Dave Williams, Tri-TAC Chair
11th Street, MS#702
October 22, 2001
Public Information and Records Integrity
Information Resources and Services Division
Office of Pesticide Programs (OPP)
Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20640
Docket Control Number OPP-34239 –
Lindane Preliminary Risk Assessments
The purpose of this letter is
to comment on EPA’s Preliminary Risk Assessments for lindane. These risk assessments were made available
for public comment on August 29, 2001 (66 FR 45677). Tri-TAC’s primary concern with the proposed risk assessments is
that they are deficient since they fail to take into account the environmental
risks associated with the use of lindane in lice and scabies treatments. Without inclusion of these risks, the risk
assessments are essentially meaningless.
Tri-TAC also has comments on EPA’s interpretation of the potential
adverse water quality impacts of lindane usage as a seed treatment.
California-based organization comprised of members from public agencies and
other professionals responsible for wastewater treatment. It is a technical advisory committee, consisting
of representatives from the California Association of Sanitation Agencies, the
California Water Environment Association, and the League of California
Cities. The constituency base for
Tri-TAC treats and reclaims more than 2 billion gallons of wastewater each day,
and serves most of the sewered population of California.
discharged from publicly owned treatment works (POTWs) in California generally
contains 20 to 30 parts per trillion (ppt) of lindane. While this has been acceptable in the past,
water quality standards for California’s inland surface waters and enclosed
bays and estuaries were promulgated by the Environmental Protection Agency in
May 2000. These standards are known as the California
Toxics Rule and establish water quality criteria for the protection of aquatic
life and human health. In the latter
case, the criteria are intended to minimize the adverse human health effects
due to substances in ambient water. The
California Toxics Rule establishes a criterion of 19 ppt lindane for protection
of human health via consumption of water and aquatic organisms. This 19 ppt
criterion for lindane was also included in EPA’s 1998 compilation of
recommended national water quality criteria.
most receiving waters in California are effluent-dominated, the 19 ppt
criterion will be applied directly as an effluent limit for many wastewater
treatment plant throughout California. POTWs in California that are
experiencing difficulties meeting lindane discharge limitations or expecting to
have difficulties include the Sanitation Districts of Los Angeles County, the
City of Los Angeles, the City of San Jose, the Sonoma County Water Agency, and
the County of Sacramento Regional Sanitation District. It is also important to note that even
though mixing zones are available for some POTWs, the EPA has begun a campaign
for nationwide elimination of mixing zones for bioaccumulative toxic
pollutants, such as lindane. Thus most
POTWs across the country can expect that, at some future date, water quality
criteria for bioaccumulative toxic pollutants such as lindane will be applied
as end-of-pipe water quality based effluent limits.
lindane is a highly regulated pesticide, the routes for it to enter the
sewerage system are extremely limited.
The main pathway is from human treatments for lice and scabies with
lindane-containing products. Lice are
insects that live on human bodies in hairy areas. A one percent lindane shampoo is available with a physician’s
prescription to control lice. After
use, shampoo is washed into the sewer system.
Similarly, scabies is a mite that lives in the human skin. A one percent
lindane lotion available with a physician’s prescription can be applied to the
skin to control scabies, with the lotion washed to the sewer system following
application. A typical lice or scabies
treatment uses one to two ounces of the one percent lotion, or approximately
0.015 ounces of the lindane active ingredient.
This is enough lindane to pollute six million gallons of wastewater to
the 19 ppt standard. In the past 17 years, lindane has been applied more than
24 million times to treat scabies.
These treatments contained enough lindane to pollute 144 trillion
(144,000,000,000,000) gallons of water.
order to reduce lindane loadings to POTWs throughout California, many agencies
actively pursued a ban on the sale and use of lindane-containing lice and
scabies prescriptions that will take effect January 1, 2002. However, Tri-TAC is concerned that lindane
lice and scabies products will continue to enter California from
out-of-state. As a single lice or
scabies treatment contains enough lindane to pollute six million gallons of
water to the 19 ppt standard, a single treatment could cause a discharge
violation at a smaller POTW. Therefore,
even small amounts of lindane entering California from out-of-state are of
comments on the Preliminary Risk Assessments for lindane follow. Each comment begins with the specific
document, page, and language upon which comments are being made.
1. Overview of Lindane Risk Assessment, p.
6. “ The chronic EECs [estimated
environmental concentrations] for Lindane in surface water (0.67 ppb, from
GENEEC) and in groundwater (0.011 ppb, from SCI-GROW) are less than the chronic
DWLOC [drinking water level of comparison] (14 ppb), indicating that chronic
exposure to lindane in food and water only is less than the agency’s level of
concern.” The chronic EEC for lindane in surface water of 0.67 ppb is
thirty-five times EPA’s allowable criterion of 0.019 ppb for the protection of
human health via consumption of water and aquatic organisms. If surface water
containing 0.67 ppb of lindane was distributed in California, we would expect a
similar amount of lindane to be present in wastewater entering treatment plants
in the state. Many California POTWs
facing possible discharge limits of 0.019 ppb under the California Toxics
Rule. Since lindane is not removed well
in conventional or tertiary wastewater treatment plants, it would be impossible
to meet the 0.019 ppb discharge limitation if water entering the plants had
lindane concentrations approaching 0.67 ppb.
2. Overview of Lindane Risk Assessment, p.
6-7. “In the USGS NAWQA study, lindane was detected in 2.58% of surface
water samples (0.67% at levels greater than 0.05 ppb, maximum concentration
reported was 0.13 ppb)… Although these long-term monitoring programs have
detected lindane in various water bodies, the Agency determined that these data
are not suitable for risk assessment, because there is no correlation of
monitoring with actual lindane use.
Therefore, these data are presented here solely for informational
purposes.” 2.58% of surface water
samples represents one in thirty-eight samples, a significant degree of
contamination for the nation’s surface water bodies. As lindane does not naturally occur in the environment,
these environmental concentrations are coming from lindane usage in some
form. As lindane is only used a
pesticide, the contamination must be coming from lindane pest treatments. It is not clear why the data should be
considered “not suitable for risk assessment.”
3. Overview of Lindane Risk Assessment, p.
are no residential or other non-agricultural FIFRA [Federal Insecticide, Fungicide,
and Rodenticide Act] uses of Lindane.” Lindane is widely used as a pesticide to treat lice and scabies in
humans. Although these uses are not
currently subject to regulation under the FIFRA, they were subject to such
regulation until 1979. Since lindane lice and scabies products are considered
to be drugs, they have also been subject to the Federal Food, Drug and Cosmetic
Act (FFDCA). On November 5, 1979 (44
Federal Register, 63749), EPA decided to exempt lindane lice and scabies
products from the requirements of the FIFRA.
The regulation of these products under both the FIFRA and the FFDCA was
felt to be duplicative, as stated in the announcement of the exemption, “EPA
and FDA concluded that the dual review of pesticide/new drug products offered
solely for human use represents an expensive duplication of time and resources
for both the Agencies and the sponsors of these products without any
significant increase in benefits to public health and/or the environment. It is further concluded that regulations of
these products solely by FDA under the FFDCA would adequately serve the intent
Regulation under the FIFRA
and the FFDCA is no longer duplicative.
Since 1979, the degree of regulation under FIFRA has changed
considerably, most notably with passage of the Food Quality and Protection Act
of 1996 (FQPA). This statute requires
EPA to review all pesticide registrations on at least a fifteen-year cycle (7
U.S.C. §136a(g)(1)(A)). The goal of
this requirement is to ensure that all pesticides continue to meet up-to-date
standards for safety, public health, and environmental protection. EPA has the
authority to require data and take action if needed between registration cycles
(7 U.S.C. §136a(c)(2)(B); §136a-1(d)(3)).
No similar provisions exist under the FFDCA. Additionally, EPA has emergency suspension authority, which means
a pesticide registration can be canceled immediately if there is an emergency,
imminent threat to public health or the environment. (7 U.S.C. §136d(c)) This
appears to be a much more direct and powerful tool to regulate pesticides when
compared to the FDA’s authority to simply require an Environmental Assessment
in such circumstances.
is Tri-TAC’s position that EPA should reassert its control over lice and
scabies treatments under the FIFRA. As
such action is beyond the scope of the action EPA is currently considering, EPA
should, at minimum, consider the human health and environmental impacts of
these treatments in its current risk assessments. As lindane lice and scabies products dominate the human health
and environmental risks of lindane, the risk assessments are essentially
meaningless without them. Under the
FIFRA, EPA has a statutory responsibility to ensure that pesticides are safe
and effective for their intended uses and to prevent unreasonable adverse
effects to man, other animals, and the environment from their usage (7 U.S.C.
§136(bb), §136a(a), §136a(d)(2); §136d(b)).
By ignoring the risks posed by lindane lice and scabies treatments, EPA
is not fulfilling its statutory responsibility.
4. Overview of Lindane Risk Assessment, p.
aggregate risk assessment for lindane examines the combined risk from exposure
through food and drinking water only since there are no residential or other
non-agricultural uses of Lindane.” As discussed in Comment Five, there is significant usage of lindane in
the residential setting, from lice and scabies treatments. The Cancer Prevention Coalition has reported
that there were 2.3 million retail lindane prescriptions filled in 1992.
5. Overview of Lindane Risk Assessment, p.
DWLOC was calculated based only on dietary exposures. As noted above neither acute nor chronic, surface water or
groundwater EECs exceed the DWLOC and therefore do not exceed the Agency’s
level of concern.” The EEC for
surface water signficantly exceeds EPA’s 0.019 ppb lindane human health
criterion for waterbodies.
6. Overview of Lindane Risk Assessment, p.
9. “..lindane and its isomers have been
detected in areas of non use (e.g., the Arctic), indicating global atmospheric
transport may occur. The source of
these lindane detections is unclear but may be the result of a combination of
lindane’s past widespread use and its extreme persistence.” It may also be the result on on-going usage
of lindane in lice and scabies treatments, as these treatments are rinsed into
sewer systems after use and thus indirectly enter surface water bodies.
7. Overview of Lindane Risk Assessment, p.
U.S. uses of lindane are restricted to (agricultural) seed treatments at
relatively low application rates.” This statement misrepresents lindane
usage inasmuch as lindane is also used for lice and scabies treatments in the
8. Overview of Lindane Risk Assessment, p.
current application rates used on major crops, acute high risk and restricted
use levels of concern are exceeded for both freshwater and estuarine/marine
organisms.” These levels are likely
to be even higher if lice and scabies treatments are considered, particularly
as these treatments are released indirectly to water bodies.
9. Environmental Fate and Ecological Risk
Assessment: Seed Treatment, p. 2. “At
present, there is only one agricultural use (seed treatment) that might affect
the environment.” This risk
assessment should also take into account aggregate ecological risk posed by the
use of lindane in lice and scabies treatments.
10. Environmental Fate and Ecological Risk
Assessment: Seed Treatment, p. 11. “Based on a screening level assessment,
both surface and ground water simulations show that lindane concentrations in
water resulting from seed treatments may reach levels of environmental concern
and may exceed the MCL for drinking water (0.2 ppb).” This assessment is incomplete. It fails to acknowledge lindane
contributions from lindane prescriptions for lice and scabies treatments. It also fails to acknowledge that the
resulting concentrations in water could exceed recommended water quality
criteria and, in California, adopted water quality standards.
11. Environmental Fate and Ecological Risk
Assessment: Seed Treatment, p. 14. “Agriculture run-off is likely the major
contamination route of lindane and other HCH isomers to surface water.” This assessment is incomplete. It fails to acknowledge that in urban areas,
as agricultural and structural uses of lindane have become more highly
restricted, contamination of water bodies is likely to be caused by lice and
12. Human Health Risk Assessment Lindane, p.
7. “No residential exposure scenarios have been identified for
pesticide uses of lindane and therefore no risk estimates will be presented in
this document for non-occupational exposure to lindane.” This conclusion is patently
incorrect. Uses of lindane to treat
lice and scabies are definitely pesticide uses. These uses involve direct application of lindane to humans and
thus a very high level of human exposure. These exposures must be considered
when doing an aggregate risk assessment for lindane.
13. Human Health Risk Assessment Lindane, p.
Agency considered aggregate exposure and risk estimates for residents who might
be exposed to lindane from multiple sources, such as residential use, food, and
water. Since no residential exposure is
expected, an aggregate risk estimate was not calculated.” See Comment Fourteen. Any aggregate exposure assessment must
include risks posed by lindane in lice and scabies treatments.
14. Occupational and Residential Exposure
Assessment and Recommendations for the Reregistration Eligibility Decision
Document for Lindane, p.4. “There are no current registered uses for
recreational, residential or other public (non-occupational) settings.” Although not currently registered under
FIFRA, lindane usage in lice and scabies treatments must be considered in
properly assessing residential risks from lindane.
Thank-you for your consideration of our comments. If you have any questions about this letter
or would like additional information,
please contact me by phone at (510) 287-1496 or by e-mail at email@example.com.
Very truly yours,