Sep 20, 2013 - Labels on ampoules 5 mL or smallerSep 20, 2013 - Labels on ampoules 5 mL or smaller
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Title: 09/20/2013 - Labels on ampoules 5 mL or smaller
Thank you for your February 18, 2013, letter to the Occupational Health and Safety Administration's (OSHA) Philadelphia Regional Office. Your letter was forwarded to the Directorate of Enforcement Programs to be answered. We apologize for the delay in responding to your inquiry. Your question concerns the labeling requirements under the revised Hazard Communication standard (HCS 2012), 29 CFR 1910.1200. This letter constitutes OSHA's interpretation only of the requirements herein, and may not be applicable to any questions not delineated within your original correspondence. Your paraphrased question and our response is below.
Background:The United States Pharmacopeial Convention (USP), a distributor, provides reference standards for various purposes. The standards are usually sold in small containers (5 milliliter (mL) vials, 2 or 5 mL ampules). USP has more than 3,000 chemicals available for sale as reference standards vials. Due to the small size of the containers, fitting all label elements on the label requires using a very small font size, which renders the hazard information illegible. Additionally, USP believes it will be cost prohibitive to comply with the new labeling requirements through the use of pull-out labels, fold-back labels, tags or other methods.
Question:USP would like to include only the signal word, hazard statement(s), and pictogram(s) on the label so that the label is easier to read. USP would also include an instruction to refer to the safety data sheet (SDS) prior to use, and provide USP's website address where the SDS can be accessed. Is this acceptable to OSHA?
Chemical users must be able to read labels without the use of any device, with the exception of corrective lenses for the employees whose vision requires corrective lenses. Some of the example labels that you provided are illegible due to the small font size and therefore do not meet the requirements of the HCS. Tags, pull-out labels, or fold-back labels may be an appropriate way for you to label small containers so that the label elements are legible. When tags are used, they must be affixed to the immediate container of the hazardouschemical in such a way that they do not become separated from the container.
As OSHA explained in a June 4, 2013, letter of interpretation, OSHA has developed a practical accommodation to address situations where the manufacturer can show that it is not feasible to use pull-out labels, fold-back labels, or tags containing the full HCS 2012 required information for shipped small containers (i.e., the actual container holding the hazardouschemical). The June 4, 2013, letter is enclosed for your reference. This practical accommodation requires the manufacturer to include, at a minimum, the following information on the label of the immediate container:
The outside package must be clearly marked to ensure the complete label elements are visible and it must clearly inform users that the small container must be stored in the outer container bearing the complete label. The complete label must be maintained on the outer package (e.g., not torn, defaced, destroyed).
The manufacturer must ensure that any alternative labeling used does not conflict with any other standards. As such, the outside packaging must not present a hazard while the material is being stored.
The outside packaging is the container (e.g., bag, box) that the immediate product container is placed into, which may or may not be the exterior shipping container.
Extremely flammable liquid and vapor, all the precautionary statements (e.g., Store in a well-ventilated place. Keep cool. Keep container tightly closed) see Appendix C, subsection C.4.19 for the full list of precautionary statements that must be present for a category 1 flammable liquid.
ABC 100 Any Street, Any Town, MA 14569
Phone # (123) 456-7890.
NOTE: As this is a flammable liquid, the outer packaging MUST not be of a material that is flammable or combustible, 29 CFR 1910.106(d)(2)(i).
While you state that it may be cost prohibitive for USP to comply with the HCS 2012 labeling requirements, all provisions of the final standard were deemed economically feasible prior to the promulgation of these requirements. Based on the information provided in your letter, USP is required to include all labeling information on the small vials you produce.
The small container accommodation you propose is not acceptable because the label does not include the product identifier, precautionary statements, and the manufacturer's name and phone number. Additionally, referring chemical users to SDSs to obtain the missing labeling elements is not acceptable. Labels are intended to serve as an immediate visual notation of key hazard information, and requiring users to refer to the SDS to obtain hazard information undermines this purpose.
Finally, the December 1, 2015, deadline only applies to distributors. Under 29 CFR 1910.1200(c), a distributor is defined as any business, other than a chemical manufacturer or importer, which supplies hazardouschemicals to other distributors or to employers. In contrast, businesses that "produce" chemicals (i.e., manufacture, process, formulate, blend, extract, generate, emit, or repackage chemicals for use or distribution) are considered "chemical manufacturers" under the HCS 2012, and must comply with the HCS 2012 labeling requirements by June 1, 2015. Although your background information describes USP as a distributor, because it repackages chemicals into reference standards vials, USP is a manufacturer under the HCS. USP must therefore comply with all the HCS 2012 labeling requirements by June 1, 2015, and the company must be listed as the chemical manufacturer on the SDS.
Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA's requirements are set by statute, standards, and regulations. Our letters of interpretation do not create new or additional requirements but rather explain these requirements and how they apply to particular circumstances. This letter constitutes OSHA's interpretation of the requirements discussed. From time to time, letters are affected when the
Agency updates a standard, a legal decision impacts a standard, or changes in technology affect the interpretation. To assure that you are using the correct information and guidance, please consult OSHA's website at https://www.osha.gov. If you have further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.