With at least one influential congressman breathing down its neck, the Food and Drug Administration (FDA) will be hard pressed to fulfill the promise of its August threshold of regulation (TOR) policy. Intense political pressure in Congress is building to dictate totally new packaging approval rules for the agency's indirect additives branch. The TOR rule went into effect on August 16. It is supposed to help the FDA reduce the imposing one-to-four-year period it often takes the agency to review requests for exemptions from the complicated food-additive petition process. Those exemptions-often referred to as "Letters of Non Objection," or LONOs- can be of critical importance to the manufacturer of the new packaging when approaching food or beverage companies. An edgy epistolary exchange between Rep. Christopher Shays (R-CT) and the Secretary of Health and Human Services, Donna Shalala, is likely to escalate into a political firefight. It will be fueled by complaints from food processors and packaging companies. Shays is chairman of the House Resources and Intergovernmental Affairs subcommittee. Sec. Shalala was supposed to have sent him a proposal on FDA streamlining of the additives approval process by October 1, 1995. That proposal is unlikely to placate the congressman. He plans to hold high-profile hearings this fall and winter designed to build support for a Republican bill that would force a new review scheme onto the FDA. The first chapter of this evolving story opened in June. At hearings in front of his subcommittee, Rep. Shays told FDA officials they'd better "get the lead out." The congressman is concerned about both indirect and direct additives, the latter important in the manufacture of new foods and beverages. He followed up those hearings with a pointed letter to Secretary Shalala, who has responsibility for the FDA. He asked her to submit her own legislative proposal on how the FDA Office of Pre-Market Approval could get back in compliance with the statutory 180-day deadline for approval of food additive petitions. That is also the unofficial deadline for TOR exemption requests. Rep Shays requested the proposal by July 31. It came and went. Finally, on September 13, Shays received a reply from Sec. Shalala saying she would have a legislative proposal to him by the end of September. The HHS secretary indicated that proposal might include allowing third-party, non-government review of additive submissions, although the FDA would still make safety determinations. Congressional sources say Shays intends to hold hearings on the FDA legislative proposal when it arrives on the Hill. Then his subcommittee will probably write a report with draft findings. "Then, who knows," adds the source. Sen. Nancy Kassebaum (R-KS), chairman of the Senate Labor and Human Resources Committee, is already circulating a draft FDA reform bill which wil include a food section. Hope for notification? Jerry Heckman, longtime Washington lawyer for the Society of the Plastics Industry (SPI), an organization of resin and packaging manufacturers, hopes Congress moves forward with a longtime legislative proposal of his: replacing the petition and exemption process with a notification process. This proposal could be attached to the Kassebaum bill. Under his plan, companies would simply let the FDA know a new package was about to go on the market. The FDA would have a certain amount of time, perhaps 90 days, to block the new product introduction. Jerry Heckman says he is "extremely optimistic" about the chances of eventual establishment of a notification system. "As far as I can tell, even the FDA is not opposed to it," he claims. Corbin Miles, director of the FDA Indirect Additives Branch, acknowledges, "We have kicked that proposal around. But with our resources now, we would be hard pressed to review a notification in 90 days." His office has a staff of 13. Given congressional budget cutting fever, that number is unlikely to increase any time soon. Miles explains that a notification system could be structured two ways. "If the burden of proof is on us to prove a package is not safe, it would be a virtually impossible task. But if our job were to find holes in the data within 90 days, that would be something else." Will FDA dance faster? The FDA clearly hopes that the TOR rule will enable it to approve indirect additives more quickly, thereby defusing some of the political pressure. But some are skeptical. In a memo written on July 24, a week after the TOR rule was published, Jerry Heckman wrote: "While the use of the Threshold concept could, if properly administered to provide timely clearances, be a big breakthrough, the tone of the preamble (in the final rule) and its predictions on timing give much cause to be wary about the outlook." The TOR says that companies who want to sell a packaging resin for indirect package contact have three options. First, they don't have to go to the FDA at all if the resin is prior sanctioned, generally recognized as safe (GRAS) or may not reasonably be expected to become a component of food. This assumes the packager is well informed enough to understand and accept such determinations. "There are always questions about whether those exceptions apply," says Ed Machuga, the FDA official who wrote the rule. A resin is prior sanctioned if the company has gotten a prior letter from agency or the resin was in use before the food additive amendment was passed by Congress in 1958. To be GRAS, the resin has to have either a history of use or acceptable published literature or data. 'Expeditious' TOR exemptions If these exceptions do not apply, a company with an indirect packaging additive can ask for a TOR exemption if the resin, destined for a food-contact application, does not result in a dietary concentration above 0.5 parts per billion. This has been a particularly big issue for manufacturers of resins with post-consumer content, where impurities are a question. Resin and packaging manufacturers often use those exemptions-conveyed in LONOs-as an unofficial "FDA seal of approval" on new packages for foods and drinks. The industry had hoped that the FDA would commit to a specific time frame for approval of LONOs as part of the final TOR. Jerry Heckman had made a case for six months at the outside. However, the final rule explicitly declined to set a time limit because that would "unduly restrict its (the FDA's) ability to allocate its limited resources to projects that may be more critical." The rule says a time limit might be established at some time in the future "as the agency gains experience with its threshold of regulation policy." But for the time being, reviews will be done as "expeditiously as resources allow." Industry believes that should mean faster than six months. But the FDA will have trouble improving its record; and even longer delays may occur. When the FDA began to informally apply the TOR criteria in 1990, it expected 30 exemption requests a year. However, in fiscal 1995, which ended on October 1, 1995, the FDA got 115 requests for exemptions. Not only are requests increasing, but so is the work the FDA has to do on each one. The FDA will have to do an environmental assessment on each request received after August 16, 1995. Buzz Hoffman, chief of the Environmental Impact Staff, says the FDA is considering proposing a new policy that would exempt a much larger number of LONO requests from the environmental assessment. "I even hesitate to make a prediction as to when it might happen," he says, although he explains it is a "high priority." The White House Council on Environmental Quality would have to approve such a proposal.
