THE WHITE HOUSE
Office of the Press Secretary
PRESS BRIEFING DR. ELAINE KAMARCK, SENIOR POLICY ADVISOR TO THE VICE PRESIDENT;
EPA ADMINISTRATOR BROWNER; SBA ADMINISTRATOR PHIL LADER; FDA ADMINISTRATOR DR. DAVID KESSLER
The Briefing Room
1:08 P.M. EST
MR. MCCURRY: Good afternoon, everybody, and welcome to the White House for our daily briefing, which is blessed today with a panorama of guest stars.
I will turn the chores of introducing everyone over to Dr. Elaine Kamarck, who many of you know. She is Senior Policy Advisor to the Vice President, and Vice President Gore's chief general in the battle to reinvent government, which she's been doing effectively for two years. We've been telling you all day today that there are right ways and wrong ways to cut the federal government, and certainly the work that has been done over the last two years through the National Performance Review is exactly the right way to save taxpayers money, as contrasted with the wrong way, which is what you're watching today up on Capitol Hill.
So, with that I will turn it over to Dr. Kamarck.
DR. KAMARCK: Thank you very much. Today, the President announced the second in what will be a series of announcements on regulatory reform and regulatory reinvention. The philosophy guiding this is simple. We want our regulatory system to protect people, not protect bureaucracy. We want results, not rules, action, not rhetoric -- in a word, common sense. And that's what I believe the regulatory changes announced today do.
Today, we announced three packages of changes, several presidential directives that are designed to make it easier for small businesses to come into compliance with the government in the regulatory arena. We announced a fairly broad set of changes in the way we do environmental regulation, and we announced a set of changes in how we regulate drugs and medical devices.
I have here with me Carol Browner, the Administrator of EPA; Dr. David Kessler, the Administrator for FDA; Phil Lader, head of the Small Business Administration who, by the way, is going to have to leave a little early, so if you have a specific question for him, we should do it soon. And we're pleased to have with us Philip Howard.
Philip, why don't you -- who is the author of "The Death of Common Sense," and we have been talking with him on and off for a period of a couple of months since he first came and gave me a prepublication copy of his book about reform of the regulatory system. Let me emphasize that today is the second in what will be a series of presidential announcements on regulatory reform, which we expect to do probably at a rate of about once a month from now into the summer. And we are going sector by sector throughout the government.
I'll take your questions or questions for the other people who are here today.
Q What is the big difference with the bill that the House passed? If it will freeze all regulations, would you support that?
DR. KAMARCK: Oh, no. We've been against the regulatory moratorium. We think that, in fact, we're way ahead of the Republicans of this area, that we don't need a moratorium, we are into the business of reform; that's what today is about.
Q I'd like Dr. Kessler to say what would be the detriment of a freeze.
DR. KESSLER: Let me tell you what would be held up. Our mammography rules that would assure quality and safe mammograms, rules regarding the safety of our seafood, rules regarding the quality of bottled water.
Carol, do you want to --
ADMINISTRATOR BROWNER: Let me just briefly mention what it would mean for EPA. The rules that I hope to adopt this year to set more stringent standards on hazardous waste incineration would be blocked. The rules to set standards for cryptospiridium, a bacteria that killed 100 people in Milwaukee from their tap water a year ago. Those are just two examples of the kind of rules that we are working very hard to get in place -- tough public health standards, rules that protect our air, our land, our water -- common sense in how we achieve those rules. We wouldn't be able to do that with a moratorium.
Q Congressman McIntosh this morning said he wants to continue his investigation of whether or not you're using taxpayers' dollars to lobby Congress on the freeze issue. Do you care to respond?
ADMINISTRATOR BROWNER: This is actually becoming fairly ridiculous. I think that we all have a better thing to do, which is to be about the business of providing public health protections for the people of this country. This idea that, somehow or another, because I speak out, because I come here today and answer questions for you all that I am lobbying, that I am violating a law that no one has ever been found to violate is nothing but an effort to intimidate and silence me, and I will not allow that to happen.
I will continue to do what I think is right for the people of this country. I will continue to educate, to inform the people of this country. What is happening in Congress today is one of the most significant debates ever in our history about how best to protect the health of the people of this country, the health of our environment. And I will not be silenced.
Q Well, can you tell me this in that connection --can you attest to the veracity of reports that the lobbyists actually wrote the moratorium, sitting outside the committee office?
ADMINISTRATOR BROWNER: I am not aware of who has written the language that has become the various bills in Congress. I will tell you that EPA has worked to provide information to members of Congress in a bipartisan manner. Wherever we are asked what the effects of these various pieces of legislation would be on our ability to do the job that the American people expect their government to do, we have provided that information.
Q And has the President approved of your speaking out, that you will not be silenced?
ADMINISTRATOR BROWNER: Oh, absolutely.
Q Did he give you a green light on that?
ADMINISTRATOR BROWNER: Absolutely.
Q Another congressman this morning said that his Democratic opponent who was defeated was receiving information faxed by the EPA to help him in his campaign.
ADMINISTRATOR BROWNER: This is the most pathetic use of taxpayers' money. Let me explain to you all what happened. A secretary who was trying to do her job fairly, honestly, and thoroughly was faxing invitations to Democrats and Republicans to come to a policy briefing on wetlands. She was handed a list from American On Line that included the names of members of Congress, their opponent from the last election and the fax number. She thought the names of the opponents were the staff of the members of Congress. And so she filled out fax sheets with the opponent's name, thinking it was staff, and the member of Congress. It went to Democrats and Republicans.
Within hours of this happening, every member was called and apologized to, including the members who participated in the ridiculous press conference on Monday suggesting that I keep secret files of GOP opponents. We have never kept any files of any opponents. Someone made an honest mistake, trying to do their job thoroughly.
Q Can you walk us through what would be needed to make these changes -- legislation, executive directive, a new --
DR. KAMARCK: On the changes that are designed to help small business deal with the regulatory agencies, the President will issue a presidential memorandum within the next few days instructing each of the agencies within the context of their laws, their practice, their regulations, to figure out how to change their practice so that they can, in fact, give small businesses a break when they're making a good faith effort at compliance. I believe -- and I will turn this over to FDA and EPA -- that there are a combination of both statutory and regulatory changes involved.
ADMINISTRATOR BROWNER: Very briefly, the 25 changes that we've announced -- the President announced today for EPA, the vast majority of them can happen within existing law. There are some limited situations where we will be discussing with Congress changes. But if you take the small business owner that we visited with today, the changes that will result in reducing his reporting requirements from 20 forms to one form, we can do that within existing law. The reduction in the record keeping and reporting requirements, the 25 percent reduction, we can do that within existing law.
The compliance centers that we're going to be setting up across the country to help small business owners understand how they can protect the environment, how they can protect the health of our air and our land, we can do that within existing law.
Q What kind of changes --
Q Pollution trading, though?
ADMINISTRATOR BROWNER: We can do that -- the trading expands on the acid rain program within the Clean Air Act, and we can do that. There's a small portion of the water law that we may need changed; we're still looking at that.
DR. KESSLER: I think it's very similar to EPA. The four specific items that the President spoke of this morning we can do through administrative action. We will issue within the next several weeks an additional number of reforms, and some of those may require a statutory change. But the vast majority can be done through administrative action.
Q You think the actions designed to help small businesses today, the new easing of all of these burdens, will help improve the administration's relationship with the small business community which was strained because of the health care debate last year?
MR. LADER: There's no question -- this action today demonstrates the President gets it, is on the side of small business. Small business needs to be about fixing up problems, not getting slapped around. And the President is squarely in the small business's corner, and the action today demonstrates that.
Q There's what some consider a compromise bill in the Senate from Senator Nickles -- and I understand Senator Reed is going to sign on to it -- for a 45-day moratorium on regulations, giving the Congress an opportunity to strike down those specific regulations that they don't like. Is that the kind of bill that you all could support, or the President might support, or is that also --
DR. KAMARCK: This is fairly new within the last couple of days, and we have talked about it a little bit, but not developed an administration position on it yet.
Q Are there any costs or budgetary savings involved in any of these moves?
DR. KAMARCK: There are fairly large budgetary savings, and I'll ask Carol to talk in a minute. But most of the savings in the regulatory area are savings to the private sector from the cost of compliance. And that's where we can see -- as we move through this, we will attempt to estimate those costs and later in the year give you a breakout. It's difficult because these are estimates of man hours saved, et cetera.
Q What about setting up these compliance centers? Isn't there a cost associated with that, and where is it going to come from?
ADMINISTRATOR BROWNER: We can do that within the existing EPA budget. But let me give you an example of just one industry and what the savings will be to that industry. The chemical industry -- right now they have to deal with 13 different emissions reports under the air rules. We are going to consolidate that into one report. The savings is estimated to be $250 million a year for that industry alone.
What this means is obviously more money to the businesses, some of which will be used for better environmental compliance, for improvements with moving beyond just the standards that are currently in place. And that was the other part of the President's announcement today, which is Project XL -- excellence in leadership -- which is about doing it better, looking at what we can give back to communities and how we can go beyond the standards in place today to achieve cleaner air, to achieve cleaner water.
Q Do you have deadlines for these things, and how quickly can you implement them?
ADMINISTRATOR BROWNER: Well, in the case of EPA, some of them we will begin to do literally immediately. They build on work we have done for the last two years. In the case of the market, the clean air market emissions trading program, we will have that rule in place by mid-summer, so those trades can begin to take place. And some of them we will have to begin later in the year. But we are pulling together a team of people whose primary purpose will be to implement all of the 25 proposals.
Q When you talk about a series of different events, how many exactly are you talking about, and what's the next step?
DR. KAMARCK: You should anticipate seeing announcements probably in three or four weeks -- significant announcements on OSHA, changes in the OSHA regulations and practice, changes in HCFA, Health Care Financing Administration, the various health changes. Some changes in the way we regulate food. Again, we'll bring back Dr. Kessler. Today, it was drugs and medical devices. We'll be dealing with food, with the Agriculture Department.
There will be a series of smaller changes in education. There's a lot of requirements placed in principals, university administrators, et cetera. We are walking through, comprehensively, every place the federal government regulates.
Q How are you assuring that there will be protection of health and safety, especially on OSHA, which is always under attack and which was, during the Reagan Revolution, targeted?
DR. KAMARCK: The effort here is not to roll back any protections of health and safety in any area, nor to roll back any protections for transparency of the financial system in areas like banking reform, which by the way, is another announcement we'll be making.
The effort here is to do what Mr. Howard has so eloquently written -- common sense regulation. It's just like, if you those of you who followed the administration's procurement reform efforts last year -- again, these systems, over time, get loaded up with a lot of silly things that, in fact, end up defying common sense. And this effort is an effort to go through these carefully, preserving the intentions of the law, but getting rid of the unnecessary burdens that the government over time has been placing on the private sector.
ADMINISTRATOR BROWNER: Let me just say what our philosophy is at the Environmental Protection Agency. It is tough standards, standards that clearly protect our air, our water, the health of our people. But common sense, flexibility, innovation, creativity in how you meet those standards.
We want to capture what's made this country great -- the creativity of the people -- so that we can find as many solutions to our environmental challenges, so that we can drive down the cost of environmental compliance. So you need tough standards, common sense and flexibility in how you meet those standards.
Q Are the industries being consulted on all these changes?
ADMINISTRATOR BROWNER: Well, we were joined -- the President was joined today by industries and environmental organizations supporting the EPA recommendations. We have worked very closely with a large group of stakeholders over the last two years. I've spent a lot of time talking to people about how to better do this job of public health and environmental protection. And we are going to continue to work with all interested parties so that we can get the job done that the American people expect.
Q Elaine, just one question on the announcement the President made today of the forgiveness of up to 100 percent. Is there any kind of rate for larger businesses, or does this just count for small businesses, and what's the cut-off?
DR. KAMARCK: This counts for small businesses. One of the things that we have to work out administratively is that if there turns out to be -- and you won't be surprised if you've been following the federal government -- there turns out to be not one definition, but several definitions in the federal government of what a small business is. So as we develop the guidance for this in the next week, we will decide on which definition to use.
Q So, in other words, you've made this decision without deciding who it applies to?
DR. KAMARCK: SBA's cut-off -- SBA defines small businesses as 500 employees or less. There are some other definitions of small businesses. What we have to do is see which ones are statutory and which ones are rule, and then we'll make the decision like that.
Q And why no help for some of the bigger businesses which also claim that they're getting an unfair deal in this?
DR. KAMARCK: I think the feeling, generally, is that large businesses have the capacity, they have the lawyers, they have the infrastructure to know what the rules are and follow them.
Now, the XL initiative, which the EPA has announced, actually is a big business initiative which allows them to set their own standards, and the deal they make with EPA, so to speak, is that if they can do better than EPA standards, guess what -- they get out of a lot of the regulatory burden. So there's a kind of different thrust for big business than there is in small business.
Here's what we find. You go out in the country, there's a lot of honest people out there, they're trying to do the right thing. They cannot keep up with what goes on in the Code of Federal Regulations, which is a fairly massive document, as you can well imagine. And our effort here is to say, if you're out there and you're honest and you're making a good-faith effort, and you get a first-time violation because you really didn't know, then we want whatever the regulatory agency is, is to allow for you to get a break, because that's what we think they need.
But this is not meant to be, in any way, shape or form, a way for people who are chronic violators or anything like that, whether they're big or small, to get out of the burden of following the law.
Q Can you explain the XL proposal? Did the President announce that today?
ADMINISTRATOR BROWNER: Yes. The President announced Project XL: Excellence in Leadership. And, again, as Elaine said, what this is, is, it's an opportunity for large business and for communities to compete competitively for 50 projects that we will select, which they will be making a commitment about doing better, going beyond what is currently required of them, doing something extra for their community, for their air, for their water.
In exchange for that commitment of doing something extra, we take away the rules. It's a very fair and exciting and bold initiative, and we literally, as we were leaving the event today, had companies coming up, wanting to apply. We know of cities that want to participate in this kind of project. And what this will allow us to do is to develop the next round of change that we can apply across the entire country. These models will then become the next round of regulatory reinvention for the EPA.
DR. KAMARCK: Can I add something to this? If you go back to the budget announcements and to the beginning of this second phase of reinventing government, we talk a lot about performance partnerships and using performance standards in government. Whether it is public health grants that were getting rid of the bureaucracy and replacing actual results-driven standards, or EPA's XL. This theme you will see running throughout the Clinton administration's reinventing government initiatives. It involves, basically, the following agreement: You agree to produce clean air, higher vaccination rates -- whatever the public purpose is -- and we, the government, will get out of your way and relieve you of significant regulatory burdens. And this is a pretty big revolution in government.
Q The environmental trading system, does that apply just to utilities, or to other industries?
ADMINISTRATOR BROWNER: Oh, no, it applies across all industries. An example would be smog. Right now, we have trading in the acid rain part of the clean air program; this would extend it to smog. So those things which form smog -- volatile, organic compounds, things that none of you probably care about -- people would be allowed --
DR. KAMARCK: White House press rooms. (Laughter.)
ADMINISTRATOR BROWNER: -- to trade across to find the cheapest way to get the air quality improvements.
Q It was limited to acid rain --
Q They extended it to smog and also --
ADMINISTRATOR BROWNER: We're worried about the rescission that's going to get rid of the $1.3 billion for clean drinking water.
Q It's extended to smog and also to water -- fluids, right?
ADMINISTRATOR BROWNER: Yes. That's another example which, as you would look within a particular river at all of the different discharges to the river, and you would set a cap on what you need to reduce the discharges by to make sure that water is clean, then allow companies to trade. So, for example, a company might say to a farmer, I'll pay to fence off your part of the river so your cows don't contribute to the pollution in the river, because that's cheaper than putting another filter on my facility, and we reach the same goal of cleaner water.
Q Dr. Kessler, looking ahead to the next round of reforms that you're planning -- you said that there were going to be more in the future -- what areas do you expect to be touched? Are you going to be looking at drug approvals processes, for example?
DR. KESSLER: We're looking in this immediate round in the next several weeks -- we're looking at additional reforms in the drug and device area. And what we're looking to do is to maintain, as the President said this morning, the consumer protection standards that have become the envy of the world, but to streamline and make sure we're as efficient as possible.
And what that means in our case, is to continue to work hard as we have over the last several years to make sure that we can expedite the approval of important drugs and get them to patients who need them. That's very important. So, many of our efforts, you will see over the next couple of weeks, are designed to continue that process, to get the review times down to the level where the balance between making sure that things are safe, but making sure they're available to patients as soon as we can give them that assurance, that's what we're trying to strike.
Q Is there going to be additional accelerated drug approval regulatory changes?
DR. KESSLER: The drug approval process is very complex. The traditional review times used to be -- three or four years ago, if you looked at review times, it was 26, 27 months. If you look at drugs approved last year under the User Fee Act that was enacted two years ago, the approval times were down dramatically -- 13 months for traditional drugs, 10 months for breakthrough drugs, the .23 cent reduction in overall -- so we really have brought down review times, and we're going to continue to work hard to bring down review times. But we're also -- what you will see over the next several weeks, are requirements that we find when we review that don't go toward the safety efficacy of the drug, requirements that were left over from a technology that may have been in use years ago and that just don't apply to the drugs and devices in the way we produce them today.
Q Administrator Browner, the President's program here sets a deadline of July 15th for focusing hazardous waste regulations on high-risk waste. I'm wondering if you have similar deadlines for the one-stop emission reports on consolidated air rules, and for both those -- for the one-stop emission reports and the consolidated federal air rules. What kind of deadlines for getting those rolling and for moving past the pilot stage?
ADMINISTRATOR BROWNER: In that instance, those are not pilots. Those are programs that will be put in place and all businesses can take advantage of them will be able to do so. Project XL are the pilots.
In each instance, we'll -- you'll like this -- have to go through the rule-making process to actually do this, which is an important thing. It provides for public input for all stakeholders to be involved. I think in both instances, we will be proposing those rules in the summer and early fall, taking public comment and would hope to complete the process by the end of the year.
Q The moratorium legislation might actually delay that process?
ADMINISTRATOR BROWNER: Absolutely. If the moratorium legislation
Q So then the moratorium legislation might actually delay that process?
ADMINISTRATOR BROWNER: Absolutely. If the moratorium legislation were to become law, then we would not be able to offer these benefits, these reductions in regulatory burdens to companies across the country.
THE PRESS: Thank you.
END1:32 P.M. EST