May 26, 2015

Mr. James C. Lee
3E Company
4520 East West Highway, Ste. 440
Bethesda, Maryland 20814

Dear Mr. Lee:

Thank you for your February 10, 2015, letter to the Occupational Safety and Health Administration's (OSHA) Directorate of Enforcement Programs. In your letter you requested interpretation on the requirements for labeling of food additives and intermediate chemicals 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 scenario and questions are presented below, followed by our responses.

Scenario: A food and beverage manufacturer uses natural and artificial food additives, which are subject to premarket approval by the U.S. Food and Drug Administration (FDA). Some of the food additives and intermediate chemicals used at the workplace to produce the food and beverage products are hazardous to the workers when exposed. These food additives become edible only after being highly diluted in a final product.

Under 29 CFR 1910.1200(b)(5)(iii), any "food additive" or "color additive," as those terms are defined in the Federal Food, Drug and Cosmetic (FD&C Act) (21 U.S.C. 301 et seq.), is exempt from the HCS 2012 labeling requirements when it is subject to the labeling requirements under the FD&C Act by the FDA.

However, FDA's labeling requirements for food additives include direction on safe uses and specific limitations governing the use of the chemical as a food additive; they do not address any occupational hazards associated with the use of food additives in the workplace. The FD&C Act is not intended for occupational hazard communication like the labeling under HCS 2012. In addition, some of the chemicals and food additives used in the manufacturing process have occupational exposure limits (OELs).

Question 1: Does the labeling exemption of HCS 2012 still apply to the food additives described above, having corrosiveness and inhalation hazards at high concentrations and high quantity as used in the workplace?

Response: Yes. Nothing in the revised HCS changes the scope of the labeling exemption found in 29 CFR 1910.1200(b)(5)(iii) for foods subject to and labeled in accordance with the FD&C Act.

Question 2: Does the existence of OELs have any bearing on applying the labeling exemptions to food additives used during manufacturing?

Response: No. Labeling exemptions are granted for food additives and certain other substances that are defined in the FD&C Act and labeled in accordance with FDA regulations. See 29 CFR 1910.1200(b)(5)(iii).

Question 3: Is the FDA's labeling for food additives adequate to protect workers from occupational injuries when it does not communicate any occupational hazards associated with the use of food additives in the workplace, nor contain a reference to safety data sheets (SDS)?

Response: The FDA's labeling requirements for food additives are to protect consumers. To the extent that workers are exposed to the substances in a manner comparable to that of ordinary consumers, there is no need for additional OSHA labeling requirements. OSHA recognizes, however, that there may be situations where worker exposure is significantly greater than that of consumers, and that under these circumstances, substances which are safe for contemplated consumer use may pose unique hazards in the workplace. For this reason, the standard's exclusion is limited to labeling; the HCS does not exempt employers from their obligations to train employees about chemical hazards in the workplace and to prepare and maintain SDSs. See 29 CFR 1910.1200(g), (h).

Question 4: OSHA previously stated in a letter of interpretation to Dr. Shaun A. Gill, March 12,[1993], that FDA's granting approval to use iron oxide as a food colorant is not evidence that iron oxide dust is non-hazardous, and is not entirely relevant to occupational exposure from iron oxide. Therefore, is FDA's approval of food additives irrelevant to the potential hazardous exposures to workers using these food additives at a food and beverage manufacturing facility?

Response: The approval of food additives used in food and beverage manufacturing may or may not be relevant when evaluating occupational exposure. These products, even where exempt from HCS labeling requirements, must still be evaluated by chemical manufacturers and importers for hazard classification to comply with the requirements of HCS 2012. See 29 CFR 1910.1200(d). In addition, employers must prepare and maintain SDSs and provide information and training to employees about hazardous chemicals in the workplace. See 29 CFR 1910.1200(g), (h).

Question 5: Should the manufacturer treat these chemicals as industrial hazardous materials, rather than food additives, and apply the HCS 2012 labeling?

Response: See responses to Questions 1 and 4. HCS 2012 labeling requirements do not apply to food additives as defined by the FD&C Act, as long as those food additives are labeled in compliance with FDA requirements.

Question 6: Are intermediate hazardous chemicals used in the production of food additives subject to both the labeling and SDS requirements under HCS 2012?

Response: Yes, unless they are a food additive or color additive labeled under the FD&C Act. See responses to Questions 1 and 3.

Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA 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 http://www.osha.gov. If you have any further questions, please feel free to contact the Office of Health Enforcement at (202) 693-2190.

Sincerely,

Thomas Galassi, Director
Directorate of Enforcement Programs

[Corrected 1/7/2016]