Safety Tidbit 3.29 - GHS and FDA

Safety Tidbit 3.29 – GHS and FDA

Reference:      OSHA Hazard Communication Standard

                        Federal Food, Drug, and Cosmetic Act

                       

A company blends various dyes to create custom colored plastic pellets for resale to injection molding clients. When I walked into their mixing and quality control area I noticed a bunch of bottles with hand-typed (meaning very old) labels. I told them that each of the containers needs to get labeled in accordance with the 2012 Hazard Communication standard. Furthermore, during my tour of the facility we stopped at the three-drawer filing cabinet which housed the hundreds of material safety data sheets. I told them that the MSDS has been replaced with a more robust and informative Safety Data Sheet and that their cabinet needed to be updated. The client’s first comment was that they were exempt from OSHA due to FDA.

This exemption made me pause as I didn’t really think the circumstance feel under the OSHA’s exemption but told them I would check further. 1910.1200(b)(5)(iii) reads:

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

21 U. S. Code 321(t) states:

(1) The term “color additive” means a material which—

(A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and

(B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto

While the chemicals used are dyes, they are not being used in the manufacture of foods, drugs, or cosmetics or medical or veterinary devices. This company was manufacturing plastic pellets for resale to injection molding companies and when asked who were their primary clients? They responded, companies primarily making flower pots for ultimate resale at home improvement centers (e.g., Lowes, Home Depot).

Hope this was helpful and thanks for reading my Safety Tidbits! Comments and questions are always welcome. ~ Bryan

P.S. If you have an interesting safety or health question please let me know.