Points of View
Understanding the EPA’s Decision on Agricultural Lindane
There has been a significant amount of misinformation regarding the Environmental Protection Agency's (EPA’s) reregistration eligibility decision (RED) on lindane that has been propagated by special interest groups and anti-lindane activists. (See Fact Checker) Importantly, the EPA’s final decision not to reregister lindane, published in July 2006, relates solely to agricultural-grade products and has no bearing on the use or availability of pharmaceutical-grade lindane medications, which are approved and regulated by the Food and Drug Administration (FDA). (See Points of View: FDA) In fact, the EPA concluded as part of its reregistration process that lindane medications do not pose undue risks to the American public or the environment when used as currently labeled.1,2 (See Points of View: EPA) Similarly, the FDA maintains that “there is a public health benefit to having lindane [medications] available on the market as second-line treatment for scabies and lice...”3
- Implications of Lindane Reregistration Eligibility Decision
The cancellation of agricultural-grade lindane products means that more than 99% of all lindane uses in the U.S. will be phased out by 2009.4,5 The remaining applications will be for medical purposes that, in contrast to agricultural uses, provide direct health benefits to patients. This is the same rational approach taken by the Canadian government.
EPA 2002 Reregistration Eligibility Decision Facts
- In July 2002, the EPA issued a reregistration eligibility decision on lindane, concluding that the benefits of agricultural-grade products outweighed the potential risks, and that such products were eligible for reregistration1,2
- The EPA’s decision was dependent on registrants of lindane agricultural products complying with specific data requests and product labeling requirements, which were subsequently satisfied to the acceptance of the EPA1,5
- As part of its reregistration process, the EPA also assessed the impact of lindane medications and concluded that there are no significant human or environmental risks when these prescription therapies are used as currently labeled1,2 (See Points of View: EPA)
EPA 2006 Reregistration Eligibility Decision Addendum Facts
- In July 2006, the EPA published an addendum to its initial reregistration decision on lindane, concluding that agricultural-grade products were no longer eligible for reregistration5
- A signficant change in the costs and benefits associated with the use of agricultural lindane (from 2002 to 2006), specifically the introduction of more suitable seed treatments for oat and rye crops for the control of wireworm and a diminished agricultural need, formed the basis of this reversed decision5
- Special interest criticisms of the EPA’s health and environmental assessments of pharmaceutical lindane were refuted by the Agency as noted in a memorandum also published in July 20066 (see Points of View: EPA)
- The cancellation of agricultural-grade lindane products will take full effect in July 2007, and the use of stockpiles will be allowed for an additional two years through 2009;7 lindane medications will remain available for the health benefit of patients with scabies, head lice and pubic lice who have limited treatment alternatives (see Points of View: FDA)
Please See Important Safety Information
- U.S. Environmental Protection Agency (EPA). Lindane Reregistration Eligibility Decision (RED). 2002. Available at: http://www.lindane.com/pdf/lindane_epa_2002.pdf.
- U.S. Environmental Protection Agency (EPA). Revised Assessment of Risk from Use of Lindane for Treatment of Lice and Scabies. July 31, 2002. Available at: http://www.lindane.com/pdf/EPA-Revised_Assessment-2002-07-31.pdf.
- U.S. Food and Drug Administration (FDA). Lindane Assessment Memorandum. Posted 2003. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM110853.pdf.
- Commission for Environmental Cooperation. The North American Regional Action Plan (NARAP) on Lindane and Other Hexachlorocyclohexane (HCH) Isomers. October 5, 2005. http://www.cec.org/files/PDF/POLLUTANTS/Lindane-NARAP-Public-Comment_en.pdf.
- U.S. Environmental Protection Agency (EPA). Addendum to the 2002 Lindane Reregistration Eligibility Decision (RED). July 2006. Available at: http://www.epa.gov/oppsrrd1/REDs/lindane_red_addendum.pdf.
- U.S. Environmental Protection Agency (EPA). Memorandum: Agency Response to Comments on the 2002 Lindane RED. Public Docket for Lindane (FDMS Docket #OPP-2002-0202). July 24, 2006. Available at: http://www.lindane.com/agency_response.pdf.
- U.S. Environmental Protection Agency (EPA). Lindane; Cancellation Order. Federal Register. 71(239): December 13, 2006. Available at: http://www.epa.gov/fedrgstr/EPA-PEST/2006/December/Day-13/p21101.htm.