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Regulation
Banned outside the United States
The sale of Posilac is illegal in virtually every developed country with the
exception of the United States. In the United States, the use of rbST has been
approved by the FDA.
In Japan, Australia, New Zealand, and Canada, rbST is not approved for use.
The European Union declared the use of rbST as safe in 1990, but in 1993, a
moratorium was placed on its sale by all 25 member nations.
Canada's health board, Health Canada, refused to approve rBGH for use on
Canadian dairies, citing concerns over animal health. The study they had
commissioned, however, found "no biologically plausible reason for concern about
human safety if rbST were to be approved for sale in Canada. The only exception
to this statement is... (possible hypersensitivity)."
Regulation inside the United States
In November 1993, the product was approved for use in the U.S. by the FDA, and
its use began in February 1994. The product is now sold in all 50 states.
According to Monsanto, approximately one third of dairy cattle in the U.S. are
injected with Posilac; approximately 8,000 dairy producers use the product. It
is now the top selling dairy cattle pharmaceutical product in the U.S.
A great deal of controversy within the FDA surrounded Posilac's evaluation in
the late 1980s. Richard Burroughs, who had a lead role in the review process,
was shocked at how few tests the agency was requiring. Burroughs ordered more
tests but was soon fired. He said, “I was told that I was slowing down the
approval process.” Alexander Apostolou, director of the FDA's Division of
Toxicology, says, “Sound scientific procedures for evaluating human food safety
of veterinary drugs have been disregarded.” When he expressed his concerns at
the agency, he was pressured to leave.
Chemist Joseph Settepani testified at a public hearing about “a systematic human
food-safety breakdown at the Center for Veterinary Medicine.” Prior to his
testimony, he was in charge of quality control for veterinary drug approvals.
Soon after, he was stripped of his duties as a supervisor and sent to work in a
trailer at an experimental farm. On March 16, 1994, others at the FDA resorted
to writing an anonymous letter to members of Congress, saying they were “afraid
to speak openly about the situation because of retribution."
The Food and Drug Administration (FDA) does not require special labels for
products produced from cows given rbST. Monsanto sued the Oakhurst Dairy over
their use of a label which read: "Our Farmers' Pledge: No Artificial Growth
Hormone."
Monsanto stated: "We believe Oakhurst labels deceive consumers; they're
marketing a perception that one milk product is safer or of higher quality than
other milk. Numerous scientific and regulatory reviews throughout the world
demonstrate that that's unfounded. The milk is the same, and the amount of
protein, fats, nutrients, etc., are all the same."
Oakhurst's President stated: "We have said from the beginning that we make no
claims to understand the science involved with artificial growth hormones. We're
in the business of marketing milk, not Monsanto's drugs."
The suit was settled when Oakhurst agreed to add a qualifying statement to their
previous label, reading: "FDA states: No significant difference in milk from
cows treated with artificial growth hormone."
The FDA has charged several dairies with selling "misbranded" products, based on
labels stating that their milk was "hormone free" or contained "no hormones".
The FDA states that all milk contains hormones and "milk cannot be produced in a
way that renders it free of hormones."
Demand for organic milk (produced without the use of synthetic hormones) in the
US has increased 500% since Monsanto introduced their rbST product; organic milk
is the fastest growing sector of the organic food market. Shortages exist, and
not enough organic milk is produced to meet demand.
Use of the recombinant supplement has been controversial. While it is used in
the United States, it is banned in Canada, parts of the EU (The EU's stance
leaves the decision up to individual nations, though none have allowed it ),
Australia, and New Zealand.
Voluntary removal of rBGH from the milk supply
As of February 2007, Safeway in the Northwestern United States stopped buying
from dairy farmers that use rBGH. The two Safeway plants produce milk for all of
Oregon, Southwest Washington, and parts of northern California. Safeway's plant
in San Leandro, CA had already been rBGH-free for two years. Trader Joes
supermarkets only sell rBST-free milk, be it organic or not. Their non-organic
rBST-free milk is not more expensive than major supermarkets' milk. Another
company going rBGH free is Chipotle Mexican Grill that has also announced it
will only serve rBGH-free sour cream at its more than 530 restaurants.
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