Date: Fri, 18 Jun 2010 13:47:50 -0500
Reply-To: DCHAS-L Discussion List <DCHAS-L**At_Symbol_Here**LIST.UVM.EDU>
Sender: DCHAS-L Discussion List <DCHAS-L**At_Symbol_Here**LIST.UVM.EDU>
From: "Humphrey, Karalyn J." <Karalyn_Humphrey**At_Symbol_Here**BAYLOR.EDU>
Subject: Seeking Guidance on Documentation to accompany new R&D chemicals
In-Reply-To: <DCHAS-L%201006170003346537.0023**At_Symbol_Here**LIST.UVM.EDU>

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

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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 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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