When Stuart Pape was an up-and-coming young lawyer and a special assistant to the commissioner of the Food and Drug Administration, he wrote a position paper proposing that the nation's food safety standards be relaxed.
The memo, commissioned after the FDA had suffered credibility damage in its unsuccessful effort to ban saccharin, wound up on a shelf somewhere in the bureaucracy, and Pape wound up leaving government service.
But he hasn't stopped drafting new food safety law. And from his new perch as a lawyer with the lobbying firm of Patton, Boggs & Blow, he is finding that you can sometimes move public policy further and faster by attacking from the outside.
As counsel to the National Soft Drink Association, Pape is the lead lawyer for a high-powered ad hoc industry group, studded with alumni of the FDA, that set out late last year to capitalize on a friendly political climate and write the most sweeping revisions in the food safety laws in 75 years.
Besides Pape, the group includes Peter Barton Hutt, formerly chief counsel at FDA; Sherwin Gardner, a former deputy commissioner of FDA; Howard Roberts, a former acting director of FDA's bureau of foods; Richard Silverman, a former FDA associate chief counsel for enforcement, and, for good measure, former congressman Paul Rogers (D-Fla.), who developed a reputation as a strong proponent of health regulation in his years as chairman of the House Commerce subcommittee on health and the environment. All are now employed by food industry associations or law firms representing industry clients.
Because of the depth of their expertise in the arcane world of food law, the legislative committee they have been working with is overmatched, in the view of several neutral observers who say that the industry spokesmen have dominated the bill-drafting process from start to finish.
Their lawmaking has focused on the same issue Pape was dealing with at the FDA in the late 1970s. They want to relax what they view as the inflexibility of the Delaney Clause, which bans from the market any foodstuff found to contain a carcinogen, no matter how small the quantity.
Early on, the industry decided to have the National Soft Drink Association, which felt most aggrieved by the saccharin episode, and the American Meat Institute, still smarting from the nitrite scare of 1979, lead the drafting effort. "Either we went that route," says Pape, "or we got a huge haul of lawyers into one room and had them all run their meters while they shot their mouths off."
Still, the process was painstaking and, to accommodate the vast variety of interest within the industry, the scope of the bill kept growing. By the time the group was ready to take it to the Hill in March, its draft had been transformed into a virtual rewrite of the basic food safety codes. In addition to watering down Delaney, it called for adding a series of procedures that would make it more difficult for the FDA to remove a suspect food substance from the market and less difficult for the industry to introduce one.
On the Hill, the group chose to knock on the door of Sen. Orrin Hatch (R-Utah), the new chairman of the Senate Labor and Human Resources Committee, whose record on the subject was to industry's liking.
Hatch was interested. He had his committee staff work on the draft for four months, relying heavily on the expertise provided by the industry. "At one point we had something like 15 lawyers in one room, all screaming at each other," said chief of staff Steven Grossman. "Our staffer finally had to walk out and let them settle it among themselves."
In June, Hatch formally introduced the food safety amendments of 1981 (S1442), a complex 70-page bill that one former FDA chief counsel, William Goodrich, says "defies reading and understanding." Public hearings are due next month.
The most controversial provision of the bill is the relaxing of the Delaney Clause. Industry claims that the clause, enacted 23 years ago, has been rendered an anachronism by scientific advances that permit the detection of harmful substances down to a part per trillion. It is routinely ignored now by the FDA, they say, because applying it would lead to the banning of such basic foods as potatoes, black pepper, nutmeg and spinach--all of which have been found to contain potential carcinogens in trace amounts.
To consumer groups, however, Delaney has become a rallying point. Gutting it "takes the government down the road of allowing a little bit of cancer in the food supply--the only question is how much," according to Michael Jacobson, executive director of the Center for Science in the Public Interest.
Consumer groups are crying foul not only at the substance of the bill but also at the drafting process. "Industry was basically allowed to write its whole dream list into the bill," says William Schultz of Public Citizen. "We weren't even allowed to see the draft before it came out."
No one disputes the pro-industry thrust of the bill, but food lobbyists and congressional staff members alike take umbrage at the charge that there was something lopsided about the way the legislation was put together.
"If the consumer groups didn't have much input," said Grossman, "it's because they weren't willing to work with us. We gave them plenty of chances. They just haven't yet come to accept the fact that there is a broad consensus for change."
Stronger words come from Howard Roberts, vice president for science and technology at the National Soft Drink Association and a former acting director of the FDA's Bureau of Foods:
"I resent the notion that the only honest person in this town is an activist. They're the ones who are being morally irresponsible in their approach. They're in the business of selling panic. That's how they make their living, that's how they sell their newsletters. Their natural tendency on every issue, especially if the word cancer is involved, is to cry wolf.
"This isn't a matter of some devious industry group sitting in a smoke-filled room and ginning up some bill that they're going to run through the Hill in a week."
Roberts predicted the legislative process would take years.Hatch has taken pains to describe the draft as merely a starting point for discussion.
Still, the consumer groups fret that industry, by having been so heavily involved in the draft of such a major piece of legislation, "has managed to swing the whole terms of the debate into their corner," in the words of Ellen Haas of the Community Nutrition Institute.
That, of course, was the whole point of the industry drafting effort. But the industry lawyers insist that their ability to shape the process derived from nothing more sinister than their intimate knowledge of the laws in question.
"Food law is at least as arcane as the tax code, maybe more so," says Pape. "It's a blend of law, social policy, science, medicine and psychology."
Adds Peter Barton Hutt, "I would say there aren't more than five people in the country who really understand it." By consensus of their colleagues, the five would include Pape and Hutt, a former general counsel of the FDA who has co-authored a book of case law on the subject. Hutt is now a partner at Covington & Burling, where he represents, among other food industry clients, the Grocery Manufacturers Association.
Pape and Hutt have had major differences this past year over how to proceed with the code revisions. The former favored the legislative approach; the latter argued for administrative reform ("Peter Hutt," said one admiring antagonist, "is one of those lawyers who thinks you can get the sun to rise in the west by administrative change.").
Whatever their disagreements, Pape, Hutt and their fellow FDA graduates were, in the view of several outside observers, able to run circles around the committee staffers they were working with. At the Hatch committee, the staff aide in charge of drafting the bill was a part-time volunteer consultant who was simultaneously pursuing a pediatric internship at Johns Hopkins University.
"It's no wonder they got hornswoggled by the industry on this one," said Thomas Grumbly, a House staffer who used to be an executive assistant to the FDA commissioner. "They were just overwhelmed."
As Grumbly's comments illustrate, not all FDA alumni endorse the bill. Richard Cooper, a former FDA chief counsel who nows works for the firm of Williams & Connolly, said it "has some useful ideas, but on the whole it goes too far in removing public protections." Goodrich, who now is head of the Institute of Shortening and Edible Oils, says he, too, likes parts of the bill, but adds, "the repeal of Delaney won't fly."
The current leadership of the FDA will not take a position on the bill until a Cabinet-level review of food safety law is completed, perhaps next month. Meantime, consumer groups have been meeting regularly with FDA staffers, and are eager for them to join the fray. "The career people tend to be a stabilizing influence," said Schultz, who is optimistic that what he views as the more onerous provisions of the bill will eventually be removed.
Pape, Hutt and others in the industry say they, too, are looking forward to testimony from the agency they once served. "To an individual, those of us who worked at the FDA have a deep appreciation for the importance of its role," Pape said.
"My views now are consistent with the ones I had there. That's true for Peter and everyone else working on this. While we may have trade association clients, we don't and they don't want to do anything that damages the FDA's ability to do its job."