Question 1: Is there an MSDS exemption from the requirements for newly synthesized and uncharacterized chemicals?
Response: OSHA's Hazard Communication Standard (HCS) 29 CFR 1910.1200 requires that manufacturers prepare and transmit MSDSs with the initial shipment of all hazardous chemicals. Research facilities which synthesize or produce chemicals are considered chemical manufacturers, if they ship hazardous chemicals, and must develop MSDSs for the hazardous chemicals that they produce and distribute to other workplaces. While the HCS is based on known information and does not require testing of chemicals in determining health effects, any relevant information which is known about the chemical or the mixture must be conveyed in the MSDS.
While your laboratory may not have information concerning the precise nature of the synthesized chemicals, it is likely that your laboratory has a significant amount of important and relevant information concerning these chemical mixtures. For instance, the newly synthesized chemical would be just one component in a mixture comprised, in part, of the original reactants. If this is the case, the MSDS must include the hazard information for the un-reacted components. Additionally, chemists generally have a good sense for the structure of the chemical they are attempting to synthesize or purify. This type of information is important to those who handle or use the chemicals at other facilities, and this information (in an MSDS) must be provided to downstream handlers/users at other laboratories
Although the research scientist may not be aware of the exact formulation of experimental mixtures and may have limited information on the health hazards, any information which is known about the mixture must be conveyed. For instance, this would include: the hazard information for the un-reacted components (as already discussed); the name of the mixture as described on the label; the name, address, and telephone number of the responsible party; and the date the MSDS was prepared.
Additional information which must be included when available includes: the presumed chemical structure(s) or name(s); the physical description of the mixture; and other information in the possession of the generating laboratory (e.g., melting point, boiling point, vapor pressure, etc.). All applicable sections of the MSDS must be filled out. If no information is known for a specific section of the MSDS, there must be a statement on the MSDS that such information is either not known or not applicable.
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.
What products are not covered by the OSHA HazCom regulation?
Certain products are not included in the HazCom regulation, see 29 CFR 1910.1200 (b)(6):
Articles
Wood and wood products,
Tobacco or tobacco products,
Food or alcoholic beverages which are sold, used, or prepared in a retail establishment,
Any drug, as that term is defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), when it is in solid, final form for direct administration to the patient,
Cosmetics which are packaged for sale to consumers in a retail establishment, and cosmetics intended for personal consumption by employees while in the workplace,
Any consumer product or hazardous substance, as those terms are defined in the Consumer Product Safety Act (15 U.S.C. 2051 et seq.) and Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.) respectively, where the employer can show that it is used in the workplace for the purpose intended by the chemical manufacturer or importer of the product, and the use results in a duration and frequency of exposure which is not greater than the range of exposures that could reasonably be experienced by consumers when used for the purpose intended;
What are articles?
Per 29 CFR 1910.1200(c), an article is defined as:
Article means a manufactured item other than a fluid or particle: (i) which is formed to a specific shape or design during manufacture; (ii) which has end use function(s) dependent in whole or in part upon its shape or design during end use; and (iii) which under normal conditions of use does not release more than very small quantities, e.g., minute or trace amounts of a hazardous chemical (as determined under paragraph (d) of this section), and does not pose a physical hazard or health risk to employees.
OSHA has issued several letters of interpretation which may help you better understand what an article is: