February 24, 2010

Questions and Answers About Animal Testing to Identify Endocrine Disrupting Substances

Overview    |   Take Action    |    Q&A: Pesticides      |    Q&A: Chemicals  

• What does "endocrine disruption" mean?
• What kinds of substances have been identified as potential endocrine disruptors?
• What is the United States doing to address endocrine disruption concerns?
• How has the EPA responded to its Congressional mandate?
• Besides animal welfare, what are some arguments against the EPA's current approach to the Endocrine Disruptor Screening Program?
• How else could EPA be implementing the Endocrine Disruptor Screening Program?
• What are the The HSUS and The HSLF doing to spare animals from Endocrine Disruptor Screening Program testing?
• How can I help?

Q: What does "endocrine disruption" mean?
A: Endocrine disruption refers to harmful effects on reproduction, development, or overall health resulting from chemical interactions with the body's hormone system.

Q: What kinds of substances have been identified as potential endocrine disruptors?
A: A range of man-made and naturally occurring substances have been flagged as potential endocrine disrupters, including artificial hormones, pesticides, chemicals used in the plastics industry and in consumer products, industrial by-products and pollutants, and even some nutrients found in plants.

Q: What is the United States doing to address endocrine disruption concerns?
A: In 1996 the U.S. Congress passed the Food Quality Protection Act, which directed the Environmental Protection Agency (EPA) to develop a program to screen all pesticides, and possibly other chemicals, to identify those which "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 EPA] may designate."

Q: How has the Environmental Protection Agency responded to its Congressional mandate?
A: On the advice of an advisory committee, the EPA has developed an ambitious testing program that goes well beyond its Congressional mandate to screen for estrogen-like effects in humans. More than 15 new screens and tests have been, or are being, developed to detect interactions with androgen and thyroid hormone systems in addition to estrogen, including tests on bird, fish, amphibian and invertebrate species that can consume as many as 2,600 animals per chemical. These deviations from the Food Quality Protection Act mandate have the potential to increase animal testing demands by up to five-fold.

The EPA's Endocrine Disruptor Screening Program consists of two main steps:

• Tier 1 screening—a "battery" of six animal tests and five non-animal tests meant to identify substances that interact with the body's hormone systems; and

• Tier 2 testing—five in-depth, long-term animal tests (e.g. breeding studies to assess toxicity to reproduction in two generations of offspring) intended to thoroughly characterize toxic effects and the exposure levels at which they occur for substances identified as "endocrine active" in Tier 1.

Late in 2009, the EPA published the first in a series of test orders calling on companies to perform the entire Tier 1 battery (600 animals and $1 million) for 67 pesticides and industrial chemicals. 

Q: Are animals used in testing given pain relief or other protections?
A: No, pain relief is not normally provided. And to make matters worse, laboratory-bred rodents, fish, and other species slated for use under the Endocrine Disruptor Screening Program are not protected under U.S. law governing animal experimentation.

Q: Besides animal welfare, what are some arguments against the Environmental Protection Agency's current approach to the Endocrine Disruptor Screening Program?
A: The EPA Congressional mandate was to focus on pesticides, which are among the most heavily animal-tested products in existence—with often dozens of tests having been carried out for every substance used or sold in the United States. In most cases, this includes a 2-generation reproductive toxicity study, which is substantially equivalent to the Endocrine Disruptor Screening Program (EDSP) Tier 2 "definitive" test for endocrine disruption (see "How has the EPA responded to its Congressional mandate?"). Yet by its actions, the EPA seems intent on disregarding existing, relevant test results in favor of a new round of "check-the-box" animal testing. This new testing is unlikely to have change how human or environmental exposure levels are regulated. In the worst case, 2,600 animal 2-generation studies could end up being repeated under the EDSP—with limited public health benefit.

Q: How else could the Environmental Protection Agency be implementing the Endocrine Disruptor Screening Program?
A: The EPA could acknowledge the vast amount of safety testing information already available for most pesticides and determine additional testing needs in a thoughtful, case-by-case manner. One approach for doing so is an existing EPA program called "registration review," under which pesticide safety information is examined on an ongoing basis to ensure that all registered products continue to meet the legal statutory standard of "no unreasonable adverse effects." If periodic registration reviews identify the need for additional safety test data, EPA could call on companies to produce data from individual Endocrine Disruptor Screening Program Tier 1 screens (see "How has the EPA responded to its Congressional mandate?") or other scientifically relevant information as appropriate. This could include data from a series of ultra-rapid cellular tests being developed under EPA's own ToxCast™ research program.

Q: What are The Humane Society of the United States and The Humane Society Legislative Fund doing to spare animals from Endocrine Disruptor Screening Program testing?
A: Our scientists and lobbyists are working to promote Endocrine Disruptor Screening Program implementation in a rational manner that builds upon existing test results, rather than disregarding them. However, this approach is just the first step toward our ultimate goal of ending animal testing forever. To this end, we have built unprecedented partnerships with scientists from universities, private companies and government agencies worldwide to support and push for a totally new—"21st century"—approach to safety testing that combines ultra-fast cell tests and sophisticated computer models to deliver results in hours instead of months or even years for some animal tests.

Q: How can I help?
A: Contact EPA Administrator Lisa Jackson through our online alert and ask her to retool the Endocrine Disruptor Screening Program to eliminate redundant screening tests and make full use of existing test results instead of requiring additional testing on animals. Take action »