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Salt Institute's Case Shakes Up Preliminary Rulemaking

By Cindy Skrzycki

Tuesday, February 8, 2005; Page E01

The Salt Institute has its blood pressure up.

The group that represents 36 domestic and foreign salt producers is appealing its loss of a lawsuit that challenged the science a National Institutes of Health agency used in 2003 to recommend that lower sodium consumption would improve people's health.

The case is being closely watched because it is the first to try to expand judicial review into the basis for agencies' preliminary rulemaking. Interest groups already can sue to try to overturn final regulations. But the sodium chloride group and the U.S. Chamber of Commerce want the courts to get into the action earlier.

According to the suit, the National Heart, Lung, and Blood Institute (NHLBI) at NIH violated the Data Quality Act by refusing to release scientific studies that concluded that reduced sodium intake results in lowered blood pressure for most people.

The law, passed in 2000 and enthusiastically implemented by the Bush administration, gives the public a way to urge agencies to correct the science and economics underlying the creation of a federal rule or policy.

The law permits an appeal if an agency denies the request for correction, but no judicial review. That's why business wants courts to be able to challenge agency decisions. "The petitions would all be meaningless, because we would have no way to appeal," said William L. Kovacs, vice president of regulatory affairs at the Chamber of Commerce. "You'd be stuck with what the agency tells you."

Critics say the law is a back-door way to second-guess regulatory professionals.

"Industry wants to take these decisions away from the regulators," said Sean Moulton, senior policy analyst with OMB Watch, a public interest regulatory watchdog group. "They want to question the data before the regulation even gets started."

He said filing data-quality petitions is a less obvious way of blocking a rule than going to court after a final regulation is issued, which can result in bad publicity for companies opposing environmental or health and safety rules.

The Chamber of Commerce and the Salt Institute filed the petition at NIH in May 2003, but the NHLBI rejected the initial inquiry and an appeal. So in March, the business groups went to federal court in Alexandria, asking it to review the decisions. The Bush administration position is that the act does not provide for judicial review and that agency rulings are final.

The court agreed, saying it did not have authority over data-quality actions. That's the decision now being appealed.

"This is an agency that doesn't want data to get out there," Richard L. Hanneman, president of the Salt Institute, said of the NIH. "The data may not support the characterization the agency put on it, and that's why they won't release it."

Amy Pianalto, spokeswoman for the NHLBI said the agency could not comment because the matter is in litigation.

Jim J. Tozzi, former Office of Information and Regulatory Affairs deputy administrator who was instrumental in getting the law passed, said judicial review is essential to make the petitioning process meaningful. Tozzi is on the board of advisers at the Center for Regulatory Effectiveness, a regulatory group sponsored by business, which has filed several petitions and has a Web site that keeps track of such filings.

"Judicial review is the policeman in the background," Tozzi said. "If it's gone, over the long run, it will hurt the program." He said the center would bring another court case in the summer or fall.

The estimates on how many petitions have been filed with agencies range from 40 to 110. That's because there are differing interpretations of what constitutes a "substantive" request. The Chamber of Commerce estimates that 80 percent of the petitions -- many of them directed at the Environmental Protection Agency, the Department of Health and Human Services and the Interior Department -- come from business. The majority are denied, but some that have been approved resulted in policy changes.

For example, the Interior Department's Fish and Wildlife Service announced Jan. 7 that it would not list the sage-grouse, which is found in 11 Western states, as an endangered species, after years of pressure from environmental groups and indications it might do so. Partnership for the West, an industry group, and an Idaho county board of commissioners filed petitions challenging the science the agency used to consider the listing.

Agency spokeswoman Megan Durham said the service considered the petitions but based its decision not to list the bird as endangered on the analysis of "expert independent scientists."

The wildlife service also decided not to list slickspot pepper grass, a flowering plant in Idaho that it said in 2002 had the highest rate of disappearance of any plant species in the state. The U.S. Air Force, which drops inert bombs and has other training exercises on about 2 percent of the plant's habitat, filed a petition challenging the listing. Durham said the Air Force's views were considered but were not the controlling factor in the decision.

Even without further court review, agencies are under pressure to adhere closely to the Data Quality Guidelines issued by the Office of Management and Budget. Rep. Joe Barton (R-Tex.), chairman of the House Energy and Commerce Committee, queried 15 agencies in a Jan. 13 letter on how they are running their programs.

In an issue separate from the dispute over sodium, John D. Graham, head of the OIRA, wrote to the director of the NIH last November, noting the agency had received six correction requests regarding its National Toxicology Program, which assesses toxic chemicals and their testing, and suggesting ways to be more responsive.

"We are working hard with agencies to make sure that petitions are addressed in a rigorous and timely manner," Graham said in an e-mail response to questions.

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