There's a hornets' net on the Hill, and it has to do with food safety legal-ese -- wording that could smooth the sting of saccharin and nitrite controversies for industry but leave consumers buzzing with criticism about new food safety proposals.
The problems come in a package called the Food Safety Amendments of 1981, proposed by Sen. Orrin Hatch (R-Utah). Consumers say they are industry-slanted; proponents say they will give "rationality" and "logic" to current food safety laws.
But William Shultz, attorney for the Public Citizen Litigation Group, calls the title of the bill "deceptive," adding, "the amendments don't have anything to do with improving food safety."
Shultz was one of several people representing consumer groups at an Oct. 5 meeting to discuss the proposed bill with Arthur Hull Hayes, commissioner of the Food and Drug Administration.
Consumer advocates -- represented at the meeting by the Center for Science in the Public Interest, the Community Nutrition Institute and the Safe Food Coalition -- are concerned that this bill will effectively destroy many of the present food regulations which they see as protecting consumers.
Central to this concern is the consumers' desire to preserve the integrity of the Delaney Clause. This clause is designed to protect the consumer against any food additive (introduced since 1958) that causes cancer in animals or man. In theory, if an additive causes cancer, it can't be used, period.
The food industry isn't crazy about the clause. Technology has advanced a lot since 1958, when the clause was introduced. It is now possible to detect minute quantities of toxins, perhaps insignificant, that no one could see even a decade ago. Selenium, says Dr. David Kessler of Hatch's Committee on Labor and Human Resources, is a good example. Studies show that this element -- essential to human nutrition -- can, in small doses, inhibit cancer, but may cause cancer when consumed in larger doses. So present regulations seem inflexible at best and unreasonable at worst, Hatch supporters argue.
The controversy over saccharin reminded everyone that the Delaney Clause looms large over a product alleged to cause cancer. Saccharin, which the FDA has linked with bladder cancer in animals, is still sold because a two-year grace period has been granted by Congress.
As the Delaney Clause now reads, the FDA could, in theory, stop sales immediately, without regard to the economic strain suffered by the manufacturer. However unlikely that possibility, industry remains uncomfortable with the clause and would like to change it.
So the wording in the new bill circumvents Delaney, without actually repealing it, by redefining the term "safety."
Legally, "safe" now means "reasonable certainty that the substance is not harmful with normal use." The Hatch bill proposes a new meaning of safety -- the "absence of significant risk under intended conditions of use."
The trouble, says Myron Zeitz, attorney for Community Nutrition Institute, is that nobody really knows what "significant risk" means. To some, it might mean that only 1 in 200,000 people will get cancer. To others, it might be 1 in 20,000.
"The whole concept of an absolutely safe food supply simply cannot be achieved," says Rick Silverman, food safety counsel to the American Meat Institute. He adds that consumer attempts to make a risk-free food supply, taken to its logical extreme, could starve the society. One purpose of the Hatch bill, he says, is to begin determining how much risk will be tolerated by the FDA.
In any case, this new definition gets around restrictions imposed by Delaney. Even if the additive poses "significant risk," it isn't necessarily banned. It could get special consideration. For instance, the new bill requires the FDA to look at factors such as increased production costs -- in addition to safety -- before it removes an additive from use.
"In determining the quantity of such added substance to be tolerated," says the bill, ". . . the Secretary shall take into account . . . the effects of such limits on the cost and availability of food to which the limits would apply."
To qualify for the additional consideration, the Hatch amendment states, the product must have a long history of use and have no reasonably practical substitute.
Once again, interpretation poses a problem. Shultz says "long history of use" could include many additives which are not even now proven safe. He says that "no reasonably practical substitute" is too loose a definition -- that it could allow such superfluous additives as coloring to remain in a soft drink if the hue of the product would change significantly.
Silverman understands the constraints to be narrower and gives a more conservative interpretation of the wording. He says only a few products would even qualify for this type of review, and even then there's no guarantee that the product will stay on the market. The FDA commissioner, he says, could demand the additive be cut back in a product, ban it altogether or encourage consumer education.
Procedural problems keep popping up, however, and opponents of the Hatch bill believe there is a lot more to worry about.
Consumer advocates who attended the meeting believe this bill establishes an "easy on, slow off" food safety policy. They say the FDA will be given an "unreasonably short" period of time (180 days) to approve a proposed additive. If the FDA fails to act on the proposal, the industry can take the matter to court to force a decision. The bill's opponents say this could rush the agency, causing it to make an uninformed decision.
Silverman says that the time limitations will motivate the agency to act on a proposal, which he says can take two to five years right now. Asked if he thought 180 days is a reasonable amount of time, he replied, "No, I don't think it's reasonable. I don't think industry expects that." What it does expect, however, is to expedite the approval process, encouraging industry to develop new products.
Once the approval process begins, the FDA will get a summary of the safety testing data from the manufacturer, not the data per se (as it does now). Judgment must be made on the summary.
The burden of proof then rests with the FDA, which must show that the additive poses "significant risk." (Now the manufacturer must prove the safety of his product.)
In addition, critics claim the bill artfully delays the removal of products from the market once they are on the shelves.
For instance, once a color additive has been provisionally approved -- meaning that testing is still going on -- the FDA, under the new bill, must go through the same procedures to stop its sales as one that has been fully approved.
Public Citizen's Shultz says the bill requires the FDA to go through a cumbersome series of steps to remove a product from the market, which could add an additional two and a half years to the process that already takes from two to five years. During this time, the questionable product could remain on the market.
This delay, say bill supporters, protects industry from the devastating economic effects of having its product yanked from the market with little warning. It allows time for phasing-out, for using up inventory and developing and substituting a new product.
But while industry enjoys this extra time, argue the critics, a potentially harmful product can remain on the shelves.
Another delay for product removal hitches on the necessity for "peer review" if the FDA deems a product unsafe. In such an event, industry can require review by an objective third party -- in this case a board of independent scientists such as the National Academy of Sciences. If the FDA's original decision is not adverse to industry, no review is required.
Hatch bill opponents say that if industry were really concerned about a safe food supply, the bill would provide for peer review in all cases, and cite this as one significant example of industry insincerity.
Industry spokesmen reply that the nitrite controversy inspired this provision -- that at the time nitrite safety came into question there were studies to prove it was not a harmful additive. A source at the American Meat Institute complains that there was no mechanism for formally introducing the data. This, she says, is a problem with legal procedure, and the Hatch bill avoids the problem. It provides a way for industry to submit its favorable data during the decision-making process.
But the whole point of this meeting -- and of the Senate hearings scheduled for November -- is to decide what exactly can be done to current food safety laws to make them flexible enough for industry and stringent enough for consumers.
The Labor and Human Resources committee takes the position that the wording in the bill may change drastically before the final legislation is passed. But, says Kessler, "the bill has been introduced to revitalize the debate over food safety laws ."
"The problem with this bill," says opponent Ellen Haas of the Community Nutrition Institute, "is that it presumes there is something seriously wrong with current food laws."
Presumably, that is why Hatch's Committee on Labor and Human Resources is scheduling three days of hearings for the bill, instead of the one day it is allowing for other committee bills next month.
Despite what critics may say about it, asserts Silverman, "this bill does a superb job of raising the right issues."
The important thing, says Haas, is not to lose sight of the goals of food safety laws. "We have to decide if the bill makes the food more safe, just as safe or less safe."