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.

Beyond Statistics: What the FDA's RFR Report Means for Food Manufacturers

Last week, the FDA issued its first annual report on the Reportable Food Registry (RFR). The report provides statistics on the first year of the RFR (2240 entries, 229 "primary reports," a breakdown of the report by hazards, etc.).

Beyond the statistics, the FDA report should be noted by food companies for two reasons:

  1. Food Safety Plans

FDA Deputy Commissioner for Foods Michael Taylor says that “[s]everal key U.S. industries are already re-evaluating their hazard and preventive controls, core principles of the Food Safety Modernization Act recently passed by Congress. We also anticipate improved reporting as we continue our vigorous outreach to food facilities through federal, state, local and foreign agencies, to help us expand the positive effect of the RFR on the safety of the U.S. food supply.”

The new hazard analysis and preventative controls requirements in the Food Safety Modernization Act (FSMA) are not effective for 18 months following passage. Deputy Commissioner Taylor's comments suggest that industry standards may already be moving in that direction . To mitigate exposure and risk, FDA enforcement actions, product liability claims, supply chain contract claims and recalls, food manufacturers may want to consider updating and/or creating food safety plans that address the hazard analysis and preventative controls prescribed by the FSMA.

  1. Allergen Controls

The FDA reports undeclared allergens/intolerances accounted for 34.9 percent of the primary reports. Industry experts assert that the FDA believes that the industry does not in general have good control over the issue of undeclared allergens. These experts believe that the FDA will give special attention to the issue of undeclared allergens/intolerances in promulgating regulations under the FSMA's requirements for hazard analysis and preventative controls (see point 1 above). In anticipation of the FDA's concern, manufacturers should consider now how they can change manufacturing processes to address the undeclared allergen issue.

The Sally Jackson Cheese Recall: the Last Purely Voluntary Recall?

There are few places in the United States that have less in common than Oroville, Washington and Washington, D.C. Tucked against the Canadian border in the peaceful and beautiful Okanagan Valley, Oroville is easier to reach from Kelowna, B.C. than from Seattle. Yet events in Oroville last Friday combined with the unusual events in the other Washington beginning last Sunday to give an Oroville business an historical significance it undoubtedly would have preferred not to have.

Last Friday, the FDA Food Safety Modernization Act, then known as S. 510, was as dead as Don Van Vliet, a/k/a Captain Beefheart, the legendary musician who passed away that day. Thus, the FDA had no more than the same power it has always had: publicity and the right to shut down a facility, but no power to force a recall. That day, Sally Jackson Cheeses of Oroville, provided evidence that linked its artisanal cheeses to outbreaks of E. Coli O157:H7, agreed to a recall of all of its products

As we know, on Sunday, the food safety bill was resurrected in an unusual weekend session of the Senate and was passed today by the House and heads to President Obama’s desk for a certain signature. The new act contains a section, effective immediately upon the President’s signature, which gives the FDA mandatory recall authority for the first time in its history. While that section includes a provision (which will become Section 423(a) of the Federal Food, Drug & Cosmetic Act) calling on the FDA to give companies a chance to effect a voluntary recall before using its mandatory powers, the difference between wielding a velvet glove and a velvet fist is significant. 

Thus, a tiny cheese manufacturer in an isolated Washington town, through an unexpected chain of events occurring nearly 2700 miles away, may have become the last food manufacturer ever to agree to a voluntary recall without the FDA’s power to order it to do so looming in the background.

The Great Egg Recall of 2010: Another Review of Lessons Already Taught

You have probably heard about the great egg recall of 2010, which has required Wright County Eggs of Galt, Iowa to recall an ever-growing number of shell eggs because of fears of salmonella enteriditis

An interesting issue here is the non-overlapping jurisdiction of USDA and FDA over eggs in the shell.  According to the FDA:

Generally, USDA is responsible for egg safety at what are called breaker plants or egg products processing facilities. In these facilities eggs are broken and pasteurized. FDA is responsible for shell egg safety and egg products once they leave the breaking facility.

Interestingly, while this outbreak is easily found on the FDA's website and at FoodSafety.gov, there is nary a word on the USDA home page.

The FoodSafety.gov page about safely handling and dealing with eggs is a good place to start for consumers worried about their own eggs. 

We also repeat the advice we have collected from previous outbreaks:

 

Updated RFR Guidance from FDA: Possession Is More Than 9/10ths

FDA recently released updates to its Draft Industry Guidance for the Reportable Food Registry (“RFR”). The RFR, not rolled out until the fall of 2009, is still new to many companies. FDA, overwhelmed by the information coming through the RFR, is still trying to determine how to use the information submitted to the RFR and how to advise industry.

Among the more interesting clarifications in the May updates is the importance FDA puts on the possession of reportable food as a trigger for obligations under the RFR. For example, if produce is still in the field (contracted but not owned by a food seller) and tests positive for a pathogen, no reporting obligation accrues.

 

FDA’s hypothetical:

 

[F]ood facility that contracted with the farmer and tested the produce in the field is not required to submit a reportable food report, provided that the facility did not manufacture, process, pack, or hold the produce and therefore never became a responsible party with respect to the produce. However, if the field had been harvested and the contaminated produce had been moved to the food facility, the facility would have become a responsible party because it “held” the food and would be required to submit a reportable food report.

 

On the other hand, if the same contaminated produce is received on a company’s premises, stays in the trailer, tests positive and is rejected, a reporting obligation is triggered (even though the company did not take ownership of the product).

 

FDA’s description of this scenario in a Q and A format:

 

Q: Our manufacturing facility receives bulk trailer shipments of ingredients from our suppliers. A truck driver brings a trailer full of bulk ingredients onto our property, drops off the trailer, and drives away. However, as company policy, we do not off-load the trailers that are delivered to our facility or take ownership of the food in the trailers until after we test a sample of the food and determine that the food is acceptable. If we “reject” a shipment, i.e., return the food to the supplier, because the sample results indicate that the food is a reportable food, are we required to submit a reportable food report?

 

A: Yes, provided that you are a facility required to register with FDA under section 415(a) of the FD&C Act, you must submit a report for the food you determined to be a reportable food, even though you returned the food to your supplier. FDA considers that your facility “held” the reportable food because the trailers were no longer in transit once they were dropped off on your property. Thus, you are a responsible party with regard to the reportable food. Provided that the adulteration did not originate with you, you do not meet the criteria for the exemption from reporting in section 417(d)(2) (see Question E.3).

 

TAKE AWAY: If a company can set up a system to do its micro-biological testing before the product arrives on its premises or at its warehouse (public or private), it should. If faced with a reportable event, the reporting requires notification to FDA of one step forward and one step back in the supply chain even if the product is never distributed. Once a report is submitted to the RFR, a company should expect that the FDA will notify the company’s customers of the reportable event despite the fact that the customer never received product. FDA notification means the customer will be told that its vendor had contaminated product that rises to the level of class I recall though this may not actually be true.  Food sellers and manufacturers, therefore, would be wise to take steps to avoid being “stuck” with RFR obligations for contaminated product it does not own.

Hurdles Faced By Plaintiffs In Class Action Lawsuit for Sale and Marketing of Cold and Flu Medications Containing Vitamin C

By Guest Blogger Tyler Anderson

On November 2, we blogged about the FDA warning letter issued to Procter and Gamble for its unlawful marketing of Vicks cold and flu medications containing Vitamin C. On November 4, 2009, a putative class action lawsuit was filed against Procter and Gamble in the U.S. District Court for the Southern District of Ohio (Sixth Circuit) alleging Procter and Gamble violated federal and state consumer protection laws through false and misleading advertising practices regarding the two Vicks products mentioned in the FDA warning letter.

Regardless of the merits of their case, the plaintiffs in this action may have a hard time obtaining their desired relief. In Count 1 of the complaint, the plaintiffs allege Proctor and Gamble violated the consumer protection laws of 43 separate states. The Seventh Circuit’s holding in its Bridgestone/Firestone decision (J. Easterbrook) and its progeny, suggests that under FRCP 23(b)(3), such a class action is unmanageable. Courts point to the impracticability of one court applying the divergent laws of differing jurisdictions in circumstances such as those at bar.

“Plausibility” pleading standards (see recent discussion of Wright v. General Mills) present additional hurdles. Applying Twombly as the court did in the Wright case, to survive a motion to dismiss the plaintiffs would need to make plausible, non-conclusory allegations that the plaintiffs purchased the Vicks products because they contained Vitamin C and the cost of the product with the Vitamin C was greater than it would have been without. No such allegations exist here, so applying the holdings of Twombly and Wright to this claim indicates that it may be subject to dismissal.

“Reliance” may be yet another avenue to dismiss the action (at least in part). Many state consumer fraud statutes require reliance. This means that the plaintiffs would be required to show that each plaintiff in the action bought the product in reliance on the purported fraudulent statement. Because purchasing decisions are individual decisions, proving reliance on a class-wide basis would be an individual inquiry that would predominate over issues of fact common to the class, which would negate class treatment.

Take-Aways from November 3 Webinar: Making Good Marketing Claims: Product Labeling Pitfalls, Third-Party Certification and "Green Washing"

Tuesday, November 3, we held our second webinar in a three-part series on bringing sustainable food products to market. Thanks again to our presenters and attendees. The recorded webcast was archived and is accessible at this link. Click here to access a PDF copy of the presentation slides.

Take-aways from the second webinar include:

• With the exception of the FDA’s policy on “natural” claims, it has been silent on “green claims.”

• “Natural” could be hottest claim on the market but is becoming controversial. Food companies should continually monitor the marketplace to see which claims are drawing challenges.

• Food companies should pay attention to consumers union findings regarding eco-label credibility.

• While third-party certification may not help every food business, certification is a tool that supports your brand and your marketing/sales strategy.

• Retail leaders in sustainability, such as Burgerville, aspire for continuity of sustainability in each link in its supply chain.

• To understand the FTC green guidelines companies need to appreciate three key points: substantiation, specificity and qualification.

• To avoid “green washing” issues, food companies need to understand the complex matrix of federal, state, local and foreign statutes, regulations and guidelines governing “green” advertising.

I hope you can join me, Steve Marinkovich from Propel Insurance, my colleague at Stoel Rives, Anne Glazer, and Peter Truitt from Truitt Bros., Inc. on November 17, at 9 am PST, noon EST, (live Twitter feed at #sustainlaw) for the last webinar in the series as we discuss the following:

• Preventing and Dealing with Consumer Fraud, Unfair Trade and False Advertising Claims from Consumers and Competitors

• Real-Life Businesses Approaches to Sustainability, Product Labeling and Marketing

• Coping with Increased Risks of Food-Borne Illness from Local or Small Farm Products

• Insurance Coverage You Need, Think You May Have but Don’t Have or Think You May Want but Shouldn’t Get

The Fuller Monty and Lady Godiva: More on the Plainview Problem

As I predicted last week, more and more companies are discovering that they had incorporated products from Plainview Milk Products Cooperative into what they sold.  The full FDA database, which is constantly being updated, is here.

While there have now been recalls of products as widely different as frosting and diet mixes, I was most struck by Godiva's recall.  As others have noted, as of the time of this post this doesn't appear anywhere in the Godiva website, either. 

Godiva's recall related to a special collection that was available only for Valentine's Day and Mother's Day. The "consume by" date for the Valentine's Day candy has passed and the "consume by" date for the Mother's Day collection has nearly passed.  Exactly one candy in the box, a praline crunch, included product from Plainview.  No one has complained of any symptoms from eating this candy.  So, if you, your mom, your grandma, your spouse or your sweetheart (a) got this box for Valentine's Day or Mother's Day, (b) haven't finished it yet, even though it has a short "consume by" window that has more likely passed; and (c) didn't eat that praline crunch, then you are supposed to discard the product and call 1-800-9GODIVA for a refund. 

The Godiva recall is being taken as a superabundance of caution, given the unlikelihood anyone meets all those criteria.  However, it does indicate that not all Plainview products were shelf-stable.  This may go on for awhile.

The Uniform Commercial Code and Food Recalls

Article 2 of The Uniform Commercial Code.  The Uniform Commercial Code ("UCC") is my Bible.  So, when I read about the pain caused to businesses and charities by the peanut butter recall, I look first to the UCC to see what might be available to help.

Article 2 of the UCC covers transactions in goods.  It expressly does not repeal laws on sales to consumers, nor does it change tort law.  But my focus here is not on torts, it is on contract law.  When a wholesaler buys tainted peanut butter paste from a factory, when a manufacturer buys that same paste from a wholesaler, when a grocer buys the products of that manufacturer directly or from another wholesaler, and when a consumer buys those products from a grocer, there is a simple contract for the sale of goods involved, and that contract is governed by Article 2.  When someone is made sick from the tainted product, there is a lot of law you can refer to; Ken has blogged on it a lot and will again.  But what happens in the case of a recall to parties who are, fortunately, unharmed by the tainted goods except in an economic way?

To begin with, to apply Article 2, there needs to be a sale.  Sale is defined in Article 1 of the UCC (the definition is applicable to Article 2 and the whole UCC) and requires the passing of title for a price.  Thus, a food bank that receives donated goods will not have any direct rights under Article 2. 

A contract for sales over $500 generally requires a writing.  This can be as simple as a purchase order or sales order or as elaborate as a 100-page contract for the sale of an airplane.  Even an exchange of e-mails can be sufficient. 

Generally, the more elaborate the contract, the more likely it is to protect sellers, not buyers.  This is because Article 2 protects sellers by default.  Article 2 contains what are called "gap filler" terms, which govern in the absence of express agreement otherwise.  Some of the most critical of these protect buyers from exactly the kind of issues that a food recall might generate.

Express and Implied Warranties.  Among the gap filler provisions are implied warranties.  The UCC implied warranties include:

In addition, sellers can give (or be deemed to have given) express warranties

 

What are these warranties like and how do they work in the context of food recalls?

The warranty of title is just what you think it is, a warranty that the person selling the goods has the power to sell them to you.  This is not exactly the same thing as saying the seller has full title to the goods; under certain circumstances, a buyer in the ordinary course of business can obtain better title than the seller itself has

The warranty against infringement relates to claims about intellectual property.  Food itself can be patented in some circumstances.  Infringement may be a topic for another day, though, no one is likely to be claiming intellectual property rights in tainted food.

It is the last three warranties that can be critical to the question of a food recall.

As we'll see in a bit, if these warranties are made, the buyer has some powerful tools in the case of a recall.  If these warranties aren't made, then the seller faces a far more favorable legal landscape.

The Warranty of Merchantability.  First, the warranty of merchantability requires that goods do all of the following:

  • pass without objection in the trade under the contract description; and
  • in the case of fungible goods, are of fair average quality within the description; and
  • are fit for the ordinary purposes for which such goods are used; and
  • run, within the variations permitted by the agreement, of even kind, quality and quantity within each unit and among all units involved; and
  • are adequately contained, packaged, and labeled as the agreement may require; and
  • conform to the promise or affirmations of fact made on the container or label if any.

If you're a buyer of food, you immediately want all these warranties, don't you?  If you buy apples, they should be apples as described by the seller, be of fair average quality, be fit for the ordinary purpose for which apples are used (cooking, eating), be of even kind, quality and quantity, be adequately packaged and labeled and conform to promises on the label (e.g., "Washington Extra Fancy").  

If you're a seller of food, you're thinking, "now, wait a minute."  

Apples are perishable, they can rot when they're not stored properly, they get worms in them, they get bruised, they get pushed around or dropped in transit, a certain percentage of them aren't perfect.  The seller is thinking, I took all those things into consideration in setting the price of these apples, and what I don't want is the buyer to be able to come back to me and say, three apples are bad, pay up.  Or worse, three apples are bad, I'm rejecting the whole batch.

So the seller says he doesn't want to make the warranty of merchantability.

The Warranty of Fitness for a Particular Purpose.  What about the warranty of fitness for a particular purpose?

What it says is this:

Where the seller at the time of contracting has reason to know any particular purpose for which the goods are required and that the buyer is relying on the seller's skill or judgment to select or furnish suitable goods, there is unless excluded or modified under the next section an implied warranty that the goods shall be fit for such purpose.

We go through the same dance again.  Imagine that you're looking to add some peanuts to a cookie dough.  You call in a bunch of peanut sellers and tell them your requirements:  quality, color, fat content, moisture content, etc.  The peanut seller says, have I got the peanuts for you!  And again the buyer is thinking, "I sure like this implied warranty of fitness for a particular purpose," while the seller is saying "I don't want to be liable if the peanuts don't make great cookies, I'm not a cookie baker."

Express Warranties.  Finally, express warranties.

Here's how they come into being:

  • Any affirmation of fact or promise made by the seller to the buyer which relates to the goods and becomes part of the basis of the bargain creates an express warranty that the goods shall conform to the affirmation or promise.
  • Any description of the goods which is made part of the basis of the bargain creates an express warranty that the goods shall conform to the description.
  • Any sample or model which is made part of the basis of the bargain creates an express warranty that the whole of the goods shall conform to the sample or model.

You won't be surprised to see that sellers and buyers make the same arguments about these warranties as well.

Disclaiming Warranties.  Sellers argue for, and often obtain, provisions in contracts like this:

SELLER MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

The language is specific because the UCC requires that the word "merchantability" appear (unless some other phrases approved in the UCC such as "with all faults" is used), and it is in all caps and bold because the UCC requires the disclaimers to be conspicuous

The Battle of the Forms.  Section 2-207 of the UCC, the so-called "Battle of the Forms" section, is the single most litigated section of the UCC.  Its revision was a central part of the abortive attempt to revise Article 2, which was not adopted in any state and was the subject of major controversy.  The current version has its own problems. 

What the battle of the forms covers, or tries to cover, is the situation that arises so often in commercial transactions when two parties act like they have a contract, but there is no one definitive expression of that contract.  The buyer sends out a purchase order with a lot of fine print on the back; the seller sends out a sales confirmation with a lot of fine print, too.  No one signs anything but the seller ships goods and the buyer pays for them and then a problem arises.  What are the terms of the parties' contract?

2-207(b) is where the real difficulties with this section of Article 2 lie.  It provides that "between merchants", terms in an acceptance that materially alter an offer become part of the contract unless one of three things has occurred:

 

  • the offer expressly limits acceptance to the terms of the offer;
  • they materially alter it; or
  • notification of objection to them has already been given or is given within a reasonable time after notice of them is received.

 

The critical issue that is covered in 2-207(c) is that a contract has in fact been formed even though the parties do not agree on all its terms.

Conduct by both parties which recognizes the existence of a contract is sufficient to establish a contract for sale although the writings of the parties do not otherwise establish a contract. In such case the terms of the particular contract consist of those terms on which the writings of the parties agree, together with any supplementary terms incorporated under any other provisions of this Act.

This is, essentially, why the buyers often win in a battle of the forms.  If one form says "you are making me a warranty" and the other form says "I'm not making any warranty", then the warranty clause is not a clause on which the parties agree.  Since the implied warranties of Article 2 are "supplementary terms", however, the seller will be subject to them unless it can disclaim them effectvely. 

Who Wins?  There are three times when a buyer can complain to a seller, with a cascading series of rights and obstacles depending on where you are in the timeline.

The easiest situation is upon delivery.  At the point of delivery, you have the "perfect tender" rule, which provides that if goods "fail in any respect to conform to the contract", they may be rejected.  Not only that, but you may reject all of them, accept all of them, or reject any commercial unit and accept the rest.  Thus, if you get a box of rotten apples in a carload, you can choose to reject them all, accept them all or reject the rotten box and keep the rest.  Indeed, you can technically reject them if a single apple is rotten.

Applied to a food recall, this is again the simplest case.  If the food has been recalled, it will not conform to the contract and may be rejected.  Even if all warranties have been disclaimed, the delivered food would not conform to the contract because it will not, in any meaningful sense, be food. 

What if delivery has occurred, but the food is recalled before it is processed, consumed or sold?

This is where the rules for revocation of acceptance may apply.  In order to revoke your acceptance of goods, the following must be true:

  • the non-conformity must substantially impair the value of the goods to the buyer
  • it was accepted because its non-conformity was difficult to discover
  • the revocation of acceptance occurs within a reasonable time of discovery of the non-conformtiy
  • the revocation occurs before any substantial change in the goods
  • the buyer notifies the seller

In the case of recalled food, the first requirement should be easy to satisfy, and the second would appear to be easy as well--the recalled status of food is usually not the buyer's responsibility vis-a-vis the seller.  The third and fifth requirements will depend on the buyer's diligence, but ordinarily in the case of a food recall, at least a merchant buyer will tend to be relatively diligent. 

The real action is in the question of whether substantial change has occurred to the goods. 

Interestingly, one of the leading cases in this area involves peanuts.  It held that peanuts that had been blanched were not substantially changed, and thus were eligible to have their acceptance revoked, while those that had been processed were substantially changed. 

If revocation of acceptance is not available, then the action will be for breach of warranty.  If the seller has made a warranty that the goods will be fit for human consumption, then it will not be difficult to make a claim for breach of warranty with respect to recalled goods.  If the warranty was disclaimed, then of course the situation would be reversed. 

The reality is that in the case of recalls that involve deaths, the really culpable party will, like PCA, most likely end up in bankruptcy.  Everyone else in the distribution chain, from distributors of raw materials to processors to distributors of processed foods to retailers to consumers, will be essentially an innocent party seeking to find some way out of its loss.  In general, whoever supplied the contract may end up with the best chance of prevailing.

 

Five New Year's Resolutions

Unfortunately, 2009 does not promise to be any easier than 2008 in protecting your business against food liability claims. Many argue that threats will only increase in the new year. Here are five things you can do to reduce exposure in the coming year:

1. Review Insurance Coverage and Limits Carefully – Both the variety and size of claims are escalating fast. For example, just a couple of years ago consumer claims from non-O157 E. coli, melamine, diacetyl or organic labeling seemed far-fetched, but all are now a grave reality. Federal, state and local governments will continue improving detection techniques since the rash of large, national food-borne illness outbreaks in 2006-08. The Obama administration will likely make increased funding in this area a priority. The odds that your company will be targeted in a nationwide outbreak resulting in claims in the hundreds of millions of dollars are increasing. Because of the exposure, insurance companies now more than ever will be looking for ways to reduce their coverage.

2. Review and Revise Supply Chain Agreements – Aside from insurance, one of the most effective ways to reduce, spread and mitigate risk is to ensure that those in your supply chain provide adequate insurance and indemnity for problems related to their products. But just because your supply agreement happens to mention insurance and indemnity does not necessarily mean those clauses will help when you need them. The only way to ensure that they will be honored and enforced is to ensure that your legal team (experienced in litigating these clauses) drafts these carefully.

3. Reassess Suppliers – Your choice of suppliers may be key to avoiding or reducing risk. Even if you demand sufficient insurance and indemnity from a supplier, a supplier of sufficient size may not be able to access insurance or have assets available to satisfy indemnity obligations. As important as your food safety, HAACP and other programs may be, they are really only as strong as your suppliers’ programs. Careful audit and assessment of your suppliers’ food safety programs is important.

4. Increase Scrutiny Against Fraudulent Imports – Melamine, tainted rice and now “laundered honey” are all good examples of how fraud in the global food chain can dramatically affect unsuspecting U.S. food sellers. [add more advice here?]

5. Review, Update and Rehearse Crisis Management Plans – How your company is prepared to respond to a crisis is a good predictor of how your company will weather the crisis. With the stakes increasing, you need to be prepared to face the worst. Continual review, updating and rehearsal of your crisis management plan is key. Everybody on the crisis management team needs to understand his or her role and be ready for different scenarios.