Budget Slashes Enforcement at FDA, EPA

The White House�s fiscal year 2006 budget submission will mean big cuts in food and drug safety inspection as well as state enforcement of environmental protections. FDA Amidst mounting concern over the safety of our food supply from threats such as mad cow disease and bioterrorism and after a storm of criticism about FDA�s botched inspection of British flu vaccine facilities, which led to a vaccine shortage this winter, FDA�s budget proposes cuts to nearly all of its inspection programs. The new FDA budget proposes major cuts in both foreign and domestic inspection programs, including significant spending reductions in the following areas:
  • 5 percent for domestic food safety inspections,
  • 5.8 percent for foreign drug plant inspections, and
  • 4.7 percent for inspections of national blood banks.
According to an agency statement given to USA Today, FDA will stretch its meager budget by targeting inspection towards only high risk cases: �Intelligent, risk-based inspections are more important than absolute numbers of inspections.� Still, overall inspections will drop significantly if the proposed budget is approved. Despite FDA promises to Congress to increase vaccine plant inspections from once every two years to once a year in response to the flu vaccine debacle, the number of drug plant manufacturing inspections will drop from 1,430 this year to 1,355 next year. Inspections of foreign drug plants will fall from 515 to 485 per year. The $1.9 billion budget provides a 4.5 percent overall increase in the FDA budget. FDA has taken the hint from the storm of public outrage over Vioxx and has asked for increased funding for drug safety reviews. The budget also includes an expansion of bioterrorism food safety programs. Considering the controversy surrounding FDA this past year, the budget cuts for inspection are particularly ironic. Last fall, contamination at a British flu vaccine plant left the U.S. scrambling for vaccines weeks before the flu season. Congressional hearings and news media coverage revealed that the FDA had failed to frequently inspect the plant, which accounted for half of the U.S. flu vaccine supply. EPA Bush�s proposed budget for the Environmental Protection Agency not only cuts overall budgetary spending by 5.6 percent but specifically targets money that passes through EPA to the states. Despite the central role states play in carrying out environmental protections, Bush�s budget request has cut $271 million of EPA funds that pass through the states. In fact, the cuts to the states are proportionally greater than the overall cut in the agency funding request. The White House asked for $400 million less than what Congress allocated to the agency in 2005 and $220 million less than the White House 2005 budget request. The 2006 budget represents the second year in a row that the state portion of EPA�s budget has decreased while the agency�s portion increased. The ratio of funding that stays at EPA to funding allocated to the states is generally about 5 to 3, which in the past has meant about $3 billion of EPA�s budget has been funneled to the states. On top of that, states spend another $15 billion, approximately, on environmental protections with money that comes from both state sources and permit fees. EPA delegates 75 percent of its work to the states, and the states are responsible for 90 percent of enforcement efforts. Therefore, as EPA�s portion of funding to the states decreases, so will state enforcement and permitting, according to Steven Brown, executive director of Environmental Council of the States (ECOS). The situation for state environmental protection is made even more dismal by growing state deficits. Currently 26 states are running a funding deficit, forcing state legislatures to cut discretionary spending, which often includes cuts to environmental enforcement. Over the past five years, EPA has promulgated 160 new rules that have major impacts on the states. Despite the necessity of these rules to protect public health and the environment, dwindling state funding has hindered implementation and enforcement of these important safeguards. At the same time, environmental enforcement has already dropped off significantly over the past several years.
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