나노물질의 안전관리를 위한 제도화 방안

Abstract

There have been rapid growth in nanotechnology investments by both the private and public sectors due to the expectation on nanotechnology to be an important contributor to achieving economic growth, as well as societal and individual benefits. However, there have also been continuing scientific uncertainty and controversy about the safety of nanomaterials. It is essential that timely policy developments take into account safety issues to establish a clear regulatory framework to address potential health and environmental impacts. Other countries, such as EU members, USA, Australia, and Canada, have devoted their efforts to ensure the safety of nanomaterials and nanoproducts by reforming their existing regulations. Australia has already begun its nano-specified regulation through ICA. The USA and EU are also shown movements to reform the TSCA and REACH, respectively. As such, it is necessary for Korea to make preparations for the reformation of existing regulations or to discuss the legislation of new regulations. Moreover, we need to raise concerns over the time scale and adequacy of nano-specific regulations for its application to nanomaterials in Korea. This research reviewed nanospecific regulatory issues that have been raised in other countries to draw implications from them and lay the regulatory foundations for nanomaterials in Korea. To reach the final goal, which is to manage nanomaterials more effectively, this study highlights the prerequisites of legal regulatory framework, potential regulatory ways, and further actions for nanowaste management. ○ Development of risk assessment tools for nanomaterials There are concerns about the scientific proofs of nanomaterials' risks, where a lack of concrete knowledge can be a major problem in the regulation of nanomaterials. The improved risk assessments of nanomaterials require significant efforts to collect existing data, extend basic and applied research program of risk assessment, and translate those data and research output into development of the risk assessment tools and policy decisions. ○ Establishment of manufactured nanomaterials inventory To manage the nanomaterials in regulatory oversight along the entire nanomaterial life cycle, manufacturers of nanomaterials should be placed under stricter obligation to file data on the characteristics of nanomaterials and the quantity of nanomaterials that they fabricate. Once data are collected and gathered regularly, it is necessary to establish the DB information system which is open to the public to maximize the utilization of information. On the other hand, it also needs to gather the information by assorting the data into either “open” or “not open” because some information would be company secrets that should not be leaked. ○ Definition of nanomaterials in regulation For the application of legislation on nanomaterials, a precise definition of nanomaterials is required. Seven specific concerns about the definition of nanomaterials taken from other countries are (1) size, (2) size distribution, (3) surface area, (4) unique properties, (5) whether aggregates and agglomerates are included, (6) whether nanomaterials are intentionally manufactured, and (7) specific definition for other nanomaterials (i.g., CNT). It is important to monitor its implementation trends in other countries and revise as appropriate. It is not necessary for the definition of nanomaterials in regulation to be in accordance with the definition used in the nanotechnology field. To determine the definition of nanomaterials in terms of regulation, it is now necessary to initiate the nano definition working group. Effective operation for the nano definition working group will require cooperation among government departments, as well as the participation of various experts and stakeholders. ○ Establishment of regulatory system for nanomaterials Nanomaterials are basically chemical substances that are already subject to chemical legislations in the EU and USA. Korea, however, does not have nano-specific regulations. It appears that the current Chemical Management Act is not suitable to handle nanomaterials due to: (1) no nano-specific standard for new or existing substances; (2) low volume exemption; and (3) lack of precautionary principle that causes a lot of burden of proof to the Ministry of Environment. The Korean REACH could be an option for nanomaterial management if reformed, and another option could be a new legislative action. These options are discussed in more detail in chapter 5. All options will lead to structural changes in governmental agencies to control and manage nanomaterials effectively. Therefore, we also need to establish an expert group to review the decision-making process under existing or new laws. In particular, for the regulatory issue, nanomaterial management will need policy and technological cooperation between various experts in establishing regulatory framework, as well as steady cooperation between government departments, to be effective. ○ Research on the current status of nanowaste disposal for its management Nanomaterials and nanoproducts have increased in quantity over the last decade, and uncontrolled release of nanomaterials into the environment is anticipated to grow rapidly in near future. However, there is no current system in Waste Management Act that handles hazardous waste due to the need for any nanowaste to be deemed hazardous before it can be subjected to the Act. Although gaps exist currently in determining whether each nanowaste is hazardous, we need to initiate fundamental researches on the quantity of disposed nanomaterials and current disposal methods in work areas, where nanomaterials are producted during the first stage of their life cycle, to effectively deal with the nanowaste problem in advance.

나노물질 및 나노제품의 개발·생산·이용·폐기의 전 주기(Life cycle)에서 야기될 수 있는 위해성의 예방과 안전성 확보는 나노기술의 산업화와 활성화에 필수적인 요소이다. EU와 미국을 비롯한 주요 국가들은 나노물질에 대한 위험성을 미리 인식하고 안전관리를 위한 노력을 경주하고 있다. 호주는 이미 화학물질 관리법인 ICA를 통하여 나노물질의 규제를 시작하였고, 미국은 TSCA 내에서 나노물질의 SNUR 적용을 확대하고 있으며 동시에 EU의 REACH에 대응하기 위한 TSCA의 개정 움직임을 보이고 있다. EU는 REACH 제도하에 나노물질의 특화된 관리 방안을 포함할 것으로 예상되며, 프랑스와 캐나다도 나노물질의 규제 움직임이 포착되고 있다. 이는 나노물질의 인체 및 환경 유해성에 대한 논의가 국제적으로 활발히 진행 중이고, 각국의 규제 제도 시행으로 향후 나노물질의 안전성이 무역장벽으로 작용할 우려가 표출되는 등 나노기술 강국으로의 도약과 국제적 위상 제고에 있어 반드시 필요한 부분이라는 인식이 반영된 결과이다. 이에 우리나라도 나노제품의 상용화와 기술개발이 급속히 확대되고 있는 시점에서 본격적인 대비책 마련이 필요하다. 본 연구에서는 나노물질의 안전관리 방향 중 제도화 방향에 집중하여 국내외 규제 동향을 조사·분석하고 시사점을 도출하여 규제안 마련의 단초를 제공하고자 하였다. 나노물질의 안전관리 제도화 과정은 법률 개정 또는 제정을 준비하기 위해서 각계 전문가 및 이해당사자들의 활발한 논의가 필요하고 많은 시간과 연구가 병행되어야 한다. 그 과정에 이르기 위한 선행과제와 관리 방안 및 향후 추진과제 등을 다음과 같이 제시하였다.