Government Analysis - Essay Example

? Day Month Year Government Analytical Essay Introduction The United s Government has predicated its fundamental belief on a system that stipulates governing is to by the people and for the people. The public has a say in important matters of law and policy. They can enact this right in the voting booth, in the court of public opinion, through the judicial system, and via a host of other avenues. In the end, laws and rules are designed for the better good of society, which means that some will almost certainly disagree and strive to have a rule amended or changed. As the government has grown in size, the bureaucracy has remained in force to handle many such proposed rule changes. From Health and Human Services, to issues of the economy, to science and technology among others, the Federal Register has been designed to keep the public informed of any new or impending changes to policy. In this age of increasing technology, such changes are readily accessible via the Internet, and comments are encouraged. This epitomizes our functioning democratic form of law. It is important that individual citizens have the right and the avenue to make their voices heard in an easily accessible manner. Not everyone can travel to Washington D.C. to argue a proposed rule, but nearly everyone can write or email interested parties. This paper will examine a current rule that is being proposed by the Food and Drug Administration, analyze its rationale, discuss recent comments made, and propose a recommendation as to its feasibility. Proposed Final Rule For quite some time, the Food and Drug Administration has been grappling with a proposal to allow certain parts of cattle to be used in dietary supplements, food, and cosmetics, provided a certain procedure was followed. This rule was actually adopted in 2005, as an amendment to an earlier rule that prohibited such use. Now, the rule is back up for debate, as new research studies have been published that seem to contradict earlier findings establishing that the cattle parts were safe in the proposed food and drug items, provided the set procedure was followed. The docket number of this rule change is FDS-2004-N-0188, and the title of the rule amendment is “Use of Materials Derived from Cattle in Human Food and Cosmetics”, with the comment period ending May 3, 2013 (Federal Register 14012). In summary, rule 69 FR 42256, adopted back on July 14, 2004, established that the use of certain parts of a cow in food and cosmetics was to be prohibited. This was due to studies that revealed there was potential risk of bovine spongiform encephalopathy (BSE) in human food (Federal Register 14012). This also applied to dietary supplements and cosmetics. After a revised comment period, and the publishing of further studies, the Federal Register opted to amend the rule back on September 7, 2005. This amended final rule allowed for the use of the small intestine of cattle in human food and cosmetics, provided an approved removal technique was used (Federal Register 14012). The small intestine, being deemed acceptable for use in cosmetics and certain food products, including dietary supplements, has now been permitted since that rule amendment in 2005. The new rule has since allowed the intestine to be utilized provided it was removed by a procedure approved by the FDA, or if an organization could provide an equally effective alternative procedure that was deemed safe and reliable (Federal Register 14012). While this procedure has continued largely unchecked for the last seven years, interested parties began to conduct and publish their own studies. These studies have created enough reasonable doubt as to the safety of the small intestine, as presently being used, that the Food and Drug Administration has decided to revisit the rule. In recent years, scientific studies, most of which have been peer-reviewed, have demonstrated that there is the possibility that the colon of cattle can be infected with matter that can be harmful to humans. In scientific terms, the proximal ileum, jejunum, ileocecal unction, and colon of cattle can potentially be infected with bovine spongiform encephalopathy (Federal Register 14012). This is the case even if the distal ileum is removed by the previously FDA method. As such, the FDA has seen fit to open the rule back up for another season of comments before making a decision on making the rule final. Analysis of the Problem The part of cattle that is called into question by this possible rule amendment is about 80 inches of uncoiled and trimmed part of the small intestine. This is measured from the ceco-colic junction to the jejunum. Under the current rule, this procedure can only be done in such a manner that completely removes the distal lineum. Back in January of 2004, the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture stated that the small intestine of cattle could possibly contain BSE and, therefore, should be prohibited for use in human food. This went on to include dietary supplements and cosmetics as well. They actually went further than that in the initial rule and mandated that the entire small intestine be completely disposed of in order to guard against any possible contamination that might occur if not properly removed. The rule was changed 18 months later to actually permit the entire small intestine for human food, providing the guidelines discussed previously were strictly followed. The reason why this particular amendment is so important is because of outcry from certain segments of the population that are concerned about BSE infectivity in the small intestine of cattle. Previous to 2004, it appears that BSE was deemed to be an issue in terms of using the small intestine of cattle in certain food products. While studies leading up to 2005 did illustrate the potential for BSE infectivity, it was not deemed a sufficient risk to the general public as long as proper removal procedures were followed (Federal Register 14013). The interesting aspect of the ruling in 2005, however, rests in the fact that both the FDA and the FSIS specifically stated that they would revisit the policy if future studies on BSE indicated a more grave health concern than previously thought. The issue of food safety in the United States is a serious one. This rule is important because the American public largely has little to do with the food they eat. Instead, they rely on outside organization and the government to regulate the safety of what they eat on a regular basis. If the FDA, through rule and policy amendments, dictates that a particular source of food is deemed to be safe, then they are, in a way, forced to abide by that decision. The issue of cattle in the U.S. has been a newsmaker in recent decades because various diseases and illnesses have been associated with the cow. If there is the possibility that an organ of the cow is potentially infected with BSE, and that infection could be passed onto humans, then serious implications result. This is the primary reason they rule has been re-opened for comment and the FDA is considering yet another amendment. So far, we know that the FDA amended the rule in 2005. This rule is still in effect and it permits the small intestine to be completely removed, using an approved procedure, and then to be used in certain food products, dietary supplements, and cosmetics. In 2007, the FSIS confirmed this policy and issued its final ruling. Critics of the rule, however, never have given up their efforts to show the government that potential serious health risks are at stake. Since 2007, numerous studies have been conducted to determine the level of infectivity in the small intestine that does not simply go away when the organ is properly removed from the cattle using the approved technique (Federal Register 14013). During the last five years, new scientific data has been released that “confirms the presence of limited amounts of BSE infectivity in the small intestine outside of the distal iliem of classical BSE infected cattle under experimental inoculation and field conditions” (Federal Register 14013). The reality is, however, that the infectivity levels reported in these new studies is even lower than previously thought, which would support keeping the rule in place as currently written. To help the public as they begin to comment on the rule amendment as it stands today, the FDA has published several of these peer-reviewed studies in order for everyone to arrive at their own informed conclusion. The United States is not the only governing body concerned with the safety of the beef supply. The European Union has its own scientific body that routinely reviews scientific studies as well in an effort to determine if any changes need to be made in the way that meat is handled and makes it way to the public. The European Food Safety Authority (EFSA) Panel on Biological Hazards (BIOHAZ) has specifically reviewed the issue related to the small intestine of cattle as well. Their results and findings were strikingly similar to that of the FDS and FSIS. To illustrate this, several EFSA documents that support these findings are attached in the Federal Register. In the end, both American and European scientific studies have concluded that, at most, there are only trace amounts of infective matter in the colon of cattle (Federal Register 14013). While theoretically this matter from cows could cause BSE, the amounts discovered are so trivial that governments on both continents have deemed it not be an issue. The conclusion reached in 2005, therefore, is still held to by the FDA. This conclusion states, basically, that the traces of infection in the small intestine results in a negligible risk of exposure to BSE in the United States (Federal Register 14013). For this reason, the rule has remained a part of the Federal Register and has not been changed. Only now has it been reopened for debated in order to allow for comments to be heard in case new information has surfaced in the interim seven years that the rule has been in effect. There are numerous reasons that the government adheres to the current rule. It is based on multiple factors and sound scientific reasoning, in their view. Based on the conclusions reached in 2005, and supported since then by numerous studies in the U.S. and the E.U., the FDA has concluded there is currently no risk to the public. They have also concluded, as of this time, that there has been a sharp decline in the amount of BSE worldwide, that it is not longer a realistic concern. They also point out the BSE-related restrictions to the food given to animals has been eased as well. In essence, there is an extremely low rate of BSE showing up in cattle throughout the United States. This appears to be a result of organization complying with existing rules and regulations, in addition to the presence of effective mitigations. Such that the risk of any ill effects for the small intestine, apart from the distal ileum, is so low as it does not even bear mentioning. Many advocates for proposed rule changes to food safety, particularly where meat is concerned, often turn to the World Organization for Animal Health (WOAH). In this case, however, the WOAH agrees with the food and drug administrations in both Europe and United States. Since 2005, they have stuck their own definition about the perceived dangers in using parts of the small intestine, including the distal ileum (Federal Register 14013). Based on this, the FDA is forced to conclude that requiring all parts of the small would intestine would not reduce the risk of contracting an illness or disease from the cow when used in various food products, dietary supplements, or cosmetics. Based on all of these factors, the FDA is now proposing to make this rule permanent. In other words, after hearing comments, if nothing is stated to alter current opinion, then the use of the small intestine will continue to be permitted indefinitely. While the rule might seem trivial to some, it is actually a rather serious matter. The safety of our nation’s food supply is critical. If cattle born disease were introduced to society on a massive scale, the repercussions could be felt nationwide. It could very well be that this rule should stand because you cannot prohibit everything that comes to the market, or there would be no food left to provide the people. If it is proven that there is no safety risk to the public as a result of using the small intestine of cattle in the way currently being employed, then the rule should certainly stand. The FDA is wise, however, in seeking out further comment in order to give the public a much needed voice in the process. When evaluating this rule, it is useful to consider how big the problem is. In this case, the problem is quite large because a majority of the population consumes meat, ingests dietary supplements, or uses cosmetics on a daily basis. As mentioned from the outset of this policy brief, most individuals consume these products without giving it a second thought. They trust government issues and independent watch groups to protect the safety and integrity of the food supply. Because of this reason alone, it is critical that all decisions related to food safety be carefully considered from all angles before a decision is made. The mere fact that this particular rule has been in interim status for over seven years communicates the seriousness with which the matter has been considered. The time has come in the view of the FDA, however, for the rule to be made permanent, pending no further reasonable objections being made during the comment period. Comments and Opposing Viewpoints For any food safety rule, there are usually strong opinions voiced on both sides of the issue. This particular rule is no exception. On the Federal Register site alone, 22 comments have been voiced. Via various scientific organizations and think tanks, even more discussion is taking place. This once again demonstrates that the problem is not as trivial as it might seem. Obviously, meat and cosmetic manufacturers have the most to lose should the rule not be adopted permanently. Cosmetic products that use the small intestine of cattle, for example, would need to be reformulated in order to account for any rule change. Likewise, numerous food products would need to be taken off the market and manufacturing techniques altered. Finally, the dietary supplements that currently utilize this part of cattle would need to change their formula, or scrap the product all together. The expense of this would be borne directly by the company, and likely passed onto the consumer. The opposing viewpoint, however, is that if there is a potential risk from using or eating these products, then the expense would be warranted and should be implemented. In this case, many of the comments about making the current rule allowing the use of the small intestine have been negative. Nursing organizations, for example, are vehemently opposed to using the small intestine. They claim that one case of BSE acquired due to cattle intestines is too many. They have seen the effects of BSE and do not wish any rule endorsed by the FDA to permit even the slightest chance that the disease could make its way to human on any level or scale. Upon reviewing these comments, however, one is struck with the reality that the opposing side has proposed little to no scientific evidence. The FDA has already expressed its willingness to review the issue for the past seven years. They have demonstrated the seriousness of the rule and have conducted and reviewed countless studies related to the reality of whether or not there is really any inherent risk of contracting BSE from the small intestine. They have determined there is no risk, but have re-opened the debate to the public in order to hear if there is any evidence to the contrary. Organizations that simply say they are against the rule without documenting and scientific evidence are not likely to receive any consideration. Instead, it is useful to consider arguments against the rule that are based on scientific merit. The Creutzfeldt-Jacob Disease (CJD) Foundation is one such organization that points to evidence about the dangerous nature of the distal ilium. While not advocating for the prohibition of the entire small intestine, the CJD Foundation points out the safe removal of the distal ilium should be mandated as a part of this rule. They are concerned about the contraction of “Mad Cow Disease”, which currently has no cure. By allowing the distal ilium to be used in the food supply, they claim, is contrary to the FDA’s pledge to keep the beef supply in America safe for the public. At the very least, the CJD Foundation, and others like them, is asking the government to consider enacting a rule amendment mandating that the distal ilium be removed from the intestine before it can be utilized. This is a preventative measure that some would claim would be well worth it if even just one life were saved as a result of the rule being placed into effect. Other organizations have used the FDA’s own language in the Federal Register to support their contention that the small intestine be prohibited in the human food and cosmetic supply chain. Reiterating that the FDA and FSIS claim there are negligible traces of BSE in the distal ilium implies that there is a remote chance it will affect humans at some point in the future. Health organizations and concerned individuals claim the FDA is allowing manufacturers to put profit and expense in front of potential safety of the American public. While one cannot eliminate risk from the food supply, many would claim that if the FDA claims there is a potential risk, then that risk should be eliminated. By allowing it to continue is akin to saying that if a few people contract the devastating BSE disease at some point in the future, then the risk was mitigated by the hundreds of millions that it did not affect. This is simply an unacceptable rationale to many, while others do understand the need to balance risk and reality, making the claim that if you eliminated all risk oriented foods from the supply chain, we would be left with little to nothing to eat or drink. More convincing evidence is needed in order to justify altering such a longstanding policy rule. When the rule was first changed to mandate the removal of the distal ilium, numerous organizations came out in opposition. At the very least, they wanted to have a period of time with which to implement the slaughtering techniques and manufacturing components that they would need to abide by the rule. As a result of these comments, and the studies previously mentioned, the rule was quickly altered in 2005 to allow for the use of all parts of the small intestine. It should come as no surprise, therefore, that cosmetic and soap companies worldwide have come out in support of making this interim final rule permanent and a part of the public record. The cosmetic industry maintains its dependence of various cattle parts to provide quality and low price products to the consumer. Citing numerous scientific studies, they maintain the safety of their products as currently stipulated. They note the billions of pounds of cattle products that are disposed of annually that cannot be consumed as food, but can be used as key ingredients in various other products. As noted in studies, the distal ilium no longer proposes any real threat of BSE disease upon the public, so they oppose altering the rules needlessly, which would result in an undue burden on their current manufacturing process (Rosenberg 2). That is a burden that they claim, quite frankly, many companies simply would not be able to economically fathom. In addition, numerous governments around the world have spoken out on this issue as well. They make the claim that regions outside of North America and Europe have been free of BSE in their cattle supply for decades now. If the current rule were not made permanent, they are asking that certain exemptions be made for cattle slaughtered in countries that can prove no risk of BSE whatsoever. Australia has led the chorus of countries that have requested the United States recognize the reality that their regions are already free of any BSE agents and, therefore, should be exempt from any such restrictions regardless. Counsel to the Australian government states, “Australia would argue that it has in place a comprehensive range of control measures to prevent the entry and/or amplification of the BSE agent. These measures protect and maintain Australia’s BSE-free status” (Cupit 2). These particular comments, echoed by at least 13 other governments, certainly warrant consideration by the Food and Drug Administration as they consider making the interim final rule permanent. The United States Senate has also lobbied on behalf of companies that would be affected were the use of certain cattle parts to be reexamined. Many companies have explicitly stated that their products have no harm to humans in the first place, since they are not for human consumption. These companies are concerned that, should the rule be reversed and certain leftover parts of cattle no long be permitted, their products would be adversely affected, as would several hundred manufacturing jobs at each representative company. This particular argument is useful in the context of this policy brief because it is the first one that focuses on aspects of the rule outside of BSE disease. The Senate acknowledges the need of the FDA to protect the American public from potentially dangerous food-born illnesses. Various companies do not argue that point either. This rule, however, specifically relates to certain parts of a cattle being utilized after the slaughtering process, respective of what the parts are actually used for. The point here is that even if the rule were reversed, these companies would like an amendment to be added to the rule that would specifically allow for the use of these cattle parts in products that are not designed for human consumption (Corzine 2). The comment seems reasonable enough, but is a really a moot point unless the Food and Drug Administration receives compelling information to reverse its latest position on the rule adopted in 2005. In a somewhat surprising twist, some food and meat processing companies have come out against this rule. Whether or not these companies have procedures already in place to restrict the use of the small intestine in any of their food products is not entirely clear, but several companies have advocated that the FDA reverse its stance on this issue. They point to a food ban that was implemented back in 1997 based on evidence that a BSE agent was circulating in various cattle feed products throughout North America. As a result, the fear was that this BSE agent would eventually make its way into the human food supply over time (Gilbert 3). Because of this, many companies at that time moved to eliminate any tissues or organs from cattle that studies showed were potentially susceptible to BSE. That ban in 1997 eventually lead to the initial 2004 FDA rule against using the small intestine, which as we know was amended in 2005 to permit the small intestine in human food products, dietary supplements, and cosmetics provided certain safeguards were put into place. Golden State Foods is one company that would prefer to see a return to the 2004 rule, so they have commented during this recent period to urge the FDA to reconsider. In their comment, and others like it, they refer to a ruling by the World Health Organization that states, “Countries should not permit tissues that are likely to contain the BSE agent to enter any food chain (human or animal)” (Gilbert 2). The FDA because of the world ‘likely’, however, would likely refute this point. The FDA, and its European Union Counterpart, have already conducted eight years of studies and have concluded that the BSE agent only shows up in negligible traces in cattle tissue and organs and, therefore, it is not likely to cause the BSE agent to enter into the human food supply chain via this route. Certain food organizations also point to findings from Harvard that stipulate “specific pathways or practices that would contribute the most to the spread of BSE if it were introduced into the United States relate to compliance with the FDA feed ban and include misfeeding on the farm and the mislabeling of feed and feed products prohibited for consumption by cattle” (Gilbert 2). The implication is that various organizations have been hesitant through the years to introduce any food related item, either for animal or human consumption that remotely could contain the BSE agent. North America has not demonstrated that is has erased all traces of BSE from the food supply, therefore, many contend that the rule granting companies the right to use the small intestines of cattle should be revoked. In the end, there were comments made on both sides of the rule, but few scientific studies were cited. Comments were made about the seriousness of the BSE agent, which nobody would argue with. BSE is a serious problem that could harm an entire society it was to be introduced into the human food supply or via cosmetics and soaps. Most of the comments, however, failed to mention the reality that studies have shown BSE have virtually been eliminated to barely traceable levels existent today. As noted in the comments as well, various governments around the world would take issue if this interim were revoked and the small intestines no longer be permitted to uses based upon their own eradication of any type of BSE agent. That argument is sound and certainly deserves great consideration as the FDA moves to make this rule permanent after the comment period ends. Recommendations The task of the Food and Drug Administration is certainly not an easy one. They are charged with the safety of food and drugs for one of the largest nations on earth. In addition, rules that they enact today have a spiral effect around the world as various exports and imports are affected based on the guidelines set forth and put into place. This should not be taken to mean that the FDA should not act quickly if information comes to their attention that appears to impact the safety and integrity of the food supply, but they must do so with careful consideration of all the facts presented to them. Based on the information presented by the FDA and other governmental agencies here and abroad, the recommendation is to permanently adopt this rule and make it final. Research clearly indicates that BSE is no longer a threat to the human food supply, particularly in regards to the use of the small intestine. This is not an argument against BSE. Nobody is arguing that if BSE were introduced into the human food supply that a disaster would be in the making. On the contrary, the FDA has spent years researching the issue and if there was any doubt in published studies that BSE were a threat, then surely they would be moving to revoke the current permission granted to slaughterhouses to use the small intestine. In considering matters of health and safety, one must balance risk versus reality. The reality is that there is virtually no risk that BSE will affect humans or animals to any degree using current guidelines that are put into place. Furthermore, if the FDA moved to make this practice against the rules, numerous organizations and governments around the world would be adversely affected as a result of the ruling. It simply would not be warranted or justified and it would create an undue burden on countless of millions around the globe. Interim rule established in 2005 should be made final and adopted. Conclusion The aim of any responsible governmental agency is to implement policies and procedures that are designed to protect the populace. While we would like to expect various companies and organizations to police themselves and ensure that their products are safe and reliable, the reality is that this simply does not always happen. Whether it be to save on expenses, or simply because they are simply not aware of the dangers or risks that their product may have, measures must be put into place to safeguard against any harmful effects. The FDA is largely charged with this task when it comes to the food supply in America. This does not give it blanket authority, however, to make policy and rule changes that are not warranted. It also must be careful that it does not implement rule changes that are based more on fear than on the realistic expectation that there is truly a problem. Moving forward with this particular rule change is the wise thing to do. The small intestine in cattle has been shown to be safe and disease free. It is currently being used in cosmetics and fragrances around the world. In addition, parts of the small intestine have safely made its way into the global food supply, with no evidence of BSE disease. To alter the rules based on trace amounts would mean altering the manufacturing process and capabilities of plants around the world. This is really not feasible at this time, and the FDA is wise to realize that they would be going beyond the scope of their responsibility to do so. The wise decision was to elicit comments once again from the public. Having, received those comments, the correct move would be to keep the current rule in place. Works Cited Corzine, Jon. “Regulations.gov.” Regulations.gov. n.d. United States Senate. Web. 20 Apr. 2013. Cupit, Andrew. “Regulations.gov.” Regulations.gov. n.d. Australian Department of Agriculture. Web. 20 Apr. 2013. Federal Register. “Rules and Regulations”. 78.42 (2013): 14012-14013. Gilbert, David. “Regulations.gov.” Regulations.gov. Golden State Foods, n.d. Web. 20 Apr. 2013. McEwen, Gerald Jr. “Regulations.gov.” Regulations.gov. The Cosmetic, Toiletry, and Fragrance Association, n.d. Web 20 Apr. 2013. Rosenberg, Ernie. “Regulations.gov.” Regulations.gov. The Soap and Detergent Association, n.d. Web 20 Apr. 2013. Read More