Saturday, June 27, 2009

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 FDA has published draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (June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.

Monday, June 15, 2009

Comical Case Names

Drunkenness of Noah, Oil on canvas, 103 x 157 ...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).

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Thursday, June 11, 2009

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 fa├žade, 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.

Wednesday, June 03, 2009

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.

Tuesday, June 02, 2009

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.

Monday, June 01, 2009

Summary of Discussion Draft of the Food Safety Enhancement Act of 2009

Representatives John D. Dingell, Henry A. Waxman, Frank Pallone, Bart Stupak, Diana DeGette, and Betty Sutton released a discussion draft of the Food Safety Enhancement Act of 2009. The draft is largely based on the food provisions of H.R. 759, the Food and Drug Administration Globalization Act of 2009, introduced in January by Reps. Dingell, Stupak, and Pallone. The Food Safety Enhancement Act of 2009 incorporates technical assistance from the new Administration as well as other stakeholders. The legislation grants the Food and Drug Administration (FDA) the authorities and resources it needs to better ensure the safety of the nation's food supply. The Committee has scheduled a legislative hearing for June 3, 2009.

From the Summary of Discussion Draft of the Food Safety Enhancement Act of 2009:

Food Safety

1. Creates an up-to-date registry of all food facilities serving American consumers: Requires all facilities operating within the U.S. or importing food to the U.S. to register with the FDA annually.

2. Generates resources to support FDA oversight of food safety: Requires registered facilities to pay an annual registration fee of $1,000 in order to generate revenue for food safety activities at the FDA; requires registered facilities to pay for FDA’s costs associated with reinspections and food recalls; allows FDA to charge a fee to domestic firms requesting export certificates for exported food.

3. Prevents food safety problems before they occur: Requires all facilities operating within the U.S. or importing food to the U.S. to implement safety plans that identify and protect against food hazards. FDA would have the authority to specify minimum food safety plan requirements and to audit food safety plans.

4. Requires safety plans for fresh produce: Directs FDA to issue regulations for ensuring the safe production and harvesting of fruits and vegetables.

5. Increases inspections of food facilities: Sets a minimum inspection frequency for all registered facilities. High-risk facilities would be inspected at least once every six to 18 months; low risk facilities would be inspected at least once every 18 months to three years; and warehouses that store food would be inspected at least once every three to four years. Refusing, impeding, or delaying an inspection is prohibited.

6. Improves traceability of food: Enhances FDA’s ability to trace the origin of tainted food in the event of an outbreak of foodborne illness. FDA would be required to issue regulations that require food producers, manufacturers, processors, transporters, or holders to maintain the full pedigree of the origin and previous distribution history of the food and to link that history with the subsequent distribution history of the food; and to establish an interoperable record to ensure fast and efficient traceback (current law permits facilities to hold a record in any format — paper or electronic — making efficient tracing of foods difficult for FDA). Prior to issuing such regulations, FDA would be required to conduct a feasibility study, public meetings, and a pilot project.

7. Enhances the safety of imported food: As an additional layer of protection, FDA can require food to be certified as meeting all U.S. food safety requirements by the government of the country from which the article originated or by certain qualified third parties. Third party certifying entities must meet strict requirements to protect against conflicts of interest with the firm seeking certification.

8. Expands laboratory testing capacity: Requires FDA to establish a program to recognize laboratory accreditation bodies and to accept test results only from duly accredited laboratories. Gives FDA the ability to require laboratories to send test results to FDA.

9. Provides strong, flexible enforcement tools: Provides FDA new authority to issue mandatory recalls of tainted foods. Strengthens criminal penalties and establishes civil monetary penalties that FDA may impose on food facilities that fail to comply with safety requirements.

10. Creates fast-track import process for food meeting security standards: Permits FDA to develop voluntary security guidelines for imported foods. Importers meeting the guidelines would receive expedited processing.

11. Enhances the safety of infant formula: Enhances FDA’s ability to assure the safety of new infant formulas before they go on the market.

12. Advances the science of food safety: Directs the Secretary to include food in an active surveillance system to assess more accurately the frequency and sources of human illness. The Secretary is also directed to identify industry and regulatory approaches to minimize hazards in the food supply.

13. Enhances FDA’s ability to block unsafe food from entering the food supply: Strengthens FDA’s authority to administratively detain unsafe food products. Grants FDA “quarantine” authority under which the agency may restrict or prohibit the movement of unsafe food products from a particular geographic area.

14. Directs FDA to assess the use of carbon monoxide in certain foods: Requires FDA to conduct a safety review of the use of carbon monoxide in meat, poultry, and seafood products.

15. Enhances transparency of GRAS program: Requires posting on FDA’s website of documentation submitted to FDA in support of a “generally recognized as safe” (GRAS) notification.

16. Requires country-of-origin labeling and disclosure: Requires all processed food labels to indicate the country in which final processing occurred. Requires food manufacturers to identify the country of origin for all ingredients on their websites. Requires country-of-origin labeling for all produce.


General Provisions

1. Creates an up-to-date registry of importers: Requires all importers of drugs, devices, and foods to register with the FDA annually and to pay a registration fee.

2. Requires unique identification numbers for facilities and importers: To enhance information about FDA-regulated entities, creates unique identification numbers for all drug, device, and food facilities and importers.

3. Creates a dedicated foreign inspectorate: Requires FDA to establish and maintain a corps of inspectors to monitor foreign facilities producing food, drugs, devices, and cosmetics for American consumers.

4. Grants FDA new authority to subpoena records related to possible violations.

5. Provides protection for whistleblowers that bring attention to important safety information: Prohibits entities regulated by the FDA from discriminating against an employee in retaliation for assisting in any investigation regarding any conduct which the employee reasonably believes constitutes a violation of federal law.