By SCOTT MCDONALD
BEIJING (AP) — Six Chinese suspects went on trial Friday accused of making and selling the industrial chemical at the center of a tainted milk scandal blamed for killing six children and sickening nearly 300,000 others.
Among those in court Friday was the owner of a workshop that was allegedly the country’s largest source of melamine, the substance responsible for the health crisis that also saw Chinese food products pulled from stores worldwide, state media said.
Police say Zhang Yujun, 40, ran a workshop on the outskirts of Jinan in eastern Shandong province that manufactured and sold a “protein powder” composed mainly of melamine and malt dextrin, the official Xinhua News Agency reported. The powder was added to watered-down milk to make it appear higher in protein content.
Prosecutors in the Shijiazhuang Intermediate People’s Court accused Zhang of producing 776 tons of the additive powder from October 2007 through August 2008, making it the largest source of melamine in the country. He allegedly sold more than 600 tons with a total value of 6.83 million yuan ($1 million), the court heard.
In the same case, a second man, Zhang Yanzhang, 24, was accused of buying and reselling 230 tons of powder to others.
State television showed both men in court in handcuffs with their heads bowed while being questioned by three judges. It was not immediately clear what penalties they face.
An official at the publicity office of Hebei Supreme Court confirmed that the trial started Friday but refused to give his name or other details.
Four other men were being tried in three separate courts across Hebei province for adding the chemical to raw milk and then selling it to Sanlu Group Co., the main company in the scandal, according to Xinhua.
Melamine can artificially inflate protein levels and was apparently added to watered-down milk to fool quality inspectors while boosting profits.
Zhang Heshe and Zhang Taizhen were accused of adding 77 pounds (35 kilograms) of the “protein powder” to 70 tons of raw milk and then selling it to Sanlu. Yang Jingmin and Gu Guoping were also charged with adding 53 pounds (24 kilograms) and 37 pounds (16.7 kilograms) of melamine, respectively.
The verdicts will be announced at an unspecified date, Xinhua reported.
The dairy company Sanlu, based in Shijiazhuang, confirmed earlier this week that it was bankrupt.
Xinhua reported Thursday that Sanlu has 1.1 billion yuan ($160 million) of net debt and that a branch of the Shijiazhuang City Commercial Bank was the creditor that applied to a court to have Sanlu declared bankrupt.
It said the intermediate court in Shijiazhuang had accepted the filing. Xinhua said Sanlu owes a creditor 902 million yuan ($132 million) it borrowed earlier this month to pay for the medical treatment of children sickened after drinking the company’s infant formula and for compensation of the babies’ families.
Wang Jianguo, spokesman for the Shijiazhuang city government, said the money was given to the China Dairy Industry Association for medical care and compensation fees for victims, according to a transcript of a news conference he gave Thursday.
A woman who answered the phone Friday at the association refused to answer any questions.
The issue of compensation for the families of the children sickened or killed has become a sensitive one, with courts so far not accepting any lawsuits filed by the families.
The Legal Daily newspaper reported that Tian Wenhua, Sanlu’s chairwoman and general manager, would go on trial Wednesday in Shijiazhuang for “selling fake and shoddy products.”
Sanlu, like a number of major Chinese dairies, had been exempt from government inspections because it was deemed to have superior quality controls — until high levels of the industrial chemical melamine were found in its baby formula and other products in September. Several other dairies were also found to have sold tainted goods.
Melamine poses little danger in small amounts, but larger doses can cause kidney stones and renal failure.
Sanlu is 43 percent-owned by New Zealand daily cooperative Fonterra Group.
Technorati Profile
What you need to know:
Not all foods are safe for pregnant women. Some contain high levels of chemicals that can affect your baby’s development. Others put you at risk for getting an infection that can hurt your baby.
What you can do:
Use common sense when preparing and selecting foods. Avoid the following:
* Swordfish, shark, king mackerel and tile fish. These fish can contain potentially risky levels of mercury. Mercury can be transferred to the growing fetus and cause serious health problems. Also avoid game fish until you check its safety with your local health department. (A game fish is any fish caught for sport, such as trout, salmon or bass.)
* Raw fish, especially shellfish (oysters, clams)
* Undercooked meat, poultry and seafood. Cook all of them thoroughly to kill bacteria.
* Do not eat hot dogs or luncheon meats. Examples are deli meats such as ham, turkey, salami and bologna. If you do eat these foods, reheat them until steaming hot.
* Refrigerated pates or meat spreads. Canned versions are safe.
* Refrigerated smoked seafood unless it has been cooked (as in a casserole). Canned versions are safe.
* Soft-scrambled eggs and all foods made with raw or lightly cooked eggs
* Soft cheeses made with unpasteurized milk. Examples are Brie, feta, Camembert, Roquefort, blue-veined, queso blanco, queso fresco and Panela. Check the label to see what kind of milk was used to make the cheese.
* Unpasteurized milk and any foods made from it
* Unpasteurized juices
* Raw vegetable sprouts, including alfalfa, clover, radish and mung bean
* Herbal supplements and teas
Also do not eat too much liver. It contains high amounts of vitamin A, which can lead to birth defects.
Some studies indicate that your baby may be at increased risk of developing a food allergy in later life if you, your partner or a family member has a food allergy. You may wish to consult a food allergy specialist for help in planning your diet during pregnancy and breastfeeding.
Tags: fish during pregnancy, food safety, healthy diet, healthy diet during pregnancy, healthy eating during pregnancy, healthy food, healthy food during pregnancy, healthy pregnancy food, mercury during pregnancy, Pregnancy, Pregnancy Food Safety, safe food, safe food during pregnancy
December 20, 2008 by
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CommentFiled under:
BPA,Bishenol A,
Banned Foods,
China Product Safety,
Dangerous Foods,
Food Dyes,
Melamine,
Red Dye 1,
U.S.A and Melamine Scare,
What it is?,
holiday food safety
Recalls: cocoa products, Topaz brand Wafer Rolls
The following recalls have been announced:
_Dorsey Marketing Inc. is recalling G&J Gourmet Market cocoa products because they might contain melamine, a chemical used in plastics and not approved to be directly added to food in the U.S. No illnesses have been reported, according to the company, based in Saint-Laurent, Quebec. The recalled products include G&J Hot Cocoa Stuffer, item 120144; G&J His and Hers Hot Cocoa Set, item 120129; G&J Cocoa item, item 120126, sold in French Vanilla Cocoa and Double Chocolate Cocoa flavors. The recalled products were imported into the United States by the company. They were distributed nationwide to Big Lots during the weeks of Sept. 22 and Sept. 29 this year and to Shopko during the week of Oct. 6. For more information, consumers can e-mail the company: recall(at)dmi-global.com.
_National Brands Inc. is recalling all its 4.76-ounce and 12.3-ounce cans of Topaz brand Wafer Rolls because the products might be contaminated with melamine. No illnesses have been reported, according to the Spring Valley, N.Y., company. The recalled products were sold in four flavors and they were distributed nationwide through retail stores. For more information, consumers can call 866-238-5201.
Holiday trimmings can be dangerous for pets
Items like chocolate and tinsel are harmful
Val Cole, Canwest News Service

It’s the holidays and — just when you thought you could finally relax and enjoy the festivities — you find yourself frantically driving to the emergency vet hospital while your sister clutches your trembling cat or dog
* Christmas items pose risk to dogs
* Ruff time for Santa
* Make the holidays better for pets
* Pets will love Christmas attention
* Pets are Christmas priority
Laurence Braun, head of Emergency and Critical Care at Canada West Veterinary Specialists and Critical Care Hospital in Vancouver, says the hospital sees an increase in holiday-related pet incidents, making it one of the busiest times of the year.
Here are some important safety tips to help keep the holidays merry and bright.
Are you giving your home some holiday cheer with poinsettias, amaryllis, mistletoe or lilies? These plants can cause many problems including vomiting, diarrhea, heart and breathing issues and even tremors.
“Because there is often a change in the household routine and with all the hustle and bustle that the holidays bring with them, families may not pay as close attention to what their pet might be getting into,” cautions Braun.
Lilies, in fact, don’t even have to be ingested to be deadly to cats. “Simply brushing up against it and then licking their fur afterwards may be enough to cause toxins to be ingested,” Braun says.
“They can cause renal [kidney] failure, which may be irreversible and can require the cat to be put on dialysis or even cause death.”

If you think you’ve put the appetizers and treats out of Fido’s reach, think again. Dr. Braun reminds us: “Cats and ingenious canines are masters of figuring out ways to jump up to locations such as counters and table tops.” Their strong noses will find gifts of wrapped food under the tree, as well.
If your dog has a sweet tooth, be vigilant about watching them around chocolate. It only takes 2/3 of an ounce of dark chocolate per pound of dog to be lethal. “Chocolate contains theobromine, which in moderate doses may cause vomiting, diarrhea, hyperactivity and tremors,” Braun explains.
“In severe cases, racing heart rhythms can progress to abnormal rhythms and even death.”
“Grapes and raisins are also toxic to dogs and can cause irreversible renal failure,” Braun adds. Your pet may not be interested in grapes, but would probably gobble up pies, tarts, cookies and breads containing raisins if given half a chance.
The high fat content in poultry skin and also in foods like butter, cookies, cheese, etc., can cause life-threatening pancreatitis with symptoms that vary from vomiting and diarrhea to “profound shock in more severe cases.”
DECORATIONS
Braun has seen pets get electrocuted or burned by Christmas tree lights and severely injured by the ornaments.
“A pet that’s an indiscriminate eater may swallow shards of broken ornaments and a curious feline can eat tinsel. Cats can swallow linear objects such as ribbons and elastics so be sure to be on the lookout for any missing decorations!”
Sometimes, the danger is lurking under the tree. “Even though your pet has his or her own water bowl, there is something enticing about a novel source of water; whether it’s the toilet bowl or the Christmas tree stand,” Braun advises.
“If you add chemicals to the water meant to keep your tree fresh longer, be sure to read the label to make sure it is safe for pets.”
Chinese health ministry bans 17 harmful substances in food
BEIJING – China has published a list of 17 acids, chemicals and other substances that have been banned as food additives, amid a four-month safety campaign following a scandal over tainted milk.

A Chinese customer browses through various instant noodles at a supermarket in Zhengzhou, Dec. 16. China has banned 17 substances as food additives as part of a four-month safety campaign launched following a scandal over tainted milk. – AFP
Illegal items posted on the Chinese health ministry’s list include boric acid, a chemical used as an insecticide or flame retardant that is known to be added to noodles or the skin of dumplings to increase their elasticity.
Formaldehyde, applied to dried seafood to improve its appearance, but also commonly used as a disinfectant, was another dangerous substance on the banned list, published on the ministry’s Web site late on Monday.
Some of the substances, such as the carcinogenic dye Sudan Red 1, had already been banned by the government, but this was the first official compilation of illegal food additives in China.
In a related story, Chinese police are investigating 27 cases of melamine-laced animal feed, state media said Monday, three months after the industrial chemical was detected in milk, triggering a worldwide food scandal.
The Ministry of Agriculture examined 22,700 batches of feed throughout the country, and found 545, or 2.4%, were found to contain excessive melamine, the official China Daily reported.
Twenty-seven cases had been transferred to police for further investigation, the report said, citing Wang Xiaohong, a top official at the ministry’s National Feed Office.
The government said this month at least six children may have died in China after drinking milk laced with melamine, a chemical normally used to make plastic, and a further 294,000 suffered kidney-related problems.
The scandal, which came to light in September, caused international concern and led to recalls and bans of Chinese-made dairy products around the world.
The melamine was mixed into watered-down milk so dairy products would have the appearance of higher protein content.
The scandal widened when eggs sent from the mainland to Hong Kong were also discovered to contain melamine in October, with the chemical similarly added to chicken feed to give it the appearance of more protein.
China is the largest feed and feed additive exporter after the US, with output estimated to be 131 million tonnes this year, according to the China Daily.
This prompted authorities to launch a four-month food safety drive at the beginning of December to try to restore confidence in the “Made-in-China” brand.
The government said when it announced the campaign that it would start out softly, with companies urged to correct their own shortcomings. But officials would soon begin raiding food producers deemed high-risk and carry out random checks, it warned.
Banned food additives
The list of banned food additives on Monday also included sodium thiocyanate, used in the manufacture of textiles, and added to milk and dairy products to keep them fresh.
Anthony Hazzard, a regional adviser for food safety in the World Health Organization’s (WHO) Western Pacific office, said the list could prove useful in reducing the illegal use of such chemicals, by raising awareness.
But he told AFP it was more efficient to have a list of additives that could be used in food rather than an unending list of ones that could not.
As part of the crackdown, the health ministry also published on Monday the names of additives that could easily be abused when added to food products.
It mentioned leavening agents as one such substance, used to make cakes and dough sticks, which could leave excessive aluminium residues if added in excessive quantities.
But the ministry warned the lists were not exhaustive.
"These lists... cannot cover all problems linked to illegally adding substances in food and abusing additives in the industry," it said in its online statement. - AFP
Update(06/10/2008): SOUTH Korea has declared a rising volume of Chinese imported kimchi, or spicy fermented cabbage, to be inedible due to banned or harmful additives found in it. The Korea Food and Drug Administration told parliament it blocked 1,637 tonnes of Chinese-made kimchi due to food safety concerns last year. The kimchi shipments were found to have ‘inedible’ additives such as cancer-causing artificial sweeteners or banned colourings, the food and drug agency said.
By FRANK JORDANS
GENEVA (AP) — The World Health Organization said Friday that tiny traces of the chemical melamine are not harmful in most foods, but it joined the U.S. and EU in setting a strict limit that regulators should impose before pulling products off the shelf.
Melamine was recently found to have contaminated milk products around the world and has been implicated in the sickening of nearly 300,000 babies in China and killing at least six infants there.
A meeting of food safety experts held by WHO in Ottawa, Canada, decided on Friday that while there is no good reason to have any melamine in food products at all, a maximum of 0.2 milligrams of melamine per kilogram of body weight can be tolerated per day.
Jorgen Schlundt, WHO's director for food safety, said that threshold is lower than the European Union's limitation of 0.5 milligrams. The U.S. Food and Drug Administration, which originally set its limit at 0.63 milligrams, later reduced its tolerable daily intake to 0.063 milligrams.
WHO's guidance is used by governments to set their minimum food safety standards.
Melamine, a nitrogen-rich chemical used in the production of plastics, was first discovered to be a major problem when it appeared in Chinese infant formula in September. Since then traces have been found in milk products around the world.
Last month the FDA said tests found traces of melamine in the infant formula of one major U.S. manufacturer and cyanuric acid, a related chemical, in the formula of a second major maker.
Schlundt stressed that the threshold the WHO has set — which stipulates that a 50 kilogram (110-pound) person could tolerate 10 milligrams of melamine per day — is not a “safe” level for melamine, but merely the amount a human being can consume without higher health risk.
Melamine is used in some food packaging and can rub off into packaged food products. It also is part of a cleaning solution used on some food processing equipment.
Red Dyes in Food, are they safe? Should they be banned?
Red Dye # 40 has been linked unofficially to some behavioral problems with young children.
Red dye No. 40 is found in hundreds of foods, including Twizzlers, Doritos, Twinkies, chocolate cake mix, vanilla frosting and crosissants.
This is a great site about red dyes and the history of what is going on with dyes in general.
Click here to read more.
Note: This is an older article and oddly enough when I researched red dye 3, I could not find any new info as far as it being banned. The FDA apparently tried to ban it at one point and failed.
Red No. 3 and Other Colorful Controversies
by Dale Blumenthal
The lure of red cherries in canned fruit cocktail is legendary in many
American families. Siblings fight over them, parents use them to bribe or
treat their children, and even adults count the cherries spooned into their
dessert. But, the days of the fruit cocktail cherry colored by FD&C Red No. 3
may be numbered. Because large amounts of the color have been shown to cause
cancer in rats, FDA recently ended certain uses of FD&C Red No. 3 and plans to
end the remaining uses. The cherries in 21st century fruit cocktail could
well be light brown.
Color has long been recognized as important in consumer acceptance of nearly
every food, medication and cosmetic product. Even the hue of the containers
can make the difference between a best seller and a “no-sale-er.”
A research project in the 1970s, reported in the October 1973 issue of
Marketing, illustrated just how big the impact of color can be on the
acceptance of food items in particular. Research volunteers were served a
meal of steak, peas and French fries. They ate part of the meal under special
lighting that concealed the fact that the colors of the food had been
altered. When, under normal lighting, the test group discovered that their
steaks were blue, peas red, and french fries green, some participants became
ill at the sight of the unnaturally colored food they had been eating.
Color Safety
Food once was colored only with natural dyes. Beets, peppers, grape skins,
saffron, and even brilliantly scarlet extracts prepared from dried bodies of
cochineal insects lent their distinctive colors to the cook’s creativity.
By the 19th century, colors derived from other chemicals came into use–with
sometimes serious health consequences (see “Additives for Eye Appeal” in the
July-August 1973 issue of FDA Consumer). Lead chromate and copper sulfate
began to be used to tint candy and pickles. Arsenic and other poisonous
impurities were added when mixing up new color additives. Dyes made from
coal-tar and petroleum derivatives also appeared in foods, drugs and cosmetics.
How, then, can a consumer be sure that the bright primary colors and the
subtle shadings that color many consumer products today are safe to eat, use
in drugs, put on skin or hair, or–as with colored contact lenses–stick in
the eyes? A monitoring process–directed by FDA and refined over several
decades–ensures that this is so.
FDA began a comprehensive assessment of the safety of color additives with the
passage of the Pure Food and Drugs Act of 1906. The country had changed from
an agricultural to an industrial nation. No longer did most Americans live on
farms and produce their own food. Instead, much of the food a nation of city
dwellers ate was processed, chemically preserved, and marketed by large firms
competing for consumers’ attention.
It was a time of triumph for synthetic dyes, followed by concern on the part
of public health officials about the safety of these dyes. Harvey Wiley,
chief of USDA’s Bureau of Chemistry, challenged the ease with which
manufacturers added chemicals to food. Food safety became Wiley’s special
cause, and he was instrumental in bringing about passage of the first federal
Food and Drugs Act in 1906.
This landmark food law prohibited the use of any color additive in foods if
the color would deceive the consumer, conceal inferiority or damage, or
otherwise result in misbranding and adulteration. However, Wiley believed
that the use of color additives in food required further investigation. He
hired an outside consultant, dye expert Bernard Hesse, Ph.D., to study the
problem.
After reviewing 80 of the most commonly used colors, many of which had never
been tested before, Hesse recommended only seven color additives as safe for
use in food. His recommendation was announced in a 1907 regulation, Food
Inspection Decision 76, which also introduced a system for voluntary
certification of synthetic food colors.
Pre-Market Approval
The Federal Food, Drug, and Cosmetic Act of 1938 elaborated on the earlier
regulations by providing for the listing and mandatory certification of
synthetic color additives used in foods, drugs and cosmetics. During the
1950s, a safety concern associated with the improper use of FDC’s Orange No. 1
prompted additional safety studies on color additives used in food, including
FDC’s Red No. 3.
Then, in 1960, Congress amended the Food, Drug, and Cosmetic Act of 1938 to
set up a pre-market approval system for new color additives and to require
demonstration of the safety of color additives already in use.
Approved color additives were divided into two groups: those requiring FDA’s
certification (synthetic dyes made mostly from coal tar and petroleum
derivatives) and those exempt from FDA’s certification (substances derived
from vegetable, animal or mineral products). Each batch of a synthetic color
is tested by the manufacturer and a sample submitted to FDA for certification
according to specifications in the Code of Federal Regulations. Colors exempt
from batch certification must also meet specifications in the CFR.
The 1960 amendments placed the color additives already in use on a provisional
list to permit their continued use while the manufacturers developed the
necessary data for a petition to support the listing of the color additive.
Many of the color additives requiring certification come in two forms:
straight colors and lakes. Straight colors in many cases are water-soluble
dyes. Certain straight colors are used to make “lakes” or water-insoluble
forms of the color additive. Lakes are used in products in which leaching or
“bleeding” of color would pose problems, such as in cookie fillings, coated
tablets, candies, chewing gum, and lipsticks. The agency is currently
planning a proposal regarding the regulation of lakes.
Manufacturers seeking approval for new color additives or for those on the
provisional list were required to submit a petition to FDA with scientific
data demonstrating that a specific color was safe for its intended uses. If
the agency approved the petition, the color was placed on a “permanent”
listing. Colors can be approved for use in food, drugs, and cosmetics (FDC),
in drugs and cosmetics only , or specifically for external drug and
cosmetic use .
To date, of the original 200 provisionally listed color additives, 90 have
been listed as safe and the rest have either been withdrawn by industry or
delisted by FDA.
FD&C Red No. 3
FDA terminated the provisional listings for FD&C Red No. 3 on Jan. 29, 1990,
at the conclusion of its review of the 200 straight colors on the 1960
provisional list. Commonly called erythrosine, FD&C Red No. 3 is a tint that
imparts a watermelon-red color and was one of the original seven colors on
Hesse’s list.
The provisionally listed uses that were recently terminated include use of the
straight color in cosmetics and externally applied drugs and all uses of the
lakes of FD&C Red No. 3.
The case of FDC Red No. 3, however, presents what one individual familiar
with color regulation calls a “regulatory inconsistency.” Although the
provisional uses (about one-third of its uses) are now banned, FDC Red No. 3
is still permanently listed for use in ingested drugs and food, such as baked
goods, cherries, dairy products, desserts, dietary supplements, food
seasonings, jellies, jams, and vegetable products.
This paradox came about because of improvements in scientific methods and the
timing of the petitioner’s submission for permanently listing the food and
ingested drug uses. After the 1960 provisional listings, studies were
performed on FDC Red No. 3. Results did not show any safety concerns, and in
response to a petition by the Certified Color Manufacturers Association
(CCMA), FDC Red No. 3 was permanently listed for use in ingested drugs and
foods in June 1969.
Cosmetic and externally applied drug uses of the color remained provisionally
listed while studies on skin exposure were conducted. Meanwhile, FDA expanded
its safety requirements in 1977 to include more extensive studies on
provisionally listed color additives. Based upon the results of new studies
on FDC Red No. 3, conducted by the International Research Development
Corporation and completed in 1982, the agency concluded that FDC Red No. 3
causes thyroid cancer in male rats.
The Cosmetic, Toiletry and Fragrance Association and CCMA argued that no
direct cancer-causing effect was seen in animals given the color in the low
levels used in consumer goods. FDA, however, decided that the evidence of
thyroid tumors in rats was clear, and that the additional research cited by
industry did not establish that an indirect mechanism--such as a hormonal
effect triggered by the dye--caused the tumors, rather than the dye itself.
Thus, FDA denied the manufacturers' petition for further permanent listings of
the color. Based on data from the studies, the agency estimated that the
lifetime risk of thyroid tumors in humans was at most 1 in 100,000.
Like FDC Red No. 3, FDC Blue No. 1 and FDC Yellow No. 5 were also
permanently listed for food and ingested drug uses in 1969. When FDA reviewed
new, more extensive studies on FDC Blue No. 1 and FDC Yellow No. 5, the
agency found that these two color additives did not cause cancer in animal
studies. (But, since FDC Yellow No. 5 causes allergic reactions in some
people, FDA requires its listing on food labels.)
As experts note, while the provisional listings for straight colors have
ended, advances in science will require continual monitoring of the safety of
color additives.
Delaney Dilemma
The decision to ban the provisional uses of FDC Red No. 3 is based on the
Delaney Clause of the 1960 Color Additive Amendments. Under that clause, FDA
cannot approve color additives shown to induce cancer in humans or animals in
any amount.
Many government officials, however, believe that the inflexibility of the
Delaney Clause should be replaced by a standard that allows for what may be an
insignificant cancer risk. Advances in technology and the ability to detect
minute quantities of cancer-causing chemicals in foods may make the risk
standard of the Delaney Clause unnecessarily stringent in some cases. In
announcing the decision to terminate the provisional uses of FD&C Red No. 3,
Health and Human Services Secretary Louis W. Sullivan, M.D., said that the
decision to ban the uses of Red No. 3 was not based on risk but on the legal
mandate of the Delaney Clause.
In 1986, FDA took a different approach in approving four cosmetic dyes for
which cancer risk was trivial. The agency based its approval of Orange
No. 17, FDC Red No. 19, and Red Nos. 8 and 9 on the legal maxim "de
minimis non curat lex," meaning that the law does not concern itself with
trifles. A government review panel had assessed the worst-case risks for
externally applied drug and cosmetic uses for D&C Orange No. 17 as 1 in 19
billion (that is, exposure to external cosmetics containing FDC Orange No. 17
may cause at most one additional case of cancer in 19 billion people over a
70-year lifetime of exposure) and for FDC Red No. 19 as 1 in 9 million. The
maximum possible cancer risk for D&C Red Nos. 8 and 9 was evaluated as 1 in 60
million.
The next year, however, the U.S. Court of Appeals for the District of Columbia
held that the Delaney Clause does not contain an exemption for cancer-causing
color additives with only trivial risks. Thus, the court ordered FDA to ban
the colors listed under the de minimis principle.
In the past two Congresses, Senator Edward Kennedy of Massachusetts and
Congressman Henry Waxman of California have introduced legislation concerning
pesticides that others in government would extend to other
additives--including colors--as well. The proposed legislation would
substitute a "negligible risk" standard for the "zero-risk" standard (such as
described in the Delaney Clause) to the regulation of pesticides. The bills
define "negligible risk" as causing at most one additional case of cancer in 1
million people over a 70-year lifetime of exposure to the compound.
President Bush endorsed the negligible risk standard for pesticides in his
October 1989 Food Safety Plan. A joint press statement issued that same day
by HHS Secretary Sullivan, USDA Secretary Yeutter, and EPA Administrator
Reilly noted that while the president's plan specifically addresses pesticide
residues, the principle of negligible risk is one that naturally applies to
other additives to the food supply.
Small Risks
The ban of the provisionally listed uses of FDC Red No. 3 applies to new
manufacture and production of affected products. Because any health risks
posed by Red No. 3 are extremely small, FDA concluded that consumers may
continue to use existing supplies of products that already contain that color.
Following the mandate of the Delaney Clause, FDA will now reconsider the
permanently listed uses of the straight form of FDC Red No. 3. The procedure
for banning a permanently listed dye, however, is more complex than that for
terminating the provisional uses and requires time for public comment.
Though in the future, new definitions of acceptable risk spawned by new
technologies may replace the Delaney definition, for now FDA must operate
under this meaning and say to consumers that because of the risks, certain
uses of FD&C Red No. 3 can no longer be allowed.
Dale Blumenthal is a staff writer for FDA Consumer.
Lists Available
For complete lists of color additives approved for use in food, drugs and
cosmetics--including the year approved, uses and restrictions--write to:
Division of Colors and Cosmetics
FDA (HFF-442)
200 C Street, S.W.
Washington, D.C. 20204
Tags: and Red 40, Blue 1, Blue 2, color additives, food dye safety, Green 3, orange no 1, Red 3, red dye, red dye 3, red dye 40, synthetic food dyes, Yellow 5, Yellow 6