The status of genetically modified foods internationally and in the United States

Biotechnology refers to the broad set of techniques that allow genetic manipulation of organisms. The techniques of biotechnology have broad implications for many industries, however it promises the greatest innovations in the production of products regulated by the Food and Drug Administration (FDA). Like many other powerful new technologies, biotechnology may carry risks as well as benefits. Several of its applications have engendered fervent emotional reactions and raised serious ethical concerns, especially internationally. ^ First, in my paper I discuss the historical and technical background of biotechnology. Second, I examine the development of biotechnology in Europe, the citizens' response to genetically modified (“GM”) foods and the governments' response. Third, I examine the regulation of bioengineered products and foods in the United States. ^ In conclusion, there are various problems with the current status of regulation of GM foods in the United States. These are four basic flaws: (1) the Coordinated Framework allows for too much jurisdictional overlap of biotechnological foods, (2) GM foods are considered GRAS and consequently, are placed on the market without pre-market approval, (3) federal mandatory labeling of GM foods cannot occur until the question of whether or not nondisclosure of a genetic engineering production processes is misleading or material information and (4) an independent state-labeling scheme of GM foods will most likely impede interstate commerce. ^

A comprehensive review of the environmental impacts and human health risks associated with the occurrence of waste pharmaceuticals in water sources of the United States, and policy implications

The occurrence of waste pharmaceuticals has been identified and well documented in water sources throughout North America and Europe. Many studies have been conducted which identify the occurrence of various pharmaceutical compounds in these waters. This project is an extensive review of the documented evidence of this occurrence published in the scientific literature. This review was performed to determine if this occurrence has a significant impact on the environment and public health. This project and review found that pharmaceuticals such as sex hormone drugs, antibiotic drugs and antineoplastic/cytostatic agents as well as their metabolites have been found to occur in water sources throughout the United States at levels high enough to have noticeable impacts on human health and the environment. It was determined that the primary sources of this occurrence of pharmaceuticals were waste water effluent and solid wastes from sewage treatment plants, pharmaceutical manufacturing plants, healthcare and biomedical research facilities, as well as runoff from veterinary medicine applications (including aquaculture). ^ In addition, current public policies of US governmental agencies such as the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and Drug Enforcement Agency (DEA) have been evaluated to see if they are doing a sufficient job at controlling this issue. Specific recommendations for developing these EPA, FDA, and DEA policies have been made to mitigate, prevent, or eliminate this issue.^ Other possible interventions such as implementing engineering controls were also evaluated in order to mitigate, prevent and eliminate this issue. These engineering controls include implementing improved current treatment technologies such as the advancement and improvement of waste water treatment processes utilized by conventional sewage treatment and pharmaceutical manufacturing plants. In addition, administrative controls such as the use of “green chemistry” in drug synthesis and design were also explored and evaluated as possible alternatives to mitigate, prevent, or eliminate this issue. Specific recommendations for incorporating these engineering and administrative controls into the applicable EPA, FDA, and DEA policies have also been made.^

Health disparities between the United States mainland and Puerto Rico, Guam, and the United States Virgin Islands (United States territories)

Health disparities have been documented for the United States mainland. No literature was found comparing the mainland population to that of Puerto Rico, Guam, and the United States Virgin Islands (United States territories). Using Healthy Lifestyle Characteristics of non-smoking, maintaining a healthy weight, consuming fruits/vegetables daily, and exercising regularly, the health of the mainland was compared to United States territories. The research questions were: (1) Among the characteristics, what are similarities/differences between citizens of the mainland United States and territories?, (2) Among the characteristics, what are similarities/differences in how the territories compare to each other?, (3) Does the mainland and the territories meet Healthy People 2010 goals for these characteristics?, (4) Are perceptions of health concordant or discordant with the characteristics for mainlanders and Puerto Ricans? ^ Using 2007 data from Behavioral Risk Factor Surveillance System (BRFSS), frequency distributions were compared for the Healthy Lifestyle Characteristics for the mainland territories. Research found smoking rates on Guam were statistically greater than the mainland, Puerto Rico or the Virgin Islands. Healthy body mass index levels and physical activity rates were better on Guam compared to other locations. Puerto Rico had significantly more overweight and obese persons, lower fruit/vegetable consumption rates, and lower physical activity rates than the mainland, Guam and the Virgin Islands. Research found mainlanders reported statistically greater participation in regular physical activity than did Puerto Ricans and Virgin Islanders; there were significant differences in fruit/vegetable consumption rates compared to both. The research found no locations met all four of Healthy People 2010 goals. Compared to mainlanders, research showed Puerto Ricans perceive their health significantly worse.^ A better understanding is needed for how United States citizens (mainlanders and territory residents) view participation in healthy behaviors and how health is affected by participating or not in healthy behaviors. For the year examined, Healthy People 2010 goals were not achieved. This study demonstrates Puerto Ricans’ health, using the four characteristics, is significantly worse than residents in the other locations. Public health programs targeting Puerto Ricans are warranted. Finally, this study highlights the need for continued research on the relationships among the mainland and territories.^

Analysis of clonality and antibiotic resistance among early clinical isolates of Enterococcus faecium in the United States.

BACKGROUND: The Enterococcus faecium genogroup, referred to as clonal complex 17 (CC17), seems to possess multiple determinants that increase its ability to survive and cause disease in nosocomial environments. METHODS: Using 53 clinical and geographically diverse US E. faecium isolates dating from 1971 to 1994, we determined the multilocus sequence type; the presence of 16 putative virulence genes (hyl(Efm), esp(Efm), and fms genes); resistance to ampicillin (AMP) and vancomycin (VAN); and high-level resistance to gentamicin and streptomycin. RESULTS: Overall, 16 different sequence types (STs), mostly CC17 isolates, were identified in 9 different regions of the United States. The earliest CC17 isolates were part of an outbreak that occurred in 1982 in Richmond, Virginia. The characteristics of CC17 isolates included increases in resistance to AMP, the presence of hyl(Efm) and esp(Efm), emergence of resistance to VAN, and the presence of at least 13 of 14 fms genes. Eight of 41 of the early isolates with resistance to AMP, however, were not in CC17. CONCLUSIONS: Although not all early US AMP isolates were clonally related, E. faecium CC17 isolates have been circulating in the United States since at least 1982 and appear to have progressively acquired additional virulence and antibiotic resistance determinants, perhaps explaining the recent success of this species in the hospital environment.

Dual Targeting of Tumor Angiogenesis and Chemotherapy by Endostatin- Cytosine Deaminase-Uracil PhosphoribosylTransferase

Antiangiogenesis is a promising anti-tumor strategy through inhibition tumor vascularformation to suppress tumor growth. Targeting specific VEGF/R has been showntherapeutic benefits in many cancer types and become a first approvedantiangiogenic modalities by Food and Drug Administration (FDA) in United States.However, interruption of homeostasis in normal tissues that is likely due to theinhibition of VEGF/R signaling pathway induces unfavorable side effects. Moreover,cytostatic nature of antiangiogenic drugs frequently causes less tumor cell specifickilling activity, and cancer cells escaped from cell death induced by these drugseven gain more malignant phenotypes, resulting in tumor invasion and metastasis.To overcome these issues, we developed a novel anti-tumor therapeutic EndoCDfusion protein which linked endostatin (Endo) to cytosine deaminase-uracilvphosphoribosyl transferase (CD). Endo targets unique tumor endothelial cells toprovide tumor-specific antiangiogenesis activity and also carries CD to the localtumor area, where it serves nontoxic prodrug 5-fluorocytosine (5-FC) enzymaticconversion reaction to anti-metabolite chemotherapy drug 5-fluorouracil (5-FU). Wedemonstrated that 5-FU concentration was highly increased in tumor sites, resultingin high level of endothelial cells and tumor cells cytotoxic efficacy. Furthermore,EndoCD/5-FC therapy decreased tumor growth and colorectal liver metastasisincident compared with bevacizumab/5-FU treatment in human breast and colorectalliver metastasis orthotropic animal models. In cardiotoxicity safety profile,EndoCD/5-FC is a contrast to bevacizumab/5-FU; lower risk of cardiotoxicityinduction or heart function failure was found in EndoCD/5-FC treatment thanbevacizumab/5-FU does in mice. EndoCD/5-FC showed more potent therapeuticefficacy with high safety profile and provided stronger tumor invasion or metastasisinhibition than antiangiogenic drugs. Together, EndoCD fusion protein with 5-FCshowed dual tumor targeting activities including antiangiogenesis and tumor localchemotherapy, and it could serve as an alternative option for antiangiogenic therapy.

Folic acid fortification, maternal obesity and neural tube defects: Policy implications

In 1996, the Food and Drug Administration (FDA) mandated that beginning in January 1998, flour and other enriched grain products be fortified with 140 μg of folic acid per 100 g of grain to prevent neural tube defects (NTDs) that occur in approximately 1 in 1,000 pregnancies in the United States (U.S.). Although this program has demonstrated important public health effects, it is argued that current fortification levels may not be enough to prevent all folic acid-preventable NTD cases. This study reviews published literature, on folic acid fortification in the U.S. and countries with mandatory folic acid fortification programs reported after 1992 and through January 2008. Published studies are evaluated to determine if the current level of folic acid fortification in the U.S. is adequate to prevent the most common forms of NTDs (spina bifida and anencephaly), particularly among overweight and obese women. ^ Although consistent improvement in blood folate levels of child bearing age women is reported in almost all studies, the RBC folate concentration has not reached the level associated with the most significant reduction of risk for NTDs (906 nmol/L); approximately half of the potentially preventable NTDs are prevented by fortification at the current U.S. level. Furthermore, the blood folate status of women in higher BMI categories (obese or overweight) has not improved as much as among women in lower BMI categories. Therefore, women classified as overweight or obese have not benefited from the preventive effects of folic acid fortification as much as normal or underweight women. ^ To reduce risk of folate preventable NTDs, especially in overweight and obese women, it may be necessary to increase the current level of folic acid fortification. However, further research is required to determine the optimal levels of fortification to achieve this goal without causing adverse health effects in the general population. ^

Foodborne illness - An age old problem requiring contemporary solutions

Foodborne illness has always been with us, and food safety is an increasingly important public health issue affecting populations worldwide. In the United States of America, foodborne illness strikes millions of people and kills thousands annually, costing our economy billions of dollars in medical care expense and lost productivity. The nature of food and foodborne illness has changed dramatically in the last century. The regulatory systems have evolved to better assure a safe food supply. The food production industry has invested heavily to meet regulatory requirement and to improve the safety of their products. Educational efforts have increased public awareness of safe food handling practices, empowering consumers to fulfill their food safety role. Despite the advances made, none of the Healthy People 2010 targets for reduction of foodborne pathogens has been reached. There is no single solution to eliminating pathogen contamination from all classes of food products. However, irradiation seems especially suited for certain higher-risk foods such as meat and poultry and its use should advance the goal of reducing foodborne illness by minimizing the presence of pathogenic organisms in the food supply. This technology has been studied extensively for over 50 years. The Food and Drug Administration has determined that food irradiation is safe for use as approved by the Agency. It is time to take action to educate consumers about the benefits of food irradiation. Consumer demand will compel industry to meet demand by investing in facilities and processes to assure a consistent supply of irradiated food products. ^

Clinical trials, informed consent, & emergency medicine: A systematic literature review

Background: In the United States, the Food and Drug Administration (FDA) regulates clinical trials. These regulations address good clinical practices as well as human subject protection (FDA, 2012). One of the most important legal and ethical concerns in clinical trials is informed consent. 21 CFR 50 governs human subjects research. Part 50.24 provides an emergency research exception to the informed consent requirement. Research was conducted to determine the appropriateness of this exception, whether the benefit justifies the exception, and its public health significance.^ Methods: A systematic literature review was conducted and articles were identified from peer-reviewed journals.^ Results: There is some variance in opinions regarding the appropriateness of the exception, but the literature reviewed found the study results of these trials justified the waiver.^ Conclusion: The exception to the informed consent requirement is likely appropriate and justified in emergency research when implemented within the specified guidelines.^

Managing the risks of medical technology: Do hazard surveillance systems provide an early warning of medical device problems?

The Food and Drug Administration (FDA) is responsible for risk assessment and risk management in the post-market surveillance of the U.S. medical device industry. One of the FDA regulatory mechanisms, the Medical Device Reporting System (MDR) is an adverse event reporting system intended to provide the FDA with advance warning of device problems. It includes voluntary reporting for individuals, and mandatory reporting for device manufacturers. ^ In a study of alleged breast implant safety problems, this research examines the organizational processes by which the FDA gathers data on adverse events and uses adverse event reporting systems to assess and manage risk. The research reviews the literature on problem recognition, risk perception, and organizational learning to understand the influence highly publicized events may have on adverse event reporting. Understanding the influence of an environmental factor, such as publicity, on adverse event reporting can provide insight into the question of whether the FDA's adverse event reporting system operates as an early warning system for medical device problems. ^ The research focuses on two main questions. The first question addresses the relationship between publicity and the voluntary and mandatory reporting of adverse events. The second question examines whether government agencies make use of these adverse event reports. ^ Using quantitative and qualitative methods, a longitudinal study was conducted of the number and content of adverse event reports regarding breast implants filed with the FDA's medical device reporting system during 1985–1991. To assess variation in publicity over time, the print media were analyzed to identify articles related to breast implant failures. ^ The exploratory findings suggest that an increase in media activity is related to an increase in voluntary reporting, especially following periods of intense media coverage of the FDA. However, a similar relationship was not found between media activity and manufacturers' mandatory adverse event reporting. A review of government committee and agency reports on the FDA published during 1976–1996 produced little evidence to suggest that publicity or MDR information contributed to problem recognition, agenda setting, or the formulation of policy recommendations. ^ The research findings suggest that the reporting of breast implant problems to FDA may reflect the perceptions and concerns of the reporting groups, a barometer of the volume and content of media attention. ^

Effects of congressional modernization laws on public access to innovative medical device technologies

The Federal Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid (CMS) play key roles in making Class III, medical devices available to the public, and they are required by law to meet statutory deadlines for applications under review. Historically, both agencies have failed to meet their respective statutory requirements. Since these failures affect patient access and may adversely impact public health, Congress has enacted several “modernization” laws. However, the effectiveness of these modernization laws has not been adequately studied or established for Class III medical devices. ^ The aim of this research study was, therefore, to analyze how these modernization laws may have affected public access to medical devices. Two questions were addressed: (1) How have the FDA modernization laws affected the time to approval for medical device premarket approval applications (PMAs)? (2) How has the CMS modernization law affected the time to approval for national coverage decisions (NCDs)? The data for this research study were collected from publicly available databases for the period January 1, 1995, through December 31, 2008. These dates were selected to ensure that a sufficient period of time was captured to measure pre- and post-modernization effects on time to approval. All records containing original PMAs were obtained from the FDA database, and all records containing NCDs were obtained from the CMS database. Source documents, including FDA premarket approval letters and CMS national coverage decision memoranda, were reviewed to obtain additional data not found in the search results. Analyses were conducted to determine the effects of the pre- and post-modernization laws on time to approval. Secondary analyses of FDA subcategories were conducted to uncover any causal factors that might explain differences in time to approval and to compare with the primary trends. The primary analysis showed that the FDA modernization laws of 1997 and 2002 initially reduced PMA time to approval; after the 2002 modernization law, the time to approval began increasing and continued to increase through December 2008. The non-combined, subcategory approval trends were similar to the primary analysis trends. The combined, subcategory analysis showed no clear trends with the exception of non-implantable devices, for which time to approval trended down after 1997. The CMS modernization law of 2003 reduced NCD time to approval, a trend that continued through December 2008. This study also showed that approximately 86% of PMA devices do not receive NCDs. ^ As a result of this research study, recommendations are offered to help resolve statutory non-compliance and access issues, as follows: (1) Authorities should examine underlying causal factors for the observed trends; (2) Process improvements should be made to better coordinate FDA and CMS activities to include sharing data, reducing duplication, and establishing clear criteria for “safe and effective” and “reasonable and necessary”; (3) A common identifier should be established to allow tracking and trending of applications between FDA and CMS databases; (4) Statutory requirements may need to be revised; and (5) An investigation should be undertaken to determine why NCDs are not issued for the majority of PMAs. Any process improvements should be made without creating additional safety risks and adversely impacting public health. Finally, additional studies are needed to fully characterize and better understand the trends identified in this research study.^

Bioterrorism preparedness at a hospital level in the Southwest Region of the United States -- A systematic review

Since the tragic events of September, 11 2001 the United States bioterrorism and disaster preparedness has made significant progress; yet, numerous research studies of nationwide hospital emergency response have found alarming shortcomings in surge capacity and training level of health care personnel in responding to bioterrorism incidents. The primary goals of this research were to assess hospital preparedness towards the threat of bioterrorist agents in the Southwest Region of the United States and provide recommendations for its improvement. Since little formal research has been published on the hospital preparedness of Oklahoma, Arizona, Texas and New Mexico, this research study specifically focused on the measurable factors affecting the respective states' resources and level of preparedness, such as funding, surge capacity and preparedness certification status.^ Over 300 citations of peer-reviewed articles and 17 Web sites were reviewed, of which 57 reports met inclusion criteria. The results of the systematic review highlighted key gaps in the existing literature and the key targets for future research, as well as identified strengths and weaknesses of the hospital preparedness in the Southwest states compared to the national average. ^ Based on the conducted research, currently, the Southwest states hospital systems are unable fully meet presidential preparedness mandates for emergency and disaster care: the staffed beds to 1,000 population value fluctuated around 1,5 across the states; funding for the hospital preparedness lags behind hospital costs by millions of dollars; and public health-hospital partnership in bioterrorism preparedness is quite weak as evident in lack of joint exercises and training. However, significant steps towards it are being made, including on-going hospital preparedness certification by the Joint Commission of Health Organization. Variations in preparedness levels among states signify that geographic location might determine a hospital level of bioterrorism preparedness as well, tending to favor bigger states such as Texas.^ Suggested recommendations on improvement of the hospital bioterrorism preparedness are consistent with the existing literature and include establishment and maintenance of solid partnerships between hospitals and public health agencies, conduction of joint exercises and drills for the health care personnel and key partners, improved state and federal funding specific to bioterrorism preparedness objectives, as well as on-going training of the clinical personnel on recognition of the bioterrorism agents.^

Legal regulation of the food industry as a public health measure

Background. The Food and Drug Administration (FDA) is an agency of the federal government that is responsible for monitoring and maintaining public health through the regulation of many industries, including food safety. Through the Nutrition Labeling and Education Act of 1990, the FDA was granted authority over the implementation and regulation of nutrition labeling on packaged foods. Many nutrients are printed on nutrition labels as well as their percent Daily Values. Research has been undertaken to examine the evidentiary basis the FDA relied upon in making its determinations regarding which nutrients to include on nutrition labels as well as their Daily Values. ^ Methods. Relevant legal policies, scientific studies, and other published literature (either in print or electronic form) were used to collect data. ^ Results. Results demonstrated that the FDA did not employ one single method in its determination of which nutrients to select for inclusion on food labels. The agency relied upon current public heath studies of that time as well as recommendations from the U.S. Surgeon General.^

Eluding antibiotic resistance: capitalizing on antimicrobial peptides interaction with the lipid bilayer

It is widely accepted that the emergence of drug-resistant pathogens is the result of the overuse and misuse of antibiotics. Infectious Disease Society of America, Center for Disease Control and World Health Organization continue to view, with concern, the lack of antibiotics in development, especially those against Gram-negative bacteria. Antimicrobial peptides (AMPs) have been proposed as an alternative to antibiotics due to their selective activity against microbes and minor ability to induce resistance. For example, the Food and Drug Administration approved Daptomycin (DAP) in 2003 for treatment of severe skin infections caused by susceptible Gram-positive organisms. Currently, there are 12 to 15 examples of modified natural and synthetic AMPs in clinical development. But most of these agents are against Gram-positive bacteria. Therefore, there is unmet medical need for antimicrobials used to treat infections caused by Gram-negative bacteria. In this study, we show that a pro-apoptotic peptide predominantly used in cancer therapy, (KLAKLAK)2, is an effective antimicrobial against Gram-negative laboratory strains and clinical isolates. Despite the therapeutic promise, AMPs development is hindered by their susceptibility to proteolysis. Here, we demonstrate that an all-D enantiomer of (KLAKLAK)2, resistant to proteolysis, retains its activity against Gram-negative pathogens. In addition, we have elucidated the specific site and mechanism of action of D(KLAKLAK)2 through a repertoire of whole-cell and membrane-model assays. Although it is considered that development of resistance does not represent an obstacle for AMPs clinical development, strains with decreased susceptibility to these compounds have been reported. Staphylococci resistance to DAP was observed soon after its approval for use and has been linked to alterations of the cell wall (CW) and cellular membrane (CM) properties. Immediately following staphylococcal resistance, Enterococci resistance to DAP was seen, yet the mechanism of resistance in enterococci remains unknown. Our findings demonstrate that, similar to S. aureus, development of DAP-resistance in a vancomycin-resistant E. faecalis isolate is associated with alterations of the CW and properties of the CM. However, the genes linked to these changes in enterococci appear to be different from those described in S. aureus.

Natural history of placebo treatment in adults acquiring travelers' diarrhea in Mexico

The natural history of placebo treated travelers' diarrhea and the prognostic factors of recovery from diarrhea were evaluated using 9 groups of placebo treated subjects from 9 clinical trial studies conducted since 1975, for use as a historical control in the future clinical trial of antidiarrheal agents. All of these studies were done by the same group of investigators in one site (Guadalajara, Mexico). The studies are similar in terms of population, measured parameters, microbiologic identification of enteropathogens and definitions of parameters. The studies had two different durations of followup. In some studies, subjects were followed for two days, and in some they were followed for five days.^ Using definitions established by the Infectious Diseases society of America and the Food and Drug Administration, the following efficacy parameters were evaluated: Time to last unformed stool (TLUS), number of unformed stools post-initiation of placebo treatment for five consecutive days of followup, microbiologic cure, and improvement of diarrhea. Among the groups that were followed for five days, the mean TLUS ranged from 59.1 to 83.5 hours. Fifty percent to 78% had diarrhea lasting more than 48 hours and 25% had diarrhea more than five days. The mean number of unformed stools passed on the first day post-initiation of therapy ranged from 3.6 to 5.8 and, for the fifth day ranged from 0.5 to 1.5. By the end of followup, diarrhea improved in 82.6% to 90% of the subjects. Subjects with enterotoxigenic E. coli had 21.6% to 90.0% microbiologic cure; and subjects with shigella species experienced 14.3% to 60.0% microbiologic cure.^ In evaluating the prognostic factors of recovery from diarrhea (primary efficacy parameter in evaluating the efficacy of antidiarrheal agents against travelers' diarrhea). The subjects from five studies were pooled and the Cox proportional hazard model was used to evaluate the predictors of prolonged diarrhea. After adjusting for design characteristics of each trial, fever with a rate ratio (RR) of 0.40, presence of invasive pathogens with a RR of 0.41, presence of severe abdominal pain and cramps with a RR of 0.50, number of watery stools more than five with a RR of 0.60, and presence of non-invasive pathogens with a RR of 0.84 predicted a longer duration of diarrhea. Severe vomiting with a RR of 2.53 predicted a shorter duration of diarrhea. The number of soft stools, presence of fecal leukocytes, presence of nausea, and duration of diarrhea before enrollment were not associated with duration of diarrhea. ^

Infant breastfeeding patterns by sex: Do males feed more?

Background: Most studies have looked at breastfeeding practices from the point of view of the maternal behavior only, however in counseling women who choose to breastfeed it is important to be aware of general infant feeding patterns in order to adequately provide information about what to expect. Available literature on the differences in infant breastfeeding behavior by sex is minimal and therefore requires further investigation. Objectives: This study determined if at the age of 2 months there were differences in the amount of breast milk consumed, duration of breastfeeding, and infant satiety by infant sex. It also assessed whether infant sex is an independent predictor of initiation of breastfeeding. Methods: This is a secondary analysis of data obtained from the Infant Feeding Practices Survey II (IFPS II) which was a longitudinal study carried out from May 2005 through June 2007 by the Food and Drug Administration and the Centers for Disease Control and Prevention. The questionnaires asked about demography, prenatal care, mode of delivery, birth weight, infant sex, and breastfeeding patterns. A total of 3,033 and 2,552 mothers completed the neonatal and post-neonatal questionnaires respectively. ^ Results: There was no significant difference in the initiation of breastfeeding by infant sex. About 85% of the male infants initiated breastfeeding compared with 84% of female infants. The odds ratio of ever initiating breastfeeding by male infants was 0.93 but the difference was not significant with a p-value of 0.49. None of the other infant feeding patterns differed by infant gender. ^ Conclusion: This study found no evidence that male infants feed more or that their mothers are more likely to initiate breastfeeding. Each baby is an individual and therefore will have a unique feeding pattern. Based on these findings, the major determining factors for breastfeeding continue to be maternal factors therefore more effort should be invested in promoting breastfeeding among mothers of all ethnic groups and social classes.^