Labels on ampoules 5mL or smaller

Response: No. Paragraph (f)(1) of the HCS [ILPI: Original HCS 2012 context · Current HCS] requires the chemical manufacturer, importer, or distributor to ensure that each container of hazardous chemicals leaving the workplace is labeled, tagged or marked with the following information: (1) a product identifier; (2) signal word; (3) hazard statement(s); (4) pictogram(s); (5) precautionary statement(s); and (6) the name, address, and telephone number of the responsible party. Although OSHA understands your concern that it may be difficult to include all of the HCS 2012 label elements [ILPI: Original HCS 2012 context · Current HCS] on small shipped containers, the accommodation you suggest does not comply with OSHA's HCS 2012 [ILPI: Original HCS 2012 context · Current HCS] labeling requirements.

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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 [ILPI: Original HCS 2012 context · Current 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 hazardous chemical 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 [ILPI: Original HCS 2012 context · Current HCS] required information for shipped small containers (i.e., the actual container holding the hazardous chemical). 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:

[ILPI note: At issuance: HCS 2012. HCS 2024 codified small-container provisions in paragraph (f)(12), including separate conditions for 100 mL and 3 mL containers and the immediate outer package. Apply those provisions rather than this historical accommodation alone.]

• Product identifier
• Appropriate pictograms
• Manufacturer's name and phone number
• Signal word
• A statement indicating the full label information for the chemical is provided on the outside package.

Additionally, the outside packaging, at a minimum, must comply with the following:

• All the applicable label elements, as defined in 29 CFR 1910.1200(f)(1) [ILPI: Original HCS 2012 context · Current HCS].
• 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.

Example: Category 1 flammable liquid, named High Flam, where the only hazard is the flammability, manufactured by ABC.

• The immediate container must contain:
  • High Flam, (product identifier),
  • Flame Pictogram, (pictogram),
  • DANGER, (signal word),
  • ABC, (manufacturer name),
  • (123) 456-7890, (phone number),
  • Full labeling information for High Flam is provided on the outside package.


• The outside package must contain:
  • High Flam,
  • Flame Pictogram,
  • DANGER,
  • 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 [ILPI: Original HCS 2012 context · Current HCS] 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).

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While you state that it may be cost prohibitive for USP to comply with the HCS 2012 [ILPI: Original HCS 2012 context · Current HCS] 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 [ILPI: Original HCS 2012 context · Current HCS] 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) [ILPI: Original HCS 2012 context · Current HCS], a distributor is defined as any business, other than a chemical manufacturer or importer, which supplies hazardous chemicals 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 [ILPI: Original HCS 2012 context · Current HCS], and must comply with the HCS 2012 labeling requirements [ILPI: Original HCS 2012 context · Current HCS] 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.