Pages

Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Friday, March 26, 2010

USDA Proposes Parallel to FDA's Reportable Food Registry

The USDA proposed some new rules this week that would:

"...require official establishments to promptly notify the appropriate District Office that an adulterated or misbranded meat or poultry product has entered commerce; require official establishments to prepare and maintain current procedures for the recall of meat and poultry products produced and shipped by the establishment; and require official establishments to document each reassessment of the establishment's process control plans, that is, its Hazard Analysis and Critical Control Point plans."

Sounds like the sort of common-sense stuff most people would assume is already required, right? I mean, you'd think that if "adulterated or misbranded meat" somehow made it onto the market, the company would be required to let regulators know. Alas, not the case.

Anyway, the proposed rules are based on recommendations from President Obama's Food Safety Working Group, and are largely similar to the FDA's Reportable Food Registry, the system that helped identify contamination early in the recent, high-profile case of hydrolyzed vegetable protein made by Basic Food Flavors.

This should go off without a hitch, but just in case, you can submit a comment in support of the proposed rule by visiting the rule's page on Regulations.Gov. There is a "Submit Comment" button at the top of the page.

Friday, March 5, 2010

Apparently Foodborne Illness Has Real Economic Costs, As Well... ($152 billion/year)

A new study by Dr. Robert L. Scharff, a former Food and Drug Administration (FDA) economist and current Ohio State University assistant professor in the department of consumer sciences, estimates that foodborne illness costs the United States about $152 billion per year in healthcare, workplace and other economic losses.

Amid all the political yelling about whether or not healthcare reform cuts enough costs, it strikes me that food safety can and should be a haven of bipartisan support. After all, not only can all Americans get behind having a safer food supply, but making our food safer is also good economic sense.

More reason to write your senators and tell them to bring to a vote and support S. 510, the pending food safety legislation.

And the FDA Issued Warning Letters, and There Was Much Rejoicing!


Consumer advocates and nutrition professionals are celebrating a victory this week in the form of a blast of warning letters sent out by the FDA to companies whose product labels violate the Federal Food, Drug, and Cosmetic Act. Among those notified in the crackdown were such well-known and well-advertised brands as Gerber, Beech-Nut, Gorton's, Sunsweet, Nestlé, Pom, and Diamond. Companies were cited for a variety of violations including unauthorized health claims, unauthorized nutrient content claims, and the unauthorized use of certain terms and descriptors that have strict, regulatory definitions.

The FDA action comes on the heels of a major report on food labeling from CSPI and a prominent editorial on the same topic by nutrition expert Marion Nestle. For those who received the FDA letters as well as the industry as a whole, the letters serve as a warning shot, a notification that this FDA will not be the laissez-faire regulator of the last administration. Among those celebrating the letters, there is a hope that this will just be the first step of many toward what could be a complete revision of food labeling rules and enforcement.

Celebratory reporting from CSPI and Marion Nestle's blog; the FDA's press release; and articles from the Washington Post and the New York Times. No press release from the Grocery Manufacturers Association...

Thursday, March 4, 2010

Ever Heard of Hydrolyzed Vegetable Protein? Get Ready to Learn More than You Ever Wanted to Know.


The FDA held a press conference this afternoon to announce what may amount to be one of the largest food recalls in years. The contaminated product is something called "hydrolyzed vegetable protein" (HVP), produced by Basic Food Flavors of Las Vegas, and contaminated with salmonella. The good news is that nobody has become ill yet from consuming the contaminated product. The bad news is that because HVP is commonly used as a flavor enhancer in all sorts of foods, the recall may ultimately affect thousands or tens of thousands of products. In terms of weight, that will be millions of pounds.

What products are involved? Well, according to the FDA, even figuring that out could take weeks. Because HVP is a basic ingredient in so many products, and because it is ultimately sold through a number of distributors and re-distributors, it can be complicated to trace all of the affected product to its final destinations. As they figure it out, regulators will be updating the official list of affected products, located here. Some of the foods that commonly include HVPs are: dips, spreads, soups, soup mixes, pre-packaged meals, chips and snack foods, and gluten-free variations of many foods. In other words, this stuff is everywhere. Even the recalled foods will only represent a small fraction of the fall-out from this ordeal, since many products with affected HVPs will not be recalled, since the production process or cooking instructions for those products are sufficient to kill the salmonella.

What's scary about the scale of this is that there's not much you can do as a consumer to keep yourself safe. It serves as a good reminder of how important it is to have good preventative measures in place, and how important it is to empower the FDA to enforce these measures.  Which is why I'm not alone in hoping that this serves as a catalyst to finally get S. 510 to a vote in the Senate.

More from the Washington Post, here.

Thursday, February 25, 2010

Great Piece on Small Farm Concerns with S. 510

I posted a few days ago about the tension between supporting improved food safety and supporting small/local agriculture. A really good treatment of this question as regarding S. 510 is up at Food Safety News. Go give it a read, here.

Basically it says that while small farmers' concerns are valid, the pending legislation does enough to protect small farms and is, when all's said and done, extremely important to our food safety system. I agree. It's time to bring S. 510 to a floor vote. Write or call your senator today.

What Makes a Tomato "Low Mold" Versus "High Mold" Anyway?


The last few days have seen lots of food news, including plenty of stories about a decade of dirty dealing in the tomato industry. California-based SK Foods and individuals from such well-know food processors as Kraft Foods, Safeway, and Frito-Lay were involved in all sorts of questionable activities, the end-result of which was that "high-mold" tomatoes made it into products (that we consumers then purchased and ingested) that should only have contained "low-mold" tomatoes.

Which raises the obvious question: what makes a tomato "high" or "low" mold? For an answer to that question we go to the Food and Drug Administration's Defect Levels Handbook, the guide to what defines an "actionable" defect in a regulated product, like tomatoes. The good news? An excess of mold in tomato products is considered an "aesthetic" defect rather than a "potential health hazard," meaning that although the defect is "offensive to the senses" it is not likely to make you sick.

How dangerous is this mold? Well according to Keith Ito, a safety specialist at the University of California, Davis' food preservation laboratory: "Several varieties of mold can grow on tomatoes and, although people should try to avoid eating them, they aren't dangerous ... [Those] normal spoilage molds" are a sign that tomatoes are overripe or have begun rotting in the field, he said."

If you're the kind of person that likes to believe processed foods are basically pure, I would recommend skipping the Defect Levels Handbook. I don't know about you, but it frightens me that there is even such thing as an "acceptable" level of "rodent filth" in my peanut butter...

(photo credit to Food Safety News for the gross moldy tomato;  credit for the Ito quote to Scripps and the Sacramento Bee)

Monday, February 22, 2010

Why Can't Raw Milk Advocates Aknowledge the Risk Their Products Pose?

A piece by David Gumpert at Grist argues on behalf of the raw milk industry in its new challenge to FDA rules banning its sale in interstate commerce. I won't go over all the details of raw milk again (you can look back at previous posts on the subject), but this piece caught my attention for the way it willfully misrepresents the risks of raw milk consumption. Gumpert cites CDC data showing that there were very few absolute cases of illness and death associated with raw milk in 2007, and tries to use this data to prove that raw milk isn't dangerous. After all, he says, more people die from being struck by lightning on golf courses each year than from consuming raw milk. I left the following comment, reprinted here in its entirety:

“More people are killed each year from lightning strikes on golf courses than die from milkborne illnesses.”

Arguments like this do nothing for the credibility of raw milk proponents. The fact is that the absolute number of illnesses and deaths related to a food consumed by a very small minority of people is a somewhat useless number - the fact that few people die from eating something that few people even consume doesn't make it safe. There may be reasonable arguments regarding the legality of FDA regulation of raw milk, but the argument that raw milk is somehow safer than pasteurized milk (as the comparison of mortality rates in the CDC numbers seems to suggest), is not one of them. Consider that from 1990 to 2006 unpasteurized milk was responsible for nearly 70% of foodborne illness outbreaks attributed to milk. More than twice as many outbreaks over 16 years is convincing enough, but only consider that unpasteurized milk consumption is almost statistically insignificant compared with that of conventional milk, and it is hard to even pretend that raw milk isn't demonstrably more dangerous. (Source: CSPI Outbreak Alert! 2008)

As a proponent of freedom of choice, I find myself generally supporting the right of individuals to consume raw milk as long as they are aware of the risks involved. What I don't support is the misrepresentation of these risks, and what I don't understand is why raw milk activists are choosing the battle they are (fighting for freedom to sell their product across state lines) when the most compelling arguments for raw milk's safety are that local, small-scale production allow a short supply chain and an intimate farmer-customer relationship.

The Tension Between Strengthened Food Regulation and the Interests of Small Farmers

As congress and state legislatures consider legislation to strengthen the food safety system in this country, an interesting tension has sprung up between two groups that would on first glance seem more likely to be allies than opponents. Food safety advocates have increasingly found themselves in disagreement over important questions with small farmers and proponents of the local food movement. Basically, the problem is that small-food types are worried that broadly increased regulation of food producers will disproportionately affect small producers, who operate on narrow margins and lack the legal teams and the resources to conform to complex regulatory requirements. Two good recent examples of this:

The National Sustainable Agriculture Coalition (NSAC), which promotes local, sustainable farming, last week came out with a detailed proposal of changes it would like to see in S. 510, the food safety bill currently pending in the senate. A good review of the NSAC concerns can be found here, courtesy of Food Safety News.

Marion Nestle, who is a major proponent of an improved food safety regime, is also ordinarily an advocate for local and sustainable food movements. But her response to a bill pending in the Wyoming legislature reveals how these two allegiances don't always go hand in hand. The bill seeks to encourage and assist small, local food producers, but one way it does so is by exempting small producers from certain licensing requirements. Nestle isn't comfortable with this arrangement, which she believes would compromise food safety.

These aren't easy questions to answer. Advocates of good food, including Dr. Nestle, are certainly aware that we need to find some kind of reasonable compromise, and I think everyone is in the process of feeling out what that might be. Keep your eyes out, as S. 510 moves forward and (hopefully) goes into the reconciliation process with the house bill, for how all this plays out.

Monday, February 8, 2010

More on Oysters: Is Regulation the Best Alternative?



I've gotten a good deal of feedback on a recent post regarding the risks of eating raw oysters, including a note from the author of this article from the Mobile Press-Register. The author, whose family business is in the live oyster trade, makes two comparisons that I actually find very interesting. Let's look at both.

First, he compares naturally occurring vibrio in oysters to allergens found in other foods, like peanuts. In a lot of ways, the comparison is a good one. In both cases, a significant minority of people are at risk of serious illness or death from consumption of a naturally occurring element of a food that most people can eat without much risk of illness. In both cases, the most important thing that restaurants and vendors can  do is inform customers when items contain the food in question. In both cases, medical professionals should be sure to inform their patients when they are at risk. The difference, as I see it, is two-fold.
  • For one thing, even the most severe anaphylactic reactions can usually be mitigated by immediate and appropriate medical care. There is no vibrio EpiPen. 
  • Secondly, although there are certainly individuals who have allergies they are unaware of, it seems to me more likely that individuals might be immunocompromised without knowing it. 
Nonetheless, I think the peanut comparison is a fair one. Just because there is a potential for serious harm associated with a food, that does not necessarily dictate that food's removal from the market.

The second comparison the author makes is with sugar. He suggests that restaurants and vendors offer both treated and untreated oysters, and allow consumers to choose whichever they prefer, just as with sugar and artificial sweeteners. I'm always a fan of increased choice, and I would be interested in seeing how this would play out (whether consumers would pay extra for the "safer" oysters, whether they would notice the difference at all). Obviously it would be more difficult to implement this sort of plan for oysters than for sugar. Whereas sugar and its substitutes are easily distinguishable from one another by their different colored containers, treated and untreated oysters would remain indistinguishable from one another to the naked eye, creating a high risk of careless errors by consumers, servers, vendors and chefs.

The big takeaway from all this for me is that even oyster producers like Mr. Nelson realize that the current system does not provide adequate protection for at-risk consumers. Like Mr. Nelson, I believe that "Any illness of this nature is unacceptable and warrants further efforts to minimize occurrence." I don't know whether self-regulation by oyster producers and businesses that sell raw oysters to the public will be enough to eliminate the serious risks associated with raw oyster consumption. If so, I don't see the need for additional regulation at the federal level, especially if it endangers American businesses like Mr. Nelson's. If, however, industry-initiated or state regulatory measures prove insufficient in this case as they have in so many other industries (see just about anything regulated by the USDA over the last century), then FDA regulation or the threat thereof might be the best tool for keeping American oyster-lovers safe.

Sunday, February 7, 2010

Food Safety Legislation Currently Before Congress

It struck me that it might be useful to provide a link to summaries and the full text of the food safety legislation that is currently pending in congress. To that end, these links will direct you to the relevant Govtrack.us pages:

H.R. 2749: Food Safety Enhancement Act of 2009 (passed in the House)

S. 510: FDA Food Safety Modernization Act (the pending companion bill in the Senate)

Is a Fee-Based Food Safety Regulatory System a Good Idea?

An editorial by Dan Flynn at Food Safety News argues that a fee-based food regulatory system, along the lines of the $500 per facility fee included in H.R. 2749 (the House food safety bill whose pending Senate counterpart, S. 510, does not include this fee), is a pragmatic solution to the problem of maintaining a working food safety system even as domestic discretionary spending comes under the axe over the next few years. I tend to agree. The editorial raises one point on which I'd love to see some hard economic data.

Flynn says: "A [regulatory] structure that works would pay a lot of dividends.  Firm, fair, predictable inspections would mean safer food with fewer recalls."


Is there data out there that would let us put a dollar amount on these dividends? Would a functioning food regulatory system, through fewer recalls and greater consumer confidence, prevent enough lost revenue to the industry to make up for the cost of a fee-based system? Fees are a hard sell to an industry that would rather make tax-payers pick up the tab, but I'd wager that any of the major peanut producers would have happily paid a relatively small fee if it could have saved them the massive losses associated with the Peanut Corporation of America debacle.

Wednesday, February 3, 2010

West Missouri Beef Recalls 14,000 Lbs



Food Safety News reports on the recall of "fresh boneless beef products" from West Missouri Beef. Does this mean you should avoid buying these products at the market today? Nope. The vast majority of the recall (like most meat recalls in our country) affects beef produced and sold back in the end  of 2009, some as early as October.

The delay on "voluntary recalls" is a serious problem with our food system. The pending Food Safety Modernization Act in the Senate would help address this problem for FDA regulated foods, but for USDA regulated meat and poultry, we're stuck with the current system for a while at least. Inspector's need the power to detain food that is likely adulterated, and the USDA needs the power to enforce involuntary (and immediate) recalls.

Because  the only people  the current system is saving are those who buy in bulk, freeze their beef,  and diligently compare the labels on that frozen beef against active recalls. And that's not many.

Tuesday, February 2, 2010

Food & Water Watch Criticizes Obama's Budget

In a previous post, we supported the new fee-based funding for FDA inspection programs included in the president's budget proposal. The folks over at Food & Water Watch are arguing today that other elements of the budget are less food-safety friendly. Specifically, the group criticizes what it sees as inadequate funding for USDA inspections. The whole story here.

The piece also takes issue with what it sees as support for further development of unsustainable fisheries. Without having read the budget, I can't comment on whether this is accurate. It raises an interesting topic, however: sustainability is the notable exception to my "if you understand what you're eating, then go for it" mentality. We all have the right to eat what we please, regardless of the damage we might do to our bodies or wallets; this doesn't extend to destroying our environment or depleting our food resources to the point of driving species into extinction.

Why We Should All Be Washing Our "Pre-Washed" Salad Greens...

Civil Eats is reporting on a new Consumer Reports test of those super-convenient pre-washed leafy greens we're all using.  Long story short, you're going to want to wash your greens, whether the bag says they've been "triple washed" or not. The folks at Consumers Union are using this as another argument to pass new food safety legislation. While I applaud that effort, I'm not sure there's a HACCP plan in the world that would make me confident enough not to wash anything I'm planning to eat raw. The Consumer Reports article is online here.

Monday, February 1, 2010

Obama Budget Includes $250m+ in FDA Fees on Food and Drug Makers

We learn from the Wall Street Journal today that President Obama's proposed budget will include over $250 million dollars in new FDA fees, paid by food and drug makers, that would help cover the cost of a variety of FDA activities, including food inspections.

Dealing only with the food part of this (drug regulation, while important, isn't really our shtick here), this appears to be a good thing. Food inspections are underfunded and, as a result, often unable to detect contamination early enough or at all. Just look at the history of food-borne illness in this country over the last decade. In these tough times for the federal budget (the proposed freeze on discretionary funding over the next few years), this would mean that FDA funding would be secure, and would fall on the shoulders of an industry that has for too long tried to minimize the role and authority of our nation's primary food safety watchdog. 

Please note that this funding depends upon congressional action, specifically on the Senate moving forward on S. 510, the companion bill to one passed in the House last year that would authorize the fees.

More FDA funding for inspections means safer food and a more accountable industry. Safer food and increased accountability mean that when we go to the store we can be confident that we're getting what we think we are, and that it won't make us sick. And that is unequivocally a good thing.

The Raw Milk Question: Organic Pastures vs the FDA

Over at Food Safety News they ran an article this morning about Mark McAfee, the California dairy farmer duking it out with the FDA over his right to market and sell raw (unpasteurized) milk. Raw milk seems like quite the contentious topic lately, and it's increasingly looking like a banner issue for groups advocating people's right to eat what they please, even where there are real food safety concerns.

Personally, I'm torn on the whole raw milk thing. On the one hand, I'm almost always in favor of letting people make their own choices about food, as long as those choices are well-informed (that is the point of this blog). Raw milk is a health risk, but as long as you know that, I feel like it's your call, just like it's your right to order a medium-rare steak, or to go out to a disreputable sushi place for dinner. On the other hand, I can't help feeling like Mr. McAfee is picking the wrong fight. I can be sympathetic to raw milk producers in large part because the safety issues involved in raw milk consumption are usually mitigated by the local and personal scale of raw milk production and sale. People almost always know the farmer, have been to the farm, and can thus make informed judgments about whether the stuff is safe. But this doesn't seem like a battle for raw milk in general; this is a farmer trying to preserve his right to market and sell his unpasteurized milk across state lines via the internet.

According to the article:
McAfee takes umbrage at interstate restrictions on licensed raw milk for several reasons.


"The logic for this is dubious,' he says in his recently filed legal papers, "since the borders between states do not transform healthful foods into poison."

He also points out that distance is not an issue here since milk from cows on the California side of Lake Tahoe cannot be sold on the Nevada side of the lake. Yet milk from cows in Yreka, which is in the far reaches of northern California, can be transported to and sold in San Diego.


While I agree that distance, rather than an arbitrary line at the state border, might be the more relevant consideration, I still don't find myself agreeing with Mr. McAfee. The practical and legal considerations on the FDA's regulation of this product mean that banning its sale across state lines is a sensible middle ground. Without banning raw milk entirely (this is left to the states, as I understand it), the FDA is acknowledging that raw milk presents a real food safety issue. By banning interstate sales, the FDA effectively limits the possibility that vendors will be able to sell a potentially dangerous foodstuff to out-of-state customers who don't have full information about the farm, the product, or the state regulations under which the milk was produced. 

Would a national system of regulation for raw milk, like that employed for most other foodstuffs, be a better option? I have a hard time believing the raw milk advocates would be in favor of this sort of system, and I'm not convinced it would be effective anyway. At the end of the day, raw milk is exactly the sort of product that I think we should be buying locally and directly from the farm, if we're purchasing it at all. That seems like the only reliable way to be a fully informed buyer.