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Previous by Date: Subject: Re: toxicity question Date: Fri, 18 Jun 2010 14:16:00 -0400 Author: "Dr. Jay A. Young" |
Next by Date: Subject: Re: Seeking Guidance on Documentation to accompany new R&D Date: Fri, 18 Jun 2010 15:57:29 -0400 Author: ILPI |
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 b e in how to generate the required documentation that the regulations say ne ed to accompany small amounts of new chemicals that leave the lab for chara cterization. Here is the info that we received from our Risk Management de partment. They have told me what it is that they are expecting us to do, b ut 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 thi s type of thing, I would very much appreciate it. Thank you, Karen Humphrey Baylor University *************************************************************************** * Here is the specific text of apparent violations 440 and 441: * 440 o Issue of Concern: Laboratory faculty/staff indicated that small quantit ies of new chemicals were being produced in the laboratory for research and development purposes but has failed to notify all employees using or handl ing 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 f or research and development must communicate the health risks associated wi th the chemical to any other faculty, staff, or student that may use or han dle the chemical. Notification may be made by a container labeling system, conspicuous placement of notices in areas where exposure may occur, writte n notification to each person potentially exposed, or any other method of n otification which adequately informs persons of health risks which the manu facturer has reason to believe may be associated with the substance. * 441 o Issue of Concern: Laboratory faculty/staff indicated that small quantit ies of new chemicals were being produced in the laboratory for research and development purposes and these chemicals are being shipped to other instit utions or laboratories for analysis, testing or characterization yet writte n communication regarding the use of the product only for R&D purposes and the associated health and safety risks of the chemical were not communicate d. o Federal Citation: 40 CFR 720.36(c)(2) o Recommended Corrective Action: If distributing research generated chemi cal substances to persons not in his employment, the researchers must in wr itten form: (i) Notify those persons that the substance is to be used only for research and development purposes. (ii) Provide a notice of health ri sks. I see no reason why we would not follow the cited codes which state, "notif ication which adequately informs persons of health risks which the manufact urer 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 par agraph (a)(2) of this section, "all persons in its employ or to whom it dir ectly distributes the chemical substance, who are engaged in experimentatio n, research, or analysis on the chemical substance, including the manufactu re, processing, use, transport, storage, and disposal of the substance asso ciated with research and development activities." The fact that we eventual ly collect and dispose of these chemicals may make any further exemption nu ll and void. Even if an exemption is allowed, why would we choose to be exempt? Don't th e people that work in that lab have a right to know the health risks of che micals they may come in contact with? We already have an example of a chemi cal vial broken and exposed to the atmosphere by a person that never intend ed to touch or use that chemical (isobutyl-cyanide). Don't emergency respon ders 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 wil l help us come into compliance with OSHA requirements: * 29 CFR 1910.1200(a)(1) The purpose of this section is to ensure th at the hazards of all chemicals produced or imported are evaluated, and tha t information concerning their hazards is transmitted to employers and empl oyees. This transmittal of information is to be accomplished by means of co mprehensive hazard communication programs, which are to include container l abeling and other forms of warning, material safety data sheets and employe e training. * 29 CFR 1910.1450 Appendix A Occupational exposure to hazardous che micals in laboratories.
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