• Korea Trade Review
• /
• v.44 no.2
• /
• pp.109-126
• /
• 2019

Import refusals can be considered a new method of non-tariff barriers. This study aims to analyze reputation spillover effects on fish and fishery products imported from ASEAN countries to the U.S. FDA. The supply of aquatic products is not stable due to various factors such as reduction of fish stocks and climate change. Fish is a basic food ingested directly, but there are many ways to control the safety of aquatic products. ASEAN countries account for about 20% of U.S.imports in fish and fishery products. For Southeast Asian countries, fish and fishery products comprise a high proportion of exports revenue. Despite the large share of exports to the U.S., Southeast Asia countries have been receiving many import refusals from the United States. In this study, a theoretical model for examining import refusals is suggested using the negative binomial counting process. The reputation spillover effect, was divided into two spillover effects of 'neighbor reputation' and 'sector reputation'. Results show that there exists a neighbor reputation spillover effect. It can be said if there was a import refusal of the same product from neighboring countries in the preceding year, the home country have a possibility to experience import refusals of the same product. Therefore, it is interpreted that neighboring countries have good standard compliance can help home countries to effectively reach the target markets. Our findings have a important policy implication for ASEAN exporters of fish and fishery products.

• Korea Trade Review
• /
• v.48 no.3
• /
• pp.131-150
• /
• 2023

The purpose of this study was to find a countermeasure to the U.S. import refusals for the Korean healthcare and life sciences industry. To this end, an analysis of trends during the pandemic was conducted using the KITA Border Rejection Database, which includes information on items and types of import refusals. The reason for rejection was also analyzed according to the FDA violation codes. The degree of countermeasure for import refusals was identified by measuring the unit rejection rate (URR). The results of the analysis showed that the major U.S. import refusals for the Korean healthcare and life sciences industry had expanded from contact lenses to COVID-19 diagnostic kits and drugs after the pandemic broke out. The major reasons for import refusals were non-compliance with the Predicate Device and Drugs Act and non-approval by the FDA for products and facilities. On the other hand, the unit rejection rate (URR) of major items in the Korean healthcare and life sciences industry was measured higher than the industry average. The results therefore showed a low level of response to U.S. import refusals. The results of the analysis of reasons for import refusals by item according to FDA violation codes were as follows. First of all, the main violation for contact lenses and COVID-19 diagnostic kits corresponded to misbranding. This was often due to the fact that Korean companies did not provide the relevant notices and information required by the FDA. Many cases also failed to demonstrate a substantial equivalency compared to predicate devices already on the market. On the other hand, applications for new unapproved drugs were not accepted as they had yet to pass relevant regulations that would prove their safety and efficacy. In conclusion, import refusals for the Korean healthcare and life sciences industry were found to be closely related to technical barriers to trade (TBT).