[Congressional Record Volume 141, Number 117 (Wednesday, July 19, 1995)]
[Senate]
[Pages S10269-S10270]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


              REGULATORY REFORM AND FOOD SAFETY STANDARDS

  Mr. HATCH. Mr. President, contrary to what opponents of S. 343 
allege, enactment of our bill would neither undermine the existing 
standard for food safety nor needlessly expose our citizens--man, 
woman, or child--to carcinogenic substances.
  Although we are today considering the Bosnian arms embargo issue, 
since the issue of the Delaney clause has arisen, I wanted to take this 
brief opportunity to respond to some inaccuracies that were propounded 
in this Chamber today.
  I will limit my remarks now to two criticisms raised today: that S. 
343 lessens the safety standard for all foods; and that the bill is 
defective in that it lacks a definition of negligible or insignificant 
risk.
  I plan to defer the rest of my remarks on Delaney clause issues for 
our continued consideration of S. 343.
  As my colleagues are aware, the three Delaney clauses contained 
within the Federal Food, Drug and Cosmetic Act to ban a limited group 
of substances--food additives, color additives, and animal drugs--if 
they are found in whatever quantity to produce cancer in laboratory 
animals.
  This inflexible zero risk standard in the law is outdated 
scientifically, as my colleague, Senator Kennedy, noted earlier.
  Some have alleged that the Delaney clause modification language of S. 
343 somehow fundamentally undermines our Nation's food safety laws. 
That simply is not the case. It is unfortunate that some of my 
colleagues are relying on the interpretation of lawyers at the Food and 
Drug Administration who apparently cannot read the law--and this is not 
the first time those in this Chamber have had that experience.
  So that this is perfectly clear to my colleagues, I want to walk 
through this issue so that you can see how the language contained in S. 
343 continues to protect the public health.
  The Delaney clause modification language in S. 343 states:

       The Secretary of Health and Human Services and the 
     Administrator of the Environmental Protection Agency 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 resulting from its intended use.

  This provision of S. 343 harmonizes the safety standard of the three 
Delaney clause provisions with the safety standard long applied by FDA 
under the other safety provisions contained within the Food, Drug and 
Cosmetic Act.
  In other words, there are substances which could be present in food, 
or added to food, or indeed, used on or in the human body, which are 
not subject to the Delaney clause language. To single out these three 
Delaney clause substances for treatment other than that accorded a 
broader group of substances used for virtually identical purposes is 
senseless, especially in view of the fact that FDA has a well-
established safety standard for those substances which does incorporate 
the negligible risk standard.
  For the edification of my colleagues, I will list these substances: 
pesticide residues that do not concentrate in processed food; food 
substances that are not classified as additives because they are 
generally recognized as safe or were approved by FDA or USDA during the 
period 1938 to 1958; dietary supplement ingredients; constituents of 
food additives; constituents of color additives; environmental 
contaminants in the food supply; cosmetic ingredients; undetectable 
animal drug residues; and ingredients in nonprescription and 
prescription drugs, biologics, and medical devices.
  To make a distinction in the safety standard for these substances 
versus food additives, color additives, or animal drugs, is, at best, 
irrational.
  My colleague from Massachusetts has expressed the concern that in 
amending section 409(c)(3) of the Food, Drug and Cosmetic Act, the 
language of S. 343 eliminates the safety standard for all foods from 
the law.
  Specifically, 409(c)(3) says:

       No regulation [food additive approval] shall issue if a 
     fair evaluation of the data before the Secretary--
       (A) fails to establish that the proposed use of the food 
     additive, under the conditions of 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 when 
     ingested by man or animal. . .[Delaney language].

  It is my understanding that my colleague is concerned that the way in 
which S. 343 was drafted, that is, modifying all of 409(c)(3) instead 
of just the proviso containing the Delaney language, eliminates 
entirely the existing safety standard.
  I believe the implication is that the modification should be made to 
the proviso only.
  I simply do not believe that is an accurate reading of the law, when 
the totality of the Food, Drug and Cosmetic Act provisions with respect 
to food safety are read together.
  I want to assure my colleagues that that was not our intent. In fact, 
I do 

[[Page S 10270]]
not recall ever hearing any one suggest that that should be the case, 
in any discussions I have had on the Delaney clause.
  There exist a number of safety standards which apply to food under 
the Federal Food, Drug and Cosmetic Act. Some of these standards 
overlap--that is, more than one standard may apply to a food or food 
ingredient or constituent, depending on the particular circumstances.
  First, there is the general adulteration standard under section 
402(a)(1) of the FD&C Act. This section, which applies to food 
generally, says that a food is deemed to be adulterated (that is, 
unsafe) if:

       It bears or contains any poisonous or deleterious substance 
     which may render it [the food] injurious to health; but in 
     case the substance is not an added substance such food shall 
     not be considered adulterated under this clause if the 
     quantity of such substance does not ordinarily render it 
     injurious to health.

  This safety standard has two parts. For poisonous or deleterious 
substances added to food, the food is adulterated if the substances may 
render the food injurious to health. For substances which are not 
added, that is, they are inherent or not the result of human activity, 
the adulteration standard is ordinarily injurious to health.
  These two principal adulteration standards have been bulwarks in the 
legislative and regulatory scheme to ensure the safety of food for 
decades. Indeed, numerous courts have had occasion to interpret these 
provisions, for example, in U.S. v. Boston Farm Center, Inc. (590 F.2d 
149 (4th Cir. 1979) and United States vs. Anderson Seafoods, Inc., 622 
F.2d 157, (5th Cir. 1980).
  These standards remain unamended in S. 343 and would continue to 
guarantee the safety of our food supply.
  Second, it is important to note that the adulteration standards found 
in section 402(a)(1) are independent of the requirement that such food 
ingredients as food or color additives be shown to be safe. Or put more 
simply, any legislative change to section 409 dealing with food 
additives, for example, would not affect the adulteration standards in 
section 402(a)(1).
  In fact, FDA has used the 402(a)(1) standard to permit quantities of 
substances, including recognized carcinogens such as aflatoxin--a 
naturally occurring toxicant from mold which particularly affects 
peanuts--to be in food. In such a case, FDA has typically employed risk 
assessment to determine the level of the carcinogenic poisonous or 
deleterious substance that presents only an insignificant risk.
  Third, numerous other safety standards are set forth in section 402 
of the FD&C act. One of the principal additional standards provides 
that a food is adulterated if it contains a poisonous or deleterious 
substance which is unsafe within the meaning of section 346.
  Section 346 provides that a food containing a poisonous or 
deleterious substance is unsafe for purposes of section 402, and thus 
is adulterated unless the substance is required in the production of 
the food or cannot be avoided by good manufacturing practice.
  It is under the principals of section 346 that FDA has regulated 
environmental contaminants, including such substances as PCBs, a 
particularly toxic group of chemicals once widely used in industrial 
production, and PBBs, a flame retardant that was mistakenly applied to 
food in Michigan.
  FDA has implemented this section through the use of action levels and 
tolerances, which are announced levels of the toxic substance that will 
be permitted in food.
  As Professor Richard Merrill observed in ``Regulating Carcinogens in 
Food: A Legislator's Guide to the Food Safety Provisions of the Federal 
Food, Drug and Cosmetic Act,'' (77 Mich L.Rev. 171 (1978), ``Most 
notably section 406 . . . does not unequivocally preclude the marketing 
of food that contains an added carcinogenic substance.'' Professor 
Merrill adds that ``FDA has taken the position that it may establish a 
tolerance for a contaminant shown to be carcinogenic--and thus 
'approve' its presence in food in quantities below the tolerance.''
  As is the case with respect to section 402(a)(1), the legislative 
language contained in S. 343 has no effect on the important safety 
standard found in the interplay between sections 402(a)(2)(A) and 
section 406.
  Fourth, section 402 contains numerous other standards related to the 
safety of food, including those that pertain to food that contains 
filthy, putrid or decomposed substance, that has been prepared under 
unsanitary conditions, that contains unlawful pesticide residues, or if 
the package of the food contains a poisonous or deleterious substance 
that may render the food injurious to health, (the same standard as set 
for in section 402(a).
  The second point on which I would like to comment is the contention 
that not defining insignificant or negligible risk in legislation 
language is a bad idea.
  I take vigorous exception to the idea that the Congress should define 
these terms in law. Imposition of the zero risk standard by legislative 
fiat is what led to the Delaney dilemma in the first place.
  When Congress first enacted a Delaney amendment in 1958, scientists 
were not able to detect potentially carcinogenic substances at the 
parts per million, or parts per billion, levels as they are today. Does 
this mean that we should lock into the law a one in a million lifetime 
risk of cancer standard? I think not. What our bill does is allow the 
agencies to make these definitions. This will allow the law to grow 
with the science.
  In closing, Mr. President, let me reiterate my continued commitment 
to Delaney reform which both protects the public health and is 
consistent with sound scientific and regulatory principles. This is 
long overdue.


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