[Congressional Record Volume 141, Number 117 (Wednesday, July 19, 1995)]
[Senate]
[Pages S10266-S10269]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


                  COMPREHENSIVE REGULATORY REFORM ACT

  Mr. KENNEDY. Madam President, on a matter that the Senate has been 
debating over the period of the last 9 days, regulatory reform bill, it 
has been temporarily laid aside for now, but I rise at this time to 
call the attention of my colleagues that the bill contains an 
unfortunate and unwarranted provision that would drastically undermine 
fundamental food safety standards in current law. I intended to offer 
this amendment yesterday prior to the time that the bill was set aside.
  I want to speak briefly to this issue. I hope the issue would have 
been addressed by those in the process of considering the regulatory 
reform bill, or have an opportunity to address it when the legislation 
comes back. It addresses one of the very serious failings of this 
legislation. I want to take a few moments of the Senate time to address 
it.
  This is a different issue than the meat inspection question we 
debated last week. It involves the unfortunate and unwarranted 
provision that would drastically undermine the fundamental food safety 
standards that exist in current law.
  America has the safest food supply in the world. Families go to a 
supermarket to purchase meat or vegetables, to buy baby food or apple 
sauce for young children they do so, secure in the knowledge that what 
they buy, and any additives contained in them, meet strict safety 
standards enforced by the Department of Agriculture and the Food and 
Drug Administration.
  When contaminated food inadvertently reaches the public, these 
agencies have the power they need to protect the public health. The 
basic food safety standards were enacted into law many years ago. 
Today, they are relied on and taken for granted by the American public. 
That is absolutely how it should be. No one has to give a second 
thought to the safety of the food that they eat today--and they should 
not have to start to worry about it tomorrow.
  The safety of American food not only benefits consumers, it provides 
a competitive advantage to the U.S. food industry in the global 
markets. The label ``Made in the USA'' on a can or jar of food is a 
signal to people everywhere that the product meets the highest 
standards of safety and cleanliness.
  Two of the cornerstones of the Federal food safety law are contained 
in section 409 of the Federal Food, Drug, and Cosmetic Act. The 
relevant language of that section reads as follows: A food additive 
shall not be approved ``if a fair evaluation of the data before the 
Secretary fails to establish that the proposed use of the food 
additive, under the conditions of the use to be specified in the 
regulation, will be safe: Provided, that no additive shall be deemed to 
be safe if it is found to induce cancer in man or animal * * *.''
  This provision is known as the Delaney clause. This simple statement 
is the basis for the establishment of safety for the food supply in the 
United States. These two provisions together deal with food safety and 
also the limitation of carcinogens in pesticides, in food coloring, and 
in other areas as well, but food additives primarily.
  What we have done in this proposal that is before the Senate is 
changed both of these standards. I wonder why? I wonder where the call 
is across the country for people that say our food is too safe? I think 
few would ever have had the circumstance where anyone 

[[Page S 10267]]
came up and said ``Senator, one of the overwhelming problems we are 
facing in our country is the food supply that is too safe. Do something 
about it.''
  It is very interesting, Madam President, that when the regulatory 
reform bill was submitted, it repealed, effectively, the Delaney clause 
that provides restrictions on food additives primarily, into the food 
supply.
  We commented on that in the course of the Judiciary Committee markup. 
Lo and behold, when that measure was reintroduced here on the Senate, 
the Johnston-Dole amendment, we found changes not just in the Delaney 
clause, but we found changes in the food safety, as well--dramatic 
change.
  It just happened between the time it got out of the Judiciary 
Committee and the time it was reintroduced here, without any hearings, 
without any notification, without any real explanation in reviewing the 
record about what was the reason for the changing in our food safety 
laws. I think that is wrong, and we will have an opportunity in the 
Senate, should that legislation come back to address it.
  Now, as I mentioned, the first paragraph here requires that any 
additive to food safety must be safe. The second proviso is the Delaney 
clause, first enacted into law in 1958 and expanded in 1960. The 
Delaney clause prohibits the use of food additives, food colorings, 
animal drugs, and in some circumstances pesticides if they are found to 
cause cancer in humans or in animals. The Delaney clause provides a 
zero-tolerance standard for cancer-causing substances in food.
  In recent years, critics have claimed that the Delaney clause is 
unscientific and overbroad. Clearly, there has been a revolution in 
food science and biochemistry since 1958, when the Delaney class was 
enacted. We now have the technology to identify cancer-causing 
chemicals in foods, in far smaller trace amounts than possible 40 years 
ago. We also understand that animals may develop tumors from certain 
chemicals through pathways of animal biology that humans do not have.
  Zero tolerance, therefore, means something different today than it 
did in 1958. Tiny amounts of substances that could not be detected at 
all in the 1950's can be detected today. In 1958, testing equipment 
might have considered zero risk to be a 1 in 100,000 chance of causing 
cancer. Today, we have scientific instruments that can detect risk 
levels as low as 1 in 1 billion. Clearly a modern standard of risk is 
warranted.
  Responsible voices have argued for reform of the Delaney clause. The 
National Academy of Sciences first recommended Delaney reform in a 1987 
report. In 1993, the Academy called for a more scientific health-based 
safety standard for approving pesticides.
  Senator Leahy and I and others have introduced detailed legislation 
in each of the last three Congresses to implement the Academy's 
recommendations, and we would welcome the opportunity to continue that 
complex sensitive task in the committees of jurisdiction.
  Unfortunately, the bill before the Senate takes an irresponsible 
approach to a subject with such grave implications. It contains 
haphazardly drafted lines in a 97-page bill on regulatory reform that 
emerges from two Senate committees without any expertise in food 
safety, without any hearings, and without any public input from the 
scientific community.
  These 10 lines would wipe out the Delaney clause, and in its place 
they insert a vague standard of negligible or insignificant risk. The 
phrase ``negligible or insignificant risk'' is not defined in the bill.
  This is on page 71 of the Dole proposal, on lines 21 and 22, where 
they say:

       . . . shall not prohibit or refuse to approve a substance 
     or product on the basis of safety where the substance or 
     product presents a negligible or insignificant foreseeable 
     risk to human health.

  And, if you look at the top, at line 15, it applies not just to 
Delaney, but it applies to all of this provision.
  What is the significance of that? Does negligible or insignificant 
risk mean a risk of 1 in 1 million? Or 1 in 1,000? How many additional 
cases of cancer are acceptable under a negligible risk standard? 
Perhaps a negligible risk means any level of risk that will not cause 
an immediate health disaster. Codification of such a vague standard 
would cause a major uncertainty for both consumers and industry. Its 
interpretation could vary from one administration to another.
  In addition, the proposed language does nothing to ensure adequate 
protection of infants and children who are uniquely susceptible to 
foodborne toxins because their diets are so different from those of 
adults.
  Madam President, this chart indicates what the current law is. Under 
the current law the language is, as I mentioned earlier, will be safe, 
which means a reasonable certainty of no harm. It is a no harm 
standard. Effectively that is the food standard now in the United 
States and effectively has been there for a period of some 40 years. 
How that is being changed at the present time under S. 343 is that food 
additives may cause negligible or insignificant risk of harm--not too 
much harm.
  So now anyone who goes into the supermarket knows that in whatever 
part of the supermarket they go to, their food will be safe--the 
certainty of no harm. That is the current standard and that is the 
standard that is defined at FDA in their statute. It is defined, 
understood. It has been tested and it has been court tested and is 
being adhered to. And that is why we have the safest food in the world.
  But in this proposal, in S. 343, it says, ``not too much harm,'' 
without defining the standard. Whose interest is that in? Is that in 
the public's interest? Is that in the family's interest? Is that in 
children's interest, or parents' interest? It is not. But it is in 
certain of the food industries' interest. Certain food industries want 
those changes.
  They have not testified. They have not submitted the scientific 
information. They have not come on up here and debated that issue with 
scientists and other food experts who understand the importance of 
these kinds of changes. All they have done is had the political muscle 
to get it into the current bill without any hearings. Madam President, 
that is not right to think we ought to be moving ahead on that without 
that kind of consideration of scientists and researchers, understanding 
the full implications about it, and without any adequate explanation or 
definition of what is insignificant risk. I have been listening out 
here on the floor of the Senate to those supporting the Dole-Johnston 
proposal saying, ``We want to have this more specific. We want to 
really understand what your proposal would be.'' We would like to ask 
them to define what is the insignificant risk? It is not defined in 
their bill and it is not time to play Russian roulette with the health 
and safety of our food supply by including that into a measure that 
could become law.
  Let us just think about this language in another way. The proposed 
language in the legislation, also, with the changes in the Delaney 
provisions which I mentioned which restrict any food additives that can 
have any cancer-causing products in them, the proposed language does 
nothing to ensure adequate protection of infants and children who are 
uniquely susceptible to foodborne toxins because their diets are so 
different from those of adults. This issue is the central conclusion of 
the 1993 National Academy of Sciences report. Dr. Philip Landrigan of 
Mount Sinai Medical Center, who chaired the committee of scientists 
responsible for the NAS report said, ``[i]f you're going to throw 
Delaney away, you're going to have to replace it with something equally 
protective of children.''
  Perhaps Delaney has its flaws, but its zero tolerance for cancer-
causing substances clearly and unequivocally protects children, and the 
Dole-Johnston proposal would clearly and unequivocally expose children 
to more hazards of cancer.
  We know that cancer now kills more children under 14 than any other 
disease. The incidence of childhood brain cancer and childhood leukemia 
has increased 33 percent since 1973.
  Why would anyone thoughtlessly permit industry to put more 
carcinogens in the food supply at a moment in time when we are already 
losing the war on childhood cancer, and adult cancer, too? The 
incidence of cancer has increased 48 percent since 1950--and that 
statistic excludes lung cancer, which has also increased dramatically 
due to smoking. Environmental toxins are already taking a heavy toll on 
the health 

[[Page S 10268]]
of Americans. This is no time to recklessly open the floodgates and 
permit cancer-causing additives to enter the food supply for the first 
time in 37 years--the first time in 37 years.
  This legislation is irresponsible. It repeals the existing zero risk 
standard without providing for a clear, scientific measure of risk. It 
ignores the rising risk of cancer faced by infants and children. This 
is not a Contract With America, it is a Contract With Cancer.
  Madam President, let me just put up here a chart that reflects what 
the National Academy of Sciences has pointed out that is something that 
ought to be obvious to all parents. That is, very small children's 
immune systems, respiratory systems, and nervous systems are all in the 
early development through childhood and through their teens, and these 
systems are much more sensitive, as a result of body weight and growth, 
to the various kinds of environmental toxins in our society. That is 
understood by any cancer researcher and has been documented by the 
National Academy of Sciences.
  Understanding that, the National Academy of Sciences reviewed the 
food consumption of infants and into their early teens. What they found 
out is that there is 21 times the amount of apple juice consumed by 
small children than adults, 11 times the grape juice, and right down 
the list--bananas, 7 times as much consumption by small children than 
adults, all the way down, with milk, and continuing along.
  Then over here it gives the percent of diet. Apple juice is 10 
percent of the diet for children; milk, 12 percent; orange juice, some 
10 percent for the diets of small children. What the National Academy 
of Sciences said is, since children are the most vulnerable and since 
they consume these kinds of products, should we not look, for example, 
at the number of carcinogens that they intake, particularly in the 
areas of pesticides, so we might be able to prevent the incidence of 
cancer increasing in the children? They did a thorough study on that, 
sensitive to the developmental problems of small children and also the 
types of pesticides that are being used on these products.
  Some of their examples: Apples have 123 different pesticides on them. 
We have to look at this from a scientific point of view. The bottom 
line on this is the Academy of Sciences says if we are serious about 
trying to develop a process concerning the use of various pesticides, 
we ought to determine what are the foods which small children eat 
primarily and look at the tolerance level for those children and 
develop a policy that is going to be sensitive to the incidence of 
carcinogens, cancer forming agents, and the risks that they have. It 
makes common sense. It can make a difference,
 particularly when we are seeing the number of child cancers which have 
been escalating. Do you think that has been included in this regulatory 
reform? Absolutely not.

  Do you think there was any willingness to consider that kind of 
recommendation of the Academy of Sciences? Absolutely not.
  Has there been any willingness on the other side to review or accept 
or incorporate this kind of concept? Absolutely not, because they have 
the votes. They have the votes to put at greater risk our food supply 
and to basically say we are not going to pay any attention to the best 
science that we have in this country at the Academy of Sciences as it 
relates to children.
  I heard out here during those earlier debates that what we want to do 
is eliminate bureaucracy and bring in the best science. This is the 
best science. But the supporters of that program are quite unwilling to 
address it or to be responsive to it.
  Finally, as we know, the Delaney clause currently applies to four 
different categories of products--food additives, certain pesticides, 
animal drugs, and food colorings. Different considerations apply to 
reform in each of these areas.
  In the case of pesticides, it may be appropriate to weigh the risks 
of the chemicals against the importance of a stable food supply. But 
there is no justification for allowing cancer-causing food colorings. 
There is no benefit to the public from an M&M colored with red dye-No. 
3 versus Red dye-No. 40. If food colorings cause cancer in laboratory 
rats, they should simply be banned from our food supply.
  That would make pretty good common sense--but not the regulatory 
reform legislation; no willingness to try to give that any kind of 
consideration.
  Thirty-five years ago, in 1960, Congress held hearings to consider 
legislation to expand the Delaney clause. An industry witness testified 
that any such expansion would be foolish hysteria. He gave the 
committee an example of a chemical that caused cancer in animals but 
that he said posed no risk to human health. That chemical was DES. The 
tragedy that ensued for thousands of women who took DES should be 
enough alone to stop the Senate in 1995 from capitulating to the food 
industry's efforts to weaken public health. We can reform the Delaney 
clause without destroying it.
  At the appropriate time, I will offer an amendment to strike the ill-
considered provision in S. 343, and replace it with a sense-of-the-
Senate resolution which, if adopted, will put the Senate firmly on 
record in favor of prompt and responsible Delaney reform.
  The amendment states unequivocally that ``the Delaney clause in the 
Food, Drug and Cosmetic Act governing carcinogens in foods must be 
reformed,'' and that the current Delaney clause should be replaced by a 
scientific standard that takes account of the right of the American 
people to safe food; the conclusions of the National Academy of 
Sciences concerning the diets of infants and children; the importance 
of a stable food supply and a sound farm economy; and the interests of 
consumers, farmers, food manufacturers, and other interested parties.
  In addition, the amendment establishes a timetable for responsible 
legislative action. It states that the Senate should enact Delaney 
reform, based on this work, by the end of the first session of this 
Congress--in other words, by the end of this year. It seeks careful, 
but expedited, consideration of the matter by the committee of 
jurisdiction, where the scientific experts as well as the food industry 
will have an opportunity to be heard.
  In fact, the Labor and Human Resources Committee is currently 
considering a comprehensive FDA reform bill. That bill would be an 
appropriate vehicle for Delaney reform. The views of the Agriculture 
Committee are also essential to consider legislation of concern to 
farmers.
  Food safety is a complex, technical subject. A substantial body of 
scientific research exists on this subject that should inform our work 
in this area through hearings and consultation with the experts. That's 
what committees are for. Let us do this right.
  This bill does not represent a rational, responsible reform of the 
Delaney clause. Instead, it represents a surrender to business greed 
for higher profits and to the most irresponsible elements of the food 
processing industry. Its philosophy on food safety is simple and 
sinister--let the buyer beware, the public be damned.
  And that is only half the problem with this provision. In its zeal to 
uproot the Delaney clause and assist the food industry, the Dole-
Johnston alternative drastically weakens the general food standard in 
current law.
  There is legitimate serious debate about Delaney reform. But there is 
no serious debate, legitimate or illegitimate, about a wholesale 
weakening of the general standard that protects food from other harmful 
additives.
  I repeat that, Madam President. As we pointed out, there may be 
reason--and I believe that there is reason--for debate about the 
Delaney clause here. But I do not see, and I wait to hear, what the 
justification is for changing the safe food standard that we have at 
the present time that has been in place for 40 years. Who is asking us 
to do this? Who is requesting it? Where is the mail that is coming in 
to our colleagues? Who are going to be the beneficiaries of it? Who are 
going to be put in greater risk because of it?
  I think the answers to those questions are quite clear. It is an 
aspect of the food production industry that is favoring their position, 
but it certainly is not the families in this country that deserve it.
  The Federal Food, Drug and Cosmetic Act now requires that for a non-
cancer-causing food additive to be approved, its sponsor must 
demonstrate that it will be safe. Under that standard, FDA approves 
additives today if 

[[Page S 10269]]
they present a reasonable certainty of no harm. But under the Dole-
Johnston proposal, the language of the Delaney reform is carried over 
to the general standard for food safety. FDA would be required to 
approve additives that caused only a negligible or insignificant risk 
of harm--in other words, instead of the current law standard of no 
harm, the proposal would establish a weaker standard of not too much 
harm.
  Perhaps this change is inadvertent. It certainly is unjustified and 
unneeded. Perhaps, in aiming at the Delaney clause on cancer-causing 
substances, the sponsors mistakenly hit the general food safety 
standard too. Or perhaps the food industry lobbyists saw their chance 
and took it--to get out from under the Delaney clause, and get out from 
under the general food safety standards too.
  It is a long way from no harm to not-too-much harm, and before we 
travel down that road we had better be very sure we know the 
consequences.
  The amendment I will offer when we return to the bill, in addition to 
dealing with the Delaney clause, will also delete the provision 
weakening the general food safety standard. The provision seems to be a 
gratuitous weakening of a standard that is working well in current law 
and does not need reform. If a change in this important law is not 
necessary, it is necessary not to change it.
  The bedrock food safety standard in current law should not be 
discarded lightly. Any legislation in this area must reflect the care 
an deliberation due a subject as important as whether the citizens of 
this country, especially infants and children, are now to be exposed to 
a higher risk of cancer and other diseases in the food they consume.
  Madam President, toward the conclusion of my remarks I remind the 
Senate once again what has been happening to cancer incidence in the 
American population. It has increased by 48 percent since 1950. This is 
excluding cancers of the lung and the stomach.
  Here we see what has been happening. We have seen the treatment of a 
number of these, particularly childhood cancers, have gotten much 
better. So the burden among the children in this country in many 
instances has been increasingly hopefully beneficial in terms of the 
treatment.
  But when we see the continued increase in the incidence of cancer, 
and the danger that brings, why should we be out here flying in the 
face of a National Academy of Sciences' study which has recommended how 
we can protect children, and throwing that recommendation, which 
represents the best in terms of scientific information, over our 
shoulder and throwing it to the winds? I fail to understand the logic 
of that position.
  Everyone knows what is going on here. Food industry lobbyists are 
trying to stampede Congress into hasty action on the Delaney clause 
that will have drastic long-term consequences for the safety of the 
food supply of 250 million Americans. I have never heard any consumer 
say that they think food is too safe.
  Those who vote for this amendment go on the record in support of 
prompt but responsible Delaney reform and against any tampering with 
the general food safety standard.
  The Delaney clause may have outlived its usefulness, but it deserves 
a decent burial. It deserves to be replaced by a modern safety standard 
that strikes the right balance between the needs of industry and the 
health of our children. And the general food safety standard deserves 
to remain intact.


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