http://www.sciencemag.org/cgi/content/full/322/5906/1310Chinese Probe Unmasks High-Tech Adulteration With Melamine
BEIJING--A weeks-long investigation into China's tainted milk scandal
has left scientists astonished by the technical sophistication of those
who used melamine to adulterate food products. Chinese investigators,
meanwhile, are puzzling over the precise mechanisms of exposure and
toxicity in infants who developed kidney damage.
At a closed workshop with U.S. experts here last week, Chinese
scientists presented early results of an ongoing probe into the mass
poisoning that left at least four infants dead and sickened more than
53,000 others after they drank baby formula tainted with melamine, an
industrial chemical used primarily as a plastics stabilizer and fire
retardant. The workshop capped a busy week in which the Chinese
government trotted out measures to improve food safety, and the U.S.
Food and Drug Administration (FDA) opened its first offices in China.
"After melamine, there will be more transparency, more openness," says
Chen Junshi, co-chair of the Sino-U.S. workshop and a risk-assessment
specialist at China's Center for Disease Control and Prevention here.
U.S. officials are speaking in more sweeping terms about the impact on
$2 trillion worth of imports a year: "This is nothing short of a
redesign of food and drug safety to meet a 21st century challenge,"
says U.S. Health and Human Services Secretary Michael Leavitt.
The melamine scandal came to light last September, when the central
government learned that scores of infants in Gansu Province had been
hospitalized with kidney stones, evidently after being fed infant
formula with high levels of melamine. In the weeks that followed,
powdered formula, fresh milk, and other products from some two dozen
companies were found to contain melamine. Police have detained more
than 30 people suspected of adulterating milk, including the general
manager of one of China's largest powdered milk makers, Sanlu, based in
Shijiazhuang. In an interview with Science last month, Premier Wen
Jiabao expressed sorrow for the poisoning and vowed an aggressive
response (Science, 17 October, p. 362).
Researchers say the adulteration was nothing short of a wholesale
re-engineering of milk. Weeks ago, investigators established that
workers at Sanlu and at a number of milk-collection depots were
diluting milk with water; they added melamine to dupe a test for
determining crude protein content. "Adulteration used to be simple.
What they did was very high-tech," says Chen. Researchers have since
learned that the emulsifier used to suspend melamine--a compound that
resists going into solution--also boosted apparent milk-fat content.
Sanlu baby formula contained a whopping 2563 mg/kg of melamine, adding
1% of apparent crude protein content to the formula, says Jerry
Brunetti, managing director of Agri-Dynamics in Easton, Pennsylvania.
Milk, he notes, is only 3.0% to 3.4% protein. Chen says a dean of a
school of food science told him that it would take a university team 3
months to develop this kind of concoction.
Investigators have concluded that as-yet-unidentified individuals
cooked up a protocol for a premix, a solution designed to fortify foods
with vitamins or other nutrients. In this case, it was deadly. Several
milk-collecting companies were using the same premix, Chen says: "So
someone with technical skill had to be training them."
So far, Chinese scientists have fingered only melamine as the toxic
agent. Published studies on cats and rats indicate that melamine reacts
with an accomplice--cyanuric acid--to form melamine cyanurate crystals
found in kidney stones. Both melamine and cyanuric acid were present in
wheat gluten imported from China during the North American pet-food
recall last year; the mixture killed dozens of cats and sickened
thousands of other pets.
In the tainted milk products, however, Chinese researchers have found
only trace amounts of cyanuric acid--parts per billion, or roughly 1%
of the amount of melamine in the samples, says Chen. "Our scientists
concluded that melamine by itself caused the kidney stones. But one
unresolved issue is how high the melamine levels have to be for this to
happen." Some experts are skeptical. George Daston, a toxicologist with
Procter & Gamble Co. in Cincinnati, Ohio, who with colleagues
published a study in Toxicological Sciences online on 9 August, doubts
that "melamine alone caused the kidney stones." He says that "melamine
and cyanuric acid are so tightly associated with each other, it can be
difficult to extract the compounds from the contaminated products."
U.S. chemists "found melamine but not cyanuric acid in their initial
attempts to identify the contaminant" in pet food, says Daston;
subsequent analyses, he says, uncovered significant amounts of cyanuric
acid. To settle questions about the new melamine cases, Chen says, "we
need more data." The World Health Organization will hold an expert
consultation on these issues in Ottawa next week.
Many other strands of the tragedy have yet to be unraveled. Although
it's evident that adulteration was to blame for baby formulas with high
melamine levels, it's unclear whether very low levels of melamine
contamination--the lowest tested level was 0.09 ppm--might have come
from nonprotein nitrogen (NPN) additives in ruminant feeds or from
plastic packaging. NPN additives such as biuret and urea are used in
cattle feed in many countries, including the United States.
The
Chinese government supported research in the 1990s on NPN feed
additives and has encouraged their use. Since then, a cottage industry
has sprung up selling dan bai jing (protein essence), whose specific
ingredients are unknown, for use in livestock feeds.
China has heightened its vigilance, and the odds of melamine slipping
through the safety net again are vanishingly low. But the problem of
adulterated livestock feeds may be harder to resolve. After FDA traced
last year's poisoned pet food to gluten from China tainted with
melamine scrap--melamine, cyanuric acid, and related compounds--China's
agriculture ministry issued a standard for determining levels of
melamine in feeds and banned the use of this and other harmful
compounds in June 2007. The ban appears to have had little effect.
Authorities in Hong Kong recently uncovered melamine in eggs and in
fish feed.
The measures announced last week should help keep attention focused on
the contamination problem. The National People's Congress is expected
to pass a new food-safety law next month that would establish a
food-hazard monitoring system and a risk-assessment committee under the
health ministry. Meanwhile, the governing State Council ordered the
ministry last month to sort out confusing food standards. For instance,
soy sauce, depending on how it's made and used, is subject to four
standards. One unresolved problem is segmentation of food control and
inspection, with one agency overseeing farms, another one responsible
for food manufacturers, and so on up to the dinner table.
"Scientifically, this is a terrible system," says Chen.
Last week, FDA opened three offices in China--in Beijing, Guangzhou,
and Shanghai--whose eight inspectors and technical experts will team up
with Chinese experts to monitor traffic in food products. It plans to
open two offices in India next month and two in Latin America in
January. China's State Food and Drug Administration also plans to open
U.S. offices to share technical expertise and work more closely on
policing imports. The global network "will require new science for
detection and investigation of contamination," says FDA Commissioner
Andrew von Eschenbach.
But the challenges facing China are immense. The country has 200
million farming households and more than 500,000 food manufacturers,
many of which employ fewer than 10 people, says Chen. "Most companies
don't care about their reputation," he says, and can dissolve and
reconstitute elsewhere. "Food adulteration is inevitable and will be
with us for many years."
Chen expects food and feed adulterators to raise their game. "The
sophistication of the techniques will improve the next time," he says.
Li Shaomin, a management professor at Old Dominion University in
Norfolk, Virginia, who studies the business environment in China,
agrees. "When millions of people experiment with new ways to make money
without moral self-constraint, the chance of new products that can
evade existing testing methods is pretty high," he says. "Unless the
people who put melamine into milk lose sleep, the product-safety
problem in China will go on."