Hello,

I am still trying to resolve some of these issues that came out of our EPA peer audit this spring.  The biggest spot of confusion right now seems to be in how to generate the required documentation that the regulations say need to accompany small amounts of new chemicals that leave the lab for characterization.  Here is the info that we received from our Risk Management department.  They have told me what it is that they are expecting us to do, but they - as yet - have been unable to come up with how to implement it.

If you have any guidance that you an offer me from your experience with this type of thing, I would very much appreciate it.

Thank you,
Karen Humphrey
Baylor University

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Here is the specific text of apparent violations 440 and 441:

*        440

o   Issue of Concern: Laboratory faculty/staff indicated that small quantities of new chemicals were being produced in the laboratory for research and development purposes but has failed to notify all employees using or handling the chemical of any health risks associated with the chemical.

o   Federal Citation: 40 CFR 720.36(c)(1)

o   Recommended Corrective Action: The manufacturer of the chemicals used for research and development must communicate the health risks associated with the chemical to any other faculty, staff, or student that may use or handle the chemical.  Notification may be made by a container labeling system, conspicuous placement of notices in areas where exposure may occur, written notification to each person potentially exposed, or any other method of notification which adequately informs persons of health risks which the manufacturer has reason to believe may be associated with the substance.

*        441

o   Issue of Concern: Laboratory faculty/staff indicated that small quantities of new chemicals were being produced in the laboratory for research and development purposes and these chemicals are being shipped to other institutions or laboratories for analysis, testing or characterization yet written communication regarding the use of the product only for R&D purposes and the associated health and safety risks of the chemical were not communicated.

o   Federal Citation: 40 CFR 720.36(c)(2)

o   Recommended Corrective Action: If distributing research generated chemical substances to persons not in his employment, the researchers must in written form:  (i) Notify those persons that the substance is to be used only for research and development purposes.  (ii) Provide a notice of health risks.



I see no reason why we would not follow the cited codes which state, "notification which adequately informs persons of health risks which the manufacturer or importer has reason to believe may be associated with the substance.." The people that need to be notified of the health risks are cited in paragraph (a)(2) of this section, "all persons in its employ or to whom it directly distributes the chemical substance, who are engaged in experimentation, research, or analysis on the chemical substance, including the manufacture, processing, use, transport, storage, and disposal of the substance associated with research and development activities." The fact that we eventually collect and dispose of these chemicals may make any further exemption null and void.



Even if an exemption is allowed, why would we choose to be exempt? Don't the people that work in that lab have a right to know the health risks of chemicals they may come in contact with? We already have an example of a chemical vial broken and exposed to the atmosphere by a person that never intended to touch or use that chemical (isobutyl-cyanide). Don't emergency responders have the right to know the health risks of chemicals they may need to respond to in case of a fire, spill or other emergency?



Even if these corrective actions are not strictly required by EPA, they will help us come into compliance with OSHA requirements:

*        29 CFR 1910.1200(a)(1) The purpose of this section is to ensure that the hazards of all chemicals produced or imported are evaluated, and that information concerning their hazards is transmitted to employers and employees. This transmittal of information is to be accomplished by means of comprehensive hazard communication programs, which are to include container labeling and other forms of warning, material safety data sheets and employee training.

*        29 CFR 1910.1450 Appendix A Occupational exposure to hazardous chemicals in laboratories.