[Congressional Record Volume 140, Number 124 (Thursday, August 25, 1994)]
[House]
[Page H]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: August 25, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
                     THE SUCRALOSE PROCESSING PLANT

  Mr. MATHEWS. Mr. President, there are other problems--I have one in 
my State of Tennessee--that we have been working on a long time, also. 
I feel I need to bring this to the attention of my colleagues this 
evening, because there comes a time when we must act. It appears this 
may be one of those situations where there will be some Members here 
who will want to join me in this effort.
  Mr. President, the distinguished William Proxmire used to bestow a 
Golden Fleece Award upon Federal spending projects that represented an 
extravagant or unjustified use of taxpayers' money. I propose a similar 
award for Federal agencies whose stubborn regulations and 
uncompromising behavior steals jobs, economic growth, and progress from 
the American people. We might call it The Golden Grinch after the Dr. 
Seuss character who stole Christmas. Whatever we call it, I propose 
that its first recipient be the Food and Drug Administration.
  As I speak, this sucralose processing plant in Newport, TN--in my 
State--stands idle and another like it is operating at reduced 
capacity. As a result, the American economy is losing 65,000 jobs, 
America's gross domestic product is losing almost $7 billion a year, 
and 14-million diabetics are being denied an important new product in 
their diets. This is happening, Mr. President, because the Food and 
Drug Administration has indulged an extensive and unreasonable series 
of delays in approving sucralose noncaloric sweetener for U.S. 
consumption.
  Sucralose is the culmination of 18 years of dogged investment and 
marketing cooperation between the United Kingdom's Tate & Lyle and 
Johnson & Johnson in the United States. In February 1987, J&J's McNeil 
Specialty Products Co., petitioned the FDA's Center for Food Safety and 
Applied Nutrition for permission to manufacture and sell sucralose in 
the United States. The company submitted a 22,000-page petition citing 
80 separate safety studies conducted over the 10 previous years.
  Mr. President, this bill here has approximately 950 pages in it; 
22,000 pages is 22 times the number of pages here in the petition. 
Before submitting the petition to FDA, 16 internationally renowned 
experts had reviewed those studies. Independently and collectively, the 
experts agreed sucralose is safe for its intended use.
  What happened after the petition arrived at FDA is an epic of 
bureaucratic frustration and decision dodging. Let me share the tale.
  The FDA's Center for Food Safety and Nutrition spent 3 years 
reviewing the company's data. In January 1990, the Center's director 
personally advised the company that the agency review was completed and 
that FDA was prepared to move forward with approval. We thought we were 
getting somewhere. In May 1990, the Center actually showed the company 
a draft regulation approving sucralose in all requested categories.
  In August--they were first notified in January they were ready to go.
  In August 1990, Johnson & Johnson and McNeil executives were informed 
by the Director they would start up production of sucralose unless he 
advised otherwise. The Director reiterated to them in August that he 
believed FDA would approve sucralose before the year end.
  Accordingly, the company set its plans in motion. Production started 
up in Georgia and Newport, TN. The Newport facility was a new plant. 
Here is a picture of it as it has been constructed. It was completed in 
1989, just 5 years ago, at a cost of $65 million. This plant has been 
sitting idle during all that period of time.
  In September 1990, the company began staffing the facility, 
eventually hiring 185 employees, because it had been assumed approval 
was on the way.
  Clearly, some of this delay was unavoidable under the circumstances. 
FDA has many first-rate scientists, and I do not mean to stand here and 
say they are all a bunch of goofs, but they have a number of first-rate 
scientists, a number of people who care about the work they are charged 
with doing. We in Congress sometimes do not do all the things we should 
do to allow them to do their job. Agency budgets have not always kept 
pace with agency needs, and the turnover is always a problem.
  To the extent we can help FDA do a better job, we will benefit 
consumers, the public health and the national economy. However, Mr. 
President, let me stress again, not all the delay in this case is 
beyond FDA's control.
  Further delay resulted from the cumbersome process FDA applies to 
food additives. Any time a third party submits comments about food 
prior to its approval, the FDA stops the review process and addresses 
those comments, although it is not legally required to do so. 
Evaluating and answering each comment is lengthy and time-consuming. 
Potentially any outside party could indefinitely delay approval of an 
additive simply by repeatedly submitting their interpretation of data.
  That is precisely what happened with sucralose.
  In October 1990, September 1991 and February 1992, a London law firm 
acting for an unnamed client submitted comments about sucralose to the 
FDA and other regulatory agencies around the world. In addition, a 
public interest group submitted four rounds of comments in May 1991, 
September 1991, March 1992 and December 1992. In each instance, FDA's 
approval process came to a halt for up to 6 months while FDA reviewed 
the data and prepared a response.
  It is instructive to contrast the behavior of the Australian National 
Food Authority with that of our FDA. When the Australians received 
similar comments from the London law firm, they wrote back asking if 
the firm was acting for another party or whether its comments were 
those of a firm of solicitors with no particular scientific expertise. 
The London law firm was never heard from again.
  The crucial point, Mr. President, is that the issues raised by these 
comments were issues that FDA had reviewed and resolved to its 
satisfaction on at least three previous occasions. They were questions 
that a group of experts, including former FDA scientists, held to have 
no human toxicological significance. What is more, the experts said 
FDA's requirement for a so-called ``scientifically defensible'' 
explanation was ungrounded and flouted established principles.
  Yet, the saga of sucralose did not end. The FDA wanted further 
explanations. An FDA Commissioner recused himself from the review. The 
company approached Health and Human Services proposing a peer review 
with independent scientists to confirm that sucralose satisfied the 
legal standard of ``reasonable certainty of no harm.'' FDA would not 
agree to be bound by findings of a scientific peer review, so the 
company had no choice but to consider yet one more study, which FDA 
promised to review promptly. The company began a study in April 1993. 
It submitted preliminary results in August, and this was 1993. FDA 
wanted the study extended, and in February and March of this year, the 
company forwarded final data from the extended study to FDA. It still 
awaits word from FDA.
  While all of this was going on--I should say while all of this was 
going astray--the World Health Organization endorsed the safety of 
sucralose. The national authorities of Australia and Canada approved 
sucralose. The American Diabetes Association and the Juvenile Diabetes 
Association pled with FDA to approve the product. And sucralose 
production was suspended in Georgia and Tennessee, putting more than 
200 people out of work in a county that has one of the highest 
unemployment rates in our State.
  Mr. President, we all appreciate the importance of a sound food 
product from the approval process. But we also understand, perhaps more 
than FDA, the importance of decisions that accept credible authority 
that are not endlessly postponed and that do not leave the people they 
affect in limbo.
  The jobs of thousands of American families, and billions of dollars 
in investments, billions of dollars added to our economy depend on 
those kinds of decisions.
  FDA and HHS seem indifferent to mail from Members of Congress. In 
January 1993, adding to the saga we were talking about, Senator Chafee, 
one of our colleagues, got an answer from Secretary Shalala in April to 
a letter he had dispatched in January. An April of 1993 letter from 
Congressman Quillen, in whose district this plant is located, was 
answered in August. A joint inquiry from me and Senator Sasser also 
drew a response from Secretary Shalala in August. She told us that we 
could read the Federal Register to learn FDA's decision.
  Mr. President, let me point out on this chart the letter which we 
addressed to FDA through the Secretary and the answer back to us. It 
says to Senator Sasser and me:

       When all questions of importance regarding the safe use of 
     sucralose are satisfactorily answered, the agency will 
     announce its decision in the Federal Register.

  And that is to two of your colleagues, Mr. President, we can read in 
the Federal Register what they have decided.
  I think the time has come for this body to determine some way in 
which we can elicit response from agencies who have the economic and 
health heartstrings of the people at their disposal.
  Mr. President, I do not want to suggest that we are being 
unreasonable or that we are asking for action on an untimely matter. As 
I indicated, 10 years of research went into this product, which is a 
sweetener made from sugar. Ten years of research went into this 
project, and then 8 years after that research was submitted to the Food 
and Drug Administration, we are still awaiting the bureaucracy to work.
  Mr. President, 200 people--185 people--have already been hired at 
this plant. They were hired based upon indications from the Food and 
Drug Administration that the product was going to be approved. Those 
200 people have been laid off now for more than 2 years, and we still 
have no answer to the questions we asked.
  Mr. President, losing these jobs, income, and output is the price 
Americans and the American economy will pay.
  Mr. President, I ask for this agency to be responsive. I ask this 
body to join me in asking FDA to do that which is clearly indicated by 
the research that they have. Either approve the product or turn this 
down and let us use this plant for some other reason.
  Clearly, when this product is on the market today, it can be bought 
in any of these other jurisdictions, it is being used generally, 8 
years is long enough for us to decide whether or not the product is 
safe. I submit the case, Mr. President.
  I yield the floor.

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