EPCRA Hazardous Chemical Inventory Reporting – Alcohol, Food, Drug, and Cosmetic Exemptions

The following set of questions and answers are designed to help you understand if your facility is required to submit hazardous chemical inventory reports for your substances which are alcohol, food, drugs, or cosmetics under the hazardous chemical inventory reporting provisions of sections 311 and 312 of the Emergency Planning and Community Right-to-Know Act and provides guidance on how to comply with the requirements [40 CFR part 370; 42 U.S.C. 11021 and 11022 (pdf)(187 KB)]. These are intended to be guidelines. Note that the SERCs, LEPCs, and local fire departments are primarily responsible for implementing these sections; Check with your state to assess your site-specific reporting requirements.

Note that under EPCRA, the term “state” includes the 50 States of the United States, the District of Columbia, the five inhabited territories of the United States, and any other territory or possession over which the United States has jurisdiction. Federally recognized Tribes are the implementing authority for EPCRA on all Indian lands. Tribal Emergency Response Commissions are a form of State Emergency Response Commission, and any Tribal Emergency Planning Committees are a form of Local Emergency Planning Committee.

On this page:

• What facilities are subject to EPCRA hazardous chemical inventory reporting?
• OSHA Food, Drug, and Cosmetics Exemptions
  • Do the OSHA HazCom Standard exemptions for certain foods, drugs, and cosmetics exempt me from EPCRA sections 311 and 312 hazardous chemical inventory reporting?

• EPCRA Food and Drug Administration Exemption

  • What is the EPCRA FDA Exemption?
  • Are all foods, food additives, color additives, drugs, and cosmetics exempt from the hazardous chemical inventory reporting requirements of EPCRA sections 311 and 312?
  • Are all chemicals intended for use in foods, food additives, color additives, drugs, and cosmetics exempt from the hazardous chemical inventory reporting requirements of EPCRA sections 311 and 312?
  • If my substance is considered a Generally Recognized As Safe ingredient, is it exempt from the hazardous chemical inventory reporting requirements of EPCRA sections 311 and 312?

What facilities are subject to EPCRA hazardous chemical inventory reporting?

The EPCRA hazardous chemical inventory reporting requirements apply to facilities that are required to prepare or have available a safety data sheet under the Occupational Safety and Health Administration’s Hazard Communication Standard [29 CFR section 1910.1200], if they have hazardous chemicals present above their EPCRA reporting thresholds. The EPCRA reporting thresholds are codified at 40 CFR section 370.10. To learn more about the hazardous chemical inventory reporting refer to: the Hazardous Chemical Inventory Reporting webpage.

The OSHA HazCom Standard requires chemical manufacturers and importers to obtain or develop a SDS for each hazardous chemical that they produce or import. It also requires that employers have a SDS available for each hazardous chemical that they use. [29 CFR section 1910.1200(g)]

There are two exemptions applicable to food, drugs, and cosmetics:

1. The OSHA HazCom Standard provides exemptions for certain foods, drugs, and cosmetics, and
2. The EPCRA sections 311 and 312 provide an exemption for any food, food additive, color additive, drug, or cosmetic regulated by the Food and Drug Administration.

Do the OSHA HazCom Standard exemptions for certain foods, drugs, and cosmetics exempt me from EPCRA sections 311 and 312 hazardous chemical inventory reporting?

The OSHA HazCom Standard states that it does not apply to [29 CFR section 1910.1200(b)(6)]:

• Food or alcoholic beverages which are sold, used, or prepared in a retail establishment (such as a grocery store, restaurant, or drinking place), and foods intended for personal consumption by employees while in the workplace;
  • For guidance refer to: OSHA Letters of Interpretation 29 CFR section 1910.1200(b)(6)(vi).
• Any drug, as that term is defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), when it is in solid, final form for direct administration to the patient (e.g., tablets or pills); drugs which are packaged by the chemical manufacturer for sale to consumers in a retail establishment (e.g., over-the-counter drugs); and drugs intended for personal consumption by employees while in the workplace (e.g., first aid supplies); and
  • For guidance refer to: OSHA letters of interpretation for 29 CFR section 1910.1200(b)(6)(vii).
• Cosmetics which are packaged for sale to consumers in a retail establishment, and cosmetics intended for personal consumption by employees while in the workplace.
  • For guidance refer to: OSHA letters of interpretation for 29 CFR section 1910.1200(b)(6)(viii).

Since these certain foods, drugs, and cosmetics are not required to have an SDS under the OSHA HazCom Standard, they are not subject to the hazardous chemical inventory reporting requirements of EPCRA sections 311 and 312.

What is the EPCRA FDA Exemption?

Any foods, food additives, color additives, drugs, or cosmetics regulated by the FDA are exempt from hazardous chemical inventory reporting under EPCRA sections 311 and 312. [40 CFR section 370.13; 42 U.S.C. 11021(e)(2)(pdf)(187 KB)]. EPA considers a substance to be regulated by the FDA as long as the substance is used in a manner which is consistent with the FDA regulations. Substances that meet this specific criteria do not need to be reported under the EPCRA section 311 and 312 Hazardous Chemical Inventory Reporting provisions.

Are all foods, food additives, color additives, drugs, and cosmetics exempt from the hazardous chemical inventory reporting requirements of EPCRA sections 311 and 312?

No. The exemption does not exempt all substances that are defined as foods, food additives, color additives, drugs, or cosmetics under the Federal Food, Drug, and Cosmetic Act in any form or use. The EPCRA FDA exemption only applies to the foods, food additives, drugs, and cosmetics that are regulated by and used in manner consistent with the FDA regulations, as codified in Title 21 of the Code of Federal Regulations.

Are all chemicals intended for use in foods, food additives, color additives, drugs, and cosmetics exempt from the hazardous chemical inventory reporting requirements of EPCRA sections 311 and 312?

No. To qualify for the exemption, the food, food additive, color additive, drug, or cosmetic must be in a use and form that is regulated by the FDA. Consequently, the exemption would not apply to unprocessed chemicals intended for eventual use in or as a drug, except to the extent that those unprocessed chemicals are regulated by FDA in their unprocessed state.

If my substance is considered a Generally Recognized As Safe ingredient, is it exempt from the hazardous chemical inventory reporting requirements of EPCRA sections 311 and 312?

EPA considers a substance to be regulated by the FDA as long as the substance is used in a manner which is consistent with the FDA regulations. The following examples are provided to help in your understanding of the applicability of this exemption.

Example 1: Carbon dioxide is regulated by the FDA as a food additive and is considered a GRAS ingredient in the following instances [21 CFR section 184.1240]:

1. As a leavening agent as defined in 21 CFR section 170.3(o)(17); a processing aid as defined in 21 CFR section 170.3(o)(24); and a propellant, aerating agent, and gas as defined in 21 CFR section 170.3(o)(25).
2. The ingredient is used in food at levels not to exceed current good manufacturing practice.

Carbon dioxide present at your facility for these uses would be exempt from the EPCRA definition of a hazardous chemical and not subject to the hazardous chemical inventory reporting requirements of EPCRA sections 311 and 312. However, any amount of carbon dioxide present at your facility for other purposes should be counted towards the reporting thresholds.

Example 2: Chlorine is regulated by the FDA for the bleaching of flour and artificial aging effects as described at 21 CFR section 137.105.

Chlorine present at your facility for these uses would be exempt from the EPCRA definition of a hazardous chemical and not subject to the hazardous chemical inventory reporting requirements of EPCRA sections 311 and 312.

However, any amount of chlorine present at your facility for any other purposes (e.g., water and wastewater treatment, production of chemicals, textile manufacturing, etc.) should be counted toward the reporting thresholds.

Example 3: Ethanol or ethyl alcohol (C₂H₅OH) is regulated by the FDA as a food additive and is considered a GRAS ingredient in two instances:

1. Use as an antimicrobial agent as defined in section 170.3(o)(2) of this chapter on pizza crusts prior to final baking at levels not to exceed 2.0 percent by product weight. [29 CFR section 184.1293]
2. Use as a preservative in the filling used in shelf-stable croissants at a concentration of 3000 ppm (or 0.3%). [GRN Notice No. 151 Ethanol (ethyl alcohol)]

Ethanol present at your facility for these uses would be exempt from the EPCRA definition of a hazardous chemical and not subject to the hazardous chemical inventory reporting requirements of EPCRA sections 311 and 312.

Ethanol produced in the manufacture of beer, wine, and distilled spirits is under the purview of Alcohol and Tobacco Tax and Trade Bureau and not the FDA. Therefore, ethanol is not exempt from the hazardous chemical inventory reporting when added to food or alcoholic beverages. These substances must be counted towards the reporting thresholds.