Friday, August 17, 2012

EPA Announces Availability of Risk Assessment Plans for 2012 Work Plan Chemicals

This morning the EPA published Peer Review Plans for the risk assessments on the seven chemicals previously identified as 2012 work plan chemicals. According to EPA, "the plans, which form part of the Agency's Peer Review Agenda, describe the focus of the risk assessment being conducted on each chemical, indicate how peer reviewers will be selected and how the peer review will be conducted, and provide the time line for the reviews."

The External Review Drafts of the plans still need to be published in the Federal Register, and when that happens and the risk assessments become officially available there will be a 60-day public comment period. There will also be conference calls of the peer review panel in which the public can provide additional comments. 

EPA notes that the public can access and submit comments on the individual peer review plans for each chemical by using the following links:

Wednesday, August 15, 2012

ECHA Publishes Practical Guide for Reporting Toxicity Data for REACH

ECHA has announced that it has made available a new "practical guide" to assist REACH registrants in "How to prepare toxicological summaries in IUCLID and how to derive DNELs." The guide "supports registrants in correctly summarising the toxicological information for substances in section 7 of IUCLID 5.4."

The most critical part of the guide explains how to undertake the take of "Derivation of No Effect Levels" (DNELs), which are used to compare toxicity to exposure in the assessment of risk. DNELs must be derived for all relevant toxicological endpoints (e.g., oral and dermal exposures) and represent the effects side of the equation for human health concerns. For environmental concerns there is a similar derivation of "Predicted No Effect Levels" (PNECs) for aquatic and terrestrial organisms. PNEC derivation is not discussed in the new practical guide.

More information on the Practical Guide can be found on the ECHA web site.

The Practical Guide in PDF format can be downloaded directly here.

Sunday, August 12, 2012

Japan Identifies 18 Chemicals for Closer Look after Priority Risk Assessments

After an extensive review of 86 chemicals, including detailed environmental and human health risk assessments, the Japanese government has identified 18 chemicals for closer review. The Tier I assessments resulted in five chemicals classified as substances that would be further monitored for production or import volume, mainly because they were considered likely to have fairly low levels. But 18 chemicals were deemed to be of significant enough potential risk to necessitate the Tier 2 assessments. Tier 2 assessments include requirements for manufacturers and importers to provide both health and safety hazard data and exposure information.

Eleven chemicals were identified based on their presumed risk to human health:
  • hydrazine
  • 1,3-butadiene
  • dichloromethane
  • 1,2-dichloropropane
  • chloroethylene
  • ethylene oxide
  • 1,2-epoxypropane
  • formaldehyde
  • acrylonitrile
  • toluidine

Seven chemicals were identified based on their presumed risk to the environment:
  • 1,3-dichloropropene
  • n-butyl acrylate
  • isopropenylbenzene
  • dichlorobenzene
  • 2,6-di-tert-butyl-4-methylphenol
  • [3-(2-ethylhexyloxy)propylamine]triphenylboron
  • 4,4'-(propane-2,2-diyl)bis(phenol)

The Japanese government will perform the assessments in accordance with Japan's Chemical Substance Control regulation.