SIRC monitors the regulatory activity on ethylbenzene to ensure appropriate treatment and provide comments on rulemakings, when relevant. Several governmental agencies and non-governmental organizations are involved in the regulation and reporting of the potential for ethylbenzene to impact the environment as well as consumer and worker safety. In addition, several other international and expert groups have reviewed ethylbenzene.
Environmental Protection Agency (EPA)
Toxic Substances Control Act (TSCA)
The Frank R. Lautenberg Chemical Safety for the 21st Century Act significantly revised the Toxic Substances Control Act in 2016, requiring EPA, among other things, to conduct a risk evaluation of existing chemicals regulated under TSCA on a priority basis. TSCA directs EPA to focus first on chemicals listed in its 2014 Chemical Substances Work Plan, which includes ethylbenzene. EPA selected priority candidates for evaluation in 2016 and 2019 but did not select ethylbenzene, one of 53 substances listed in the Work Plan not yet under review. EPA is expected to next nominate candidates for TSCA risk evaluation in early 2022.
Integrated Risk Information System (IRIS)
The EPA’s Integrated Risk Information System characterizes the health hazards of chemicals and develops chronic toxicity values for use in the full range of EPA risk management programs. IRIS assessments represent EPA’s official position regarding a chemical substance’s carcinogenicity or toxicity. The IRIS program assessed ethylbenzene in 1987 and 1991 and assigned a chronic oral toxicity value of 0.1 mg/kg bw/day [milligrams per kilograms of body weight per day], a chronic inhalation toxicity value of 1 mg/m3 [milligrams per cubic meters of air] (4.34 ppm [parts per million]), and a cancer classification of D (not classifiable as to human carcinogenicity). The IRIS program began an updated assessment of ethylbenzene in 2014 but in April 2019, suspended its assessment of ethylbenzene as well as eight other “non-priority” substances.
Toxics Release Inventory (TRI)
The EPA annually collects and compiles information on the release and management of select chemicals (i.e., recycling, energy recovery, and treatment) by U.S. manufacturing facilities and makes this Toxics Release Inventory information public. The TRI listing of ethylbenzene dates to 1987. Ethylbenzene has not been formally assessed for any particular health effect under TRI and is included as one of many chemicals considered to be hazardous air pollutants.
Endocrine Disruptor Screening Program (EDSP)
Ethylbenzene remains on the EPA’s “List 2” of chemicals slated for eventual review under its Endocrine Disruptor Screening Program.
Voluntary Children’s Chemical Evaluation Program (VCCEP)
The Voluntary Children’s Chemical Evaluation Program was a component of EPA’s Chemical Right-to-Know initiative, a program intended to study potential health risks to children and prospective parents associated from exposure to chemicals. The American Chemistry Council’s ethylbenzene panel volunteered ethylbenzene for this program and sponsored a Tier 1 assessment that included new toxicity tests for neurotoxicity, developmental neurotoxicity, immunotoxicity, and reproductive toxicity and an assessment report that evaluated hazards, exposure, and risk. The assessment was reviewed at a peer consultation in 2007 and published in 2015. Learn more here.
Occupational Safety and Health Administration (OSHA)
The U.S. Occupational Safety and Health Administration’s permissible exposure limit for ethylbenzene, adopted in 1971, is 100 ppm (parts per million), meaning that a worker should not be exposed to more than an average of 100 ppm ethylbenzene during a regular eight-hour workday, without respiratory protection.
Food and Drug Administration (FDA)
The U.S. Food and Drug Administration regulates the use of food additives or substances that may migrate into foods from packaging, food preparation, or serving materials. Ethylbenzene is not specifically regulated by FDA.
Office of Environmental Health Hazard Assessment (OEHHA)-Proposition 65
California’s Office of Environmental Health Hazard Assessment added ethylbenzene to the state’s Prop 65 list of chemicals “known to the state” to cause cancer in 2004. No Significant Risk Levels for oral and inhalation exposure were established in 2008 at 41 µg/day [micrograms per day] and 54 µg/day, respectively.
Office of Environmental Health Hazard Assessment (OEHHA)-Public Health Goal
In 1997, California’s Office of Environmental Health Hazard Assessment established a state Public Health Goal of 300 ppb (parts per billion) (0.3 µg/L [micrograms/liter]) for ethylbenzene in drinking water.
Legislation and regulatory guidelines related to ethylbenzene exist and may vary from state to state. These requirements govern the manufacture, sale, transportation, use, and/or disposal of ethylbenzene.
- Air emission standards–The U.S. Clean Air Act Amendments of 1990 regulate air emissions for hazardous air pollutants through technology-based standards that do not address potential health effects. Most states have adopted these standards for several chemicals, including ethylbenzene.
- Chemicals of concern–During recent years, several states have enacted legislation which authorizes the development of regulations which identify lists of “chemicals of concern.” These lists are primarily based on existing lists developed by other authorities, such as the U.S. EPA, U.S. National Toxicology Program, the European Union, etc.
- State-developed standards–Several states have established regulations specifically for ethylbenzene that establish health-based emission standards or guidelines.
American Conference of Governmental Industrial Hygienists (ACGIH)
The American Conference of Governmental Industrial Hygienists has set various threshold limit values (TLV) for ethylbenzene since 1948. The present value of 20 ppm (TLV-TWA) was adopted in 2011. In addition, in 2002 ACGIH classified ethylbenzene as an A3 carcinogen: “confirmed animal carcinogen with unknown relevance to humans.” Ethylbenzene is included in ACGIH’s Under Study List which indicates this substance is presently under consideration for updates to its values or notations.
ACGIH is composed of state and federal governmental hygienists and is not a regulatory body. While its recommendations are not enforceable, ACGIH and its actions are important because the adopted TLVs are often used as voluntary exposure guidelines in the internal policies of individual companies. However, industry is generally opposed to automatic or reflexive use of the guidelines for enforceable regulatory use because ACGIH does not consider feasibility and other regulatory criteria in its assessments.
Ethylbenzene is included in the Canadian Domestic Substances List based on its classification by the International Agency for Research on Cancer as a “possible human carcinogen.”
Health Canada published a “State of the Science Report” for ethylbenzene in 2006 with the last update in April 2016.
The Canadian Labour Code sets an occupational exposure limit of 20 ppm for ethylbenzene.
European Union (EU)
Ethylbenzene is registered under EU Regulation (EC) No. 1907/2006, Registration, Evaluation, Authorisation and Restriction of Chemicals, or REACH. REACH is administered by the European Chemicals Agency.
Ethylbenzene is unclassified as to carcinogenicity in Europe. Ethylbenzene has received the following EU GHS health hazard classifications: Acute Tox. 4 (inhalation), Asp. Tox. 1, and STOT RE 1 (hearing organs).
Occupational exposure limits vary by country in Europe, but for the EU, the IOELVs (Indicative Occupational Exposure Limit Values) for ethylbenzene are 100 ppm and 200 ppm for 8-hour and short-term exposures, respectively. Ethylbenzene is not currently regulated for food contact in the EU but is considered a non intentionally added substance (NIAS) in Commission Regulation (EU) 10/2011, subject to risk assessment.
Other global regulations
Many other nations have wide and varied regulations pertaining to ethylbenzene, including:
- The China State Administration of Work Safety classifies ethylbenzene as “Carcinogen Category 2, suspected human carcinogen.”
- Ethylbenzene is not classified as a carcinogen by the Japan Industrial Safety and Health Law, but it is considered a “Category 2” based on the former IARC 2B classification.
- Countries in Latin America and the Asia-Pacific region have various workplace exposure limits in the range of 20 ppm to 100 ppm.
- Japan and Korea have recommended guidelines for indoor air exposures to volatile organic compounds, including ethylbenzene.
- Australia has drinking water guidelines for ethylbenzene, but it is not classified as a carcinogen.
- Costa Rica and Mexico have ethylbenzene classified as A1 and A3 carcinogens, respectively.
International Agency for Research on Cancer (IARC)
IARC classifications are based on hazard assessments and not risk assessments. IARC classifications are not indicators of real-world potential risk. The mere presence of, or exposure to, a chemical is not an indication of risk or potential harm. IARC classifications are not enforceable as regulations, but they are often used as a reference in regulatory actions and policies.