Team:Cornell NY/Policies
Policies
What It Costs
Mastitis costs the dairy industry billions of dollars every year in both treatment of infected dairy cattle and in loss of sellable milk. Through our extensive human centered design outreach, a farmer told us that even the smallest improvement in current management of the disease would be worth an investment from the farmer’s perspective because of just how costly the occurrence of mastitis is.
A typical case of mastitis costs approximately $300. A standard medicine for mastitis such as Spectramast [x], costs between $6-$8 per treatment. Treatment must be given daily for a course of about a week, so the cost of the medicine itself is between $42-$56. Additionally, while a cow is being treated for a mastitis, as well as a few days post-treatment, the milk produced by that cow cannot be sold. The current price of milk is approximately $16.50/cwt [3]. Since a healthy cow produces around 100 lb of milk a day, over a course of 9 days without saleable milk there would be approximately $150 in losses. Also, once a cow recovers, they usually have permanent defects due to scarring which leads to a 10% less milk production for the rest of their lactation lifespan.
Bacteriocins also are better than the presently available medicines for mastitis.Currently, the most common treatment for mastitis is the use of intramammary antibiotic tubes. Unfortunately, these treatments often lack specificity and are given without knowledge of the type of bacteria actually causing the infection [1][2]. The specificity that our bacteriocin treatment offers leads to a smaller risk of eventual development of resistance, as well as more importantly the ability to specifically target the type of bacteria causing the disease without altering other bacterial ecology. Since the price range of the bacteriocins is likely to be in the range of other current antibiotics, it is clear that there would be a reason to purchase bacteriocins.
Current milking shells on the market cost $40-$50, but are simply solid steel parts. Since we are adding technology to our shell, it is natural that they would cost more. Each of the 8 LED lights will cost $0.67 [5], for a total of $5.36. A temperature sensor add-on would cost $15 [6].
Does It Harm Me?
Whenever we perform any scientific protocol, we always have to think about the risks and impacts of the project, a task that is, indeed, not that simple. One aspect of risks that we have to assess is the effects of the recombinant organisms and peptides that are used in the project on humans [5]. Ideally, the E. coli cells that we used to take up the various genes to produce our bacteriocins would not have any impact on the hosts because they are kept within the laboratory setting. However, if the cells managed to leave the laboratory setting, then the biggest concern would be if another organism were to take up the DNA lost from these E. coli cells.
In addition, using bacteriocins is our approach to mastitis treatment in place of the traditional application of antibiotics. Milk that has antibiotic residues must be discarded, but it is safe to consume milk that has bacteriocins. One of the greatest applications of bacteriocins in today’s industry is food preservation in meat and fish products, fruits and vegetables, and beverages. Furthermore, bacteriocins produced by lactic acid bacteria (LAB) are generally recognized as safe (GRAS) and are effective against major Gram-positive pathogens in food-borne sicknesses. One of the major concerns, however, is the maximum level of bacteriocins allowed in the milk. Nisin, a bacteriocin that we use in this project, is used worldwide in preservation of dairy products, sausages, and canned and packaged meat, but there is still no consensus on the maximum concentration at which it is still considered safe. More studies need to be conducted to further look into the maximum levels of nisin, among other bacteriocins, that are considered to be safe [5].
[5] Sobrino-Lopez, A., O. Martin-Belloso. 2007. Use of nisin and other bacteriocins for preservation of dairy products. http://www.sciencedirect.com/science/article/pii/S0958694607002361
Cow Harm
In several experiments where bacteriocins have been used to treat mastitis, especially when they are injected into the mammary glands of the cows, the glands became irritated with the injection and often turning swollen and tender [6]. In a particular study done by Wu et. al on the effect on nisin, a bacteriocin, on the treatment of mastitis, the cows’ mammary glands only became swollen after injection of a large dose of nisin. The study also notes that it is common to have irritated mammary glands after an injection. Apart from that, the experiments have not shown to cause cows any other harm. Traces of bacteriocins have been found in the milk from cows that have been treated bacteriocins 24 hours and 48 hours after the treatment, but the residues were much lower than the limit set for using nisin to preserve milk. This supports that nisin was safe for subclinical mastitis therapy in lactating cows [7].
[6] Taylor, J., A. Hirsch, and A. T. R. Mattick. 1949. The treatment of bovine streptococcal and staphylococcal mastitis with nisin. Vet. Rec. 61:197-198. [7] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2043217/#r22
Legality
As Legendairy, we one day hope to take our project from proof of concept to a physical product, and knowing that this is a feasible option is important. To do so, we must examine the guidelines that the U.S. Public Health Service and Food and Drug Administration set. The FDA sets guidelines to regulate the approval of antimicrobial drugs and review equipment, in line with the Grade A Pasteurized Milk Ordinance [8]. To approval bacteriocins as an antimicrobial drug, our next steps would be [9]:
-Demonstrating that bacteriocins are safe to the cow through an irritation study and analysis of milking during the treatment period -Determining the efficacy of the drug -Conducting clinical trials which set an appropriate dose
These tests involve treating a cow, and checking for both treatment and prevention of subclinical mastitis. Culture results test for the presence of pathogens such as Staphylococcus aureus and Streptococcus agalactiae, which are allowed to be generalized to other Staphylococcus and Streptococcus species. Since our bacteriocins each target different pathogens, some of which fall under the above species, and some of which don’t, each of the bacteriocins would have to undergo approval with their specific pathogen [9].
To manufacture the customizable shell, our next steps would be:
-Testing by Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) which ensures that the chemicals used to construct the liner are not harmful -Ensuring that the silicone of the liner falls in line with FDA CFR 177.2600, “Rubber articles intended for repeated use” [10] -Manufacturing the liner with a stainless steel metal of the American Iron and Steel Institute which is an FDA approved component [9]
Though we still have a ways to go until our products would be FDA approved, the process is certainly promising, and components of our design could easily be adjusted to match the FDA standards.
[8] Milk and Milk Product Equipment: A Guideline for Evaluating Construction. N.p.: U.S. Department of Health and Human Services Public Health Services Food and Drug Administration, Aug. 2000. PDF. [9] "CVM GFI #49 Target Animal Safety And Drug Effectiveness Studies for Anti-Microbial Bovine Mastitis Products (Lactating and Non-Lactating Cow Products)." U.S. Food and Drug Administration. U.S. Food and Drug Administration, 4 Apr. 1996. Web. 28 Sept. 2016. [10] "CFR - Code of Federal Regulations Title 21." U.S. Food and Drug Administration. U.S. Food and Drug Administration, 1 Apr. 2016. Web. 28 Sept. 2016.
