I
104TH CONGRESS
1ST SESSION
H. R. 2085
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
JULY 20, 1995
Mr. SANDERS (for himself, Mr. MEEHAN, Mr. MCDERMOTT, Mr. OWENS, Mr.
STARK, Mrs. MINK of Hawaii, Mr. OBERSTAR, Mr. SHAYS, Mr. JOHN-
STON of Florida, Mr. EVANS, Ms. VELA´ZQUEZ, Mr. MORAN, Mr. YATES,
Mr. DEFAZIO, Mr. DELLUMS, Mrs. MALONEY, Mr. HINCHEY, Mr. RAN-
GEL, Mr. GONZALEZ, Mr. OBEY, Mr. GUTIERREZ, Mrs. SCHROEDER, Mr.
KLECZKA, Mr. LIPINSKI, Mr. LEWIS of Georgia, Mr. STUPAK, Mr. REYN-
OLDS, and Mr. MARKEY) introduced the following bill; which was referred
to the Committee on 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 pur-
poses.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Bovine Growth Hor-
mone Milk Labeling and Residue Test Act’’.
SEC. 2. FINDINGS.
The Congress finds the following:
(1) Synthetic recombinant bovine growth hor-
mone (in this section referred to as ‘‘synthetic
BGH’’) is a product of genetic engineering and is
the first food product of genetic engineering to be in
direct widespread use in the consumer marketplace
and to be ingested in significant amounts by infants
and children.
(2) Synthetic BGH injections in dairy cows re-
sult in a residue of synthetic BGH in the milk pro-
duced by injected cows.
(3) Synthetic BGH injections of dairy cows re-
sult in increased levels of bovine insulin-like growth
factor in the milk produced by injected cows. Ac-
cording to the American Medical Association and
others, further studies are required to determine
whether human ingestion of higher than normal lev-
els of bovine insulin-like growth factor is safe.
(4) Synthetic BGH injections result in a variety
of health problems in injected cows, including sig-
nificant increases in mastitis (an infection of the
cow’s udder that results in visibly abnormal milk).
(5) The cow health problems resulting from
synthetic BGH injections will result in a significant
increased use of antibiotics in injected cows. Many
of the antibiotics used to treat mastitis in dairy cows
are not detected in the usual milk monitoring proc-
ess. The Food and Drug Administration determined
that synthetic BGH poses a ‘‘manageable risk’’ to
consumers because of the increased risk of anti-
biotics entering the consumer milk supply.
(6) Consumers are concerned about hormones
and antibiotics in their food and humane treatment
of animals and have shown overwhelming support
for labeling of milk and milk products produced with
synthetic BGH.
(7) According to the Office of Management and
Budget, synthetic BGH use will result in an increase
in Federal budget costs of over $500,000,000 in the
next 5 years and a decrease in overall dairy farm in-
come of $1.3 billion dollars in that same period.
(8) As of 1994, the European Community had
a moratorium on the commercial use of synthetic
BGH and the Canadian Parliament had rec-
ommended a similar moratorium. Australia and New
Zealand, where one quarter of the world’s milk is
produced, refused to approve synthetic BGH.
(9) Consumers have a right to know if the milk
they consume has been produced with synthetic
BGH.
(10) Both States and individual companies have
begun to take actions to label products produced
with synthetic BGH.
(11) Confusion surrounding label claims and
regulations have resulted in lawsuits against States
and companies who have implemented label pro-
grams.
(12) There is a need for a common label to pro-
vide consumers across the country with a simple and
accessible means of identifying milk produced with
synthetic BGH.
(13) A synthetic BGH residue test is needed to
validate label claims in order to ensure consumers
that the labels are truthful and not misleading.
(14) A residue test is generally required when
a drug is found to leave a residue in a human food
product.
(15) Scientific organizations, including the
American Medical Association and the Consumers
Union, have stated that a synthetic BGH residue
test can be devised. Much of the preliminary re-
search for a test has already been completed. Claims
have been made that a test already has been suc-
cessfully developed in a lab.
SEC. 3. LABELING.
Section 403 of the Federal Food, Drug, and Cosmetic
Act is amended by adding at the end the following:
‘‘(s)(1)(A) If it is milk that—
‘‘(i) is intended for human consumption; and
‘‘(ii)(I) is produced by cows that have been in-
jected with synthetic BGH; or
(II) has been commingled with milk pro-
duced by such cows,
unless the labeling of the milk bears the following
statement: ‘This milk was produced by cows injected
with synthetic BGH.’
‘‘(B) If it is a milk product that is intended for
human consumption and is derived from milk described
in subparagraph (A), unless the labeling of the milk prod-
uct bears the following statement: ‘This milk product was
derived from milk produced by cows injected with syn-
thetic BGH.’
‘‘(2)(A) A person who sells synthetic BGH, purchases
the hormone, distributes the hormone, or injects the hor-
mone into a cow shall prepare and maintain records that
comply with the regulations issued by the Secretary under
subparagraph (B).
‘‘(B) Not later than 30 days after the date of enact-
ment of this paragraph, the Secretary shall issue regula-
tions that require—
‘‘(i) persons who sell synthetic BGH;
‘‘(ii) persons who purchase synthetic BGH;
‘‘(iii) persons who distribute synthetic BGH;
and
‘‘(iv) persons who inject synthetic BGH into
cows,
to create and maintain records that contain the applicable
information specified in subparagraph (C).
‘‘(C) Regulations issued under subparagraph (B)
shall require records to contain a description of—
‘‘(i) the quantity and source of the synthetic
BGH obtained (by manufacture, purchase, or any
other means);
‘‘(ii) the date on which the hormone was ob-
tained; and
‘‘(iii) the identity of each person to whom the
hormone was sold or otherwise distributed, the cows
into which any portion of the hormone was injected,
and each person who has an operator or ownership
interest in the cows.
‘‘(3) Not later than 30 days after the date of enact-
ment of this paragraph, the Secretary shall issue regula-
tions that establish—
‘‘(i) requirements with respect to the sale, dis-
tribution, and administration of synthetic BGH; and
‘‘(ii) such other requirements with respect to
the use of synthetic BGH as the Secretary may de-
termine to be necessary to carry out the objectives
of this Act.
‘‘(4) As used in this paragraph—
‘‘(i) The term ‘synthetic BGH’ means—
‘‘(I) a substance described as bovine
somatotropin, bST, BST, bGH, or BGH; and
‘‘(II) a growth hormone, intended for use
in bovine animals, that has been produced
through recombinant DNA techniques.
‘‘(ii) The term ‘cow’ means a bovine animal.’’.
SEC. 4. RESIDUE TEST.
(a) IN GENERAL.—At the earliest possible date, the
Secretary of Health and Human Services (acting through
the Commissioner of Food and Drugs) shall develop a sci-
entifically valid synthetic BGH residue test to—
(1) detect the presence of the residue of syn-
thetic BGH in milk produced from cows injected
with such hormone, and
(2) assure compliance with section 403(s) of the
Federal Food, Drug, and Cosmetic Act.
After the test is developed the Secretary shall make the
test available to public health and agricultural agencies of
the States and commercially available at the lowest pos-
sible cost to dairy producers and processors.
(b) DEFINITIONS.—As used in subsection (a):
(1) The term ‘‘synthetic BGH’’ means—
(A) a substance described as bovine
somatotropin, bST, BST, bGH, or BGH; and
(B) a growth hormone, intended for use in
bovine animals, that has been produced through
recombinant DNA techniques.
(2) The term ‘‘cow’’ means a bovine animal.
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