Lindane

Lindane is the active ingredient in some products used to treat head lice and scabies. Health professional organizations throughout Michigan have supported action to phase out pharmaceutical use of lindane in Michigan. HB 4402 allows use of lindane in pharmaceutical products in Michigan only under the supervision of a physician in his or her office.

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Learn about protecting children from pharmaceutical lindane. (pdf)

Learn about lindane in the Great Lakes. (pdf)

Learn about alternative treatments to lindane for head lice and scabies. (pdf)

PROTECT CHILDREN FROM PHARMACEUTICAL LINDANE

Michigan Department of Community Health

Michigan Health Professional Organizations

U.S. Food and Drug Administration (FDA)

State of California

U.S. Environmental Protection Agency (EPA)

U.S. Agency for Toxic Substances and Disease Registry (ATSDR)

International Actions on Lindane

Expert Opinions

Lindane in the Great Lakes

References

What do government agencies and experts say about lindane?

MICHIGAN DEPARTMENT OF COMMUNITY HEALTH:

"The Michigan Department of Community Health does not recommend the use of Lindane to treat scabies patients."¹
The same is true for head lice: "The State of Michigan does not recommend using Lindane."²

HEALTH PROFESSIONAL ORGANIZATIONS IN MICHIGAN HAVE SUPPORTED A LINDANE PHASE-OUT:

Michigan Chapter of the American Academy of Pediatrics
Michigan Council of Nurse Practitioners
Michigan Nurses Association
Michigan Pharmacists Association
Michigan Association of School Nurses
Wayne County Medical Society of Southeast Michigan

U.S. FOOD AND DRUG ADMINISTRATION (FDA):

In 2003, the FDA released a public health advisory for lindane. It cited a variety of concerns, including: “In post-marketing reports, neurologic side effects occurred in patients who misused Lindane, as well as in patients who used Lindane according to labeled instructions. Among adverse events reported in the FDA database, 70% reported neurologic events including seizure, dizziness, headache and paresthesia.”³
The Agency issued nearly identical Black Box Warnings for lotions and shampoos containing lindane in 2003: “Lindane lotion should be used with caution for infants, children, the elderly, and individuals with other skin conditions (e.g. atopic dermatitis, psoriasis) and in those who weigh <110lbs (50 kg) as they may be at risk of serious neurotoxicity.”⁴
An internal FDA assessment concluded: “Lindane was labeled a second line therapy in 1995 because, while it is similar in action to other approved therapies, it has a higher percutaneous absorption than other approved scabicides and pediculocides. This greater systemic exposure may translate to a greater potential for serious adverse events.”⁵

STATE OF CALIFORNIA:

“Commencing January 1, 2002, any product used for the treatment of lice or scabies in human beings that contains the pesticide Lindane shall not be used or sold in the state.”⁶
“The main source of Lindane in sewers is from the treatment of head lice and the treatment of scabies, which is a mite that can live in human skin.”⁷

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U.S. ENVIRONMENTAL PROTECTION AGENCY (EPA):

"Since 1998, the registrants have voluntarily cancelled a large number of Lindane uses, including direct treatment of livestock, pet products, ornamentals, home lawns, fallow areas, commercial food processing facilities and storage areas, greenhouses, wood treatment, forestry, Christmas tree plantations, military use on human skin and clothing..."⁸
The U.S. EPA classifies lindane as one of twenty-two "Bioaccumulative Chemicals of Concern" in the Great Lakes.⁹ New discharges of these chemicals are prohibited into "mixing zones" due to "continuing evidence that the highly bioaccumulative nature of these toxic chemicals presents a significant potential risk to human health, aquatic life and wildlife."¹⁰
Since 1988, the U.S. EPA has classified lindane as an "Extremely Hazardous Substance" in Section 302 of the Emergency Planning and Community Right-to-Know Act.^{11, 12}
The U.S. EPA classifies lindane as a "Priority Pollutant" under the Clean Water Act "for the protection of aquatic life and human health in surface water..."¹³
Lindane is included in the U.S. EPA's Toxic Release Inventory (TRI) Program,¹⁴ which "requires facilities in certain industries, which manufacture, process, or use significant amounts of toxic chemicals, to report annually on their releases of these chemicals."¹⁵
"Lindane and the other HCH isomers are mobile in the environment, and through long-range atmospheric transport, are deposited in the Arctic, where they have been detected in air, surface water, groundwater, sediment, soil, ice, snowpack, fish, wildlife, and humans."¹⁶
All uses except pharmaceutical uses are now restricted. "On August 2, 2006, EPA announced that registrants Chemtura USA Corporation, followed by AGSCO Inc, Drexel Chemical Co., and JLM Industries, Inc., requested to voluntarily cancel all remaining pesticide registrations of the organochlorine pesticide lindane. EPA also has made a determination that the remaining uses of lindane are not eligible for reregistration."¹⁷

U.S. AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY (ATSDR):

The U.S. ATSDR ranks lindane 32nd of the 275 substances on its list of CERCLA (Superfund) "Priority Pollutants."¹⁸ This list reflects a "prioritization of substances based on a combination of their frequency, toxicity, and potential for human exposure at NPL [National Priorities List] sites."¹⁹

INTERNATIONAL ACTIONS ON LINDANE:

"...Lindane is banned for use in 52 countries, [and] restricted or severely restricted in 33 countries."²⁰
The International Agency for Research on Cancer (IARC), the premier agency on carcinogen classification, currently considers hexachlorocyclohexanes, the class of chemicals to which lindane belongs, as "possibly carcinogenic to humans."²¹
The United Nations Environment Programme announced the nomination of lindane to become one of five new contaminants to be added to the original 12 in the Stockholm Convention on Persistent Organic Pollutants (POPS): "Mexico is nominating the pesticide lindane together with a related group of chemicals known as hexachlorocyclohexanes. It explains that producing the 99%-pure gamma hexachlorocyclohexane needed for every ton of lindane results in six to ten tons of unusable isomers. The resulting waste-isomer problem compounds the risks posed by lindane itself."²²
The Rotterdam Convention adopted in 1998 includes lindane among the 39 pesticides and industrial chemicals banned or severely restricted for health or environmental reasons by participating parties.²³

EXPERT OPINIONS:

Jim Gulliford, assistant administrator for EPA's Office of Prevention:

“Jim Gulliford, assistant administrator for EPA’s Office of Prevention, called lindane ‘one of the most toxic, persistent, bioaccumulative pesticides ever registered.’”²⁴

Ann Heil, Senior Engineer, Los Angeles County Sanitation Districts:

“Lindane can contaminate water resources, especially when its use is widespread. A single head lice or scabies treatment can contaminate 6 million gallons of water - and cost an average of $4,000.00 to remove from wastewater.”²⁵

These quotations were compiled by
the Michigan Network for Children's Environmental Health,
117 N. Division St., Ann Arbor, MI 48104, 734-761-3186 xt.115
Email MNCEH
www.mnceh.org
Emphasis was added by MNCEH.

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REFERENCES:

¹ Michigan Department of Community Health. Scabies Prevention and Control Manual. Version 1.0. May 2005. Accessed 12-22-06 at: www.michigan.gov/documents/BHS_NHM_Michigan_Scabies_Prevention
_and_Control_Manual_131983_7.pdf.

² Michigan Department of Community Health. Michigan Head Lice Manual: A comprehensive guide to identify, treat, manage and prevent head lice. Version 1.0. July 2004. Accessed 12-22-06 at: www.michigan.gov/documents/Final_
Michigan_Head_Lice_Manual_103750_7.pdf.

³ U.S. Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Public Health Advisory: Safety of Topical Lindane Products for the Treatment of Scabies and Lice. 2003. Accessed 8-5-06 at: www.fda.gov/cder
/drug/infopage/lindane/lindanePHA.htm.

⁴ U.S. Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Lindane Lotion USP, 1% RX Only, 2003. Accessed 10-17-06 at: www.fda.gov/cder/foi/label/2003/006309lotionlbl.pdf and U.S. Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Lindane Shampoo, USP, 1% RX Only, 2003. Accessed 10-17-06 at: www.fda.gov/cder/foi/label
/2003/006309shampoolbl.pdf.

⁵ Mathis, L. Lindane Shampoo and Lindane Lotion: Assessment.
Center for Drug Evaluation and Research 2003. Accessed 8-16-06 at: www.fda.gov/cder/drug/infopage/lindane/lindanememoassessment.pdf.

⁶ California Assembly Bill 2318, chaptered version, An act to add Section 111246 to the Health and Safety Code, relating to environmental health. Approved by Governor September 5, 2000. Filed with Secretary of State September 7, 2000. Accessed 3-5-08 at: www.assembly.ca.gov/acs/acsframeset2text.htm.

⁷ California Assembly Bill 2318, chaptered version, An act to add Section 111246 to the Health and Safety Code, relating to environmental health. Approved by Governor September 5, 2000. Filed with Secretary of State September 7, 2000. Accessed 3-5-08 at: www.assembly.ca.gov/acs/acsframeset2text.htm.

⁸ U.S. Environmental Protection Agency. Lindane Voluntary Cancellation and RED Addendum Fact Sheet: Registrants’ Cancellation Request and EPA’s Lindane RED Addendum. July 2006. Accessed 8-17-06 at: www.epa.gov/oppsrrd1/REDs
/factsheets/lindane_fs_addendum.htm.

⁹ U.S. Environmental Protection Agency. Great Lakes Initiative, Bioaccumulative Chemicals of Concern Affected by the ban on Mixing Zones in the Great Lakes. Accessed 1-8-07 at: www.epa.gov/waterscience/gli/mixingzones/chemicals.html.

¹⁰ U.S. Environmental Protection Agency. Great Lakes Initiative, Fact Sheet: Final Regulation to Ban Mixing Zones in the Great Lakes. Accessed 1-8-07 at: www. epa.gov/waterscience/gli/mixingzones/finalfact.html.

¹¹ U.S. Environmental Protection Agency. Chemical Emergency Preparedness and Prevention. Background. Accessed 1-8-07 at: http://yosemite.epa.gov/oswer
/ceppoehs.nsf/content/BackGround.

¹² U.S. Environmental Protection Agency. Alphabetical Order List of Extremely Hazardous Substances (Section 302 of EPCRA). Accessed 1-8-07 at: http://yosemite.epa.gov/oswer/ceppoehs.nsf/EHS_Profile?openform.

¹³ U.S. Environmental Protection Agency. Water Quality Criteria. Accessed 1-8-07 at: www.epa.gov/waterscience/criteria/wqcriteria.html.

¹⁴ U.S. Environmental Protection Agency. Toxic Release Inventory (TRI) Program, TRI Chemicals. Accessed 1-8-07 at: www.epa.gov/triinter/chemical/index.htm.

¹⁵ U.S. Environmental Protection Agency. Toxics Release Inventory (TRI) Program Fact Sheet. Accessed 1-8-07 at: www.epa.gov/triinter/tri_program_fact_sheet.htm

¹⁶ U.S. Environmental Protection Agency. Lindane and Other HCH Isomers—EPA Risk Assessment Fact Sheet. 2006. Accessed 8-16-06 at: www.epa.gov/oppsrrd1
/REDs/factsheets/lindane_isomers_fs.htm.

¹⁷ United States Environmental Protection Agency. Lindane Voluntary Cancellation and RED Addendum Fact Sheet: Registrants’ Cancellation Request and EPA’s Lindane RED Addendum. July 2006. Accessed on 8-17-06 at: www.epa.gov/
oppsrrd1/REDs/factsheets/lindane_fs_addendum.htm.

¹⁸ U.S. Agency for Toxic Substances and Disease Registry. 2005 CERCLA Priority List of Hazardous Substances. Accessed 1-8-07 at: www.atsdr.cdc.gov/cercla
/05list.html.

¹⁹ U.S. Agency for Toxic Substances and Disease Registry. CERCLA Priority List of Hazardous Substances. Accessed 1-8-07 at: www.atsdr.cdc.gov/cercla/index.html.

²⁰ U.S. Environmental Protection Agency. Lindane and Other HCH Isomers—EPA Risk Assessment Fact Sheet 2006. Accessed 8-16-06 at: www.epa.gov/oppsrrd1
/REDs/factsheets/lindane_isomers_fs.htm.

²¹ International Agency for Research on Cancer (IARC). IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42, Supplement 7. Lyon, France. Last updated February 10, 1998. Accessed 10-17-06 at: http://monographs.iarc.fr
/ENG/Monographs/suppl7/suppl7.pdf.

²² United Nations Environment Programme, “New chemicals for control under POPs Convention,” Press Release, Novem-ber 2, 2005. Accessed 1-5-07 at: www.unep.org/Documents.Multilingual/Default.asp?DocumentID=457&ArticleID
=5018&l=en.

²³ United Nations Environment Programme, Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in Inter-national Trade. Accessed 1-5-07 at: www.pic.int/home.php.

²⁴ Cited in Safer Pest Control Project News, August 8, 2006. Accessed 8-15-06 at: http://spcpweb.org/news.

²⁵ Davis, Stephanie. Winter 2002. Practical Waste Reduction. Environmental Quality Management. 12 (2): 89-95. Accessed 3-5-08 at: www3.interscience.
wiley.com.ezproxy.bu.edu/journal/102526742/issue.

LINDANE IN THE GREAT LAKES

Lindane is a pesticide used in certain pharmaceutical treatments for children’s head lice and for scabies. The U.S. EPA classifies lindane as one of 22 "Bioaccumulative Chemicals of Concern" in the Great Lakes, as a "priority pollutant" under the Clean Water Act, and as an "Extremely Hazardous Substance." Lindane is no longer used in the U.S. for agricultural, veterinary, or military purposes. Although the majority of lindane was used in agriculture, all forms of lindane are persistent, bioaccumulative, and toxic. Support HB 4402 to restrict pharmaceutical use of lindane!

Lindane in Great Lakes' Water

Lindane in Michigan Sewage

Lindane in Great Lakes' Aquatic Life

Lindane in Great Lakes' Air

Lindane in Michigan's Contaminated Sites

LINDANE IS COMMONLY FOUND IN THE WATER OF THE GREAT LAKES

Lindane is present in Lake Huron, Erie, Superior and Ontario water, according to a 2007 EPA and Environmental Canada "State of the Great Lakes" report. Lindane was "commonly found" in Lake Huron.

LINDANE IS IN MICHIGAN SEWAGE SYSTEMS

The Detroit Wastewater and Sewerage Department found detectable levels of lindane in leachates prepared from solid residuals of wastewater during the sewage treatment process. Lindane was found in the grit, scum, and filter press cake from 2002 to 2004. Levels ranged from 0.01 to 0.89 ug/L (micrograms per liter or parts per billion) in the leachates. Lindane in the Detroit Wastewater system is likely the result of pharmaceutical uses of lindane.

LINDANE IS IN GREAT LAKES FISH AND MUSSELS

“The most recent years of available analytical data in the U.S. EPA’s Great Lakes Fish Monitoring Program indicate the concentration of lindane in sport fish fillets (Chinook and Coho Salmon and Steelhead Trout) have ranged between trace detection and 0.005 ppm between 1982 and 2000.”

The National Oceanic and Atmospheric Administration’s National Status and Trends Program has found gamma-hexachlorocyclohexane (lindane) in the tissues of mussels in the Great Lakes at “high concentrations” in at least one site from 1992 until the latest data available (2005).

LINDANE IS FOUND IN THE AIR IN THE GREAT LAKES REGION

Lindane is being monitored in air and precipitation with the Integrated Atmospheric Deposition Network in the Great Lakes region with average concentration of 15-90 pg/m3 in the early 90s, decreasing to 5-30 pg/m3 since 2000.”

LINDANE IS PRESENT AT CONTAMINATED SITES IN MICHIGAN

Lindane has been identified in 189 of the EPA’s National Priorities List of hazardous waste sites (Superfund sites). At least twelve of these sites are located in Michigan.

The Michigan Department of Environmental Quality has found lindane at three of its contaminated (Part 201) sites: Grand Blanc (Genesee County), Rhodes (Gladwin County), and Scottville (Mason County).

Download this information as a fact sheet (pdf).
Note: fact sheet was created by MNCEH and includes all references.

TREATMENTS FOR HEAD LICE AND SCABIES

Many different treatments for head lice and scabies are commonly used in place of lindane.

Least-Toxic Treatments for Head Lice

Chemical-Based Treatments for Head Lice

Least-Toxic Treatments for Scabies

Chemical-Based Treatments for Scabies

LEAST-TOXIC TREATMENTS FOR HEAD LICE

Manual removal/combing can be effective, but must be done "every three to four days for two weeks following any session in which a large, adult louse is found" (UpToDate.com). UpToDate.com also recommends adding products containing oils or enzymes, such as cream rinse and olive oil, to hair during each session as this may aid in nit removal by combing.

Oil-based suffocants, such as petroleum jelly and mayonnaise "can obstruct the respiratory spiracles of active lice, and potentially block the holes in the operculum of the eggs, thereby suffocating the louse." Anecdotally, some parents have treated head lice infestations with olive, tea tree, rosemary, lavender, germanium, and eucalyptus oils. While presumably safer, the efficacy of these methods has not been scientifically evaluated.

Other suffocants can be effective. For example, Cetaphil cleanser is a simple "[d]ry-on, suffocation-based, pediculicide lotion [that] effectively treats head lice." It is applied wet and then blown dry with a hair dryer, to form an adherent film. This 'shrink-wrapped' film layer completely covers the louse, plugging its breathing holes and causing death by suffocation." Parents reported that this treatment required less time to perform than others they tried. "There were no reports of local irritation, discomfort, embarassment, or other adverse symptoms associated with treatment." The cure rate has been reported as 96% and the "results are comparable or superior to the results previously reported for treatments with permethrin, pyrethrin, and malathion."

Hot air used during "one 30-minute application" on the head has been shown to be "an effective, safe treatment and on to which lice are unlikely to evolve resistance." The developers of hot air treatments for head lice and their associates found that their custom-built "LouseBuster was effective in killing lice and their eggs when operated at a comfortable temperature, slightly cooler than a standard blow-dryer." Additionally, handheld blow-dryers have been found to be highly-effective at killing eggs and moderately effective at killing adult lice. Additional research is being conducted on this relatively new treatment.

CHEMICAL-BASED TREATMENTS FOR HEAD LICE

1% permethrin, and insecticide, is the only chemical treatment recommended by the American Academy of Pediatrics. It has "low toxicity to humans and does not cause allergic reaction to individuals with plant allergies." It comes in the form of an over-the-counter cream rinse and "can be used in children as young as two months.

0.33% pyrethrins plus 4% piperonyl butoxide is available over the counter. It "is neurotoxic to lice and has extremely low mammalian toxicity." The pyrethrins have a favorable safety profile, and percutaneous absorption is minimal." The Michigan Department of Community Health (MDCH) recommends two applications of the shampoo seven to ten days apart.

0.5% malathion is a highly ovicidal organophosphate pediculicide available by prescription only. The U.S. formulation of malathion is designed to deter the development of resistance. Malathion 0.5% is "effective when applied for only 20 minutes. This shorter application time is safer for children and also decreases the likelihood that residual product remains in the hair, further contributing to resistance." The MDCH and others recommend that malathion "should be used with extreme caution and only in cases where resistance to other products is strongly suspected" due to the risk of accidental ingestion and its high flammability.

Ivermectin is an oral prescription drug shown to be effective and "no instances of resistance to ivermectin among head lice have been reported to date." Treatment for lice is off-label, though "no serious side effects have been reported."

LEAST-TOXIC TREATMENTS FOR SCABIES

2-10% sulfur ointment contains sulfur mixed with petroleum jelly or cold cream. It is an alternative when other remedies are not advisable, such as on more sensitive patients like newborn babies, pregnant wmoen, and nursin mothers. It is reasonably effective (82%) and also relatively inexpensive.

CHEMICAL-BASED TREATMENTS FOR SCABIES

5% permethrin is "the treatment of choice" of the Centers for Disease Control. Dermatologists Strong and Johnstone also recommend 5% permethrin as the treatment of choice. It is "well-tolerated and has low toxicity," and "only a small amount is absorbed through the skin, and this is rapidly detoxified without retention in the body."

Ivermectin is a prescription drug requiring a single oral dose and is shown to be "as effective as lindane...[and] simpler to use" for the treatment of scabies. "It is very effective, safe to use, cheap, and convenient." Treatment for scabies is off-label.

Benzyl benzoate is an affordable, topical cream and "is very effective when used correctly" and has been shown to be effective with treatment-resistant scabies. "Because of the side effects and the availability of less toxic agents, this scabicide had fallen into disrepute" and is not allowed for "pregnant and lactating women, infants, and young children less than two years of age." "However, recent studies have found it to be effective in the management of permethrin-resistant crusted scabies and in combination with ivermectin in patients with relapses after a single treatment with ivermectin."

10% crotamiton is a prescription cream that is "approximately 50-70% effective in the treatment of scabies." However, the safety and effectiveness in children and safety in pregnant women has not been established.

Download this information as a fact sheet (pdf).
Note: fact sheet was created by MNCEH and contains all references.