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“COMPREHENSIVE REGULATORY REFORM ACT” mentioning the U.S. Dept of Agriculture was published in the Senate section on pages S10266-S10269 on July 19, 1995.
The publication is reproduced in full below:
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 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 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 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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