---March 24, 1994---





Last month, the first genetically-engineered food product went on
sale in the U.S., after final approval by the Food and Drug
Administration (FDA).  The product is a cow growth hormone
(called recombinant bovine growth hormone, or rBGH), intended for
needle injection into milk cows every two weeks to make them
produce more milk.  Norway, Sweden, Denmark, the Netherlands, and
the Canadian provinces of Alberta, British Columbia, and Ontario
have banned commercial use of synthetic bovine growth hormones.
(The rBGH hormone is sometimes called rBST, recombinant bovine

Bovine growth hormone (BGH) is a normal product of the pituitary
gland of cows.  To make the synthetic product, rBGH, drug
companies have learned to snip out a fraction of cow DNA that
codes for this hormone, insert it into the DNA of E. COLI
bacteria, grow the bacteria in vats, and extract large quantities
of rBGH from the vats.  (A synthetic human growth hormone has
been manufactured by similar techniques for several years.)[1]
Introduction of the rBGH product last month was met by an uproar
from consumers who want the product banned until safety questions
have been resolved and who want milk labeled if it is produced
from rBGH-treated cows.  Monsanto, the chemical company that has
brought the first rBGH product to market, vigorously opposes

FDA has sided with Monsanto in opposing labeling of milk produced
by drug-treated cows, and has gone one step further.  FDA opposes
labeling of products that are free of rBGH.  FDA has even
threatened legal action against milk suppliers and grocers who
label their milk as free of the rBGH drug.[2]  FDA says there is
"no significant difference" between milk from rBGH-treated cows
and milk from cows not treated, and thus a label saying
"rBGH-free" would imply a difference that did not exist, and this
would constitute false labeling.[3]  Monsanto has filed two
lawsuits against milk processors who labeled their product as
free of rBGH and has mailed warnings to others who might be
tempted to label their milk as rBGH-free.[4]  The FDA's position
on labeling was developed under the direction of Michael R.
Taylor, a lawyer who joined FDA in 1991 after almost a decade as
a partner in the law firm that Monsanto hired to gain FDA
approval of rBGH and that last month brought Monsanto's lawsuits
against milk producers who labeled their products rBGH-free.
(See RHWN #381.)

Despite what FDA statements might lead consumers to think,
Monsanto's rBGH is not identical to a cow's natural growth
hormone.  The two hormones have a different amino acid sequence.
The Monsanto product is the cow's natural hormone with an extra
amino acid (methionine) attached.[5]

According to agricultural researchers at the University of
California at Davis, the FDA faced a similar situation once
before, when the agency evaluated synthetic human growth hormone
(rHGH).[6]  A manufacturer of rHGH produced a product that
differed from the natural product (HGH) in the same way that
Monsanto's rBGH differs from natural BGH; that is to say, the
rHGH had an additional methionine residue at one end.  The
PHYSICIANS DESK REFERENCE, a standard medical reference book on
drugs, says that 30% of rHGH-treated patients developed
antibodies (in other words, had an allergic reaction) compared to
only 2% of HGH-treated patients.  By analogy, this seems to raise
the distinct possibility that some people will have an allergic
reaction to Monsanto's rBGH who might not have an allergic
reaction to natural BGH. FDA has steadfastly refused to evaluate
the potential for human allergic reactions to rBGH.

There is considerable evidence that rBGH appears in the milk of
rBGH-treated cows.[7]  However, FDA has not developed, and has
not required Monsanto to develop, a measuring technique that can
distinguish between Monsanto's rBGH product and the cow's natural
hormone.  This appears to be a violation of law by FDA.  Section
512 of the 1968 Animal Drug Amendments to the 1938 Federal Food,
Drug and Cosmetic Act requires manufacturers submitting new
animal drug applications to provide "a description of practical
methods" for analysis and monitoring of drug residues in food.[8]

The American Medical Association pointed out in 1991 that it is
possible to develop a measuring technique to distinguish between
the natural product BGH and the genetically-engineered product
rBGH.[9]  For reasons that are known only to FDA, the agency has
not developed such a technique. Because FDA has not developed the
necessary analytic technique, the agency can continue to say that
rBGH is indistinguishable from BGH, implying falsely that the two
hormones are identical.

Although human health effects of milk from rBGH-treated cows are
uncertain, health effects on cows are better understood.
Normally for about 12 weeks after a cow calves, she produces milk
at the expense of her own tissues.  She loses weight, she is
infertile, and she is more susceptible to diseases such as
mastitis (inflammation of the udder). Eventually her milk output
diminishes, her food intake catches up, and she begins to rebuild
her body.  By injecting rBGH, a farmer can postpone for another 8
to 12 weeks the time when the cow begins rebuilding her body.

This means that the cow is stressed for another 8 to 12 weeks and
is more susceptible to infection during that period.[10]
The Monsanto rBGH product, sold under the trade name Posilac,
comes with an insert sheet containing information about the drug.
The Posilac insert sheet says, in part, "Cows injected with
Posilac are at an increased risk for clinical mastitis (visibly
abnormal milk).  The number of cows affected with clinical
mastitis and the number of cases per cow may increase.  In
addition, the risk of subclinical mastitis (milk not visibly
abnormal) is increased.  In some herds, use of Posilac has been
associated with increases in somatic cell counts."[11] Somatic
cell counts are another name for pus in milk.  The insert sheet
mentions other health effects of rBGH on cows: "Use of Posilac
has been associated with increases in cystic ovaries and
disorders of the uterus during the treatment period."  And: "Use
of Posilac may result in increased digestive disorders such as
indigestion, bloat, and diarrhea."

There is abundant evidence that, when cows get mastitis, farmers
give them antibiotics.  Mastitis (or the pus it puts into milk)
is a major cause of lost revenues to dairy farmers.  According to
the U.S. General Accounting Office (GAO), FDA has approved use of
30 antibiotics on dairy cows but an additional 50 antibiotics are
suspected of being used illegally on dairy cows.  A 1988 Illinois
survey found over 200 different animal drugs on dairy farms, 58%
of them not approved for use on dairy cows.  Furthermore, the
routine tests that FDA applies to milk nationwide can only detect
4 types of antibiotics, so FDA is not in a position to protect
consumers from illegal use of antibiotics (which are sold without
prescription at farm supply stores).  Antibiotic residues in milk
--which seem certain to increase with rBGH use --may cause
adverse allergic reactions in some consumers, and very likely
will contribute to development of strains of bacteria that are
resistant to antibiotics, thus reducing the effectiveness of
antibiotic medicinals against human and animal diseases.[12]

[More next week.]

    --Peter Montague

[1] Gail Feenstra, "Introduction," in William C. Liebhardt, THE
California Sustainable Agriculture Research and Education
Program, 1993), pgs. 19-20.
[2] Keith Schneider, "F.D.A. Warns the Dairy Industry Not to
Label Milk Hormone-Free," NEW YORK TIMES February 8, 1994, pg. A1.
[3] Michael R. Taylor, "Interim Guidance on the Voluntary
Labeling of Milk and Milk Products From Cows That Have Not Been
Treated With Recombinant Bovine Somatotropin," FEDERAL REGISTER
Vol. 59 No. 28 (Feb. 10, 1994), pgs. 6279-6280.
[4] "Statement on Misleading Promotion and Advertising
Activities," an anonymous statement on Monsanto letterhead dated
March 4, 1994, faxed to us by staff of Tom McDermott [(314)
694-3605] of Monsanto in St. Louis, Mo.
[5] Judith C. Juskevich and C. Greg Guyer, "Bovine Growth
Hormone: Human Food Safety Evaluation." SCIENCE Vol. 249 (1990),
pgs. 875-884.
[6] Gail Feenstra, cited above, pg. 27.
[7] This evidence is reviewed in Gail Feenstra, cited above, pgs.
[8] FDA requirements are discussed in Samuel S. Epstein,
"Potential Public Health Hazards of Biosynthetic Milk Hormones,"
pgs. 73-84.
[9] Council on Scientific Affairs, American Medical Association,
"Biotechnology and the American Agricultural Industry," JOURNAL
pg. 1433 says, "Therefore, an antibody-based detection assay
could be devised to determine the percentage of recombinant vs
native bST present in the milk from rbST-treated animals."
[10] Donella Meadows, "Out to Pasture," GREEN ALTERNATIVES,
February/March 1994, pg. 56.  And Kathleen Byrnes, "Synthesis,"
University of California Sustainable Agriculture Research and
Education Program, 1993), pgs. 319-349.
[11] We asked Monsanto for a copy of the Posilac insert sheet.
Staff of Tom McDermott [(314) 694-3605] in St. Louis, Mo., told
us March 23 they were not sure whether their division had a copy;
they said they would check and call us back, but we did not hear
from them again before our press deadline.  We received a copy
from the Pure Food Campaign [1130 17th Street, N.W., Suite 630,
Washington, DC 20036; telephone (202) 775-1132].
[12] Michael K. Hansen, "Testimony before the Agriculture
Committee of the Canadian Parliament on Potential Animal and
Human Health Effects of rbGH Use by Michael K. Hansen, Ph.D.,"
dated March 9, 1994.  Available from: Consumer Policy Institute,
Consumers Union, 101 Truman Ave., Yonkers, NY  10703-1057.
Telephone (914) 378-2000.
[13] Marietta Sue Brady and others, "Resistance Development
Potential of Antibiotic/Antimicrobial Residue Levels Designated
as 'Safe Levels,'" JOURNAL OF FOOD PROTECTION Vol. 56 No. 3
(March 1993), pgs. 229-233.
Descriptor terms: food safety; fda; genetic engineering;
biotechnology; bgh; hgh; dna; bacteria; milk; labeling; monsanto;
lawsuits; rtk; michael taylor; revolving door; amino acids;
methionine; posilac; pus; mastitis; antibiotics; resistance;
diarrhea; allergies; allergic reactions; antibodies; animal


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