Risk Evaluation and Notification Requirement

Draft Questions Answers for the New Chemicals Program, 3-2-3-3, question 301-2 (undated), [hereinafter Draft PMN Q A], available at http //www.epa.gov/oppt/newchems/ pubs/qanda-newchems.pdf. The OSHA laboratory standards are in 29 C.F.R. 1910.1450, and require the formulation and implementation of a Chemical Hygiene Plan. 

A non-production basis manufacture of chemicals must be interpreted using common sense to mean the type of manufacture typically performed in a laboratory, and not primarily for commercial sale. Technically, anything made in a laboratory is produced on a lab scale. 

As a practical matter, it makes much more sense to perform R D in a laboratory that meets these requirements. A researcher in a non-qualifying laboratory needs to conduct a thorough evaluation of risk information in the company s possession or control for each new R D substance before it makes or imports (or processes if there is a SNUR) the substance. So long as the chemical identity of the R D substance is known, it will be possible to conduct that risk evaluation and determine if a SNUR applies. 

A manufacturer can notify its employees of any known risks associated with the R D chemical by using labels on the containers holding the R D chemical, conspicuous signs, written notices to each R D employee, or any other written notice that adequately advises of the health risks. As a practical matter, it is advisable to use container labeling, conspicuous signs, or written notices to each R D employee because these communication methods are explicitly listed in the regulations and the manufacturer will have the burden of proving that an alternative method is adequate. 

If a manufacturer is going to distribute the R D substance to anyone who is not an employee of that manufacturer, the written notice must also state that the substance may only be used for R D purposes. The notice must describe health risks associated with the chemical except if the recipient is a R D laboratory that otherwise quahfies for an exemption from the requirement to evaluate chemical-specific risks.  

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