FOOD ADDITIVES: COMPETITIVE, REGULATORY, AND SAFETY

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FOOD ADDITIVES: COMPETITIVE,
REGULATORY, AND SAFETY PROBLEMS
HEARINGS
BEFORE THE
SELECT COMMITTEE ON SMALL BUSINESS
UNITED STATES SENATE
NINETY-FIFTH CONGRESS
FIRST SESSION
ON
FOOD ADDITIVES: COMPETITIVE, REGULATORY,
AND SAFETY PROBLEMS
PART 1
JANUARY 18 AND 14, 1977
Printed for the use of the Select Committee on Small Business
U.S. GOVERNMENT PRINTING OFFICE
9 O480 WASHINGTON t 1977
For sale by the Superintendent of Documents, U.S. Government Printing Offies
Washington, D.C. 20402
_)1 2,1 a
-
SELECT COMMITTEE ON SMALL BUSINESS
GAYLORD NELSON, Wisconsin, OWmrnws
THOMAS J. McINTYRE, New Hampshire LOWELL P. WICKER, JR., Connecticut
SAM NUNN, Georgia DEWEY F. BARTLETT, Oklahoma
WILLIAM D. HATHAWAY, Maine BOB PjCKWOOD, Oregon
FLOYD K. HASKELL, Colorado
JOHN C. CULVER, Iowa
WILLIAM B. CHEUKAUKY, $to# Direotor
BaNZAMIN GORDON, Staff Hoonom4t
LARRY S. Gasulsuao, Mftorfty 0ounsel
KARMN YouNo, Research Aessant
(n)
CONTENTS
OPENING STATEMENT
Nelson, Hon. Gaylord, a U.S. Senator from the State of Wisconsin, and Page
Chairman, Senate Small Business Committee ------------------ 1
ALPHABETICAL LIST OF WITNESSES
THuRSDAY, JANUARY 18, 1977
Ahart, Gregory J., Director, Human Resources Division, U.S. General Ac-
counting Office, accompanied by Albert B. Jojokian, GAO; and Stuart
Fleishman, GAO ------------------------------------------ 8
Gardner, Sherwin, Acting Commissioner, Food and Drug Administration,
Public Health Service, U.S. Department of Health, Education, and.
Welfare, accompanied by Dr. Howard R. Roberts, Acting Director,
Bureau of Foods, FDA; Richard A. Merrill, Chief Counsel, FDA; Mr.
Ronk, Bureau of Foods, FDA; and Dr. Blumenthal, Director, Division
of Toxicology, FDA --------------------------------------- 86
Wolfe, Sidney, M.D., Public Citizen's Health Research Group- --------- 441
EXHIBITS
Letter dated March 1, 1977, to Sherwin Gardner, Acting Commissioner,
Food and Drug Administration, U.S. Department of Health, Education,
and Welfare, from Senator Gaylord Nelson, Chairman, Senate Small
Business Committee ------------------------------------- 184
Letter dated May 6, 1977, to Senator Gaylord Nelson, Chairman, Senate
Small Business Committee, from Sherwin Gardner, Acting Commis-
sioner, Food and Drug Administration, U.S. Department of Health,
Education, and Welfare ----------------- 187
Letter dated January 81, 1977, to Judy Robinson. professional staff mem.
ber, Subcommittee on Migratory Labor, Committee on Labor and Public
Welfare, from Robert C. Wetherell, Jr., Director, Office of Legislative
Services, Food and Drug Administration ----------------------- 417
Letter dated February 21, 1977, to Senator Gaylord Nelson, Chairman,
Senate Small Business Committee, from Robert M. Heywood, M.D.,
Allergy Unit, Department of Internal Medicine, Marshfleld Clinic- ----- 424
Letter dated January 17. 1977, to Senator Gaylord Nelson, Chairman,
Senate Small Business Committee, from Del Harding. Director of Public
Relations, National Jewish Hospital and Research Center ----------- 425
Summaries of GAO Studies:
"Need to Establish the Safety of Color Additive FD&C Red No. 2,"
report of the Comptroller General of the United States, October 20,
1975 ------------------------------------------- 27
"Regulation of Food Additive Aspartame," report of the Comptroller
General of the United States, April & 1076 --------------------- 432
"Need to Resolve Safety Questions on Saccharin," report of the Comp-
troller General of the United States, Auqust 16. 1976- ----------- 485
Article, "Toxicological Methods and Trends in Toxicological Research,"
by Leo Friedman. Director, Division of Toxicology, from FDA Bylines
No. 4. January 1974 ----------------------------------- 4
Letter dated Januarv 11, 1977. to the Actinz Commissioner. Fond and Drug
Administration, from Anita Johnson, Esq., and Sidney Wolfe, M.D.,
Public Citizen's Health Research Group ----------------------- 468
(R)
IV
BEARING DATE
January 18,1977:
Mo rni ng session .....
LETTERS; ADDITIONAL TESTIMONY SUBMITTED FOR THE RECORD;
ADDITIONAL INFORMATION
Article, "FDA Regulates Half of Backlogged Chemicals in NCI Testing
Program," from Food Chemical News, January 81, 1977, pp. 51-52 ------ 491
Letter dated December 16, 1976, to Dr. Paul F. Hopper, acting executive
director, Food Safety Council, care of General Foods Corp., from Senator
Gaylord Nelson, Chairman, Senate Small Business Committee -------- 498
Letter dated February 24, 1977, to Senator Gaylord Nelson, Chairman,
Senate Small Business Committee, from Robert W. Harkins, Ph. D., vice
president, Scientific Affairs, Grocery Manufacturers of America, Inc--- 495
Letter dated February 28, 1977, to Senator Gaylord Nelson, Chairman,
Senate Small Business Committee, from Ben F. Feingold, M.D., Depart.
ment of Allergy, Kaiser Permanente Medical Center --------------- 518
Letter dated March 4, 1977, to Judith Robinson, legislative assistant to
'Senator Nelson, from Sanford A. Miller, Ph. D., Massachusetts Institute
of Technology ----------------------------------------
Letter dated February 11, 1977, to Senator Gaylord Nelson, Chairman,
Senate Small Business Committeei from Robert G. Schonfeld, chief,
Program Liaison Branch, Office of Cancer Communications, National
Cancer Institute ---------------------------------------- SM
Letter dated January 5, 1971, to James S. Turner, Center for Study of
Responsive Law, from Sam D. Fine, Associate Commissioner for Compli-
ance, Food and Drug Administration -------------------------- 556
Article, "The Delaney Anticancer Clause: A Model Environmental Protec-
tion Law," by Jameq S. Turner, from the Vanderbilt Law Review, vol. 24,
No. 5, October 1971, pp. 889-902 ----------------------------- 559
Letter dated December 21, 1976, to Judy Robinson, care of Senator Gaylord
Nelson, from Michael Jacobson, Ph. D., codirector, Center for Science in
the Public Interest- -------------------------------------- 578
Letter dated May 6, 1976, to Alexander Schmidt, M.D., Commissioner,
Food and Drug Administration, from Michael Jacobson, Ph. D., codirec-
tor, Center for Science in the Public Interest -------------------- 579
TrzsTiNo MvrHoDoWO)Y
Report of the Second Task Force for Research Planning in Environmental
Health Science, for submission tr, the Subcomrnitttre on Ta hor. Hpalth,
Education, and Welfare, Committee on Appropriations, U.S. House of
Representativs, De-,mber 1976--- .. .. ------ 5W
Article, "Methods for Detecting Carcinogens and Mutagens With the Sal-
monella/Mammallan-Microsome Mutagenicity Test," by B. N. Ames,
3. McMann, and E. Yamasaki, from Mutation Research, 81, 1975, pp.
847-864 ---------------------------------------------- 604
Letter dated February 21, 1977, to Judith Robinson, professional staff
member, Subcommittee on Employment, Poverty, and Migratory Labor,
from Marvin S. Legator, Ph. D., professor and director, University of
Texas Medical Branch ------------------------------------ 621
FOOD ADDITIVES: COMPETITIVE, REGULATORY, AND
SAFETY PROBLEMS
THURSDAY, JANUARY 13, 1977
U.S. SENATE,
SzECT Cox rzTEE ON SMALL BusINss,
Washington, D.C.
The committee met, pursuant to notice, at 9:30 a.m., in room 1318,
Dirksen Senate Office Building, Hon. Gaylord Nelson, chairman,
presiding.
Present: Senator Nelson.
Also present: Benjamin Gordon, staff economist Karen Young,
research assistant; and Judith Robinson, Senator Nelson's staff.
OPENING STATEMENT OF HON. GAYLORD NELSON, A U.S. SENATOR
FROM THE STATE OF WISCONSIN, AND CHAIRMAN, SENATE
SMALL BUSINESS COMMITTEE
Senator NELSON. The committee will come to order.
We are today opening 2 days of hearings to assess where we are with
respect to the marketing, regulation, and safety of food additives.
This is the first time since 1972, when the Senate Select Co .mittee on
Nutrition and Human Needs conducted hearings, that the current
regulatory and commercial status of food additives has been aired in
public congressional hearings.
Concern about the safety of a number of additives led to the exami-
nation of the subject by this committee tand the General Accounting
Office.
Safety questions raised about certain additives include the potential
to cause cancer, birth defects, genetic damage, and other harmful effects
on human health.
The GAO, in three separate reports to us, revealed a large number
of problems relating to: (1) Food additives testing-the state-of-the-
art for screening and evaluation of safety; (2) the desirability for an
independent testing system, free from economic bias on the part of
product promoters; (3) the need for new statutory suspension author-
ity for regulatory agencies to utilize when safety questions about addi-
tives-and other substances to which the public is widely exposed-
arise; (4) the need to set some guidelines for reaching regulatory
decisions based on benefits versus risk; and (5) the need to ascertain
what research is being conducted into alternatives for additives that
pose safety questions.
"No segment of the environment to which humans are exposed is as
chemically complex as food, and, in large part, the chemical and
(1)
2
biological properties of food components and their relationships to
human illness and disease are poorly understood," says the second
National Institute of Environmental Health Sciences Task Force
report on "Human Heath and the Environment: Some Research
Needs," which is about to be issued.
We have reached the point in the United States where more proc,
essed, convenience, snack, and franchised food products are purchased
than fresh foods.
This means that consumers are consuming more chemicals that make
it possible to process foods with a long sheff and shipping life.
Ian of these substances are safe and economic to use as stabilizers,
emulsifiers, antioxidants, flavoring and coloring agents, nonnutritive
sweetners, texturizers, and for other purposes.
However, by 1970, the use of food additives had more than doubled
in two decades to more than 1 billion pounds a year, according to in-
dustry figures. The average American, the industry estimates, eats 5
pounds of additives a year. More kinds of food additives are approved
for use in the United States than in any other nation.
The FDA regulates more than 2,100 additives for uses in food
directly, and more than 10,000 additives in packaging and other in-
direct uses.
Unfortunately, many chemicals long used in the food supply are
being shown to'be harmful under new scientific scrutiny; many were
never adequately pretested prior to approval and widespread use; and
the number of new chemicals or new uses of them continue to prolifer-
ate without a real assessment of their nutritional value and sometimes
with potential health hazards.
The questions must be asked:
Where are we now, with respect to the chemicalization of our food
sup ly?
an the food supply to ths Nation and the world be expanded safely
with or without the large numbers of chemicals that are now going
into the food?
What synergistic effects are chemicals in the food supply having on
human health when they are combined with the mass of other chemicals
and substances in the environment, including drugs I
If we are going to continue the widespread use of these chemicals
and, in fact, increase their use, there must be carefully developed
scientific evidence showing that they are safe, necessary and free from
long-term possibly irrevocable, effects on the human race. The technol-
ogy now exists to do so.
Foods must be safe and wholesome before they are placed on the
grocery shelf. Labeling and nutritional education cannot prevent can-
cer or birth defects if the food supply causes insidious hazards. Sci-
entists are concerned that long-term, low-doses of chemicals may cause
not only cancer, but birth defects or genetic damage.
Scientific knowledge now exists to screen these chemicals for such
effects.
We are here today to begin building a record documenting the ex-
tensive use, marketing, regulation and safety of food additives.
These hearings may lead to legislation, designed to meet the needs
of the times with respect to mass human exposure and the state-of-
the-art for testing.
a
As information is generated in the hearings, the committee will
consider whether to conduct further hearings, and will accept material
for the hearing record that contributes new and relevant information.
Our first witness this morning is Mr. Gregory J. Ahart, Director of
Human Resources Division of the General Accounting Office.
Mr. Ahart, if you would identify your associates, so that the re-
porter will have a correct record.
STATEMENT OF GREGORY 7. AHART, DIRECTOR, HUMAN RE-
SOURCES DIVISION, U.S. GENERAL ACCOUNTING OFFICE, AC-
COMPANIED BY ALBERT B. 3IO0KIAN, GAO; AND STUART
FLEISHMAN, GAO
Mr. Thank you, Mr. Chairman.
AHART.
On my immediate right is Mr. Albert B. Jojokian, and on his right
is Mr. Stuart Fleishman, who works with Mr. Jojokian.
Mr. Chairman and members of the committee, we are pleased to
appear here today to discuss our reports on the Food and Drug Ad-
ministration's (FbA's) regulation of three color and food additives-
Red No. 2, saccharin, and aspartame. In addition we have issued a re-
port to the Congress on chemical carcinogens including food additives
and we have recently initiated a broad scale review of FDA's regula-
tion of food additives. We will discuss these also.
Our reviews concerning the three additives were directed primarily
toward developing information on (1) The history of FDAs regula-
tion of them, (2) the current status of testing the safety of the addi-
tives, and (3) whether the regulatory actions taken by FDA on the
three additives complied with the Federal Food, Drug, and Cosmetic
Act as amended (21 U.S.C. 301).
RGULATION OF RED NO. 2
Red No. 2 is the name given to a certified lot of the dye generically
known as amaranth. The composition and purity of amaranth varies.
FDA has established composition and purity specifications that ama-
ranth must meet before it can qualify for use in food, drugs, and cos-
metics. Only amaranth meeting such specifications is classified as Red
No. 2.
Since July 12, 1960, the color additive amendments to the Food,
Drug and Cosmetic Act have required FDA to establish regulations
listing color additives that are safe for use in food, drugs, or cosmetics.
Such regulations may list color additives for use generally in food,
drugs, or cosmetics or may prescribe the conditions under which the
color additives may be safely used.
The act provides that a color additive is deemed unsafe and should
not be listed in a regulation permitting its use in food, drugs, or cos-
metics if it is found by FDA to induce cancer in man or animal.
The Food, Drug and Cosmetic Act, as amended in 1960 placed all
color additives commercially established at that time, including Red
No. 2, on a provisional list to alhw their use for a reasonable period
until their safety could be reviewed and regulations for their use
could be !ssued.
4
Senator NELSON. How many food additives were being used at that
time?
Mr. AHART. Mr. Jojokian, do you know about how many there were I
Mr. JOJOKTAN. I do not know the exact figure, but I understand
there are 1,300 additives, intentional additives, and I believe 600 un-
intentional additives.
Senator NELsoN. One thousand three hundred intentional?
Mr. JOJOKIAN. That is an estimate.
Senator NELoS. Those were additives added directly to the food?
Mr. JOJOCAN. Yes, that is correct.
Senator N=sox. When you say unintentional, you mean in the
packaging, which may infiltrate the food?
Mr. JOJOKrAN. That is correct.
Senator NELSoN. What are the true figures now?
Mr. JoJTOKIAN. I believe there are about that many today.
Senator NEIsoN. But we have been adding additives every year.
,Mr. AIIART. I do not think we have the exact information as to how
manv there were then or how many there are now.
We would be glad to furnish that for the record if we could get
hold of the data.
Senator NELSoN. If the act required in 1960, that many of the ad-
ditives being used at that time be placed on a "GRAS" or provisional
list, how would the FDA put them on a list if they did not know
what they were?
Mr. AHART. I assume that information is available, and we just do
not have it here.
Senator NELSox. All right.
[The information follows:]
An FDA official told GAO that FDA did not have information on the total num-
ber of food additives that were in use in 1960. According to the October 12, 1960,
Federal Register, 181 color additives were placed on the provisional list at that
time.
Mr. AHART. The 1960 amendments provided that the provisional
listing was to terminate no later than 21/2 years from the effective date
of enactment-July 12, 1960-or January 12,1963.
Senator NELSoN. For purpose of the appropriate place in the rec-
ord, the staff advised me there are now about 2,100 approved direct
additives, contrasted with the 1,300 that you just mentioned.
Mr. AHART. Thank you, Mr. Chairman. The amendments also pro-
vided, however, that FDA could postpone the termination date if such
action was consistent with the objective of carrying to completion, in
good faith, as soon as reasonably practicable, the scientific investiga-
tions necessary for making a determination as to the additives' safety.
We found that FDA had permitted the use of Red No. 2 in food,
drugs;- and cosmetics for 15 years without making a final determina-
tion of its safety. FDA postponed termination of the provisional
listing for Red No. 2, 14 times on the basis of requests from manu-
facturers or industry associations to allow completion of scientific
investigations concerning its seafety.
Since 1970 several scientific studies involving animals, including
some performed or sponsored by FDA, raised questions concerning
the safety of Red No. 2 in food. In some of these studies Red No. 2 or
5
amaranth was shown in test animals to be toxic to reproductive sys-
tems or to be carcinogenic.
Mr. GORDON. You described the statute as allowing use for a "rea-
sonable" period until safety could be reviewed; that a termination date
of January 12 1963 was given; that postponementof termination date
was permitted if such action was consistent with the objective of car-
ring to completion in good faith, as soon as reasonably practicable,
t e seientific investigations necessary for making a determination as
to the additives' safety.
Would you say that the 15 years during which this product was al-
lowed to be on the market without proof of safety is a reasonable
period I
Mr. AHirT. In my Judgment, Mr. Gordon, it is not.
1t seems unnecessarily long to us. The statute itself provided the
provisional use of color additives for a reasonable period of time with
a limit of 21/ yers unless FDA extended the time to allow completion
of safety studies, and it seems to me -the Congress did not have in mind
str etching the period to -anythinga s long as 15 years before you could
reach a conclusion regarding safety.
Mr. GoRDON. Could you see the public benefiting from this delay I
Mr. Axiw. I assume there is some public benefit.
At least it is my understanding that Red No. 2 has some economic
benefits over some alternatives that would be available.
In other words, it would be cheaper to the manufacturer, and the
reduction, however, large it is, if passed on to the consumer, -there
might be some public benefit in that gard.
Senator NELSON. When you are talking about economic benefit, that
is not the function of the Food and Drug Administration.
The function of the FDA is to protect the public health.
Mr. AHART. That is correct.
Senator Nu SoN. And to make sure what is on the market is safe.
Considerations of economic benefits certainly are not within the pur-
view of the FDA is that correct?
Mr. AHART. I do not think I indicated it was. I was asked to answer
the general question whether there was any public benefit from the
continued use of Red No. 2 during this long period of time.
Senator NELSON. I see.
Mr. Aiw. Because of its concern about the safety of Red No. 2,
FDA in July 1972 issued a proposal to limit human exposure to the
color additive. However, at the time our report was issued on Octo-
ber 20, 1975, FDA had not made a final determination regarding its
safety.
Because we believed that continued use of Red No. 2 before resolv-
ing its safety exposed the public to unnecessary risk, we recommended
that the Secretary of the Department of Health, Education, and Wel-
fare (HEW) direct the Commissioner of FDA to promptly establish
the safety of Red No. 2 or prevent its use in food, drugs, and cosmetics.
Senator NELsoN. What date was that ?
Mr. AHwr. That was in October 1975, Mr. Chairman. October 20,
1975.
On January 19,1976, FDA announced a ban on the use of Red No. 2
in food, drugs, and cosmetics. FDA took the action because new evi-
a
dence showed that Red No. 2 caused a statistically significant increase
in the number of malignant tumors in test animals and because of
what it termed "the absence of other data to allow a definitive judg-
ment of safety."
UZOULATION OF SACCHAI N
In our report on saccharin we pointed out that saccharin was "gen-
erally recognized as safe" for use in food until about 1970 when studies
raised questions about its potential to cause cancer in test animals.
Saccharin is an acid and pure saccharin generally is unsuitable for
use in foods and beverages because it is only slightly soluble. It is
most often combined with either sodium, calcium, or ammonium salts
which neutralize the acid and produce a more readily soluble com-
pound.
The Food, Drug and Cosmetic Act, as amended by the Food Addi-
tives Amendment of 1958 (21 U.S.C. 348), requires 'FDA to establish
regulations prescribing the conditions under which a food additive
may be safely used. The act defines "food additive" as any substance
which becomes or may be expected to become a component of food,
either directly or indirectly or which may otherwise affect the char-
acteristics of the food. The proposed use of a food additive whose safe-
ty is not generally recognized by qualified scientists must be approved
by FDA.
Food additives "generally recognized as safe" are referred to as
GRAS substances. Such substances added to food are not considered
food additives and are exempt from the requirement for FDA ap-
proval.
Senator NiLsoN. You say they are not considered food additives.
They, in fact. are food additive, however.
Mr.'AimmT. The GRAS food additives are not considered food addi-
tives subject to FDA's approval.
Approval is not required.
Senator NELSON. But they are additives which were at the time gen-
erally accepted as safe, is that rightI
Mr. AHArr. That is correct, Mr. Chairman.
Senator NELSON. Were there about 600 of them at the time, or there-
abouts, on the GRAS list?
Mr. FLEISHM iz. We do not know the exact figure. There is a very
large number that the FDA is presently reviewing, something like 675.
Senator NELsON. In a review of the GRAS list, if they are found to
be unsafe, they come under the same statutory provisions as new addi-
tives, do they 'not
Mr. JoJioxAN. If new evidence raises safety questions about a
GRAS substance, FDA then may issue an interim regulation until
those questions are resolved. r
Senator NELSON. And if they are found to be unsafe, the same stat-
utory provisions apply, as would apply to new additives?
Mr. JOJOKIAN. That would be correct. If they come under an interim
regulation, then they are considered a food additive.
Senator NELSON. When did the FDA start its review of the GRAS
list, what year was that?
Mr. JOJOxKIN. I believe 1970.
Senator NnEoN. Are you familiar with how far along the FDA is
in that review?