Learn How to Prepare for an FDA Inspection
Next Wednesday at the ACI Food Regulatory Summit in Chicago I'll be presenting a talk entitled "Curtailing Downstream Liability Arising Out of On-Site Inspections: How to Prepare and What to Do Should Government Come Knocking." My slide-deck can be linked here.
Topics that I plan to cover include:
- FDA's plan to increase frequency of inspections and how it plans to do it
- How to be prepared for FDA's greatly expanded records access authority
- How to avoid new fees that will be imposed by FDA
- Developing an appropriate strategy to deal with FDA
- Preparing a privileged FDA inspection plan and training
More information about the ACI conference and registration can be found here.
Looking for Information and Presentations on FSMA, Recalls and The RFR? Look No Further.
I’ll be speaking at several events over the next two months on the Food Safety Modernization Act (FSMA) and how this comprehensive and far reaching legislation affects the status quo for food companies. Two of these events are free, and all promise to address relevant and critical issues for those involved in the food industry.
a. May 24 at Parker Smith Feek's offices in Bellevue for a discussion of the new FSMA, the Reportable Food Registry and how to survive a food product recall (event was rescheduled from March 22). Registration is free and coming soon. Contact me if you’re interested and I’ll get a spot reserved.
b. April 29 webinar sponsored by AON on FSMA. Link to the free registration is here.
c. May 12-14 Northwest Food Processors Association’s Executive Business Retreat in Coeur d'Alene, Idaho.
d. June 15-16 ACI Food Safety Regulatory Compliance Summit in Chicago. I'll be speaking specifically on "Curtailing Downstream Liability Arising Out of On-Site Inspections: How to Prepare and What to Do Should the Government Come Knocking." If you register by April 15, I can arrange for a discount. Just let me know.
If you can't make these events or would like a customized in-house presentation on FSMA, the Reportable Food Registry, recalls or other food liability topics, please let me know. Also, stay tuned for new blog entries addressing such topics as the Reportable Food Registry (RFR), restaurant menu labeling, and strategies to defeat food marketing/labeling putative class claims.
ACI Food-Borne Illness Conference in Chicago October 27 - 28, 2010
American Conference Institute (“ACI”) will hold its 4th National Conference on Food-Borne Illness Claims in Chicago, October 27 to 28. Highlights of this year's conference will include:
• Appearances by a number of current and former high-level regulators such as Dr. Arthur Liang from CDC, Dr. David Goldman from USDA, Dr. David Acheson formerly of FDA, Dr. Bob Brackett formerly of CFSAN, Jack Guzewich from FDA, Dr. Bill Keene from Oregon Public Health Division and Benjamin Miller from Minnesota Department of Agriculture
• Mock witness examination of a testifying epidemiologist
• Insights from of the nation's top in-house and outside food-borne illness counsel
The complete conference brochure can be linked here.
Unfortunately, my schedule won't allow me to join the conference this year (I've spoken at the first three ACI national conferences on food-borne illness). But I can arrange for a conference discount. Just give me a call (206-386-7595) or send me an email.
Regulatory Compliance Alone Is Not Enough: Understanding and Mitigating Consumer Fraud Claims
Click on the image below to view the slide-deck from the presentation that I recently gave with Scott Rickman from Del Monte at ACI’s summit on Food Safety and Regulatory Compliance in Chicago. The ACI summit was a nice introduction to food regulation byFDA, USDA, FTC, EPA and DHS. Our presentation was intended to start from the premise that the job of a food lawyer (whether inside or outside counsel) does not end at ensuring regulatory compliance. Products that are regulatory-compliant may still be subject to putative class claims.
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Please feel free to contact me if you have any trouble finding the cases or other references in the slide-deck.
ACI Announces 3rd National Forum on Food-Borne Illness Litigation
The American Conference Institute announced this week its latest food litigation conference. Here’s the conference brochure. The conference will take place in Chicago on October 26-27 at the Sutton Place Hotel.
Plaintiffs’ lawyer Bill Marler and defense lawyer Al Maxwell are co-chairing the conference. This year promises a greater variety of presentations by in-house food personnel, government regulators, and others. As in past years, I expect a stimulating exchange of information and vigorous debate about competing views of food liability issues. Feel free to email me or comment if you are attending or want more information.
2009 Priorities for USDA in Food Safety
I just returned from ACI’s Second National Forum on Food-Borne Illness, which included several interesting presentations and discussions. One was by Dan Engeljohn, Deputy Assistant Administrator of the Office of Policy and Program Development at the Food Safety and Inspection Service (“FSIS”). Mr. Engeljohn spoke about FSIS’s priorities for “2009 and beyond.” Takeaways from this presentation include:
Non-O157 STECs
FSIS is increasingly concerned with strains of E. coli other than O157:H7. Non-O157:H7 strains such as E.coli O121:H19 and O111 are growing more prevalent in the environment. FSIS is putting additional resources into developing methodology for detection of non-O157 STECs.
As FSIS, CDC, FDA and local health departments develop this methodology, the industry can expect more reported outbreaks and more liability exposure. Most experts believe that many non- O157:H7 outbreaks go undetected. Increased focus on detection of non-O157 E. coli strains is yet another reason to examine the sufficiency of your companies' insurance limits.
Frozen, Not Ready to Eat Meals
According to Mr. Engeljohn, because of recent salmonella scares, FSIS remains concerned about “frozen, not ready to eat” meals and specifically “frozen, not ready to eat” poultry meals. He explained that “evidence is mounting that these products cannot be safely prepared unless salmonella is controlled in the source materials.” In other words, FSIS now believes that no amount of package labeling or consumer education can prevent consumers from undercooking these meals.
FSIS jurisdiction over salmonella in poultry is limited. FSIS attempts restrict the sale of “frozen, not ready to eat” meals or impose more stringent standards against salmonella in poultry may be a reach for the agency. As discussed in Supreme Beef Processors v. USDA Salmonella, "is not an adulterant per se, meaning its presence does not require the USDA to refuse to stamp such meat 'inspected and passed.'" Absent statutory reform, FSIS action in this area may be challenged.
Listeria
Mr. Engeljohn stated that FSIS is “deeply concerned” about listeria. It believes that gains made in recent years at meatpacking plants may be undone by problems at supermarket deli counters. FSIS believes that little is being done to address critical control points at the retail level, such as proper cleaning and sanitizing of meat slicers. FSIS may be exploring ways to exercise more jurisdiction to regulate supermarket delis.
Registration Still Open For The ACI Food-Borne Illness Litigation Conference in Scottsdale
December 4-5 is the American Conference Institute’s 2nd National Forum on Food-Borne Illness Litigation. The first forum turned out to be a very engaging and diverse forum (e.g. plaintiffs lawyers, industry lawyers, top state and federal officials) on emerging issues in food-borne illness. I will be one of the many speakers. Ralph Weber, an accomplished trial lawyer from Wisconsin, and I will be offering "practical advice for litigating the case, retaining experts, assessing damages and planning a trial strategy." The focus of my presentation will be a discussion of how to develop trial strategy and themes at the earliest possible point, selection of experts and assessment of damages.
I’d urge anybody involved in dealing with risks from food-borne illness think about attending. If you register, mention the promotion code 724L09.S and you’ll get $200 off the conference price. Hope to see you there.
