is safe. Adequate protection of the public health would appear to require the latter approach.

The proposed section 409 (b) (2) (D) provides that a petition for a regulation permitting a food additive to be used shall contain a description of practicable methods for quantitative determination of such additive and, "to the extent known," its breakdown or reaction products, in or on food referred to in the petition. Many chemical additives are changed by the complex processes of food manufacture into other chemical entities, breakdown, or reaction products, before the food is consumed. These breakdown or reaction products may have effects on the human body that are different from the effects of the original chemical. It would appear necessary for protection of the public health for the person who proposes to use an additive not only to investigate those breakdown or reaction products that are known but also to make a conscious effort to determine what reaction or breakdown products may occur that might be a hazard and to investigate their toxicity.

H. R. 8112 would permit a poisonous or deleterious substance to be added to food solely on a showing of safety and without a showing of functional value or usefulness to the consumer. Because it is impossible to prove the absolute safety of such a chemical to all people under all possible conditions of use, we think it would be proper to permit a poisonous or deleterious substance in amounts judged as safe, only upon a showing that it would have functional value, i. e., would be useful to the manufacturer and the consumer.

There are other respects in which the bill we believe would require revision, but because of the problems mentioned above we have not attempted to discuss them in detail.

We therefore recommend against enactment of H. R. 8112. H. R. 6747, the chemical-additives bill sponsored by this Department, does not have the loopholes that are apparent in H. R. 8112. We recommend enactment of H. R. 6747 in lieu of H. R. 8112.

The Bureau of the Budget advises that it perceives no objection to the submission of this report to your committee.

Sincerely yours,

M. B. FOLSOM, Secretary.

Mr. WILLIAMS. Before hearing the witness scheduled for today, I wish to make a few remarks about these hearings in general and to say a few words about the bills pending before us.

Before I do that, though, I would like to welcome the chairman of our full committee, the IIonorable Oren Harris, who is an ex-officio member of this subcommittee. We are delighted to have him sit with us in these hearings this morning.

During the 2d session of the 84th Congress, the Subcommittee on Health and Science, under the chairmanship of the late full committee chairman, J. Percy Priest, held 5 days of hearings on 10 bills dealing with chemical additives.

The hearings indicated basic agreement with regard to the need for chemical additive legislation, but also considerable disagreement with regard to the procedures to be followed in determining the safety of chemical additives.

This disagreement failed to be resolved, and consequently no chemical additive legislation was enacted during the last Congress.

I would like to call to the attention of the witnesses who will testify before the subcommittee in these hearings that, of the 11 members of the subcommittee, only 3 members served on the Subcommittee on Health and Science during the last Congress.

I think I can speak for the three members who sat through the hearings last year, that they may find a little "refresher course" desirable before taking up these bills in executive session. For eight of our subcommittee members, including myself, however, the problems with which these bills deal will be novel ones.

I would like the witnesses to bear this in mind because they may erroneously assume that the members of the subcommittee are already fully familiar with the background and the details of this legislation.

Ten years have passed since the House of Representatives, during the 81st Congress, created a select committee, under the chairmanship of Congressman Delaney, to investigate the use of chemicals in food and cosmetics. The select committee was continued during the 82d Congress, and great credit is due to the chairman and the members of the select committee for the thorough hearings and the extensive report which was filed by that committee.

During the subsequent Congresses, numerous bills have been introduced dealing with the subject of chemical additives. As I have mentioned already, we have pending before us eight different bills on chemical additives.

The first bill, H. R. 366, by our colleague on the committee, Mr. O'Hara, of Minnesota, is similar to the last of the chemical-additive bills which Mr. O'Hara introduced during the 84th Congress and on which hearings were held during that Congress.

H. R. 6747, introduced by Mr. Harris, the chairman of the Committee on Interstate and Foreign Commerce, was introduced at the request of the Department of Health, Education, and Welfare, and it might, therefore, be referred to as the "administration bill." That is H. R. 6747. During the 84th Congress, no administration-sponsored bill was introduced.

H. R. 7700, introduced by Mr. Fulton, is similar to two identical bills introduced by Congressman Delaney, H. R. 7798, and Congresswoman Sullivan, H. R. 7938.

I am advised that H. R. 7798 and H. R. 7938 have superseded two other bills, H. R. 4014 and H. R. 4432, respectively, previously introduced by these same sponsors.

Next we have two identical bills, H. R. 8390 and H. R. 8629, introduced by Mr. Harris and Mr. Wolverton, respectively. I have been given to understand that these bills were introduced at the request of the National Canners Association.

Finally, we have H. R. 8112, introduced by Congressman Miller of Nebraska, who also introduced a bill on this subject during the 84th Congress.

Although, as I have mentioned, some of these bills are identical, the subcommittee has a difficult assignment in trying to appreciate and follow the differences between these bills. In order to make the task of the subcommittee easier, I have directed the staff to attempt to prepare a comparison of these bills, highlighting the differences between them. The staff comparison will be made a part of the record at this point.

I would like to inquire if all members have received a copy of this. (The document referred to is as follows:)

95208-58

Principal features of chemical additives (or food additives) bills to amend the Federal Food, Drug, and Cosmetic Act

SCOPE OF THE BILLS

H. R. 336, O'Hara

H. R. 6747, Harris

H. R. 7700, Fulton

H. R. 7798, Delaney;
II. R. 7938, Sullivan
(which supersede
II. R. 4014, Delaney;
and H. R. 4432, Sulli-
van)

H. R. 8390, Harris;
H. R. 8629, Wolver-
ton

H. R. 8112, Miller

Basically the various bills cover the same substances although the substances are referred to differently as follows:
New food additives. Chemical additives. Chemical additives. Chemical additives. New food additives. 1 Food additives and in-
cidental food additives.
Substances used or intended to be used in any phase of food handling or preparation or distribution are additives if they become The term "food addi
a component of the food and are not generally recognized as safe for the intended use.

Yes, if it becomes or could reasonably be expected

be an additive.

P. 1, line 6.

Would substances that No.
produce chemical
changes in food, such
as radiation from Iso-
tones, be additives?

P. 1, line 8.
This bill uses "may"
instead of "could reason-
ably be expected to".
Yes, the definition In-
cludes substances that
Indirectly affect the
characteristics of food
(p. 1, line 8).

Definition also in-
cludes substances that
could reasonably be ex-
pected to become a
component of food.

to become a component of food packed in the container, it would

P. 1, line 5.
P. 1, line 5.
These bills use "likely" instead of "could
reasonably be expected to".

P. 1, line 8.

tivo" means ingredi
ents that intentionally
become a part of food
for the purpose of im
parting a desired qual-
ity to it, if they are
not recognized as safe
under the conditions
of Intended uso.
P. 1, line 8:

The term "incidental
food additive" means
substances intended for
uso in any phase of
manufacturing, process-
ing, or handling food
which results in its
getting into food (p. 2,
line 25).

It would be an incidental
food additive (p. 2
line 25).

FOOD ADDITIVES

But the exemption in
this bill does not apply to
incidental food additives.

The bill does not mon-
tion such residues.

The residues are auto-
matically tolerated in
the processed food if
they do not exceed the
tolerance level allowed
on the crop, and if
they have been ro-
moved during proces.
sing to the extent pos-
sible in good manufac
turing practice (p. 3,
lino 16).

The incidental food addi-
tive is a substanco
whose addition to food
is foreseeable from its
intended use (p. 2,
line 25).

Except that all incl
dental food additives
would have to go
through the clearance
procedures (p. 15, line
10).

Principal features of chemical additives (or food additives) bills to amend the Federal Food, Drug, and Cosmetic Act

SCOPE OF THE BILLS

H. R. 336, O'Hara

H. R. 6747, Harris

H. R. 7700, Fulton

H. R. 7798, Delaney;
II. R. 7938, Sullivan
(which supersede
II. R. 4014, Delaney;
and H. R. 4432, Sulli-
van)

H. R. 8390, Harris;
H. R. 8629, Wolver-
ton

H. R. 8112, Miller

P. 1, line 8:

Would a chemical used Yes, if it becomes or could reasonably be expected to become a component of food packed in the container, It would It would be an incidental