Addendum to the 2002 

Lindane Reregistration 

Eligibility Decision (RED) 

July 2006 
United States Prevention, Pesticides EPA 738-R-06-028 

Environmental Protection and Toxic Substances July 2006 

Agency (7508P) 

Addendum to the 

2002 Lindane 

Reregistration 

Eligibility Decision 

(RED) 
______________________ 

________________________ 

Addendum to the
 

2002 Lindane Reregistration 
 

Eligibility Decision (RED) 
 

Case No. 315 

Approved by: 

Debra Edwards, Ph.D. 

Director, Special Review and 

Reregistration Division 

Date 


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I. Introduction 

This document serves as an addendum to the July 2002 Lindane Reregistration 

Eligibility Decision document (2002 RED). This document addresses whether pesticide 

products containing the active ingredient lindane are eligible for reregistration under the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and whether existing 

tolerances for residues of lindane in food and feed are safe under the provisions of the 

Federal Food, Drug and Cosmetic Act (FFDCA). 

This RED Addendum reflects the Agency’s conclusions on the remaining lindane 

seed treatment uses in light of the information gathered since the 2002 RED. The seed 

treatment use is a source of human exposure to lindane, and it will add to the reservoir of 

lindane already present in the environment. EPA believes that dietary exposure to 

lindane from the seed treatment use may pose a risk to nursing infants who consume 

breast milk contaminated with lindane. EPA, however, is not able to quantify that risk at 

this time or determine whether current exposures result in any harm. Lindane’s persistent 

and bioaccumulative nature is also of concern to the Agency. In addition, the Agency’s 

updated analysis of the seed treatment use indicates very minor benefits to growers. In 

light of these factors, EPA now concludes that the six lindane seed treatment uses are 

ineligible for reregistration. 

As of July 27, 2006, the Agency had received requests from all lindane technical 

and end-use product registrants to voluntarily cancel all lindane product registrations. 

Once the cancellation process is complete, EPA will propose to revoke the existing 

lindane fat tolerances pursuant to section 408(l)(2) of the Food Quality Protection Act 

(FQPA). 

II. Background 

In July 2002, EPA issued a RED for lindane that captured the Agency’s thencurrent analysis of the registered uses of lindane as well as the existing tolerances. The 

2002 RED concluded in part that existing tolerances for lindane were no longer needed as 

the uses associated with those tolerances had all been cancelled, or voluntary cancellation 

had been requested. The 2002 RED also concluded that the current uses of lindane for 

seed treatment would be eligible for reregistration under FIFRA provided several 

conditions were met. First, EPA determined that a number of changes to the terms and 

conditions of registration of the seed treatment products were necessary to prevent 

“unreasonable adverse effects on the environment.” These changes are specified in the 

2002 RED. Second, EPA determined that the use of lindane for seed treatment was likely 

to result in residues in raw agricultural commodities derived from plants grown from 

seeds treated with lindane. Therefore, new tolerances for the existing seed treatment uses 

were needed. Third, EPA identified additional data that were needed to characterize 

lindane metabolites in order to establish appropriate tolerances for lindane. In summary, 

EPA determined that the currently registered lindane seed treatment products would be 

eligible for reregistration if: 1) the registrants amended product labels to reflect the terms 

and conditions specified in the 2002 RED; 2) the registrants provided the metabolism 

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data set forth in the 2002 RED; and 3) EPA was able to establish all required tolerances 

for residues of lindane in food. 

Following the 2002 RED, the registrants submitted revised labels for all end-use 

products reflecting the risk mitigation measures specified in the 2002 RED. The Agency 

has reviewed and approved these labels. The registrants also submitted the required 

product and residue chemistry data, and the Agency reviewed these data and found them 

to be acceptable. To satisfy generic data requirements, Crompton (now Chemtura) 

submitted a required seed leaching study; a nature of the residue study, also known as a 

plant metabolism study, originally required in the 1985 Lindane Registration Standard 

Data Call-In (DCI); and an anaerobic aquatic metabolism study to satisfy an anaerobic 

soil metabolism data requirement also originally required under the 1985 Lindane 

Reregistration Standard DCI. 

The Agency has taken a number of actions with respect to lindane since the 2002 

RED. EPA received and reviewed a number of comments on the 2002 RED. EPA also 

revoked all current tolerances of lindane, except for fat tolerances, because the associated 

uses had been cancelled (70 FR 55282, Sept. 21, 2005). EPA did not revoke the fat 

tolerances because residue data suggested that livestock that were fed lindane-treated 

seeds would bear residues of lindane in meat commodities (i.e., fat). In February 2006, 

EPA prepared and released for public comment a document titled “Assessment of 

Lindane and Other Hexachlorocyclohexane Isomers” (2006 Assessment). This 

assessment provided information on potential health effects of lindane as well as its 

associated isomers. 

III. Lindane's toxicity 

The Agency’s conclusions regarding effects of lindane in humans are largely 

based on studies in animals. Lindane primarily affects the nervous system. In acute, 

subchronic, and developmental neurotoxicity studies and chronic toxicity/oncogenicity 

studies, lindane was found to cause neurotoxic effects. Lindane also appears to cause 

renal and hepatic toxicity. In addition, there is evidence that lindane may act as an 

endocrine disruptor. Moreover, infants and children are expected to be more susceptible 

to the potential adverse effects of lindane than adults. In both a developmental 

neurotoxicity study and a 2-generation reproduction study, offspring demonstrated 

increased susceptibility to lindane’s adverse effects. The 2002 RED and its supporting 

documents provide a detailed summary of lindane’s toxicity. 

IV. Sources of Lindane Exposure 

A. Seed Treatment Use 

The seed treatment use is a source of human exposure to lindane. There are 

several possible routes by which this exposure may occur. First, individuals may be 

exposed to lindane residues when eating plants grown from treated seeds. Residue data 

demonstrate that the aerial portion of a growing crop will uptake lindane residues present 

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on treated seed (2002 RED, pp. 44-45). Second, consumption of meat is a potential 

source of lindane exposure. It is possible that livestock feed may be derived from grain 

grown from lindane-treated seed. EPA expects that livestock fed lindane-treated seed 

will bear residues of lindane in meat commodities (i.e., fat). USDA annual pesticide 

monitoring data show one detection of lindane residues in milk in 1998, one detection in 

the fat of poultry in 2000, and three detections (one from imported cows) in the fat of 

livestock (e.g., cows) in 2001 and 2002 (USDA Pesticide Data Program). In addition, the 

USDA's Food Safety and Inspection Service (FSIS) detected lindane in the fat of 

domestic and imported meat products in 1998, 1999 and 2000. For example, in 2000, 

four imported samples (three calf and one pig) and 16 domestic samples (cow, sheep, 

turkey, goat, veal) contained lindane. EPA acknowledges these detections cannot be 

attributed solely to treated seeds. 

Third, treated seeds are a potential source of lindane in drinking water. Modeling 

also shows that lindane concentrations in both surface water and groundwater may reach 

environmentally significant levels (greater than the Maximum Contaminant Level [MCL] 

of 0.2 ppb), even when lindane is restricted to seed-treatment uses only. Even 

considering lindane’s very low use rate for seed treatment, lindane may be expected to 

reach water resources at environmentally significant levels because of its mobility and 

high persistence. Based on a screening-level assessment, lindane from seed treatment 

may reach water resources at levels above the MCL of 0.02 ppb (U.S. EPA 2002 EFED 

RED Chapter at p. 3). This conclusion is based solely on lindane’s use as a seed 

treatment and does not consider past uses of lindane (U.S. EPA 2002 EFED RED 

Chapter). Water monitoring data, to be discussed in Section IV.B.i. of this addendum, 

show that residues of lindane are present in surface water in the United States. 

Exposure to lindane may also occur through volatilization from treated seeds. 

Field studies from Canada report an increase in lindane in the atmosphere in areas where 

lindane-treated seeds are used (2006 Assessment at p. 20). Due to lindane’s persistence 

and mobility, these lindane releases may contribute to human exposure via any route. 

B. Other Sources of Exposure 

In addition to the seed treatment use, U.S. populations may be currently exposed 

to lindane from several other sources.

 i. Past/historical uses 

Lindane was first registered in the U.S. in the 1940s. Since that time, lindane has 

been registered for use on a wide variety of fruit and vegetable crops (including seed 

treatment), ornamental plants, tobacco, greenhouse vegetables and ornamentals, forests, 

Christmas tree plantations, log dips, livestock dips, household sprays, domestic outdoor 

and indoor use by homeowners (including dog dips, household sprays, and shelf paper), 

commercial food or feed storage areas and containers, wood or wooden structures sites, 

and human skin/clothing (a military use). In 1977, EPA initiated a Rebuttable 

Presumption Against Registration (RPAR) review of lindane, now called a Special 

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Review, that resulted in the cancellation of lindane uses in smoke fumigation devices for 

indoor domestic use. Following the RPAR, EPA issued a Registration Standard for 

Lindane in September 1985 that included a requirement for the submission of additional 

data to support lindane registration and to address exposure concerns. Between 1993 and 

1998, long-range transport and environmental concerns about lindane increased; in 

response to these concerns, lindane registrants voluntarily cancelled all registered uses of 

lindane in 1998 and 1999, except for seed treatment uses on 19 agricultural crops and a 

dog mange treatment. The dog mange use was voluntarily cancelled in December 2001. 

Finally, in 2001 and 2002, the registrants voluntarily cancelled all but the following six 

lindane seed treatment uses: barley, corn, oats, rye, sorghum, and wheat. As of 2002, the 

only remaining agricultural uses for lindane were the six seed treatment uses that are 

being addressed in this document. 

Any of these past uses potentially result in continued exposures to lindane today 

due to its persistent, bioaccumulative nature and potential for long-range transport. 

Indeed, as shown below, lindane has been detected in a variety of foods as well as surface 

waters. EPA cannot link these residue detections with particular uses of lindane. 

The Food and Drug Administration's Center for Food Safety and Applied 

Nutrition (CFSAN)'s Total Diet Study summary of residues from 1991 to 2001 indicates 

that many food items contain residues of lindane 

(http://www.cfsan.fda.gov/~acrobat/tds1byps.pdf). The summary shows almost 50 types 

of food items in which lindane has been detected at least once between 1991 and 2001. 

The food items with the most detects were plain milk chocolate candy bars, yellow 

mustard, and commercial chocolate chip cookies. In addition, FDA's pesticide residue 

monitoring program indicates that, between 1993 and 2003, lindane is consistently 

detected in 2% to 3% of foods tested (http://www.cfsan.fda.gov/~dms/pesrpts.html). 

The United States Geological Survey (USGS) National Water Quality Assessment 

program (NAWQA) database includes 373 surface-water samples in which lindane was 

detected. Four of these samples had lindane concentrations of 0.1 ppb or greater, with a 

maximum concentration of 0.219 ppb detected in a sample from the agricultural "Harding 

Drain" in Stanislaus County, California in February 2000. The samples were collected 

between 1992 and 2004, with 199 of the samples with detections collected in 1999 or 

later. The USGS classified 115 of the samples with detections as having come from 

water bodies in areas of agricultural land use, 101 from water bodies in mixed land-use 

areas, and 49 from water bodies in urban land-use areas. Eight samples were classified as 

having been collected from areas classified as "other."

 ii. Imported meats 

Lindane may currently be used in other countries to directly treat livestock against 

external parasites. Because U.S. tolerances currently exist for lindane in livestock fat, 

livestock or meat products that have been treated with lindane and containing lindane 

residues can be legally imported into the United States. Approximately 8 percent of red 

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meat and 5 percent of animal fat consumed by the U.S. population is imported, and red 

meat is among the fastest growing U.S. imports (Jerardo 2003). 

iii. Subsistence diets 

Indigenous populations are exposed to lindane via consumption of subsistence 

diets. As noted in the 2006 Assessment, indigenous populations rely heavily on animal 

fats and protein in their subsistence diets. For example, EPA reported high harvest 

amounts of walrus, seal and whale for Alaska communities. Residues of lindane and 

other HCH isomers are present in these animals even though they are not in areas where 

lindane is manufactured or used. As explained in Section V of this addendum, lindane 

and other HCH isomers are mobile once released into the environment and can be 

transported long distances. Lindane and other HCH isomers tend to accumulate in colder 

climates, such as the arctic, and concentrate in the food chain. Thus any manufacture or 

use of lindane, or other HCH isomers, is a potential source of exposure to indigenous 

populations (2006 Assessment at pp. 26, 44-45).

 iv. Pharmaceutical use 

Lindane is also used as a treatment for lice and scabies. Individuals who use 

lindane pharmaceutical products will be exposed to lindane in amounts that will exceed 

exposure from the seed treatment use. The pharmaceutical use, though, is also a source 

of exposure to the general population. EPA believes that lindane from the 

pharmaceutical use may reach drinking water via “down the drain” release; that is, 

lindane enters drinking water when individuals using the pharmaceutical products wash 

off their hands/bodies. Based on information from Los Angeles County, California, EPA 

estimated average effluent concentrations of lindane discharged from publicly owned 

treatment works to be 0.03 ppb (2002 RED at p. 23). In fact, California banned the 

pharmaceutical uses of lindane due to concerns about water contamination and acute 

neurotoxicity concerns from direct application. Although FDA has recommended that 

lindane be prescribed as a second line treatment since 1995, these products remain a 

source of exposure.

 v. Use in foreign countries 

As far as EPA is aware, lindane is still being used in a few other countries. For 

example, EPA believes that lindane is still used in India. In addition, lindane is registered 

for use in Bolivia, Burkina Faso, Cameroon, Cape Verde, Chad, Kenya, Malaysia, Mali, 

Mauritania, Mexico,1

 Papua New Guinea, Syria, Tanzania, Togo, and Zimbabwe 

(Lindane NARAP Annex B). Because of lindane’s persistence and potential for long 

range transport, EPA believes that releases of lindane in these other countries could result 

in exposures in the United States. Bailey et al. (2000) demonstrated that organochlorine 

pesticides including lindane can travel from eastern Asia to North America in as little as 

five days. 

1

 Mexico, however, has stated that it intends to phase out all uses of lindane. 

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V. Environmental Fate 

Lindane is a persistent organochlorine compound that is widely distributed in the 

environment with a long half-life in various environmental compartments. The presence 

of lindane and other HCH isomers (namely α- and β-HCH) in the environment and 

human and wildlife tissues, as well as the environmental fate and exposure routes of 

lindane, have been documented in detail in scientific literature as well as in the Agency’s 

2002 RED and 2006 Assessment. The fate characteristics of lindane, including 

persistence, bioaccumulative potential, and potential for long-range transport, are the key 

elements to understanding the extent and scope of exposures associated with the use of 

lindane. Lindane’s toxicity in association with these fate characteristics results in risks of 

concern for the Agency. Below is a summary of these concerns. 

Based on the submitted environmental fate data, physical and chemical properties, 

lindane is a persistent, moderately mobile, and relatively volatile compound. Selected 

physical-chemical properties of lindane are summarized in Table 1. Lindane can migrate 

over a long distance through various environmental media such as air, water and 

sediment. Due to the persistent nature and long-range transport, lindane has been 

detected in air, surface water, groundwater, sediment, soil, ice, snowpack, fish, wildlife 

and humans. The source of these lindane detections is unclear; but it may be the result of 

a combination of past widespread use in the U.S. and other countries, lindane’s extreme 

persistence, current seed treatment use, current use in foreign countries, and use as a 

pharmaceutical. 

Table 1. Fate and Physical-Chemical Properties of Lindane

 Parameter Value 

 Molecular Weight 290.82 

 Solubility (25 oC) 7 mg/L

 Vapor Pressure (25 oC) 9.4 x 10-6 torr

 Henry’s Law Constant (atm-m3/mol) 3.5 x 10-6 @ 25°C

 Hydrolysis Half-life (pH 5, 7, 9; 25 oC) Stable, stable, 43-53 days

 Aqueous Photolysis Half-lives (pH 5) Stable

 Soil Photolysis Half-life Stable

 Aerobic Soil Metabolism Half-lives 980 days

 Organic Carbon Partition Coefficients (Koc) 1368 mL/g (mean of 4 soils)

 Octanol – Water Partition Coefficient (log Kow) 3.78 

 Bioconcentration Factors (BCF) In fish bluegill sunfish, 780 (fillet), 

2500 (viscera), 1400 (whole fish 

tissues) 

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A. Persistence 

Once released into the environment, the primary process by which lindane 

dissipates is volatilization into the air, although abiotic and biotic degradation as well as 

uptake by crops can also occur. However, lindane is resistant to abiotic processes like 

photolysis and hydrolysis (except at high pH), and degrades very slowly by microbial 

actions. The hydrolysis half-lives of lindane were reported to be stable at pH 5 and pH 7, 

and ≥ 43 days at pH 9 (U.S. EPA 2002 EFED RED Chapter). Since lindane does not 

contain chromophores that absorb light >290 nm, direct photolysis is not expected to 

occur. In an aerobic soil metabolism study, lindane degraded very slowly, with a 

calculated half-life of 980 days (U.S. EPA 2002 EFED RED Chapter). Since most 

degradation pathways occur slowly, the presence of degradates is generally low. Possible 

lindane degradates could include pentachlorocyclohexene, 1,2,4,-trichlorobenzene, and 

1,2,3-trichlorobenzene (U.S. EPA 2002 EFED RED Chapter). 

Additional evidence of its persistence is the fact that lindane has been found at 

numerous hazardous waste sites which have been abandoned. Of the 1,662 current or 

former industrial sites on the National Priorities List, lindane was found in 189 (ATSDR 

1997 at p. 1). 

B. Bioaccumulation and Bioconcentration 

Lindane can bio-accumulate easily in the food chain due to its high lipid solubility 

and can bioconcentrate rapidly in microorganisms, invertebrates, fish, birds and 

mammals (WHO 1991). The octanol-water partition coefficient (log Kow = 3.78, Table 

1) for lindane indicates that it has the potential to bioaccumulate. Lindane has potential 

to enrich in lipid-containing biological compartments. However, lindane is a multimedia 

chemical, existing and exchanging among different compartments of the environment 

such as the atmosphere, surface water, soil and sediment. In addition, temperature, 

humidity, and other environmental properties may have significant influence on 

environmental degradation rates. These properties likely affect the presence of lindane in 

the environment as well as the variability in the bioaccumulation, bioconcentration and 

biomagnification in the various biological compartments. Differences in accumulation 

are also likely due to different modes of uptake, metabolism and sources of 

contamination. 

The estimated bio-concentration factors (BCF) of lindane were 780x in fillet, 

2500x in viscera and 1400x in whole fish (U.S. EPA 2002 EFED RED Chapter). 

Although lindane may bioconcentrate rapidly, most data suggest that bio-transformation, 

depuration and elimination are relatively rapid once exposure is eliminated. After 14 

days of depuration, lindane levels were reduced by 96% in fillet, 95% in viscera, and 

85% in whole fish. 

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C. Transport and Mobility 

Lindane has often been detected in ambient air, precipitation, and surface water 

throughout North America, and it has also been detected in areas of non-use (e.g., the 

Arctic), indicating long-range transport of lindane occurs. The source of these lindane 

detections is unclear, but may be the result of a combination of manufacture (i.e., release 

during manufacture, disposal of HCH isomers), past widespread use in the U.S. and other 

countries, its extreme persistence, current seed treatment use, current use in foreign 

countries, and the pharmaceutical use of lindane. Once released into the environment, 

lindane can partition into various environmental media. Lindane present in soil can leach 

to groundwater, sorb to soil particulates and transport to surface water via runoff, or 

volatilize to the atmosphere. However, the Henry’s law constant (Table 1) of lindane 

suggests that volatilization is the most important route of dissipation from water and 

moist soils followed by aerial long-range transport. Adsorption of HCH isomers to soil 

and sediments is generally a preferential partitioning process after volatilization. 

Leaching of HCH isomers through soil is governed by their water solubility and their 

propensity to bind to soil. The calculated Koc of lindane ranges from 942 to 1798 mL/g, 

with a mean of 1368 mL/g for four soils tested (U.S. EPA 2002 EFED RED Chapter). 

These data suggest that lindane has low leaching potential. Data also indicate that 

lindane is expected to adsorb to suspended solids and sediment in water. Based on the 

results of a number of laboratory soil column leaching studies that used soils of both high 

and low organic carbon content as well as municipal refuse, lindane has low subsurface 

mobility in soils (Melancon et al. 1986, Reinhart et al. 1991). 

D. Volatility and Long-Range Transport 

The behavior of lindane in the environment is complex because it is a multimedia 

chemical, existing and exchanging among different compartments of the environment 

such as the atmosphere, surface water, soil and sediment. Volatilization from soil and 

surface waters is a major dissipation route for lindane. The Henry’s law constant for 

lindane suggests that it will volatilize from moist soil and surface water into the air, 

although microbial and chemical degradation and uptake by crops can also occur (Walker 

et al. 1999). Lindane can also enter the air as adsorbed phase onto suspended particulate 

matter, but this process does not appear to be a major contributor like volatilization 

(Walker et al. 1999 and Bidleman 2004). Brubaker and Hites (1998) measured the gas 

phase kinetics of the hydroxyl radical with lindane, and reported that it has long 

atmospheric half-lives in air and, therefore, can be transported long distance. 

Once airborne, lindane may move into the upper troposphere for more widespread 

regional and possibly transcontinental distribution as a result of large-scale vertical 

perturbations that facilitate air mass movement out of the near surface. Also, it may 

reversibly deposit on terrestrial surfaces close to the source and still be transported over 

large distances, even global scales, through successive cycles of deposition and reemission as result of ambient temperature and latitude differences known as “global 

distillation or fractionation” (Wania and Mackay 1996 as cited in U.S. EPA 2002 EFED 

RED Chapter at pp 9-10). Recently, soil and air samples were collected for 

10
 
organochlorine pesticides in northwest Alabama to estimate soil-to-air fluxes and their 

contribution to the atmospheric concentration (Harner et al. 2001). The researchers 

concluded that the atmospheric concentration of lindane in northwest Alabama may be 

due to atmospheric advections or regional sources rather than the studied soils. A field 

study conducted by Waite et al. (2001) in Saskatchewan, Canada demonstrated 

volatilization of lindane from fields planted with lindane-treated canola seed. Waite 

reported that significant quantities (12-30%) of applied lindane volatilize from treated 

canola seed to the atmosphere during the growing seasons and have direct implications 

on regional atmospheric concentrations of lindane. The study also estimated that a range 

of 66.4 to 188.8 tons of atmospheric load of lindane occurred during 1997 and 1998, 

following the planting of canola in the region of the Canadian-prairies. Poissant and 

Koprivnjak (1996) reported that 90% of elevated lindane concentration in the atmosphere 

at Villeroy, Quebec in 1992 was from secondary emissions of applied lindane-treated 

corn, while the rest was from the volatilization of residual lindane from the previous year 

seed treatment (U.S. EPA 2002 EFED RED Chapter at pp. 8-9). 

Recently, seasonal air concentrations of lindane and other HCH isomers were 

monitored using Passive Air Samplers (PAS) along an urban to rural transect in Toronto, 

Canada (Motelay-Massei et al. 2005). The air concentrations of lindane were 159 pg/M3 

to 1020 pg/M3 in the rural sites during the spring-summer monitoring period. A similar 

trend of air concentrations of lindane was also observed by Hoff et al. (1992) in Ontario, 

Canada. Both studies concluded that the continuing use of lindane during spring is likely 

associated with higher concentration of lindane in the air samples. Analysis of 1990 to 

2001 data from the Integrated Atmospheric Deposition Network (IADN) also confirmed 

that annual agricultural application was a key variable in explaining the annual cycle of 

atmospheric lindane concentrations (Buehler et al. 2004). Jianmin et al. (2003) modeled 

lindane transport and deposition to the Great Lakes from usage areas in the Canada 

prairies and corn-belt regions of southern Ontario and Quebec. Results showed that 

lindane transport to the Great Lakes during spring-summer came mainly from application 

sites in the prairies, with minor contribution from the corn-belt. They compared the 

modeled concentration with the monitoring data of the IADN sites, which were within 

50-134% of those measured during summer, 16-51% in fall and 3-20% in winter. 

E. Surface Water, Sediments and Groundwater 

Lindane is moderately mobile and can migrate over a long distance through 

various environmental media like water and sediment. Adsorption of lindane to soil and 

sediments is generally a preferential partitioning process after volatilization. The 

calculated Koc of lindane ranges from 942 to 1798 mL/g, with a mean of 1368 mL/g for 

four soils tested (U.S. EPA 2002 EFED RED Chapter). These data suggest that lindane 

has low leaching potential. Data also indicate that lindane is expected to adsorb to 

suspended solids and sediment in water. Lindane reaches water resources via surface 

runoff and through rain and snow deposition (ATSDR 1997 at p. 190 citing Tanabe et al. 

1982; Wheatley and Hardman 1965). “For example, Lake Ontario received <2 kg/year of 

γ-HCH because of suspended sediment loading from the Niagara River between 1979 and 

1981” (ATSDR 1997 at p. 190 citing Kuntz and Warry 1983). Studies also show that the 

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Great Lakes received 3.7 to 15.9 metric tons/year of lindane through atmospheric 

deposition (ATSDR 1997 at p. 190 citing Eisenreich et al. 1981). Lindane has also been 

detected in stormwater runoff in Denver, Colorado and Washington, D.C. (0.052–0.1 

μg/L) (ATSDR 1997 at p. 190 citing Cole et al. 1984). 

VI. Dietary Risk 

A. Presence of Lindane in Breast Milk 

Although there currently are no programs in the United States for monitoring 

lindane levels in human breast milk, EPA believes that lindane is present in the breast 

milk of at least some nursing mothers in the United States. In general, lindane is very 

persistent and highly soluble in fat or fatty tissue. Therefore, it has the potential to bioaccumulate in the food chain and bioconcentrate in microorganisms, invertebrates, fish, 

birds, and mammals. In practical terms, this means that when women are exposed to 

lindane through food, water, or the atmosphere, they will accumulate lindane residues in 

their fatty tissue, including breast milk and breast milk fat, and that these lindane residues 

will remain there for an undetermined amount of time.2 Thus, to the extent women in 

the United States are exposed to lindane, EPA believes that that lindane likely will 

accumulate in their breast milk or breast milk fat. 

Moreover, in the 1970s and 1980s, lindane was detected in breast milk in women 

in Binghamton, New York; Saint Louis, Missouri; several places in Mississippi, and in 

Philadelphia, Pennsylvania. Lindane also has been detected in breast milk of women in 

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, the former Czechoslovakia, 

Denmark, the former Federal Republic of Germany (FRG), Greece, Finland, France, 

Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, 

Netherlands, Nigeria, Norway, Poland, Rwanda, Spain, Sweden, Switzerland, Taiwan, 

Thailand, Tunisia, Turkey, the United Kingdom, Vietnam, Yugoslavia, and Zaire (Jensen 

1991). Several of these countries, like Canada, have had production and use patterns 

similar to those in the United States. Given the U.S. and world-wide presence of lindane 

in breast milk, EPA expects that, if U.S. monitoring programs existed, lindane would be 

detected in breast milk in other U.S. locales as well. 

B. Lindane from Treated Seed Could Contribute to Breast Milk Contamination 

EPA believes that lindane from the treated seed use could contribute to levels of 

lindane in breast milk. As discussed earlier, there are several routes by which women in 

the United States could be exposed to lindane from treated seed. These include: (1) 

eating food grown from treated seed; (2) eating the meat of animals fed with feed grown 

2

 Several studies suggest, however, that once exposure stops, certain species may be able to eliminate 

lindane from their systems. EPA, however, cannot determine how quickly or slowly lindane may be 

eliminated from the human body. In comments, NRDC states that lindane is converted in to beta-HCH in 

the body (EPA NRDC Comments at p. 1). NRDC provides no support for this statement and EPA has 

found nothing independently to confirm or refute this statement. Beta-HCH accumulates to a greater extent 

than lindane and cannot be as efficiently eliminated (EPA 2006 Assessment at p. 19). 

12
 
from treated seed; (3) consuming drinking water contaminated with lindane from the seed 

treatment use; and (4) being exposed to lindane that volatilizes from the seed treatment 

use. EPA believes that all of these are potential routes of exposure. 

C. Infant Exposure to Lindane from Breast Milk and Resulting Risk 

Infants will be exposed to lindane if they are fed contaminated breast milk. 

Indeed, for women, lactation is the most important route of elimination for persistent 

contaminants such as lindane (Jensen 1991 at p. 10). EPA is not able to conduct a 

scientifically quantitative assessment of the risks associated with exposure to lindane in 

breast milk due to the uncertainties regarding current monitoring data and the lack of a 

validated method for quantifying the infant exposure. In general, concentrations of manmade chemicals in human milk often are more than ten times higher than in cow’s milk 

from the same area. Frequently, limit values established for contaminants in cow’s milk 

are exceeded in human milk. Newborns and infants, whose main foodstuff is breast milk, 

may have a higher relative daily intake of these pollutants than adults (Jensen 1996). 

As far as EPA is aware, there have been no overt illnesses in infants from 

exposure to lindane in breast milk. In addition, breast milk is the natural and superior 

foodstuff for newborns, and infants, and nursing provides important immunological and 

psychological benefits. Moreover, virtually all national and international experts agree 

that women should not forgo breast feeding even though breast milk may be 

contaminated with low levels of lindane, other organochlorine pesticides, and persistent 

industrial chemicals like PCBs (Jensen 1991 at p. 288). 

Nevertheless, there is a dearth of long-term studies of the effects of infant 

exposure to lindane in breast milk. Thus, the potential long-term effects of newborn and 

infant exposure to lindane in breast milk are difficult to assess. EPA is currently unable 

to determine whether there are in fact adverse effects from exposure of infants to lindane 

in breast milk. However, EPA believes that, because of lindane’s prior detections in 

breast milk, its physio-chemical properties, and its continued presence in the diet, the 

potential for adverse effects to infants from consumption of breast milk cannot be 

dismissed due to a lack of data. 

VII. Impact on Growers 

Lindane is registered in the U.S. as a seed treatment use on wheat, barley, oats, 

rye, corn, and sorghum. An application to register lindane for use as a seed treatment for 

canola is pending before the Agency. In support of the 2002 RED, EPA assessed the 

potential impacts on growers of cancellation of the lindane seed treatment uses (U.S. 

EPA 2002 BEAD Analysis). At the time of the 2002 RED, there were registered 

alternatives for all lindane seed treatment uses except oats and rye. Imidacloprid and 

thiamethoxam were identified as the primary seed treatment alternatives to lindane (U.S. 

EPA 2002 BEAD Analysis at p. 1). 

13
 
For the wheat, barley, corn, and sorghum seed treatment uses, grower-level 

effects of cancellation of lindane were expected to be minor. For these uses, EPA 

estimated an increased treatment cost to growers using lindane ranging from 0.3% of 

gross revenue to 4.4% of gross revenue. In some cases, these increased treatment costs 

would be offset by the effectiveness of alternatives on other pests. For example, for 

sorghum, EPA estimated increased treatment costs to growers using lindane of 3.5-4.4% 

of gross revenue. However, the Agency found that this increase would likely be offset by 

increased yields due to control of chinch bugs and aphids (U.S. EPA 2002 BEAD 

Analysis at p. 9). Overall, for uses for which alternatives are registered, EPA concluded 

the impact of cancellation of lindane to individual growers using lindane would be minor. 

Further, the Agency estimated that only 6% to 7% of total acres of wheat, barley, and 

corn planted and only 1% of total acres of sorghum planted were being treated with 

lindane. 

At the time of the 2002 RED, no alternatives were registered for oats and rye. 

EPA estimated cancellation of the lindane seed treatment use could result in a 9% yield 

loss to growers using lindane; however, the Agency estimated that only 1% of total acres 

of oats and rye planted were being treated with lindane. For the growers affected, this 

crop loss would be partially offset by a lower treatment cost, but the Agency concluded 

that cancellation of the lindane seed treatment for oats and rye would have a major effect 

on individual growers using lindane (U.S. EPA 2002 BEAD Analysis at pp. 3-4). 

Since the time of the 2002 RED, additional alternatives to the lindane seed 

treatment uses have been registered. Most notably, imidicloprid is now registered as a 

seed treatment use for oats and rye. Thus, there are now alternatives for all lindane seed 

treatment uses. The registration of imidicloprid for oats and rye significantly alters the 

Agency’s 2002 assessment of grower-level impacts. A 9% yield loss to growers using 

lindane would no longer be expected if lindane were cancelled, though growers switching 

to imidicloprid would experience increased treatment costs of 0.52-1.7% of net revenues. 

The Agency considers this to be a minor effect (U.S. EPA 2005 BEAD Update). For all 

uses, the Agency expects an average increase in treatment cost of 0.29% of net revenues. 

In addition, it appears that use of lindane-treated seeds is declining. In 2002, EPA 

estimated that approximately 4.8 million acres of corn crops were grown from lindanetreated seed (7 percent of the total corn acreage). This translated to approximately 52,000 

pounds of lindane used for corn seed treatment. Updated information shows a substantial 

reduction in these figures. For 2004-2005, EPA estimates that less than three million 

acres of corn crops were grown from lindane-treated seed (less than 4 percent of the total 

corn acreage). This amounts to less than 30,000 pounds of lindane used for corn seed 

treatment. These revised figures suggest that use of lindane to treat corn seeds has 

declined by greater than 40 percent. 

The Agency has received reports that some farmers using treated seeds will opt 

for lindane-treated seeds because lindane-treated seeds appear to repel sandhill cranes 

from corn crops. Two studies have estimated that sandhill cranes will damage 20 percent 

of corn crops grown near wetlands. It appears that this use is most common in 

14
 
Wisconsin. EPA has no information indicating how much the potential 20 percent crop 

damage would be prevented by the use of lindane-treated seeds. As a result, the Agency 

is unable to quantify any resulting benefit from using lindane-treated seeds in this 

manner. Due to reduced availability of lindane-treated seeds, Wisconsin has submitted a 

FIFRA §18 emergency exemption request to use anthraquinone to control sandhill crane 

damage. EPA granted Wisconsin’s FIFRA § 18 emergency exemption request and 

believes anthraquinone is an alternative for protecting crops from sandhill cranes. 

VIII. Regulatory Determination 

Pursuant to FIFRA, EPA must determine, after submission of relevant data, 

whether pesticide active ingredients are eligible for reregistration. (FIFRA § 4(g)(2)(A).) 

In order to be reregistered, EPA must find that an active ingredient meets the standard in 

section 3(c)(5) of FIFRA. (See FIFRA § 4(a)(2).) This requires EPA to examine, in part, 

whether a pesticide causes unreasonable adverse effects on the environment. Pursuant to 

section 2(bb) of FIFRA, “unreasonable adverse effects on the environment” is defined, in 

part, as “any unreasonable risk to man or the environment, taking into account the 

economic, social, and environmental costs and benefits of the use of any pesticide.” In 

other words, to determine whether a pesticide causes unreasonable adverse effects on the 

environment, EPA must examine broadly the costs and benefits of the pesticide’s use, 

including economic, social and environmental costs and benefits. 

Based on new information the Agency received since the 2002 RED, and the 

review of existing information, EPA has determined that the seed treatment uses of 

lindane are ineligible for reregistration under FIFRA because the current risks outweigh 

the benefits of the use of the pesticide. As of July 27, 2006, the Agency had received 

requests from all lindane technical and end-use product registrants to voluntarily cancel 

all lindane product registrations. Once the cancellation process is complete, EPA will 

propose to revoke the existing lindane fat tolerances pursuant to section 408(l)(2) of 

FQPA. 

EPA believes the costs and benefits associated with the seed treatment use have 

changed significantly since the 2002 RED. At the time of the 2002 RED, there were no 

alternatives to the seed treatment use for oats and rye for control of wireworm. EPA 

estimated that without the availability of lindane-treated seeds, untreated plots might 

suffer as much as a 9% yield loss. The Agency considered this to be a major impact on 

growers who used lindane treatment for these crops. However, this was the only major 

impact on growers. For all other lindane seed treatment uses, alternatives existed and 

grower impacts were expected to be minor. 

In March 2006, EPA registered imidicloprid as a seed treatment use on oats and 

rye for wireworm control. The Agency believes imidicloprid is as effective as lindane for 

control of wireworm. With the availability of imidicloprid, EPA no longer expects a 

yield loss in the absence of lindane. Growers are expected to see increased treatment 

costs of 0.52-1.7% of net revenues with use of imidicloprid. The Agency considers this 

to be a minor impact. In addition, at least with respect to corn, use of lindane-treated 

15
 
seeds has dropped by over 40 percent, from approximately 4.8 million acres to less than 3 

million acres (less than 4 percent of total corn acreage). 

Overall, the benefits of the lindane seed treatment uses are now negligible. For all 

uses, if lindane were cancelled, the Agency would expect to see average treatment costs 

increase by $1.82 per acre. This is equal to 0.29% of net revenues. For some crops, the 

increased treatment costs may be partially offset by better control of certain pests. In 

sum, the benefits of the lindane seed treatment use to growers are very minor, and 

cancellation of the lindane seed treatment uses is not expected to have an appreciable 

impact on growers. 

Under FIFRA, EPA must balance the benefits of the lindane seed treatment use 

against the human health, environmental and social costs in determining whether the risk 

posed is unreasonable. EPA has identified a number of sources of exposure to lindane 

beyond the seed treatment. Past uses of lindane, consumption of imported meat, and 

pharmaceutical uses of lindane are all current sources of exposure. For indigenous 

populations who rely on subsistence diets, exposure to lindane or HCH isomers may 

result from current or past manufacture or use due to the long-range transport of lindane. 

EPA believes these sources of lindane have produced a reservoir of lindane in the 

environment that may remain for some time due to lindane’s persistence. 

The seed treatment use adds to this current lindane exposure. There are multiple 

routes by which individuals may be exposed to lindane from the seed treatment use. As 

discussed previously, consumption of crops grown from treated seed, consumption of 

livestock fed treated seed and consumption of drinking water are all routes of exposure to 

lindane from the seed treatment use. There may be additional exposure due to 

volatilization of lindane from treated seeds. The lindane seed treatment use will add to 

the existing reservoir of lindane in the environment. 

EPA believes this potential ongoing exposure may be of particular concern to 

nursing infants. Due to lindane’s tendency to accumulate in fatty tissues, it has been 

detected in the breast milk of women in the United States and in many other foreign 

countries. Although there is no current monitoring data for the U.S., EPA believes it is 

reasonable to conclude that lindane is present in the breast milk of U.S. women given 

ongoing exposure to lindane and the chemical’s fate characteristics. EPA acknowledges 

there is uncertainty on the level of risk posed to nursing infants and that no adverse 

effects have been reported. However, the potential for adverse effects from consumption 

of lindane in breast milk cannot be dismissed. 

EPA finds the overall costs of continued registration of lindane for seed treatment 

are high. The seed treatment use will only add to the existing sources of lindane 

exposure. Ongoing releases of lindane into the environment are of concern due to the 

environmental fate characteristics of the chemical. Lindane is persistent and mobile and 

will accumulate in human fat tissue. This potential for ongoing and future exposure to 

lindane is of particular concern for nursing infants because of the potential for exposure 

to lindane via breast milk. 

16
 
In sum, EPA finds that these costs of continued lindane registration far outweigh 

the benefits of the seed treatment use. Therefore, the lindane seed treatment uses are not 

eligible for reregistration under FIFRA. 

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