Gerritsen-Ebben M G, Brouwer D H, van Hemmen J J
TNO Quality of Life, Food and Chemical Risk Analysis, Chemical Exposure Assessment, Zeist, The Netherlands.
Commun Agric Appl Biol Sci. 2007;72(2):87-93.
Regulatory authorities in North America, Europe and Australia use different approaches for the estimation of exposure reduction effectiveness of personal protective equipment (PPE) in registration processes of agrochemical pesticides. TNO has investigated current views and facts for the use of default values and set up a discussion paper which can be used as a starting point to achieve an internationally harmonised set of PPE protection factors for regulatory use. For inhalation exposure Loading it is proposed to use the assigned protection factors (APF) as deduced by BSI (British Standard Institution) and ANSI (American National Standards Institution). Since these values are somewhat variance and since in agricultural settings efficient control and proper training and education with respect to inhalation protection devices is generally absent, it is good to err on the safe side and to use the Lowest of both values, if available. For dermal exposure Loading differentiations are made for operators and re-entry workers and further for hand and body protection. Next to this the restrictions and framework for the use of the proposed defaults are very relevant. Oral exposure loading is only considered in special cases where dermal exposure may be relatively high and the hand-mouth shunt may lead to appreciable oral exposure loading. The presented defaults for PPE have been discussed with experts of regulatory authorities and industry, but a formal discussion still has to take place. This needs to be done on EU level between Member States. The current proposal is based on state-of-the-art knowledge and policy considerations, but further research is needed to better underpin the proposed values and/or to adapt them.
北美、欧洲和澳大利亚的监管机构在农用化学农药注册过程中，采用不同方法来评估个人防护装备（PPE）的暴露减少效果。荷兰应用科学研究院（TNO）研究了当前关于使用默认值的观点和事实，并撰写了一份讨论文件，可作为实现一套国际统一的、供监管使用的PPE防护系数的起点。对于吸入暴露负荷，建议使用由英国标准协会（BSI）和美国国家标准学会（ANSI）推导得出的指定防护系数（APF）。由于这些值存在一定差异，且在农业环境中，通常缺乏对吸入防护设备的有效控制以及适当的培训和教育，因此为安全起见，如果有两个值，最好采用其中较低的值。对于皮肤暴露负荷，区分了操作人员和重新进入作业的工人，以及手部和身体防护。除此之外，所提议默认值的使用限制和框架也非常重要。仅在皮肤暴露可能相对较高且手口分流可能导致可观的经口暴露负荷的特殊情况下，才考虑经口暴露负荷。本文提出的PPE默认值已与监管机构和行业的专家进行了讨论，但仍需进行正式讨论。这需要在欧盟层面的成员国之间进行。当前的提议基于最新知识和政策考量，但仍需要进一步研究，以便更好地支持所提议的值和/或对其进行调整。
