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Health & Safety RegulationsWe work on health and safety regulation cases in a variety of areas. Click on the links to view cases in these areas: Public Citizen and United Steelworkers v. OSHAPublic Citizen and the United Steelworkers have challenged an OSHA rule setting a new standard for workplace exposure to the carcinogenic chemical hexavalent chromium. The rule was issued as a result of a previous lawsuit by Public Citizen and PACE International Union challenging OSHA’s unreasonable delay in updating the standard. Although the rulemaking improved the standard considerably, it unlawfully left workers exposed to substantial risks of lung cancer because OSHA failed to set a standard as low as its own rulemaking record indicated was necessary. A number of industry groups also challenged the standard as too high, but most ultimately withdrew their challenges. The cases are fully briefed and awaiting argument in the U.S. Court of Appeals for the Third Circuit.
San Luis Obispo Mothers for Peace and Public Citizen, Inc. v. United States Nuclear Regulatory CommissionIn this case, Public Citizen and the San Luis Obispo Mothers for Peace are challenging the Nuclear Regulatory Commission's "design basis threat" regulation, which describes the types of terrorist threats against which nuclear power plants and certain other facilities must maintain effective security measures. In 2005, Congress ordered the agency to conduct a rulemaking to revise its design basis threat regulation. Based on the explanation in the rulemaking notice, it appears that instead of deciding what threat nuclear reactors are likely to face and requiring them to have security forces capable of meeting that threat, the NRC based the threat on what it thought it was reasonable to require a private security force to defend against.
Consolidation Coal v. Billy D. WilliamsIs the Court of Appeals' finding that it is "inherently unfair" to bar a 2001 claim for black lung benefits filed six years after a medical determination of total disability due to pneumoconiosis contrary to the time limits imposed by Congress?
U.S. Forest Service v. Earth Island Institute, et al.Whether the court of appeals erred in ordering a preliminary injunction under the Administrative Procedure Act [barring the Forest Service from proceeding with two projects in the Eldorado National Forest], including by:
Sidney Wolfe v. FDAPublic Citizen filed a complaint and a motion for a temporary restraining order to prevent the Food and Drug Administration from closing a July 14, 2006 meeting of its Blood Products Advisory Committee. The Federal Advisory Committee Act requires advisory committee meetings to be open to the public except in the case of a few narrow exceptions. If the President or head of the agency determines one of those exceptions applies to a portion of the meeting, he must state in writing the reasons for that determination. In announcing that the July 14 meeting would be closed, the FDA did not even report the topic of the meeting, let alone give specific reasons for its closure. The agency just stated that the meeting would be closed to permit discussion of trade secrets and/or confidential commercial information. Subsequent to the announcement of the meeting, Sidney Wolfe, director of Public Citizen Health Research Group, learned that the topic of the meeting was the Navy's proposal to test a blood substitute called Hemopure on civilian trauma patients. Biopure Corp., the manufacturer of Hemopure, has told Dr. Wolfe that little, if any, of the presentations and discussions at the July 14 meeting are likely to disclose information it considers a trade secret or confidential commercial information. In response to the lawsuit, the meeting was canceled on July 13.
Public Citizen and Nuclear Information and Resource Service v. Nuclear Regulatory CommissionChallenging the NRC's decision to strip from the nuclear reactor licensing process the tools needed for meaningful public public participation. This case was filed by Public Citizen and the Nuclear Information and Resource Service (NIRS) to challenge a rule issued in January 2004 by the U.S. Nuclear Regulatory Commission (NRC). The new rule abolished formal on-the-record hearings in most nuclear reactor licensing proceedings, making it more difficult for the public to effectively raise legitimate safety concerns. The case challenged the rule under the Administrative Procedure Act, arguing that Congress intended that the Atomic Energy Act guarantee formal hearing rights to members of the public whose interests might be affected by the NRC's licensing of nuclear reactors. Although the First Circuit Court of Appeals upheld the NRC's new rule, the agency was forced to make concessions regarding the scope of the rule, and the court held that "should the agency's administration of the new rules contradict its present representations or otherwise flout this principle [of full and true disclosure of the facts], nothing in this opinion will inoculate the rules against future challenges." The court upheld the NRC's ability to limit discovery and cross-examination, but rejected the idea that those procedures can be eliminated, saying that "the Commission's new rules may approach the outer bounds of what is permissible" under the Administrative Procedures Act.
Center for Science in the Public Interest and Public Citizen Health Research Group v. FDAChallenging the FDA's decision to override Congress by allowing food companies to claim that a food helps to prevent a disease, where the claim is not supported by significant scientific agreement. The FDA announced in July that it will allow food companies to make health claims even when the evidence is too weak or inconclusive to meet the statutory standard. Indeed, the FDA has announced that it will even permit claims where the weight of the evidence suggests that the claim is likely false, as long as the claim is qualified by a disclaimer. Moreover, the FDA has stated that, when considering a "qualified claim," it will not follow the notice-and-comment rulemaking procedure that Congress required as a prerequisite for allowing a health claim for food. CSPI and Public Citizen Health Research Group filed suit to challenge the FDA's new regulatory regime.
Public Citizen and San Luis Obispo Mothers for Peace v. Nuclear Regulatory CommissionChallenging Improper Rulemaking on Nuclear Plant Security Public Citizen and the California anti-nuclear group San Luis Obispo Mothers for Peace have challenged the Nuclear Regulatory Commission's effort to bypass lawful rulemaking procedures in addressing nuclear facilities' security against terrorist attacks. The Commission revised its rule defining the threats against which plants must protect themselves without notice or public comment, in violation of the Administrative Procedure Act, the Atomic Energy Act, and the NRC's own regulations. Public Citizen and the Mothers for Peace are asking the U.S. Court of Appeals for the D.C. Circuit to compel the agency to follow lawful procedures as it addresses this important safety issue.
Public Citizen Asks Court to Order Agency to Follow the Law for Providing Written InformationFDA Illegally Delaying Prescription Drug Information Program Public Citizen filed a suit against the U.S. Department of Health and Human Services (HHS) because the Food and Drug Administration - a part of HHS - was not requesting public comment on rules regarding patient information leaflets that are distributed with prescription drugs by pharmacists, instead relying on a faulty private sector program that does not give patients the vital drug safety information they need. The agency's refusal to request comment violated a statute passed in 1996. Shortly after we filed suit, the agency agreed to hold a public meeting to solicit public comment.
Public Citizen v. Department of Health and Human Services, et al.(Formerly Levine v. Department of Health and Human Services) Disclosure of Medical Errors Public Citizen fought to enforce Medicare beneficiaries' right to be informed of the outcome of government investigations into the quality of the medical services they received. For more information, please click here. TestimonyStatement of David C. Vladeck before the Senate Committee on Governmental Affairs on S.981, The Regulatory Improvement Act of 1997 Testimony of David C. Vladeck before the Senate Committee on the First Amendment Implications of Regulating the Advertising and Promotion of Tobacco Products to Children and Adolescents Comments of Public Citizen, Inc. Regarding FDA's Proposal to Regulate the Sale and Promotion of Tobacco Products to Minors (Executive Summary)
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