GOVERNMENT Rohrabacher says, "Under 'corporatization/ the patent examiners, on whom all American inventors rely for an honest evaluation, will lose the civil service protection they've enjoyed for more than 100 years. The exposure will undoubtedly lead to attempts to attack and influence this entire process, which until now has been considered a core government function." He also says that the redesigned PTO would "have an open call on the U.S. treasury for any money it wants."
"There are a lot of nice sound bites out there, and the only thing that we can fight sound bites with is facts," says Balmer. "That's what we're do ing." Under the proposed legislation, patent and trademark examiners will have the same protection against re moval from their jobs as under existing law, and the bill retains the existing procedure under which the main user fees are set by Congress and annual in flationary adjustments are made by the commissioner of patents and trade
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marks. In addition, the bill contains other significant controls, including provisions authorizing reviews and au dits by the General Accounting Office. And borrowing authority would be controlled by the appropriations com mittees of Congress. The next action for H.R. 3460 will be a Rules Committee hearing, fol lowed by a vote on the House floor. A fight on the floor is virtually guaran teed because Rohrabacher has a com mitment from House Speaker Newt Gingrich (R-Ga.) to allow a vote on his bill. Rohrabacher likely will move to substitute his bill for some or all of the provisions of H.R. 3460. Both sides are putting on a full-court press in preparation for the vote. Π
Delaney reform at heart of pesticide bill Legislation that would reform the con troversial 1958 Delaney clause and re place it with a negligible-risk standard for cancer-causing pesticides on pro cessed foods is once again moving in Congress. Although several other im portant pesticide issues need to be re solved this year, the Delaney clause was the main topic at a June 12 hearing of the Senate Committee on Agricul ture, Nutrition & Forestry. The Food Quality Protection Act (S. 1166) establishes a new negligible-risk standard for pesticide residues on food that would amend both the Federal Food, Drug & Cosmetic Act (FFDCA) and the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) with respect to pesticide residues. The Delaney clause to FFDCA states that no chemical may be added to a food if that chemical causes cancer in humans or animals. Under current enforcement, if a pesticide tests carcinogenic in the laboratory, then resi dues of that pesticide above certain lev els in processed foods can be in violation of the Delaney clause. Under FIFRA, the Environmental Protection Agency sets tolerance levels, or limits, on the amount of a pesticide that can be present on raw food. Thus, if that pesticide concentrates during processing to a level higher than the tolerance, EPA has no choice but to re move that product from use. Efforts to modify the Delaney clause have been slowly gaining mo-
Goldman: reasonable certainty of no harm
Vroom: continue R&D of new products
mentum since May 1989 when the 9th U.S. Circuit Court of Appeals, based in San Francisco, ruled in Les v. Reilly that EPA had to strictly enforce the clause with respect to pesticide residues on processed foods. Until then, EPA had applied a de minimis policy with respect to chemical residues. If the risk a residue presented was determined to be inconsequential, its use was tolerated. Committee Chairman Richard G. Lugar (R-Ind.) explained why he and other senators want the law changed. "Strict enforcement and implementation of the Delaney clause means that farmers will lose access to safe and effective crop protection products. As EPA Administrator Carol M. Browner has said, the pesticides impacted by strict interpretation of the Delaney clause do not pose an unacceptable risk to public health." This is the position held by pesticide manufacturers, farm organizations, and even the Clinton Administration. Lynn R. Goldman, EPA assistant administrator for prevention, pesticides, and toxic substances, testified that her agency wants to see the Delaney clause replaced by a single health-based safety standard. "We have proposed that the standard be defined as a reasonable certainty of no harm," Goldman said. "This is the standard that currently applies to many [noncarcinogenic] pesticides used in processed foods, as well as food additives and color additives." Goldman does, however, have an argument with Lugar's bill. "S. 1166 would allow the use of a pesticide that
poses greater than negligible risk, if the dietary risks to the consumer are outweighed by overly broad and unclear benefits considerations," she said. She noted, too, that the bill allows consideration of undefined indirect benefits and does not place any specific limit on health risks. These same arguments were used by other witnesses as they tried to persuade the committee to keep the Delaney clause intact and not add pesticide benefits to the equation. Philip J. Landrigan, Ethel H. Wise Professor and chairman of the department of community medicine at Mount Sinai Medical Center, New York City, said that once benefits are given consideration, longterm health problems are too easy to ignore. "Despite its shortcomings, the Delaney clause is a powerful piece of legislation that has served well to protect several generations of American children against carcinogenic pesticides," Landrigan said. He would be willing to see the Delaney clause replaced only if a stronger health-based standard were to succeed it. Supporters of the Senate bill say the use of the Delaney clause has gone beyond protection against cancer to create serious problems for farmers. They contend that the analytical ability to detect smaller and smaller concentrations of residues has made the zero-risk standard of the Delaney clause scientifically unjustified and virtually impossible to achieve. Jay J. Vroom, president of the American Crop Protection Association, the agricultural chemicals industry trade
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group, testified that, because of the Les v. Reilly decision, EPA is ready to begin banning the use of some pesti cides for which farmers have no sub stitutes. The proposed bill "represents a targeted effort to bring modern sci ence to bear on the laws governing pesticides/' Vroom said. "In addition to maintaining these useful but threat ened products, we need to reform the Delaney clause to ensure continued research and development of new ad vanced products." Both sides of the Delaney issue cite studies by the National Research Coun cil for support. Over the past decade, NRC has published several studies looking at risks from chemicals, food safety, and, in 1993, an investigation into pesticides in the diets of infants and children. This last report has made children's health the center of Delaney clause arguments. Even Lugar's bill specifically calls for protection of chil dren from possible pesticide risks. Other provisions, in addition to the one repealing the Delaney clause, are likely to be included in any bill that emerges from the committee. One such provision would renew EPA's authori ty to charge fees for pesticide reregistration, which expires in 1997. Without industry fees, EPA's Goldman says, registration activities would just about grind to a halt. Legislation proposed by Sen. Rod Grams (R-Minn.) that would streamline registration of household disinfectants and antimicrobial prod ucts may well be included in the com mittee bill. These products are current ly regulated by EPA as pesticides. The agricultural chemical industry hopes provisions will be added to streamline registration of so-called mi nor-use pesticides, many of which are used on fruits, vegetables, and orna mental plants. EPA's current process is too expensive for manufacturers to af ford the registration costs for products used in low volumes. The Senate committee may hold ad ditional hearings on this bill, but time for passage is running out. EPA is poised to ban many pesticides be cause of the Delaney restrictions, and companies are already not reregister ing products because they are unsure of their Delaney status. In the House, a similar bill, H.R. 1627, has already been approved by the House Agricul ture Committee. David Hanson
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