Endocrine Disruptor Regulations and Lists in USA

Little Pro on 2016-03-09

Section 408(p) of the Federal Food Drug and Cosmetic Act (FFDCA) requires the Environmental Protection Agency (EPA) to develop a screening program using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the Administrator may designate.

Currently EPA is managing a science-based Endocrine Disruptor Screening Program (EDSP) that uses a two tiered approach to screen pesticides, chemicals, and environmental contaminants for their potential effect on estrogen, androgen and thyroid hormone systems.

  • Tier 1 screening data is used to identify substances that have the potential to interact with the endocrine system. Chemicals that go through Tier 1 screening and are found to exhibit the potential to interact with the estrogen, androgen, or thyroid hormone systems will proceed to Tier 2 for testing.
  • Tier 2 testing data identifies any adverse endocrine-related effects caused by the substance, and establish a quantitative relationship between the dose and that adverse effect. The results of Tier 2 testing will be combined with other hazard information and exposure assessment on a given chemical resulting in the risk assessment. Risk assessments are used to inform risk mitigation measures, as necessary and regulatory decisions concerning chemicals.

EPA has developed Endocrine Disruptor Screening Program Test Guidelines (in vitro and in vivo) intended to meet testing requirements under TSCA, FIFRA and FFDCA to determine if a chemical substance may pose a risk to human health or the environment due to the disruption of the endocrine system. Those testing guidelines can be found below.

Tier 1 Endocrine Disruptors Screening Testing Guidelines

890.1100 – Amphibian Metamorphosis (Frog)
890.1150 – Androgen Receptor Binding (Rat Prostate)
890.1200 – Aromatase (Human Recombinant)
890.1250 – Estrogen Receptor Binding
890.1300 – Estrogen Receptor Transcriptional Activation (Human Cell Line HeLa-9903)
890.1350 – Fish Short-Term Reproduction
890.1400 – Hershberger (Rat)
890.1450 – Female Pubertal (Rat)
890.1500 – Male Pubertal (Rat)
890.1550 – Steroidogenesis (Human Cell Line – H295R)
890.1600 – Uterotrophic (Rat)

Tier 2 Endocrine Disruptors Screening Testing Guidelines

890.2100 – Avian Two-Generation Toxicity Test in the Japanese Quail
890.2200 – Medaka Extended One Generation Reproduction Test
890.2300 – Larval Amphibian Growth and Development Assay (LAGDA)

Latest Updates of Endocrine Disruptor Regulations in USA

The US-EPA has already started implementing its policies regarding EDC testing. In 2009, it has sent out the first test orders to industry requiring testing of 67 chemicals using the Tier 1 test battery. In 2013, the final second list of chemicals for Tier 1 screening has been published. This list includes 109 chemicals and substances that have been listed as priorities within EPA's drinking water and pesticides programs. As of today, EPA has published the results of tier 1 screening of 52 pesticides.

It shall be noted that the tier 1 screening for above chemical substances are only determinations of their potential to disrupt endocrine function. A result indicating potential should not be construed as meaning that EPA has concluded that the chemical is an endocrine disruptor. EPA plans to require additional testing, known as Tier 2 testing, for chemicals that have potential impacts on the endocrine system.

List of Endocrine Disruptive Chemicals in USA

EPA has not published any official list of confirmed endocrine disruptors. Being a human endocrine disruptor does not lead to immediate ban or restriction in the United States. Endocrine disruptors will be subjected by EPA to a comprehensive risk assessment by taking into account of the differences between the levels of exposure that can produce adverse effects, and the typical exposure levels experienced by humans and wildlife. EPA would then determine if this safety standard is appropriate to protect public health and the environment, including groups that might be particularly sensitive, or if limiting certain uses of the chemical or ban should be considered.


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 Tags: Topics - USAEndocrine Disruptors