Team Diarrhea to the Rescue!

Minnesota Senator Amy Klobuchar introduced the Food Safety Rapid Response Act of 2009, S 1269. The bill is intended to enhance foodborne illness surveillance and improve food safety by through more rapid and coordinated response to foodborne disease outbreaks. The bill would direct the Centers for Disease Control (CDC) to promote best practices for foodborne illness surveillance and improve the surveillance capacities of the states.

Like the Emperor’s New Clothes, no one wants to talk about the lack of capacity at many state and local health departments. However, this is not just a state and local issue. Our federal food safety system stands (or falls) on the shoulders of the ability and capacity of the states.

Contrast a few states, like Minnesota, known for fine foodborne disease surveillance. Minnesota has a group of investigators, known as Team Diarrhea, that race into action when there is a suspected foodborne disease outbreak. Minnesota was the first to trace the source of the recent Salmonella disease outbreak to peanut butter from Georgia. Essentially, our federal food safety system depended on people in Minnesota getting sick or dying to detect a national food safety problem that started in Georgia?

S 1269 would help create a more rapid and coordinated response to foodborne illness outbreaks. The bill could possibly lead to the institution of Team Diarrhea nationally.

Senator Klobuchar’s press release.

Hat tip to Cynthia Dizikes in MinnPost.com.

Public Workshops on the FDA Reportable Food Registry

FDA announced three public workshops on the Reportable Food Registry. The public workshops are to explain the purpose of the Registry, how it will work, and the responsibilities of persons required to submit a report regarding instances of reportable food to FDA through the Reportable Food electronic portal. In addition, the role of federal, state and local public health officials in voluntarily reporting instances of reportable food to FDA will be discussed.

Electronic registration is encouraged. Please go to Reportable Food Registry Public Workshops for more information.

On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by creating a new section referred to as 417, Reportable Food Registry. Section 417 requires the Secretary of Health and Human Services to establish within the Food and Drug Administration (FDA) a Reportable Food Registry. The congressionally-identified purpose of the Reportable Food Registry is to provide a "reliable mechanism to track patterns of adulteration in food [which] would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health" (Pub. L. 110-085, § 1005(a)(4)).

The Secretary has delegated to the Commissioner of FDA the responsibility for administering FD&C Act section 417. To further the development of the Reportable Food Registry, section 417 requires FDA to establish an electronic portal by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. A "reportable food" is an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.

(FD&C Act § 417(a)(2)). "Responsible party" is defined as the person who submits the registration information to FDA for a food facility that manufactures, processes, packs, or holds food/feed for human or animal consumption in the U.S.

The Registry is scheduled for implementation on September 8, 2009, and applies to all FDA-regulated categories of foods except dietary supplements and infant formula. FDA has published draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (June 2009). This guidance contains questions and answers relating to the requirements under section 417 of the FD&C Act, including (1) how, when and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food.

Comical Case Names

Drunkenness image via Wikipedia

From Lowering the Bar. Legal Humor. Seriously, by Kevin Underhill:

United States v. 11 1/4 Dozen Packages of Articles Labeled in Part Mrs. Moffat’s Shoo-Fly Powders for Drunkenness, 40 F. Supp. 208 (W D.N.Y. 1941) (holding product was misbranded because it was not in fact a cure or treatment for drunkenness).

Julius Goldman's Egg City v. United States, 464 U.S. 814 (1983).

United States v. Approximately 64,695 Pounds of Shark Fins, No. 05-56274 (9th Cir. Mar. 17, 2008).

A Scary Reminder that Restaurant Allergen Negligence Can be Fatal

I sat up half the night with an Epi-pen watching my wife to see if she was still breathing. The restaurant we ate at that night contaminated my wife’s meal with tree nuts. Although we had told the server that my wife was allergic to nuts -- and the server assured us there would be no nuts -- someone or some system failed at the restaurant.

The restaurant, Gulfstream, an upscale eatery in Orange Country, California, looked beautiful. Everyone at the restaurant presented a polite façade, but ultimately seemed unconcerned about their negligence, which could have killed one of their patrons. The restaurant management has not answered or returned my phone calls.

The Orange Country HCA Environmental Health agency was perhaps worse. The agency would not take my complaint on food contaminated with hidden allergens. The HCA person acknowledged the agency inspected the restaurant, but she thought allergens were solely the consumers’ responsibility. Moreover, the health agency employee seemed unaware that allergic reactions could be serious or even fatal. She dismissed my complaint as not their concern.

Someone ought to instruct Orange County government about the contents of the FDA Food Code, which is adopted by the state of California. We clearly have a ways to go on educating food service managers and health inspectors about food safety.

FSIS and FDA to Host a Public Meeting on Listeria Risk Assessment

FSIS and FDA to host a public meeting to discuss the interagency retail Listeria monocytogenes risk assessment on June 23 in Washington, DC, to discuss the background, approach and scope of a new interagency risk assessment.

Today's Hearing on the Draft Food Safety Enhancement Act of 2009

Documents and video from today's Energy & Commerce Subcommittee on Health hearing on “Food Safety Enhancement Act of 2009” are available here.

Stalemate at the USDA

Tom Laskawy at the Beyond Green blog has an interest post on the reasons why Vilsack “can't find anyone to run the USDA's Food Safety and Inspection Service. You wouldn't think it would be that hard. There must be dozens of scientists and food safety experts who fit the bill.”  . . . “The three candidates mentioned for the post so far, Michael Osterholm, Michael Taylor (though it's unclear if he was really up for the job) and Mike Doyle (so many Mikes!) are all champions of what Marion Nestle likes to call "late-stage techno-fixes." Or, as Obamafoodorama puts it, ‘Zap the crap!’" . . .

The President's Food Safety Working Group has a “spanking new website, [but] the administration hasn't released the names of anyone who's serving on it. The administration's food safety stalemate applies over there as well.”

Read the whole article here.

Search Warrants-What Happens When the FDA Storm Arrives

FDA’s use of criminal search warrants is increasing according to John R. Fleder in his recent article in Update, “Search Warrants—What Happens When the FDA Storm Arrives.” The article offers precautionary steps to ensure a business is prepared to deal with the possibility of a FDA search.