​​Topic 5: State Regulatory Toxicology

LEARNING OBJECTIVES
After completing this lesson, you will be able to:
  • Define what is meant by “State  Regulatory Toxicology”.
  • ​Give an example of a state regulatory regulation.

What is State Regulatory Toxicology?

  • Deals with regulatory toxicology for the US on a state level (e.g. Texas, Delaware, Arizona).

  • Established by authorities applicable to a given state.

  • State regulatory toxicology only applies with the state’s boundaries; however, they may influence adjacent states or even national regulatory toxicology.
  • Under the layer of the US national government sits a complex web of state and local laws and policies, in addition to regulatory authorities.
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  • The make-up of state and local governments varies widely across the US; while they have mutual specific features, their organizations differ.
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  • Whatever their design, state and local governments can sometimes have a much greater impact on people's lives than the federal government. 

​The Federal-State Toxicology and Risk Analysis Committee (FSTRAC) is made up of representatives from U.S. state health and environmental agencies and U.S. EPA personnel. 

  • ​Is an integral part of EPA’s communication strategy with states and tribes for human health risks associated with water contamination.

  • Fosters cooperation, consistency, and an understanding of EPA’s and different states’ goals and problems in human health risk assessment.
 
  • Allows states and the federal government to work together on issues related to the development and implementation of regulations and criteria under the Safe Drinking Water Act and Clean Water Act.

​FSTRAC members have supported development of: 

  •  Human Health Benchmarks for Pesticides (HHBP)
                 -Represent levels of pesticides in drinking water that are not anticipated to cause health effects.
                 -Used to help assess drinking water quality for pesticides that do not have other regulatory toxicology standards .

Example agencies that set state toxicology regulations:

The goal of state agencies is the same as federal agencies, protect people and the environment from health effects associated with chemical exposures.

States have differing regulatory toxicology requirements and focuses. Reasons for the differences could be due to: state history, geography, culture, population size and diversity, major industries, etc…

​Examples of state regulatory toxicology as it concerns chemicals in air:
  • Texas
Effects Screening Levels (ESLs)  – Air concentrations generally applicable to a specific chemical set by the Texas Commission on Environmental Quality (TCEQ). Play an important role in the regulation of air emissions from companies located in the state. List of ESLs.
  • California
Reference Exposure Levels (RELs)  – Air concentrations generally applicable to a specific chemical set by the California Environmental Protection Agency (CalEPA). Represent an air concentration that does not pose a health risk to people. List of RELs.

Example state toxicology regulations and the requirement that must be followed:

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Table 1: Example of state toxicology regulations and the requirement that must be followed.

Example agencies that set state toxicology regulations

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Table 2: Example agencies that set state toxicology regulations.
An example of a State Regulatory Agency is the CalEPA Office of Environmental Health Hazard Assessment (OEHHA)
  • Provides requirements and guidance for the California Proposition 65 Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition  65) 
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Figure 1: An example of a State Regulatory Agency signal.
Proposition 65
  • Purpose:
    • Enable consumers to make informed decisions regarding chemical exposures.
  • Why?
    • Established to protect California citizens from chemicals known to the state to cause cancer, birth defects, or other reproductive harms.
  • Scope:
    • Addresses chemical exposures to the citizens of California that may occur through consumer products, workplace exposures, and exposures occurring via the environment.
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Figure 2: Warning signal on Proposition 65.


Basics
  • OEHHA publishes a list of chemicals known to cause cancer, birth defects or other reproductive harm
  • The list is updated regularly and currently contains approximately 900 chemicals
  • Once a chemical is listed, companies have 12 months to comply with warning requirements under the regulation


Proposition 65 is referred to as a “risk-based” regulation in that the warning requirements only apply if the risk from chemical exposure are too high as defined by the regulation.

​Exposure examples:
  • Oral
  • Inhalation
  • Skin contact
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Figure 3: Exposure examples.
Proposition 65 upcoming changes…
  • The regulation has undergone revisions, New Proposition 65 Warnings, that will now require companies to add a symbol and change the phrasing of the warning. For example: “WARNING: This product can expose you to chemicals including arsenic, which is known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.” 
Topic 5: Key Points
In this section, we explored the following main points:​​​
  • What is State Regulatory Toxicology?
  • An example of how federal and state agencies work together
                  What is the Federal-State Toxicology and Risk Analysis Committee (FSTRAC)
                 Two example outcomes of the FSTRAC’s workgroup 
  • Example of State Agencies
  • Highlight two state specific guidance and rules as it concerns chemicals in air
                 Guidance
                        Effects Screening Levels (ESLs)
                        Reference Exposure Levels (RELs)
  • Rules
                   California Proposition 65
                   Texas Risk Reduction Program rule

    ​Topic 5: Knowledge Check