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The FDA has just released a classy new report on Global Engagement, summarizing its efforts to deal with issues raised by the globalization of drugs, medical devices, and foods.

This is a big deal.  In 2009, 300,000 foreign facilities in more than 150 countries exported $2 trillion worth of FDA-regulated products to the United States.

Given these numbers alone, the FDA has some challenges.

In 2011, one out of every six FDA-regulated food products in the U.S. came from abroad.  Imports of fresh fruits, vegeta­bles, coffee, tea, and cocoa have more than doubled since 2000.

We import:

• 80 percent of seafood
• ~50 percent of fresh fruit
• ~20 percent of fresh vegetables

As the report explains,

• Many products entering the United States are made or grown in countries that lack the necessary regulatory over­sight to ensure their quality and safety.
• Greater numbers of suppliers, more complex products, and intricate multinational supply chains introduce risks to product safety and quality, including more oppor­tunities for economic adulteration and the spread of contaminated products.
• FDA can only realistically inspect a small percent­age (less than 3 percent) of the enormous volume of food products arriving at U.S. ports of entry, making it crucial that the Agency focus on ensuring that food products meet U.S. standards before they reach the United States.

To deal with this problem, the FDA has opened offices in:

• China: Beijing, Shanghai, and Guangzhou
• India: New Delhi and Mumbai
• Latin America: San Jose, Costa Rica; Santiago, Chile; and Mexico City, Mexico
• Europe: Brussels, Belgium; London, United Kingdom; and Parma, Italy
• Asia-Pacific: FDA headquarters
• Sub-Saharan Africa: Pretoria, South Africa
• Middle East and North Africa: Amman, Jordan

The FDA seems seriously concerned about its global initiatives and the safety problems posed by our globalized food supply.

The volume seems impossible to manage.  Let’s hope the FDA’s efforts do some good.

I’ve been collecting items on food safety for the last week or two. Here’s a roundup for a quiet Friday in July:

Antibiotics in animal agriculture

     USA Today does great editorial point/counterpoints and here is one from July 12 on use of antibiotics as growth promoters or as  prophylactics in farm animals and poultry.  This selects for antibiotic-resistant bacteria.   If we get infected with antibiotic-resistant bacteria, too bad for us. 

     The paper’s editors think that use of antibiotics for these purposes is irresponsible:  Our view on food safety: To protect humans, curb antibiotic use in animals.

     Dr. Howard Hill, a veterinarian who directs the National Pork Producers Council, defends these uses of antibiotics: Don’t bar animal antibiotics.

The source of the 2006 E. coli 0157:H7 outbreak in California spinach

     USDA and UC Davis investigators are still trying to figure out how the toxic E. coli O157:H7 got onto the spinach. Investigators did not find the bacteria on the spinach field itself, but they did find it in water, cattle, and cattle feces at a cattle crossing over a stream one mile away. Leading hypotheses: runoff from that stream or wild boar.

     Subsequent studies showed low levels of E. coli 0157:H7 in wild animals and birds.  A new study confirms that just under 4% of wild boar harbor the bacteria. 

     The investigators say the spinach outbreak of 2006 was the result of a combination of circumstances: “Everybody is starting to realize that maybe unusually heavy rainfall prior to planting could be an issue in terms of where water is routed.”

     Dairy farming is moving into California’s Central Valley in a big way.  Runoff from those farms will not be sterile and growing vegetables along water routes may be risky.  Compost, anyone?

The chemical behind Kellogg’s cereal recall

     Kellogg recalled 28 million packets of breakfast cereals last month because people reported funny smells and getting sick from something in the packaging.  At first, Kellogg would not say what the chemical contaminant might be.  

     Then it said the chemical is methylnaphthalene. Mothballs! (Are they still making mothballs?  Their smell is unforgettable)

     Tom Philpott’s comments on Grist.com point out what’s really at stake: “And of course, the real scandal is what Kellogg’s is marketing to kids: a tarted-up slurry consisting mainly of sugar, corn products, partially hydrogenated oil, and food colorings. But that’s a whole different story.”

Salsa and guacamole are sources of foodborne illness

     The CDC reports that salsa and guacamole are becoming more frequent sources of contaminants leading to illness.  CDC started collecting information on sources of outbreaks in 1973.  Its first outbreak due to salsa or guacamole occurred in 1984.  Since then, there have been 136 such outbreaks.  Restaurants and delis were responsible for 84%.  Between 1984 and 1997, salsa and guacamole outbreaks accounted for 1.5% of total foodborne outbreaks.  But the percentage rose to 3.9% from 1998 to 2008.

     Moral: make your own!

China deals with melamine in milk powder

     China is taking creative steps to prevent melamine from getting into milk powder and infant formula.  To discourage fraudulent producers from boosting up the apparent level of protein in milk with melamine, it simply reduced the amount of protein required.

The latest on food irradiation

     FoodSafetyNews.com presented a two-part series on food irradiation (part 1 and part 2), both of them quite favorable to the technology. As I discuss in my book, Safe Food, I don’t have any safety ojections to food irradiation, but I consider it a late-stage techno-fix for a problem that should never have occurred in the first place.

     I conclude with my favorite quote from former USDA official Carol Tucker Foreman: “sterilized poop is still poop.”

Enjoy a safe weekend!

Nestlé (the corporation, not me) is moving its Healthy Kids Program to China, and intends to put the program into every country in which it operates by the end of 2011.

The program “aims to improve the nutrition, health and wellness of children aged 6-12 years old by promoting nutrition education, balanced diet, greater physical activity and a healthy lifestyle.”

Nestlé believes that education is the single most powerful tool for ensuring that children understand the value of nutrition and physical activity to their health through the course of their lives. As a Council member of the Chinese Nutrition Society, Nestlé is indeed honoured to work together with the authorities and several other organizations to promote nutrition awareness and health education for the Chinese children.

Want to make some guesses about what this program will say about nutrition?  Note yesterday’s post.  Probiotics in juice drink straws, anyone?

One clue comes from that barge loaded with food products that Nestle is sending up the Amazon into the Brazilian outback: The vessel will carry 300 different goods including chocolate, yogurt, ice cream and juices.”

In a move that should bring cheer to anyone who cares about the integrity of organic certification, the USDA has banned the Organic Crop Improvement Association (OCIA) from certifying foods from China as organic.  According to the accounts in today’s New York Times and the USDA’s enforcement announcement, OCIA used employees of a Chinese government agency to inspect state-controlled farms and food processing facilities.

Oops.  This is sending the fox out to guard the chickens (organic, hopefully).  The Chinese government has a vested interest in selling certified organic foods and can only be expected to be lenient in enforcing rules for organic production.

Honest, reliable, consistent inspection is the cornerstone of consumer trust in organics.  If producers aren’t following the rules to the letter (and, we wish, the spirit), why would anyone be willing to pay higher prices for organics?  Since it’s impossible to prove that organics are more nutritious than conventional foods, the entire system rests on trust.  And the value of trust rests with the inspectors.

Advocates of organics have been worried for ages about the credibility of organic foods from China and whether cheap organics produced according to high standards.  Now we know, and the answer is not pretty.  With respect to OCIA’s arrangement with Chinese government inspector, the New York Times explains:

The department objected to the arrangement after a 2007 audit, saying the partnership violated a rule barring certifiers from reviewing operations in which they held a commercial interest.  The department moved to revoke the association’s accreditation and the group filed an appeal. The department’s disciplinary process is conducted in secret, and negotiations often drag on. In O.C.I.A.’s case, it took nearly three years to resolve.

This cozy arrangement has been going on for at least the last three years?

It’s good that USDA is taking this on now.

But USDA really needs to take a hard look at conflicts of interest in organic certification, domestic as well as foreign.  Some USDA-authorized certifying agencies are much more lenient than others.  Witness: certification of fish and pet food as organic, despite the lack of final rules for such certification.  Some certifying agencies manage to find ways to do this; others refuse.

The organic industry ought to be pushing USDA as hard as it can to establish and enforce the highest possible standards for organic certification.  I’m looking forward to reading what the Organic Trade Association—and OCIA—have to say about all this.

I thought we were finished with melamine by now, but no such luck.   Recall that we first encountered Chinese melamine (ordinarily a benign component of plastic dinnerware and countertops) as a toxic adulterant of pet food in 2007.  Melamine, it turned out, had been used for decades to boost the apparent – not actual – protein content of foods and ingredients.  It is high in nitrogen and the test for protein in foods measures nitrogen, not protein itself.

In the wake of the pet food scandal, China cracked down on food safety violations.  That did not stop use of melamine and within just a few months, it turned up in infant formula and caused a reported 300,000 Chinese babies to develop kidney problems.  Chinese authorities again dealt harshly with perpetrators, executing some and giving others long prison sentences (to catch up with this story, see previous posts).

And now here we go again, and with one of the same companies implicated in the 2008 infant formula problem – Shanghai Panda Dairy Company.  Chinese authorities are again cracking down but, as the New York Times reports, the problem seems intractable.

Why?  Maybe Chinese adulterators are getting a double message.  Here are a couple of items I picked up off Chinese news sources on the Internet (Google the names to find the sites):

• Li Changjiang, the director of the inspection agency that failed to deal with the melamine problem, was forced to resign from the agency. He has overcome his disgrace, more or less.  He was just appointed deputy head of a major anti-pornography group.
• Zhao Lianhai organized the parents of victims of the infant formula adulteration to try to get compensation.  He was put under house arrest in November and formally arrested in December.

Melamine is an enormous embarrassment to the Chinese and they will get a grip on it eventually, but let’s hope sooner rather than later.  In the meantime, best to avoid food products made in China that are supposed to contain protein from milk or soybeans.

Update January 6: today’s Wall Street Journal reports that Chinese authorities have known about the melamine in milk:

Tuesday, the newspaper 21st Century Business Herald reported industry participants were aware of melamine use by Shanghai Panda as early as April 2009. The paper, which didn’t identify its sources, said that in November China’s minister of health, Chen Zhu, referred to melamine tainting by the company during an internal meeting of Communist Party officials. Those comments, the newspaper reported, prompted Wenzhou-based Zhejiang Panda Dairy Products Co. in early December to announce on its Web site that, while its name was similar to Shagnhai Panda, the two companies aren’t related.

Eating Liberally’s ever curious kat connects the dots between the current swine flu crisis (getting worse by the minute) and China’s interest in buying America’s largest pork producer, Smithfield Foods.  She wonders what I think about all that.  See the latest Ask Marion: “Who needs bioterrorism when we’ve got manure lagoons.”

April 29 update: Here is Grain’s report on these connections.

I had never heard of OMP (osteoblast milk product or protein) until this morning when a reporter from the Associated Press in Beijing sent me an e-mail about it.  A milk company in China, it seems, is adding OMP to its milk and the Chinese food safety agency is investigating. The companies say OMP is safe and FDA-approved.

It didn’t take long to find out what this is about.  Japanese investigators isolated a protein, kininogen, from milk and demonstrated in laboratory experiments that it promotes bone growth.  These and other experiments in rats and people also show that it stimulates bone formation (I haven’t read them so I can’t comment on their quality).

FDA approved?  Not exactly.  In response to a petition from a company called Snow Foods, the FDA agreed that the use of milk proteins as additives to dairy foods is GRAS (generally recognized as safe) for human consumption.  But its “approval” letter assumes that the proteins are mainly lactoferrin and lactoperoxidase, which are pretty well known to be safe. The FDA’s letter says nothing about the use of kininogen as a bone-promoting agent.

I can see why the Chinese government is concerned.  It is one thing to demonstrate the effects of a protein in experiments, and quite another to add that protein to a food likely to be consumed by children.  The protein is already in milk and there is no evidence that adding more of it will make any difference to bone growth.   Without further studies to make sure that adding this protein does no harm, putting it into milk seems like a bad idea.

This seems like more about marketing than health, and it sounds like it is part of the huge current effort to sell more milk to the Chinese people.  I am bewildered by the pressure on the Chinese population to drink more milk and eat more milk products.  Aren’t most Chinese sensitive to undigested lactose?  None of this makes any sense to me.  Milk is not an essential nutrient or food and the Chinese have done fine for millennia without it.

I will be watching the unfolding of this story with much interest.  Stay tuned.

Bill Marler, of the legal firm specializing in food safety cases, lists his top 10 picks for the food safety scandals of 2008, beginning with globalization and ending with pet food.

And Food Chemical News (December 31) says the FDA will be testing for melamine in farmed fish and fish feed from China.  When Hong Kong officials said they found melamine at 6.6 ppm in fish feed, the FDA wondered whether melamine could accumulate in fish tissues.  Apparently, that is exactly what it does.  The Los Angeles Times  (December 24) says FDA testing found whopping amounts of melamine – 200 ppm – in catfish, trout, tilapia and salmon that had eaten melamine-tainted fish feed.  This is way higher than the maximum “safe” level of 2.5 ppm in food.  So put fish from China on your list of what not to eat.

Let’s hope the new president picks someone for USDA undersecretary and FDA commissioner who takes food safety seriously.  That’s my wish (well, one of them) for the new year. Peace to all.