Bovine growth hormone
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Bovine somatotropin or bovine somatotrophin (abbreviated bST and BST), or bovine growth hormone (BGH), is a
peptide hormone Peptide hormones or protein hormones are hormones whose molecules are peptide, or proteins, respectively. The latter have longer amino acid chain lengths than the former. These hormones have an effect on the endocrine system of animals, including h ...
produced by cows'
pituitary glands In vertebrate anatomy, the pituitary gland, or hypophysis, is an endocrine gland, about the size of a chickpea and weighing, on average, in humans. It is a protrusion off the bottom of the hypothalamus at the base of the brain. The hypop ...
. Like other hormones, it is produced in small quantities and is used in regulating metabolic processes. Recombinant bovine somatotropin (usually "rBST"), is a synthetic version of the bovine growth hormone given to dairy cattle by injection to increase milk production.


Synthesis

After the biotech company
Genentech Genentech, Inc., is an American biotechnology corporation headquartered in South San Francisco, California. It became an independent subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within ...
discovered and patented the
gene In biology, the word gene (from , ; "...Wilhelm Johannsen coined the word gene to describe the Mendelian units of heredity..." meaning ''generation'' or ''birth'' or ''gender'') can have several different meanings. The Mendelian gene is a b ...
for BST in the 1970s,Keith Schneider. 10 June 1990
"Betting the Farm on Biotech."
''the New York Times''
it became possible to synthesize the hormone using
recombinant DNA technology Molecular cloning is a set of experimental methods in molecular biology that are used to assemble recombinant DNA molecules and to direct their replication within host organisms. The use of the word ''cloning'' refers to the fact that the meth ...
to create recombinant bovine somatotropin (rBST), recombinant bovine growth hormone (rBGH), or artificial growth hormone.


Industrial production

Four large pharmaceutical companies,
Monsanto The Monsanto Company () was an American agrochemical and agricultural biotechnology corporation founded in 1901 and headquartered in Creve Coeur, Missouri. Monsanto's best known product is Roundup, a glyphosate-based herbicide, developed in ...
,
American Cyanamid American Cyanamid Company was a leading American conglomerate which became one of the nation's top 100 manufacturing companies during the 1970s and 1980s, according to the Fortune 500 listings at the time. It started in fertilizer, but added ...
,
Eli Lilly Eli Lilly (July 8, 1838 – June 6, 1898) was an American soldier, pharmacist, chemist, and businessman who founded the Eli Lilly and Company pharmaceutical corporation. Lilly enlisted in the Union Army during the American Civil War and ...
, and
Upjohn The Upjohn Company was a pharmaceutical manufacturing firm founded in 1886 in Hastings, Michigan, by Dr. William E. Upjohn who was an 1875 graduate of the University of Michigan medical school. The company was originally formed to make ''fria ...
, developed commercial rBST products and submitted them to the US
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) for approval.Bovine Somatotropin. Joint FAO/WHO Expert Committee on Food Additives Monograp

/ref> Monsanto was the first firm to receive approval. Other countries (Mexico, Brazil, India, Russia, and at least ten others) also approved rBST for commercial use.William D. Dobson. June 199
The BST Case
University of Wisconsin-Madison Agricultural and Applied Economics Staff Paper Series No.397
Monsanto licensed Genentech's patent, and marketed their product as "Posilac". In October 2008, Monsanto sold this business, in full, to
Eli Lilly and Company Eli Lilly and Company is an American pharmaceutical company headquartered in Indianapolis, Indiana, with offices in 18 countries. Its products are sold in approximately 125 countries. The company was founded in 1876 by, and named after, Colonel ...
for $300 million plus additional consideration.


Banning

rBST has not been allowed since at least 2000 on the market in Canada, or since 1990 in the
European Union The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are located primarily in Europe, Europe. The union has a total area of ...
(EU). Australia, New Zealand, Japan, Israel, and Argentina have also banned the use of rBST. The FDA,
World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level o ...
, and
National Institutes of Health The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the lat ...
have independently stated that dairy products and meat from rBST-treated cows are safe for human consumption. An EU report on the
animal welfare Animal welfare is the well-being of non-human animals. Formal standards of animal welfare vary between contexts, but are debated mostly by animal welfare groups, legislators, and academics. Animal welfare science uses measures such as longevit ...
effects of rBST states that its use often results in "severe and unnecessary pain, suffering and distress" for cows, and is "associated with serious
mastitis Mastitis is inflammation of the breast or udder, usually associated with breastfeeding. Symptoms typically include local pain and redness. There is often an associated fever and general soreness. Onset is typically fairly rapid and usually occurs ...
, foot disorders and some reproductive problems".
Note: According to the report, somatotropine, which is often used, is a misnomer as "tropic factors affect direction or extent of body movement while trophic factors affect growth". So the Commission uses the spelling somatotrophin.


History

In 1937, the administration of BST was shown to increase the milk yield in
lactating Lactation describes the secretion of milk from the mammary glands and the period of time that a mother lactates to feed her young. The process naturally occurs with all sexually mature female mammals, although it may predate mammals. The proces ...
cows by preventing mammary cell death in dairy cattle. Until the 1980s, use of the compound was very limited in agriculture as the sole source of the hormone was from bovine carcasses. During this time, the knowledge of the structure and function of the hormone increased. With the advent of
biotechnology Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used ...
, one of the pioneering biotech companies,
Genentech Genentech, Inc., is an American biotechnology corporation headquartered in South San Francisco, California. It became an independent subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within ...
, in 1981 succeeded in cloning and patenting the gene for BST.
Monsanto The Monsanto Company () was an American agrochemical and agricultural biotechnology corporation founded in 1901 and headquartered in Creve Coeur, Missouri. Monsanto's best known product is Roundup, a glyphosate-based herbicide, developed in ...
had been working along the same lines and struck a deal with Genentech in 1979 to license Genentech's patents and collaborate on development of a recombinant version of BST – a process on which Monsanto would invest $300 million. The two companies used
genetic engineering Genetic engineering, also called genetic modification or genetic manipulation, is the modification and manipulation of an organism's genes using technology. It is a set of technologies used to change the genetic makeup of cells, including ...
to clone the BST gene into '' E. coli''. The bacteria are grown in
bioreactors A bioreactor refers to any manufactured device or system that supports a biologically active environment. In one case, a bioreactor is a vessel in which a chemical reaction, chemical process is carried out which involves organisms or biochemistry, ...
, then broken up and separated from the rBST, which is purified to produce the injectable hormone. They published their first field trial results in 1981. Lilly, American Cyanamid, Upjohn, and Monsanto all submitted applications to market rBST to the FDA, and the FDA completed its review of the human safety component of these applications in 1986 and found food from rBST-treated cows to be safe; however, strong public concern led to calls for more studies, investigations, and public discussions, which included an unprecedented conference on the safety of rBST in 1990 organized by the
National Institutes of Health The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the lat ...
at the request of Senator
Patrick Leahy Patrick Joseph Leahy (; born March 31, 1940) is an American politician and attorney who is the senior United States senator from Vermont and serves as the president pro tempore of the United States Senate. A member of the Democratic Party, ...
. FDA approved Monsanto's application in 1993. Monsanto launched rBST, brand-named "Posilac", in 1994.


Mechanism of action

An average dairy cow begins her lactation with a moderate daily level of milk production. This daily output increases until, at about 70 days into the lactation, production peaks. From that time until the cow is dry, production slowly decreases. This increase and decrease in production is partially caused by the count of milk-producing cells in the
udder An udder is an organ formed of two or four mammary glands on the females of dairy animals and ruminants such as cattle, goats, and sheep. An udder is equivalent to the breast in primates and elephantine pachyderms. The udder is a single mass han ...
. Cell counts begin at a moderate number, increase during the first part of the lactation, then decrease as the lactation proceeds. Once lost, these cells generally do not regrow until the next lactation. Administration of rBST or BST prior to peak production, in cows that are well-fed, slows the rate at which the number of mammary cells decreases, and increases the amount of nutrients directed away from fat and toward the mammary cells, leading to an extension of peak milk production. The effects are mediated by the
insulin-like growth factor The insulin-like growth factors (IGFs) are proteins with high sequence similarity to insulin. IGFs are part of a complex system that cells use to communicate with their physiologic environment. This complex system (often referred to as the IGF " ...
(IGF) system, which is
upregulated In the biological context of organisms' production of gene products, downregulation is the process by which a cell decreases the quantity of a cellular component, such as RNA or protein, in response to an external stimulus. The complementary pro ...
in response to BST or rBST administration in well-fed cows.


Use on farms

From 2000 to 2005, the
US Department of Agriculture The United States Department of Agriculture (USDA) is the federal executive department responsible for developing and executing federal laws related to farming, forestry, rural economic development, and food. It aims to meet the needs of comme ...
National Agricultural Statistics Service The National Agricultural Statistics Service (NASS) is the statistical branch of the U.S. Department of Agriculture and a principal agency of the U.S. Federal Statistical System. NASS has 12 regional offices throughout the United States and Pue ...
survey of dairy producers found that about 17% of producers used rBST. The 2010 USDA National Agricultural Statistics Service survey of Wisconsin farms found that about 18% of dairy farms used rBST.


Role in synchronized fertilization on dairy farms

By using cows that produce offspring within a one to two-week period, synchronized breeding allows dairy farmers to artificially inseminate cows for maximum pregnancy rates with minimal effort. BST is a
placental lactogen Placental lactogen, also called chorionic somatomammotropin, is a polypeptide placental hormone, part of the somatotropin family. Its structure and function is similar to that of growth hormone. It modifies the metabolic state of the mother during ...
(PL) hormone and falls under the class of growth hormone, or somatotropin. It is relevant to the practice of artificially expediting placental development in farm mammals, specifically
dairy cattle Dairy cattle (also called dairy cows) are cattle bred for the ability to produce large quantities of milk, from which dairy products are made. Dairy cattle generally are of the species '' Bos taurus''. Historically, little distinction was ...
. The mechanism through which the hormones of this somatotropin exert their effects can be observed at the cellular and molecular level in placental tissue. For mammals exposed to the hormone, bovine somatotropin associates with N-glycosylated proteins that are heavily involved in placental gestation. Knowledge of this and how BST works in conjunction with growth hormones allows for agricultural researchers to experiment on the effects of synchronization in farm animals. Synchronization involves treating cattle with a dose of BST before artificially inseminating them, according to a fixed interval schedule. Synchronization and BST treatment may be used to increase first-service pregnancy rates while following this timed artificial insemination protocol. This would therefore allow agricultural researchers to observe the effects of hormones in relation to natural
estrous cycle The estrous cycle (, originally ) is the set of recurring physiological changes that are induced by reproductive hormones in most mammalian therian females. Estrous cycles start after sexual maturity in females and are interrupted by anestro ...
s. Dairy cattle experienced increased rates of pregnancy during synchronization when exposed to BST. The effects of BST on this treatment are dependent on the step in the estrous cycle, seeing how BST has a stimulatory effect of
progesterone Progesterone (P4) is an endogenous steroid and progestogen sex hormone involved in the menstrual cycle, pregnancy, and embryogenesis of humans and other species. It belongs to a group of steroid hormones called the progestogens and is the majo ...
on the
corpus luteum The corpus luteum (Latin for "yellow body"; plural corpora lutea) is a temporary endocrine structure in female ovaries involved in the production of relatively high levels of progesterone, and moderate levels of estradiol, and inhibin A. It is t ...
.


Controversy

Though approved by the FDA in 1993, rBST has been immersed in controversy since the early 1980s. Part of the controversy concerns potential effects on
animal health Veterinary medicine is the branch of medicine that deals with the prevention, management, diagnosis, and treatment of disease, disorder, and injury in animals. Along with this, it deals with animal rearing, husbandry, breeding, research on nutr ...
and
human health Health, according to the World Health Organization, is "a state of complete physical, mental and social well-being and not merely the absence of disease and infirmity".World Health Organization. (2006)''Constitution of the World Health Organiza ...
.


Animal health

One
meta-analysis A meta-analysis is a statistical analysis that combines the results of multiple scientific studies. Meta-analyses can be performed when there are multiple scientific studies addressing the same question, with each individual study reporting m ...
published in 2003 suggested a negative impact of rBST's effects on bovine health. Findings suggested an average increase in milk output ranging from 11–16%, an approximate 24% increase in the risk of clinical
mastitis Mastitis is inflammation of the breast or udder, usually associated with breastfeeding. Symptoms typically include local pain and redness. There is often an associated fever and general soreness. Onset is typically fairly rapid and usually occurs ...
, a 40% reduction in fertility, and 55% increased risk of developing clinical signs of
lameness A limp is a type of asymmetric abnormality of the gait. Limping may be caused by pain, weakness, neuromuscular imbalance, or a skeletal deformity. The most common underlying cause of a painful limp is physical trauma; however, in the absence ...
. The same study reported a decrease in body condition score for cows treated with rBST, though an increase in their dry matter intake occurred. Another meta-analysis (2003) reported on body condition scores (BCS) but could not reach a conclusion due to lack of
homogeneity Homogeneity and heterogeneity are concepts often used in the sciences and statistics relating to the uniformity of a substance or organism. A material or image that is homogeneous is uniform in composition or character (i.e. color, shape, size, ...
in
study design Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings. The goal of a clinical study is to assess the saf ...
and reporting. They found a trend towards decreased BCS in treated cows but state "Depending on the level of body condition in these cows, this effect may have been beneficial or detrimental." This analysis did not report on clinical mastitis. A more recent meta-analysis (2014) published by the ''Journal of the
American Veterinary Medical Association The American Veterinary Medical Association (AVMA), founded in 1863, is a not-for-profit association representing more than 99,500 veterinarians in the US. The AVMA provides information resources, continuing education opportunities, publicati ...
'' showed no significant increase in risk of clinical
mastitis Mastitis is inflammation of the breast or udder, usually associated with breastfeeding. Symptoms typically include local pain and redness. There is often an associated fever and general soreness. Onset is typically fairly rapid and usually occurs ...
nor other adverse effects on cow health and well-being. This review included 26 peer-reviewed studies that involved the use of the rBST-Zn formulation available to US producers in accordance with the label instructions for treatment initiation (57 to 70 days after birth), dose (500 mg, every 14 days), and route (subcutaneous). Mastitis has cost American dairy industries an estimated $1.5 to 2 billion per year in treating dairy cows. In 1994, an EU scientific commission was asked to report on the incidence of mastitis and other disorders in dairy cows and on other aspects of their welfare. The commission's statement, subsequently adopted by the EU, stated that the use of rBST substantially increased health problems with cows, including foot problems, mastitis, and injection site reactions, impinged on the welfare of the animals, and caused reproductive disorders. The report concluded, on the basis of the health and welfare of the animals, rBST should not be used.
Health Canada Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the department of the Government of Canada responsible for national health poli ...
prohibited the sale of rBST in 1999; the external committees found that there was health risk to humans, and the drug present a threat to animal health, and, for this reason, cannot be sold in Canada. Monsanto-sponsored trials reviewed by the FDA asked whether the use of rBST makes cows more susceptible to mastitis. According to the FDA, which used data from eight Monsanto-sponsored trials in its decision in 1993 to approve Monsanto's rBST product, the answer is yes. The data from these eight trials, which involved 487 cows, showed that during the period of rBST treatment, mastitis incidence increased by 76% in
primiparous In biology and human medicine, gravidity and parity are the number of times a woman is or has been pregnant (gravidity) and carried the pregnancies to a viable gestational age (parity). These terms are usually coupled, sometimes with additional te ...
cows and by 50% for multiparous cows. Overall, the increase was 53%. Conversely, however, a study from the University of Georgia on the monitoring post-approval of rBST, showed that there was no statistically significant (P > 0.05) derivation in cases of clinical mastitis in dairy cows treated with rBST.


Macronutrient composition

The overall composition of the milk including the fat,
protein Proteins are large biomolecules and macromolecules that comprise one or more long chains of amino acid residues. Proteins perform a vast array of functions within organisms, including catalysing metabolic reactions, DNA replication, res ...
, and
lactose Lactose is a disaccharide sugar synthesized by galactose and glucose subunits and has the molecular formula C12H22O11. Lactose makes up around 2–8% of milk (by mass). The name comes from ' (gen. '), the Latin word for milk, plus the suffix ' ...
content is not altered substantially by the use of rBST in dairy cows. The milk may have a slight change in fat content within the first few weeks of rBST treatment as the cow is allowed to adjust her metabolism and feed intake. The changes in the fat content have been shown to be temporary. The composition of the milk has been examined in more than 200 different experiments. Natural variation within milk is normal with or without rBST treatment in cows due to genetics, location, feed, age, and other environmental factors. Protein in milk content has also been studied and was shown to have no apparent change in rBST treated cows. The vitamins and minerals that are normally in milk were also unaltered in milk from rBST treated cows. Freezing point, pH, thermal properties, and other manufacturing characteristics of milk were shown to be the same regardless of whether it came from rBST treated cows or not.


Hormones

BST is destroyed in the
digestive system The human digestive system consists of the gastrointestinal tract plus the accessory organs of digestion (the tongue, salivary glands, pancreas, liver, and gallbladder). Digestion involves the breakdown of food into smaller and smaller compone ...
and even if directly injected, has not been found to have any direct effect on humans. Researchers have found that "IGF-1 in milk is not denatured by
pasteurization Pasteurization or pasteurisation is a process of food preservation in which packaged and non-packaged foods (such as milk and fruit juices) are treated with mild heat, usually to less than , to eliminate pathogens and extend shelf life. ...
and the extent to which intact, active IGF-1 is absorbed through the human digestive tract remains still however uncertain" implicating that an extensive study on the nature of IGF-1 in relation to rBST milk is required. FDA rBST labeling guidelines state, "FDA is concerned that the term 'rbST free' may imply a compositional difference between milk from treated and untreated cows rather than a difference in the way the milk is produced. Without proper context, such statements could be misleading. Such unqualified statements may imply that milk from untreated cows is safer or of higher quality than milk from treated cows. Such an implication would be false and misleading". The FDA has determined that no significant difference has been shown between milk derived from rBST treated and non-rBST treated cows. The FDA, World Health Organization, and National Institutes of Health have independently stated that dairy products and meat from rBST-treated cows are safe for human consumption. The
American Cancer Society The American Cancer Society (ACS) is a nationwide voluntary health organization dedicated to eliminating cancer. Established in 1913, the society is organized into six geographical regions of both medical and lay volunteers operating in more than ...
issued a report declaring, "The evidence for potential harm to humans rom rBGH milkis inconclusive. It is not clear that drinking milk produced using rBGH significantly increases IGF-1 levels in humans or adds to the risk of developing cancer. More research is needed to help better address these concerns."Staff, American Cancer Society. Last Medical Review: 18 February 2011; Last Revised: 18 February 2011
Recombinant Bovine Growth Hormone
/ref>


Human health

The effect of rBGH on human health is an ongoing debate, in part due to the lack of conclusive evidence. A few of the most debated issues include:
Insulin-like growth factor 1 Insulin-like growth factor 1 (IGF-1), also called somatomedin C, is a hormone similar in molecular structure to insulin which plays an important role in childhood growth, and has anabolic effects in adults. IGF-1 is a protein that in humans ...
(IGF-1) is a hormone found in humans that is responsible for growth promotion,
protein synthesis Protein biosynthesis (or protein synthesis) is a core biological process, occurring inside cells, balancing the loss of cellular proteins (via degradation or export) through the production of new proteins. Proteins perform a number of critical ...
, and
insulin Insulin (, from Latin ''insula'', 'island') is a peptide hormone produced by beta cells of the pancreatic islets encoded in humans by the ''INS'' gene. It is considered to be the main anabolic hormone of the body. It regulates the metabolism ...
actions over the lifecycle. The hormone has been shown to influence the growth of tumors in some studies and may be linked to the development of prostate, colorectal, breast, and other cancers. IGF-1 is also found in milk. Previous research has proposed an increase of IGF-1 in rBST-treated cows, but this claim is currently not substantiated. In addition, no current evidence shows that orally consumed IGF-1 is absorbed in humans and the dietary amount is negligible when compared to what the body produces on its own. "IGF-1 in milk is not denatured (inactivated) by pasteurization. The extent to which intact, active IGF-1 is absorbed through the human digestive tract remains uncertain." The American Cancer Society has reviewed the evidence concerning IGF-1 in milk from rBST-treated cows, and found that: "While there may be a link between IGF-1 blood levels and cancer, the exact nature of this link remains unclear. Some studies have shown that adults who drink milk have about 10% higher levels of IGF-1 in their blood than those who drink little or no milk. But this same finding has also been reported in people who drink
soy milk Soy milk (simplified Chinese: 豆浆; traditional Chinese: 豆漿) also known as soya milk or soymilk, is a plant-based drink produced by soaking and grinding soybeans, boiling the mixture, and filtering out remaining particulates. It is a sta ...
. This suggests that the increase in IGF-1 may not be specific to cow's milk, and may be caused by protein, minerals, or some other factors in milk unrelated to rBGH. There have been no direct comparisons of IGF-1 levels in people who drink ordinary cow's milk vs. milk stimulated by rBST. At this time, it is not clear that drinking milk, produced with or without rBST treatment, increases blood IGF-1 levels into a range that might be of concern regarding cancer risk or other health effects. IGF-1 concentrations are slightly higher (to variable degrees, depending on the study) in milk from cows treated with rBST than in untreated milk. This variability is presumed to be much less than the normal range of variation of IGF-1 in cow's milk due to natural factors, but more research is needed." Research is supportive of milk supplying vital nutrients used in childhood development. As of 2014, evidence does not link rBST-treated milk with adverse health outcomes for children. Several studies have looked at the relationship between
type 1 diabetes mellitus Type 1 diabetes (T1D), formerly known as juvenile diabetes, is an autoimmune disease that originates when cells that make insulin (beta cells) are destroyed by the immune system. Insulin is a hormone required for the cells to use blood sugar f ...
and infant feeding. Environmental triggers that may elicit an autoimmune reaction is the mechanism in which is being studied. Some studies have shown early exposure to bovine milk may predispose an infant to type 1 diabetes, whereas other studies show no causality. The
American Society of Animal Science The American Society of Animal Science (ASAS) is a non-profit professional organization for the advancement of livestock, companion animals, exotic animals and meat science. Founded in 1908, ASAS is headquartered in Champaign, Illinois. ASAS mem ...
published an article in 2014 after reviewing health issues arising from the rBST debate. The article indicated "there are no new human health issues related to the use of rbST by the dairy industry. Use of rbST has no effect on the micro- and macrocomposition of milk. Also, no evidence exists that rbST use has increased human exposure to antibiotic residues in milk. Concerns that IGF-1 present in milk could have biological effects on humans have been allayed by studies showing that oral consumption of IGF-1 by humans has little or no biological activity. Additionally, concentrations of IGF-1 in digestive tract fluids of humans far exceed any IGF-1 consumed when drinking milk. Furthermore, chronic supplementation of cows with rbST does not increase concentrations of milk IGF-1 outside the range typically observed for effects of farm, parity, or stage of lactation. Use of rbST has not affected expression of retroviruses in cattle or posed an increased risk to human health from
retrovirus A retrovirus is a type of virus that inserts a DNA copy of its RNA genome into the DNA of a host cell that it invades, thus changing the genome of that cell. Once inside the host cell's cytoplasm, the virus uses its own reverse transcriptas ...
es in cattle. Furthermore, risk for development of type 1 or
type 2 diabetes mellitus Type 2 diabetes, formerly known as adult-onset diabetes, is a form of diabetes mellitus that is characterized by high blood sugar, insulin resistance, and relative lack of insulin. Common symptoms include increased thirst, frequent urination, ...
has not increased in children or adults consuming milk and dairy products from rbST-supplemented cows. Overall, milk and dairy products provide essential nutrients and related benefits in health maintenance and the prevention of chronic diseases." Keeping in mind that bovine somatotropin is a protein growth hormone, it can increase average milk yield anywhere from 10 to 15%, which in turn would lead to cows consuming substantially more nutrients in order to keep up with the increased milk production. Most of a cow's energy consumption goes directly towards milk production. In certain areas of the world, like Ethiopia where this was studied extensively, as the cows needed to intake more nutrition to balance out their milk production, there was also an increased level of
chemical fertilizers A fertilizer (American English) or fertiliser (British English; see spelling differences) is any material of natural or synthetic origin that is applied to soil or to plant tissues to supply plant nutrients. Fertilizers may be distinct from ...
and heavy metal traces found in the milk due to increased exposure to agricultural chemicals. These chemicals can then easily be passed on to humans and lead to a contaminated milk supply. BST increases the longevity or the activity of the mammary cell leading to higher milk production and some other non-desirable side effects. Despite public controversy of the use of growth hormones in food-producing animals, the number of violations has decreased substantially in the past two decades. For comparison, the level of antibiotic-residue detected in bulk milk tank trucks in 2012 was one fifth the level that it was in 1996. As reported by the USDA, the US pattern for milk BTSCC declined steadily from 316,000 cells per mL of milk in 2001 to 224,000 cells/mL in 2010 and 206,000 cells/mL in 2011 (USDA, 2013). Mammary health in the animals themselves has improved over this time period as well as the overall health of the dairy herd in general. This is mostly attributed to better application methods of rBST and a better understanding of how the hormone affects the animals.


Environmental impact

On an industry level, supplementing one million cows with rBST would result in the same amount of milk produced while needing 157,000 fewer cows. Farmers are, therefore, able to improve milk production with a smaller dairy population. Some studies show that rBST-treated cows reduce the greenhouse gas footprint in comparison with conventional and organic dairy operations. Cady's study showed that excretion of
nitrogen Nitrogen is the chemical element with the symbol N and atomic number 7. Nitrogen is a nonmetal and the lightest member of group 15 of the periodic table, often called the pnictogens. It is a common element in the universe, estimated at se ...
and
phosphorus Phosphorus is a chemical element with the symbol P and atomic number 15. Elemental phosphorus exists in two major forms, white phosphorus and red phosphorus, but because it is highly reactive, phosphorus is never found as a free element on Ea ...
, two major environmental pollutants arising from animal agriculture, was reduced by 9.1 and 11.8%, respectively.
Carbon dioxide Carbon dioxide ( chemical formula ) is a chemical compound made up of molecules that each have one carbon atom covalently double bonded to two oxygen atoms. It is found in the gas state at room temperature. In the air, carbon dioxide is t ...
is recognized to be the most important
anthropogenic greenhouse gas Greenhouse gas emissions from human activities strengthen the greenhouse effect, contributing to climate change. Most is carbon dioxide from burning fossil fuels: coal, oil, and natural gas. The largest emitters include coal in China and lar ...
, and livestock metabolism and fossil fuel consumption are the main sources of emissions from animal agriculture. * Livestock metabolism-use of rBST in lactating cows decreases the quantity of energy and protein needed in comparison to conventional dairy operations along with reducing the total feedstuff used. * Fossil fuel consumption-targets atmospheric pollution and resource sustainability environmental concerns. With cows treated with rBST, producing a higher milk yield reduces the feed requirement which in turn decreases with electricity for milk production and the energy required from fossil fuels for cropping. In addition, the
global warming potential Global warming potential (GWP) is the heat absorbed by any greenhouse gas in the atmosphere, as a multiple of the heat that would be absorbed by the same mass of carbon dioxide (). GWP is 1 for . For other gases it depends on the gas and the time ...
is reduced equivalent to removing 400,000 family cars from the road. When conventional, conventional with rBST, and organic dairy operations are compared, 8% fewer cows are needed in an rBST-supplemented population, whereas organic production systems require a 25% increase to meet production targets. This is due to a lower milk yield per cow due to the pasture-based system which is attributed with a greater maintenance energy expenditure associated with grazing behavior.


Lawsuit against WTVT

In 1997, the news division of
WTVT WTVT (channel 13) is a television station licensed to Tampa, Florida, United States, broadcasting the Fox network to the Tampa Bay area. Owned and operated by the network's Fox Television Stations division, WTVT maintains studios on Kenne ...
(Channel 13), a Fox-owned station in
Tampa, Florida Tampa () is a city on the Gulf Coast of the U.S. state of Florida. The city's borders include the north shore of Tampa Bay and the east shore of Old Tampa Bay. Tampa is the largest city in the Tampa Bay area and the seat of Hillsborough ...
, planned to air an investigative report by Steve Wilson and
Jane Akre Jane Akre is an American journalist best known for the whistleblower lawsuit by herself and her former husband, Steve Wilson, against Fox station WTVT in Tampa, Florida. Akre and Wilson are featured in the 2003 documentary film '' The Corporation ...
on the health risks associated with Monsanto's bovine growth hormone product, Posilac. Just before the story was to air, Fox received a letter from Monsanto saying the reporters were biased and that the story would damage the company. Akre stated that Wilson and she went through 83 rewrites over eight months. Negotiations broke down and both reporters were eventually fired. Wilson and Akre alleged the firing was for retaliation, while WTVT contended they were fired for
insubordination Insubordination is the act of willfully disobeying a lawful order of one's superior. It is generally a punishable offense in hierarchical organizations such as the armed forces, which depend on people lower in the chain of command obeying ord ...
. The reporters then sued Fox/WTVT in Florida state court under the state's
whistleblower A whistleblower (also written as whistle-blower or whistle blower) is a person, often an employee, who reveals information about activity within a private or public organization that is deemed illegal, immoral, illicit, unsafe or fraudulent. Whi ...
statute. In 2000, a Florida jury found that while no evidence showed Fox/WTVT had bowed to any pressure from Monsanto to alter the story, Akre, but not Wilson, was a whistleblower and was unjustly fired. She was awarded a $425,000 settlement. At the time of the decision, "the station claimed it did not bend to Monsanto's letter and wanted to air a hard-hitting story with a number of statements critical of Monsanto." Fox appealed the decision stating that under Florida law, a whistleblower can only act if "a law, rule, or regulation" has been broken and argued that the FCC's policy against distortions or misrepresentations presented as news did not fit that definition. On 14 February 2003, the appeals court overturned the verdict, finding that Akre was not a whistleblower because of the Florida "legislature's requirement that agency statements that fit the definition of a "rule" (must) be formally adopted (rules). Recognizing an uncodified agency policy developed through the adjudicative process as the equivalent of a formally adopted rule is not consistent with this policy, and it would expand the scope of conduct that could subject an employer to liability beyond what Florida's Legislature could have contemplated when it enacted the whistle-blower's statute."


Regulation

Use of the recombinant supplement has been controversial. The assessment of the FDA is that there is no significant difference between milk from treated and untreated cows. Twenty-one other countries have also approved marketing of rBST: Brazil, Chile, Colombia, Costa Rica, Ecuador, Egypt, Guatemala, Honduras, Jamaica, Lebanon, Mexico, Panama, Paraguay, Peru, Salvador, South Africa, South Korea, Uruguay, and Venezuela. However, regulatory bodies in several countries, such as Canada, Japan, Pakistan, Australia, New Zealand, and Argentina, along with the EU, rejected Monsanto's application to sell rBSTeuropa.eu: "Commission proposes ban on BST."
press release IP/99/978.
because rBST increases the risk of health problems in cows, including
mastitis Mastitis is inflammation of the breast or udder, usually associated with breastfeeding. Symptoms typically include local pain and redness. There is often an associated fever and general soreness. Onset is typically fairly rapid and usually occurs ...
, reduced fertility, and reduced body condition. In Canada, bulk milk products from the United States that have been produced with rBST are still allowed to be sold and used in food manufacture (cheese, yogurt, etc.) due to loopholes in the ingredient labelling system.Parliamentary Research Branch: "RECOMBINANT BOVINE SOMATOTROPIN (rbST)"
PRB 98-1E, prepared by: Frédéric Forge Science and Technology Division October 1998 Revised 11 August 1999
In 1990, the EU placed a moratorium on its sale by all member nations. It was turned into a permanent ban starting from 1 January 2000; the decision was based solely on veterinary concerns, laws, and treaties. An in-depth report published in 1999 analysed in detail the various human health risks associated with rBST. Canada's health board,
Health Canada Health Canada (HC; french: Santé Canada, SC)Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the department of the Government of Canada responsible for national health poli ...
, refused to approve rBST for use on Canadian dairies, citing concerns over animal health. The study found the occurrence of an
antibody An antibody (Ab), also known as an immunoglobulin (Ig), is a large, Y-shaped protein used by the immune system to identify and neutralize foreign objects such as pathogenic bacteria and viruses. The antibody recognizes a unique molecule of t ...
reaction, possible hypersensitivity, in a subchronic (90-day) study of rbST oral toxicity in rats that resulted in one test animal's developing an antibody response at low dose (0.1 mg/kg/day) after 14 weeks. However, the board stated, with the exception of concerns raised regarding hypersensitivity, "the panel finds no biologically plausible reason for concern about human safety if rBST were to be approved for sale in Canada." The
Codex Alimentarius The Codex Alimentarius () is a collection of internationally recognized standards, codes of practice, guidelines, and other recommendations published by the Food and Agriculture Organization of the United Nations relating to food, food productio ...
Commission, a
United Nations The United Nations (UN) is an intergovernmental organization whose stated purposes are to maintain international peace and security, develop friendly relations among nations, achieve international cooperation, and be a centre for harmoni ...
body that sets international food standards, has, as of 2017, refused to approve rBST as safe. The Codex Alimentarius does not have authority to ban or approve the hormone, but its decisions are regarded as a standard and approval by the Codex would have allowed exporting countries to challenge countries with a ban on rBST before the
World Trade Organization The World Trade Organization (WTO) is an intergovernmental organization that regulates and facilitates international trade. With effective cooperation in the United Nations System, governments use the organization to establish, revise, and ...
.


Abuse on dairy farms

Recombinant bovine somatotropin is an artificially synthesized form of the bovine growth hormone. It is legal for use as an artificial cattle lactation stimulant in several countries, including the US. However, its use is prohibited in most of Europe for reasons of consumer preference, animal well-being, and skepticism of new technology. Farmers who opt to use the synthetic hormone do so because they believe it increases milk production without other inputs. However, concerns of both product safety and livestock abuse have prompted discussions for new methods in
assaying An assay is an investigative (analytic) procedure in laboratory medicine, mining, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a ...
the levels of dairy cattle rBST. One proposed method involves quantifying the presence or absence of the rBST-binding antibody in serum. However, this method would require blood samples to be taken regularly and is thus considered by some critics to be too invasive. The development of other alternative methods continues to undergo development. One such example, tested by W.W. Thatcher at the University of Florida, involves collecting milk samples from the cows and analyzing them directly for the presence of the rBST antibody. Dairy cattle do respond to the rBST
antigen In immunology, an antigen (Ag) is a molecule or molecular structure or any foreign particulate matter or a pollen grain that can bind to a specific antibody or T-cell receptor. The presence of antigens in the body may trigger an immune respon ...
and have shown positive results in immunosorbent trials on milk samples. Tests involving pasteurized milk samples have even shown consistent results, with immunoglobulin rBST still detectable and distinguishable despite other antibodies remaining present. Research on the viability of this new technique, as well as many others, as a means of monitoring the levels of rBST in dairy cattle continues to be an issue of practicality, profitability, and humaneness towards livestock in the dairy industry.


United States

In 1993, the product was approved for use in the US by the FDA, and its use began in 1994. The product is now sold in all 50 states. The FDA stated that food products made from rBST-treated cows are safe for human consumption, and no statistically significant difference exists between milk derived from rBST-treated and untreated cows. The FDA found BST to be biologically inactive when consumed by humans and found no biological distinction between rBST and BST. In 1990, an independent panel convened by the National Institute of Health supported the FDA opinion that milk and meat from cows supplemented with rBST is safe for human consumption.


Labeling

The FDA does not require special labels for products produced from cows given rBST, but has charged several dairies with "misbranding" their milk as having no hormones, because all milk contains hormones and cannot be produced in such a way that it would not contain any hormones. Monsanto sued
Oakhurst Dairy Oakhurst Dairy is a company in the dairy industry that sells mostly milk products, as well as juices. It was founded in 1918, and is headquartered in Portland, Maine. History The company's earliest predecessor was a dairy farm founded in 1902 by A ...
of Maine over its use of a label which pledged not to use artificial growth hormones. The dairy stated that its disagreement was not over the scientific evidence for the safety of rBST (Monsanto's complaint about the label), but, "We're in the business of marketing milk, not Monsanto's drugs." The suit was settled when the dairy agreed to add a qualifying statement to its label: "FDA states: No significant difference in milk from cows treated with artificial growth hormones." The FDA recommends this additional labeling, but does not require it. The settlement itself caused much controversy, with anti-rBST advocates claiming that Oakhurst had capitulated in response to intimidation by a larger corporation and others claiming that Oakhurst's milk labels were in and of themselves using misleading scare tactics that deserved legal and legislative response.


Ohio

In 2008, Ohio's Department of Agriculture (ODA) banned the use of labeling in dairy products as rBST-free because it was deemed misleading to consumers. However, the International Dairy Foods Association and the
Organic Trade Association The Organic Trade Association (OTA) is a membership-based business association that focuses on the organic business community in North America. OTA's mission is to promote ethical consumerism, promoting and protecting the growth of organic trade to ...
claimed ODA's ban was a violation of the
first amendment First or 1st is the ordinal form of the number one (#1). First or 1st may also refer to: *World record, specifically the first instance of a particular achievement Arts and media Music * 1$T, American rapper, singer-songwriter, DJ, and reco ...
by not allowing consumers to decide whether they deem the milk was safe and filed suit against the bill. "The district court granted summary judgment in favor of Ohio, concluding that using 'rBST' as a label was inherently misleading because it implies a compositional difference between those products that are produced with rBST and those that are not."


Kansas

In 2009, the
Kansas Legislature The Kansas Legislature is the state legislature of the U.S. state of Kansas. It is a bicameral assembly, composed of the lower Kansas House of Representatives, with 125 state representatives, and the upper Kansas Senate, with 40 state senators ...
passed a bill that would have required dairies that did not use rBST to print disclaimers on their labels that stated, "The Food and Drug Administration has determined there are no significant differences between milk from cows that receive injections of the artificial hormone and milk from those that do not." The bill was vetoed in the last days of the 2009 legislative session by then-Governor
Kathleen Sebelius Kathleen Sebelius (; née Gilligan, born May 15, 1948) is an American businesswoman and politician who served as the 21st United States secretary of Health and Human Services from 2009 until 2014. As Secretary of Health and Human Services, Sebel ...
. The legislature removed the labeling language and passed the bill without the provision.


Pennsylvania

In 2007,
Pennsylvania Pennsylvania (; ( Pennsylvania Dutch: )), officially the Commonwealth of Pennsylvania, is a state spanning the Mid-Atlantic, Northeastern, Appalachian, and Great Lakes regions of the United States. It borders Delaware to its southeast, ...
adopted a regulation that would have banned the practice of labeling milk as derived from cows not treated with rBST. Pennsylvania's Agriculture Secretary Dennis Wolff made a statement in support of the measure. This prohibition was to go into effect 1 January 2008, but after the comment period, the guidelines were adjusted to only ban "rBST-free" claims and instead allow claims that farmers had pledged not to use rBST and accompany such claims with a disclaimer such as, "No significant difference has been shown between milk derived from rbST-treated and non-rbST-treated cows."


Response from milk producers and retailers

In response to concerns from consumers and advocacy groups about milk from cows treated with rBST, some dairies, retailers, and restaurants have published policies on use of rBST in production of milk products they sell, while others offer some products or product lines that are labelled "rBST-free" or the like. Other dairies and industry groups have worked to assure the public that milk from rBST-treated cows is safe. In reaction to these trends, in early 2008, a pro-rBST advocacy group called American Farmers for the Advancement and Conservation of Technology (AFACT), made up of dairies and originally affiliated with Monsanto, formed and began lobbying to ban such labels. AFACT stated that "absence" labels can be misleading and imply that milk from cows treated with rBST is inferior."Fighting on a Battlefield the Size of a Milk Label"
from ''
The New York Times ''The New York Times'' (''the Times'', ''NYT'', or the Gray Lady) is a daily newspaper based in New York City with a worldwide readership reported in 2020 to comprise a declining 840,000 paid print subscribers, and a growing 6 million paid ...
''
The organization was dissolved in 2011. The International Dairy Foods Association has compiled a list, last updated in 2009, of state regulations in the U.S. for referencing use of growth hormones on milk labels.


Response from health organizations

* The
American Cancer Society The American Cancer Society (ACS) is a nationwide voluntary health organization dedicated to eliminating cancer. Established in 1913, the society is organized into six geographical regions of both medical and lay volunteers operating in more than ...
"has no formal position regarding rBGH". * The
American Nurses Association The American Nurses Association (ANA) is a 501(c)(6) professional organization to advance and protect the profession of nursing. It started in 1896 as the Nurses Associated Alumnae and was renamed the American Nurses Association in 1911. It is b ...
supports the development of national and state laws, regulations, and policies that specifically reduce the use of rBGH or rBST in milk and dairy production in the United States.


Response from political organizations

* Health Care Without Harm opposes the use of recombinant bovine growth hormone due to its adverse impacts on animals and potential harm to humans. * Oregon Physicians for Social Responsibility recommends buying products from cows not injected with recombinant bovine growth hormone (rBGH or rBST).


Production and profitability

One study found a profit of $15.88 US per cow on average by using bST.


See also

*
Genetic engineering Genetic engineering, also called genetic modification or genetic manipulation, is the modification and manipulation of an organism's genes using technology. It is a set of technologies used to change the genetic makeup of cells, including ...
*
Genetically modified food Genetically modified foods (GM foods), also known as genetically engineered foods (GE foods), or bioengineered foods are foods produced from organisms that have had changes introduced into their DNA using the methods of genetic engineering. Gene ...
*
Growth hormone treatment Growth hormone therapy refers to the use of growth hormone (GH) as a prescription medication—it is one form of hormone therapy. Growth hormone is a peptide hormone secreted by the pituitary gland that stimulates growth and cell reproduction. I ...
*
Industrial agriculture Industrial agriculture is a form of modern farming that refers to the industrialized production of crops and animals and animal products like eggs or milk. The methods of industrial agriculture include innovation in agricultural machinery and fa ...
*
List of recombinant proteins The following is a list of notable proteins that are produced from recombinant DNA, using biomolecular engineering. In many cases, recombinant human proteins have replaced the original animal-derived version used in medicine. The prefix "rh" for "r ...
*
Recombinant DNA Recombinant DNA (rDNA) molecules are DNA molecules formed by laboratory methods of genetic recombination (such as molecular cloning) that bring together genetic material from multiple sources, creating sequences that would not otherwise be f ...
*
Somatotropin family The Somatotropin family is a protein family whose titular representative is somatotropin, also known as growth hormone, a hormone that plays an important role in growth control. Other members include choriomammotropin (lactogen), its placental an ...


References

{{DEFAULTSORT:Bovine Somatotropin 1981 in biotechnology Agriculture in the United States Agricultural research Animal welfare Biotechnology products Dairy farming technology Eli Lilly and Company brands Genetic engineering and agriculture Growth hormones Peptide hormones Veterinary drugs