How to Write a SDS
1. All hazardous chemicals require a Safety Data Sheet. This is to be written by the manufacturer/distributer and sent to the purchaser/user. (29 CFR 1910.1200 OSHA Hazard Communication)
2. Chemicals developed in a laboratory and sent to another laboratory are required to have an SDS and it must be sent with the chemical containers to the next user. (OSHA interpretation letter dated 2/5/04).
3. Newly synthesized chemicals must comply with the EPA TSCA requirements (40 CFR 700-799). There are exemptions for research and development (EPA Bulletin 1986-1, 40 CFR 720.36). This exemption can be partially met by including a statement on the MSDS (see EH&S memo 6/15/00 and EMD SDS):
"This product is being sent to you as a Research and Development product as defined by the Toxic Substances Control Act (TSCA) of 1976. Due to TSCA's R&D exemption, this product is not listed on the U.S. EPA's Toxic Substances Control Act inventory. As a TSCA-exempt R&D substance, this product must be used by or directly under the supervision of a technically qualified individual(s) as defined by TSCA. This product may not be used for commercial purposes or in formulations used for commercial purposes."
- Other requirements are:
- Production of small quantities
- Supervision by a technically qualified individual
- No general commercial use
- Evaluation of risks
- Notification of risks
- Notification of the requirements that the substance be used only for R&D (above statement)
- Recordkeeping
- Documentation of prudent lab practices
- Names & addresses of those receiving substance, identity of substance, amount distributed & copy of written notification (SDS statement)
- Keep record for 5 years
4. Chemicals that are considered "Hazardous Drugs" must be handled using the OSHA "Controlling Occupational Exposure to Hazardous Drugs" guidelines (OSHA Technical Manual, Sect. VI, Chap. 2). Hazardous drugs are defined as genotoxic, carcinogenic, teratogenic or reproductive hazard, or cause serious organ or other toxic manifestation at low doses in experimental animals or treated patients. If a drug is designated (or being developed to be designated) as an antineoplastic agent, it is considered a hazardous drug.
Steps to writing an SDS
1. Review OSHA requirements (29 CFR 1910.1200; Guidance for Hazard Determination)
- Collect as much data as possible pertaining to the physical and chemical properties and toxicity data for chemical.
- All potential health hazards must be determined, not just those identified by OSHA.
- Analyze existing data to determine the physical and health hazards.
2. Use OSHA short form or ANSI format. Use 16-Section SDS Checklist as a guide. Review UN Annex 4 Guidance on the Preparation of Safety Data Sheets (SDS). OSHA will be adopting this format in the near future under the Global Harmonization initiative.
3. Review Sigma or other manufacturer's SDSs for similar products.
4. Use established Risk and Safety Statements (see Sigma printout).
5. Include TSCA R&D exemption wording.
IMPORTANT NOTE: These instructions are for chemicals and products distributed within the USA only! Other countries have different SDS requirements (EU REACH). The SDS must be in the native language of the country the chemical or product is sent to.