Science and Law
12th February 2015

Litigators! Are you on Top of the Latest Endocrine Disruptor Science?

Endocrine disrupting chemicals (EDCs) are substances found in the environment (air, soil, water supply) and in foods, beverages and other manufactured products. EDCs are not new but the attention drawn to their risks in our environment is.

Litigators! Are you on Top of the Latest Endocrine Disruptor Science?

This article was authored by Daniel Linkie, Ph.D., a consultant for the pharmaceutical industry at ARRENDEE LLC. Dr. Linkie provides expertise in identifying the risks and the actions needed to lower the operational barriers impeding drug and device product development.

 

Endocrine disrupting chemicals (EDCs) are substances found in the environment (air, soil, water supply) and in foods, beverages and other manufactured products. EDCs are not new but the attention drawn to their risks in our environment is.

EDCs are defined as chemicals that interfere with the endocrine system. On its surface, disruption of the endocrine system seems to be a reasonable metric to evaluate since hormones produced by the endocrine system regulate growth, development and overall health. DDT (dichlorodiphenyltrichloroethane) and DES (diethylstilbestrol), notable examples of EDCs, entered the marketplace in the early 1940’s when FDA regulatory oversight was limited to product safety and an Environmental Protection Agency (EPA) did not exist. Both DDT (a pesticide) and DES (a synthetic nonsteroidal estrogen used for the treatment of various female health conditions) were either selectively limited in their worldwide use or banned outright following alleged adverse health controversies surrounding their use.

In response to these controversies, the US government embarked upon more formal regulations and environmental protection actions through the Safe Drinking Water Act of 1974 and Toxic Substances Control Act of 1976. Both were Congressional actions directing EPA to establish standards limiting contaminants in water and the air. Since then, amendments, new actions and the expansion of regulatory oversight have broadened product surveillance.

More recently, Section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) required the U.S. Consumer Product Safety Commission to convene a Chronic Hazard Advisory Panel (CHAP) to study the effects on children’s health of all phthalates and phthalate alternatives as used in children’s toys and child care articles. Among the health concerns raised regarding phthalates, CHAP has been particularly focused on the potential for these compounds to pose hazards relating to their endocrine disrupting properties. The CHAP issued a report in July 2014 in which they made specific recommendations to the Commission regarding any phthalates (or combinations of phthalates).

Why should litigators now concern themselves with EDCs? Because for some reason, environmentally-focused, organizations have focused on this one particular mechanism of action – i.e., the ability of a chemical to “disrupt” the endocrine system” – to highlight human health concerns. For example, one organization is systematically collecting information on 1000s of chemicals present in our outdoor environment, food packaging, place of work, and in household goods. In the wake of these investigations, there are likely to be wide-ranging allegations that some of these chemicals (simplistically referred to as EDCs) and their metabolites may enter the air, water and food chain. Setting aside the legitimacy of focusing on endocrine disruption as an organizing principle for keeping our food and environment safe, the risk to product and chemical manufacturers is enormous.

The scale of potential chemicals now under surveillance is huge as is the task of their classification. State organizations work with EPA and share responsibilities for monitoring more than 10,000 chemicals considered by some to be dangerous to human health as potential mutagens and carcinogens. These massive undertakings, technically underserved, are behind schedule and open to concerns of legal actions that could take the form of harmful product designation.

With the subsequent passage of the Food Quality Protection Act and the Safe Drinking Water Act Amendment (1996), the regulatory reach of EPA extended to pesticides and, in conjunction with FDA, to establishing pesticide labeling and acceptable tolerances for pesticides in foodstuffs.

What has this meant for EDCs and why should litigators take notice? Increasingly sensitive and specific test methods developed in the past two decades have been used to accelerate and expand investigations of pesticides. More specifically, various regulatory agencies around the world have begun to formalize their focus on endocrine disruption as a mechanism of action that should be specifically focused on. For example, this emphasis on identifying and eliminating potential EDCs from the environment has resulted in inclusion of 73 pesticide ingredients (64 active and 9 inert chemicals) into EPA’s Endocrine Disrupter Screening Program (EDSP).

If litigators are to effectively defend their clients’ products, they must be aware of the relevant risks and the safeguards in place to control for potentially hazardous endocrine disruptor effects. This awareness requires an understanding the science and the evolving regulatory landscape for EDCs.

Critical to understanding the current state of EDCs are two forthcoming activities of scientific and regulatory importance:

  1. A planned February 2015 conference sponsored by EPA and NIEHS: “The role of environmental exposure in childhood obesity, metabolic syndrome and neurobehavioral abnormalities”
  2. A conference sponsored by the European Commission (EC) in keeping with their continuing efforts to establish regulations for what they consider to be “known” and “suspected” EDCs.

Further insights to US policy and a more global perspective for EDCs are anticipated.

In summary, scientific consultants at ISS are uniquely suited to address the litigation potentials surrounding EDCs and to assist you in managing the scientific and regulatory knowledge required for your clients.

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