Gita Armarosa Putri Sembiring 2010 / 295888 / HK / 18283 / HI International Undergraduate Program Faculty of Law Universitas Gadjah Mada

United States of America v. Nova Scotia Food Products Corp. 1. Issues There are 2 kinds of issue in this case, the first one would be about the applicability of this regulation over this matter and also about procedural issues that related to the regulation which expected to be applied to the case. The issues on the applicability is related to the whether the general provision on the food safety shall be regarded to this whitefish case even tough that provision is actually failed to distinguish the species of fish where this failure meant to the commercial death for the whitefish industry. This can be happen because the general provision on food safety that required the whitefish to be heated not less the 180 F in order to assure the safety of consumption. But, this requirement actually affects the products quality and caused commercially unsaleable. The issue on the procedural matter is related to the inadequacy of information and methodology from the interested parties that shall be disclosed by the agency in making of such regulation. The other matter would be about the failure of government to consider the commercial feasibility related to the issued provision. 2. Rules The case is mainly discuss about the T-T-S ( time-temperaturesalinity ) regulation that stipulated in the 21 C.F.R Part 122 ( 1977 ) The legal basis also relied upon statute 371 (a) which stated that: a public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. We also shall refer to the FDA ( Food and Drugs Administration )s own rule that spesifically requires that every notice of proposed rulemaking contain: references to all data and information on which the Commissioner relies for the proposal . 3. Analysis Nova Scotia Food Products Corp. as the appellants argued that the agency has failed to disclose the scientific data from the interested parties as the material upon which the proposed rule would be

applied that leads to the lack of precise parameters on the provision. There is no any correlation among the regulation to the scientific requirements that would make the commercial factors to be survived. Prior to the enactment of the regulation, ne of interested party, Bureau of Commercial Fisheries of the Department of the Interior, has gave its objection toward the application of this regulation due to the awareness of possibility that T-T-S regulation may not be commercially feasible and it is demanded for the specific parameter of the fish. It has been cognizance but neglected and the agency kept on applying the T-T-S requirement that regulated in 21 C.F.R 172.177 ( 1977 ). The appellant believes that scientific data from the interested party shall be disclosed in order to give the focus interpretation. Moreover, this matter is regulating about scientific decision and scientific material shall be exposed to the interested party to hear their opinion. If this procedural matter is done well, hence the gap between the regulation and the society needs can be conjuncted. In the case of United State of America v. Nova Scotia Food Products Corp., the matter of inadequacy of interested parties material leads to the commercial unsaleable. It can be happen because the regulation that applied has no specific parameters for each species of fish which is actually needed. 4. Conclusion Based on the analysis above it can be seen that the inadequacy of material considerations from interested parties in decision-making process leads to the arbitrary of decision-making. We also may conclude that the failure to disclose the interested parties scientific data related to the regulation shall be regarded as procedurally erroneous because the agency shall consider why T-T-S ( timetemperature-salinity ) requirement that mentioned in the provision made applicable to all species of fish while when it is further examined, this regulation actually brings harm in whitefish commerciality. Due to this matter, we believe that the T-T-S regulation was promulgated in the lack of present scientific knowledge and experience. Hence, it may be concluded that the T-T-S regulation was promulgated under the arbitrary manner and is invalid. Based on this matter, the T-T-S regulation shall be reviewed again by the agency. In accordance to the explanation, it is believed that T-T-S regulation shall not be applied until the it has been reviewed so all related

matters regarding the public health and commercial survival can be uphold well by such regulation.