I

103D CONGRESS

2D SESSION H. R. 4669

To amend the Federal Food, Drug, and Cosmetic Act to require labeling

for milk and milk products produced from cows which have been treated

with synthetic bovine growth hormone, to direct the development of

a synthetic bovine growth hormone residue test, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

JUNE 28, 1994

Mr. SANDERS (for himself, Mr. ANDREWS of Maine, Miss COLLINS of Michigan, Mr. DEFAZIO, Mr. DELLUMS, Mr. ENGEL, Mr. FOGLIETTA, Mr.

GONZALEZ, Mr. GUTIERREZ, Mr. HINCHEY, Mr. JOHNSTON of Florida,

Mrs. KENNELLY, Mr. KLECZKA, Mrs. MINK, Mr. MORAN, Mr. NADLER,

Mr. OBERSTAR, Mr. OBEY, Mr. OLVER, Mr. OWENS, Mrs. UNSOELD,

Mrs. SCHROEDER, Mr. SHAYS, Ms. VELA ́ZQUEZ, Mr. VENTO, Mr. WASHINGTON, and Mr. YATES) introduced the following bill; which was referred

to the Committee on Energy and Commerce

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to

require labeling for milk and milk products produced

from cows which have been treated with synthetic bovine

growth hormone, to direct the development of a synthetic

bovine growth hormone residue test, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Bovine Growth Hor3 mone Milk Labeling and Residue Test Act’’.

4 SEC. 2. FINDINGS.

5 The Congress finds the following:

6 (1) Synthetic recombinant bovine growth hor7 mone (in this section referred to as ‘‘synthetic

8 BGH’’) is a product of genetic engineering and is

9 the first food product of genetic engineering to be in

10 direct widespread use in the consumer marketplace

11 and to be ingested in significant amounts by infants

12 and children.

13 (2) Synthetic BGH injections in dairy cows re14 sult in a residue of synthetic BGH in the milk pro15 duced by injected cows.

16 (3) Synthetic BGH injections of dairy cows re17 sult in increased levels of bovine insulin-like growth

18 factor in the milk produced by injected cows. Ac19 cording to the American Medical Association and

20 others, further studies are required to determine

21 whether human ingestion of higher than normal lev22 els of bovine insulin-like growth factor is safe.

23 (4) Synthetic BGH injections result in a variety

24 of health problems in injected cows, including sig25 nificant increases in mastitis (an infection of the

26 cow’s udder that results in visibly abnormal milk).
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1 (5) The cow health problems resulting from

2 synthetic BGH injections will result in a significant

3 increased use of antibiotics in injected cows. Many

4 of the antibiotics used to treat mastitis in dairy cows

5 are not detected in the usual milk monitoring proc6 ess. The Food and Drug Administration determined

7 that synthetic BGH poses a ‘‘manageable risk’’ to

8 consumers because of the increased risk of anti9 biotics entering the consumer milk supply.

10 (6) Consumers are concerned about hormones

11 and antibiotics in their food and humane treatment

12 of animals and have shown overwhelming support

13 for labeling of milk and milk products produced with

14 synthetic BGH.

15 (7) According to the Office of Management and

16 Budget, synthetic BGH use will result in an increase

17 in Federal budget costs of over $500,000,000 in the

18 next 5 years and a decrease in overall dairy farm in19 come of $1.3 billion dollars in that same period.

20 (8) As of 1994, the European Community had

21 a moratorium on the commercial use of synthetic

22 BGH and the Canadian Parliament had rec23 ommended a similar moratorium. Australia and New

24 Zealand, where one quarter of the world’s milk is

25 produced, refused to approve synthetic BGH.
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1 (9) Consumers have a right to know if the milk

2 they consume has been produced with synthetic

3 BGH.

4 (10) Both States and individual companies have

5 begun to take actions to label products produced

6 with synthetic BGH.

7 (11) Confusion surrounding label claims and

8 regulations have resulted in lawsuits against States

9 and companies who have implemented label pro10 grams.

11 (12) There is a need for a common label to pro12 vide consumers across the country with a simple and

13 accessible means of identifying milk produced with

14 synthetic BGH.

15 (13) A synthetic BGH residue test is needed to

16 validate label claims in order to ensure consumers

17 that the labels are truthful and not misleading.

18 (14) A residue test is generally required when

19 a drug is found to leave a residue in a human food

20 product.

21 (15) Scientific organizations, including the

22 American Medical Association and the Consumers

23 Union, have stated that a synthetic BGH residue

24 test can be devised. Much of the preliminary re25 search for a test has already been completed. Claims
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1 have been made that a test already has been suc2 cessfully developed in a lab.

3 SEC. 3. LABELING.

4 Section 403 of the Federal Food, Drug, and Cosmetic

5 Act is amended by adding at the end the following:

6 ‘‘(s)(1)(A) If it is milk that—

7 ‘‘(i) is intended for human consumption; and

8 ‘‘(ii)(I) is produced by cows that have been in9 jected with synthetic BGH; or

10 (II) has been commingled with milk pro11 duced by such cows,

12 unless the labeling of the milk bears the following

13 statement: ‘This milk was produced by cows injected

14 with synthetic BGH.’

15 ‘‘(B) If it is a milk product that is intended for

16 human consumption and is derived from milk described

17 in subparagraph (A), unless the labeling of the milk prod18 uct bears the following statement: ‘This milk product was

19 derived from milk produced by cows injected with syn20 thetic BGH.’

21 ‘‘(2)(A) A person who sells synthetic BGH, purchases

22 the hormone, distributes the hormone, or injects the hor23 mone into a cow shall prepare and maintain records that

24 comply with the regulations issued by the Secretary under

25 subparagraph (B).
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1 ‘‘(B) Not later than 30 days after the date of enact2 ment of this paragraph, the Secretary shall issue regula3 tions that require—

4 ‘‘(i) persons who sell synthetic BGH;

5 ‘‘(ii) persons who purchase synthetic BGH;

6 ‘‘(iii) persons who distribute synthetic BGH;

7 and

8 ‘‘(iv) persons who inject synthetic BGH into

9 cows,

10 to create and maintain records that contain the applicable

11 information specified in subparagraph (C).

12 ‘‘(C) Regulations issued under subparagraph (B)

13 shall require records to contain a description of—

14 ‘‘(i) the quantity and source of the synthetic

15 BGH obtained (by manufacture, purchase, or any

16 other means);

17 ‘‘(ii) the date on which the hormone was ob18 tained; and

19 ‘‘(iii) the identity of each person to whom the

20 hormone was sold or otherwise distributed, the cows

21 into which any portion of the hormone was injected,

22 and each person who has an operator or ownership

23 interest in the cows.
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1 ‘‘(3) Not later than 30 days after the date of enact2 ment of this paragraph, the Secretary shall issue regula3 tions that establish—

4 ‘‘(i) requirements with respect to the sale, dis5 tribution, and administration of synthetic BGH; and

6 ‘‘(ii) such other requirements with respect to

7 the use of synthetic BGH as the Secretary may de8 termine to be necessary to carry out the objectives

9 of this Act.

10 ‘‘(4) As used in this paragraph—

11 ‘‘(i) The term ‘synthetic BGH’ means—

12 ‘‘(I) a substance described as bovine

13 somatotropin, bST, BST, bGH, or BGH; and

14 ‘‘(II) a growth hormone, intended for use

15 in bovine animals, that has been produced

16 through recombinant DNA techniques.

17 ‘‘(ii) The term ‘cow’ means a bovine animal.’’.

18 SEC. 4. RESIDUE TEST.

19 (a) IN GENERAL.—At the earliest possible date, the

20 Secretary of Health and Human Services (acting through

21 the Commissioner of Food and Drugs) shall develop a sci22 entifically valid synthetic BGH residue test to—

23 (1) detect the presence of the residue of syn24 thetic BGH in milk produced from cows injected

25 with such hormone, and
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1 (2) assure compliance with section 403(s) of the

2 Federal Food, Drug, and Cosmetic Act.

3 After the test is developed the Secretary shall make the

4 test available to public health and agricultural agencies of

5 the States and commercially available at the lowest pos6 sible cost to dairy producers and processors.

7 (b) DEFINITIONS.—As used in subsection (a):

8 (1) The term ‘‘synthetic BGH’’ means—

9 (A) a substance described as bovine

10 somatotropin, bST, BST, bGH, or BGH; and

11 (B) a growth hormone, intended for use in

12 bovine animals, that has been produced through

13 recombinant DNA techniques.

14 (2) The term ‘‘cow’’ means a bovine animal.

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