OSHA GHS Compliance and CGA C-7-2014

Compliance Alert –OSHA GHS Compliance For Medical Gas Cylinders
Q – Must we remove the existing medical gas label under the epoxy clear-coat on small Oxygen, USP cylinders?

A – The OSHA Global Harmonization System regulation provides specific changes to current labeling of cylinders. The changes include new “Signal Words”, new unified descriptions of hazards, new pictograms, etc. The OSHA regulation contains a provision for certain classes of chemical labels to be regulated by other agencies (EPA, FDA, etc.):

1910.1200(b)(5) This section does not require labeling of the following chemicals:

(i) Any pesticide as such term is defined in the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), when subject to the labeling requirements of that Act and labeling regulations issued under that Act by the Environmental Protection Agency;

1910.1200(b)(5)(ii)

(ii) Any chemical substance or mixture as such terms are defined in the Toxic Substances Control Act (15 U.S.C. 2601 et seq.), when subject to the labeling requirements of that Act and labeling regulations issued under that Act by the Environmental Protection Agency;

1910.1200(b)(5)(iii)

(iii) Any food, food additive, color additive, drug, cosmetic, or medical or veterinary device or product, including materials intended for use as ingredients in such products (e.g. flavors and fragrances), as such terms are defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Virus-Serum-Toxin Act of 1913 (21 U.S.C. 151 et seq.), and regulations issued under those Acts, when they are subject to the labeling requirements under those Acts by either the Food and Drug Administration or the Department of Agriculture; <bolded for emphasis>

Even though the OSHA regulation allows exceptions for the GHS labeling of medical gases, we must continue to abide by the FDA regulations (and current guidance/enforcement) to determine the contents of medical gas labels. For medical gases, FDA accepts CGA C-7- 2014, Guide to Classification and Labeling of Compressed Gases in lieu of their own detailed regulations found in 21 CFR 201.

CGA C-7-2014 represents the medical gas industry consensus and has the endorsement of GAWDA as the official position for all compressed gas labeling, including medical gas labeling.

For medical gas labels under a clear-coat, the old label should be removed and a new label applied which complies with CGA C-7-2014.

Please direct questions to:
Tom Badstubner, GAWDA Medical Gas Consultant – tom@asteriskllc.com, or Mike Dodd, GAWDA DOT/OSHA/EPA Consultant – mldsafety@hotmail.com

This is information was developed to assist GAWDA members in complying with government regulations; it does not constitute legal advice, and users are advised to obtain legal counsel to develop their individual compliance programs. Additionally, GAWDA does not guarantee that use of this material will ensure compliance with any regulatory or legal standard.