JAPAN

January 3, 2002

Mr. Herman B.W.M. Koeter
Principal Administrator
Environment, Health and Safety Division
Organisation for Economic Co-operation and Development
2, rue Andre-Pascal
75775 Paris Cedex 16
France

Dear Mr. Koeter:

On behalf of the Alkylphenols & Ethoxylates Research Council (APERC), I am pleased to submit the attached comments on the Japan Ministry of Environment (MoE) assessment report entitled "Report on the Test Results of Endocrine Disrupting Effects of Nonylphenol on Fish," which is posted on the OECD Sharing Assessment Report web site. The Council and its members have sponsored extensive research on nonylphenol (NP) in the areas of analytical method development, aquatic toxicity, environmental occurrence, fate and degradation, toxicology and pharmacokinetics. Since the OECD is providing access to the MoE assessment report on NP as an example of risk assessment for compounds with endocrine activity for the purpose of sharing information, and the document is not subject to any OECD statutory process or deadline, it is our hope that the Secretariat will accept these comments even though they are being submitted after the comment deadline listed on the web site.

In summary, APERC supports risk assessment based on sound science and validated methodology and notes that the MoE report contains sufficient information for a baseline risk assessment. A maximum predicted environmental concentration (PEC) of 0.59 µg/L has been derived, which is statistically based (95th percentile) on environmental monitoring and is consistent with typical approaches for risk assessment. A baseline predicted no effect concentration (PNEC) of 0.82 µg/L, which is based on survival, can be derived from the two key studies provided in the assessment. However, the MoE report selects a PNEC value of 0.608 µg/L based on endpoints of uncertain ecological relevance (testis-ova formation accompanied by active spermatogenesis), which was calculated by dividing the no observable effect concentration (NOEC) by an application factor of 10.

Given the extensive database available on NP, APERC believes that instead of applying a safety factor of 10 to a single NOEC, a more refined PNEC should be calculated using probabilistic or population based methodologies, which are typically used in other jurisdictions and are sanctioned by the OECD guidelines. Such methodologies take advantage of all the available data to derive concentrations that are protective of the environment and would result in a PNEC that is somewhat higher than the baseline value derived by Japan.

It should be noted that even using the conservative baseline PNEC value of 0.608 µg/L derived by Japan and the worst case PEC of 0.59 µg/L, there is an adequate safety margin for exposed fish species in Japan's waters from exposure to NP (i.e PEC/PNEC < 1). As such, APERC sees little need to reduce environmental levels of NP in Japan. The MoE report supports the conclusion that adequate risk management practices are already in place.

APERC supports the use of responsible environmental management practices to achieve acceptable levels of NP and other chemicals. Moreover, as noted in the MoE report, substitution can lead to serious environmental effects. For this reason, APERC recommends a comprehensive health and environmental assessment of substitutes before they are considered.

Please contact me by e-mail or telephone (202-637-9071) if you have any questions about the attached comments or need additional information.

Respectfully,

Barbara S. Losey
Deputy Director

cc: Hanni Rosenbaum
     OECD Secretariat

                                                                                                                             

 

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