by Marion Nestle

Currently browsing posts about: Food-safety

Jul 29 2013

FDA’s latest round of food safety proposals: food imports

The FDA has finally released safety rules for imported foods, two years after Congress passed the food safety law.  OK.   We now have them.  At last.

Here’s what the FDA is up against:

  • 150 different countries ship foods to the U.S.
  • These account for about 15% of the food supply, but 50% of fresh fruits and 20% of fresh vegetables.
  • The agency has the capacity to inspect about 2% of imported foods.

To deal with this disconnect, the FDA proposes to hold importers accountable for the safety of what they ship to us.

The proposed rules allow two ways to do this: Importers can do their own onsite safety audit, or they can verify that their suppliers did so.

Both methods involve verification by certified verifiers that suppliers used “prevention-oriented food safety practices” (HACCP in other words), and achieved the same level of food safety as domestic growers and processors.

Neither requires inspection by FDA, although importers may use inspection.

The proposed rule and the third-party accreditation proposed rule are available for public comment for the next 120 days.

The previous proposed rules, for produce safety and food production facilities (see below), have been given another 60 days for public comment.  Comments on all proposals will now be due at the same time.  The FDA expect to issue the rules 12 to 18 months after the comments come in and then it will take another 18 months for rules to go into effect.

What does all this mean?

The FDA hardly has the resources to manage U.S. inspections so expecting it to do foreign inspections is unrealistic.  This plan shifts the regulatory burden to producers and shippers (why does this sound like foxes guarding henhouses?).

The FDA also intends to certify third-party auditors.  These invariably involve conflicts of interest, although that system  seems to have worked fairly reasonably well for organic foods.  But we are talking about the safety of imported foods here, and lives are at stake.

This is undoubtedly the best the FDA can do given its limited resources and its problems with Congress.  This Congress is hardly likely to view food safety as a national priority and give the FDA what it needs.

Recall: FDA appropriations go through agricultural appropriations committees, not health appropriations.  And this Congress cannot even pass a decent farm bill.

Congratulations to the FDA for making the best of a bad situation.  And fingers crossed that the proposals survive, get implemented by 2015, and nothing bad happens in the interim.

The document collection:

For a detailed discussion of the pros, cons, and questions, see the account in Food Safety News

May 23 2013

Kathleen Merrigan on agriculture’s political problems

The Farm Journal reports on a speech given by Kathleen Merrigan, who recently stepped down as USDA Deputy Secretary, to  Crop Life’s 2013 National Policy Conference.     

Why did she step down?  “Because it’s a hard job.”

Her speech dealt with problems faced by agriculture in today’s political climate.  She listed ten.  These begin with (1) immigration, (2) tax reform, and (3) food safety.

Number 9 was GMO labeling:

Merrigan described this as a sort of “whack-a-mole” problem. USDA and FDA haven’t allowed organic producers to put “non-GMO” on labels, but support is growing in some states, such as Washington, to require labeling. She says people want a verdict and she doesn’t expect the issue to go away. 

I don’t either.

Mar 25 2013

White House weakened food safety rules

I subscribe to Food Chemical News, at great expense but for good reason.  On Friday, I received this alert addressed to Dear Subscriber:

Food Chemical News has discovered a stunning set of documents, made available by the Department of Health and Human Services as part of a transparency initiative, that prove FDA was forced by the White House Office of Management and Budget to remove certain elements from the draft of its FDA Food Safety Modernization Act preventive controls proposal. It had long been speculated among FDA watchers that the agency intended to include requirements for product testing, maintaining supplier verification programs and tracking consumer complaints in its FSMA proposal, published in the Federal Register Jan. 16, but the eight documents we found this week, while searching for other information, confirm it.

Food Safety News picked up the story.

Food Chemical News is reporting that documents released on regulations.gov on Feb. 28 reveal cuts made by the White House Office of Management and Budget (OMB) to the implementing regulatory package for the Food Safety Modernization Act (FSMA).Those apparent cuts include striking out requirements for food companies to test for microbial contamination of environments and finished food products, as well as rules for companies to maintain supplier verification programs and track consumer complaints.

We encourage readers to review the documents here and comment on anything of interest in our comment section.

The documents say that the White House deleted:
  • Requirements for environmental monitoring for pathogens.
  • Requirements for finished product testing for pathogens.
  • An assumption that if environmental monitoring finds pathogens on food-contact, the pathogens are also in the food.
  • Requirements for a supplier approval and verification program.
  • A requirement that companies review consumer complaints about safety.
  • FDA authority to copy company records.
The White House also:
  • Added a year to the length of time companies and farms of all sizes have to comply with the law. 
Why?  Undoubtedly election-year politics.  The election is over.  
The FDA needs to do its job.  
Let’s get these items reinserted.
The safety of Americans is at stake here.  
Mar 14 2013

Food safety problems can happen anywhere, even Noma

I was interested to read in Food Safety News last week that Noma, the Copenhagen restaurant ranked as the world’s best, was the site of a norovirus outbreak that affected a large proportion of its customers.  

I tweeted something about this and was contacted immediately by Lisa Abend to correct errors in the story.  Her careful, highly detailed account in Time describes what happened and why. 

Noma immediately issued its own explanation, notable for providing much information beyond the usual “we regret.”

Since receiving the news, we have been working closely with The Danish Veterinary and Food Administration to find the source of the problem. As a result of our collaboration, we have determined the most likely cause of illness was Norovirus, which may have been brought in by a member of staff, who was symptom-free.

Noma even made the health inspector’s report easily available.

Did it lose customers over this incident?  Hardly.

I’ve not been to Noma, but I would love the chance to eat there.

The short-term lessons here are worth noting:

  • Transparency helps.
  • Cooperating with health authorities helps.
  • Fixing the problem helps. 

The long-term lessons are also worth pondering:

  • Food safety problems can happen anywhere.
  • Food safety has to be a priority for any place that makes or serves food.
  • Make sure employees wash hands frequently.
  • Pay employees to stay home while sick.
  • Make sure employees have health care coverage.

Without these actions, even people eating at expensive restaurants are at risk of norovirus and worse.

Feb 21 2013

Grand jury indicts Peanut Corporation of America officials

The wheels of justice really do grind slow, but they sometimes do grind.  A federal grand jury has indicted four officials of the Peanut Butter Corporation of America for “conspiracy, wire fraud, obstruction of justice and others offenses related to contaminated or misbranded food.”

Translation: Salmonella that sickened more than 500 people and killed at least 8.

The documents in the case have just been unsealed:

I’ve been following this particular food safety tragedy for several years now.  The offenses were so egregious—officials blatantly ignored positive tests for Salmonella, for example—that some kind of punishment seemed warranted.

According to the account in USA Today:

The indictment alleges that PCA officials affirmatively lied to their customers about the presence of salmonella in PCA’s products,” said Stuart Delery, principal deputy assistant attorney general.

Delery also said some officials at PCA, no longer in business, fabricated lab results certifying to customers that the products were salmonella free “even when tests showed the presence of salmonella or when no tests had been done at all.”

As lawyer Bill Marler writes,

These indictments will have a far reaching impact on the food industry.  Corporate executives and directors of food safety will need to think hard about the safety of their product when it enters the stream of commerce.  Felony counts like this one are rare, but misdemeanor charges that can include fines AND jail time can and should happen.

Is this a sign that courts might be taking food safety problems more seriously?  If so, it’s about time.

Addition, February 22:  Food Safety News has a handy timeline of the Peanut Corporation events.

Feb 19 2013

The horsemeat scandal–an object lesson in food politics

The unfolding drama around Europe’s horsemeat scandal is a case study in food politics and the politics of cultural identity.

Cultural identity?  They (other people) eat horsemeat.  We don’t.

Most Americans say they won’t eat horsemeat, are appalled by the very idea, and oppose raising horses for food, selling their meat, and slaughtering horses for any reason.

These attitudes have created dilemmas.  Since Congress effectively banned horse slaughter in 2006, roughly 140,000 horses a year have been transported to Canada and Mexico to be killed.  Whether this is better or worse for the horses is arguable.  Some—perhaps most—of that meat will be exported as food.

As Mal Nesheim and I wrote in our book about the pet food industry, Feed Your Pet Right, most—more than 90%—of domestic horsemeat ended up in pet food (the rest was eaten or shipped to Europe).  In the 1920s, horse slaughterhouses started pet food companies as a means to dispose of the meat.  Horsemeat remained a major ingredient of dog foods throughout the 1940s.

Since then, pet food companies replaced horsemeat with meats from other animals.  Although it continues to be permitted in pet food, I’m not aware of any company that would dare use it.  It would have to be disclosed on package labels.

That brings me to the European horsemeat crisis, one brought about by advances in DNA technology that allow officials to test for species in foods.

I’m indebted to Joe O’Toole, president of Lucullus, a French specialty food company, for keeping me up to date on the unfolding saga of how horsemeat got into European hamburger and so many other foods.  He sent me links to early stories:

The problem first emerged earlier in January when the Food Safety Authority of Ireland handed over results of DNA tests it had carried out on burgers produced in Ireland for sale in the UK. Samples from 10 of 27 products sourced from three processing plants had tested positive for horse DNA. One sample is said to have contained 29 percent horse.

As the article explained, the immediate response was “a relatively faultless exercise in damage control.”  Food processors immediately recalled their products and Tesco, Britain’s largest supermarket chain, placed an ad and followed it up with a video apology.  This is viewed as excellent damage control.  Although Tesco shares dropped by 1 percent for a loss of  $475 million, it could have been worse.  

Leaving aside the cultural prohibitions against eating horsemeat, here’s what I find fascinating:

  • DNA technology made this possible.
  • The supply chain is so complicated and involves so many countries—Romania, Ireland, Netherlands, Spain, Poland, France, and, no doubt, others—that where the meat comes from is impossible to trace.
  • The finger pointing  over who is to blame.
  • The enormous number of companies involved.
  • The idea that this is a drug issue (horses are treated with drugs).
  • The idea that horse transport is used as a cover for smuggling (drugs and people).
  • The involvement of organized crime (if selling horsemeat is illegal…).

By far the best place to start on this story is Felicity Lawrence’s Horsemeat Scandal: The Essential Guide, in The Guardian. She did this as a Q and A:

1. Where did the horsemeat scandal begin?

2. Where did the horse and pig found by the Irish in beef products come from?

3. Why did some products contain so much more horse than others?

4. How did the rest of Europe get involved?

5. Is the source of the Irish horsemeat the same as the French one?

6. Why are the supply chains so complex?

7. Why has it happened?

8. How is the meat industry regulated?

9. What about industry claims that it has full traceability?

10. What happened to government control of food safety and standards?

11. Where do the horses come from?

12. What part do UK horse abattoirs play?

13. Why are governments talking about organised crime?

14. Is it a health problem?

I will have more to say about this later, as more details emerge.  Stay tuned!

Addition, February 27: Australia Food Safety News offers this terrific infographic on the scandal.

Jan 14 2013

FDA issues food safety rules–at long last

I’m catching up with events that occurred while I was out of the country.  One was the release by FDA of two of its long-awaited proposals for food safety rules.

These go into the Federal Register on January 16. But they were announced on January 4, perhaps to commemorate the two-year anniversary of President Obama’s signing the Food Safety Modernization Act authorizing these rules.

The two massive sets of proposed rules, 680 and 547 pages, respectively, are:

Still to come: proposed rules for

  • Food importers
  • Preventive controls for animal feed
  • Accreditation of third-party auditors

Notice that all of these are proposals.  Terrific as it is to have them released, no breath-holding is in order.

Once the proposals appear in the Federal Register, interested parties will have 120 days to comment.  It will probably take a year for the FDA to write final rules.   For the produce standards at least, larger farms get 2 years before implementation kicks in.  Smaller farms get 3 or 4 more years to figure out how to comply.

Some farms, such as those bringing in less than $500,000 per year, are exempt.  Chalk that up to successful lobbying by small farmers.

The FDA estimates that the new rules will cost large farms about $30,000 a year, and small farms $13,000.   It says that following the rules will prevent 1.75 million cases of foodborne illness a year and save more than $1 billion in costs.

The rules for produce focus on prevention of contamination through:

  • Agricultural water
  • Biological soil amendments
  • Poor worker hygiene
  • Domesticated and wild animals
  • Equipment, tools and buildings.

All food producers will need to develop, submit, and follow a written food safety plan that includes:

  •  A hazard analysis
  • Preventive controls
  • Monitoring procedures
  • Corrective action procedures
  • Verification procedures
  • A recall plan

That’s the basic outline.  The devil is in the details and in this case there are plenty of them (I have much sympathy for whoever has to write these things).  The proposals devote hundreds of pages to definitions.  Here, for example, is FDA’s summary of its definition of farm and farm activities.  Hint: RAC = Raw Agricultural Commodity.

  • The basic purpose of farms is to produce RACs and RACs are the essential products of farms.
  • Activities that involve RACs and that farms traditionally do for the purposes of growing their own RACs, removing them from the growing areas, and preparing them for use as a food RAC, and for packing, holding and transporting them, should all be within the definition of “farm” in §§ 1.227 and 1.328.
  • Activities should be classified based in part on whether the food operated on is a RAC or a processed food, and on whether the activity transforms a RAC into a processed food.
  • Activities farms may perform on others’ RACs should appropriately be classified as   manufacturing/processing, packing, or holding in the same manner as these activities are classified off-farm when the RACs are to be distributed into commerce.
  • Manufacturing/processing, packing, or holding food– whether RACs or processed foods, from any source–for consumption on the farm should remain within the farm definition.

I include this example to illustrate what food producers are up against.  It explains why practically every group commenting on the proposals said the same things: “we are glad they are out but must reserve comment until we—and our lawyers—have a chance to go over the rules in detail.”

My guess is that we will be hearing plenty more about these reactions when they do.

In the meantime, the elephant in the room issue is funding.  The FDA’s budget is already overstressed.  How can it possibly add monitoring and enforcement responsibilities without additional staff and funding?  How can it get new resources from this Congress?

Recall: the FDA gets its funding from congressional agriculture appropriations committees, not health committees.

The FDA addresses the funding issue in a website Q and A:

G.5.  Does FDA have sufficient funding to implement the new rule?  The funding we have available through the annual budget cycle and fees impacts the number of FTEs we have and will be a factor in the way that FDA handles its significant and far-ranging activities, including the way that this legislation is implemented… Without additional funding, FDA will be challenged in implementing the legislation fully without compromising other key functions. We look forward to working with Congress and our partners to ensure that FDA is funded sufficiently to achieve our food safety and food defense goals.

Indeed.

To submit a comment:

  • Go to http://www.regulations.gov.
  • Refer to Docket No. FDA-2011-N-0920.
  • Do it by May 16.
Jan 10 2013

Predictions for 2013 in food politics

For my monthly (first Sunday) Food Matters column in the San Francisco Chronicle, I devote the one in January every year to predictions.  Last year I got them all pretty much on target.  It didn’t take much genius to figure out that election-year politics would bring things to a standstill.  This year’s column was much harder to do, not least because the FDA was releasing blocked initiatives right up to the printing deadline.

 Q: I just looked at your 2012 crystal ball column. Your predictions were spot on. But what about 2013? Any possibility for good news in food politics?

A: Food issues are invariably controversial and anyone could see that nothing would get done about them during an election year. With the election over, the big question is whether and when the stalled actions will be released.

The Food and Drug Administration has already unblocked one pending decision. In December, it released the draft environmental assessment on genetically modified salmon – dated May 4, 2012. Here comes my first prediction:

The FDA will approve production of genetically modified salmon: Because these salmon are raised in Canada and Panama with safeguards against escape, the FDA finds they have no environmental impact on the United States. The decision is now open for public comment. Unless responses force the FDA to seek further delays, expect to see genetically modified salmon in production by the end of the year.

Pressures to label genetically modified foods will increase: If approval of the genetically modified salmon does nothing else, it will intensify efforts to push states and the FDA to require GM labeling.

Whatever Congress does with the farm bill will reflect no fundamental change in policy: Unwilling to stand up to Southern farm lobbies, Congress extended the worst parts of the 2008 farm bill until September. Don’t count on this Congress to do what’s most needed in 2013: restructure agricultural policy to promote health and sustainability.

The FDA will start the formal rule-making process for more effective food safety regulations: President Obama signed the Food Safety Modernization Act in January 2011. Two years later, despite the FDA’s best efforts, its regulations – held up by the White House – have just been released for public comment. Lives are at stake on this one.

The FDA will issue rules for menu labels: The Affordable Care Act of 2010 required calorie information to be posted by fast-food and chain restaurants and vending machines. The FDA’s draft applied to foods served by movie theaters, lunch wagons, bowling alleys, trains and airlines, but lobbying led the FDA to propose rules that no longer covered those venues. Will its final rules at least apply to movie theaters? Fingers crossed.

The U.S. Department of Agriculture will delay issuing nutrition standards for competitive foods: When the USDA issued nutrition standards for school meals in January 2012, the rules elicited unexpected levels of opposition. Congress intervened and forced the tomato sauce on pizza to count as a vegetable serving. The USDA, reeling, agreed to give schools greater flexibility. Still to come are nutrition standards for snacks and sodas sold in competition with school meals. Unhappy prediction: an uproar from food companies defending their “right” to sell junk foods to kids in schools and more congressional micromanagement.

The FDA will delay revising food labels: Late in 2009, the FDA began research on the understanding of food labels and listed more relevant labels as a goal in its strategic plan for 2012-16. Although the Institute of Medicine produced two reports on how to deal with front-of-package labeling and advised the FDA to allow only four items – calories, saturated and trans fat, sodium and sugars – in such labels, food companies jumped the gun. They started using Facts Up Front labels that include “good” nutrients as well as “bad.”

Will the FDA insist on labels that actually help consumers make better choices? Will it require added sugars to be listed, define “natural” or clarify rules for whole-grain claims? I’m not holding my breath.

Supplemental Nutrition Assistance Program participation will increase, but so will pressure to cut benefits: Demands on Snap – food stamps – reached record levels in 2012 and show no sign of decline. Antihunger advocates will be working hard to retain the program’s benefits, while antiobesity advocates work to transform the benefits to promote purchases of healthier foods. My dream: The groups will join forces to do both.

Sugar-sweetened beverages will continue to be the flash point for efforts to counter childhood obesity: The defeat of soda tax initiatives in Richmond and El Monte (Los Angeles County) will inspire other communities to try their own versions of soda tax and size-cap initiatives. As research increasingly links sugary drinks to poor diets and health, soda companies will find it difficult to oppose such initiatives.

Grassroots efforts will have greater impact: Because so little progress can be expected from government these days, I’m predicting bigger and noisier grassroots efforts to create systems of food production and consumption that are healthier for people and the planet. Much work needs to be done. This is the year to do it.

And a personal note: In 2013, I’m looking forward to publication of the 10th anniversary edition of “Food Politics” and, in September, my new editorial cartoon book with Rodale Press: “Eat, Drink, Vote: An Illustrated Guide to Food Politics.”

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