
1. Vegetables and vegetable products (accounting for 20.6 percent of total violations);
2. Fishery and seafood products (20.1 percent); and
3. Fruits and fruit products (11.7 percent).
An examination of violations in these three categories reveals that refusals for sanitary violations in seafood and fruit products, pesticide violations in vegetables, and unregistered processes for canned food products in all three categories were persistent over time (fi g. 1).

More....



Of the 70,369 violations reported from 1998 to 2004, 33 percent were for misbranding or the lack of appropriate labeling and 65 percent were for adulteration or safety and packaging integrity problems (e.g.,leaky containers/swollen cans maysuggest the presence of microbial growth). Adulteration violations pose a wide range of food safety risks, from less severe risks, such as an insect in cooked soup, to immediate risks to human health, like botulism in canned food. The data indicate that the most common adulteration violations were for the appearance of fi lth in a food product and for failure to fi le information or register a specifi ed process. When specifi c pathogens were identified in import refusals, they tended to be found in food products typically associated with such risks (e.g., Listeria in cheese and cheese products).