As reported in the recent Citizens for Sensible Safeguards report Special Interest Takeover, one of the many threats to our regulatory system is the lack of enforcement of existing regulation. In recent years, the budgets for agency enforcement efforts have been slashed and personnel have been cut. The EPA's Office of Enforcement and Compliance Assurance, for example, has seen a reduction in staff of 12 percent, bringing its staff numbers to the lowest levels since the formation of the agency. The resulting lack of enforcement of existing safeguards threatens the public health, safety, and environment. The following is a roundup of recent examples of inadequate enforcement of public safeguards. USDA Ignores Canadian Beef Regulations As has been widely reported in the media, last fall the USDA allowed 7.3 million pounds of Canadian processed beef into the United States in violation of a trade ban enacted after some Canadian cows were found to have been infected with "mad cow" disease. When the USDA allowed the Canadian beef to enter the United States, it disregarded two food safety standards: one "that brain and spinal tissue of US-bound Canadian beef be removed before shipping to the United States, and another stipulating that the beef must be processed in facilities that are used only for the slaughter of animals eligible for export to the United States," according to the BNA. In issuing permits for Canadian beef, the USDA risked contaminating US beef supplies, putting American consumers at risk. Now the agriculture department's Inspector General, Phyllis K. Wong, will investigate the USDA's actions at the request of Senators Thomas Daschle (D-SD), Tom Harkin (D-IA), and Mark Dayton (D-MN). EPA's Lack of Enforcement Leads to Increased Refinery Emissions According to a report released by the EPA's Office of Inspector General(IG), the EPA's Office of Enforcement and Compliance Assurance (OECA) "has not established and communicated clear goals, systematically monitored refinery program progress, reported actual outcomes, or tracked progress toward achievement of" the goals of its settlement agreements with petroleum refineries that pollute. Petroleum refineries became a national priority for the OECA in 1996, when it was discovered that refineries "had the highest inspection-to-enforcement ratio of the 29 industry sectors ranked by EPA," the report said. According to the report, The 145 operating petroleum refineries in the United States span 9 of EPA's 10 regions and 33 States. Petroleum refineries account for significant releases of pollution into the environment. In 2001, refineries released over 35,000 tons of toxic air pollutants, with 75 percent released to the air, 24 percent to the water, and 1 percent to the land. These pollutants seriously affect human health and the environment, and they include pollutants known or suspected to cause cancer or other serious human health effects. The current compliance strategy for refineries was developed and implemented by EPA in conjunction with the U.S. Department of Justice. The integrated strategy, with tactics ranging from compliance assistance to inspection and enforcement, has been implemented over the last 8 years and has evolved to meet specific compliance problems. As of this March, the IG reported, refineries have agreed "to invest more than $1.9 billion in pollution control technologies, pay civil penalties of $36.8 million, and implement supplemental environmental projects valued at approximately $25 million." EPA projects a significant reduction of pollutants as a result of the compliance program. However, according to the report, OECA has not been able to provide "useful and reliable information necessary to effectively implement, manage, evaluate, and continuously improve program results." In 2000, OECA began to pursue voluntary "global" settlements with petroleum refinery companies. This method allowed companies to avoid investigation and litigation by entering into a consent decree in which the company would work with the OECA to reduce emissions. However, as reported in the IG analysis, OECA is not sufficiently monitoring the companies' performance and improvement. Furthermore, EPA was slow to respond to consent decree documents submitted by companies, and the resulting delays have pushed back implementation of emission reduction projects. EPA is required to release a response to the report within 90 days. In comments on the draft of the report, EPA said it believes that the IG report downplayed the complexity of refinery regulation and was unbalanced in its criticism of OECA, though EPA did agree that some of the recommendations should be implemented. FDA Ignores Law on Drug Trial Information Concerned that they do not fully understand the safety of many pharmaceuticals, patient advocacy groups and the American Medical Association have recently called for drug manufacturers to disclose clinical trials to a government database. What many of these professionals did not know was that the release of such information was already mandated by a little-enforced 1997 law, the FDA Modernization Act of 1997. According to the Washington Post, the FDA acknowledges that it has not enforced the law, arguing that the statute did not explicitly give the agency enforcement authority. One sign of the incompleteness of the database (which can be found online at ClinicalTrials.gov) is that only 13 percent of the registered trials on the website were reported by the pharmaceutical industry, even though over 80 percent of trials are funded by for-profit companies.