Northwest Cheese Top Stories of 2010

Recalls, Seizures Without a doubt, the biggest NW cheese story of 2010 - in fact, the biggest cheese story of the year, period - was the series of events that started in February with Estrella Family Creamery's first recall of cheese. The Estrellas continued to make headlines throughout the year, culminating in the FDA seizure in October and its ongoing aftermath. Later in December, we witnessed the e coli outbreak that was eventually traced to cheese made by Sally Jackson. But the overall food safety story is much bigger than these two producers (others were also caught up in the recall net, including Bravo Farms in California) - I think we are going to see regulatory changes in the future that will have wide reaching effect on the cheese we love to eat. Stay tuned.

Oregon State University Bequest  This news has flown largely under the radar but I think its effects will be HUGE for the cheese industry in Oregon. OSU announced in early December that it received a $860,000 donation that will be devoted to developing an OSU Dairy Center. OSU is reviving its shuttered creamery as a cheesemaking incubator for new cheesemakers and I'm looking forward to the promised Beaver Cheese coming in 2011. The state's cheesemaking community will benefit from this for years to come. Watch out Vermont!

Beecher's Expands to NYC  Seattle's favorite urban cheesemaker announced in March of 2010 that they will open a new satellite store in New York City in early 2011. This represents a significant expansion of Kurt Dammeier's cheese empire and provides a new growth model for the industry. Will other small-mid sized cheesemakers follow suit? Will New Yorkers love their new Flatiron cheese as much as Seattleites love Flagship? Only time will tell.

Artisan Cheese Renaissance Ongoing in the NW  I keep thinking that at some point the rapid increase in numbers of small cheesemakers in the Pacific NW will decline or at least slow down but that's not been the case...2010 was a banner year for the business. New cheesemakers in the region this year included Yarmuth Farms and Tieton Farm and Creamery in Washington, Cheese Louise Creamery in Oregon and two new sheep's milk dairies in Idaho, Lark's Meadow Farm and Blue Sage Farm. Another demonstration of the region's ongoing love affair with cheese was the opening of a new cheese shop in Seattle in May: Calf & Kid.

Closures/Evolutions  Despite an ongoing recession, only a few cheesemakers left the fold this year, including Siskiyou Crest Goat Dairy in Southern Oregon (which voluntarily surrended its licensed cheesemaker status in favor of selling goat shares) and Sally Jackson in Washington. The loss of industry pioneer Sally Jackson's cheeses is a blow for the entire cheesemaking community and represents, on a number of levels, the end of an era.

Awards Keep Rolling In The awards for cheeses made in the Pacific Northwest continue. At the American Cheese Society Conference held in Seattle, NW Cheesemakers took 42 awards in a wide range of categories. I was especially pleased to see tiny Mystery Bay Farm on the Olympic Peninsula in Washington pull out top honors for flavored chevre - that's among 1400+ entries! While you might be inclined to think that awards are solely about marketing (and that's true to an extent) they are also about having your products judged alongside those of your peers. These awards demonstrate that our region's cheeses are as good or better than any cheese in the nation.

In Memoriam  This year saw the passing of two bright lights in our region's cheesemaking community: Chuck Evans of Rollingstone Chevre in Idaho and Kathy Obringer of Ancient Heritage Dairy in Oregon.

Happy New Year!

** Reminisce with the Northwest Cheese Top Stories of 2009

Sally Jackson Recalls All Cheese Due to Possible E Coli Contamination

Sally Jackson has recalled all of her cheeses due to possible e coli contamination.

The recall is the result of an investigation that has been underway for several weeks. Apparently an e coli 'cluster' was discovered in several Pacific Northwest states, and the illnesses were traced to cheese consumed by the various people who fell ill. Investigators have focused on Sally Jackson's cheeses as a possible source of the outbreak.

It's not immediately clear if this is related to notice Jackson received earlier this month from the state of Washington demanding that she upgrade her facility.

For more info, see the FDA Recall notice here.

update: While Jackson has issued a voluntary recall, it must be emphasized that investigators have not yet definitively linked her cheese to the e coli outbreak.

update: See the 12/17 article in the Seattle Times here. According to the Times, preliminary tests show that one wheel of Jackson's cheese did contain e coli, but that strain has not been positively connected to the outbreak strain as of yet.

update: Sally Jackson's cheese has been confirmed to be the source of the e coli outbreak.

Sally Jackson Could be Forced to Close

 

Wrapped Cheese

The Washington State Dept of Agriculture has given Sally Jackson 30 days to upgrade her facilities or be forced to close.

As many know, Sally Jackson was one of the first of the new wave of cheesemakers in the Pacific Northwest. She started in 1979 and has been quietly making cheese ever since - that's 31 years and counting. Unfortunately, now her days could be numbered. State regulators are requiring the Jacksons to upgrade their facilities to meet the standards of a Grade A dairy. "They've allowed me to make cheese for thirty years and now all of the sudden I'm using unapproved milk," she said. "I'm struck dumb."

The problem stems, I believe, from the very fact of her longevity. In 1979, with few other cheese facilities operating in the state, regulators likely did not give much attention to this tiny farm making cheese way out in the middle of nowhere on the east side of the Cascade Mountains. As times changed, Jackson's operation was essentially grandfathered in. While she underwent the same inspections as other cheesemakers, the state allowed her to continue to make cheese without ever acquiring a formal Grade A dairy license - a requirement that did not exist in 1979 (or at least not in its current form). So at first blush, this situation looks to be at least in part a result of the state's inaction over the years.

Now, however, the regulatory environment is changing. As we've seen in other contexts, state and federal regulators are taking a closer look at small cheesemakers, and Sally Jackson has evidently become the most recent target of their scrutiny. Here's hoping that this can be resolved, as forced closure would be a really unfortunately scripted ending for one of Washington's longest running cheesemakers.

update: on December 17th, Jackson issued a recall of all of her cheeses due to possible e coli contamination. It's not clear if this notice is related to the later recall.

update: Bill Marler has copies of state inspection reports and other communications related to this situation here.

Oregon State University Receives Big Grant For Dairy & Cheese Development

Oregon State BeaversBig news in the world of Oregon dairy and cheese! Oregon State University announced yesterday that it has received an $860,000 grant to create a new dairy center and new professorship within the College of Agriculture. Paul Arbuthnot and wife Sandra donated the funds to create the Arbuthnot Dairy Center, designed to become a center for research and outreach for the benefit of small dairy processors. Paul Arbuthnot is the former president of Sunshine Dairy, one of the last remaining dairy plants still operating within the city of Portland. Professor Lisbeth Goddik of the OSU Food Science Department will hold the first professorship endowed by the grant. Goddik has been working for several years to resurrect the OSU Creamery, which closed in the 1960s. The new facility was licensed for cheese production earlier this year, and Goddik hopes to develop several OSU produced cheeses in 2011. Goddik said that the grant will, among other things, assist her in bringing in national and international experts to assist local cheesemakers, as well as develop new styles of cheese.

See the full news release here.

Interview: Products Liability Attorney Ken Odza

Ken OzdaGiven the recent news about potential cheese contamination and various recalls, I thought it would be useful to understand just what the underlying legal issues and processes are in these types of situations. Toward that end, I spoke with Ken Odza, a products liablity attorney and partner with the firm Stoel Rives in Seattle, Washington. Mr. Odza is an expert in the field of product liability and has litigated numerous cases in the area of foodborne illness, insurance recovery and other commercial and business matters. His firm also writes the blog Food Liability Law, where they recently posted a Listeria Recall Toolkit discussing some useful strategies a business might emply in the event of a listeria-related recall.

@ @ @ @ @

What happens in a typical food product recall situation?

Currently, the FDA does not have mandatory recall authority. So all recalls have to be voluntarily initiated by a food seller. In 99% of the cases where a product needs to be recalled (for example, when it has tested positive for something like listeria) the company, not the government, recalls the product.

The law defines certain levels of recall - Class I, II or III. A listeria problem in a ready to eat product such as cheese is typically a Class I recall because it's viewed as such a dangerous pathogen. A Class I recall comes with a high level of publicity.

In the Estrella case there has been a seizure order issued by a federal judge. What is a seizure order and how does that fit into the whole process?

If a producer refuses to recall the products, the next step is usually that the FDA will work the publicity angle. And so you see that the FDA issued a press release about the Estrellas in September. Next, if a company still doesn’t cooperate, the FDA may take the rare step of requesting involvement of the US Attorney's office to obtain a seizure order by the federal court. A seizure order like the one issued in the Estrella case is a really extreme measure. The number of seizures the FDA does in a year is really small.

If your products are the subject of a seizure order, you have the right to file a claim for the seized goods in order to avoid their disposition by the government. To prevail, you'd have to overcome the FDA's showing that the products are adulterated - which means you'd have to prove somehow that the FDA tests were wrong, or made up, or show some problem with the testing itself. The reality is that prevailing against the FDA is very challenging, to say the least. And, if you lose, you will be ordered to pay the government's fees, costs of storage and other costs.

[note: for general background on the Estrella Family Creamery case, see here. For legal specifics, download the Estrella seizure order here and/or see FDA seizure procedures manual here]

What other penalties are possible?

Even more significant than seizure of your product and a shut-down of your business is criminal liability. Under the Food, Drug and Cosmetic Act, it’s a crime to sell adulterated food. It’s a crime even if you’re not doing it intentionally, and even worse of a crime if you are doing it intentionally. The FDA has been pivoting toward enforcement. In the event of an FDA seizure, criminal defense counsel should also be retained.

How does a recall typically play out over time?

The economic cost of a recall alone can overwhelm a food business. Here's a hypothetical example: say you are selling cheese, from a certain batch made on a certain day, that tests positive for listeria. But some cheese that you made later is not positive for listeria. So you tell FDA - we’re only recalling the positive batch. The FDA will say – how do you know the other batches aren’t contaminated? You say - because my results are negative for listeria in other batches.  The FDA will say - that's not good enough. They’re going to want to know what kind of environmental swabs have been done of the facility, where, when, etc. If you can’t show that the environment itself was clean between your production runs, you may have to recall every product you’ve ever manufactured out of that plant. Imagine the costs, even if no one had ever gotten sick.

And then, as soon as a retailer hears about a problem with your product, they’re going to pull your product no matter what, and not wait for test results. And they're going to charge that cost back to you. So you're not only facing your own recall costs, but your customers' costs as well. During the peanut recall of 2009, for example, the company (Peanut Corporation of America) couldn’t afford to recall their own products, and as a result they went bankrupt. Recall costs can be overwhelming.

Do you think the FDA is specifically focused on the artisan cheese industry right now?

More and more, I see the FDA moving toward a risk-based approach. They don’t have the resources to have inspectors everywhere all the time. So I think they’re looking at the cheese community and saying - there's a lot of folks out there doing this, it's an expanding sector. These new producers may not have the resources to do sophisticated food safety prevention in the same way that larger companies do, so maybe we ought to pay more attention to this industry.

The food-borne illness that concerns the FDA more than any other is is Listeriosis. Listeriosis, caused by the bacteria listeria monocytogenes, kills a higher percentage of its victims than any other food-borne illness. Listeria is often found in deli products such as cheese, processed meats, hot dogs. That’s probably another reason why the FDA is  focusing on these recent cheese-based listeria outbreaks so closely.

Cheesemakers React to Recent Safety News

Recent news about problems with raw milk cheeses sold by Morningland Dairy, Estrella Family Creamery and now Bravo Farms in California is making waves with consumers and the cheesemaking industry.

I have been contacted by a number of reporters in the past few weeks and all have asked me how cheesemakers are reacting to the news. My answer is: across the board, cheesemakers are taking a hard look at their operations. They are evaluating and re-evaluating their processes and looking for ways to maintain and improve their safety practices.

This is really important: everyone in the industry - raw milk cheesemakers and pasteurized milk cheesemakers alike - wants to make and sell safe, healthy and preferably delicious products. All over the internet, people are jumping to conclusions about raw milk cheeses and the production thereof without even a cursory understanding of the process of making cheese. Their reactionary rush to judgment damning the industry is frustrating, to say the least.

But I digress. In any event, I thought it would be instructive to ask cheesemakers if they'd be willing to open up a bit about how they're feeling these days. I promised all anonymity (so don't even ask). Here are some of their answers:

I am concerned about any potential surprise investigations because the investigators usually don't have any experience with farms at all. The ones who visited here [recently] had never even been on a farm before. Not a good thing in my opinion. I expect a group of them to show up at anytime and haul a wad of cheese off for testing. I am certain it will be clean of any problems, but the whole thing is worrisome, to say the least. 

So far I haven't noticed any drop in sales, in fact, we have picked up a few new outlets. But you know, I haven't sold a raw milk cheese in a week or more....that is interesting.

 ***

We already do and document things that make our production safe, but it makes me want to do more, just to be sure.

 ***

[The recent news] does make me paranoid.  I try to be super aware of my surroundings . . . the frustration is that USDA can go around being police dogs but why won't they hand out information on how to prevent [listeria and other problems]?

 ***

I have not changed any practices here. [. . . ] I spend a considerable amount of time, money, thought, resources, research, dialogue, and general improvement strategies to maintain this farm in as clean a manner as I possibly can.  And with it comes a price - a big price.  I have had 2 cheesemongers tell me recently that they think I make some of the best cheese around, but since they cannot make their margin on it, they seldom order from me.  This is frustrating.

So I continue my scrubbing, personal hygiene demands, sanitizing, deep cleaning regularly, and always going the extra steps to do what I believe to be right.

 ***

I get ticked off at the people who sell raw milk without having to standards or regular testing or even worse, make and distribute cheese illegally. I go to all this trouble to stay in compliance with [the law] and they have no one to answer to.  If there are regulations that I must comply with in order to be able to make cheese, then I will do my job and follow the mandated rules and regulations.  I do believe people should be able to have access to raw milk, but I standards should be maintained for everyone's safety.  As you get farther away from the source, there is a greater potential for contaminants to enter the picture and someone might get sick from an unwashed hand touching something they should not touch.

One cheesemaker that currently produces only raw milk cheeses is going so far as to switch to pasteurized milk cheeses:

I've been very upset . . . I am so mad when someone is careless, cuts corners, or anything that brings down the overall quality of any food product.  The public's trust is priceless.

 We feel it's going to directly affect us as a raw milk cheese maker in that we likely will not be able to get product liability insurance--this last year was more difficult than the year before in that respect. In order to maintain insurance coverage we are going to pasteurize . . . Someone else's behavior reflects across the industry and costs others, as well.  [The pasteurizer] will cost us about $30,000.  So, of course I'm a little bitter right now, but not at the government, because I, too, want to eat safe cheese.

One cheesemaker that produces only pasteurized milk cheeses says that they are not even willing to take the risk of making raw milk cheese.

I would never make raw milk cheese.  It is simply just too much risk for me to take.  60 days is not a guarantee that the product is safe and some pathogens have toxins that will stay in the product even after the live cells die.  If a company decides to make raw milk cheese, they should have a rigorous environmental sampling program testing drains, walls, air handling, overhead piping, etc. in addition to testing all final product for pathogens.   

That being said, this producer does believe it is possible to make raw milk cheese safely:

It is definitely possible to make [raw milk cheese] safely, but you need very good controls all the way through the process.  I think you would need to have your own milk supply and the raw milk supply must be of top quality.  From there the air quality in the processing facility, cleaning practices, and manufacturing practices must be of the highest standard. Then finished product testing must be completed. 

 __________

If anyone would like to contribute to the conversation email me (see link at the upper right of the page) or add a comment below.

FDA Reconsidering 60 Day Rule For Raw Milk Cheeses

This isn't news for some people. But I've heard rumors for awhile now that the FDA's so-called '60 day rule' is under re-consideration, though because all of the mentions have seemed so fleeting, and no one in the cheese world seems to be talking about it much, I wasn't quite sure if it was true. Now I can confirm for certain that the issue is indeed under review.

The current rules (for the full legalese, see here) allow cheesemakers to sell cheeses made from raw milk IF the cheeses are aged at least 60 days. This restriction has been the source of much controversy among cheesemakers and cheese aficionados for years, who believe that the 60 day rule unfairly limits the craft of making cheese.

So I asked the FDA Office of Public Affairs about this last week, and here's what they had to say:

With regard to the [60 day rule], we are reconsidering the rule because we've discovered that pathogens are capable of surviving beyond 60 days. We are still examining the risk factors and it's too early in the process for any discussion about how/when we'll proceed.

In fact, reconsideration has been on the FDA's radar since at least 1997 at the recommendation of the Office of the Surgeon General, according to this document (Download Document) which the FDA forwarded to me.

Part of the reason there hasn't been much talk about the issue is because the FDA has not initiated any formal action to change the rule. The rulemaking process involves, among other things, posting notice in the Federal Register, hearings, and a public comment period (more specifics here). You might be more familiar with administrative rulemaking in the context of environmental regulations, which have had quite a bit more media coverage in the past few years.

I was not able to get any information from the FDA about a timeline on reconsideration of the rule...but this is going to be something to watch, for sure.

Regulation and the Cheese Industry

Cheese Industry Regulation

The recent events at Estrella Family Creamery (and the recall at Morningland Dairy in Missouri) have given quite a jolt to the cheese industry as well as to consumers. I'm receiving tons of comments and emails from people expressing their outrage at the rather dramatic events in Washington that included the forced closure of the Estrellas' business.

I want to provide a little context here. Milk and milk products like cheese are VERY highly regulated. Cheesemakers and milk producers go into business knowing that there are a whole host of state and federal laws they must comply with, laws that include frequent and sometimes invasive inspections of their facilities and practices. The relationship between cheesemakers and inspectors resembles the relationship between restaurants and local health departments - your business is in some sense on the line at all times and the inspector wields a lot of power over what you do and how you do it. Still, you have to be inspected - and pass - if you want to stay in business serving food to the public. Can the health department (or the FDA, in this case) shut down your business? Yes, they can. While it's not something that you see very often, the power has always been there lurking in the shadows.

There is a purpose behind all of these regulations and inspections, and that's public health and safety. Of course there is plenty of room for debate as to the substance of the regulations themselves, and there should be debate. For example, in the cheese industry, many cheesemakers feel that the regulatory scheme with regard to cheese was designed for industrial producers and doesn't fit smaller creameries. But be that as it may, in general, I think everyone wants safe food, right? And regulations, inspectors and so on are part of what our country has developed to make food safer. I don't feel that food producers, restaurants or cheesemakers should be free to do whatever they want, whenever they want. There is simply too much that can go wrong in the world of food production and preparation.

While it's tragic that things have gone this far for the Estrellas, the law does provide processes for addressing whatever regulatory concerns may be raised by authorities. In their case, the issues will be hashed out in court. There, the FDA will have to prove to a judge that its concerns are accurate and relevant (as they should have to) and the Estrellas will have a chance to address the issues raised and argue otherwise.

If you don't like the regulations (and no doubt there's a lot that needs to be reviewed and changed with regard to cheesemaking) take the time to learn about the existing laws and the state/federal rulemaking process. Cheesemakers in particular are going to need to become experts on their rights (and responsibilities) as much as they are experts on the process of making cheese. Then I suggest we all get involved - because I suspect that recent events are only the beginning of what could be a long and protracted battle over the future of artisan cheesemaking.

* * * * *

Some people are asking whether the FDA is specifically targeting raw milk cheeses and/or raw milk cheese producers, since both Estrella Family Creamery and Morningland Dairy produce only raw milk cheeses. I think it's too soon to tell what kind of agenda the FDA is pursuing here, if any. Given the rapid growth of the cheesemaking industry in the past 5-10 years, I think increased attention and oversight should not be entirely unexpected. That being said, according to this article from the NY Times, the so called '60 day rule' (cheeses made from raw milk can be sold to the public if aged at least 60 days) is being reconsidered by the FDA.

update: for more on the status of the 60 day rule see my subsequent post here.

* * * * *

Speaking of inspections, I've just come across copies of FDA inspection reports at Estrella Family Creamery. (Download: FDA Inspection Report - via Bill Marler's blog via efoodalert). Incidentally, both of these blogs have been taking a pretty tough stance on events related to the Estrellas.

Federal Court Filings Reveal Details of Estrella Family Creamery Closure

I've been able to hunt down the court filings related to the recent closure of Estrella Family Creamery (see download available below). The documents reveal the FDA's reasoning behind the recent enforcement actions in detail.

Most significant is the affidavit of FDA official Lisa Ellrand (Exhibit A to the document). Let's reconstruct the timeline.

Earlier this year, the FDA performed a number of tests at Estrella Family Creamery. Several of these tests were positive for listeria. As we already know, recalls were initiated on February 11th, 2010 (Red Darla) , February 17th, 2010 (Brewleggio, Wynoochee River Blue and Domino), and on March 5, 2010 (Old Apple Tree Tomme).

According to the FDA inspector's affidavit, the FDA again performed tests at the creamery several times in August of 2010. Samples collected in August also tested positive for listeria.

According to the FDA inspector's affidavit, the tests revealed that the same strain of l. mono was present in the tests performed in early 2010 and the tests performed later in the year, in August. According to the FDA, this indicates that the creamery's eradication practices had not been sufficient, over time, to remove the offending pathogen.

The affidavit also states that Estrella's own lab reports revealed positive tests in May, June, July and August of 2010. There seems to be some contention that the Estrellas kept these results from FDA inspectors.

In early September of 2010, the FDA asked the Estrellas to initiate a recall. According to the FDA, they declined. (I believe that at that time, the Estrellas' reasoning was that no products were available to the public.) The FDA then issued its caution letter of September 4th, 2010.

The affidavit also details a pattern of unsanitary practices at the creamery.

In the end, because there was no evidence that the pathogen was fully eradicated from the creamery, the FDA shut the creamery down.

Download the recent court filing below:

Estrella filing

Update: See the article, with comments by Kelli Estrella, in the Seattle Times here.

FDA Issues Press Release on Estrella Family Creamery Closure

The FDA has issued a press release (actually, updated a previous one) on the recent closure of Estrella Famly Creamery. Though it does not contain a lot of new information, the general gist of the action seems to be encapsulated in the following excerpt:

[The] United States Attorney’s Office for the Western District of Washington filed a complaint in the United States District Court for the Western District of Washington alleging that cheese and other articles of food held at Estrella Family Creamery are adulterated under the Federal Food, Drug, and Cosmetic Act because they have been held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health.

See the press release here.