New Retail Food Action Plan

In its latest step to increase the safety of the American food supply, the U.S. Food and Drug Administration (FDA) announced a Retail Food Safety Action Plan that includes several measures to help assure the safety of food sold in stores, restaurants, schools, and other foodservice operations. In support of the Action Plan, FDA also unveiled a cooperative agreement with the National Association of County and City Health Officials . FDA and the Association will promote the use of best practices by local authorities and attempt to increase retail food safety oversight as well as encourage the implementation of  FDA’s Voluntary National Retail Food Regulatory Program Standards for retail food programs.

FDA today also released a Supplement to the 2009 FDA Food Code. The Food Code contains  model food-safety regulations for  retail and food-service operations including restaurants, schools and food stores. Local, authorities use the Food Code to develop food safety rules consistent with national regulatory policy.

Key changes contained in the new Supplement include:

 

  • Requiring that food establishments have a certified food protection manager  with the following additional requirements:
    • that all operating procedures required by the Food Code are developed and implemented;      
    • that it can be verified that all employees are informed about their obligation to report certain health conditions that relate to transmission of food borne illness; and
    • that any food the establishment receives after operating hours is delivered in a manner that does not create a food safety hazard;  
  • Requiring that food establishments have a plan for responding to and properly cleaning-up after an employee or other becomes physically ill in areas where food may be prepared, stored or served;  
  • Clarifying appropriate exceptions to the prohibition of bare hand contact with ready-to-eat foods prepared in the establishment;
  • Clarifying the requirements for the safe storage and display of ground and whole-muscle meat and poultry;
  • New requirements for devices used to generate chemical sanitizers on- site in the food establishment;
  • Establishing clearer guidelines for the amount time a food establishment should be given to correct violations of different types of provisions in the Food Code.

Listeria Outbreak/FSMA Produce Regulations

The FDA confirmed this week that Listeria matching the strain that has caused health effects, was found on equipment and fruit at the Jensen Farms packing facility in Colorado.FDA Link..The recall that was announced on September 14 apparently actually began several days earlier and according to press reports included shutting down operations, the harvest and calling back trucks that were on the road.  Four deaths out of 35 reported illnesses have occurred.

This recall brings into focus the new regulations  that are to be promulgated by the FDA by January 2012 with respect to produce safety. Under Section 105 of FSMA the FDA is to establish standards for the safe production and harvesting of produce where the FDA has determined that standards would minimize the risk of serious adverse health consequences. FDA is required to publish a proposed rule on the minimum standards and publish updated Good Agricultural Practices by January of 2012. The standards are intended to include science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, nearby animals, water, and other hazards.

By this month, September 2011, the FDA is also expected to also publish a Notice of Proposed Rule Making which indentifies activities that constitute on -farm packing, holding, manufacturing and processing that will be subject to, or exempt from the Preventive Control Plan requirements under Section 103 of FSMA.

Arsenic in Apple Juice: Strong Poison or Much Ado About Nothing?

It's the battle of the network talking heads, M.D. division.  In this corner, Dr. Mehmet Oz, host of the Dr. Oz Show on FOX, and former Oprah Winfrey contributor.  In the other corner, Dr. Richard Besser, former head of the Centers for Disease Control and now chief health and medical director of ABC News.  The issue:  is there too much arsenic in apple juice marketed to consumers, including kids? 

Click on the links above to see the positions of the two sides.  Basically, Dr. Oz did a study of apple juice and found elevated levels of arsenic in excess of the amounts the FDA approves for simple bottled water.  Weighing in on the side of Dr. Besser (or perhaps vice versa), though, is the FDA itself, which rather loudly is proclaiming "tosh."  Or, rather, "Apple Juice is Safe to Drink." 

It's hard to wade through the rhetoric here to figure out who's "right", particularly when even Dr. Oz is not recommending anyone give up apple juice because of the risk of arsenic.  The FDA and the manufacturers all dispute both Dr. Oz's test results--they both tested juice from the same batches and came up with significantly lower levels of total arsenic--and criticize him for testing only for total arsenic, instead of distinguishing between inorganic arsenic, which is really bad, and organic arsenic, which the FDA says is generally safe and is ordinarily the kind of arsenic found in apple juice (but not in bottled water).  Dr. Oz's response doesn't seem to be all that persuasive; if the juice doesn't test for too much inorganic arsenic (or too much total arsenic), does it matter that it comes from countries that use arsenic as pesticides?  And arguments about whether apple juice is better for you than eating raw apples are neither made stronger nor weaker if the level of arsenic is insignificant. 

Although known to the ancients as a poison, arsenic has many benign uses, including being used in the first effective treatment of syphillis.  Along with other poisonous chemicals, it was used for centuries in makeup.  The plot of Dorothy L. Sayers novel Strong Poison centers on a murder by arsenic poisoning, where the murderer (SPOILER ALERT!) developed a resistance to arsenic over time, and thus survived while eating the exact meal as his victim.  The story was suggested by the tale of King Mithridates, as A.E. Housman wrote in "A Shropshire Lad,"

They put arsenic in his meat
And stared aghast to watch him eat;

Today, arsenic is used in semiconductors and light-emitting diodes.

It is not for this blog, of course, to weigh in on the actual merits of the controversy.  But we note that comments in the popular media about the safety of food can have a really strong, negative impact on purveyors of food items, whether they are true or not.  A strong debate about food safety is always welcome, but the use of sensationalist headlines and a failure to meet scientific arguments head on can leave misleading impressions that can have really significant impacts on real people.  Stay tuned.

Product Traceability Pilot Studies

In the wake of recent recalls the progress of implementation of the Food Safety Modernization Act (FSMA) has become more significant. The Pilot Traceability Project was announced as of last week. This project is intended to provide a structure for tracing ingredients back to their source in the event of a recall. Section 204 of FSMA requires the FDA to “establish pilot projects in coordination with the food industry to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a food borne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated …or misbranded." 

The Pilot projects will be carried out by the Institute of Food Technologists (IFT) at the direction of FDA.

A product tracing system involves documenting the production and distribution chain so that a product can be traced back to a common source or forward through distribution channels if there’s evidence of contaminated food.  The actions that follow may include removing the product from the marketplace and alerting the public if it has already been distributed.

The FDA indicated that: “What we’re looking for is a system that is practical, feasible, and rapid,” says Sherri McGarry, senior advisor in FDA’s Office of Foods. “Our No. 1 priority is protecting public health.”

McGarry explained that IFT will work with the key groups that have a stake in this endeavor—food industry, state and federal government agencies, and consumers—in developing the pilot programs. The goal is to include industries that represent the food supply chain, including farms, restaurants, and grocery stores.

The pilot programs will evaluate the types of data that are most needed for tracing, ways to connect the points in the food supply chain, and how quickly data can be made available to FDA. A key goal in the pilot projects will be to explore methods to track food and identify a common source or supplier starting at multiple points of sale. “We’re looking for a system that will allow FDA to quickly connect the dots along the food supply chain,” says McGarry. 

Business should keep an on eye on this process as the resulting programs may impose similar requirements on FSMA registrants in the future. 

On Monday, September 19, 2011, I will be speaking at The DEMATIC Material Handling and Logistics Conference  in Salt Lake City , Utah and presenting, "Field to Fork:  How the new Food Safety Modernization Act Will Affect You."  

Introducing David Goodnight

We at the Food Liability Law Blog, and at Stoel Rives, are extremely pleased that David Goodnight, one of our most noted trial lawyers, has agreed to join the team as a point person for food and beverage litigation.  David brings a wealth of trial experience as well as an incredibly calm "bedside manner" to the team.  He's the perfect person to talk to if there's someone standing outside your door with what appears to be a subpoena or a warrant.  He not only will know what you should do, he'll help to lower your anxiety level. 

Here's what one of his food and beverage clients just said about David:

Stoel Rives, under David Goodnight's leadership, provided absolutely outstanding legal counsel for our small business.  The partners at our firm marveled at his ability to litigate a very complex arbitration case to a successful outcome and then help connect us to the deep resources of Stoel Rives to solve the varied corporate and tax challenges we face as a small business.  We were very impressed by the breadth and depth of legal counsel at Stoel Rives and have recommended your firm to a number of our friends who own small businesses and people that were in need of professional legal advice.   Truly, we can't thank David Goodnight and the legal team at Stoel Rives enough for what they have done for our company.

And here's another testimonial from a client in the pharmaceutical industry:

I could not have been more fortunate than to have the opportunity to work with David as our attorney to handle a legal matter for my company. His expertise and clear explanation of options, strategies, possible outcomes, and recommendations helped me to make the right decisions for our company. I never felt worried about our position with David on our team. He helped me and our company to take a strong position in a difficult legal matter without putting us at risk to overspend or overextend ourselves at anytime. His calm, strong, and thoughtful attitude made me feel that he was working for our good at all times. Thanks to David, we achieved success in the legal matter that he handled for us. If our company or I am ever in the position to need an attorney with David’s expertise, I would not hesitate to call on him again. He’s remarkable.

 

 

 

David's clients include GE, Amazon.com, International Paper, Qwest Corporation, Century Link and Weyerhaeuser Company.  He has been selected numerous times as one of Washington's top 100 lawyers, is recognized by Chambers and selected as a litigation star by Benchmark and Washington CEO.  We're extremely pleased to have him join our team. 

Please join us in welcoming David to the blog.

A Misleading Headline About Farmers Markets

The Seattle Post-Intelligencer is just a website now, not an ink-and-paper newspaper, but I still read it for local news.  My interest in doing so, however, was diminished somewhat when I saw this breathless headline:

Oh, no, I thought, I'd just come back from the Phinney Farmers Market with some onions, will I have to throw them away?
 
No.
 
When you go from the article to the material provided to the King County Board of Health by its staff, you see that all of the issues identified in the article, and almost the entire justification for the proposed fee increase (the remainder being the fee hadn't increased since 1995), relate to the people selling prepared food at the markets.  Indeed, the county was proposing a lower fee for markets that only sold fresh fruits and vegetables. 
 
We've written a few articles here about legal issues at farmers markets.  Obviously, it's important that prepared food vendors at farmers markets comply with health laws.  But a headline like the P-I's can only serve to scare people away from buying fresh fruits and vegetables from local growers, and without any justification.

Good luck, Ken (and Watch this Space)!

When Ken called me to tell me he was taking his new job at Kellogg's, I immediately thought of this cartoon.  Growing up outside Detroit, a highlight of every summer was a trip to Battle Creek, where they let you tour the factory, and at the end would give you samples of the latest Kellogg's cereal.  I can guaranty you I ate Cocoa Krispies and Froot Loops before you did.  The Cocoa Krispies were served on vanilla ice cream, too, as I recall.  That's still good.

When Ken first came to Stoel Rives, he was the second lawyer in our office admitted in Alaska, and unlike the first (me) he had actually practiced there.  We first spent time together discussing Alaska projects, but it was our mutual shared love of the Seattle Mariners that was the bedrock of our longstanding friendship.  Kellogg's is lucky to have him, even though he's promised that he will not, and his children will not, change their Mariner loyalty.  And he's fortunate to be working at a company associated with the kind of joy shown in that old Doonesbury cartoon.  Battle Creek makes one think of cereal and box tops traded in for toys, and cereal and box tops make one think of Kellogg's (even though Post is located there, too).  It's a great opportunity for Ken to work on food safety inside at such an iconic company, and we wish him well.  Plus we expect to hear from him--and even have him blog right here. 

While Ken has obviously been a gigantic part of our food liability efforts here at Stoel, he leaves behind both a legacy of people he has trained and worked with, and a culture adapted to the legal needs of the food industry.  Watch this space in future weeks as we introduce you to some of the great people who stand ready to serve you!

Japan to World: Remember Me?

Way before Hurricane Irene, the earthquake in Richmond, the liberation of Libya, the death of Osama bin-Laden, the liberation of Egypt . . . way back in the mists of time, or, to be specific, March 11, 2011, there was an earthquake in Japan, and damage to nuclear power facilities that affected the safety of Japan's food supply.  We wrote about it here and here

I have to admit I didn't give a lot of thought to what was going on in Japan, what with all that other stuff going on, but this morning I saw this article in Slate.  What the article points out is that both the actual food safety situation, and the psychological food safety situation, in Japan will be issues for a long time to come:  years, not months. 

By coincidence, I received an email from Second Harvest Japan.  And that led to this link to a means of making a tax-deductible donation to provide food to people in the affected areas.  So I did that.  I'd ask you to consider doing it, too.