In the modern society, a fear that anything produced with the assistance of biotechnology has the ability to harm or cause adverse health conditions extremely increases. Usually unbiased, such assumptions lead to underestimation of biotechnologies’ usefulness, which does not allow to prevent a disease as in cases with children’s vaccinations. Another innovation that has been undeservedly mistrusted is recombinant bovine growth hormone, also known as rBGH or rBST. It is one of the products fabricated with the help of biotechnology. However, it has gained a villainous reputation due to the misinformation to the public about the potential yet unproven relationship to possible health risks from consuming products made from cows that have been treated with rBGH. Although its use is unnecessary because of availability of milk, this paper aims to prove that recombinant bovine growth hormone (rBST/rBGH) does not pose a health risk to people that consume milk or meat produced from cows that have been treated with it.

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Regulations of rBGH Use

The decision to use the goods that were produced via recombinant bovine growth hormone since they are safe for human consumption was made by FDA under a variety of regulations. Despite the absence of rBGH’s adverse effects, the publicity is concerned about the regulatory policy of FDA’s permission to market products with this hormone. It results in a number of studies that confirm the safety of the hormone for the animals as well as for humans. The regulatory process involves a cycle of permissions, investigations, and FDA’s recommendations to ensure that products with this hormone are appropriate for human consumption. For instance, FDA developed a guideline, “Good Laboratories Practices,” for pharmacological companies that conduct experiments using rBGH (Juskevich & Guyer, 1990). Other regulations involve “Guideline for Toxicological Testing” provided by the FDA to test human exposure to possible biological effects of protein products with rBGH. The decision to market the products containing this hormone was made after the results of the experiments have met a variety of regulations. It allows considering them as a manifestation of a responsible and strict approach of the FDA to ensure that using rBGH is safe. It may be illustrated by the list of national and international review committees, who participated in results’ evaluation. The following committees have been involved: The Joint FAO/WHO Expert Committee on Food Additives (1999), Health Canada (1999), Royal College of Physicians and Surgeons of Canada (1998, 1999), Commission of the European Communities (1988/1989), American Medical Association (1991), U.S. National Institute of Health (1990), Health Care Without Harm (2007), and many others (American Cancer Society, 2014). Acquainted with these regulations, publicity would have sufficient evidence of the FDA’s soundness and rBGH products’ appropriateness in particular. Moreover, despite the fact that the safety of Posilac for animals and humans is being confirmed regularly, the FDA keeps on monitoring the safety and effectiveness of Posilac. It is done through review of all reported adverse drug experiences and post-approval surveillance (FDA, 2017).

The criteria for the evaluation of the safety of bGH food for humans are known, which demonstrate openness to publicity and fair politics concerning the decision-making. One of them is ineffectiveness of pituitary GH preparations from animals in humans (Juskevich & Guyer, 1990). It means that despite some physiological effects of GH in animals, it cannot be extrapolated on humans. Another finding is that GH from nonprimate species is ineffective in primate species as the effect of GH does not go beyond a phylogenetic tree. However, GH was effective in rats, and the multiply studies, including the rates, demonstrate that their consumption of rBGH has not resulted in GH treatment-related or accidental deaths. After the experiments in the hematology, clinical chemistry, and urinalysis parameters, no toxicologically significant effects were discovered.

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rBGH Effects on Milk Composition

Treatment of cows with rBGH has minor effect on milk components as during the course of lactation, milk consumption of treated cows met the normal variation. rBGH treatment does not affect lactose as well as does not lead to consistent changes concerning calcium, phosphorus, vitamins, and minerals. In addition, it does not have considerable impact on milk’s nutritional quality. Nevertheless, to avoid negative consequences due to lack of scientific data regarding the oral activity of IGF-I, another serial of experiments was required because of potential effects of growth factors on cells and cellular metabolism. Though the IGF of bovine and human are identical, treating cattle with rBGH was not expected to result in increased biologically significant IGF-I concentrations to people. Within the toxicity studies of IGF-I it has been revealed that no treatment-related deaths or clinical signs connected with IGF were evident. Furthermore, treatment-related changes in the hematological parameters of the groups were not observed. Finally, oral treatment of rates with IGF-I did not cause any of the above-mentioned changes.

Apart from studying the animals’ reaction on the treatment, the range of IGF-I concentrations in salable milk and bulk tank milk was measured. The numerous studies confirmed that IGF-I concentrations in the milk of rbGH-treated cows was higher than in non-treated ones. Nevertheless, due to additional factors that contribute to such an increase, in particular stage of lactation and parity, it is not a matter of treatment only. The research indicated that rbGH treatment does not influence IGF-II milk concentrations. Therefore, the researchers concluded that increase in growth factors secondary to rbGH treatment unlikely present human food safety concerns (Juskevich & Guyer, 1990). As oral treatment of rbGH influences IGF-I within the physiological range in breast milk, the FDA scientists concluded that use of rbGH in dairy cattle does not pose any health risk to the consumers, including the milk used for infant formula.

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Recent Studies of rBST’s Affects

Similarly to growth hormone, recombinant bovine somatotropin allows reducing animal waste and carbon footprint, as well as enhancing effectiveness of feed sources in animals. Through the 20 years of its use, its impact on human health has been reviewed. The results of abovementioned studies have been confirmed in the recent researches’ ones stating that there is no evidence of human health concerns due to consumption of products with rBST (Collier & Bauman, 2014). After 20 years of hormone’s commercialization, the results of scientifically advanced studies show that there are no human health issues related to the use of rBST by the dairy industry (Collier & Bauman, 2014). In the 1990s, the committee concerning the health issues of rBST use held that rBST can be used without any appreciable health risk to consumers. However, the committee considered the possible increased concentrations of IGF-I in the milk of cows that were treated with rBST, the possibility of increased health risks due to exposure of human neonates and young children, and potential impact of rBST on the expresses of certain viruses in animals (Collier & Bauman, 2014). Furthermore, the committee reported that purchasers’ health is not affected when using milk of the cows that were taken antibiotics to treat mastitis. In addition, it has been announced that the increased potential for drug residues in milk may be managed by currently used practices. As the value of milk worldwide is rather high, the dairy products with rBST have been checked in national nutrition surveys. The effects of rBST on composition of milk were studied by the previous researchers, who revealed that manufacturing characteristics as well as nutritional components were not altered by rBST. The recent studies that checked the milk of different labels and compared the composition of milk indicated that there is no significant difference between the organic, rBST free, and unlabeled kinds of milk (Collier & Bauman, 2014). The composition of milk depends on a variety of factors such as stage of lactation, genetics, diet, breed, season, and environment, and all of them affect milk composition of animals in the same way as in rBST-treated cows. The studies confirmed that commercial dairy farms do not identify unmanageable risk of mastitis.

In prior studies, there were concerns regarding rBST potential to cause cancer due to a relationship between blood levels of IGF-I and the development of different types of cancers (American Cancer Society, 2014). Nevertheless, the latter studies provided no evidence of validity of such a connection. Regardless of the links between cancer and IGF-I blood levels, they remain unclear and require further examination. In addition, it is unclear whether milk produced with or without rBGH treatment increases IGF- I to the extent when it may result in cancer (American Cancer Society, 2014). Thus, though there might be potential risks between higher IGF-I and cancer risk, the evidence does not demonstrate the validity of such a relationship.

rBGH for Infant and Young Children

Another published evidence of milk products, which covers one of the main public concerns, is rBGH dairy’s impact on infants. Therefore, the studies examining rBGH safety for human consumption is investigation of this milk impact on infant’s organism. The scientists revealed that a variety of factors influence infant’s reaction on these products, including gestational age of the neonate, the type of the protein as well as the feeding regime (Juskevich & Guyer, 1990). Though the issue of milk with rBGH for infants’ consumption is controversial due to the complexity of factors involved, the results demonstrate that the uptake of macromolecules into intestinal epithelial cells in infants is not more significant than in adults (Juskevich & Guyer, 1990). It means that the danger of the hormone’s use for infants has not been indicated although this aspect requires further investigations.

Based on the absence of rBST effects on milk’s nutrient composition, it has been concluded that supplement of rBST does not affect the value of milk and dairy foods regarding nutrient contents that are significant for children to grow (Collier & Bauman, 2014). Within the studies of effects of rBST dairy products by human neonates or young children with type 1 diabetes, JECFA stated that the use of rBST would not impact the risk for type 1 diabetes. Though type 1 diabetes is triggered by complex foreign proteins, the IGF-I in cows’ milk and human milk are identical in structure, the IGF-I will not be recognized as a foreign protein, and will not trigger complications in diabetics (Collier & Bauman, 2014). In addition, evidence concerning milk IGF-I’s involvement in type 1 diabetes is absent. The investigations of insulin combinations with recombinant IGF-I showed that IGF-I in milk would not lead to hypoglycemic effects in humans. In 1998, JEFCA announced that rBST does not affect the expressions of lentivirus in cows (Collier & Bauman, 2014). Though the identical researches have not been published since that time, the study of retroviruses demonstrated that human somatotropin increases the immune function in human immunodeficiency virus-infected people (Collier & Bauman, 2014). Thus, increased expression of retroviruses in animals treated with rBST was not proved as well as no risk on human health of cows’ retroviruses were discovered.

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Petition against FDA’s Approval

Though the FDA and other committees regularly publish the studies that confirm the absence of adverse effects of rBST milk, the petitions and articles against rBST use are being presented. Leavitt and von Eschnenbach (2007), “Dockets Management Branch” of the FDA, and the citizens signed a demand to remove the approval for Posilac use titled as “Petition Seeking the Withdrawal of the New Animal Drug Application Approval for Posilac – Recombinat Bovine Growth Hormone (rBGH).” The statements of grounds section rest on adverse effects of rBGH use, namely the veterinary toxicity, abnormalities of milk, increased IGF-1 levels in milk of treated cows, absorption of IGF-I from the Intensine into the blood, increased IGF-I levels with raised various types of cancers and inhibit apoptosis, the international ban to use products with rBGH as well as the FDA’s refusal to label rBGH dairy due to lack of basis (Epstein, 1990). Concerning the veterinary toxicity, the authors do not refer to any published study but claim that the FDA has cheated with animal health test data (Leavitt & von Eschnenbach, 2007). Since such an argument is not supported by the evidence, it cannot be counted as reliable or deserving further consideration. When listing the abnormalities, the protesters refer to reduction in short-chain fatty acid, increase in long-chain fatty levels , increase in the thyroid hormone triioidothyronine enzyme levels, frequency of pus cells due to mastitis, and contamination with unapproved drugs for treating mastitis (Epstein,1990). The petition refers to particular studies (Epstein, 1990) that focus on the cases of negative adverse effects, which were not mentioned by the FDA. It is worth questioning the competency of the researchers and the competency of the variety of committees who reviewed rBGH’s effects. This aspect and increased IGF-1 levels refer to the studies that interpret data different from FDA’s cases and provide another evaluation. As they do not regard the studies used by FDA, and FDA does not consider all of the cases listed in studies and mentioned in a petition, it may be assumed that both rely on different data and cannot be compared. Further, the petition denies the common knowledge that IGF-I is not a protein but a peptide, which does not correspond to the state of affairs. In terms of rBGH’s connection with cancer, it is stated that rBGH increases risks of breast cancer and prostate cancer based on reviewed publication although it did not demonstrate an explicit relationship. Next, the petitioners refer to the fact that rBGH is banned in Canada and the European Union without evidence, which is not a valid argument against rBGH. In the last point of critics, it is claimed that the FDA mislead the dairy producers and their consumers as its statements are extreme (Epstein, 1990). Though, it has not been showed how those misleading statements are ‘extreme.’

Conclusion

While somatotropin and bovine somatotropin are natural growth hormones in human and cattle respectively, rBGH or rBST are synthetically growth hormones. Since the time it has been invented and commercialized, its use meets a variety of human health safety concerns among the publicity. The main of them may be divided into two, namely whether milk of treated cows increases blood levels of growth hormone in consumers, including potential health risk, and whether the increased use of antibiotics that treat mastitis in rBGH cows contributes to antibiotic resistant bacteria in humans. The studies assisted or headed by the FDA of “the first wave” (the 1990s) and “the second wave” (recent studies) confirm that there is no evidence of rBGH’s adverse effects on human health. To demonstrate this position, a variety of experts from the studies and main arguments have been discussed in the given paper. Despite the numerous findings towards rBGH safety, the petition signed in 2007 represents intolerance to FDA’s approval by the publicity. The arguments listed in the petition are invalid or provide a different selection, interpretation, and evaluation of data, thus inconclusive. Finally, the opponents of rBGH failed to provide sufficient evidence of health hazards whereas studies towards rBGH use contain sufficient facts. The FDA’s position was selected as the right one because its arguments are more trustworthy, valid, provided by the experimental details, and more representative. The investigation demonstrates that rBST is not only safe but also may be used for commercial purposes without any health concerns. Though the safety concerns will be raised due to the publicity’s fears and incompetence in the issue, the dairy products with rBST would allow reducing expenses for manufacturing, lead to increased products quality checks, make the dairy products more affordable for low-income people, and remain safe.

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