The Department of Health and Human Services has "illegally permitted the public to be exposed to six cancer-causing color additives used in foods, drugs and cosmetics," a House subcommittee says in a report scheduled to be released today. The report also charges that the Office of Management and Budget has improperly interfered with HHS' regulation of color additives.
"This report reflects Congress' bipartisan view that HHS has blatantly violated federal law in failing to ban six potentially hazardous dyes," said Rep. Ted Weiss (D-N.Y.), chairman of the Intergovernmental Relations and Human Resources Subcommittee of the House Committee on Government Operations, in a press release.
Three Food and Drug Administration commissioners have recommended banning the six color additives, but HHS Secretary Margaret M. Heckler "has repeatedly refused to approve the recommendations," a committee statement said.
On Monday, for the 28th time in 22 years, the FDA postponed a decision about whether the 10 widely used color additives should be banned, even though six have been shown to cause cancer in laboratory animals. The other four are suspected cancer causers.
The decision on these 10 remaining chemicals is now postponed until Sept. 3.
The the color additives are on a provisional list, which allows them to remain in use until a final decision is made.
The congressional subcommittee charges that this action "violates two critical provisions of the Color Additives Amendment of 1960: the Delaney anticancer clause, which prohibits the use of any color additive found by FDA scientists to cause cancer in laboratory animals; and the general safety clause, which requires manufacturers to prove 'with reasonable certainty' that color additives are safe for their continued use." The Color Additives Amendment modifies the Food, Drug and Cosmetic Act.
"Once a color additive has been determined by agency scientists to be a carcinogen cancer-causing agent in appropriately conducted animal studies relevant to human exposure, HHS is required by the Delaney anticancer clause to prohibit its continued marketing," the congressional report concludes. "The failure to [ban] color additives years after they have been conclusively found to be animal carcinogens is in clear violation of the requirements of law."
The subcommittee recommends that HHS ban the six dyes that have been showed to cause cancer in animals.
At the center of the color additives controversy is the question of how federal law, as embodied in the Delaney clause's prohibition against using carcinogens in food, should be interpreted.
The food industry says the Delaney clause should not be strictly interpreted because modern technology now allows the detection of minuscule levels of carcinogens that pose no health risk to humans. Some industry officials say, for instance, that a person would have to eat 280,529 pounds of maraschino cherries a year to be affected by Red No. 3.
"Today, we find things at parts per billion or parts per trillion, and at that level, you're not subjecting the average person to any kind of exposure that has any consequence whatsoever," said Dr. Harry r for Food Safety and Applied Nutrition, testified before the subcommittee last fall that "based on exposure estimates, all the uses of Red 3 were calculated to pose an upper-level human cancer risk in the neighborhood of the one cancer in 100,000 population range, 10 times higher than the one-in-1-million risk that is normally deemed to be 'acceptable' by federal health and safety regulatory agencies."
Consumer advocates and some members of Congress maintain that the potential hazards of these color additives far outweigh their benefits and that scientists' abilities to establish a "safe" level of carcinogens is questionable. They argue that the FDA should adhere to the Delaney clause or go through the appropriate channels to change the law.
"No scientists other than those from industry will say you can find safe levels of carcinogens. It's just not possible," says Dr. Sidney Wolfe, director of Public Citizen, a Washington-based organization that, with another consumer group, has sued the FDA over the delayed decision.
Several times over the last two years, the FDA has recommended that HHS ban the six known cancer-causing dyes. On each occasion, the recommendations have been approved by former HHS Assistant Secretary Ed Brandt. Heckler, however, has never approved the proposed bans.
"It's quite clear that judgments are not being made on scientific grounds. And the American people are not receiving the kind of protection which they expect and are entitMussman, executive vice president for scientific affairs with the National Food Processors Association, an industry group that conducted research on Red No. 3.
However, Dr. W. Gary Flamm, director of the FDA's Office of Toxicological Sciences, Centeled to," says Rep. Weiss. "There has been an abuse of the system. We discovered that OMB was all over the lot and that industry people were involved, discussing matters with OMB and HHS."
Robert Bedell, deputy administrator for Information and Regulatory Affairs with OMB, said his office has acted properly. Bedell said that since 1981, every department submits proposed regulations to OMB to review "to see if it conforms to the president's regulatory principles."
"Even if costs cannot be considered, and I think that is an open question, it is important to know just how costly rule-making decisions are," Bedell said. "And you may want to rethink whether it is worth that cost to ban the substance or continue its use."
Bedell denied that OMB interfered with HHS regulation of food dyes.
Neither Heckler nor FDA Commissioner Frank Young would agree to be interviewed. Written questions were provided to HHS in advance, as requested, but they were never answered.
"Frankly, there's a lid on all this," said FDA spokesman Jim Greene.
The story really began in 1960, when the FDA started to evaluate 204 food dyes, of which 128 have been approved and 66 have been banned. It's up to industry to prove that the dyes are safe.
The FDA, however, still has to decide on 10 of the dyes. Six of the 10 are known carcinogens, according to FDA and industry officials.
Three of the 10, Red No. 3 and Yellow Nos. 5 and 6, are food dyes of which Americans consumed 3.4 million pounds in 1984. That's slighly more than half of all food dyes consumed in the United States. The other seven color additives (Red Nos. 8, 9, 19, 33, 36 and 37 and Orange No. 17) are used in drugs and cosmetics.
The conflict not only pits consumers against industry, but also has divided the FDA itself.
Last fall, in a memo to Young, Dr. Sanford Miller, director of the FDA's Center for Food Safety and Applied Nutrition, wrote: "As we previously indicated, we don't believe that additional peer review is likely to dispose of the adverse data, resolve all of the questions about the safety of these color additives, and result in a determination that these color additives have been shown to be safe within the meaning of the act.
"In other words, the only effect that we can realistically see from additional peer review is a further delay that would risk a lawsuit, asserting that FDA is not adhering to its responsibilities under the law. In our judgment we have already extended the provisional list so many times for such tenuous reasons that we are in danger of losing both a lawsuit and our credibility as a regulatory agency," Miller wrote.
In a December 1984 memo to Heckler, FDA Commissioner Young recommended banning the six carcinogenic dyes. Both FDA scientists and Young's two predecessors also had proposed banning the additives.
Six weeks later, however, Young changed his mind, deciding that there was, indeed, a need for additional scientific review.
Early last month, Young appointed a review committee to evaluate existing data on the dangers of these dyes and report back to him by June 28. But an FDA memo from the division that conducts much of the scientific evaluation pointed out that no new information has become available since a similar review was performed a year ago.
The whole situation, according to Rep. Weiss, is complicated by a policy reversal that has curtailed FDA's autonomy and allowed other branches of government to become involved in regulatory decisions. HHS had given FDA the authority to enforce the Food, Drug and Cosmetic Act. But in 1981, that authority was returned to the HHS.
It has recently become apparent, said Weiss, "that the FDA commissioner . . . is not his own person. The secretary makes the determinations within the political framework where political appointees operate -- and when you start substituting political or economic considerations for objective science, you're just asking for trouble."
According to other government officials and consumer advocates, there already has been plenty of trouble.
On March 16, 1983, former FDA commissioner Dr. Arthur Hayes sent a memo to HHS recommending a ban of Red No. 19, saying that "on the basis of animal studies showing it to be a carcinogen, we cannot continue to allow it to be used." This was the first time a ban had been urged for any of the 10 additives still under dispute.
The following day, Ed Kavanaugh, president of the Cosmetic, Toiletry and Fragrance Association, sent a letter to Heckler complaining that the FDA's position was "arbitrary and unreasonable" and requested a meeting. That day, Kavanaugh also sent letters to James J. Tozzi, deputy administrator in the Office of Information and Regulatory Affairs of OMB; and C. Boyden Gray, counsel to Vice President Bush.
Hayes' proposal to ban the dye advanced only one step further. Former Assistant Secretary Brandt approved the recommendation on April 4, 1983. But the following day, a meeting of the interagency Risk Management Group was convened by Tozzi of OMB. According to a memorandum of the meeting, the focus of the discussion was Red No. 19 and the HHS decision.
The day after the meeting, Tozzi sent a letter to HHS citing industry data about Red No. 19 that indicated there was a lifetime cancer risk of 1 in 15 billion, and concluding that "the FDA's position appears to be unjustified." Besides the letters from industry, Tozzi's was the only document that opposed a ban of Red No. 19 that was submitted to the Government Operations subcommittee.
Tozzi, who is now with Multinational Business Services of Washington, confirmed the meetings, but said OMB's role is appropriate. "Scientists don't have any monoply on determining acceptable levels of risk."
Last fall, during the subcommittee hearing, Brandt was asked whether HHS had taken any action on the FDA's recommendation to ban Red No. 19, which he had approved 18 months previously. Brandt replied: "I learned this week that the [March 16, 1983 recommendation] document has not yet reached the desk of the [HHS] secretary." It is not known whether it has now reached Heckler.
"The problem lies squarely in the office of Margaret Heckler," said Rep. Edward F. Feighan (D-Ohio), who has tried unsuccessfully for several months to discuss color additives with Heckler. "I can't begin to speculate what her reasons could be for continuing to expose a large number of American people to carcinogenic agents -- and to do that knowingly."
Feighan, Weiss, Wolfe and others said they were worried that the FDA may be in its decline.
"What's been one of the best agencies has turned into a paper tiger," said Wolfe. "The FDA is a law enforcement agency -- not a plaything for industry that Heckler and Young are making it right now."
FDA spokesman Jim Greene refused to comment about industry's involvement in decision-making. "We're concerned primarily with the science of the issue, not the politics. . . . The agency always proceeds with certain caution when it looks at any color or food additives."
"We've encouraged FDA and, of course, HHS to take a reasonable, common-sense approach," said Ed Kavanaugh, president of CTFA, a trade group that represents the nation's major cosmetic firms.
Kavanaugh and the National Food Processors' Mussman said that the reasonable approach is to reexamine the Delaney clause.
"It's time now -- and has been for a while -- for considering how the Delaney clause can be modified to meet todays' needs," said Mussman, who maintained that people are exposed daily to minute levels of many carcinogens. "If we were to ban every substance that could be carcinogenic, we would have massive problems as far as food supply and nutrition."
Kavanaugh, like Mussman, acknowledged that studies show the disputed drug and cosmetic dyes cause cancer in laboratory animals at certain concentrations. "Some will -- can -- cause cancer in rats and mice. But the fact that you have a mouse that gets cancer does not mean that translates any risk of cancer to humans," he said. "These colors are safe. No company wants to use a product or ingredient that's in question."
Kavanaugh, who estimated that the industry has spent $10 million on testing, is skeptical about the FDA. "Testing is a great way of avoiding decision-making. We think we've met our burden over and over again by submitting test after test. The FDA had enough information for many years to make a decision -- why they haven't is beyond us.
"It's an awful thing to put industry through. We've been living under the gun for the last two years," Kavanaugh said. "What's a company to do?