[Congressional Record Volume 141, Number 113 (Thursday, July 13, 1995)]
[Senate]
[Pages S9856-S9879]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                  COMPREHENSIVE REGULATORY REFORM ACT

  The Senate continued with the consideration of the bill.
  Mr. DOLE. Mr. President, I know there has been a unanimous-consent 
agreement. Do we have any time agreements or just consent to start 
something?
  Mr. HATCH. We did not have any time agreements because the Senator 
from California was not here. Now that she is, we would like to work 
out a time agreement.
  Mr. GLENN. If the majority leader will yield, we are going to try to 
get time agreements for everything coming to the floor from now on. I 
hope we can get 15 minutes a side for everything that comes to the 
floor. We are going to propose that. I hope people listening can think 
about this and agree to it. We have been wasting time with people 
talking, and also on various subjects that do not have anything to do 
with the legislation that we are considering here. So I hope everybody 
can come up with time agreements, if possible.
  Mr. DOLE. In some cases, there may be second-degree amendments on 
either side. So it may take a bit longer than 30 minutes.
  Mrs. BOXER. Mr. President, I ask the majority leader, if he will 
yield on that point, I feel very strongly that I want to have a vote on 
my amendment. If there is going to be a second-degree, I will not agree 
to a time agreement. I will be happy to agree to 15 minutes on each 
side, but if there is a second-degree, I cannot agree because there is 
no way for me to get a vote on my underlying amendment. It is a problem 
for me.
  Mr. GLENN. I think that would be the general attitude all the way 
through this thing. Unless we know what is coming up on the second-
degree amendment, we are not likely to agree to a time agreement on it. 
If we can agree to these things without second-degreeing everything----
  Mr. HATCH. But we do not even know the form of the amendment.
  Mr. DOLE. We do not even know what the first-degree amendment is.
  Mr. HATCH. That is the way the Senate operates.
  Mr. GLENN. Then maybe we cannot get time agreements.
  Mr. DOLE. Mr. President, at 11 o'clock, we said we were going to 
start mowing them down around here, and I know the Senator from 
Louisiana was surprised when I filed cloture. But, frankly, I was 
surprised when he offered an amendment to knock out Superfund. I did 
not know that was going to happen. So there has been a double surprise 
here. We are trying to come to grips with that amendment.
  In the meantime, I think there has been agreement to go to the 
amendment of the Senator from California. But to suggest that we cannot 
get time agreements and you cannot offer second-degree amendments, then 
I think we are going to be in real trouble, because both sides always 
reserve the right to offer second-degree amendments. It seems to me 
that it is something we need to work out before we start.
  Mr. President, the liberal opponents of commonsense regulatory reform 
must be celebrating after watching some of this week's reports on the 
evening news, and reading some of the stories and columns in some of 
our most distinguished newspapers.
  Last night, a report on ABC's ``World News Tonight'' claimed 
Republican supporters of regulatory reform are ``on the defensive.'' 
And it is no wonder, considering how the media have fed the American 
people a steady diet of phony claims that we are out to promote tainted 
meat and unhealthy food.
  Liberal New York Times Columnist Bob Herbert a few days ago took a 
page 

[[Page S 9857]]
out of the liberal consumer activist playbook, labeling our regulatory 
reform bill ``An all-out assault on food safety regulations,'' adding 
that it ``Would block implementation of the Agriculture Department's 
meat safety initiative for 2 to 3 years, and probably longer.''
  If this outright distortion wasn't enough, listen to this from 
Margaret Carlson's ``Outrage of the Week'' on CNN's ``Capital Gang'': 
``Senator Bob Dole, under the guise of regulatory reform, is letting 
the meat industry lawyers block this [meat safety test].'' Wrong again.
  One network aired a report Monday night that included the following, 
and I quote:

       With Senator Dole's regulatory reform bill, industries 
     could challenge rules they considered too costly or too 
     burdensome. Thirteen-year-old Eric Mueller died in 1993 from 
     E. coli poisoning after eating a fastfood hamburger. His 
     father says any delay in adopting new meat inspection rules 
     is a travesty.

  This is indeed a tragic story. The only problem is, this report, like 
so many others, was simply wrong in its suggestions about this bill.
  Our legislation has always made it explicitly clear that regulations 
are exempted from any delay if there is ``an emergency or health or 
safety threat.'' Additionally, the Agriculture Department has already 
conducted a cost-benefit analysis of the meat inspection rule and it 
passed. But the facts did not stop that network from reporting Monday 
night that, ``A delay is looking more and more likely.''
  However, on Tuesday, if it was not clear enough already, we 
specifically added to the bill the words ``food safety, including an 
imminent threat from E. coli bacteria.''
  But that did not stop the media's drumbeat on food safety. Last 
night, a network anchor for whom I have great respect claimed that on 
regulatory reform, Republicans ``went further than the public may want 
on the issue of food inspection.'' Wrong again. I do not know how many 
times we have to say it to get the media to understand the fact that 
this bill does not compromise food safety. Yesterday, the former head 
of the FDA and four eminent scientists and physicians spoke at a press 
conference to explain how our bill protects food, health, and the 
environment--but the media did not seem to notice.
 I did not see it anywhere. It was not on ABC News, CBS or NBC. They 
get some liberal Senator on the floor to make some claim, and that was 
the news. That was the liberal spin and the one the media jumped to in 
a second.
  But ABC did not stop with the issue of food safety. Then they broke 
out the chainsaws, the strip mining, pesticides, potentially dirty 
drinking water, and cute endangered animals in their effort to explain 
the impact of regulatory reform. They do not know any bounds once they 
get carried away with the liberal spin in this body.
  Mr. President, these are just a few examples of the kinds of 
distortions we have had to confront on this bill. And I am not the only 
one who has noticed this trend. According to a study released last week 
by the Advancement of Sound Science Coalition, ``media coverage of the 
congressional debate over environmental regulatory reform slants 
`clearly against the regulatory revisions.' '' According to Dr. Robert 
M. Entman of North Carolina State University, who conducted the study, 
there was a 3-to-1 negative imbalance in news stories about reform 
between last November and this May 11. Not surprisingly, the study 
claims that 74 percent of paragraphs that evaluated reforms were 
critical, criticism reached 87 percent on editorial pages, and 70 
percent of the stories on the commercial television networks and in 
weekly news magazines criticized reform. I ask unanimous consent that 
the Advancement of Sound Science Coalition's statement about its study 
be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

  Media Reports Slanted Against Regulatory Reform Efforts, Study Shows

       Washington, DC, July 7, 1995--Media coverage of the 
     Congressional debate over environmental regulatory reform 
     slants ``clearly against the regulatory revisions,'' 
     according to a study released today by The Advancement of 
     Sound Science Coalition (TASSC).
       ``While some outlets refer in favorable terms to the 
     general idea of reform, most devote far greater space and 
     time to denouncing the specific legislation calling for 
     rigorous application or risk and cost benefit analysis,'' 
     according to the study, conducted by Dr. Robert M. Entman, 
     Professor of Communication, North Carolina State University 
     and Adjunct Professor of Public Policy, University of North 
     Carolina (Chapel Hill).
       ``This study demonstrates once again that the media, 
     whether it is consciously aware of it or not, is portraying 
     important, scientific issues in the same `who's up, who's 
     down' play by play style of reporting that they use in 
     describing political campaigns or football games. While all 
     stories deserve more balanced treatment, stories involving 
     science cry for more fair reporting,'' said Dr. Garrey 
     Carruthers, Chairman of TASSC, a national organization of 
     scientists, researchers, academicians and others.
       The most striking finding in Dr. Entman's study is the 
     ``negative imbalance in covering the proposed reform 
     legislation.'' Dr. Entman said that there was a three-to-one 
     negative imbalance in news stories about reform. Fully 74 
     percent of paragraphs that evaluated the reforms were 
     critical. On editorial pages, criticism reached 87 percent, a 
     seven-to-one negative ratio. Among his other findings:
       70 percent of the stories on the commercial television 
     networks criticized reform.
       Weekly magazines surveyed also were 70 percent critical.
       Certain key words function to reinforce negative 
     impressions. For example, the word ``lobby'' or related words 
     show up 10 times as often when referring to those supporting 
     reform as those opposing it, even though both sides are 
     lobbying the Congress.
       Headlines, which frame the audience's emotional response to 
     the content of the story, were often emotional or slanted 
     opposed to the reform ideas. For example, Time magazine's 
     ``Congressional Chain Saw Massacre'' or Newsday's ``GOP 
     Frenzy Is Gutting Safety Rules.''
       Visual images portrayed supporters of reform as enemies of 
     the environment. For example, scenes of industrial plants 
     with numerous pipes and tanks; smokestacks spewing smoke; a 
     large bulldozer. Viewers were repeatedly exposed to 
     ``archetypal images of pollution and danger,'' the report 
     states, images likely to ``stir negative emotions toward 
     reform.''
       While analysis of the ``why'' of this media slant was 
     beyond the scope of Dr. Entman's study, the report says, 
     ``reasons go beyond the standard interpretation of liberal 
     bias. They include the media's tendency to oversimplify; 
     journalists' lack of training in policy analysis; and the 
     commercial incentives that news organizations interpret as 
     requiring appeals to emotion over cognition.''
       Dr. Carruthers said TASSC commissioned the study because 
     ``we want to offer information on how scientific issues are 
     communicated to the public as another means of ensuring that 
     only sound science is used in making public policy 
     decisions.''
       ``Too often, legislation or regulations are the result of 
     political decisions, where the science does not back up the 
     action. One way to better understanding this phenomena is to 
     understand how the media portray scientific issues. TASSC is 
     committed to pointing out not only when unsound science is 
     used to make a decision, but also to point out the media's 
     important role in the public's understanding of science and 
     research,'' Carruthers said.
       To conduct his study, Dr. Entman examined 29 major 
     newspapers across the country, Time, Newsweek and the three 
     broadcast network evening news programs. Stories review 
     included those published or broadcast between November 1, 
     1994 and May 11, 1995.

  Mr. DOLE. Mr. President, I know the media have a tough job to do. But 
if I believed everything I saw on the evening news or in the 
newspapers, I would vote against this bill, too. I imagine if all of 
the anchor people were on the floor, they would vote against it because 
they would not read it. They would just listen to some liberal on the 
other side of the aisle and swallow it all and say ``I am against it.'' 
Fortunately, the facts are on our side, even if some folks in the media 
are not.
  This is not a question of partisanship, not a question of anything 
but commonsense reform. Maybe those who report the news at the big 
networks do not worry about things that people have to put up with, the 
people in my State of Kansas, like businessmen and women, farmers, and 
ranchers. That is not their concern. They buy into ``the more 
Government the better.'' If you have little Government, let us have a 
little more regulation, which costs the average family $6,000 a year.
  So we will continue to try to correct the record. We know that it 
will never make the news. In fact, I challenged the media yesterday, 
when we had all these imminent scientists and a former FDA commissioner 
there, to report something they said. There was not one peep, because 
they were trying to give us facts, not the liberal spin. It makes a 
great difference in this body and in this town.
  Mr. GLENN. Mr. President, I would like to reply to the distinguished 
majority leader's statement. I want to make it very clear that in S. 
343 we say 

[[Page S 9858]]
that if there is a real problem, the agency can make an exception and 
say that the rule can go in.
  But the rule that could involve safety, health, E. coli, and 
cryptosporidium and all the rest of these things, in the original 
legislation, could only be in effect 180 days, to give them a chance to 
take into account all the requirements of the law, and then unless they 
had it done within 180 days, the regulation that protected the health 
and safety of people in this country would be negated. It would no 
longer be effective.
  Now we have changed that on the floor this evening with the proposal 
by Senator Johnston that makes it 1 year instead of 180 days. Most of 
these regulations take 3, 4, 5 years to come into final form. We still 
have the danger there that we can, with this legislation, have a 
requirement to complete all this re-analysis in 180 days. It is not 
done, the regulation goes out, and whether it dealt with E. coli, 
cryptosporidium or the other things that have caused actual deaths in 
the country and we know are dangerous, and not need a new 
investigation, but the regs would be knocked out.
  Mr. ROTH. Mr. President, will the Senator yield?
  Mr. GLENN. I am happy to yield to the Senator.
  Mr. ROTH. It is true under the original legislation that not later 
than 180 days after the promulgation of the final major rule to which 
the section applies, the agency shall comply with the provisions of the 
subchapter, and as therefore necessary revise the rule.
  But I am not aware of anywhere where it says the rule is terminated.
  Mr. GLENN. The rule could be judicially challenged because it had not 
complied with the requirements of the legislation, so there would be a 
judicial challenge. The Senator is right. There would have to be a 
judicial challenge, but we are such a litigious society today, I do not 
doubt there would be multiple lawsuits if there is any crack in the law 
that can benefit a meatpacker or food processor or whoever it may be.
  Mr. ROTH. I do not think the court would terminate the rule. A person 
could go into court and ask that they force the agency to comply with 
the requirement that the analysis be made.
  I think the important point to recognize and understand, there is 
nothing in this legislation, unless the distinguished Senator form Ohio 
knows something I do not know, that provides for the termination of the 
rule.
  Mr. GLENN. Let me reverse this. Does the distinguished Senator from 
Delaware----
  The PRESIDING OFFICER. Under a previous order, the order of business 
was to recognize the Senator from California. If the Senator would wrap 
this up in a few seconds.
  Mr. GLENN. Mr. President, I ask unanimous for 2 more minutes.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. GLENN. I ask my distinguished friend from Delaware, is there 
anywhere in there that says there cannot be a judicial challenge? I 
know there is not. That means there would be a judicial challenge, the 
analysis would not be completed, the time would have run out.
  Mr. ROTH. The question is, was it violated? If they do not make the 
study within the times required, then, yes, they can go into court and 
force the agency to make the study.
  There is nothing in it that requires the termination of the rule.
  Mr. GLENN. The Senator does not think there would be a judicial 
challenge?
  Mr. ROTH. Not under these circumstances.
  Mr. GLENN. I think that is guaranteed in this. We would have a 
judicial challenge to this, and the rule would be out because the 
studies had not been completed.
  Mr. ROTH. It says here in the legislation a major rule may be adopted 
and may become effective without prior compliance with the subchapter. 
It specifically provides the rule shall become effective.
  Mr. GLENN. Followed by subchapter--if the agency in good cause finds 
conducting cost-benefits impractical and so on, but then not later than 
180 days, which is now changed to a year after promulgation.
  The final rule to which this section applies, ``the agency shall 
comply with the provisions,'' if they have not done so, it would be 
subject to judicial challenge. With the provisions of this subchapter, 
each one of those subchapter provisions would have to be met, or the 
judicial challenges, and it is thereafter necessary to revise the rule, 
and if they have not done that, it would still be subject to judicial 
challenge.
  Mr. ROTH. But nowhere does it say the rule terminates. In fact, to 
the contrary. It says the rule goes into effect. The language that the 
Senator just quoted does give the right to go into court and require 
the agency to make the appropriate study. That is all it does.
  The PRESIDING OFFICER. Amendment No. 1517 is set aside. The Senator 
from California is recognized to offer an amendment.


                Amendment No. 1524 to Amendment No. 1487

     (Purpose: To protect public health by ensuring the continued 
              implementation of mammography quality rules)

  Mrs. BOXER. Mr. President, I send an amendment to the desk and ask 
for its immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The legislative clerk read as follows:

       The Senator from California [Mrs. Boxer], for herself, Mrs. 
     Murray, Ms. Mikulski, Mr. Lautenberg, Mr. Bradley, Mrs. 
     Feinstein, Mr. Dorgan, Mr. Kennedy, Mr. Reid, Mr. Bumpers, 
     Mr. Biden, Mr. Leahy, Ms. Moseley-Braun, and Mr. Daschle 
     proposes an amendment numbered 1524 to amendment No. 1487.

  Mr. DOLE. Mr. President, I send a second-degree amendment to the 
desk.
  The PRESIDING OFFICER. Is there objection to dispensing of the 
reading of the amendment?
  Mrs. BOXER. I object.
  The PRESIDING OFFICER. Objection is heard.
  Mr. HATCH. I ask unanimous consent that the reading of the amendment 
be dispensed with.
  The PRESIDING OFFICER. Is there objection?
  Mrs. BOXER. I object.
  The PRESIDING OFFICER. The clerk will report.
  The amendment is as follows:

       On page 19, line 7, strike the period and insert the 
     following:
       ``; or (xiii) a rule intended to implement section 354 of 
     the Public Health Service Act (42 U.S.C. 263b) (as added by 
     section 2 of the Mammography Quality Standards Act of 
     1992).''.
                Amendment No. 1525 to Amendment No. 1524

  Mr. DOLE. Mr. President, I send a second-degree amendment to the desk 
and ask for its immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The legislative clerk read as follows:

       The Senator from Kansas [Mr. Dole] proposes an amendment 
     numbered 1525 to amendment No. 1524.

  The amendment is as follows:

       In lieu of the matter proposed to be inserted, insert the 
     following:
       It is the sense of the Senate that nothing in this Act is 
     intended to delay the timely promulgation of any regulations 
     that would meet a human health or safety threat, including 
     any rules that would reduce illness or mortality from the 
     following: heart disease, cancer, stroke, chronic obstructive 
     lung diseases, pneumonia and influenza, diabetes mellitus, 
     human immunodeficiency virus infection, or water or food 
     borne pathogens, polio, tuberculosis, measles, viral 
     hepatitis, syphilis, or all other infectious and parasitic 
     diseases.

  Mr. DOLE. Mr. President, I believe this is a responsible second-
degree amendment, that we can dispose of a number of these issues in 
the spirit expressed this morning by the Democratic leader and managers 
of the bill so we can move on and try to complete action on this bill 
no later than next Tuesday. It is offered in that spirit, the spirit of 
cooperation.
  My view is it is a good amendment. I hoped it might be acceptable. It 
seems to me that it would save hours and hours of debate here and put 
to rest all the arguments that some people like to make about which 
party or which side of the aisle is more concerned about some of the 
health and safety regulations. We are ready to stipulate we are just as 
concerned as they are on the other side. We think this would lay that 
to rest. I would hope the amendment would be accepted.
  Mr. HATCH. Mr. President, we have now been on this bill 6 days and we 
have handled very few amendments. One reason is that everyone wants to 
exempt some rule or other, or some special interest or other, or some 
issue or other, from the provisions of this 

[[Page S 9859]]
bill. This bill's whole purpose is to make sure that the best available 
science is applied to regulations.
  Now, the distinguished Senator from California is very sincere in 
bringing up her amendment. But, it is another in a series of amendments 
that we will spend the next 3 months debating if we do not find some 
way of making clear that the only purpose of this bill is to improve 
the regulatory process and that everybody should support that goal.
  No one is more concerned about breast cancer than I am. It is a 
grave, grave disease, and each and every Member in this body is 
disturbed about its incidence and the increase in its incidence. I do 
not want to see standards delayed unnecessarily any more than Senator 
Boxer or Senator Murray or Senator Glenn.
  First of all, I think it is important to know that the Mammography 
Quality Standards Act was enacted in 1992, 3 years ago. If the 
proponents of this amendment want to talk about hamstringing the FDA 
from issuing regulations on the bill, I think they ought to ask 
themselves, ``What has the FDA been doing in the almost 3-year period 
since the bill's enactment?'' They have controlled the FDA for a year 
and a half of that time.
  I understand that my colleagues have stated today that new, proposed 
regulations are expected this fall to implement the bill. I think we 
ought to ask ourselves, ``Why has the FDA allowed almost 3 years to 
elapse before the regulations are issued?''
  I can answer part of that question. The program is already up and 
operating. The program is already up and operating.
  As I believe Senator Glenn noted earlier, the program is operating 
under interim final regulations issued on December 23, 1993. Interim 
final regulations are, by definition, final. They have the full force 
and effect of law. There is no requirement that they be made final.
  I would just like to ask my colleagues, ``What public health issues 
have been raised that need to be addressed now in new regulations?"
  The second thing I would ask is this, ``If these regulations are such 
a priority and are needed to save women's lives, then why, on May 8, 
when the administration issued its regulatory agenda for the year--and 
I am holding the Federal Register which contains that agenda--then why 
did the administration when it issued all of its regulatory priorities 
and set target dates for each regulation, why did they not list a 
projected date for the MQSA final regulation?
  In fact, they did not list an October date or a September date or any 
date. Ten weeks ago they talked about the current interim final 
regulation. They did not even mention a new, proposed regulation in the 
book that was supposed to outline the whole regulatory agenda for the 
government. In other words: It was not a crisis then, so why is it a 
crisis today?
  I know my colleague, Senator Boxer, is worried that the Act would get 
caught up in the $100 million threshold in the bill and would be 
subject to cost-benefit analysis. In fact, in the administration's own 
regulatory plan, issued only 10 weeks ago, that is just 2\1/2\ months 
ago, the administration printed the following in the Federal Register: 
``Mammography Quality Standards Act of 1992, Anticipated Costs and 
Benefits: Direct Federal costs in 1994 are $13 million.''
  That is $87 million less than what would trigger this bill's cost/
benefit requirements.
  The administration goes on to say:

       There are approximately 10,000 mammography facilities in 
     the United States. Approximately 8,200 have accreditation or 
     have applied for accreditation and will not incur significant 
     additional cost. The remaining 1,800 facilities will incur 
     approximately $26 million in one-time costs, and recurring 
     costs of about $27 million. Amortizing the one-time costs, 
     the annual costs of the interim rule is about $33 million.

  This $33 million is still $67 million less than needed to trigger the 
effect of this bill.
  Thus, the OMB certified estimate, printed in the Federal Register 
only 10 weeks ago, was $33 million. That was 10 weeks ago.
  How can it be over $100 million today? Or anywhere near $100 million 
now? Or even within the next number of years?
  I would like to ask my colleagues who offer this amendment another 
question: ``Why will it take years for FDA to do a cost-benefit 
analysis on something as important, as significant, and as 
understandable as the Mammography Quality Standards Act of 1992?"
  I suspect part of the reason is that FDA historically has not had a 
very good record of moving things through very quickly. This is 
abundantly true with drug approvals, now taking 10 to 15 years at a 
cost of hundreds of millions of dollars for a major drug. No other 
country in the world takes that amount of time.
  Medical device approvals are also lagging way behind the expectations 
of Congress. This is true for countless other regulatory undertakings.
  In fact, with the FDA we have an agency which is fighting S. 343 as 
hard as it can.
  We have an agency which is sending up packets of information, raising 
all sorts of red herrings about this bill. We have an agency who wants 
business as usual, who wants to preserve the status quo, who does not 
want the pressures that this bill will bring upon them to do their job 
in a better fashion and in a better manner.
  I am not sure we can count on the FDA to seriously take into account 
the mandates of this bill with this kind of attitude.
  I would also like to ask why women should not have access to the most 
cost-effective procedures? I think it is important to note that our 
bill does not have the so-called supermandate provision. Our bill does 
not change any existing requirement of Federal law with respect to the 
need for quality standards for mammography clinics, including the 
quality of the mammograms, the training for clinic personnel, or 
recordkeeping.
  All our bill does is say that in implementing the law, the agency 
must act in a way so that benefits outweigh costs. It goes to the 
process of implementation, not the need for implementation.
  As one who, as I think everybody in this body knows, was very 
involved, with Senator Adams and Senator Mikulski, in drafting the 
Mammography Quality Standards Act of 1992, as one who has been a leader 
in this effort, I wish to point out that I recognize the need for that 
law.
  But I also think both the Act and American women can benefit by 
subjecting the law to a cost-benefit analysis. Especially if the costs 
of regulation under this law reach a threshold of $100 million in this 
country.
  I am aware that last year one rural hospital in Utah had to close 
down its mammography machine because of the implementing regulations.
  I would suspect that this has not led to better quality mammograms 
for the citizens of that rural area. I suspect what it means is that 
women in that rural area will not get mammograms at all, because of 
some of the bureaucratic ensnarlments which occur in the implementation 
of legislation, and indeed at times, in the legislation.
  S. 343 is essential and it should not be continually tested on this 
type of basis--which some believe is purely a political basis--when it 
only delays going forward on this bill.
  I do not think that my constituents in that rural Utah community have 
benefitted by this situation. I do not think that is the way the law or 
the regulatory process are supposed to work.
  I think that the FDA is fighting this bill with everything it can 
because this bill will correct a lot of the excesses out at the agency, 
and, indeed, at every Federal agency. It will make them do better, do a 
better job of regulating.
  So it keeps coming back to the question of why women should not have 
access to the most cost-effective procedures?
  As I say, I was involved in writing the MQSA. I have been involved 
with this issue for years, and with virtually every other health care 
issue.
  I understand how important the MQSA is. Frankly, this bill would not 
have the dire effects on the MQSA that proponents of this amendment 
allege, even if the costs of regulation under the law should rise to 
the level of $100 million--which they will not according to an official 
appraisal by the administration just 10 weeks ago.
  Let me just mention what the second-degree amendment that Senator 
Dole has filed says:


[[Page S 9860]]

       It is the sense of the Senate that nothing in this Act is 
     intended to delay the timely promulgation of any regulations 
     that would meet a human health or safety threat, including 
     any rules that would reduce illness or mortality from the 
     following: heart disease, cancer, stroke, chronic obstructive 
     lung diseases, pneumonia and influenza, diabetes mellitus, 
     human immunodeficiency virus infection, water or food-borne 
     pathogens, polio, tuberculosis, measles, viral hepatitis, 
     syphilis, or all other infectious and parasitic diseases.

  You know, the 10 leading causes of death have just been pretty well 
defined in this sense-of-the-Senate resolution. It makes it clear the 
Federal regulators can go right ahead and promulgate regulations that 
are necessary in this area.
  What this bill requires is that they do it in a good, cost-efficient 
manner with good risk assessment considerations as part of the process.
  This makes sense.
  But the reason we listed all of these diseases in the amendment is 
that we know we are going to get papered to death on the other side 
with amendment after amendment with every special interest trying to 
exempt themselves from the effects of this bill, when in most cases 
they would be exempt anyway, just as mammography is. This is all for 
the purpose of making political statements.
  We think it is time for the Senate to get around to passing this 
bill. We need to get time agreements and debate the serious issues that 
are really needed to resolved, including the amendment of the 
distinguished Senator from Louisiana.
  I yield the floor.
  Mr. GLENN addressed the Chair.
  The PRESIDING OFFICER (Mr. Thompson). The Senator from Ohio.
  Mr. GLENN. Mr. President, I point out that the second-degree 
amendment starts out with ``It is the sense of the Senate.'' That is 
all it is, a sense of the Senate. It does not give anything binding and 
has no standing in law whatsoever. It just says the thoughts of the 
Senate at the moment happen to be that.
  What we are talking about is giving real protections here that the 
Senator from California is offering as a proposal to exempt this from 
some of the requirements that would be imposed upon it by S. 343.
  One of the reasons she is concerned about this, of course, is because 
the existing rule, as has already been pointed out, is going to be 
improved. They have an improved regulation coming out supposedly in 
October. That would be subject now to all of the review processes. It 
would have to go back through all of the requirements that are in S. 
343, the Dole bill. That does cause delay.
  My colleague from Utah asks: Why can we not get it out? They have 3 
years. What is the delay? If they are concerned about this, why do we 
not get that out?
  I think there is a lack of knowledge around here about what a 
regulation is and how voluminous it could be. We used as an example 
yesterday just one. Let me give an example. This is important for 
people to understand. Regulations are not something you go over there 
for and have a little meeting, decide this is what you are going to put 
out, and then you put out the regulation. They are required by the law 
that we passed here to go through multiple procedures such as peer 
review, public meetings, and scientific analysis in all of these areas.
  I use this as an example to show why it is not so easy to get a 
regulation out.
  Mr. JOHNSTON. Will the Senator yield for a question?
  Mr. GLENN. I would rather go through my statement. Then I will yield.
  The Clean Water Act passed in 1972; was amended in 1972; an amendment 
passed in 1977; in 1987, it had another amendment. For the Clean Water 
Act, one of the things that was required was effluent limitations on 
metal products and machinery. It took 8 years to get that one 
regulation out of EPA. Could they have done it faster? I do not know 
whether they could have or not. But for the ``Effluent Limitations 
Guidelines and Standards for Metal Products and Machinery'', which is 
the title of it, it took 8 years to get out. This is just the index of 
that regulation, what is covered. I do not know how many pages it is. 
It is several hundred pages.
  The other document we have here--this is what they were required to 
do by the law which we passed here. They do not dream these things up. 
They are by law. This is the development document for how they do the 
index and how they do the regs. This is the guideline for it--2 inches 
thick of fine paper.
  Listen to this: The final documents on this regulation cover shelf 
space of 123 feet. To give some idea what that means, we asked the 
Architect yesterday how high this Chamber is. It is about 42\1/2\ feet. 
The regulations on this one regulation out of several hundred put out 
pursuant to the Clean Water Act of 1972 are 42\1/2\ feet. That means 
the documentation would be three piles of paper in this well to the 
ceiling right here--three piles of paper, and that is just one 
regulation and the backup substantiating documents.
  Why do we need that much? I do not know. Look in the mirror, Members 
of Congress. Look in the mirror, Members of the Senate, as to why we 
required that much. We are the ones who put out the guidelines for the 
people as to what is required, what they have to do, and all the 
studies they have to make in order to make this whole thing work. That 
is what is required just in one regulation. That is the reason you 
cannot get these things out in such a short period of time.
  We have had, under the Presidential Executive order, requirements to 
do some of the cost-benefit analysis and to do some of the risk 
assessment and so on that is being asked for here. Some of those things 
are already underway. But when we ask why they cannot get these things 
out faster, that happens to be one of the reasons.
  I just hope that the public and the media that have been excoriated 
here a little bit this afternoon--not on this side of the aisle--but I 
hope the public and the media have been paying attention to the debate 
on this bill, because yesterday we spent most of the day trying and 
finally succeeding in getting votes on two proposals to exempt two 
rules now in the pipeline designed to protect our people from illness 
and from death:
  The Daschle amendment to exempt from the potentially destructive 
provisions of this act a rule that protects meat and poultry from 
contamination with E. coli was defeated by a vote of 51 to 49; the Kohl 
amendment to exempt from the potentially destructive provisions of S. 
343 a rule to protect our drinking water from contamination from 
cryptosporidium was tabled 50 to 48.
  What do we want to conclude from those votes? What principles should 
we draw from those votes?
  S. 343 has a number of exemptions built into it. No one seems to have 
pointed these things out. There are a number of exemptions already in 
this thing.
  For instance, first, the IRS rules or other rules concerning 
assessment and collection of taxes and duties--these are all 
exemptions.
  Second, any rule implementing international trade agreements. The 
Maquiladora in Mexico get an exemption, protection. For the safety and 
health of Americans, we do not.
  Third, any rule that authorizes the introduction into commerce of a 
product like a bioengineered tomato is free and clear, for instance. It 
is exempted.
  Fourth, any rule or agency action relating to the public debt--that 
is, selling a Government bond--is exempted, and should be. I agree with 
these.
  Fifth, any rule required to be promulgated at least annually pursuant 
to statute. For instance, duck hunting rules. I favor this. We exempted 
duck hunting rules that have to be put out by Federal mandate each 
year. Duck hunting rules are exempt from this bill. But serious health 
and safety protections are not.
  Sixth, any rule that approves corporate mergers and acquisitions. 
Wall Street gets an exemption. But the average American's protection 
from bad meat and bad water does not get an exemption. It does not get 
that same kind of exemption.
  Seventh, any rule relating to the safety and soundness of banks and 
lending institutions is exempted.
  Eighth, any rule by the FERC [Federal Energy Regulatory Commission] 
that reduces regulatory burdens is exempted. Electric utilities, for 
instance, get an exemption. For protection from bad meat and bad water, 
we could not even get that same kind of exemption. 

[[Page S 9861]]

  Mr. President, I do not object to the above exemptions. I favor those 
exemptions. But I say along with it, do we not want to hit some balance 
and say that the health and safety of our families, of our children, 
our fathers and mothers, deserves similar protections?
  The health and safety concerns addressed in the E. coli and the 
cryptosporidium votes yesterday are not imagined. Those dangers are not 
dreamed up dangers or mere possibilities. Quite the opposite. E. coli 
and similar foodborne illnesses kill some 3,000 to 7,000 people every 
year in this country. A couple of years ago in Milwaukee, 
cryptosporidium in the water supply made over 400,000 people seriously 
ill and 100 of them died.
  So these are not imagined dangers, they are real dangers. We know the 
danger from them. They are not fictitious thoughts that need more and 
more and more review to determine if there is a danger. Nothing should 
be permitted to hold up the corrective regulations as could happen 
under S. 343.
  I wish to protect the exemptions listed above. I think they are 
correct, and I am glad they are in there. Yes, we want to protect 
those, of course. But I would note that with the exception of duck 
hunting and the Federal Energy Regulatory Commission, the other six 
exemptions deal with economic matters.
  Now, that, too, is fine as far as I am concerned, but I also firmly 
believe that we should show the same concerns for known health and 
safety matters with all of our people.
  Mr. ROTH. Will the Senator yield for a question?
  Mr. GLENN. Just a moment until I finish my statement here.
  Now, it was also brought up that our side of the aisle, apparently it 
is being talked about that we are delaying things somewhat. It was said 
that the administration is sending up red herrings. Last night, the 
distinguished majority whip, I believe, termed them nit-picking on our 
side.
  Yesterday, since we started debate on this bill, we have had 16 
amendments put out, 11 by Republicans; 6 of those were withdrawn; we 
had five votes on Democratic matters here and these were on such things 
as E. coli, killing 500 people a year; cryptosporidium, from which 100 
people died--foodborne diseases kill 3,000 to 7,000 people annually--
votes on Abraham and Nunn on small business matters; Senator Dole put 
forward an E. coli amendment himself; Johnston-Levin combined to deal 
with supermandate problems.
  So I do not see that these are nit-picking, and these are not red 
herrings. These are very substantive amendments, most of them dealing 
with the health and safety of the people of this country.
  What the Senator from California is talking about is something that 
is very important--mammography, the standards for it, and surely having 
that exempted so that they would not have rules delayed for several 
years, or the potential for the new and improved rules, they hope, to 
be delayed for several years, while S. 343, if passed, would force them 
to go back into a reanalysis that could take a lengthy period of time, 
as I indicated, from what happens under just one regulation and all the 
voluminous paperwork which is part of that process.
  I do not see these things as being nit-picking as they were referred 
to last night, nor do I see them as a red herring now.
  So I would like to point out once more before I yield the floor here 
that the second-degree amendment by the distinguished majority leader 
is a sense-of-the Senate and nothing more. It is not binding in law. 
And that is what the Senator from California is talking about. I do not 
disagree. I do not know whether I would vote for this sense-of-the 
Senate or not. I presume that I would. But it still does not have 
standing in law. And so it means nothing except it is filling up the 
tree and trying to delay things further, I guess. Delay on this one 
certainly is not coming from our side of the aisle.
  I yield the floor.
  Mr. JOHNSTON. Mr. President, will the Senator yield for a question?
  Mr. ROTH. Will the Senator yield for a question?
  Mr. GLENN. I suggest the absence of a quorum temporarily.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. JOHNSTON. Mr. President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Is there objection? The Chair hears none, and 
it is so ordered.
  Mr. JOHNSTON. Mr. President, I was going to ask the Senator from Ohio 
and perhaps the Senator from Delaware to tell me about the status of 
the rulemaking under mammography. What I wish to know is if the 
information I have is correct, which is that there is an interim final 
rule which has been published and is in effect on mammography. Is that 
correct? I ask the Senator from Delaware, does he know that, or the 
Senator from Utah?
  Mr. HATCH. Yes, that is correct.
  Mr. JOHNSTON. It is. And it has the effect of an interim final rule?
  Mr. HATCH. That is correct.
  Mr. JOHNSTON. And as I understand it, in October there will be a 
proposed rule to be published by the FDA. Some say it is not on the 
President's schedule; some say it is on the President's schedule. Does 
the Senator from Utah know?
  Mr. HATCH. We have been told that that is the case, that there will 
be a proposal in October. However, it was not listed in the May 5 
Federal Register which outlined the administration's regulatory program 
for the year. But we now have been told by the FDA that it is proposed 
for October.
  Mr. JOHNSTON. There is in fact some doubt as to whether that will 
be----
  Mr. HATCH. I do not think there is much doubt. I think it will 
happen, but I cannot guarantee it.
  Mr. JOHNSTON. But it is a proposed rule to be published in October, 
by some statements?
  Mr. HATCH. That is right.
  Mr. JOHNSTON. There may or may not be doubt about whether they will 
actually go to the proposed rule, but they might as of October go to a 
proposed rule.
  Mr. HATCH. That is right.
  Mr. JOHNSTON. Now, that proposed rule----
  Mr. HATCH. The odds are they will.
  Mr. JOHNSTON. That proposed rule is not an effective rule; it is, in 
effect, a proposal for rulemaking which will require the full 
rulemaking process. Is that not correct?
  Mr. HATCH. That is correct.
  Mr. JOHNSTON. Now, I also understand that their analysis shows that 
it has a $97 million impact, and under the President's Executive order, 
which calls for risk analysis, which has a $100 million cutoff, that 
would not qualify under the President's order as a major rule?
  Mr. HATCH. That is correct.
  Mr. JOHNSTON. They are, however, as I understand it, treating this as 
a major rule. Is that correct?
  Mr. HATCH. We are told that, but we do not know that. That is the 
rumor.
  Mr. JOHNSTON. I understand that they are treating it as a major rule, 
that they are proceeding with a risk assessment and with a cost-benefit 
analysis as though it were a major rule.
  Mr. HATCH. That is our understanding.
  Mr. JOHNSTON. Now, I also understand that under the President's 
Executive order, this risk analysis which they are getting ready to 
perform and the cost-benefit analysis which they are getting ready to 
perform--first of all, has that been done, the risk assessment and 
cost-benefit analysis? Has it been done or is it a plan to do?
  Mr. HATCH. We do not know whether it has been done. Certainly they 
should plan to do it.
  Mr. GLENN. Mr. President, I was going to put in a quorum call because 
the distinguished Senator from California had to unavoidably be absent 
for a few minutes, and she asked I put in a quorum call. I did not know 
whether this was going to go on very long or not. I would like to wait 
until she comes back. She will return within 10 minutes, I understand. 
And I hate for all the discussion going on on her amendment without her 
being in the Chamber. She asked me to put in a quorum call for just a 
few minutes, and I will do that and delay things for just a few 
minutes. So I suggest the absence of a quorum.
  Mr. ROTH. Will the Senator withhold that request? I had a question or 
two I would like to ask him. 

[[Page S 9862]]

  Mr. GLENN. This is all on the same subject, though.
  Mr. ROTH. Regarding the statement the Senator just made, a question 
referring to that.
  Mr. GLENN. It is all on the same subject. I would rather wait until 
she gets back. I let this go a while in spite of her request. It is 
going to go on here for quite a while apparently, so I suggest the 
absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk proceeded to call the roll.
  Mr. ROTH. I ask unanimous consent that the order for the quorum call 
be rescinded
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. ROTH. Mr. President, I would like to raise two or three questions 
with my distinguished colleague, the Senator from Ohio. I would like to 
point out that the legislation of the distinguished Senator from Ohio, 
S. 1001, of course, contains cost-benefit analysis, the same as does 
the bill before us. But in contrast to the legislation that we are 
considering which has an exception to the cost-benefit analysis, I 
wonder if the distinguished Senator from Ohio could tell me where S. 
1001 contains any exception from the cost-benefit analysis where it is 
impracticable because of an emergency or health or safety threat?
  Mr. GLENN. I would reply to my friend from Delaware that I think the 
major difference that protects the health and safety of the people in 
this country is that all the rules that are under S. 1001, all the 
rules in the pipeline stay in effect. We would not knock any of them 
out. We did not send them back and make them go through another long 
and lengthy process during which time the people would not have the 
same protection. And also we have no petition process in S. 1001. These 
things can be bogged down.
  Mr. ROTH. I would point out to the distinguished Senator, what we are 
talking about is a future rule. And if we are not in the immediate 
case, there are going to be other situations where there are going to 
be serious threats to health or safety. My question to you is, where is 
the exception in your legislation where it is impracticable to be 
making a cost-benefit analysis?
  Mr. GLENN. I am not sure in the future it is any different from this 
bill at all, as far as in the future. What we are talking about are all 
these things like E. coli, and cryptosporidium that there could have 
been a challenge made to them in this interim period after the April 1 
cutoff.
  Mr. ROTH. Let me point out that in S. 343, it specifically provides 
that ``A major rule may be adopted, may become effective without prior 
compliance with this subchapter if, A, the agency for good cause finds 
that conducting cost-benefit analysis is impracticable due to an 
emergency or health or safety threat that is likely to result in 
significant harm to the public or natural resources.''
  My question to you is, where is there that kind of exception, that 
kind of waiver in 1001?
  Mr. GLENN. Well, let me tell you about E. coli in particular as it 
applies here. The agency has told us the rule that includes E. coli 
protection is a general one and cannot legitimately be considered an 
emergency rule. Accordingly, the emergency provisions of S. 343 do not 
apply to the regulation in the pipeline concerning E. coli. And the 
Dole amendment on E. coli does not prevent the USDA proposed regulation 
on meat and poultry inspections from being sent back to square one 
again for cost-benefit analysis and risk assessment.
  Mr. ROTH. Again, as far as E. coli is concerned, that specifically is 
covered in our legislation. But again I would like to know the line and 
page in S. 1001 where there is an exception to the cost-benefit 
analysis along the same lines contained in S. 343.
  Mr. GLENN. I cannot give the line and the page right now. But I will 
look it up here. We will try to get an answer very shortly.
  Mr. HATCH. Will the Senator yield?
  Mr. ROTH. Yes.
  Mr. HATCH. The fact of the matter is that if there is no emergency, 
then why not do a cost-benefit analysis?
  If there is an emergency, there is nothing in Senator Glenn's bill 
that takes care of it.
  But there is in our bill which is now under consideration on the 
floor. Under section 622(f) and section 632(c)(1)(A), cost-benefit 
analysis and risk assessments are not required if ``impracticable due 
to an emergency or health or safety threat that is likely to result in 
significant harm to the public or natural resources.''
  There are no exemptions in the Glenn bill at all for cost-benefit 
analysis where there is an emergency.
  I did not mean to interrupt you, but I wanted to point that out.
  Mr. ROTH. I think it is important to understand that, in a case of 
health or safety threat. It does not have to be an emergency. The 
legislation provides that an exception can be made in the case of an 
emergency or health or safety. So there are three different exceptions. 
So there does not----
  Mr. GLENN. I would point out----
  Mr. ROTH. Or a threat.
  Mr. GLENN. I would point out to my friend from Delaware the exception 
for that would only be for 180 days. Then it has to go through all the 
reanalysis and may be held up for years.
  Mr. ROTH. That is totally inaccurate. There is nothing in the 
legislation that says the rule terminates.
  Mr. GLENN. But it is judicially challengeable. And there is nothing 
in there that says it is not challengeable.
  Mr. HATCH. We just accepted an amendment this morning to make 1 year.
  Mr. GLENN. One year. I am corrected on that. The original language 
was 180 days in the legislation. And the Senator from Louisiana changed 
that to 1 year. And that is correct. That has been changed.
  Mr. ROTH. I reemphasize a point I made earlier that it can only be 
challenged in court to have the analysis made. It does not result in 
the rule itself being terminated. As a matter of fact, this section 
starts out that a major rule ``may be adopted and may become effective 
without prior compliance with the subchapter.''
  But a second question I would like to ask the distinguished Senator 
from Ohio is, he spoke about E. coli and of food poisoning and a number 
of others. And yet I do not find any of those matters to be listed in 
the Democratic list of concerns with S. 343. There were presumably 9 
major problems with the legislation plus another 17 minor problems. But 
I do not recall seeing any of these issues being included as part of 
the problems with the 777 version of the Dole-Johnston substitute.
  I have in my hand the document given to us by the Democrats as areas 
of concern with the legislation before us. At 9:30 this morning, we 
were supposed to have a discussion of these provisions or concerns. 
That was not held. But nowhere--but nowhere--do I see the issues raised 
in this paper that the distinguished Senator raised this afternoon.
  Mr. GLENN. Obviously, we missed one. We have one more to add. Put it 
on. Fine.
  Mrs. BOXER addressed the Chair.
  Mr. GLENN. I am serious about that. One comment and then I will 
yield.
  Mr. ROTH. I yield to----
  Mr. HATCH. May I ask one question?
  Mr. ROTH. May I ask who has the floor?
  The PRESIDING OFFICER. The Senator from Delaware.
  Mr. HATCH. If I may ask one question of my colleague?
  Mr. ROTH. I am happy to yield for a question without losing my right 
to the floor.
  Mr. HATCH. If I may ask one question, whether it is 1 year, 180 days 
or 1 minute, is it not true that the rule will not terminate?
  Mr. ROTH. Absolutely. That is exactly the point I have been making.
  Mr. HATCH. The rule continues to remain in effect.
  Mr. ROTH. Absolutely. There is nothing in the legislation that 
terminates the rule.
  Mr. HATCH. That is true on the rule on mammography, is it not?
  Mr. ROTH. Absolutely.
  Mr. HATCH. So, what are we arguing about?
  One reason we filed this perfecting amendment is because there is no 
need for this amendment from the distinguished Senator from California, 
because the bill addresses the issue. There is an interim rule. The 
fact they do not have a final rule is the fault of the administration 
and the FDA.
  I will say that the amendment of the Senator from California will 
bring 

[[Page S 9863]]
about a beneficial but unintended effect, because I am quite certain 
the FDA is going to work hard to get their rule done by October. So 
that will be a good effect of this amendment, in my opinion, but I 
still believe there is no reason to keep making these special 
exemptions for anything. Is that not true?
  Mr. ROTH. That is absolutely correct.
  Mr. GLENN. No, that is not----
  Mr. ROTH. Let me----
  Mr. JOHNSTON. Mr. President, will the Senator yield for a question or 
series of questions, or does he want to finish his statement?
  Mr. ROTH. I would rather continue just for the moment. I will be 
happy to yield in just a few minutes. I think it is extremely important 
to understand that in the Dole-Johnston legislation, on page 25, we 
have a specific exception to cover the case of emergency health and 
safety from the general rule of requiring a cost-benefit analysis.
  Again, I find no such exception in S. 1001. As a matter of fact, I 
look on page 5 of S. 1001 and it says that:

       The term ``rule'' shall not include--
       (A) a rule of particular applicability that approves or 
     prescribes for the future rates, wages, prices--

  So forth and so forth.

       (B) a rule relating to monetary policy proposed or 
     promulgated by the Board of Governors of the Federal Reserve 
     System or by the Federal Open Market Committee;
       (C) a rule relating to the safety or soundness of a 
     federally insured depository.

  It goes on with various housing, foreign banks, so forth.

       (D) a rule issued by the Federal Election Commission or a 
     rule issued by the Federal Communications Commission pursuant 
     to section 203 of the Communications Act of 1934.

  Those are the exceptions to the rule, in contrast to our legislation 
where we specifically provide a generic waiver.
  Nor do I find anywhere, and I again ask the distinguished Senator 
from Ohio, where there is any kind of exception in the case of E. coli 
or breast cancer in the legislation proposed by him.
  Mr. GLENN. I reply to my friend from Delaware, in our legislation, S. 
1001, rules in the pipeline are permitted to go ahead and be in effect, 
where under S. 343, they would have to go back and would have 1 year to 
comply. If they did not comply, then I do not see anything in here at 
all that says it could not be judicially challenged, which it could.
  Mr. ROTH. What about next year under your legislation?
  Mr. GLENN. You cannot guarantee getting these things through. Ours 
leaves things in the pipeline, and we have no petition process. The 
rules in the pipeline would stay in effect. That is what we are talking 
about.
  Mr. ROTH. The question I am raising, if you have a situation arise 
where it is an emergency, a safety threat or a health threat in the 
future and it is impractical to make a cost-benefit analysis, where is 
the exception in your legislation?
  Mr. GLENN. In the future--if we are talking about in the future, I 
think both pieces of legislation are pretty much identical to what 
happens in the future. We are talking about the interim period.
  Mr. ROTH. That is the point I am making. Our legislation, S. 343, on 
page 25 has a specific exception to cover these situations. There is no 
such exception, no such waiver in S. 1001. If I am wrong, I ask for the 
page and line number.
  Mr. GLENN. I think the difference on this, I reply to my friend, is 
that you have so many more decisional criteria that have to be complied 
with in this and all complied with within a year, which is not likely, 
in most cases, to be completed within a year.
  Mr. ROTH. But I think the complaint, I will say, is the time that 
would take in making the cost-benefit analysis.
  Let me ask you this. Does your legislation exempt E. coli? Does it 
have any exemption covering E. coli?
  Mr. GLENN. It would not have to because in the pipeline that is 
covered, and we have no cutoff threshold that would knock it out of the 
pipeline, we let things in the pipeline stay in there. So E. coli--
incidentally, while we are on the subject of E. coli, here is out of 
Tennessee right now, July 4, five cases of E. coli being treated. One 
woman, I think one child has already died, I believe it is. These are 
the press reports I was just handed a few moments ago, multiple 
newspaper reports about an E. coli outbreak in Tennessee right now. So 
these were not theoretical things we were talking about on the floor 
yesterday.
  Mr. ROTH. The point I would like to make is, yes, there are going to 
be serious health, safety and other problems. But the important 
difference between the legislation before this committee and the 
amendment being proposed by the distinguished Senator from Ohio is that 
there is a waiver that anticipates what might happen in the future. 
That is a critically important difference.
  Today it may be E. coli, tomorrow it may be heart disease, a third 
day it may be something else. But under our legislation, we have 
anticipated that situation by having a generic exception that covers 
those situations. That is the reason it is not necessary to spell out 
each of these exceptions as being proposed, except for public relations 
reasons.
  Mr. GLENN. Let me ask this, then. Does the Senator from Delaware 
believe that rules in the pipeline now that deal with health and safety 
should be permitted to remain in effect without having to go through a 
whole new series of hoops?
  Mr. ROTH. Well, we voted yesterday April 1 to make those effective 
under the Johnston amendment.
  Mr. GLENN. I am talking about things in the pipeline that are not to 
be completed until after April 1. That is the whole area of contention 
right now--E. coli, cryptosporidium, and all the rest.
  Mr. ROTH. Here the exception applies. That is the purpose of this 
exception. It applies to those that are in the pipeline.
  Mrs. BOXER. I have a parliamentary inquiry.
  Mr. ROTH. It applies in the future.
  Mrs. BOXER. Parliamentary inquiry.
  The PRESIDING OFFICER. The Senator from Delaware has the floor.
  Mrs. BOXER. I have a parliamentary inquiry.
  The PRESIDING OFFICER. Does the Senator from Delaware yield?
  Mr. ROTH. No, the Senator does not yield.
  The PRESIDING OFFICER. The Senator has the floor.
  Mr. ROTH. Mr. President, I think it is critically important to 
understand that the argument made by the proponents of the pending 
amendment is that a future anticipated regulation on mammograms would 
be delayed by compliance with S. 343, and that during such delays, 
lives would be lost.
  In order to address such issues, the majority leader last Tuesday 
offered an amendment, which was adopted by the Senate, that provides 
that in exactly those circumstances described by proponents, the 
relevant agency may issue the rule first and allow it to take effect 
and, thereafter, finish compliance with S. 343.
  Through the Johnston amendment, adopted today, the agency would have 
1 year to finish its compliance. The language of that amendment says 
that a rule, such as the mammogram rule, ``may become effective without 
prior compliance''--Let me read that again: ``may become effective 
without prior compliance if the agency, for good cause, finds that 
conducting cost-benefit analysis is impractical due to a health threat 
that is likely to result in significant harm to the public.''
  Mr. GLENN. Will the Senator yield for a question?
  Mr. ROTH. Yes, I will be happy to yield for a question.
  Mr. GLENN. But in that case, the rule would still have to go back and 
go through the new requirements of S. 343 on being reanalyzed, and a 
new rule as an improvement would not be able to go into effect until 
that had been completed, which may be several years later.
  Mr. ROTH. No, no, that is not correct. Again, I will reread what I 
read twice. It says, ``may become effective without prior compliance * 
* *'' That is critically important.
  What we are trying to anticipate in the language on page 25 of S. 343 
is making certain that where a situation arises because of cancer, 
because of heart disease, or whatever it may be, the rule can become 
effective without making the cost-benefit analysis if the agency finds 
that conducting such analysis is impractical due to a health 

[[Page S 9864]]
threat. Our language is generic. It anticipates that there may be many 
different situations. That is the reason we do not want to get into 
spelling out exception by exception.
  Mr. GLENN. Might I ask a question?
  Mr. ROTH. Yes.
  Mr. GLENN. I ask this question with specific reference to the 
mammography proposal. Would it be the opinion of the Senator from 
Delaware that the mammography proposal and the proposal that will be 
made in October, and on which a lot of work has already been done, 
those should be permitted to go through and be in full effect without 
having to go back and comply with a lot of new rules and regulations, 
as required in S. 343? In other words, it could go into effect and stay 
in effect.
  Mr. ROTH. The agency has that authority under our legislation, that 
is correct.
  Mr. GLENN. Without any challenge, without having to go back and go 
through the requirements of S. 343, is that correct?
  Mr. ROTH. Basically, that is correct. They are expected to go ahead 
and make a cost-benefit analysis the year following. They are required 
to make it. But that, again, in no way terminates the rule. The rule 
continues so people are protected. That is what the whole point of the 
exception is.
  Mr. GLENN. A point I made a while ago on what is involved in a 
regulation is that the likelihood of this being completed in a year is 
probably not very good. It is probably pretty remote. Most rules take 
several years to finalize. What happens at the end of that 1-year 
period? It would be judicially challengeable and could be knocked out. 
That is the uncertainty we do not want to leave people with. That is 
the construction of the argument right there.
  Mr. ROTH. An individual can go into court and ask that the analysis 
be made. But that will, in no way, terminate the rule.
  So the important fact is that we are protecting the American people, 
the American public. And where there is a health problem, an imminent 
threat, or whatever, an exception to the rule is allowed. So what we 
have done in S. 343, in contrast to S. 1001, has anticipated this need.
  So, again, the distinguished Senator from Ohio made many complaints 
that, as I said, seem curious to me. He complains that the emergency is 
exempted and S. 343 is insufficient. Yet, his bill, S. 1001, has no 
exemption at all. The question is, why? Is it not needed? Again, he 
complains that S. 343 has no individual listing on the E. coli or 
mammography rule. Yet, his bill, S. 1001, has no exemption at all. Why? 
It is not needed.
  Mr. GLENN. Are you asking me a question?
  Mr. ROTH. No.
  Mr. GLENN. Everything that is in the pipeline stays there. It does 
not have to go back for reanalysis. That is the reason.
  Mrs. MURRAY. Will the Senator from Delaware yield for a question, Mr. 
President?
  Mr. ROTH. My question is--
  Mrs. MURRAY. Mr. President, will the Senator from Delaware yield for 
a question?
  Mr. ROTH. In just a moment. Again, I want to point out that, in the 
future, a situation can arise under S. 1001 where there is a threat to 
health or safety, or an emergency and, yet, there is no exception, no 
waiver permitted under S. 1001. The important point, of course, is that 
this situation has been addressed in S. 343.
  Mr. HATCH. Will the Senator yield for another question?
  Mr. ROTH. I am happy to yield.
  Mr. HATCH. Excuse me. We want to make sure this is understood. Is it 
true that this interim rule was issued in December of 1993 on 
mammography?
  Mr. ROTH. Yes, that is true.
  Mr. HATCH. Is it not also true that it was in the pipeline before 
April 1 of this year?
  Mr. ROTH. Yes.
  Mr. HATCH. Which is the date in this bill, and we protect rules in 
the pipeline, also, do we not?
  Mr. ROTH. That is true.
  Mr. HATCH. I think what the Senator is trying to explain here is that 
the Glenn bill has no protection, no exception at all for E. coli, 
mammography, or any of these other items. And we do. We provide that if 
there is even a threat, they do not have to do cost-benefit analysis or 
risk assessment.
  Mr. ROTH. That is correct.
  Mr. HATCH. If there is a threat, we do not have to do cost-benefit 
analysis or risk assessment.
  Mr. ROTH. That is correct.
  Mr. GLENN. No, it is not.
  Mr. HATCH. Yes, it is.
  Mr. GLENN. What the Senator says is not correct, no matter what you 
say. Our bill has the Administrative Procedure Act to go along with----
  The PRESIDING OFFICER. The Senator from Delaware has the floor.
  Mr. GLENN. Will the Senator yield for my statement?
  Mr. ROTH. Without losing my right to the floor.
  Mr. GLENN. The Administrative Procedure Act says that when the 
agency, for good cause, finds and incorporates the finding and a brief 
statement of reasons therefore----
  The PRESIDING OFFICER. The Senator can only yield for a question. 
Does the Senator from Delaware yield for that purpose?
  Mr. GLENN. Well, I will ask a question. Would the Senator agree with 
the Administrative Procedure Act, that it covers our bill, in that when 
it says, ``When the agency for good cause finds and incorporates the 
finding and a brief statement of reasons there in the rules issued, 
that notice and public procedure thereon are impracticable and 
unnecessary and contrary to the public interest,'' it would also mean 
that the agency could control what is an emergency and not? In your 
bill, it goes back for a year's reanalysis. It is required.
  Mr. ROTH. I point out that the Senator is making my argument. That 
legislation applies, obviously, to S. 343. So what you are, in effect, 
saying is that none of these exceptions that have been discussed in the 
last 3 days are necessary because they are already covered by the 
Administrative Procedure Act.
  Mr. GLENN. Well----
  Mr. ROTH. That is the main point I have been trying to make, that 
these specific exceptions are not necessary. If you want to put it on 
the basis of the basic rule, fine. But I will also point out that, in 
our specific legislation, we have waivers both with respect to cost-
benefit and with respect to risk assessment. So that is the reason we 
do not think any of these special cases are necessary.
  Mr. GLENN. Would the Senator agree, then, that we should change S. 
343 to just say that rules in the pipeline stay in effect?
  Mr. ROTH. Mr. President, I would not.
  Mr. GLENN. That means they have to go back through a whole new 
procedure that will delay them for years and years.
  Mr. ROTH. The Administrative Procedure Act exception, as I said, 
applies to S. 343 equally. But we do have a better exception. The APA 
exception only applies to notice and comment for the rule. The 
exception in S. 343 applies to cost-benefit analysis, and that is what 
is critically important.
  The PRESIDING OFFICER. The Senator from California is recognized.
  Mrs. BOXER. Thank you, Mr. President. I ask unanimous consent to have 
printed in the Record a clip regarding E. coli that has been occurring 
in Tennessee in the last few days.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                [From the News Sentinel, June 30, 1995]

                 Bacteria Studied in Illness of Boy, 11

                            (By Ken Garland)

       Maryville.--State health officials hope to know by this 
     afternoon if an 11-year-old Maryville boy--hospitalized since 
     Sunday--is suffering from a severe form of sometimes-fatal E. 
     coli bacteria.
       Logan Duckett, son of John and Debbie Duckett, was in fair 
     condition Thursday and is expected to suffer no lasting 
     effects from the illness, said Dr. Charles Raper, his doctor.
       The boy was hospitalized after suffering since June 22 with 
     diarrhea, Raper said. Preliminary test results by the 
     hospital laboratory indicated he might be suffering from 
     0157:H7, the name for the severe form of E. coli.
       The state health department is conducting laboratory tests. 
     ``We're waiting on confirmation,'' said Dr. Paul Irwin, East 
     Tennessee director of the Tennessee Department of Public 
     Health. ``We know it's E. coli; we just don't know if it is 
     0157:H7.''
       E. coli is a bacteria found in meat that has been tainted, 
     usually with feces, Raper said. Proper cooking of the meat 
     will kill the bacteria, officials said.

 
[[Page S 9865]]

  Mrs. BOXER. Mr. President, I am very pleased to get the floor more 
than an hour after I introduced a very important amendment. There is a 
lot of talk about the bill in general. I guess it is time to give a 
little bit of a wake-up call to some of my colleagues.
  This second-degree amendment which would act as a substitute for the 
Boxer-Murray-Mikulski amendment is the most cynical parliamentary 
attempt to gut an amendment that I have ever seen.
  I have only been here a few years. I have seen a lot of second 
degrees from both sides. Usually when you second-degree an amendment, 
it has something to do with the underlying amendment. The underlying 
amendment that I have put forward would say that the rules regarding 
mammography shall move forward and they will not be encumbered by this 
bill.
  We have heard three learned Senators squabbling over there for 60 
minutes. No one understands anybody else. Ask what is on page 9, page 
4, line 1--if these three cannot agree, and they are friends--imagine 
the field day the lawyers will have.
  Should we move this mammography rule forward? Is it stuck? Is it 
stopped? I want to say I do not want to play Russian roulette with the 
women of this country.
  When I laid down my amendment, it was very clear. I am really glad we 
can talk about it. It basically said it was very important to keep this 
rule moving. It is interesting that my friend from Utah complains it 
has taken so long.
  On the one hand, he says there is too much regulation and the 
bureaucrats cannot wait to regulate; on the other hand, he complains 
that this regulation is taking too long. We cannot have it both ways. 
Better they are careful with this rule.
  I will go into what this rule does. It is complicated. The fact is, 
we should not derail it now; 46,000 women every year die of breast 
cancer, and many of them, tragically, die because the mammogram they 
took was inaccurate or the technician was not highly trained, or the 
equipment was not good, it was slipshod.
  Then I am told that I am offering a special-interest amendment. I 
take great offense. What is the special interest? The women of America? 
Give me a break. The women of America want this amendment.
  I have a letter on all Members' desks, supporting this amendment, 
from the National Breast Cancer Coalition. Is that a special interest? 
If women who have had breast cancer, who have had loved ones have 
breast cancer, survivors, if that is a special interest, I do not know 
what is going on around here.
  I will name the special interests--the people who do not want to be 
regulated, who do not want to upgrade their mammography equipment, who 
want to get away with hiring people to work for them who are not as 
well trained and maybe come at a cheaper price. We should talk the 
truth around here for a change.
  Mrs. MURRAY. Mr. President, will the Senator yield?
  Mrs. BOXER. I am happy to yield to the Senator.
  Mrs. MURRAY. Mr. President, I ask my colleague from California, her 
amendment specifically exempts the Mammography Quality Standards Act 
regulation from the underlying bill, is that correct?
  Mrs. BOXER. That is correct.
  Mrs. MURRAY. The second-degree amendment placed on the desk by 
Senator Dole is simply a sense of the Senate, is that correct?
  Mrs. BOXER. That is correct. It is a sense of the Senate that does 
not even deal with this subject matter. It just says that nothing in 
this bill will harm anybody.
  Mrs. MURRAY. If the Senator from California will let me ask another 
question, certainly she sat with me throughout the budget debate and 
listened to our colleagues say sense-of-the-Senate resolutions are not 
binding, and I assume she feels as I do, and I will ask the Senator, 
will the Senator be able to go back to her friends diagnosed with 
breast cancer or to women in her State and say, ``Don't worry, we have 
taken care of you with a sense of the Senate that is not binding?''
  Mrs. BOXER. I say that any Senator who went to someone who was 
worried about breast cancer and said the sense of the Senate was going 
to do one thing to move forward the rule on mammography would simply 
not be telling the truth.
  Of course, the Senator is correct. We cannot tell anybody who cared 
about this issue that the Dole substitute does a thing to help move the 
mammography rule along.
  Mrs. MURRAY. I thank my colleague.
  Mrs. BOXER. Thank you.
  I had the feeling that my Republican colleagues would offer a second-
degree amendment like this because they have done it before on other 
amendments.
  They did not tell me they were going to do this, but they wanted a 
time agreement, and I said absolutely. I would give 15 minutes on my 
side, 15 on their side if there were no second-degree amendments. They 
said, ``Gee, we have not seen your amendment, Senator, how can I do 
that?''
  I gave my amendment, and miraculously in 30 seconds the majority 
leader appeared with this sense-of-the-Senate substitute. That was fast 
work. But it will not work. It will not work. I am telling my friends 
that 46,000 women die of breast cancer every year, so I will stand on 
my feet for 46,000 minutes or 46,000 hours or whatever it takes, and I 
know my friend from Washington is in complete agreement so there are 
two of us, at least.
  And by the way, there are a lot more on this amendment and I will 
mention who they are.
  Mr. KENNEDY. Mr. President, will the Senator yield?
  Mrs. BOXER. I am happy to yield to the Senator.
  Mr. KENNEDY. The Senator has in a very important way changed this 
debate from just the questions of regulations of rules into real terms.
  What we are talking about as the Senator from California and the 
Senator from Washington, we are talking about mothers, we are talking 
about sisters, women in our society for whom the incidence for cancer 
has grown significantly over the period of recent years with regard to 
breast cancer.
  Does the Senator realize that when the Senate, in the last Congress 
went on record, it was a unanimous vote, unanimous out of our committee 
to develop these regulations, unanimous in the U.S. Senate to move 
ahead, unanimous in the House of Representatives in their committee, 
and unanimous on the floor to develop the regulations? The need is out 
there.
  Can the Senator possibly explain to any Member why, when it was the 
result of careful consideration both in terms of the committees and the 
debate here, the recommendations that were made by the testimony that 
was given overwhelmingly favorable with a sense of urgency in asking 
not to delay and to move ahead, and now we have the final regulations 
just being brought up, that we are asked to follow through some other 
procedure, some other procedure, some other words, which we find out 
the meaning of which is still very much left in doubt?
  I do not know whether the Senator from California was here when we 
debated the Civil Rights Act, when we spent months here trying to 
debate the difference between significant and manifest.
  Here we have a change in the food standards into insignificant risk 
without definition. We will come back to that later during the course 
of the debate on food standards and food safety.
  Can the Senator explain to the American people why, if there was such 
a sense of urgency that Republicans and Democrats, all Americans, are 
getting behind and say get about the business of doing it? Does it make 
any sense to the Senator?
  Mrs. BOXER. I say to my friend, who is such a leader in all health 
issues, including this breast cancer issue--it makes no sense to me. 
And that is why I committed myself, and I know my colleagues have as 
well, and I am so appreciative the Senator was able to get to the floor 
at this time, to focus on this issue.
  Mr. KENNEDY. Just finally, is the Senator concerned, as I would be, 
that there may be manufacturers who are out there, who are producing 
equipment today, that do not meet the standards, and that would be put 
in a position to question the standards in the future because their 
equipment does not meet those standards, and they would be able to 
delay the implementation of those standards? Or there may be groups out 
there that are going 

[[Page S 9866]]

to question and challenge it because they do not have the training and 
they do not want to comply with the various things. We have heard that, 
as a reality. We have heard of manufacturers. We have heard of 
corporate interests that want to resist these kinds of standards.
  But what we are faced with is why should we side with those interests 
when we have something which is of such importance to women, not just 
to women in our society, to mothers in our society, to sisters, to 
wives, to members of our families--that is so important.
  Why should we desist and give in to these special interests, which 
are the special interests which are the manufacturers that will be able 
to tie this up, even under the existing standard, with the look-back 
provisions, and all the other kinds of mechanisms which have been 
reviewed? I would like to stay away from those. We can get into those 
in debate, because there are those here in the Senate who would like to 
just tie us up and talk about procedure when the Senator is talking 
about the impact on real people. Why should we side with those 
companies or manufacturers who will delay this rather than with the 
sound health policy that would implement it?
  Mrs. BOXER. Let me say to my friend, he is so right, because he 
worked so hard on getting the bill through and getting the law passed 
in 1992. Now the rule is coming to fruition in October. We are going to 
have the rule.
  If the Senator would have been here, I say to my friend from 
Massachusetts, three friends from the opposite side of the aisle could 
not even agree on how this new legislation is going to work. What we 
are saying is, do not put at risk the women of America for this battle 
over words. The Senator is so right. We get down to this battle over 
words and lines on pieces of paper. I am just so pleased the Senator 
from Massachusetts came here because, after all, why do we have rules? 
Because we pass legislation.
  And the Senator reminds me--which I frankly did not remember--that 
Republicans and Democrats voted unanimously for the legislation that is 
leading to this rule that is coming forward in October. Why on Earth we 
are going to get into a delaying tactic here, I do not know.
  I say further to my friend, I am worried even about this debate, that 
people listening to this debate, business people, may think we are 
losing our will to move forward with safer standards. It is not just 
the Senator from California, or Massachusetts, or Washington, who are 
fearful of this. We have the agencies telling us very clearly that if 
this bill passes without amendment, this rule will be derailed. If we 
are going to make a mistake--and our colleagues assure us they are 
wrong--I do not want to make a mistake in this subject area. Frankly, 
there are other areas I would not get so upset.
  What I find very interesting is the Senator from Utah said we cannot 
take this anymore. It will be 3 months. It will be exemption after 
exemption after exemption from this bill.
  The bill has a ton of exemptions for business. But when the Democrats 
offer exemptions for E. coli--which we just heard there is another 
problem in Tennessee in the last few days on that; and we offer an 
amendment on cryptosporidium, and today on mammography--oh, we are 
trying to slow it down. We are standing here for the special interests.
  God, I hope the American people are watching this.
  The majority leader's sense of the Senate has no force of law. We 
have already stated that. It has nothing to do with the underlying bill 
on mammography. It is a general statement which we all can agree with. 
In nothing that we ever do, do we intend to hurt the fight against 
disease. But yet, the underlying Boxer amendment, which we are going to 
get a vote on--because, unlike my Republican friends, I am going to 
clearly state what I intend to do, so I hope they are listening. I 
intend to get a vote on the underlying amendment, period. You can 
second-degree me all night and all day tomorrow and the day after and 
the day after and the day after and the day after--we will have a vote 
on the underlying amendment.
  So I hope sooner rather than later we can come to that agreement. We 
did come to that agreement on the E. coli amendment, where the Senator 
from Louisiana had his second-degree voted on separately and then the 
underlying amendment came after. Sad to say, we got 49 votes.
  Everything you could think of is in the second-degree amendment, in 
the substitute, except that you should not beat your wife. That was not 
in there. But nothing specifically to do with exempting the mammography 
rule.
  Let me tell my colleagues what they are stopping here, if we do not 
get to the underlying Boxer amendment: Specifying performance standards 
for x-ray equipment. I would say that is rather important, because if 
you get a mammogram and the x-ray equipment does not meet the standard, 
or a high enough standard, they can miss the cancer.
  I had a friend who had her mammogram; they told her it was fine, but 
thank God she found the lump herself and we hope she will make it. They 
missed it. How am I going to tell her that, oh, I just decided for 
convenience I would not press my amendment and we are going to vote for 
some sense of the Senate? I cannot.
  (Mr. GREGG assumed the chair.)
  Mr. KENNEDY. Will the Senator yield on that point?
  Mrs. BOXER. Yes, I will.
  Mr. KENNEDY. I do not know if the Senator is familiar with the 1992 
study by the Physician Insurers Association of America that found that 
35 percent of all claimants with breast cancer had a negative mammogram 
and 14 percent had equivocal mammogram results.
  This is prior to the time when we took action to pass this 
legislation, the rules of which are about to go into effect to protect 
American women.
  Mrs. BOXER. So is my friend saying that half of the mammograms may 
not have been fully accurate?
  Mr. KENNEDY. Mr. President, 35 percent false negative; 14 percent 
were equivocal--in the 1992 study, which is the most comprehensive 
study. As compared to the mammography, the most recent studies now, 
according to the GAO report, find that high-quality mammography can 
find 85 to 90 percent of breast tumors in women over 50, and discover a 
tumor up to 2 years before a lump can be felt.
  That is in 85 to 90 percent, with the high-quality mammography, with 
well-trained people, versus the recent study, the 1992 study, that 
showed 35 percent false negatives with another 14 percent that were 
equivocal. This is what we are talking about: Real life and death.
  I think that the Senator would agree with me that we are not saying 
that these mammogram standards will solve all of the problems and that 
all breast cancer is going to be resolved. We are not going to be able 
say that all of the people who should have those tests and who should 
receive them will receive them. But it is a beginning.
  Final point this: We heard so much that one of the first orders of 
business by our colleagues on the other side of the aisle was medical 
malpractice reform. You can do more about medical malpractice reform by 
implementing these mammogram standards because you are going to get 
accuracy and you are going to save lives and not have the resulting 
kinds of challenges that come out.
  So I think the point that the Senator was talking about, a friend 
that experienced these tragic or unfortunate kinds of results, is 
illustrated by all of the testimony that we had, which, as the Senator 
from Washington and the Senator from California and others have pointed 
out, is the reason we got the unanimous results.
  So it is important, I think, to understand what is before the U.S. 
Senate; that is, whether we are going to go forward with a procedure--
could we have order, Mr. President?
  The PRESIDING OFFICER. Would the Senators please take their 
conversations to the Cloakroom?
  The Senator from Massachusetts?
  Mr. KENNEDY. I thank the Chair.
  The Senator from California has the floor, but I think the Senator 
from California and the Senator from Washington will agree that we are 
talking about a process and a procedure that will be able to really 
have an impact and save real people's lives. We know that will be the 
result based on the information that we have, and that under 

[[Page S 9867]]
this legislation we are putting them at risk.
  There will be those though say, ``Well, we have a new kind of way, a 
new process and procedure. We do not know how it will be interpreted. 
But why don't you take your chance and roll the dice?'' Would the 
Senator be willing to do that with her daughter? I certainly am not 
prepared to do it with mine. And I do not think any American family 
would be prepared to do it with their wife, daughter, or their mother. 
Why should we ask the American people to go ahead and take that chance 
and not address that issue during the course of this debate?
  Mrs. BOXER. I want to say to my friend from Massachusetts--and I 
thank him for bringing those statistics to our attention--that 35 
percent of the women are told they are OK, there is nothing wrong, when 
in fact there was a lump present. The Senator is so right to come to 
this Chamber to talk about his daughter and to talk about my daughter. 
One of the things I said is that the first time a Senator's wife has a 
problem, they will be on this floor saying, ``Oh, let us pass the Boxer 
amendment.'' You know it hits home.
  Mrs. MURRAY. Will the Senator from California yield on that question?
  Mrs. BOXER. Yes.
  Mrs. MURRAY. I want to make sure I understand the process here 
because I am very concerned about the 46,000 women every year who die 
because of breast cancer. Friends of mine, friends of yours, and 
relatives want to make sure that we have in place the best possible 
assurance that when those women have a mammogram it will be safe and it 
will be accurate.
  If the current bill passes as written, there is a real concern that 
the rules and regulations that are going to go into effect can be 
challenged, that they will not be put into place.
  Is that correct?
  Mrs. BOXER. The Senator is absolutely correct. As we said, and we saw 
on this floor arguments over interpretation, this bill is a lawyer's 
dream. I am not willing to put the women of America at risk so that a 
bunch of lawyers can go to court and squabble like we just saw happen 
on the floor of the U.S. Senate.
  The Senator is right.
  Mrs. MURRAY. So the underlying amendment will assure those 
regulations will go into place after October and women can have a 
mammogram and know that there is a degree of assurance of accuracy in 
it that does not exist today.
  Is that correct?
  Mrs. BOXER. That is true. The rule is going to specify performance 
standards for X ray equipment; it is going to expand and standardize 
requirements for recordkeeping on medical records and reports.
  By the way, many times women are not notified in a timely fashion of 
the results of their mammogram. It sounds strange. But it is true. That 
is one of the areas this rule will cover.
  Lastly, there will be expanded quality assurance to allow flexibility 
for review based on achievement of objectives.
  The fact of the matter is that there will be more specific personnel 
requirements of the people who take these mammograms to ensure that 
they know what they are doing and do not miss a lump. They will specify 
procedures and techniques for mammograms of women with breast implants.
  As I know the Senators know, we have worked on this issue. It is a 
big problem when a woman has a breast implant to figure out what is 
behind that implant. And it could be breast cancer that is undetected.
  All of this will be in the rule. My friends on the other side of the 
aisle think so little of this amendment and this rule that they are 
willing to second degree it with a litany of wonderful promises that 
have absolutely no force and effect and impact of law.
  Mrs. MURRAY. On that point, would the Senator from California agree 
that if the sense of the Senate passes, there is no way to go home and 
assure our mothers and sisters and our daughters that they are going to 
have safe, accurate mammograms?
  Mrs. BOXER. I would say to my friend that not only is there no way to 
assure them, but I would warn them that a bill that had unanimous 
support has essentially been derailed, and a rule that was about to be 
promulgated was taken off track.
  So I think the Senator is exactly right in bringing this home to a 
person-to-person discussion.
  I am happy to yield.
  Mr. KENNEDY. Let us come back just for a moment and look at where we 
are. We have accepted now the Nunn amendment, which provides certain 
provisions or procedures that are going to affect the small business. 
Now, we have the response of one of the floor managers which said that 
since this does not reach the capacity, that you might not even be 
affected. Under the Nunn provision, this would be affected.
  Under the criteria for the examination, one of the matters that they 
have to look at prior to the implementation is voluntary compliance. 
That is one of the provisions. We have the voluntary compliance. We 
have geographical distribution, and other requirements for other 
provisions which I know others would love to be debating all afternoon 
about. But there are the voluntary requirements.
  There will be those who will say, ``Why should we go ahead? Let us 
see what we can do from a voluntary point of view.''
  Let us look at what happened when we had the voluntary compliance. 
Prior to the passage of the law, the American College of Radiology had 
a voluntary quality assurance program, and 38 percent of the clinics 
failed. Here they tried to do it voluntarily.
  People asked why we need regulations. What we are saying is that 
those mothers who went in and got tested, and with inadequate 
manufacturing, inadequate procedures, and poorly trained people, 
thought they were free, and then come down with breast cancer when it 
could have been avoided, or at least their recovery could have been 
assured.
  They say, ``Well, you have that heavy hand of Government regulation 
over there.'' I certainly would want that heavy hand if it is going to 
protect any member of my family. And I think most Americans would, 
because individuals cannot make air clean, they cannot make water 
clean, and they cannot solve all of their problems in terms of 
pesticides and other factors.
  Let us see, voluntary--what happened in this particular issue 
affecting so many of the women in our country? We had a voluntary 
quality assurance program, and 38 percent of the clinics failed and a 
third did not even participate in the program. They said, We are not 
even going to participate. We do not know what happened because a third 
refused to participate in a voluntary program. That is an alternative.
  We could go back into those kinds of procedures when we are about to 
see the implementation of something that is going to give assurance to 
the American public that we are going to have quality in terms of 
manufacturing, well trained, with a good kind of enforcement, 
hopefully, and assurance.
  I just am amazed that--I am not really amazed because we go through 
this on many different issues. But this is really one of just such 
enormous importance and consequence to the families in this country 
when they say, ``Well, let us just try and not have regulations. Let us 
just have a voluntary process.''
  Mrs. BOXER. If I may on my time ask my friend a question, that is, or 
my friend from Washington, how many times have you been in a community 
meeting in your home State of Massachusetts or your home State of 
Washington where a constituent has come over and looked you in the eye 
and grabbed you by the sleeve, and said, ``Please, Senator. Please, 
Senator, don't regulate mammograms. Don't regulate food and safety. You 
are doing too much to make the water safe"?
  I really do not understand what is behind this bill. I mean, I do. I 
do. I think there is a lot of speculation behind it. But from the 
standpoint of the overall issues, has my friend ever been told that the 
heavy hand of Government is making mammograms too strict? I ask him.
  Mr. KENNEDY. Absolutely not.
  I think the American people hopefully are beginning to understand 
what this debate is about. Even with regard to OSHA, with 10,000 rules 
a year, if you had 99.9, or your child got 99.9, you would say, 
``Pretty good; pretty good.'' Well, if you said 99.9 percent of the 
regulations were not tested, I am not even prepared to say that, and 
neither is the 

[[Page S 9868]]
head of OSHA.
 But if you are up to, say, 99.9, you would still have 100 regulations 
that made no sense, that none of us would support. And we are hearing 
them every morning, we hear our favorite 10. They are using that to 
undermine the importance of the protection of mammography or for our 
food or for our air, for our water. The American people, hopefully, are 
beginning to understand this.

  All of us understand the importance of making progress and reducing 
the regulation and releasing the energies and expansion and trying to 
eliminate bureaucracy and duplication and overlap, and the leadership 
is being provided by Senator Glenn, by Senator Levin, and others in a 
bipartisan manner--Senator Roth I see in the Chamber at this time. It 
has been bipartisan efforts that have come out of those committees 
virtually unanimous, Republican and Democrat. But we are throwing these 
over, at least not being able to address those kinds of issues and are 
being asked now to suspend, or effectively emasculate this particular 
kind of provision on mammography. That makes no sense.
  I wish to commend the Senator and ask if she would agree with me that 
just doing a sense-of-the-Senate is really, I think, trying to raise a 
false sense of expectation. Would the Senator not agree that we are 
really doing something when we are not? And for all the lists that are 
made out there that the majority leader--I mean we will take some time 
and go through other kinds of diseases that may not have the total 
numbers of the ones that have been included, but nonetheless, unless 
they are listed or exempted, otherwise would fall under this process 
and procedure and put at risk families in this country. That would be 
unacceptable. Is the Senator troubled by that process as well?
  Mrs. BOXER. I am troubled by this process. I think it is a back-door 
way to undo legislation that, as my friend has pointed out, was 
unanimous--everyone agreed with the legislation--but when it comes to 
the rulemaking, they try to stop it.
  It is interesting; I do not know if my friends saw the poll which was 
done that clearly showed that when the American people were asked, ``Do 
you want to cut regulation that has to do with protecting health and 
safety and the environment?'' 62 percent said no.
  Well, what does that mean? It means you do not go at the Clean Water 
Act, you do not go at the Clean Air Act, and you do not go at the 
Mammography Quality Standards Act, and you do not go at the Safe 
Drinking Water Act, but you back door it. And this is a clear-cut 
example of back-door politics. You do not take it on because the 
American people would be in an uproar. They want clean air. They want 
clean water. They want protection when they go for a mammogram or 
another medical procedure. They are fearful without standards.
  We already know we have problems. The Senator pointed out that we 
have problems in this area. Is this a time to turn back when a third of 
the women get a result which says they are fine, there is no lump 
found, and in fact it is a false reading? My goodness, I think they 
would want us to do more, and that is what the rule is all about.
  Mr. KENNEDY. Could I just ask one question? And I see others who want 
to inquire. Does the Senator find it somewhat ironic? Here we have seen 
in terms of national health policy that women have been effectively 
shunted aside. That was a tragic reality. It was tragic in terms of the 
NIH programs and investigation in osteoporosis, breast cancer and 
ovarian cancer, a wide range of different areas, even though there is 
basic research that is being done at the NIH in terms of clinical 
applications. But by and large one could say that women's health issues 
were not a matter of central importance in terms of the American health 
agenda. Now we have seen in very recent years, in the last Congress, 
one of the earliest pieces of legislation was to ensure that there was 
going to be a fundamental commitment in terms of the NIH for women's 
health-related issues for research. We are gradually catching up.
  I would like to hear in this Chamber why we have the fact that women 
have half the number of heart attacks as men but only have half the 
recoveries men do. What is it about that? I mean why? We are putting 
resources in terms of research into these areas which affect real 
people and affect our families, and now we have seen that at last, 
under this administration with the leadership of President Clinton, 
Mrs. Clinton, Barbara Mikulski, and both of our distinguished Senators 
who are here, Senator Boxer and Senator Murray, we have seen the effort 
to make sure that we are going to continue that progress. And here we 
have at the start of this Congress rolling into July a major assault on 
a major health issue that affects better than half of our population.
  Do the Senators find in their own mind, I would ask either the 
Senator from California or the Senator from Washington, some puzzlement 
when we have been so far behind on women's health issues--and certainly 
that has been true in research in these other health policy questions--
on one extremely important matter, and that is in terms of breast 
cancer, which affects so many, and increasingly so, and we know that we 
can make progress --there are so many areas that still escape us about 
what we can do in terms of making progress, but we know that in this 
area we can make a difference in terms of giving some assurance to 
women that there is a better chance of curing and treating breast 
cancer with these kinds of standards, that when we do have that 
opportunity, there are those who want to say no, or let us just go a 
different way and maybe we will end up with the same result. We do not 
know quite what these words mean. But why do the women of this country 
have to jump through these additional hoops as well?
  Does the Senator find that somewhat ironic, that we find ourselves in 
that position on a Thursday afternoon when we ought to be trying to 
find out and be debating what more we could do in terms of women's 
health issues, children's health issues, parents' issues in this 
Chamber rather than try to put them at greater risk?
  Mrs. BOXER. Not only do I find it puzzling, but I have to say to my 
friend, as he put his question forward, I realized something very 
interesting, and that is this is the third exemption amendment, as the 
Senator knows, that we are facing. The first one was E. coli, which is 
that bacteria that is found in hamburger meat and kills kids mostly and 
old people, and we have a case now in Tennessee--I do not know if the 
Senator is aware of it.
  Mr. KENNEDY. We had Mrs. Sullivan from Haverhill, MA, who works hard 
all day--I address the Senate; I will not take much time--works all 
day, goes to school at night, active life, whose greatest problem was 
she ate a hamburger and $300,000 later and in a most painful, 
excruciatingly painful kind of condition at Mass General Hospital has 
been able to survive but is still today in a weakened condition. And we 
had, earlier this morning, her sister, who happens to be a nurse, and 
obviously because she was a nurse was able to, I think in a family 
situation perhaps, get somewhat earlier kind of treatment for that 
extraordinary woman whose life will never be the same--that with regard 
to food health standards. And then we have, as the Senator pointed out, 
the machine in here that is rolling over the protection of food safety 
for the American people. I just wonder why the Senator thinks this is 
the case.
  Mrs. BOXER. I think if you read the Contract With America, there was 
a guideline in there. But what I wanted to make a point about, I say to 
my friend from Massachusetts, is this. When he asked the question, is 
it not interesting whenever an issue of women's health comes up we 
cannot seem to get any forward movement? What I wanted to point out to 
my friend from Massachusetts is this. When the E. coli amendment came 
up, I say to my friend, there was a substitute second-degree amendment 
that tried to deal with the E. coli problem. So there was a second-
degree amendment to deal with the E. coli problem. And unfortunately it 
passed. It was not an effective way to go. We lost by two votes. Then 
the cryptosporidium one came up. They defeated that, up or down. But 
now that the Senators from California, Washington and Massachusetts and 
the other women in the Senate on the Democratic side, put together an 
amendment on breast cancer, guess what? What is the second-degree 

[[Page S 9869]]
amendment, I say to my friend? It has nothing to do with breast cancer. 
It has nothing to do with mammography. What is wrong?
  Mrs. MURRAY. Would the Senator yield?
  Mrs. BOXER. Yes.
  Mrs. MURRAY. Is this the first sense-of-the-Senate that we have dealt 
with as well?
  Mrs. BOXER. Oh, yes. This is the first sense-of-the-Senate. They 
substitute a very strong amendment to move forward mammography rules 
with a big fat nothing. A sense-of-the-Senate that does nothing and 
does not even mention women's health or mammography. It is 
extraordinary. And that is why I am willing to stand here day after 
day, and night after night, and morning after morning, with my friends, 
until we get a vote up or down on the mammography issue, and if my 
friends want to stay here through the weekend and through next weekend 
and the weekend after that.
  Mr. KENNEDY. Would the Senator yield?
  Mrs. BOXER. Yes.
  Mr. KENNEDY. I want to commend all those who have been involved with 
this. But would she not agree with me--I did not want to take the focus 
off the issue really of the mammography--but basically what we are 
talking about--I call this the ``Polluters and Poisoners Protection 
Act.'' We are basically talking about not only in terms of questioning 
the safety on terms of breast cancer mammography standards, but we are 
talking about unsafe drinking water that will affect that family, and 
unsafe meat and the E. coli which you just referenced on that, and we 
are going to come down here to the change on the unsafe fruits and 
vegetables, and the unsafe baby foods with the changes in the food 
standard.
  And as the Senator has focused on the E. coli, cryptosporidium debate 
last night, and now the mammography standards, basically we are talking 
about these other elements. Would the Senator not agree with me?
  Mrs. BOXER. Absolutely. This is part of the process.
  Mr. KENNEDY. This is part of the whole process. I want to indicate 
that the Senator has really brought the focus and attention on this 
area. We cannot solve all of the problems in these areas of drinking 
water, and meat and the vegetables and baby foods. We can make them a 
great deal safer. We think that we are putting at very significant risk 
all these kinds of protections for the American people. But the Senator 
from California is saying on the mammography we have specifics. ``Do 
not take this away from protecting the American women. Take your hands 
off these standards that can make a real difference for the protection 
of mothers and sisters and daughters.'' And I just want to commend her 
and thank her very much.
  But I did want to inquire whether the Senator from California or the 
Senator from Washington agreed with me that we have parallel threats to 
these other areas in this legislation. And that the American people 
ought to understand that as well.
  Mrs. BOXER. I certainly hope that the American people are watching 
this debate. You know, you can get off on these different sections of 
the bill. The lookback procedures, the petitions, all the rest of it. 
And that is what I believe the proponents of this bill want us to 
debate. They want to debate, how many days will it be reviewed? How 
many months will it be reviewed? The bottom line is this bill, if it 
passes without substantial amendment, is going to derail an urgent rule 
that is coming forward in October that will provide standards for those 
who are in the business of providing mammography, the majority of which 
are terrific people, but there are always those who cut around the 
edges. And that is why we need these rules, these national standards, 
so that a woman in California gets the same quality mammogram as a 
woman in Massachusetts or Tennessee or New Hampshire or Vermont or 
Rhode Island or Louisiana or Washington.
  Mrs. MURRAY. Will the Senator from California yield?
  Mrs. BOXER. Or Minnesota.
  Mrs. MURRAY. Will the Senator from California agree with me--because 
I feel very puzzled and baffled and really concerned--that this 
amendment which deals very specifically with women, our mothers, our 
sisters, our daughters, our friends, who have had breast cancer, and 
who are counting on us as the Nation's leaders to assure them that when 
they go in for a mammography, that they have strict standards; that 
this amendment that deals with women, and women alone, has a sense-of-
the-Senate second-degree; that I believe, if I am not mistaken, when 
the Senator spoke to it this morning she was not even able to send her 
own amendment to the desk. When her amendment was at the desk we were 
not allowed to speak about breast cancer for over an hour, but we did 
listen to a long litany about charts and graphs and process and long 
words and ambiguities. And we are finally here able to speak to the 
realness of this. But I also heard when this was being discussed 
before, ``Do not worry about this. It is only going to cost $98 
million.'' Is that what the Senator from California heard as well?
  Mrs. BOXER. Oh, yes. Yes. They say, ``Oh, the estimate of cost is $98 
million. Since our bill says if you are under $100 million you do not 
come under this, do not worry. Do not worry.''
  Mrs. MURRAY. Would the Senator yield?
  Is it not clear that $98 million is darn close to $100 million, and 
could reach $100 million? And not only that, it is my understanding 
that in the House bill that has passed the threshold is $25 million.
  Mrs. BOXER. Yes.
  Mrs. MURRAY. When it gets to conference we will see somewhere between 
$25 and $100 million. So mammographies will be impacted.
  Mrs. BOXER. Absolutely.
  Mrs. MURRAY. Would the Senator not agree, in this legislation as 
currently drafted, it says if there is a significant impact on a 
substantial number of small entities it will be exempt as well? This 
amendment will not only be applicable because of the cost but it will 
also be because a substantial number of mammograms are done by small 
entities.
  Is that not correct?
  Mrs. BOXER. My friend is so correct. And I do not like to use--well, 
I will be as delicate as I can. I think claims on this Senate floor 
that mammography improvements are safe, without the Boxer-Murray 
amendment are false claims, because of what my friends have pointed out 
in this question time.
  First, the fact that we know $98 million is the cost of this 
regulation. And that is about as close as you can get to $100 million. 
And, of course, when this bill goes to conference, with Newt Gingrich 
and his friends, they have a $25 million trigger. You do not need to go 
to Poli Sci 101 to know where the numbers come out. We will be lucky if 
it is $50 million. So ipso facto, protection gone.
  And the second point that both my friends pointed out, which is 
important for this debate, is that under some amendments that we passed 
here, small businesses will be exempted if a substantial number, by the 
way not defined, talk about a lawyer's dream, substantial number of 
small businesses are impacted.
  We are talking about endangering the lives of women. And when my 
friend says our sisters, our grandmothers, our daughters, our 
granddaughters, I think it affects our grandpas and our dads and 
brothers and our husbands too. When a woman gets breast cancer this is 
not only her fight. It is a family struggle. And when a family finds 
out that it was a mammogram that was not read correctly, or an x-ray 
machinery was defective, imagine the feeling that they lost a member of 
their family that could have been saved. And that is what we are 
talking about here. So if they want to talk on the other side about 
lookbacks and sunsets, and waivers and all the rest--it is new speak. 
We now have new speak around here. We do not get to the issues. Thank 
God for the Senator from Massachusetts for coming over here and helping 
us focus. Thank God for him
 for all these years fighting these battles, sometimes quite a lonely 
fight. I hope the American people listen, listen up. I am going to get 
a vote on the underlying amendment.

  Mrs. MURRAY. Will the Senator from California yield?
  Mrs. BOXER. Yes.
  Mrs. MURRAY. Then I assume the Senator from California feels, as I do 
at this point, that we will not be dismissed by a sense-of-the-Senate 

[[Page S 9870]]
amendment; that on the underlying amendment, that clearly says to all 
women in this country that we will continue forward and put in place 
assurances for them on mammographies, there will be a vote on this 
floor.
  Mrs. BOXER. We both guarantee that, and I know the Senator from 
Massachusetts joins us in that, as I am sure the Senator from Minnesota 
does, who is here listening and I am hoping will be asking us some 
questions in a short time. We are going to have a vote on the 
underlying amendment, period. Period. There is no recess that is going 
to stop us, either. You want to push us up against the recess? OK. 
Forty-six thousand women a year die of breast cancer. We will stay. We 
will stay through the summer. We will stay through Thanksgiving, 
Christmas. We will stay. We will stay through Hanukkah, Passover, 
Easter.
  Mrs. MURRAY. The next Congress.
  Mrs. BOXER. The next Congress, and none of us wants to have to do 
that because we have families, too. We have families, too. But we will 
do that because one in nine women is going to get breast cancer. Count 
up the women in this Chamber. Somebody is going to get breast cancer.
  I will say this, sometimes you cannot help what happens. Sometimes 
you cannot help what happens. But many times you can, and we know that 
early detection is the major tool that we have in the fight against 
breast cancer.
  Mr. WELLSTONE. Will the Senator yield for a question?
  Mrs. BOXER. I will be glad to yield to my friend.
  Mr. WELLSTONE. I will not take but a couple of minutes. I have from 
my office watched the Senator from California, the Senator from 
Washington, and the Senator from Massachusetts out on the floor, and I 
really have been moved by what you have said.
  My wife, Sheila, is not here today. But her mom passed away from 
breast cancer, and we feel very, very strongly about these issues.
  The Senator talks about having an up-or-down vote and we will be here 
for as long as it takes. If I could just ask my colleagues, why do you 
feel so strongly about this? Let us just forget all the statistics, all 
the charts, all the numbers. Why do you feel so strongly about this?
  Mrs. BOXER. Well, I thank my friend for asking the question. I feel 
so strongly about this because I think that this bill is a backdoor 
attack on a very important series of laws that were passed in a 
bipartisan way to protect the American people. I feel very strongly it 
is a backdoor war on these laws. That is how I feel, because I do not 
think there would be support for repealing any of these acts. There are 
a lot of special interests out there that do not want the Clean Water 
Act and the Clean Air Act. Why? Because they feel it in their 
pocketbook.
  While we all agree we do not want unnecessary and burdensome 
regulations, and all of us are willing to vote to end that, we feel 
deeply committed that we will not reverse years of progress. I do not 
care if it is in the Contract With America.
  So I feel very strongly that when there is an attack on a law that 
protects the health and safety of the American people, it is an 
obligation of U.S. Senators to point it out and to stand on their feet 
and to fight. I think that is what we are doing.
  We all know people who have been misdiagnosed.
  I talked about a friend of mine who, because the mammogram was not 
read properly, suffers terribly, and we pray that she will make it. But 
every day is like a nightmare because she did not catch it early.
  Mrs. MURRAY. If the Senator from California will yield.
  Mrs. BOXER. Yes.
  Mrs. MURRAY. The Senator has asked a critical question, why would 
somebody be willing to stand out here on their feet and speak over and 
over until they are given an up-or-down vote on a very simple 
amendment. It is because of the women we know--personal friends and 
personal relatives who have died from breast cancer because it was not 
detected early. One out of nine women today will be diagnosed with 
breast cancer. Nine out of ten women will survive if it is detected 
early. I am determined to make sure that on my watch on this floor of 
this Senate that I will not allow any of those women to go undetected. 
I think it is incumbent upon all of us to see that that occurs.
  Mr. HATCH addressed the Chair.
  Mr. KENNEDY. Will the Senator yield?
  Mr. HATCH. Will the Senator yield?
  Mrs. BOXER. I am not yielding at this time.
  The PRESIDING OFFICER. Will the Senator yield to the Senator from 
Utah?
  Mrs. BOXER. No, I will not. When I simply asked for a parliamentary 
inquiry before, Senators would not yield to me.
  Mr. HATCH. I would have yielded to you. You did not ask me.
  Mrs. BOXER. I yield to my friend for a parliamentary inquiry without 
losing my right to the floor.
  Mr. HATCH. I appreciate that. I thank you. Let me make a couple 
comments. There is nobody on this floor that feels more deeply about 
mammography than I do. Nobody.
  Mrs. BOXER. I ask, is this a parliamentary inquiry?
  Mr. HATCH. Yes, I am going to ask a question, and I want to make a 
few statements so I can get to the question.
  There is nobody on this floor who has worked harder, as one of the 
prime cosponsors of the mammography bill. But is it not true that there 
is an interim rule in effect on mammography?
  Mrs. BOXER. The interim rule does not affect the issues that I read 
to the Senate. I will reread them. It does not go to these issues. 
These issues are of crucial importance. They involve the performance 
standards for x-ray equipment; expanding and standardizing requirements 
for recordkeeping; expanding quality assurance; clarifying personnel 
requirements; and specifying procedures and techniques for mammography 
for examinees who have breast implants.
  Mr. HATCH. Are they not in effect now?
  Mrs. BOXER. No, there is no rule. I will be happy to share this with 
the Senator. This is a description of the rule that is going to go into 
effect in October.
  Mr. KENNEDY. Will the Senator yield?
  Mrs. BOXER. Yes; I will be happy to yield.
  Mr. KENNEDY. As I understand, if the Senator stated it accurately, 
the new rules are likely to be significant improvements to the interim 
rule. They include performance standards for radiological equipment; 
standards for uniform imaging of women with breast implants; and 
establishing consumer plate procedures.
  None of these areas are addressed in the interim regulations. So the 
interim rule, although much better than what would have existed, still 
will be strengthened with the permanent requirements.
  I see others who want to speak, but let me mention, I was listening 
to the exchanges. I was going back into the hearing record and the 
testimony of Dr. Roper, who was the head of the CDC when we were having 
those hearings, and pointing out the controlled studies have shown that 
a 35- or 40-percent reduction in mortality related to breast cancer is 
possible.
  I will make a comment and ask the Senator whether she agrees with 
this. Does the Senator agree that Dr. Roper's testimony was powerful 
testimony when he pointed out that controlled studies have shown that a 
35- or 40-percent reduction in mortality related to breast cancer is 
possible? However, in order to achieve this level mammography, clinical 
examination must be performed, interpreted, and reported as accurately 
as possible. Subsequent steps, including biopsies and other 
followthrough procedures, must be timely and of high quality.
  We, along with the Public Health Service Agency and relevant 
professional organizations, provide leadership to aggressively pursue a 
program designed to ensure the highest standards of excellent and early 
detection of breast cancer with mammography and assure the maximum 
benefit for lifesaving technology for all Americans.
  This is the testimony in favor of this legislation by the head of the 
Centers for Disease Control, appointed by the previous administration. 
Controlled studies have shown that a 35- to 40-percent reduction in 
mortality for cancer is what we are talking about for women. 

[[Page S 9871]]

  Let me just ask the Senator whether she would agree with what was a 
very powerful comment, and that was during the course of our hearing, 
Mrs. Langor, who is the head of the National Association on Breast 
Cancer. This is her statement. I ask what is the reaction of the 
Senator from California.

       We hear many sad things at NABCA, but one of the saddest is 
     the story of the woman who has done everything correctly. She 
     scheduled her mammogram, has received a clean bill of health, 
     then she finds she is dying of breast cancer, not always due 
     to negligence, but rather due to inexperience, poor equipment 
     maintenance, or wrong equipment. She was relying on her 
     medical provider to develop quality care. Her life has been 
     destroyed. Her confidence is gone. She has conveyed this 
     message to every woman she knows. A vital element in our 
     attempts to control the breast cancer epidemic is knowing 
     that after our hard work reaching, educating, and reassuring 
     every American woman about mammography, that it is 
     increasingly safe and affordable, mammography is also 
     universally effective. It is the right of American women to 
     receive screening mammography of the highest quality and the 
     responsibility of lawmakers to grant them that right.

  You cannot say it any better than that. That is what the mammography 
standards bill has done. This legislation is putting this at risk. At 
risk is that very eloquent statement.
  I ask the Senator, again, why we should take any risks at all in 
doing it after we have had all the testimony in the world. We know 
about the problems we cannot solve. We can make an important impact in 
terms of the safety and continued life of women in our society. Why 
should we throw that over and go to some other kind of process and 
procedure which, for me, is not worth the paper that we have it written 
on.
  Mrs. BOXER. I thank my friend. He is so right. Women are already at 
risk for breast cancer. Forty-six thousand a year die of it, and now we 
are going to add to the risk and derail a rule that--no matter how many 
times the Senator asked me the question, I will come back and tell you, 
no, there are no final regulations in place for the x-ray machines. 
There are no regulations. There are regulations in place for 
accreditation.
  Mr. JOHNSTON. Will the Senator yield for a question?
  Mrs. BOXER. Yes.
  Mr. HATCH. Will the Senator yield for a unanimous-consent request?
  Mrs. BOXER. Of course.


                      Unanimous-Consent Agreement

  Mr. HATCH. I would like to resolve this.
  Mr. President, I ask unanimous consent that amendments numbered 1524 
and 1525 be withdrawn.
  Mrs. BOXER. Reserving the right to object.
  Mr. HATCH. This is agreed to by both sides. We are going to give you 
a separate vote.
  The PRESIDING OFFICER. Is there objection?
  Mrs. BOXER. Reserving my right to object.
  The PRESIDING OFFICER. Is there objection to the Senator's request?
  Mrs. BOXER. Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mrs. BOXER. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mrs. BOXER. If the Senator will propound the unanimous-consent 
request, I think we are ready.
  Mr. HATCH. I ask unanimous consent that amendments 1524 and 1525 be 
withdrawn.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.
  So, the amendments (Nos. 1524 and 1525) were withdrawn.


                      Unanimous-Consent Agreement

  Mr. HATCH. Mr. President, I will soon send an amendment to the desk 
and ask for its immediate consideration.
  I ask unanimous consent that no other amendments be in order, that a 
vote occur on the amendment at 5:05 p.m., with the time equally divided 
in the usual form.
  The PRESIDING OFFICER. Is there objection?
  Mrs. BOXER. Reserving the right to object. I want to make sure that 
before the vote on the Boxer-Murray-Mikulski amendment there be 1 
minute on either side.
  Mr. HATCH. If we hurry, we have almost 8 minutes.
  Mrs. BOXER. I want to make sure that there is a little time on each 
side.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.
  Mr. HATCH. Mr. President, I ask unanimous consent that following the 
vote Senator Boxer be recognized to offer an amendment, the text of 
which is amendment No. 1524, and that no amendments be in order to the 
Boxer amendment, and a vote occur immediately after 1 minute for 
Senator Boxer and 1 minute for Senator Hatch, without any intervening 
action or debate on the Boxer amendment.
  Mr. JOHNSTON. Reserving the right to object, and I shall not, I have 
had a conversation with the Senator from Utah and the Senator from 
Oklahoma about whether we would be able to accept the other pending 
amendment, which is the Superfund amendment, accept that by unanimous 
consent. Do we know whether we can do that at this time?
  Mr. HATCH. I am not prepared to do that at this time. But we will 
certainly look at that.
  Mr. JOHNSTON. I say to my colleagues that I think that is in the 
works. That is, I have requested that we be able to do that. And so I 
hope after the vote on the Boxer amendment, we would be able to accept 
that by unanimous consent. I would assume that no one on our side would 
object. But I would like to get that notice out just in case.
  Mr. HATCH. Certainly.
  The PRESIDING OFFICER. Is there objection to the unanimous-consent 
request?
  Without objection, it is so ordered.


                Amendment No. 1531 to Amendment No. 1487

  Mr. HATCH. Mr. President, I send an amendment to the desk and ask for 
its immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The legislative clerk read as follows:

       The Senator from Utah [Mr. Hatch] proposes an amendment 
     numbered 1531 to amendment No. 1487.

  Mr. HATCH. Mr. President, I ask unanimous consent that reading of the 
amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment is as follows:

       At the appropriate place in the amendment, add the 
     following: It is the sense of the Senate that nothing in this 
     Act is intended to delay the timely promulgation of any 
     regulations that would meet a human health or safety threat, 
     including any rules that would reduce illness or mortality 
     from the following: heart disease, cancer, stroke, chronic 
     obstructive lung diseases, pneumonia and influenza, diabetes 
     mellitus, human immunodeficiency virus infection, or water or 
     food borne pathogens, polio, tuberculosis, measles, viral 
     hepatitis, syphilis, or all other infectious and parasitic 
     diseases.

  Mr. HATCH. Mr. President, I ask unanimous consent that no further 
amendments re: exemptions for mammography be in order during the 
pendency of S. 343.
  The PRESIDING OFFICER. Is there objection?
  Without objection, it is so ordered.
  Mrs. BOXER addressed the Chair.
  The PRESIDING OFFICER. The Senator from California.
  Mrs. BOXER. If I can be clear about the order. The Senator from 
California has 5 minutes and the Senator from Utah has 5 minutes, is 
that correct? I want to make that clear. Or is the floor open to 
whoever seeks recognition?
  The PRESIDING OFFICER. The time between now and 5:05 is evenly 
divided between the two Senators, which means the Senator has about 
3\1/2\ minutes.
  Mrs. BOXER. Thank you very much, Mr. President.
  I have no objection to voting for the sense-of-the-Senate resolution 
offered by Senator Dole. That is fine. It has nothing to do with my 
amendment, however, which gets to the issue of mammography. I hope 
Senators, in a bipartisan spirit, will support both.
  There is nothing wrong whatsoever with Senator Dole's amendment. It 
is just that, for the last, let us see, about 3 hours he intended for 
it to substitute for the Boxer-Murray-Mikulski amendment which, to this 
Senator, made no sense, and to many other Senators, it made no sense.

[[Page S 9872]]

  I am not going to yield to anybody because I only have 2\1/2\ 
minutes. I hope that Senators are listening to this debate. It has been 
clearly demonstrated via the fact that if we do not pass the Boxer-
Murray amendment, we are playing Russian roulette with women's lives. 
Let me tell you why. In October, a rule is going to go on the books 
that sets standards for mammography.
 It is carrying out a law that passed in 1992.

  This is not fun and games. This is about breast cancer that is going 
to strike one out of every nine women in this Chamber. The most painful 
situation is one where a woman was told her mammogram was fine, only to 
find out the technician could not read it or the machine was faulty and 
she has to undergo the most radical kind of therapy.
  So my friends can argue about line 6 and line 2 and sunset clauses 
and all the rest. If Members care about this, Members vote yes. Play it 
safe for the women of this country and do not gamble. The rule that is 
about to come out is a rule that will make it far safer. Why on God's 
green Earth do we want to derail that? To score a political point?
  Think again. The American people are catching on to this debate. This 
is a back-door assault on a bill that was passed in 1992 by Republicans 
and Democrats alike. But rather than repeal sections of it, we are 
making it so hard that the rule to carry it out will never go into 
place.
  The first day a Senator's wife comes down with breast cancer and it 
was missed on a mammogram, we will be on the floor changing this bill.
  Mr. President, 46,000 women every year die of this disease. We have 
talked about our moms, our grandmothers, our sisters, and our 
daughters. What about the fathers and sons and the grandfathers? It 
affects each and every American, just as when a man gets prostate 
cancer and is taken away from the family.
  If ever there was a time to pull together as Senators for both 
parties, this is it. Why do we have to fight over everything around 
here?
  Ms. MIKULSKI. Mr. President, I rise today to join my colleague, 
Senator Boxer, in offering this amendment that protects the public 
health by ensuring the continued implementation of mammography quality 
rules.
  As the original coauthor of the Mammography Quality Standards Act, I 
was especially proud when this act was adopted in 1992. The Mammography 
Quality Standards Act requires all facilities providing mammography to 
be accredited and certified. This is extremely important in our efforts 
to detect breast cancer early when treatment is available and less 
invasive.
  For the past year, the mammography quality standards have been 
reviewed by a Mammography Advisory Committee. It is my understanding 
that the FDA is now prepared to move forward with the publishing of 
these rules in October.
  The women of America have waited since October 1992 for these 
mammography quality standards to be implemented. A delay at this time 
will result in needless deaths and disability by women who are tested 
by facilities and equipment not meeting Federal, uniform quality 
standards for mammography.
  We are so close in getting these final rules for mammography quality 
standards approved. We must ensure that the mammogram women receive is 
of the highest quality possible.
  I urge immediate passage of this amendment.
  Mr. COHEN. Mr. President, I am pleased to sponsor this important 
amendment to ensure that regulations providing for quality standards in 
mammography screening are fully implemented as swiftly as possible.
  Despite promising scientific advances in the treatment and diagnosis 
of breast cancer, this disease remains a major health threat to 
millions of American women. Breast cancer is the second leading cause 
of death among women. Last year alone, it is estimated by the National 
Cancer Institute that over 182,000 new cases of breast cancer were 
diagnosed and more than 46,000 women in the United States died as a 
result of this devastating disease.
  This disease often strikes women in the prime of their lives and, as 
women get older, the odds of developing breast cancer steadily 
increase. One in eight women will develop breast cancer at
 some point in their lives. With statistics this sober, nearly every 
family will be directly affected by this disease.

  In 1992, I cosponsored the Mammography Quality Standards Assurance 
Act because I knew of the critical importance of accurate breast cancer 
screening. Mammograms are among the most difficult tests to perform. If 
images are not clear or if tests are improperly read, cancers can be 
missed, leading to delayed treatment and premature death.
  Prior to the adoption of this act, only a patchwork of Federal State, 
and voluntary standards existed for mammography. Women could not be 
assured that their mammograms were properly administered, interpreted 
or communicated to them or their physicians.
  In absence of a cure, mammography and the early detection of breast 
cancer is still the most effective weapon women have to fight this 
increasingly common--and often fatal--disease.
  Currently, the FDA has in place interim rules for the Mammography 
Quality Assurance Act which establish national standards to ensure the 
safety and accuracy of breast cancer screening procedures. However, the 
final proposed regulations are not expected until this October. While 
the interim regulations are enforceable and have established rules for 
accreditation, certification and annual inspection, it is crucial that 
we do not delay in full implementation of final regulations.
  I am aware that there are questions as to whether S. 343 would have 
any effect on the implementation of these standards, but I believe that 
it is critically important to be absolutely sure that these regulations 
are not derailed, or delayed. The mammography standards were passed 
nearly 3 years ago and we must move forward on this important women's 
health issue.
  The proposed final regulations further ensure the safety of 
mammography in significant ways. They specify performance standards for 
x-rays, develop procedures for examining women with breast implants and 
standardize requirements on medical records and mammography reports. 
Each of these reforms are essential to ensuring that all mammography 
done in this country is as reliable as possible.
  Early detection of breast cancer will save countless lives. The 
Mammography Quality Standards Assurance Act ensures that women get the 
best possible breast cancer screening and that they will have the best 
chance of treating their cancer once diagnosed.
  We owe it to each family touched by this devastating disease that 
these critical standards be exempted from any additional regulatory 
delays and that they become effective before more precious lives are 
lost to breast cancer.
  The PRESIDING OFFICER (Mr. Abraham). All time has expired.
  Mr. HATCH. Mr. President, I think this is important, and I am glad to 
have an opportunity to get the points on the record.
  I have to say again that interim regulations are by definition final. 
Perhaps the new, proposed regulations will be here in October; we have 
been assured by those on the other side that this is so.
  But I have to keep point out that these interim regulations do have 
the full force and effect of law.
  This particular debate is filled with misrepresentations. 
Nevertheless, I still think it is an important debate and I am glad to 
have an opportunity to get some key points on the record.
  Mammography is an important tool in our effort to fight a dread 
disease which now affects an estimated one in nine women.
  I believe we should do all we can to protect against breast cancer. I 
am one of the original sponsors to help to write one bill that does 
this. I am the sponsor of a bill last year to require that another 
breast cancer screening tool, self-examination, be taught at all 
federally funded health clinics. My record in this area is clear.
  But whether or not we want to fight breast cancer is not the point of 
this debate. Of course, we all want to fight breast cancer, and all 
other cancers for that matter.
  The point is that there are regulations in effect to implement the 
Mammography Quality Standards Act. They were promulgated in December 
1993, 1\1/2\ years ago.
  Nothing I have heard in this Chamber changes that or has convinced me 
a new proposed regulation under MQSA, 

[[Page S 9873]]
would make a significant improvement in the health of women who might 
get breast cancer.
  Nevertheless, in the spirit of moving the larger debate along and 
recognizing that by the administration's own published estimate, it is 
likely new rules from MQSA would not be subject to the cost-benefit 
analysis of this bill, I, personally, am willing to accept this 
amendment.
  If this amendment is necessary to give America's women peace of mind, 
I think it should go forward, even though I, personally, believe it is 
not needed.
  I do have to underscore again that this bill addresses the 
mammography situation. It addresses the E. coli. If a rulemaking meets 
the bill's thresholds, there still can be exemptions for health 
emergencies or even health threats. It is hard to believe that the 
administration would not consider the possibility of meat contamination 
or increased exposure to breast cancer threats to public health.
  Our bill allows those exemptions as I have cited before.
  I personally resent the representations that have been made on the 
floor in this regard. It is important that members read the language of 
the bill; perhaps they have not.
  The Glenn bill does not allow such exemptions. We put a lot of effort 
to make sure we take care of these problems.
  I am frustrated because we are undergoing untold hours on the floor 
just, for the most part, so that political points can be made.
  I think it is time to start working on the heart of this bill. If 
there are major problems in this bill that really need to be corrected, 
we should address them.
  I hate to say this, but I have been working in good faith to try to 
accommodate the other side, to try to work on this problem and get this 
matter resolved, and make sure that they are happy with these 
provisions.
  I am concerned because I perceive that we are continuing to get 
amendments which are permutations of issues which have already been 
resolved, such as the impact of the bill on the ability of Federal 
agencies to address public health problems.
  One has to conclude that the purpose of all this is to drag out the 
debate. That is fine.
  My personal recommendation is that we should vote for both amendments 
and get this past us and move on from there. We need to start working 
on the bill, rather than all these amendments that really do not 
deserve to see the light of day because we have taken care of them in 
the bill.
  I do not see how anybody can disagree with that.
  Mr. President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  The PRESIDING OFFICER. The clerk will call the roll.
  The bill clerk called the roll.
  Mr. FORD. I announce that the Senator from New Mexico [Mr. Bingaman] 
is necessarily absent.
  The PRESIDING OFFICER. Are there any other Senators in the Chamber 
desiring to vote?
  The result was announced--yeas 99, nays 0, as follows:

                      [Rollcall Vote No. 304 Leg.]

                                YEAS--99

     Abraham
     Akaka
     Ashcroft
     Baucus
     Bennett
     Biden
     Bond
     Boxer
     Bradley
     Breaux
     Brown
     Bryan
     Bumpers
     Burns
     Byrd
     Campbell
     Chafee
     Coats
     Cochran
     Cohen
     Conrad
     Coverdell
     Craig
     D'Amato
     Daschle
     DeWine
     Dodd
     Dole
     Domenici
     Dorgan
     Exon
     Faircloth
     Feingold
     Feinstein
     Ford
     Frist
     Glenn
     Gorton
     Graham
     Gramm
     Grams
     Grassley
     Gregg
     Harkin
     Hatch
     Hatfield
     Heflin
     Helms
     Hollings
     Hutchison
     Inhofe
     Inouye
     Jeffords
     Johnston
     Kassebaum
     Kempthorne
     Kennedy
     Kerrey
     Kerry
     Kohl
     Kyl
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Mikulski
     Moseley-Braun
     Moynihan
     Murkowski
     Murray
     Nickles
     Nunn
     Packwood
     Pell
     Pressler
     Pryor
     Reid
     Robb
     Rockefeller
     Roth
     Santorum
     Sarbanes
     Shelby
     Simon
     Simpson
     Smith
     Snowe
     Specter
     Stevens
     Thomas
     Thompson
     Thurmond
     Warner
     Wellstone

                             NOT VOTING--1

     Bingaman
       
       
  So the amendment (No. 1531) was agreed to.
  Mr. HATCH. Mr. President, I move to reconsider the vote by which the 
amendment was agreed to.
  Mr. ROBB. I move to lay that motion on the table.
  The motion to lay on the table was agreed to.
  The PRESIDING OFFICER. The Chair recognizes the Senator from 
California.


                Amendment No. 1532 to Amendment No. 1487

     (Purpose: To protect public health by ensuring the continued 
              implementation of mammography quality rules)

  Mrs. BOXER. Mr. President, I call up my amendment which is at the 
desk, and I ask for its immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from California [Mrs. Boxer], for herself, Mrs. 
     Murray, Ms. Mikulski, Mr. Lautenberg, Mr. Bradley, Mrs. 
     Feinstein, Mr. Dorgan, Mr. Kennedy, Mr. Reid, Mr. Bumpers, 
     Mr. Biden, Mr. Leahy, Ms. Moseley-Braun, and Mr. Daschle, 
     proposes an amendment numbered 1532.
       On page 19, strike the period and insert the following: ``; 
     or (xiii) a rule intended to implement section 354 of the 
     Public Health Service Act (42 U.S.C. 263b) (as added by 
     section 2 of the Mammography Quality Standards Act of 
     1992).''.

  Mrs. BOXER. Mr. President, I ask for the yeas and nays.
  The PRESIDING OFFICER. Is there a sufficient second?
  There is a sufficient second.
  The yeas and nays were ordered.
  Mrs. BOXER. Mr. President, I believe under a previous order I have 60 
seconds to present the amendment.
  The PRESIDING OFFICER. The Senator is correct.
  Mr. FORD. Mr. President, may we have order? The Senator deserves to 
be heard.
  Mr. President, we are not in order. Mr. President, I make a point of 
order that the Senate is not in order.
  The PRESIDING OFFICER. The Senate will come to order.
  Mrs. BOXER. Mr. President, the amendment that is before the Senate 
would exempt the new mammogram rules from this bill. When you vote on 
the Boxer-Murray-Mikulski amendment, I ask you to think about your 
mother, your sister, your daughter, your granddaughter, and cast a vote 
that will assure them the best chance to survive breast cancer. And the 
best chance to survive breast cancer is to have the best equipment run 
by the best personnel.
  That is what these rules are all about. We do not want to derail 
those rules because, otherwise, the cancer could be missed. And all of 
us know too many cases where tragedy has ensued. The better standards 
that are being proposed in the rule that will come out in October will 
absolutely be derailed because they came out after the April date that 
is specified in this bill.
  So without the Boxer-Murray-Mikulski amendment, and so many other 
good Senators who are on it, we will derail safe mammograms.
  Please vote aye and join with the National Breast Cancer Coalition in 
support of mammography quality standards.
  Mr. HATCH addressed the Chair.
  The PRESIDING OFFICER. The Senator from Utah.
  Mr. HATCH. I am going to recommend that everybody in the Chamber vote 
for this amendment, but I have to say this is another 3- or 4-hour 
expenditure of time that did not have to occur.
  The administration, by its own official publication, said only 10 
weeks ago that the anticipated costs of implementing the Mammography 
Quality Standards Act of 1993, a bill that I helped to write, would be 
about $33 million.
  Now we are told up to $97 million, although the administration has 
not provided us with any details on that cost estimate or why it has 
changed so dramatically in 10 short weeks. But in any case, $97 million 
is still $3 million less than the threshold of this bill and could be 
made even less if the administration so desired.
  On the other hand, I do think we should vote for it, because it may 
give some peace to some people who do not 

[[Page S 9874]]
understand this matter is already covered.
  I continue to believe that our bill would not engender the ill 
effects the other side believes.
  However, breast cancer is a serious, serious problem, and I would not 
want to create any feelings in that community that the Congress does 
not take the problem seriously. Because we do.
  So I think that we should vote for the Boxer amendment, and then move 
on.
  The PRESIDING OFFICER. The question is on agreeing to the amendment. 
The yeas and nays have been have been ordered. The clerk will call the 
roll.
  The assistant legislative clerk called the roll.
  Mr. FORD. I announce that the Senator from New Mexico [Mr. Bingaman] 
is necessarily absent.
  The result was announced--yeas 99, nays 0, as follows:

                      [Rollcall Vote No. 305 Leg.]

                                YEAS--99

     Abraham
     Akaka
     Ashcroft
     Baucus
     Bennett
     Biden
     Bond
     Boxer
     Bradley
     Breaux
     Brown
     Bryan
     Bumpers
     Burns
     Byrd
     Campbell
     Chafee
     Coats
     Cochran
     Cohen
     Conrad
     Coverdell
     Craig
     D'Amato
     Daschle
     DeWine
     Dodd
     Dole
     Domenici
     Dorgan
     Exon
     Faircloth
     Feingold
     Feinstein
     Ford
     Frist
     Glenn
     Gorton
     Graham
     Gramm
     Grams
     Grassley
     Gregg
     Harkin
     Hatch
     Hatfield
     Heflin
     Helms
     Hollings
     Hutchison
     Inhofe
     Inouye
     Jeffords
     Johnston
     Kassebaum
     Kempthorne
     Kennedy
     Kerrey
     Kerry
     Kohl
     Kyl
     Lautenberg
     Leahy
     Levin
     Lieberman
     Lott
     Lugar
     Mack
     McCain
     McConnell
     Mikulski
     Moseley-Braun
     Moynihan
     Murkowski
     Murray
     Nickles
     Nunn
     Packwood
     Pell
     Pressler
     Pryor
     Reid
     Robb
     Rockefeller
     Roth
     Santorum
     Sarbanes
     Shelby
     Simon
     Simpson
     Smith
     Snowe
     Specter
     Stevens
     Thomas
     Thompson
     Thurmond
     Warner
     Wellstone

                             NOT VOTING--1

       
     Bingaman
       
  So the amendment (No. 1532) was agreed to.
  Mr. JOHNSTON. I move to reconsider the vote by which the amendment 
was agreed to.
  Mrs. BOXER. I move to lay that motion on the table.
  So the motion to lay on the table was agreed to.
  Mr. JOHNSTON. What is the pending business?


                           Amendment No. 1517

  The PRESIDING OFFICER. The pending business is the Johnston amendment 
No. 1517.
  Mr. SMITH. Mr. President, as the chairman of the Senate Subcommittee 
on Superfund Waste Control and Risk Assessment, and as a member of the 
Governmental Affairs Committee, I have been closely following the 
progress of the pending regulatory reform legislation, S. 343, as it 
pertains to Superfund. I believe this is an important bill, and I think 
it makes a significant improvement in modernizing an outdated 
regulatory system.
  I have to admit that I have some concerns about Superfund being 
specifically targeted for reform in this legislation. Before I outline 
these concerns, however, I think it is important to recognize how we 
have gotten to this point.
  Everyone in this Chamber can agree that our Nation's system of 
environmental regulations has had its successes: Americans are 
breathing cleaner air, and drinking cleaner water today than they did a 
generation ago. Nonetheless, there is uniform consensus that the 
Superfund program, however well intended, is not living up to its 
promises. Over the last 14 years we have spent over $30 billion dollars 
on this program, yet today, we have completed the cleanup at only 70 of 
the more than 1,300 sites on the national priorities list. Clearly we 
can and must do a better job of cleaning up these sites.
  Beginning this past January, I conducted a series of 7 hearings and 
received testimony from more than 60 witnesses in an effort to formally 
incorporate a wide variety of views on the issue of Superfund reform. 
In addition, Congressman Mike Oxley, the chairman of the House 
Subcommittee on Commerce, Trade and Hazardous Materials, and I met with 
numerous groups in candid, off-the-record meetings. Participants 
included: environmental groups, potentially responsible parties, 
representatives of the environmental justice movement, State and local 
governments, the Environmental Protection Agency, the Department of 
Defense, the Department of Energy, the Department of Interior, think 
tanks, and insurance companies.
  After taking the time to digest and analyze the information provided 
by these groups, I released, on June 28, 1995, a Superfund reform 
outline which is a comprehensive effort to radically reform the 
Superfund program. At this time, I ask that a copy of my proposal be 
entered in the Record after my statement.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (See exhibit 1.)
  Based on comments I have received in response to this proposal, I 
plan on quickly moving to draft a Superfund reauthorization measure 
that will be available later this summer. I have pledged to the 
majority leader, Senator Dole, that this legislation will be available 
for full Senate consideration and final passage later this year.
  This past Monday, I visited a variety of Superfund sites in New 
Hampshire. One of these sites, the Coakley Landfill in North Hampton, 
NH, involved the cleanup of a former landfill site. After 10 years of 
study, the Environmental Protection Agency determined that in addition 
to capping the site, it wants to require the construction of a $10-
million-dollar groundwater pump and treat system. The EPA is insisting 
on this remedy even though there are no pathways to human exposure, and 
even though the pollutant could be addressed in the same amount of time 
through natural attention. All of the potentially responsible parties, 
the State of New Hampshire, and the local communities have agreed that 
this expensive system in not necessary. Nonetheless, the EPA is 
continuing to go forward.
  I can understand the impatience of my colleagues in dealing with this 
frequently onerous program, and I can appreciate their desire that 
Superfund be addressed in this legislation. Frankly, in light of its 
past record, the Superfund program is the poster child for regulatory 
reform. Nonetheless, given the fact that my subcommittee has been 
working diligently to quickly develop legislation on this issue, I 
believe that this matter should be addressed in the context of a 
comprehensive Superfund reauthorization bill, rather than in S. 343. 
For this reason, I am asking my Republican colleagues to join me in 
supporting the Baucus amendment.
  I want to make something perfectly clear. Although I would prefer 
that these issues be dealt with in the context of a Superfund 
reauthorization measure, I agree in spirit with the changes included in 
this legislation. The fact is that all too frequently the Superfund 
program ignores common sense principles when dealing with toxic waste 
cleanups.
  I believe that risk assessment and benefit-cost analysis should be 
utilized in determining how and when we will be cleaning up these toxic 
waste sites. While I think it is appropriate that this language not be 
included in the regulatory reform legislation, I want to make it very 
clear that the use of appropriate risk assessment and benefit-cost 
analysis will be part of a comprehensive Superfund reform measure.
                               Exhibit 1

                        Superfund Reform Outline

                 (Introduction from Senator Bob Smith)

       The Superfund program has had its successes. It is not, 
     however, a successful program. When seeking input on the 
     future of hazardous waste cleanup in the United States, I 
     held no preconceived notions about what would or would not 
     work. I believed that every legitimate idea had a place on 
     the table, and was guided by one important premise: the 
     Superfund program is in need of dramatic reform. My goal has 
     been--and will continue to be--to solicit input and support 
     from all interested parties to achieve that reform.
       Creation of this document was an open process. The 
     Subcommittee on Superfund, Waste Control, and Risk 
     Assessment, which I chair, held 7 hearings and received 
     testimony from more than 60 witnesses in an effort to 
     formally incorporate a wide variety of views on the issue of 
     Superfund reform. In addition, Congressman Mike Oxley, the 
     Chairman of the House Subcommittee on Commerce, Trade, and 
     Hazardous Materials, and I met with numerous groups in 
     candid, off-

[[Page S 9875]]
     the-record meetings. Participants included: environmental groups, 
     potentially responsible parties, representatives of the 
     environmental justice movement, state and local governments, 
     the Environmental Protection Agency, the Department of 
     Defense, the Department of Energy, the Department of 
     Interior, think tanks, and insurance companies. I also 
     solicited the input of all members of the subcommittee, 
     Chairman John Chafee, Ranking Member Max Baucus, and the 
     Majority Leader.
       The release of this Superfund Reform Outline is a natural 
     extension of that process. The purpose of the document is to 
     solicit additional constructive comments, ideas and 
     criticisms that can be used during the bill-drafting process. 
     The document is divided into three parts. Section I provides 
     a brief history of the Superfund program, beginning with its 
     inception in 1980 and continuing through to present day. 
     Section II explains the principles that were used to guide 
     the development of the reform measures. Section III provides 
     a detailed summary of my recommended proposals.
       The legislative proposals contained in Section III are 
     intended to serve as the building blocks for a comprehensive 
     reform of the Superfund program. They are not intended to be 
     all inclusive, and no signal, either positive or negative, is 
     intended if any item has been omitted from the outline. It is 
     plausible that the final version of a comprehensive Superfund 
     reform program may not precisely mirror all of the elements 
     contained in this document.
       I would appreciate that any specific comments on this plan 
     be provided in writing. These comments should include your 
     name, address and phone number, and should be forwarded no 
     later than July 10, 1995, to:
       Jeff Merrifield, Counsel, Subcommittee on Superfund, Waste 
     Control and Risk Assessment, Hart Senate Office Building, 
     Washington, DC 20510.
       The Superfund program must be transformed into a more 
     responsive, efficient and fair system for cleaning up 
     hazardous waste sites and returning them to productive use. I 
     believe this document provides a blueprint for reaching that 
     goal. I look forward to receiving your input.


                        section i--brief history

       The Comprehensive Environmental Response, Compensation and 
     Liability Act (``CERCLA''), also known as ``Superfund'', was 
     passed and signed into law during the post-election session 
     of Congress in 1980. The Superfund program was intended to 
     enhance the federal government's ability to compel parties 
     responsible for causing contamination at sites such as Love 
     Canal, New York, and the ``Valley of the Drums'' in Kentucky, 
     to either clean up the contamination or reimburse EPA for the 
     costs of doing so.
       The cleanup program that Congress enacted was premised on 
     the principle that the ``polluter pays,'' through a system of 
     strict, retroactive, joint and several liability. If those 
     responsible for site contamination (potentially responsible 
     parties or ``PRPs'') could not be found, or were unable to 
     pay, EPA could use a special Trust Fund (hence the term 
     ``Superfund'') to pay for the cost of cleaning up these 
     sites. This ``Superfund'' was funded through taxes on the 
     chemical and petroleum industries. Superfund was further 
     amended in 1986 when Congress enacted the Superfund 
     Amendments and Reauthorization Act of 1986 (``SARA''). SARA 
     extended and expanded the Superfund taxes and authorized 
     expenditures of $8.5 billion through December 31, 1991.
       Although the Superfund program has achieved some successes, 
     there is widespread agreement that the program is troubled. 
     When CERCLA was enacted, it was expected that only a few 
     hundred sites would need to be cleaned up and that the 
     program would require relatively modest funding. Both of 
     these expectations have proven to be inaccurate. Currently, 
     there are over 1,300 sites on the Superfund list (known as 
     the National Priorities List or ``NPL''), and during the last 
     few years, EPA has been adding an average of approximately 
     30-40 new sites per year to the NPL. To date, the 
     construction of long-term cleanup remedies have been 
     completed at fewer than 300 contaminated sites.
       As the magnitude of the problem has increased, the 
     projected cost of the program has risen accordingly. Congress 
     originally set aside $1.6 billion for NPL cleanups when it 
     created the Trust Fund in 1980. Six years later, Congress 
     increased the amount in the Fund to $8.5 billion. In 1990, 
     Congress added another $5.1 billion. Overall, it is estimated 
     that the total amount of money spent on Superfund since 1980, 
     including the settlement costs of PRP's, is in excess of $25-
     $30 billion.
       Given these problems, the Superfund program has been widely 
     criticized, primarily on the following four major grounds: 
     (1) the liability system is unfair and has resulted in 
     excessive litigation and other transaction costs, diverting 
     attention and money from site
      cleanup; (2) the cumbersome and often overly prescriptive 
     remedy selection process has delayed clean up actions and 
     driven up cleanup costs; (3) states and local citizens do 
     not have the ability to fully participate in the selection 
     and implementation of appropriate remedies; and (4) the 
     stigma of being listed as a Superfund site often creates 
     economic disincentives for the redevelopment and reuse of 
     contaminated properties.


                     SECTION II--GUIDING PRINCIPLES

       Community Empowerment.--The citizens who are most adversely 
     impacted by the cleanup of hazardous waste sites near their 
     homes should be empowered with a greater role in the 
     decisionmaking process and an increased responsibility in 
     helping to select the remedial action that will protect human 
     health and the environment, foster rapid economic 
     redevelopment, and promote expedited restoration of natural 
     resources.
       Enhanced State Role.--The states have developed an 
     extensive and sophisticated level of expertise in addressing 
     the problems of hazardous waste contamination outside of the 
     Superfund program. Reform of Superfund should recognize this 
     level of expertise, and should endeavor, to the greatest 
     extent possible, to empower the states to assume the lead 
     role in the Superfund process. An enhanced state role 
     recognizes that the states have a much greater day-to-day 
     involvement with their citizenry and are in a better position 
     to respond to the needs and desires of the affected 
     communities.
       Sensible Cleanup Standards.--The goal of protecting human 
     health and the environment must remain at the forefront of 
     any Superfund reauthorization measure. Nonetheless, sensible 
     Superfund reform efforts recognize that our ability to clean 
     up some sites is constrained by both a technical inability to 
     provide permanent solutions, as well as a limitation on 
     national financial resource. Cleanup decisions should be 
     premised on a careful analysis of the potential risks to 
     human health and the environment, as well as a logical 
     balancing of financial expenditures on remedy selection.
       Establish Fairer Liability Requirements.--When Superfund 
     was originally adopted in 1980, its primary purpose was to 
     clean up hazardous waste sites that threatened human health 
     and the environment. The adoption of retroactive liability to 
     pay for this program has unfairly penalized a number of 
     individuals and corporations that disposed of hazardous 
     materials in compliance with then existing federal and state 
     environmental laws. In addition, this liability system 
     created an incentive for litigation which has resulted in 
     slower cleanups and more money going to lawyers. The reform 
     of the Superfund should not only strive to lessen incentives 
     for litigation, but it should also result in a greater 
     percentage of money being dedicated towards cleaning up 
     sites.
       Restoring Natural Resources.--The sole purpose of natural 
     resource damages is to provide for the rapid restoration and 
     replacement of significant natural resources that have been 
     damaged by contact with hazardous materials. Financial 
     compensation from persons who
      caused these damages should be used solely for the purpose 
     of restoring or replacing these resources, and should not 
     serve as a means of seeking retribution or punitive 
     damages from potentially responsible parties.
       Expedited Economic Reuse.--Although the original purpose of 
     Superfund was to provide for the quick cleanup of hazardous 
     waste sites, the Superfund cleanup process has resulted in 
     delayed site cleanups, economic uncertainty for affected 
     communities, and a disincentive for industry to redevelop so 
     called ``brownfield sites.'' Reform of Superfund should 
     provide incentives for the voluntary cleanup of industrial 
     sites and the expedited reutilization of urban areas to 
     promote rapid economic redevelopment and reuse.
       The Future of Superfund.--Superfund was originally intended 
     to be a temporary program lasting for only a short period of 
     time. A comprehensive reform of Superfund should result in 
     meeting that goal. Over the next few years, this program 
     should be targeted towards completing the cleanup of the 
     Superfund sites remaining on the list, significantly reducing 
     the federal involvement, and allowing states to take the 
     primary role in the cleanup of our nation's hazardous waste 
     sites. While the Environmental Protection Agency should 
     continue to be involved in the emergency removal program and 
     research and development efforts, the eventual elimination of 
     the national priorities list should result in a system where 
     the states, and not the federal government, determine the 
     speed, method and order that hazardous waste sites will be 
     cleaned up.


                     section iii--proposed reforms

               1. Community Response Organizations (CROs)

       A. Creation of CROs.--Under this title, the Environmental 
     Protection Agency (``EPA'') or applicable state (see state 
     role below) will provide for the establishment of community 
     response organizations (``CROs'') to provide direct, regular 
     and meaningful consultation throughout the response action 
     process. CROs shall be established whenever: (1) the EPA or 
     the applicable state determines that such a group will be 
     helpful in the cleanup process; (2) when the local government 
     requests such an organization; (3) when 50 citizens, or at 
     least 20 percent of the population of a locality in which the 
     national priorities list (``NPL'') facility is located, 
     petition for a CRO; or (4) when a representative group of 
     potentially responsible parties (``PRPs'') request 
     establishment of a CRO.
       B. CRO Activities.--CROs should comprise a broad cross-
     section of the community, and its duties should include: (1) 
     serving as a forum to assist in gathering and transmitting 
     community concerns to the EPA, states, PRPs and other 
     Agencies on a variety of issues related to facility 
     remediation, including facility health studies, potential 
     remedial alternatives, and the selection and implementation 
     of remedial and removal action and land use; and (2) serve as 
     a resource for 

[[Page S 9876]]
     transmitting site information back to the community. CROs shall be the 
     preferred recipients of any
      technical assistance grant (``TAG''), and in addition, can 
     receive administrative assistance from the EPA and the 
     States.
       C. CRO Participants.--A CRO shall have a membership not to 
     exceed 20 persons, who shall serve without pay. The EPA or 
     applicable state will solicit, accept nominations and select 
     the members of the CRO. The makeup of the CRO shall represent 
     a broad cross section of the local community, including 
     persons who are or historically have been adversely affected 
     by facility contamination in their community. Local residents 
     shall comprise no less than 50 percent of the total 
     membership of the CRO. Membership on the CRO will represent 
     the following groups:
       1. persons residing or owning residential property near the 
     facility or persons who may be directly affected by releases 
     from the facility. At least one person in this group shall 
     represent the TAG recipient if such a grant has been awarded 
     prior to the formation of a CRO;
       2. members of the local community who, although not 
     residing or owning property near the facility, may be 
     potentially affected by releases from the facility;
       3. members of the local medical community and/or public 
     health officials;
       4. representatives of local Indian tribes or local Indian 
     communities;
       5. local representatives of citizen, environmental, or 
     public interest groups with members residing in the 
     community;
       6. local government which may include pertinent city or 
     county governments;
       7. workers employed at the facility during facility 
     operations;
       8. facility owners;
       9. representatives of potentially responsible parties, who 
     represent, wherever practicable, a balance of PRP interests; 
     and
       10. members of the local business community.

                    2. Enhancing the Role of States

       A. Empowering the States to List and Delist Sites.--Section 
     105 would be modified to provide the states with sole 
     authority to veto the addition of any site that
      the EPA proposes to add to the National Priorities List. 
     States would also be given the authority, with the 
     concurrence of the PRPs, to have sites taken off the NPL 
     to be managed under existing Resource Conservation and 
     Recovery Act (``RCRA'') authorities.
       B. State Delegation for NPL Sites.--States would have the 
     option of receiving delegation for the cleanup of NPL sites 
     on either a site-by-site or statewide basis. Under this 
     provision, states would request the delegation of all NPL 
     sites within their state, or they could select specific sites 
     on a site-by-site basis, or the state could choose to assume 
     delegation of no sites.
       States that choose to take NPL sites under this delegation 
     plan, would be required to utilize federal liability and 
     remedy selection procedures.
       States that currently have authorization for a corrective 
     action program under RCRA, could submit a self-certificate of 
     competence to the EPA. Such certificate shall specify whether 
     the state seeks site-by-site or statewide delegation. The EPA 
     would be required to grant automatic certification of these 
     state programs.
       States that do not have RCRA corrective action authority 
     would certify that they have the financial and personnel 
     resources, organization and expertise for carrying out the 
     implementation of the program. Within 90 days of the 
     submission of the state certification, the EPA would be 
     required to review the certification and determine if the 
     state's proposal was sufficient to run a delegated program. 
     At the end of 90 days, if the EPA failed to state an 
     objection to the state certification proposal, the delegation 
     would automatically take effect.
       C. Sole State Control of Delegated Sites.--Once a state 
     receives its certification from the EPA, the state will have 
     the exclusive authority for implementing and enforcing the 
     federal Superfund program. Delegated states would have the 
     sole authority for implementing the program, including, but 
     not limited to, remedy selection, enforcement, as well as 
     activities under CERCLA sections 104, 106 and 107. The EPA's 
     periodic review of the state programs shall be limited to 
     auditing the state's use of program funds and a narrow 
     ability to decertify states that fail to materially conduct 
     enforcement and cleanup activities.
       D. State Remedy Selection.--States that are delegated 
     Superfund authority would be required to apply cleanup 
     standards consistent with the federal Superfund program. Any 
     state with a delegated program could apply cleanup standards 
     more stringent than those required under the federal program, 
     however, the state would be required to bear the additional 
     costs of such remedies rather than the Trust Fund or the 
     PRPs.
       E. Non-Superfund Sites.--The states would be authorized to 
     conduct cleanup activities for all facilities that are not on 
     the Superfund list. This would include, with
      the exception of the 90 sites added under this proposal, all 
     of the sites which are currently on the Comprehensive 
     Environmental Response, Compensation, and Liability 
     Information System (``CERCLIS'') list.
       F. Voluntary Cleanup Programs.--In addition to delegated 
     authorities outlined above, state could also seek expedited 
     EPA approval of state voluntary response programs. Under this 
     provision, a state would be able to establish voluntary 
     cleanups at hazardous waste sites with the exception of the 
     following: (1) portions of NPL sites for which a ROD has been 
     issued; (2) portions of sites where RCRA subtitle C plans 
     have been submitted and closure requirements have been 
     specified in a plan or permit; (3) portions of sites where 
     corrective action permits or orders have been issued, 
     modified, or amended to require specific corrective measures 
     pursuant to RCRA sections 3004 or 3008; (4) portions of sites 
     controlled by or to be remediated by, a department agency, or 
     instrumentality of the executive branch of the federal 
     government; or (5) portions of a site where assistance for 
     response activities may be obtained pursuant to subtitle I of 
     RCRA from the Leaking Underground Storage Tank Trust Fund.
       G. State Assistance Grants.--An appropriate level of 
     assistance grants should be provided to the states over a 3 
     year period to build and enhance state Superfund program 
     capabilities. Additional block-grant funding shall also be 
     provided for voluntary and non-CERCLA cleanups that are 
     administered and conducted by the states.

                      3. National Priorities List

       A. Flexible Cap.--Amend Section 105 to provide that the EPA 
     would be allowed to add a total of thirty (30) new sites to 
     the NPL each year for three (3) years following passage of 
     the bill. The EPA would be required to determine and 
     prioritize, on a national basis, which 90 sites present the 
     greatest threat to human health and the environment. These 
     sites would be added to the NPL only upon concurrence from 
     the associated state (see State Role below).
       B. Sunset Provision.--Three years from the enactment of 
     this legislation, the EPA would not be authorized to add any 
     additional sites to the NPL. At the completion of cleanup at 
     sites remaining on the capped NPL, the EPA authority shall be 
     limited of providing a national emergency response 
     capability, conducting research and development, providing 
     technical assistance, and conducting oversight of grant 
     programs to the states.
       C. Expedited Delisting.--Amend Section 105 to provide that 
     sites shall be delisted once the construction of the selected 
     remedy is certified as complete. An informal rulemaking shall 
     be completed 90 days after the passage of the act outlining 
     the process through which expedited delisting shall take 
     place. If the implemented remedy
      includes institutional or engineering controls, then the EPA 
     or the applicable state should conduct a review of the 
     site every 5 years. Delisting shall in no way relieve the 
     EPA or the applicable state regulators from conducting 
     ongoing cleanup activities, monitoring or post-cleanup 
     operations and maintenance requirements.

                          4. Remedy Selection

       A. Enhanced Cleanup Flexibility.--Amend section 121(b) to 
     eliminate the preferences for permanence and treatment in 
     selecting a remedy at Superfund sites. The EPA shall be 
     directed to consider all options for addressing contamination 
     at a site including, containment, treatment, institutional 
     controls, natural attenuation, or a combination of these 
     alternatives, and select the remedy that protects human 
     health and the environment at the lowest cost. The remedy 
     selected shall recognize the limitations of currently 
     available technology.
       Interim containment and remediation shall be used at sites 
     where no current technology is available to remediate sites 
     to the containment levels necessary to protect human health 
     and the environment. Interim remedies shall be preferred 
     where: (1) other treatment remedies are available only at a 
     disproportionate cost; (2) innovative treatment technologies 
     will be available within a ``reasonable time'' (3-5 years); 
     and (3) the threat can be contained during the interim time 
     period. The EPA or the applicable state shall review the 
     interim containment plan every five years after the date of 
     construction to determine if a continued threat to human 
     health the environment warrants a modification of the interim 
     containment remedy.
       B. Revise the ARAR Mandate.--Amend section 121(d) to 
     eliminate the requirement that remedial actions must meet 
     applicable, relevant and appropriate requirements 
     (``ARARs''). Instead, allow the EPA and the applicable states 
     to utilize remedies that are more responsive to the specific 
     site conditions and risks.
       C. Protection of Human Health.--Amend section 121 to 
     specify that selective remedies should be protective of human 
     health and the environment. Remedies shall be judged to be 
     protective of the environment if they (1) protect against 
     significant risks to ecological resources which are necessary 
     to the sustainability of a significant or valuable ecosystem 
     and (2) do not interfere with a sustainable functional 
     ecosystem that is consistent with the targeted land use. The 
     objective is protection of human health and the environment 
     from realistic and significant risks through cost-effective 
     and cost-effective remedies.
       D. Requiring an Unbiased Risk Based Analysis.--Amend 
     section 121 to require that risk-based decisionmaking be 
     utilized to: (1) identify the principal elements of potential 
     risk posed by the site, and any cumulative effects posted by 
     adjacent NPL
      sites; (2) analyze the relative health and environmental 
     benefits of alternative remedies and (3) demonstrate that 
     the approved remedy will protect human health and 
     environment in light 

[[Page S 9877]]
     of the actual or planned future use of the land and water resources. 
     The tools that the EPA or applicable state would be 
     required to utilize in making this risk assessment would 
     include:
       1. actual or plausible exposure pathways based on actual or 
     planned future use of the land and water resources 
     (industrial, commercial, residential, etc.);
       2. site-specific data shall be used in preference to 
     default assumptions; and
       3. where site-specific data are unavailable, utilize an 
     acceptable range and distribution of realistic and plausible 
     default assumptions regarding actual or likely human 
     exposures and site-specific conditions, instead of high-end 
     or worst case assumptions.
       E. Planning for Future Land and Water Use.--Amend section 
     121(b)(1) to require EPA or the applicable state to quantify 
     the actual or planned future use of the contaminated land and 
     water resources based on a mix of several factors including: 
     (1) previous use of the landholdings; (2) site analysis and 
     surrounding land use patterns; (3) current zoning 
     requirements and projected future land uses; and (4) input 
     from CROs, elected municipal and county officials, local 
     planning and zoning authorities, facility owners and 
     potentially responsible parties. The EPA or the applicable 
     state shall then utilize the balancing factors listed below 
     in selecting a remedy:
       F. Reasonable Remedy Selection.--Amend section 121(b)(1) to 
     require the EPA or the applicable state to select the most 
     effective remedy that protects human health and the 
     environment, unless the remedy is technically infeasible or 
     the incremental costs are not reasonably related to the 
     incremental benefits. The following balancing factors should 
     be utilized in determining the most sensible, cost effective 
     remedy:
       1. the effectiveness of the remedy to protect human health 
     and the environment;
       2. reliability of the remedy to protect human health and 
     the environment over the long-term;
       3. any short-term risks posed by implementation of the 
     remedy to the affected community, and to remediation workers;
       4. the relative implementability and technical feasibility 
     of the remedy; and
       5. acceptability of the remedy to the affected community.
       G. Establishing Reasonable Groundwater Cleanup 
     Strategies.--Section 121 should be amended to require that 
     remedy selection for groundwater should include a 
     consideration of the current and future use of the resource, 
     including both the nature and timing of uses. The remedy 
     selection should consider a range of possible remedies 
     including pump and treat, point of use treatment, containment 
     and natural attenuation. The application of the possible 
     remedies shall be weighed against the balancing factors 
     outlined in section F (above) to determine the most cost 
     effective remedy that protects human health and the 
     environment that is not technically infeasible or where the 
     incremental costs are not reasonably related to the 
     incremental benefits. The type and timing of the resource 
     use, technical feasibility and reasonableness of cost shall 
     also be considered where the contamination threatens 
     uncontaminated, usable groundwater.
       H. Enhancing Emergency Response.--Amend section 104 to 
     increase the duration of Emergency Response actions to 24 
     months, and increase the authorized cap to $4 million per 
     site. Provide increased flexibility to emergency response 
     managers to conduct removal and cleanup activities beyond the 
     currently authorized level, where such action may 
     significantly reduce or eliminate the necessity for further 
     remedial activities at such a site.
       I. Reviewing Past Remedy Decisions.--At sites where a 
     record of decision (``ROD'') has not been signed, the EPA or 
     the applicable state shall apply the remedy cleanup 
     provisions contained within this bill. At sites where a ROD 
     has been signed, but where construction has not begun, the 
     EPA, the applicable state or the PRP can request a review of 
     the ROD to determine if the remedy reform changes contained 
     within the bill would result in a lower cost remedy that 
     protects human health and the environment than the one being 
     proposed. At sites where construction has begun, or where 
     construction has been completed, the EPA or applicable state 
     may conduct and implement a modification of the ROD where the 
     EPA or applicable state or the RPR can demonstrate that the 
     changes in remedy selection contained in the bill would 
     result in a total life cycle cost reduction of at least 10 
     percent. Under no circumstances could a review of a ROD 
     result in the selection of more costly remedies, nor would 
     there be any reimbursement for past costs. Appropriate 
     limitations would be placed on this review process to limit 
     the potential for additional litigation.

                         5. Liability Standards

       A. Repeal Retroactive Liability for Pre-1981 Disposal.--
     Amend section 107 to provide that no person shall be held 
     liable for the removal or response costs related to
      hazardous substance disposal at non-federal NPL sites that 
     occurred prior to December 11, 1980. Such costs shall be 
     paid from the Hazardous Substance Superfund (``the 
     Fund''). For those sites where disposal occurred both 
     prior to and after December 11, 1980, the fund would 
     utilize an independent allocator who would apportion the 
     liability for this pre- and post-1980 disposal. Such 
     allocator would also determine the proportionate level of 
     liability for post-1980 disposal as is described below. 
     Retroactive liability repeal would not apply to federal 
     liability that occurred at nonfederal facility NPL sites. 
     This retroactive repeal program would include a mechanism 
     to ensure that PRPs remain on the site to conduct the 
     cleanup program.
       The fund would also assume the costs of any ongoing 
     operations and maintenance costs (``O&M) for the 
     proportionate level of pre-1981 disposal activities. The 
     independent allocation process mentioned earlier would also 
     determine the level of pre- and post-1980 liability for 
     ongoing O&M for any facilities that were in construction or 
     had completed construction prior to the passage of this act.
       The fund would also assume that proportionate level of 
     liability for pre-1981 disposal activities at those 
     facilities where construction was underway at the time of the 
     act, but where the payment for that construction had not been 
     completed. In addition, the fund shall reimburse PRPs for 
     construction payments made after June 15, 1995, where such 
     activity was incurred to address pre-1981 liability. At PRP 
     led sites, the PRP shall remain responsible for conducting 
     cleanup activities, but shall be reimbursed from the fund 
     consistent with the principles outlined above.
       B. Proportionate Liability for Post-1980 Disposal.--Section 
     107 would be amended to create a proportionate liability 
     scheme for removal costs, response costs and NRD at non-
     federal facilities at which hazardous substances were 
     released. Such proportionate liability system would utilize 
     an independent allocator that would determine the appropriate 
     level of liability of each party currently liable under 
     section 107(a) of the existing law.
       No person shall be held liable for more than the share of 
     removal, response or natural resource damage (``NRD'') costs 
     attributable to that person's conduct. In determining the 
     person's proportionate share of liability, the following 
     factors shall be considered: (1) the amount of hazardous 
     substances contributed by each party; (2) the toxicity of the 
     hazardous substances involved; (3) the mobility the 
     materials; (4) the degree of involvement of each party in the 
     generation, transportation, treatment, storage, or disposal 
     of the hazardous substances; (5) the degree of care 
     exercised, taking into account the hazards posed by the 
     material; (6) the degree of cooperation with federal, state 
     and local officials; and (7) any other equitable factors as 
     the allocator determines are appropriate.
       At non-federal sites, the fund shall pay the costs of 
     ``orphan shares,'' which shall be defined to include the 
     shares attributed to bankrupt or dissolved parties, as well 
     as
      shares that cannot be attributed to any party due to 
     insufficient proof. Any PRP unwilling to pay its allocated 
     share can be sued by EPA for all unrecovered costs at the 
     site, including any orphan shares and de micromis shares. 
     Thus, non-settlors may be held liable for the orphan 
     shares and de micromis shares in addition to their own 
     shares. Settling parties would receive complete 
     contribution protection.
       C. De Micromis Disposal Exclusion.--Amend section 107 to 
     provide an exception from liability for certain parties who 
     arranged for, or accepted for, disposal, treatment, or 
     transport of municipal solid waste which contained not more 
     than 110 gallons of liquid materials containing hazardous 
     waste, or not more than 200 pounds of solid materials 
     containing hazardous waste.
       D. Lender Liability.--Amend CERCLA to limit the liability 
     of lenders or lessors that: acquire property through 
     foreclosure; hold a security interest in the property; hold 
     property as a lessor pursuant to an extension of credit; or 
     exercise financial control pursuant to the terms of an 
     extension of credit. This section would limit the lenders 
     potential liability to the gain in property value resulting 
     from another party's response action to a release or 
     threatened release. A lender would still be liable if it had 
     caused the damage, release or threat.
       1. Fiduciary Activities.--The liability of fiduciaries 
     would be limited to the excess of the assets held in the 
     fiduciary capacity that are available for indemnity. 
     Nonetheless, fiduciaries may be held liable for failure to 
     exercise due care which causes or contributes to the release 
     of hazardous materials. In addition, a fiduciary could be 
     held liable for independent actions taken or ownership of 
     properties unrelated to their fiduciary capacity.
       2. Owner Operator Definition.--Amend section 101(20) 
     Superfund to provide that the term owner or operator does not 
     include a person who does not participate in management but 
     holds indicia of ownership to protect the security interests 
     of others, nor does it include a person who does not 
     participate in management of the facility prior to 
     foreclosure.
       3. Participation in Management.--Amend section 101(20) of 
     Superfund to provide that ``participation in management'' 
     means actually participating in the management or operation 
     affairs of a vessel or facility, and does not include merely 
     having the capacity to influence, or the unexercised right to 
     control, vessel of facility operations.
       E. Response Action Contractor Liability.--(``RACs'') Amend 
     section 119 of the Act to provide a negligence standard for 
     activities undertaken by RACs. In addition, amend section 
     101(2) to provide that ``owner and operator'' does not 
     include in persons performing on written contracts to provide 
     response action activities.

[[Page S 9878]]

       F. Other Small Business Liability.--There are a variety of 
     other CERCLA liability concerns that have been raised by 
     small business that have not been outlined in this 
     legislative specifications paper. Nonetheless, such concerns 
     are intended to be addressed within the context of a 
     comprehensive CERCLA reform measure.

                         6. Federal Facilities

       A. Enhanced State Delegation.--Qualified states could be 
     delegated CERCLA authority at Federally owned or Federally 
     operated facilities, consistent with certification 
     requirements described above.
       Delegation would be contingent upon: (1) states applying 
     identical clean up standards and processes at Federal sites 
     as are applied to non-Federal sites, (2) allowing 
     uncontaminated or cleaned up parcels of property to be reused 
     as rapidly as possible, and (3) applying a definition of 
     uncontaminated property that includes property where 
     hazardous materials were stored but not released.
       The Department of Energy's Defense Nuclear Facilities where 
     the federal government is the sole PRP would remain under the 
     jurisdiction of the EPA. In addition, a limited number of 
     Department of Defense sites with exceedingly complex 
     environmental contamination would also remain under the 
     jurisdiction of the EPA.
       A risk-based prioritization processes, consistent with 
     remedy selection criteria described above, will be utilized 
     to rank proposed actions at federal facility operable units. 
     Existing Federal Facility Compliance Agreements would be 
     renegotiated based on the identified priorities. These 
     agreements would form the basis by which federal facilities 
     would be regulated by the EPA or the applicable states.
       B. Clarifying Radionuclide Regulation.--A minimum standard 
     for radionuclides would be established. Such standard would 
     also account for naturally occurring radioactive materials 
     (``NORM'').
       C. Promoting Innovative Technology.--The use of Federal 
     facilities to encourage and promote innovative cleanup 
     technology that can be used at Superfund sites would be 
     authorized. EPA would be required to develop an expedited 
     permitting process to collect cost and performance data on 
     new characterization, cleanup and waste management 
     approaches.

                      7. Natural Resource Damages

       A. Recoverable Damages.--Amend section 107 to provide that 
     natural resource damages shall only be recoverable for actual 
     injury to measurable, and ecologically
      significant functions of the environment that were committed 
     to allocated to public use at the time of the conduct 
     giving rise to the damage. The recovery shall be limited 
     to the reasonable cost of restoring, rehabilitating or 
     acquiring a substitute or alternative resource as well as 
     the cost of assessing damages to that resource. With the 
     exception of direct monetary damages resulting from a lost 
     use of the natural resource, there shall be no recovery 
     for lost use or non-use damages.
       B. Liability Cap.--Amend section 107 to clarify that no 
     natural resource damage liability shall result from 
     activities where the release or releases of hazardous 
     substances occurred prior to 1980. Where the placement of 
     hazardous materials occurred prior to 1980, but where 
     additional releases resulting from that placement occurred 
     after 1980, the PRP shall be liable for post-1980 releases 
     with a total potential liability not to exceed 50 percent of 
     the amount spent on remedial action. Where the placement of 
     materials occurred both before and after 1980, and where the 
     release or releases of hazardous substances occurred after 
     1980, the total potential liability of the PRP shall not 
     exceed 75 percent of the amount spent on remedial action. 
     Where the placement and release of the hazardous materials 
     occurred wholly after 1980, the total potential liability of 
     the PRP shall not exceed 100 percent of the amount spent on 
     medial action.
       C. Evidentiary Standard.--Amend section 107 to eliminate 
     the rebuttable presumption in favor of trustee assessments 
     for any natural resource damages claim in excess of $2 
     million. For all claims in excess of $2 million, the trustee 
     shall establish all elements of the NRD claim by a 
     preponderance of the evidence, which shall be reviewed de 
     novo by a court, upon petition of any party who is 
     potentially liable for NRD at the site.
       D. Natural Recovery.--Amend section 107 to require that 
     trustees shall give equal consideration to actions that 
     promote the use of natural recovery as an acceptable 
     alternative to replicating the precise physical, chemical, 
     and biological properties of resources prior to injury.
       E. Cost Considerations.--Amend section 107 to require that 
     restoration alternatives should include a consideration of 
     the most cost effective method of achieving the restoration 
     objective (i.e., the restoration, replacement or acquisition 
     of ecologically significant resource functions) and not 
     solely the replication of the resource.
       F. Cleanup Consistency.--Amend section 107 to require that 
     the NRD restoration standards and restoration alternatives 
     selected by a trustee shall not be duplicative of, or 
     inconsistent with, actions undertaken pursuant to sections 
     104, 106 and 121 of the act. In addition, trustees should be 
     involved early in the remedy selection process to ensure 
     consistency between resource restoration and cleanup 
     activities.
       G. Double Recovery.--Amend section 107(f) to provide that 
     there shall be no recovery for NRD under Section 107 if 
     compensation has already been provided pursuant to CERCLA or 
     any other federal or state law.

  Mr. JOHNSTON addressed the Chair.
  The PRESIDING OFFICER. The Senator from Louisiana, [Mr. Johnston] is 
recognized.
  Mr. JOHNSTON. I ask unanimous consent that the pending amendment be 
agreed to and that a motion to reconsider be laid on the table.
  The PRESIDING OFFICER. Is there objection?
  The Senator from New Mexico.
  Mr. JOHNSTON. Was that reached, Mr. President?
  The PRESIDING OFFICER. Does the Senator from New Mexico object?
  Mr. DOLE. No.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  So the amendment (No. 1517) was agreed to.
  The PRESIDING OFFICER. The Senator from Arizona is recognized.
  Mr. McCAIN. Mr. President, I ask unanimous consent to address the 
Senate as in morning business for 10 minutes.
  The PRESIDING OFFICER. Is there objection?
  Mr. LAUTENBERG. Reserving the right to object.
  The PRESIDING OFFICER. The Senator from New Jersey.
  Mr. LAUTENBERG. I would ask the Senator from Arizona how long he 
would like to take. We have an amendment that is pending.
  Mr. McCAIN. If there is a pending amendment and the managers are 
interested in moving forward, I will withdraw that unanimous-consent 
request, if it is the will of the Senate.
  Mr. DOMENICI. Mr. President, I understand there is no amendment 
pending; is that correct?
  The PRESIDING OFFICER. That is the Chair's understanding.
  Mr. LAUTENBERG. The Senator from New Mexico is right.
  Mr. DOMENICI. Mr. President, I wonder if the Senator will let me send 
an amendment to the desk, and then I will be glad to yield 10 minutes 
to him.


                Amendment No. 1533 to Amendment No. 1487

 (Purpose: To facilitate small business involvement in the regulatory 
              development process, and for other purposes)

  Mr. DOMENICI. Mr. President, I send an amendment to the desk on 
behalf of myself, Senator Bingaman, and Senator Bond and ask for its 
immediate consideration.
  The PRESIDING OFFICER. The clerk will report.
  The assistant legislative clerk read as follows:

       The Senator from New Mexico [Mr. Domenici], for himself, 
     Mr. Bond, and Mr. Bingaman, proposes an amendment numbered 
     1533 to amendment No. 1487.

  Mr. DOMENICI. Mr. President, I ask unanimous consent that the reading 
of the amendment be dispensed with.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  (The text of the amendment is printed in today's Record under 
``Amendments Submitted.'')
  Mr. JOHNSTON. Will the Senator yield for a unanimous-consent request?
  Mr. DOMENICI. Absolutely.
  Mr. JOHNSTON. Mr. President, I have cleared this request with Senator 
Lautenberg and with Senator Lott.
  I ask unanimous consent that when an amendment by Senator Lautenberg, 
which deletes the language of the toxic release inventory, is 
considered, that there be 1 hour evenly divided; that no second-degree 
amendments be in order; and that there be a vote up or down on the 
amendment.
  The PRESIDING OFFICER. Is there objection?
  Mr. NICKLES. I object.
  The PRESIDING OFFICER. Objection has been heard.
  Mr. DOMENICI addressed the Chair.
  The PRESIDING OFFICER. The Senator from New Mexico still has the 
floor.
  Mr. DOMENICI. I yield to Senator McCain 10 minutes, if the Senate 
will permit me to do that.
  The PRESIDING OFFICER. Is there objection?
  Mr. DOMENICI. I ask unanimous consent that I be permitted to yield 10 
minutes, and when he finishes, the floor be returned to the Senator 
from New Mexico to debate the pending amendment.
  The PRESIDING OFFICER. Without objection, it is so ordered. The 
Senator from Arizona. 

[[Page S 9879]]

  Mr. GLENN. Will the Senator yield?
  Mr. McCAIN. I have the floor. I will be glad to yield.
  Mr. GLENN. I want to ask a question of Senator Domenici. Would he be 
willing to enter into a time agreement?
  Mr. DOLE. Will there be any second-degree amendments on Domenici?
  Mr. DOMENICI. Let me say to Senator Levin, this has nothing to do 
with toxic matters, nothing to do with that part.
  Mr. DOLE. Mr. President, if the Senator from Arizona will yield to me 
a moment, we would like to get a time agreement on the Domenici 
amendment and then whatever we work out on the Lautenberg amendment. We 
would like to have a window of opportunity from 7 until 8 where there 
will be no votes. So if we can have one vote before 7, and then any 
other votes will be after 8 o'clock. Maybe we can work that out during 
the 10 minutes.
  Mr. BYRD. Will the Senator yield?
  The PRESIDING OFFICER. The Senator from Arizona has the floor.
  Mr. McCAIN. I will be glad to yield to the Senator from West 
Virginia.
  Mr. BYRD. I wanted to ask the distinguished majority leader why we 
could not just work ahead and not have a window of opportunity?
  Mr. DOLE. You mean work right on through?
  Mr. BYRD. Yes.
  Mr. DOLE. We will both be here. That will be all right with me. I 
think it is going to work out that way. I do not know how much time the 
Senator from New Jersey would want. If we reach an agreement, I think 
it is going to be about an hour on each amendment. I am perfectly 
willing to continue to operate without any window, but a number of my 
colleagues have obligations away from the Capitol. Obviously, the 
important thing is to finish the bill. That is the most important 
thing.
  Mr. BYRD. Mr. President, will the distinguished majority leader 
yield?
  Mr. McCAIN. I yield to the Senator.
  Mr. BYRD. Without the time being charged to the distinguished Senator 
from Arizona, without his losing his right to the floor.
  I can understand the desire of Senators to have a window, but there 
are some of us who understand that we have to stay here. We do not have 
any obligations away from the Hill. I have a wife and my little dog, 
Billy, at home. I would like to get home a little more often a little 
earlier. These windows of opportunities keep us here, those of us who 
are willing to, they keep us here in order to accommodate a few who 
want to run hither, thither, and yon, perhaps for good reason. But it 
delays the rest of us from getting the work done and getting home.
  At the same time when we have these windows of opportunities, who 
stays around here and listens to the Senators talk? This is a poor way 
to do business. I do not say this critically of the majority leader, 
because I have been the leader on previous occasions. I just hope we 
would not fall into a habit here of having these windows of 
opportunities and keeping others here who are willing to stay here and 
work and get home and know what is being said by Senators who take the 
floor for debate.
  Mr. DOLE. I appreciate the comments of the Senator from West 
Virginia, my friend. I think someone said 2 hours would do. I said, no, 
an hour should be adequate. Maybe that will not happen. Obviously, the 
important thing is to finish this bill. I think we have made some 
progress here, hopefully, this afternoon. If we can have time 
agreements, if they are less than an hour, there will be less than an 
hour window. I will work with the Senator from West Virginia. My little 
dog, Leader, misses me and your old dog Billy, we have not gotten them 
together yet.
  Mr. JOHNSTON. Mr. President, if the leader will yield, Senator 
Lautenberg has a request for a 1-hour time agreement. That would be a 
good 1-hour window right there.
  Mr. HATCH. Will Senator Dole under the same unanimous consent agree 
to another comment? Will the leader yield? We also have Senator 
Feingold. I just want to get it out so people know how many possible 
votes we have. Senator Feingold has an amendment. We have a couple of 
other Senators who may want to bring up amendments tonight.
  Mr. GLENN. Senator Pryor has one also.
  Mr. PRYOR. Mr. President, I have one.
  The PRESIDING OFFICER. The Senator from Arizona has the floor.
  Mr. HATCH. I just want everybody to be aware.
  Mr. DOLE. If the Senator from Arizona will yield to me one additional 
moment.
  Mr. GLENN. Could I have 20 seconds here? All of these agreements on 
who is going to come up with whatever, all the agreements on time are 
going to be contingent on not having second-degree amendments. I think 
we can work out time agreements or an agreement not to have second-
degree amendments.
  Mr. DOLE. I cannot speak for anybody on that. I do not have any 
amendments. Others on either side may wish to reserve that right. It is 
my understanding the other side cannot agree to any vote before 7:15. 
Somebody on that side must already be out the window.
  So we would be happy to try to work it out. We can have two votes at 
8 o'clock. If we can get agreements on the Domenici and Lautenberg 
amendments, we can do it at 8 o'clock.
  Mr. GLENN. Senator Lautenberg can accept a time agreement, but not if 
there is restriction on second-degrees.
  Mr. DOLE. As I understand it, we cannot give that assurance.
  Mr. GLENN. OK. So there will not be any time agreement.
  Mr. DOLE. What about Domenici, is that subject to second-degree?
  Mr. GLENN. We are still going through Domenici to see what is in it.
  Mr. DOLE. Why do we not let Senator McCain proceed? I think he has a 
very important statement.
  The PRESIDING OFFICER. The Senator from Arizona has the floor.

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