On the recordMarch 16, 1995
Ten thousand pages. You know, I have yet to have the first Federal employee come up and attack me for that. [Laughter] I've yet to have the first citizen say, ``How dare you waste my money. With this new arbitrary system, you got rid of these 10,000 pages. I can't sleep at night for thinking about it being gone.'' [Laughter] And believe me, nobody will notice this as long as we take care to protect the public health, the public safety, and the public interest. The second thing I want to talk about are fundamental reforms in the area of the environment and drug and medical services. Environmental regulation touches every part of our lives. And this is a moment of transition in our environmental policy. The modern era began in 1970 with Earth Day, the passage of landmark legislation and the creation of the Environmental Protection Agency. The results, we should never forget, are a great American success story, envied and copied around the world. Because we made a common commitment to protect the environment, people are living longer and living better, and we have a chance to pass the country along to our children and grandchildren in far better shape than would have been the case otherwise. But the methods that worked in the past aren't necessarily adequate to the present day. Our environmental programs must work better and cost less to meet the challenges of the future. Today we are announcing a landmark package of 25 environmental reforms. Let me describe them in general terms. First we recognize that market mechanisms generally make more sense than micromanagement by the Government. Letting utilities buy and sell their rights under the Clean Air Act, for example, has saved utilities and their customers $2 billion and given us cleaner air. Today we will dramatically extend this market concept to other areas of clean air and water protection. Second, too many businesses are afraid to come to the EPA for help in cleaning up their act because they're afraid they'll be punished. That's the story you just heard. We're going to open compliance centers to help small businesses and say to them, ``If you discover a problem, you'll have 180 days to fix it with no punitive fine.'' And third, because you shouldn't need a forest full of paper to protect the environment, EPA will cut its paperwork requirements on businesses and communities by 25 percent, that is 20 million hours of work for businesses and communities that will be saved for other purposes next year. While these steps will improve the current system, others will move well beyond it to a shift in the way we actually think about regulation. EPA will launch a pilot program called Project XL, excellence and leadership, which is simple but revolutionary. They will say to the companies in the pilot and, hopefully, eventually, the companies all across the country, ``Here is the pollution reduction goal. If you can figure out how to meet it, you can throw out the EPA rulebook. You figure out how to meet the goal.'' I want to say, especially here, how much I appreciate both the environmental groups and the business groups that are here. We know that pollution prevention pays. We know pollution prevention and reduction is a great source of job creation for America, as well as a guaran- tee for our children that this country will be worth living in. We also ought to be smart enough to know that people who are living with the consequences of this might be able to figure out how to fix it better than folks who are writing rules about it. So we're going to see if we can figure out how to do it in this way. The other set of major reforms we're talking about involve the realms of drugs and medical devices. When I was running for President, I don't know how many Americans I had come up to me and talk to me about this all over the country but especially in places where a lot of this kind of work is done. There was a time when consumers might find that their food was adulterated, their drugs were quackery or had dreadful side effects. Today, Americans don't have to worry about the safety or effectiveness when they buy anything from cough syrups to the latest antibiotics or pacemakers. The Food and Drug Administration has made American Drugs and medical devices the envy of the world and in demand all over the world. And we should never forget that, either. And we are going to stick with the standards we have, the highest in the world. But strong standards need not mean business as usual in every area. Today we are announcing a set of reforms that will make our high- quality drugs and medical devices available to consumers more quickly and more cheaply. First, FDA will stop using a full-blown review every time a biotech drug company makes a minor and risk-free manufacturing change in an established drug. Second, FDA will stop requiring costly assessments on drugs that obviously have no significant impact on the environment. Third, FDA will eliminate 600 pages of cumbersome regulations controlling the production of antibiotics and other drugs. And I'll give you $100 if anybody comes up to you and complains within the next 12 months--[laughter]--when you do that. And finally, 140 categories of medical devices that pose low risk to patients, from finger exercisers to oxygen masks, will no longer need preapproval by FDA before they are put on the market. These FDA reforms, and others we'll announce in the next few weeks, will keep quality at world-class levels and save industry and consumers nearly half a billion dollars a year. And I am pleased, again, to say that there are representatives from the drug and medical device industry here as well. We appreciate your support. I am very, very excited about this. These changes, taken together, represent real and fundamental reform. Now, they lack the sledgehammer subtlety of a moratorium, but if we're going to be responsible, we ought to fix the problem, not just seek to freeze the problem. To go from yesterday's Government to tomorrow's Government we need movement, not paralysis. We need to continue our commitment to a Government that works better, costs less, reflects our values, and can make a difference and that doesn't drive us up the wall but drives us into the future together. That is common sense, and we can give it to the American people together. Thank you very much.
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