Polybrominated diphenylethers (PBDEs) Significant New Use Rule (SNUR) Questions and Answers

1. What is EPA announcing?

EPA is issuing a regulation to complement the phase-out of two flame retardant chemicals. This regulation will ensure that no new manufacture or import of these two chemicals can occur after January 1, 2005, without first being subject to EPA evaluation. The two chemicals, PentaBDE and OctaBDE, are members of the chemical family polybrominated diphenylethers (PBDEs) and have been commonly used as flame retardants in commercial products such as furniture foam, plastics, fabrics, and appliances.

This procedure, known as a Significant New Use Rule (SNUR), allows EPA to designate any new manufacture or import as a "significant new use." Advance notification is required prior to commencing the new use. Thus before the chemical can be manufactured or imported for the significant new use, the company would be required to provide advance notification to EPA under Section 5 of TSCA. This approach gives EPA the opportunity to evaluate any concerns, and if necessary, regulate future manufacture, import, or uses associated with these two chemicals.

2. Why is this important?

Over the course of several years, EPA has evaluated scientific studies and available information, and there is growing evidence that PBDE chemicals bioaccumulate and are persistent in the environment, and that people are being exposed. For example, traces of the chemicals have been found in fish, in samples of human blood and in women’s breast milk. Also, there is evidence that these chemicals may cause liver toxicity, thyroid toxicity, and neurodevelopmental toxicity. EPA believes that this rule is necessary to ensure that any new manufacture or import is subject to Agency review.

3. How does this action complement the decision by the sole US manufacturer to phase out production by December 31, 2004?

This action builds on the November 3, 2003, announcement by the Great Lakes Chemical Corporation, the only U.S. manufacturer of these chemicals, who agreed to voluntarily phase-out production by December 31, 2004. In 2003, EPA commended Great Lakes Chemical Corporation for taking this responsible action. EPA is concerned that manufacture or import could be reinstated in the future, and thus believes it is necessary to have the opportunity to evaluate any new manufacture or import associated with these chemicals.

4. Why are these chemical important and are there substitutes?

These chemicals provide a very important benefit because of their ability to save lives and property by slowing ignition and rate of fire growth, and therefore increase available escape time in the event of a fire. However, EPA also believes both the phase out and the Significant New Use rule will further spur the development of safer alternatives.

EPA has been working to ensure that following the phasing out of these two chemicals, acceptable alternatives are available to industry. Such alternatives would need to meet technological requirements of industry users, flame retardancy requirements in US standards, and present lower hazards than the chemicals for which they are substituting. To promote these goals and to explore the safety of alternative flame retardant chemicals, EPA has convened a group of stakeholders in its Furniture Flame Retardancy Partnership, including chemical manufacturers and users, the furniture industry, government agencies, and consumer groups, who will work together to evaluate possible alternatives to PentaBDE.

5. Should consumers discard any products that might contain PentaBDE or Octa?

No, the EPA does not believe that there is a need to remove or replace products that may contain these chemicals. EPA has not concluded that PBDEs pose an unreasonable risk to human health or the environment. However, due to growing concerns, EPA believes that the phase out and the regulatory action taken in this announcement are useful steps to minimize and ultimately help prevent further exposure to these chemicals.

6. What does a SNUR require?

A SNUR requires persons to submit a Significant New Use Notice (SNUN) to EPA at least 90 days before they manufacture, import, or process the substance for the significant new use as defined in the regulation. The SNUN provides EPA with the opportunity to evaluate the intended use, and if necessary, to prohibit or limit that activity before it occurs and protect against unreasonable risks, if any, from exposure to the substances, in much the same way as it does for new chemicals.

7. What are PBDEs commonly used for?

The PBDEs are major components of commercial formulations often used as fire retardants in furniture foam, plastics for TV cabinets, consumer electronics, wire insulation, and back-coatings for draperies and upholstery, and plastics for personal computers and small appliances. These chemicals slow ignition and rate of fire growth, and, as a result, increase available escape time in the event of a fire involving the above consumer products.

8. How are people exposed to PBDEs?

PBDEs are not chemically bound to plastics, foam, fabrics, or other products in which they are used, making them more likely to leach out of these products. PBDEs may enter the air, water and soil during their manufacture and use in consumer products. The primary route of human exposure is currently unclear.

9. What is the Agency doing to better understand the occurrence of PBDEs in the environment?

EPA is addressing PBDE information needs with a three-pronged approach which includes: 1) efforts to better understand the environmental properties, exposure pathways, and how these chemicals are getting into human tissue; 2) research and detailed testing to determine health and environmental effects from exposure to PBDEs; and 3) evaluation of potential PBDE substitutes, which includes the analysis of technical performance, cost-effectiveness, and risk-risk trade-offs related to fire prevention and toxicity.

10. What efforts are underway to discourage continued use of the PBDEs?

In November 2003, the Great Lakes Chemical Corporation announced a voluntary phase out of PentaBDE and OctaBDE by the end of 2004. Great Lakes is the only U.S. manufacturer of these PBDEs. To follow up on this voluntary action, EPA is working with chemical manufacturers and end users to facilitate an orderly transition to safer substitutes. The State of California has enacted a law banning use of PentaBDE and OctaBDE by January 2008 (recently changed to June 1, 2006) and other states (including Maine, Hawaii, Washington, and New York) are also considering or have passed similar legislation. In Europe, the European Union enacted a ban on PentaBDE and OctaBDE in all products which took effect on August 15, 2004.

EPA is also working with the National Association of State Fire Marshals, chemical manufacturers, manufacturers of end products such as furniture or plastics for electronics, environmental and public health groups, other federal agencies, state governments, and other nations to answer key questions and help people make informed decisions based on risk. EPA is considering both regulatory and voluntary actions.