Doug Ryan

Abstract –
The use of growth hormones in the US, Canada, and Europe is a complicated and unresolved issue. Canada and Europe have banned the use of rBGH in their dairy cows, claiming that the hormone has detrimental effects in humans. The hormone rBGH, sold under the name “Posilac,” is a recombinant protein produced by the international biotechnology company known as Monsanto. Lab trials performed by Monsanto, as well as the FDA, have shown that rBGH does not affect the health of lab mice in any way. Yet, a controversy still exists between the United States and Europe. Also, there are a growing number of farmers and citizens of the US who feel that rBGH is unsafe, and should be taken off of the market.
Although the FDA and the laboratories of Monsanto have approved the use of rBGH, organizations in Europe and Canada maintain that the injection of rBGH into cattle poses health problems to its citizens. The FDA, the National Institute of Health, and the World Health Organization (WHO) all recognize that rBGH is safe for human consumption. Genetically Modified Foods (GMFs) are essential to the food supply in the United States; they are economically important and have not been shown to cause health risks. rBGH should remain on the market, and other nations should not be so reluctant to adapting the use of rBGH in their dairy production programs.

What is rBGH?
The Bovine Growth Hormone (BGH) is a hormone found in the pituitary gland of cows3. It is a naturally occurring growth hormone in cattle3. Cows secrete the hormone BGH into the bloodstream, where the hormone binds to liver cells to secret the protein Insulin Growth Factor-1 (IGF-1)3. IGF-1 is used by the cow’s body to harness fat into energy, as well as preventing the death of mammary cells in utters. Because the hormone prevents mammary cell death, and it increases the breakdown of fat, BGH is thought to increase milk production in cattle (Baker).
Recombinant Bovine Growth Hormone (rBGH) is a genetically-engineered recombinant protein3. rBGH is not grown in cattle. Instead, the sequence of DNA that encodes for the production of BGH is inserted into the bacteria E. Coli. After the E Coli grow and divide, they begin producing rBGH (as the sequence of DNA encoding BGH has been inserted into their genome) (Brown). Thus, bacteria have been programmed to create BGH (Brown). Once the bacteria have produced the hormone BGH they are split open, and the protein rBGH is separated from the bacterial cells (Brown).
The purified rBGH is then injected into the bloodstream of cows. Because the prevention of mammary cell death is an effect that rBGH has on cows, the injection of rBGH into cows allows the animals to produce an average of ten more pounds of milk a day5.

What are some concerns with rBGH?
One major criticism of rBGH is that the production process of the recombinant protein changed over time. The criticism here is that the protein is not the same molecule that the FDA approved. Monsanto did make a few changes to the protein production process, but the FDA was fully aware of the changes. A representative of the FDA had the following to say, regarding the changes made in the production process of rBGH:
“Based on our examination, we reaffirmed our conclusion that the manufacturing changes resulted in only biologically inconsequential variations in the product used in the safety and effectiveness studies and, therefore, the rbGH product we approved is the same as the product used in the studies.”

- Dennis E. Baker, Associate Commissioner for Regulatory Affairs, FDA

This statement reaffirms the fact that, although Monsanto has made some changes in the production process of rBGH, no significant health concerns exist as a result of this inconsequential biological change to the molecule (Baker).
Another major criticism concerning the use of rBGH is the fact that no conclusive studies have been carried out by the FDA or Monsanto. People are concerned that rBGH may be linked to thyroid cysts and other, potentially more serious diseases, such as breast cancer. To counter these allegations and prove the safety of rBGH, Monsanto conducted a 90-day test on lab mice to study the effects of daily doses of rBGH. The FDA reviewed the experiment and its data, and had the following to say concerning the safety of the recombinant protein rBGH:

“Thyroid cysts were observed in the gross and histopathological examinations in all treatment groups, including the positive and negative control groups. Neither the frequency nor severity of the cysts was attributable to rbGH treatment. Similarly, a prostatitis was observed in animals from all treatment groups including the positive and negative control groups and again this was not attributable to rbGH treatment. No adverse effects of rbGH were observed in any animals of the toxicology group.”

- Dennis E. Baker, Associate Commissioner for Regulatory Affairs, FDA

These statements concur with the statements made by the scientists at Monsanto (Baker). No adverse affects have been found in any tests carried-out by either the FDA or Monsanto (Baker). After the initial 90-day test was performed by Monsanto scientists, the experiment and its results were re-reviewed by FDA staff. As no data supported the claim that rBGH has negative effects on animals, the protein was allowed to remain on-sale in the United States (Baker).

Some information about hormones:
Hormones naturally occur in animals (Brown). They are essential for growth in humans and cattle. It is true that significant imbalances in hormone production or an excessive amount of hormone ratios in an animal’s body can cause health issues (Raynaud). However, the levels of IGF-1 found in milk, which is the health concern brought up by people concerned with rBGH use, is insignificant compared to the levels of IGF-1 naturally occurring in human plasma (Baker). The average adult produces 10,000,000 nanograms of IGF-1 a day (Baker). An average adult can have anywhere from 40 to 310 nanograms of IGF-1 per milliliter of plasma in their body (Baker). The average amount of IGF-1 in cow’s milk that is untreated with rBGH is around 2.5 mg/mL (Baker).
This ratio, 2.5 mg/mL is quite small. Cows that are treated with rBGH produce about 5 mg of IGF-1 per milliliter (Baker). Notice that the ratio has doubled. This statistic can be misleading, as the level of IGF-1 in rBGH-treated cattle is “100% higher than those not treated with rBGH.” However, doubling such a small number, and increasing IGF-1 concentrations by 100% is not significant compared to the amount of IGF-1 already found in human plasma (Baker). Arguing that rBGH increases IGF-1 concentrations 100% in milk is facetious; rBGH does increase IGF-1 concentrations 100% in cow’s milk, but this is such a low number compared to naturally occurring IGF-1 found in human plasma.

Who approves of rBGH use?
Besides Monsanto’s obvious approval of rBGH, the FDA also supports the use of this protein in dairy cattle (Baker). Along with the FDA, the National Institute of Health, the World Health Organization, and the Joint Expert Committee on Food Additives, have all approved the use of rBGH in dairy cattle (Baker). These are all independent scientific committees, they have reached their decisions independently, and they represent many nations.
The fact that multi-national organizations have independently reached the same conclusions is strong evidence for the safety of rBGH. The degree of scientific proof that critics of rBGH require is not realistic. The organizations listed above have carried out rBGH experiments and have not found any problems with their animal tests (Baker).
One organization, Health Canada, still refuses to allow the use of rBGH to be sold in Canada (Baker). Health Canada recently fired three scientists (Margaret Haydon, Shiv Chopra, and Gerard Lambert) for not approving rBGH for sale in Canada6. Some view this as an outrage, as the scientists claimed they were only doing their job to protect food safety6. These scientists found the Monsanto trials to lack evidence concerning the safety of rBGH6. However, Health Canada officials claimed that the firing was a result of the scientists’ pasts; Health Canada claimed that the scientists needed constant reprimanding and had a long history of disagreeing with the department officials6.

Conclusion:
The use of rBGH will increase in the near future. The safeness of the recombinant protein is gaining credence in international laws (Baker). As already mentioned, the World Health Organization and the Joint Expert Committee on Food Additives, both expert groups on public safety, have already agreed upon the safety of rBGH (Baker).
As the area of biotechnology expands, more and more foods will become genetically modified. It is important that world-wide organizations begin to see eye-to-eye on matters concerning public health and safety. Genetic-engineering is an inescapable fact of the future, and although safety should always come first, these global organizations need to learn how to set the same standards for all food. One side needs to be right; if food is deemed safe to eat in one area of the world, it should be safe to eat in all areas of the world.
Part of the scare with genetically modified foods is the reputation they have. People are put-off by words like “genetic-engineering” and “steroid.” This irrational fear comes mostly from a lack of understanding of the facts. This is not the first time language has impeded the use of scientific discovery in society. For instance, have you ever noticed that doctors always say “We need to do an MRI,” instead of saying “We need to do an NMRI?” An MRI is actually officially an NMRI, meaning “Nuclear Magnetic Resonance Imaging.” Why do doctors drop the “N?” Frankly, people don’t like the word “nuclear,” especially when it involves their body, or something that’s about to happen to them. Of course, MRIs are harmless, so long as they are performed properly. In a similar way, growth hormones are harmless, as they are regulated, tested, and safely administered. Controversy over “steroids” or “genetic modification” in the public comes mostly from an incorrect understanding of the language of science.