ON THE NEED FOR THE DEVELOPMENT OF HYGIENIC STANDARDS (MACs) IN THE WATER AND AIR OF THE WORKING AREA FOR PERFLUOROOCTANOIC ACID IN THE RUSSIAN FEDERATION

Abstract

Currently, perfluorooctanoic acid (PFOA) has no hygienic standards in the air of the working area and objects of the human environment in the Russian Federation. By the decision of the Stockholm Convention SC-9/12, PFOA, its salts and derivatives are included in Part I of Annex A of the Stockholm Convention on Persistent Organic Pollutants in 2019 (with exceptions for possible use). The Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade included PFOA, its salts and derivatives in the list of potential candidates for inclusion in Annex III of the Rotterdam Convention at the next meeting COP10 in 2021. The use of this chemical on the territory of the Russian Federation entails water and air pollution. Industrial emissions and waste water from fluoropolymer production, thermal use of materials and products containing polytetrafluoroethylene, biological and atmospheric degradation of fluorotelomer alcohols, waste water from treatment facilities are the sources of the release of PFOA into the environment. Analysis of international databases has showed that PFOA is standardized in the air of the working area in Germany, Japan, and Switzerland. In the countries of the European Union, as well as the USA and Canada, the issue of PFOA standardizing in drinking water is being now actively under discuss. Taking into account the high toxicity and hazard of the substance and the serious concern of the civil society of the Russian Federation, the Federal Service for Supervision of Consumer Rights Protection and Human Wellbeing requested the Russian Register of Potentially Hazardous Chemical and Biological Substances to develop MACs for perfluorooctanoic acid in the air of the working area and water as soon as possible. The MACs for PFOA have been proposed using risk analysis: 0,005 mg/m3, aerosol, hazard class 1 – in the air of the working area and 0,0002 mg/L, the limiting hazard indicator – sanitary-toxicological, hazard class 1 – in the water.

Uncertainties in risk analysis and modern approaches to their reduction

“…Many researchers point out that high uncertainty at the exposure assessment stage might be caused by toxicological parameters being established predominantly in experiments [11][12][13]. In particular, a reference dose, which is considered safe, is calculated based on results of various animal experiments performed on rats, mice, or rabbits [14][15][16][17][18] and then recalculated for the human body using some coefficients [19][20][21][22]. However, the US Food and Drug Administration (US FDA) conducted some studies to compare results of experimental pre-clinical and clinical investigations.…”

Uncertainties in risk analysis and modern approaches to their reduction

“…Как отмечают многие исследователи, на этапе оценки экспозиции высокая степень неопределенности может быть обусловлена тем, что токсикологические параметры устанавливаются преимущественно в экспериментальных условиях [11-13]. В частности, установление референтного уровня воздействия, считающегося безопасным, рассчитывается по результатам различных опытов на животных (крысах, мышах, кроликах) [14][15][16][17][18], и потом делается перерасчет для человека с использованием ряда коэффициентов [19][20][21][22]. Однако сопоставление экспериментальных доклинических и клинических исследований, по данным Управления по контролю лекарств и пищевых добавок (FDA) США, показало, что около 90 % проанализированных химических соединений, признанных безопасными в ходе этих исследований, демонстрируют высокую токсичность в процессе клинических испытаний.…”