Date: Fri, 18 Jun 2010 17:24:58 -0400
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From: ILPI <info**At_Symbol_Here**ILPI.COM>
Subject: Re: Seeking Guidance on Documentation to accompany new R&D
In-Reply-To: <C3E98B533BBA314490DC0D1C18E02317095A5434**At_Symbol_Here**pb01msx.wgipb.local>

Don, with all due respect, you're completely wrong.  The first link I provided in my original response (below) contains a hyperlink to this official OSHA interpretation on the matter: msds/osha/I20040205.html  (our hyperlink-enhanced version, there is a link to the original at the bottom of that page).

Some highlights from that reference that is a must-read for anyone who ships "samples".

Question 1: Is there an MSDS exemption from the requirements for newly synthesized and uncharacterized chemicals?
Response 1: .....In short, while much of the specific information for the newly synthesized chemical may not be available, the MSDS must be as complete as possible and must be transmitted when the hazardous chemicals are shipped. This information provides a basis of knowledge for the recipient laboratory and is the best, and often only, source of information they will have when they receive the mixture.

Question 2: Is there a MSDS exemption from the requirements based on the sample size? 
Response 2: No. The HCS standard provides no exception for "chemical manufacturers" based on sample size. 

Question 3: Under what circumstances are MSDSs not required? 
Response 3: MSDSs are generally not required when chemicals are produced solely for in-house analysis. As you are aware, the requirements of 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories, address protections for employees at the laboratory. Generation of an MSDS for in-house use is less critical, as the in-house researchers already have access to the basic information that downstream users derive from an MSDS. 

Under 29 CFR 1910.1200 there is currently **no testing requirement**.   If a property is not known, then putting "not known", "not determined" etc. is perfectly OK with OSHA.  As long as the sheet contains the required items and nothing is left blank, the sheet meets the standard's requirements.  See ef/osha.html for the items that are currently required.

Rob Toreki

On Jun 18, 2010, at 4:38 PM, Long, Don wrote:

If you're shipping these chemicals off-site for further analyses, then they are "samples" not product, and probably fall under slightly different rules. It's kinda hard to make an MSDS or any other informative documentation if you are still waiting characterization results. If you start writing MSDSs without all of the complete information you are setting yourself up for a trip to the lawyer.
We ship samples off-site all of the time for characterization analyses, and that's just what they are - samples. The state and feds (we are sub-contractors for the Army) require the usual sample analysis request paperwork, sample identification labels and the like, but no MSDSs or HMIS labels - we don't know exactly what it is yet.
Just my opinion based on experience..............

Don A. Long
Southwest Research Institute Laboratory
Pine Bluff Chemical Agent Disposal Facility
PO Box 20130
White Hall, AR  71612

-----Original Message-----
From: DCHAS-L Discussion List [mailto:DCHAS-L**At_Symbol_Here**LIST.UVM.EDU]On Behalf Of ILPI
Sent: Friday, June 18, 2010 2:57 PM
To: DCHAS-L**At_Symbol_Here**LIST.UVM.EDU
Subjec t: Re: [DCHAS-L] Seeking Guidance on Documentation to accompany new R&D chemicals

It sounds like they simply want you to create an MSDS for materials shipped off-site, which, as I mentioned the other day, is required under 29 CFR 1910.1200 (the Hazards Communication Standard): http://www.ilp

Anyone can write an MSDS: m/msds/faq/partc.html#whocan

Thus, you should have a formal written policy that explains this non-obvious requirement to researchers.  Most of those researchers should be able to write those MSDS's themselves if they are "new" research compounds they've created.  Staff should obviously be trained on this policy and told they can contact the appropriate campus department for assistance in creating those MSDS's if needed.

Proper labeling of all compounds under 1910.1200 (shipped off site or not) would seem to offer compliance with the EPA's other desire.  Our hypertext-annotated version of 29 CFR 1910.1200 is located here:  and the page for the Standard is broken down clearly into the major requirements.  If you read through that you'll see that everything the EPA is talking about below is basically addressed by compliance with 1910.1200.

Rob Toreki

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On Jun 18, 2010, at 2:47 PM, Humphrey, Karalyn J. wrote:


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

******************************************************** ********************

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.

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