United States Prevention, Pesticides EPA-738-R-04-007
Environmental Protection And Toxic Substances April 2004
Agency (75Q8W)
&EPA Reregistration
Eligibility Decision (RED)
Lindane
a
738R04007
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United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(7508C)
EPA-738-F-02-011
Revised April 2O04
R.E.D. FACTS
Pesticide
Reregistration
Lindane
All pesticides sold or distributed in the United States must be registered by
EB\, based on scientific studies showing that they can be used without posing
unreasonable risks to people or the environment. Because of advances in
scientific knowledge, the law requires that pesticides which were first registered
before November 1, 1984, be reregistered to ensure that they meet today's more
stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health and
environmental effects of each pesticide. To implement provisions of the Food
Quality Protection Act of 19%, EB\ considers the special sensitivity of infants
and children to pesticides, as well as aggregate exposure of the public to pesticide
residues from all sources, and the cumulative effects of pesticides and other
compounds with common mechanisms of toxicity. The Agency assesses the risk
associated with the use of the pesticide, and develops mitigation measures or
regulatory controls to effectively reduce each pesticide's risks. ER\ then
reregisters pesticides that meet the safety standard of the FQB\ and can be used
without posing unreasonable risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA. explains the basis for its
decision in a Reregistration Eligibility Decision (RED) document. This feet sheet
summarizes the information in the RED document for the reregistration of
lindane.
Use Profile Lindane is an organochlorine insecticide used as a pre-plant seed treatment
for barley, corn, oats, rye, sorghum, and wheat. The pesticide is formulated into
dust, emulsifiable concentrate, flowable concentrate, and liquid ready-to-use
products. Lindane is applied to seeds using the following equipment: liquid seed
treater, planter/seed box, air seed treater, canister tube applicator, and slurry-type
seed treater. Approximately 233,000 Ibs of active ingredient of lindane are used
annually for seed treatment.
Undane is also currently approved by the U.S. Food and Drug
Administration (FDA) for use in pharmaceutical products intended to control head
lice and scabies (mites) in humans.
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Regulatory
History
IJndane was first registered as a pesticide in the U.S. in the 1940's for use
on a wide variety of food crops, ornamentals, livestock, homeowner, and other
sites. In 1977, EB\ initiated for lindane a Rebuttable Presumption Against
Registration (RBVR) review, now called a Special Review. The lindane RB\R
was triggered based on questions of oncogenicity, fetotoxicity/ teratogenicity,
reproductive effects, its potential to cause blood dyscrasias, and acute toxicity to
wildlife. EB\ published Rasition Documents (PDs) in 1977 through 1983,
resulting in the cancellation of certain uses of lindane.
EB\ issued a Registration Standard for lindane in September 1985, which
included a Data Call-in (DO) requiring submission of additional data to support
the lindane registration and address exposure concerns from treated structures and
animals. After issuance of the 1985 Registration Standard, many of the registered
uses of lindane were cancelled, resulting in only seed treatment use on six crops
(barley, com, oats, rye, sorghum, and wheat) that still remain registered and
subject to reregistration.
Human Health
Assessment
Toxicity
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
kidney (renal) and liver (hepatic) toxicity. In addition, there is some evidence
that lindane may act as an endocrine disrupter; however, further investigation is
necessary to ascertain the relevance and impact of such findings on public health.
In 2001, EBV classified lindane as having "suggestive evidence of
carcinogeniciry, but not sufficient to assess human carcinogenic potential" based
on an increased incidence of benign lung tumors in female mice only. Therefore,
pursuant to Agency cancer guidelines, cancer risks were not quantified.
Dietary Exposure
EB\ assessed dietary risk by estimating exposure to lindane residues from
consumption of food and drinking water that can occur over a single-day (acute)
or longer (chronic). The acute and chronic dietary (food) risks are less than
100% of the acute Population Adjusted Dose for the general U.S. population and
all population subgroups. Infents (< 1 year) and children (1-6 years) were the
most highly exposed population subgroup for acute and chronic exposure,
respectively.
Because lindane persists in the environment and has long-range
atmospheric transport potential, the Agency performed a supplementary chronic
dietary risk assessment for the subsistence diets of indigenous peoples of the
Arctic region of the U.S. (Alaska) who rely heavily on game for their food
source. For indigenous people of Alaska, the chronic dietary risks are generally
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Human Health
Assessment
Continued
not of concern, and although the Agency does not have information on a typical
day's diet to assess acute dietary risk, limited residue data indicates that acute
dietary risks are unlikely to be of concern.
Drinking water exposure to lindane can occur through ground and surface
water contamination. EPA used models to conduct a screening-level assessment
of potential high-end estimates of lindane concentrations in surface and ground
water sources of drinking water from seed treatment uses.
Pharmaceutical Use Risk
Lindane has been approved by the FDA as a prescription drug to treat lice
and scabies." EBV has conducted an assessment of these uses to determine the
risk of a lice or scabies treatment. Based on the Agency's current understanding
of available data, the Agency does not believe that lindane pharmaceutical
products used for treatment of lice pose human health risks of concern, when
used in accordance with directions provided on the label. However, based on
other blood-level analyses, the Agency cannot conclude at this time with
reasonable certainty that exposure to lindane through scabies treatment will not
result in unacceptable exposure and risk.
Risk from All Registered Pesticide Lindane Exposures
To assess risks from all lindane exposures, the Agency combined risk from
food and drinking water exposure only, because there are no registered
residential or other non-occupational uses of lindane that need to be considered
for regulatory purposes at this time, fbr the agricultural seed treatment uses of
lindane, both acute and chronic estimated drinking water concentrations are below
the corresponding drinking water level of comparisons (DWLOCs) for all
drinking water sources, and are not of concern to the Agency.
Occupational Exposure
Occupational exposure to lindane occurs either on-farm or at commercial
seed treatment facilities to fanners or workers who mix, load and/or apply
lindane as a seed treatment, and persons who handle or plant treated seed. Based
on the Agency's assessment, on-farm handling of the lindane dust formulation to
mix/load and plant treated seed result in risks of concern. Because of the lower
seed planting rate, the on-farm treatment of com and sorghum seeds with the
lindane dust formulation is permitted, provided additional personal protective
equipment (PPE) is utilized. Commercial treatment of seeds with the liquid
formulation for all registered uses is permitted. Also, the Agency has no risk
concerns for post-application exposures to agricultural workers, and no risk
mitigation measures are necessary beyond a 24-hour restricted entry interval
(REI). However, provided the soil is not disturbed and there is no contact with
the treated seeds, workers may enter the planted field during the 24-hour REI.
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Environmental
Assessment
EBVs ecological risk assessment for lindane suggests that the use of
can result in adverse acute and chronic effects to terrestrial organisms,
and adverse acute effects to aquatic organisms. Lindane is also a potential
endocrine disruptor in birds, mammals, and possibly fish.
Avian (dietary) aversion toxicity studies and a field study suggest that birds
are repelled by treated seeds; hence, the Agency believes that the risk to birds by
treating certain seeds with lindane are lower and not of concern. Moreover, the
Agency believes that the risks for local populations of mammals in areas where
lindane treated seeds are planted are low, and that mammals may be similarly
averse to earing seeds treated with lindane. Although the assessment indicates
acute risks of concern for freshwater fish and invertebrates, and estuarine marine
invertebrates, the screening-level model used to assess these risks has likely
produced highly conservative estimates which overestimated the environmental
concentrations and resulting risks to aquatic species. Actual aquatic risks are
expected to be lower and not of concern, and the Agency is requiring data to
confirm this determination.
Risk Mitigation
Measures
To mitigate human health and ecological risks of concern for lindane, the
measures are to be implemented:
On-farm treatment of wheat, barley, oats, and rye with the lindane dust
formulation is prohibited;
Maximum application rate for corn is reduced to 0.0558 Ib ai/100 lb seed;
Markers must wear double layer clothing (coveralls over long-sleeved shirt
and long pants, chemical-resistant footwear), chemical-resistant gloves, and
a dust/mist respirator for on-ferm treatment of corn and sorghum seeds
only with the dust formulation;
A 24-hour REI is necessary for all seed treatment uses;
All lindane end-use product labels must specify a 30-day plantback interval
for leafy vegetables and a 12-month plantback interval for all other
unregistered crops. The registrant may also conduct a confined
accumulation of rotational crops (OPFIS 860.1850) study to show that
these plantback intervals can be reduced.
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Additional Data
Required
EPA is requiring the submission of the following additional generic data to
confirm the regulatory decision for lindane:
* OPPTS 830.6314 Oxidation/reduction: chemical incompatibility
• OPPTS 830.6317 Storage stability
• OPPTS 830.7050 UV/Visible light absorption
• OPPTS 860.1300 Nature of residue (plant metabolism study)
* OPPTS 835.SSQ1 Seed leaching
Additional studies are currently reserved and may be required, pending
results of the studies listed above. See the lindane RED document for further
details.
The Agency also is requiring product-specific data, including product
chemistry and acute toxicity studies, and revised Confidential Statements of
R>rmula (CSFs).
Regulatory
Conclusion
EPA has determined that all existing tolerances for lindane should be
revoked. These tolerances are no longer necessary because all lindane products
for which the tolerances were originally established have been canceled. EJft. has
also determined that a number of changes to the terms and conditions of
registration of the seed treatment products are necessary to prevent
"unreasonable adverse effects on the environment." EPA has identified additional
data needed to characterize lindane metabolites in order to complete its
assessment of potential dietary risks. Finally, EB\ has determined that the use of
lindane for seed treatment is likely to result in residues in raw agricultural
commodities derived from plants grown from seeds treated with lindane.
Therefore, new tolerances are required before the currently registered lindane
products may be reregistered. In sum, lindane seed treatment products would be
eligible for reregistration if the registrants make the changes to the registration
terms and conditions specified in the RED document, provide the required data,
and EPA is able to establish all required tolerances for residues of lindane in
food.
EPA notes that the establishment of new tolerances for the seed treatment
uses of lindane is conditioned on: 1) the receipt and review of additional data to
characterize lindane metabolites; and 2) EBVs ability to make a determination
that establishing the new tolerances meets the safety standard in Federal Food,
Drug and Cosmetic Act (FFDCA). EB\ is considering whether the statute
requires the Agency to include in its safety assessment those exposures resulting
from the use of lindane in pharmaceutical products.
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For More
Information
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for lindane during a 60-day public comment period, as
announced in a Notice of Availability published in the Federal Register on
September 25, 2002. 'You may access this Federal Register notice on the Internet
through ERVs website at http://www.epa.gov/fedrgstr/ .
The Federal Register notice describes how to access the RED and related
documents and submit comments, including how to use ERVs electronic public
docket and comment system, EB\ Dockets. EB\ Dockets is available on the
Internet at httrj://www.epa.gov/edocket/. Electronic copies of the RED and all
supporting documents related to the Agency's decision on lindane are available on
the internet and can be accessed at http://www.era.gov/reregistration/lindane ,
Printed copies of the RED document and feet sheet are available from
ERVs National Service Center for Environmental Publications (ERVNSCEP),
PO Box 42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198; fex
513^89-8695.
Following the comment period, the lindane RED document also will be
available from the National Technical Information Service (NTIS), 5285 Port
Royal Road, Springfield, VA 22161, telephone 1-800-553-6847, or 703-605-
6000.
R>r more information about ERVs pesticide reregistration program, the
lindane RED, or reregistration of individual products containing lindane, please
contact ERVs Office of Pesticide Programs, Special Review and Reregistration
Division at 703-308-8000, or visit our website at http://www.epa.gov/pesticides/.
For information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticide Information Center (NPIQ. Call toll-free 1-800-858-7378,
from 6:30 am to 4:30 pm ffccific Time, or 9:30 am to 7:30 pm Eastern Standard
Time, seven days a week. Their Internet address is http://npic.orst.edu.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
APR 2 6 2004
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments received
related to the preliminary risk assessment for the insecticide lindane. The Agency has revised the
human health and environmental effects risk assessments based on the comments received during
the public comment period and additional data received from the registrant. Based on the EPA's
revised risk assessments for lindane, EPA has identified risk mitigation measures that the Agency
believes are necessary to address the human health and environmental risks associated with the
current use of lindane. EPA is now publishing its reregistration eligibility, risk management, and
tolerance reassessment decisions for the current uses of lindane, and its associated human health
and environmental risks. The Agency's decision on the individual chemical lindane can be found
in the attached document entitled, "Reregistration Eligibility Decision for Lindane" which was
approved oh July 31, 2002. There will be a 60-day public comment period for this document,
commencing on the day the Notice of Availability publishes in the Federal Register.
A Notice of Availability for the reregistration eligibility decision (RED) document for
lindane is being published in the Federal Register. To obtain a copy of the RED document,
please contact the OPP Public Regulatory Docket (7502C), US EPA, Ariel Rios Building, 1200
Pennsylvania Avenue NW, Washington, DC 20460, telephone (703) 305-5805. Electronic
copies of the RED document and all supporting documents are available on the internet at
http://www.epa.gov/pesticides/reregistration/lindane.
As part of the Agency's effort to involve the public in the implementation of the Food
Quality Protection Act of 1996 (FQPA), the Agency is undertaking a special effort to maintain
open public dockets and to engage the public in the reregistration and tolerance reassessment
processes. This open process follows the guidance developed by the Tolerance Reassessment
Advisory Committee (TRAC), a large multi-stakeholder advisory body that advised the Agency
on implementing the new provisions of the FQPA. As part of this process, the preliminary risk
assessments were made available to the public for comment on August 29, 2001. Based on the
information received, the risk assessments were revised and made available again to the public
on January 31, 2002 for input on measures to reduce risks. In cooperation with the U.S.
Department of Agriculture, the Agency also conducted a close-out conference call on July 31,
2002 with various stakeholders to discuss the risk management decisions and resultant changes
to the lindane labels.
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Please note that the lindane risk assessment and the attached RED document concern only
this particular pesticide. FQPA requires that, when considering whether to establish, modify, or
revoke a tolerance, the Agency consider "available information" concerning the cumulative
effects of a particular pesticide's residues and "other substances that have a common mechanism
of toxicity." EPA did not perform a cumulative risk assessment as part of this reregistration
review for lindane because it has not yet determined if mere are any other chemical substances
that have a mechanism of toxicity common with that of lindane. For purposes of this
reregistration decision, EPA has assumed that lindane does not have a common mechanism of
toxicity with other substances.
This document contains a generic and product-specific Data Call-In (DCI) that outlines
further data requirements for this chemical. Note that registrants of lindane must respond to
DCIs issued by the Agency within 90 days of receipt of this letter. This RED document also
contains labeling changes for lindane products. It is necessary that end-use product labels be
revised by the manufacturer to adopt the changes set forth in Section IV of this document.
Instructions for registrants on submitting revised labeling and the time frame established to do so
can be found in Section V of this document.
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will continue to have concerns about the risks posed by lindane. Where
the Agency has identified any unreasonable adverse effect to human health and the environment,
the Agency may at any time initiate appropriate regulatory action to address this concern. At that
time, any affected person(s) may challenge the Agency's action.
If you have questions on this document or the proposed label changes, please contact the
Chemical Review Manager for lindane, Mark T. Howard at (703) 308-8172. For questions about
product reregistration and/or the Product DCI that accompanies this document, please contact
Karen Jones at (703) 308-8047.
Sincerely,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachment
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REREGISTRATION ELIGIBILITY
DECISION
for
LINDANE
CASE 0315
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
V
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Errata/Addendum Sheet for the Lindane Reregistration Eligibility Decision (RED)
FROM: Mark HowarcT7^
Reregistration Branch 3
Special Review and Reregistration Division
TO: Public Docket for Lindane
The Lindane Reregistration Eligibility Decision (RED) was signed on July 31,2002 and
was then published shortly thereafter on the internet. Since then, the Lindane RED has been
updated twice. First, in September 2002, Appendices A, B, C, D, G, and I were added. Then, in
April 2004, Appendices E, F, and H were added to the RED. Also in April 2004, four required
guideline studies were deleted as data gaps from the RED, as they had been submitted and
determined to be acceptable by EPA. Lastly, lindane end use product (EPA registration number
8660-53) was cancelled July 29,2002 and has been deleted from the t(No Batch" list of
chemicals in Appendix G. The regulatory decision of the RED did not change as a result of these
changes (i.e., none of the criteria to make lindane eligible for reregistration have changed).
These changes are updated in the Lindane Fact Sheet, as well.
Appendices added:
Appendix A: Lindane Use Patterns Reflecting Label Changes
Appendix B: Data Supporting Guideline Requirements for the Reregistration of Lindane
Appendix C: EPA's Technical Support Documents for Lindane
Appendix D: MRID Bibliography for Lindane
Appendix E: Generic Data Call-In
Appendix F: Product Specific Data Call-In
Appendix G: EPA's Batching of Lindane Products for Meeting Acute Toxicity Data
Requirements for Reregistration
Appendix H: List of Registrants Sent DCI
Appendix I: List of Electronically Available Forms
Guideline studies completed, determined to be acceptable and deleted as data gaps from the RED:
OPPTS 830.1550 Product identity and description
OPPTS 830.1620 Description of the production process
OPPTS 830.6316 Explodability
OPPTS 830.6320 Corrosive characteristic
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TABLE OF CONTENTS
Lindane Team iii
Glossary of Terms and Abbreviations v
Executive Summary vii
I. Introduction 1
II. Chemical Overview 2
A. Regulatory History 2
B. Chemical Identification 5
C. Use Profile 6
D. Estimated Usage of Pesticide 7
HI. Summary of Lindane Risk Assessments 8
A. Human Health Risk Assessment 8
1. Dietary Risk from Food 9
a. Toxicity 9
b. Reference Dose and Uncertainty Factor 10
c. FQPA Safety Factor 10
d. Population Adjusted Dose (PAD) 11
e. Exposure Assumptions 11
f. Food Risk Assessment 13
2. Drinking Water Concentrations from Agricultural Uses 14
a. Modeling Data 15
b. Monitoring Data 16
3. Risk from Pharmaceutical Uses 17
a. Scabies Treatment 17
b. Lice Treatment 21
c. Drinking Water Concentrations from Pharmaceutical Uses 23
d. Spontaneous Adverse Event Reports 23
4. Risk from All Registered Pesticide Lindane Exposures 24
5. Occupational Risk 26
a. Toxicity 26
b. Exposure - 27
c. Occupational Handler Risk Summary 29
d. Occupational Incident Reports 32
B. Environmental Risk Assessment 33
1. Environmental Fate and Transport 34
2. Risk to Terrestrial Species 35
a. Toxicity (Hazard) Assessment 35
b. Exposure and Risk 35
3. Risk to Aquatic Species 37
a. Toxicity (Hazard) Assessment 37
b. Exposure and Risk . '. 37
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4. Risk toilnsects 38
5. RisktoPlants 38
6. Risk to Endangered Species 38
7. Ecological Incident Reports 40
8. Bio-Accumulation Risks 40
IV. Risk Management and Reregistration Decision 41
A. Determination of Reregistration Eligibility 41
B. Summary of Phase 5 Comments 43
C. Regulatory Position 44
1. FQPA Assessment 44
a. "Risk Cup" Determination 44
b. Tolerance Summary 44
c. Residue Analytical Methods 49
2. Endocrine Disruptor Effects 49
D. Regulatory Rationale 50
1. Human Health Risk Mitigation 50
a. Dietary Risk 50
b. Pharmaceutical Risk 51
c. Risk for All Registered Pesticide Lindane Exposures 54
d. Occupational Risk 55
2. Environmental Risk Mitigation 58
E. Labeling Statements 60
F. Lindane Risk Mitigation Summary 61
V. What Registrants Need to Do 62
A. Manufacturing-Use Products 64
1. Additional Generic Data Requirements 64
2. Labeling for Manufacturing-Use Products 65
B. End-Use Products 65
1, Additional Product-Specific Data Requirements 65
2. Labeling for End-Use Products 65
C. Existing Stocks 65
D. Labeling Changes Summary Table 65
APPENDICES 73
APPENDIX A: Lindane Use Patterns Reflecting Label Changes 74
APPENDIX B: Data Supporting Guideline Requirements for the Reregistration of Lindane 76
APPENDIX C: EPA's Technical Support Documents for Lindane 82
APPENDIX D: MRID Bibliography for Lindane ; 84
APPENDIX E: Generic Data Call In (DO) 117
APPENDIXF: Product Specific Data Call-In 121
APPENDIX G: EPA'S Batching of Lindane Products for Meeting Acute Toxicity Data
Requirements for Reregistration 129
APPENDIX H: List of Registrants Sent DCIs 133
APPENDIX I: List of Electronically Available Forms 135
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Lindane Team
Office of Pesticide Programs:
Health Effects Risk Assessment
Becky Daiss
Thurston G. Morton
Suhair Shallal
David Jaquith
Ray Kent
Sanjivani Diwan
Environmental Fate Risk Assessment
Nicholas Federoff
Faruque Khan
Jose Melendez
Dirk Young
Biological and Economics Division
David Brassard
Istanbul Yusuf
Registration Division Support
Dana Pilit
George Larocca
Risk Management
Mark T. Howard
Deborah Smegal
Michael Goodis
in
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AT
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GLOSSARY OF TERMS AND ABBREVIATIONS
AERS Adverse Event Reporting System .
ai Active Ingredient
aPAD Acute Population Adjusted Dose
aRfD Acute Reference Dose
BCF Bioconcentration Factor
CIEL Centre International d'Etudes du Lindane
cPAD Chronic Population Adjusted Dose
CFR Code of Federal Regulations
cRfD Chronic Reference Dose
CSFII Continuing Surveys for Food Intake by Individuals (USDA)
D Dust
DAF Dermal Absorption Factor
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DWECs Drinking Water Estimated Concentrations
DWLOC Drinking Water Level of Comparison
E-FAST Exposure and Fate Assessment Screening Tool
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disruptor Screening Program
EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration
EFED Environmental Fate and Effects Division
EHS Ecological Incident Information System
EPA U.S. Environmental Protection Agency
FC Flowable Concentrate
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FIRST FQPA Index Reservoir Screening Tool
FQPA Food Quality Protection Act
FR Federal Register
FRN Federal Register Notice
FWS U.S. Fish and Wildlife Service
GENEEC Tier I Surface Water Computer Model
HED Health Effects Division
HCH Hexachlorocyclohexane
IADN Integrated Atmospheric Deposition Network
IDS Incident Data System
IUPAC International Union of Pure and Applied Chemistry
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that
can be expected to cause death in 50% of test animals.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause
death in 50% of the test animals when administered by the route indicated (oral, dermal,
inhalation).
LOAEL Lowest Observed Adverse Effect Level
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LOG Level of Concern
LOQ Limit of Quanitation
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
N/A Not Applicable
NARAP North American Regional Action Plan
NAWQA USGS National Water Quality Assessment
NMFS National Marine Fisheries Service
NOAEL No Observed Adverse Effect Level
NPDES National Pollutant Discharge Elimination System
OPP EPA Office of Pesticide Programs
PAD Population Adjusted Dose
PAM Pesticide Analytical Method
PD Public Document
PDCI Product-Specific Data Call-In
PHED Pesticide Handler's Exposure Data
POTW Publically Owned Treatment Works
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRB Product Reregistration Branch
PRZM/
EXAMS Tier II Surface Water Computer Model
RAC Raw Agriculture Commodity
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPAR Rebuttable Presumption Against Reregistration
RQ Risk Quotient
RTU Ready-to-Use Liquid
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SRRD Special Review and Reregistration Division
TBD To Be Determined
TRAC Tolerance Reassessment Advisory Committee
TRR Total Radioactive Residue
UF Uncertainty Factor
ug/g Micrograms Per Gram
|ig/L Micrograms Per Liter
USDA United States Department of Agriculture
USGS United States Geological Survey
VI
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Executive Summary
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 may be
reassessed under the provisions of the Federal Food, Drug and Cosmetic Act (FFDCA).
Lindane was initially registered by USDA in the 1940's and over the years since has been
approved for use on a wide variety of fruit and vegetable crops (including seed treatment),
ornamentals, tobacco, greenhouse vegetables and ornamentals, forestry, farm animal premises,
and other uses. Tolerances were established for a wide variety raw agricultural commodities; see
40 CFR §180.133. A number of reviews and regulatory actions affecting lindane have taken
place in the last twenty years with the result that there are now only a very limited number of
products containing lindane registered for use as seed treatments. All other uses of lindane have
been canceled.
EPA has determined that all existing tolerances for lindane should be revoked.
Consistent with longstanding EPA policy, the reason for revoking these tolerances is that they are
no longer necessary because all lindane products for which the tolerances were originally
established have been canceled. In reaching this conclusion, the Agency does not need to make
any determination whether the exposures permitted under these tolerances would meet the
FFDCA safety standard.
EPA has determined that a number of changes to the terms and conditions of registration
of the seed treatment products are necessary to prevent "unreasonable adverse effects on the
environment." These changes include such measures as reduced maximum application rates, use
of additional personal protective equipment, and discontinue on-farm use of the dust formulation
for some crops. In addition, EPA has determined that the use of lindane for seed treatment is
likely to result in residues in raw agricultural commodities derived from plants grown from seeds
treated with lindane. Therefore, new tolerances are required before the currently registered
lindane products may be reregistered. EPA has identified additional data needed to characterize
lindane metabolites in order to complete its assessment of potential dietary risks. In summary,
EPA finds that the currently registered lindane seed treatment products would be eligible for
reregistration if the registrants make the changes to the terms and conditions specified in this
document and provide the required data, and EPA is able to establish all required tolerances for
residues of lindane in food.
EPA notes that the establishment of new tolerances for the seed treatment uses of lindane
is conditioned on: 1) the receipt and review of additional data to characterize lindane
metabolites; and 2) EPA's ability to make a determination that establishing the new tolerances
meets the safety standard in FFDCA. Because EPA does not know what the data will indicate
about lindane metabolites, and for other reasons, EPA is unable to determine whether it will be
able to make a determination that new tolerances for lindane would be safe.
vn
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FFDCA § 408(b)(2)(A)(i) provides that EPA may establish a new tolerance "only if....
the tolerance is safe." The statute defines "safe" to mean "that there is a reasonable certainty that
no harm will result from aggregate exposure " "Aggregate exposure" includes both exposure
to residues in food "and exposure from other non-occupational sources." See § 408(b)(2)(D)(vi).
In light of these statutory provisions, EPA is considering whether the statute requires the
Agency to include in its safety assessment those exposures resulting from the use of lindane in
pharmaceutical products. Lindane is currently approved by the Food and Drug Administration
for use in pharmaceutical products intended to control head lice and scabies. EPA and FDA have
worked together to examine the available data to assess the potential of lindane pharmaceuticals
to cause adverse effects, sharing our assessments and commenting on the other agency's
assessments. As discussed more fully later in this document, although the information for
assessing risks is limited, the exposure and risk assessment indicates that the use of lindane for
head lice control does not pose risks of concern. The limited information available on the
scabies product, however, suggests that there is some possibility a portion of the patient
population using lindane for scabies control may experience adverse effects. FDA has taken
steps - including stronger warnings, clearer use directions, and other measures - to limit such
potential adverse effects. Based on these additional steps, FDA has concluded that the
therapeutic benefits of the lindane pharmaceutical products outweigh the limited potential to
cause adverse effects in the patient population. Therefore, FDA regards these products as safe
and effective for the purposes for which they were approved.
The existence of pharmaceutical sources of exposure to lindane raise questions of public
policy and statutory interpretation that have not been resolved. These questions include: whether
"aggregate exposure" encompasses exposures resulting from the use of lindane in pharmaceutical
products; and if so, whether there is any reasonable statutory interpretation that could avoid
apparently questionable public policy results. EPA is particularly concerned that the statute be
interpreted and applied in a manner that yields results that are protective of public health and
consistent with common sense. If § 408 were interpreted to cover exposure from pharmaceutical
uses, then EPA might never be able to establish new tolerances, or to leave existing tolerances in
effect, for a substance that is used both as a pesticide and a pharmaceutical product, if the
pharmaceutical product caused adverse effects in humans. This result could occur regardless of
the level of risk posed by the exposures permitted under the tolerance(s) and their associated
pesticide registrations, and even though the pharmaceutical product has been deemed "safe and
effective." In other words, EPA would be concerned about relying on an interpretation of
FFDCA § 408 that could compel regulatory actions which would have no impact on the major
source of exposure, and where the source of such exposure is fully regulated and approved under
a public health standard.
EPA is interested in additional information and views that would help it determine how to
approach the issues discussed above. First, because there are many uncertainties about the extent
of risk from the use of lindane for scabies control, EPA encourages the development of
additional information that might support a more certain assessment of the potential risks of the
lindane scabies product. EPA is also continuing to pursue a dialogue with FDA to refine aspects
viii
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of the analysis. Second, EPA invites public comment on the regulatory and public policy
questions raised by the use of chemicals, such as lindane, both as pesticides and Pharmaceuticals.
There will be a 60-day public comment period for this document, commencing on the day the
Notice of Availability publishes in the Federal Register.
Finally, EPA notes that, in addition to the reviews of lindane described above, the
governments of Canada, Mexico and the United States are also considering joint actions to
reduce the risks associated with lindane. Specifically, the three countries, working through the
Commission for Environmental Cooperation (CEC), established by the North American
Agreement for Environmental Cooperation, have agreed to develop a North American Regional
Action Plan (NARAP) on lindane (CEC Council Resolution 02-07). The purpose of the NARAP
is to reduce environmental and health risks from lindane on a regional basis. The Agency is also
aware that internationally, other countries are taking significant actions to reduce and eliminate
risks from lindane.
Overall Risk Summary
The Agency's human health risk assessment for lindane indicates some risk concerns.
Both acute and chronic risks from food alone are low and not of concern to the Agency.
Drinking water risk estimates based on screening-level models from both ground and surface
water exposures are also low and do not pose a risk concern for drinking water exposure. There
are risk concerns for workers with on-farm use of the dust formulation to treat certain seeds. All
occupational risks of concern are mitigated with the use of certain personal protective equipment
or engineering controls. Ecological risks from the seed treatment of lindane are of concern;
however, the Agency believes the assessment is conservative and overestimates the risks. The
pharmaceutical use of lindane to treat lice does not pose risks of concern to the Agency, but the
use of lindane to treat scabies does pose a risk of concern based on EPA's risk assessment.
Dietary Risk - Food
The acute dietary (food) risks are less than 100% of the acute Population Adjusted Dose
(aPAD) for the general U.S. population and all population subgroups. Infants (<1 year), the most
highly exposed population subgroup, are estimated to be exposed to lindane at a level of 17% of
the aPAD. The chronic dietary (food) risks are also less than 100% of the chronic Population
Adjusted Dose (cPAD) for the general U.S. population and all population subgroups usually
considered. Children (1-6 years), the most highly exposed population subgroup, are estimated to
be exposed to lindane at a level of 11% of the cPAD.
Because of the persistence of lindane and its long-range atmospheric transport potential,
lindane is detected in colder regions, such as the Arctic, where the compound becomes less
volatile. Because indigenous peoples of the Arctic region of the U.S. (Alaska) rely heavily on
game for their food source, the Agency performed a supplementary chronic dietary exposure and
risk assessment for these subsistence diets. For indigenous people of Alaska, the chronic dietary
risks are generally not of concern. For the most highly exposed subpopulation, children (1-6
years), the subsistence diet heavy in game results in estimated lindane exposures ranging from
ix
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13-65% of the cPAD, with one scenario at 138% of the cPAD. The highest estimate was based
on highly conservative assumptions, including children eating blubber every day for six years,
which probably overestimates dietary risk. An acute dietary assessment is not possible for
indigenous people of Alaska at this time, because the Agency does not have information on a
typical day's diet. Nevertheless, based on limited residue data, the Agency believes acute dietary
risks are unlikely to be of concern.
Dietary Risk - Drinking Water
Drinking water exposure to lindane can occur through ground and surface water
contamination. EPA used models to conduct a screening-level assessment of potential high-end
estimates of lindane concentrations from seed treatment uses In surface and ground water sources
of drinking water. Based on currently registered uses, the highest drinking water estimated
concentrations (DWECs) of lindane in surface water sources are 0.98 ppb for acute exposure and
0.46 ppb for chronic exposure. The ground water DWEC for lindane is 0.011 ppb for both acute
and chronic exposure.
Pharmaceutical Use Risk
Lindane has been approved by the FDA as a prescription drug to treat lice and scabies.
EPA has conducted an assessment of these uses to determine the risk of a lice or scabies
treatment. Based on the Agency's current understanding of available data, the Agency does not
believe that lindane pharmaceutical products used for treatment of lice pose human health risks
of concern, when used in accordance with directions provided on the label. However, based on
other blood-level analyses, the Agency cannot conclude at this time with reasonable certainty that
exposure to lindane through scabies treatment will not result in unacceptable exposure and risk.
The Agency also assessed the risks associated with estimated concentrations of lindane in
surface water used as a source of drinking water which might result from consumer use of
lindane for both lice and scabies treatments. Based on reported lindane concentrations of
discharged effluent from water treatment facilities in California used in a model to predict
dilution in receiving streams, the acute and chronic DWECs are extremely low (10~5 to 10"4 ppb
range).
Risk from All Registered Pesticide Lindane Exposures
To assess risks from all lindane exposures, the Agency combined risk from food and
drinking water exposure only. To determine the maximum allowable contribution from water
allowed in the diet, EPA first looks at how much of the overall allowable risk is contributed by
food and then determines a "drinking water level of comparison" (DWLOC) to determine
whether DWECs exceed this level. DWECs that are less than the corresponding DWLOC are
not of concern to the Agency. Because there are no registered residential or other non-
occupational uses of lindane that need to be considered for regulatory purposes at this time, the
assessment for lindane combines exposures from food and drinking water sources only. For the
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agricultural seed treatment uses of lindane, both acute and chronic DWECs are below the
corresponding DWLOCs for all drinking water sources, and are not of concern to the Agency.
Occupational Risk
Occupational exposure to lindane is of concern to the Agency for some worker scenarios,
necessitating the need for certain measures to mitigate these risks. In particular, the on-farm
handling of the lindane dust formulation to mix/load and plant treated seed results in risks of
concern (MOEs < 100). To mitigate these risk concerns, on-farm treatment of wheat, barley,
oats, and rye seeds with the dust formulation of lindane is prohibited. Because of the lower seed
planting rate, the on-farm treatment of corn and sorghum seeds with the lindane dust formulation
is permitted, provided additional personal protective equipment (PPE) is utilized. Commercial
treatment of seeds with the liquid formulation for all registered uses is permitted. Specific PPE
for workers that are to treat seeds on-farm or commercially, and handle and plant treated seeds
are specified in this RED document. Also, the Agency has no risk concerns for post-application
exposures to agricultural workers, and no risk mitigation measures are necessary beyond a 24
hour restricted entry interval (REI). However, provided the soil is not disturbed and there is no
contact with the treated seeds, workers may enter the planted field during the 24-hour REI.
Ecological Risk
The Agency's assessment suggests that the use of lindane can result in adverse acute and
chronic effects to terrestrial organisms, and adverse acute effects to aquatic organisms. Lindane
is a potential endocrine disruptor in birds, mammals, and possibly fish.
The registrant has agreed to reduce the maximum application rate to corn, which is a use
that resulted in the highest risk to birds. However, avian (dietary) aversion toxicity studies and a
field study suggest that birds are repelled by treated seeds; hence, the Agency believes that the
risk to birds by treating certain seeds with lindane are lower and not of concern. The risks to
mammals are also further reduced with the lowering of the maximum application rate to corn.
Moreover, the Agency believes that the risks for local populations of mammals in areas where
lindane treated seeds are planted are low, and that although there are no data available to
demonstrate that mammals avoid consuming lindane treated seeds as do birds, it is possible that
mammals will be similarly adverse to eating seeds treated with lindane. The Agency also has
acute risks of concerns for freshwater fish and invertebrates, and estuarine marine invertebrates.
However, the screening-level model used to assess these risks has likely produced highly
conservative estimates which overestimated the environmental concentrations and resulting risks
to aquatic species. Actual aquatic risks are expected to be lower and not of concern, and the
Agency and is requiring data to confirm this determination.
XI
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Risk Management Decision
The Agency will revoke all existing lindane tolerances because all lindane products for
which the tolerances were originally established have been cancelled. The Agency has also
determined that the currently registered lindane seed treatment products would be eligible for
reregistration if the registrants make the changes to the terms and conditions specified in this
document and provide the required data, and EPA is able to establish all required tolerances for
residues of lindane in food. This RED document includes guidance and time frames for
complying with any label changes for products containing lindane.
xn
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Introduction
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into
law. This Act amends FIFRA to require tolerance reassessment for all existing tolerances. The
Agency has decided that, for those chemicals that have tolerances and are undergoing
reregistration, the tolerance reassessment will be initiated through this reregistration process.
The Act also requires that by 2006, EPA must review all tolerances in effect on the day before
the date of the enactment of the FQPA, which was August 3, 1996.
FQPA also amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a
safety finding in tolerance reassessment based on factors including an assessment of cumulative,
effects of chemicals with a common mechanism of toxicity. Lindane is an organochlorine
chemical. Although chemical class is not necessarily equivalent to a common mechanism of
action, in some cases, chemicals within the same class have been shown to share a common
mechanism of action and are being considered together for purposes of a cumulative assessment
(e.g., the organophosphates). The Agency has not performed a cumulative risk assessment as
part of this reregistration review of lindane, because it has not determined if there are any other
chemical substances to have a common mechanism of toxicity. If the Agency identifies other
substances that share a common mechanism of toxicity with lindane, then the cumulative risks of
these chemicals will be considered;
This RED document for lindane presents the Agency's revised human health and
ecological risk assessments; the tolerance reassessment; and the RED for lindane. This
document consists of five sections. Section I contains the regulatory authority and framework for
reregistration/tolerance reassessment. Section II provides a profile of the use and usage of the
chemical. Section III gives an overview of the revised human health and environmental effects
risk assessments. Section IV presents the Agency's reregistration eligibility and risk management
decisions. Section V identifies label changes necessary to implement the risk mitigation
measures. Finally, among the Appendices is a description of the revised use patterns, generic and
product-specific Data Call-in (DCI) information. The revised risk assessments and other
supporting technical documents are not included in this document, but are available on the
Agency's web page at http://www.epa.gov/pesticides/reregistration/lindane and in the public
docket.
1
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II. Chemical Overview
A. Regulatory History
Lindane is an organochlorine insecticide that was first registered with USDA for use as a
pesticide in the 1940's. Lindane was registered for a wide variety of fruit and vegetable crops
(including seed treatment), ornamentals, tobacco, greenhouse vegetables and ornamentals,
forestry, Christmas tree plantations, hardwood log dips, livestock dips, farm animal premises,
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 structure
sites, and human skin/clothing (military use only). Lindane was manufactured in the U.S. until
1977. All other lindane used in this country was imported from France, Germany, Spain, Japan,
India, Romania, and China.
In 1977, EPA initiated a Rebuttable Presumption Against Registration (RPAR) review of
lindane, which is currently termed as Special Review. The lindane RPAR was triggered based
upon questions of oncogenicity, fetotoxicity/ teratogenicity, reproductive effects (i.e., litter size
and testicular effects), its potential to cause blood dyscrasias (including aplastic anemia), and
acute toxicity to wildlife. Position Documents (PDs) were published in 1977 (PD-1), in 1980
(PD-2/3), and in 1983 (PD-4). A Notice of Intent to Cancel Pesticide Products Containing
Lindane was issued October 19, 1983 (48 FR 48512). AH of the RPAR triggers were either
rebutted or withdrawn except for oncogenicity. As a result of a risk/benefit analysis based on
oncogenic risks, the RPAR decision resulted in the phasing out of the registrations for lindane
smoke fumigation devices for indoor domestic use, and in the cancellation of lindane dog dips
for the control of pests other than mites. The dog dip cancellation was challenged, and
subsequently the dog dip use for pests other than mites was permitted for veterinary use.
In September 1985 the Agency issued the Lindane Registration Standard that reflected a
reassessment of the database, required additional studies to support the lindane registration and
conveyed concerns for applicator exposure and secondary exposure from treated structures or
animals. In addition, the restricted use classification for certain use patterns, which have since
been cancelled, was continued from the PD-4, along with expanding the protective clothing
requirements for certain uses. Because of dietary exposure concerns to lindane and the lack of
data to support the then current tolerances, no additional lindane tolerances were to be considered
until the data gaps identified in the Registration Standard were filled. Although the Agency's
Carcinogen Assessment Group classified lindane in the B2-C range as a Probable/Possible
Human Carcinogen, the Agency decided to regulate lindane as a class C carcinogen pending the
receipt of further studies. The data have since been provided, and the Agency has classified
lindane as "suggestive evidence of carcinogenicity, but not sufficient to assess human
carcinogenic potential." Because of concerns about the potential for exposure to non-target
aquatic organisms, a prohibition against aerial application and special disposal directions for
used dip solutions were carried forward from the 1983 Notice of Intent to Cancel. Labeling
changes intended to reduce the exposure of birds to lindane treated seed were also carried
forward.
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After the Registration Standard was issued in 1985, the registrant task force, Centre
International d'Etudes du Lindane (CIEL), was involved in conducting studies and negotiating
with EPA over study requirements and possible voluntary cancellations. Between 1993 and
1998, long-range transport and environmental concerns about lindane increased. In response, the
lindane technical registrants requested voluntary deletion all uses except seed treatment on 19
agricultural crops. These crops are: barley, broccoli, Brussels sprouts, cabbage, cauliflower,
celery, collards, corn, lettuce, kale, kohlrabi, mustard greens, oats, radishes, rye, sorghum,
spinach, Swiss chard, and wheat. These use deletions are reflected in four Notices of Receipt of
Requests for Amendments to Delete Uses in Certain Pesticide Registrations, were published in
the Federal Register on August 26, 1998 (Volume 63, Number 165, Page 45481-45483);
September 30, 1998 (Volume 63, Number 189, Pages 52257-52260); December 2, 1998 (Volume
63, Number 231, Page 66542-66543); January 27, 1999 (Volume 64, Number 17, Pages 4096-
4097); and August 18, 2000 (Volume 65, Number 161, Page 50524-50526).
The use deletions from the four preceding Federal Register Notices are: livestock
(including cattle, goats, horses, sheep, mules, hogs, mules, and sheep); pet care uses; ornamentals
(trees and shrubs); turf (lawns & golf courses); recreational areas; uncultivated areas, fallow or
agricultural areas; commercial transportation facilities; food processing handling/storage
areas/plants; grain/cereal/flour bins and storage areas; farm or agricultural structures (including
barns; wood-protection treatment of buildings); wood treatment, stored timber and lumber
treatment; military use on human skin and clothing. Furthermore, the following food and/or feed
and/or fiber crop uses were deleted: almonds, alfalfa, apples, apricots, asparagus, beans (all
types), beets, cantaloupe, carrots, cherries, clover, cotton, cucumbers, cucurbits (all types),
eggplant, flax, grapes, guave, lentils, mangoes, melons, mint, mushrooms, nectarines, okra,
onions, peaches, peas (all types), pecans, pears, peppers, pine apples, plums, prunes, pumpkins,
quinces, rape, safflower, soybeans, squash, (all types), strawberries, sudan grass, sugar beets,
summer squash, sunflower, tomatoes, and watermelon. In addition, tobacco use was also
cancelled.
Currently, the only food/feed use of lindane which is being supported for reregistration is
seed treatment on barley, corn, oats, rye, sorghum, and wheat. Since the 1998 and 1999 use
deletions, the registrants are no longer interested in supporting the seed treatment use on
broccoli, Brussels sprouts, celery, cabbage, cauliflower, collards, kale, kohlrabi, mustard greens,
lettuce, radishes, spinach, and Swiss Chard for reregistration. In 2001 and 2002, the technical
registrants have submitted letters requesting voluntary cancellation of these crops. A Federal
Register Notice announcing use deletions from the technical labels registered to Inquinosa was
published on June 13, 2002 (Volume 67, Number 114, Page 40730-40732). Another notice
announcing these use deletions for the other technical lindane registrations was issued on July 17,
2002 (Volume 67, Number 137, Page 46976-46978]. Additional notices from other technical
registrants announcing these use deletions from lindane labels are to be issued soon.
In addition, during the reregistration process for lindane, the registrant submitted a
petition for the use of lindane on canola seeds. The risks associated with this proposed use were
assessed and included in this RED document and supporting technical documents for
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informational purposes. The decision whether to grant the petition and register canola as a new
use is outside the scope of this RED and will be made separately by the Agency.
Lindane is also available, and regulated by the U.S. Food and Drug Administration
(FDA), for the pharmaceutical treatment of scabies and head lice. A 1 % Undone lotion is
available for the treatment of scabies, and a 1% lindane shampoo is available for the treatment of
head lice. Both uses have been on the market since 1947, but was labeled as a second line
therapy in 1995 after a review by the FDA.
International Agreements and Treaties
Lindane, among other pollutants, is subject to bilateral and multilateral international
agreements and treaties. These include:
• The Great Lakes Binational Toxics Strategy, a voluntary agreement between the U.S. and
Canada. Lindane is listed as a Level II substance. Level n substances are those for which
one country or the other has grounds to indicate its persistence in the environment,
potential for bioaccumulation, and toxicity. Website: http://www.epa.gov/glnpo/bns/
• The Persistent Organic Pollutants (POPs) Protocol to the Convention on Long-Range
Transboundary Air Pollution (LRTAP), a legally-binding regional treaty. Lindane is
listed as an annex II substance. Annex II includes POPs scheduled for restrictions on use.
Website: http://www.unece.org/env/rrtap/
The Rotterdam Convention on Prior Informed Consent (PIC), a procedure for certain
hazardous chemicals and pesticides in international trade, a legally-binding global treaty.
Lindane is a chemical subject to the PIC procedure. Website:
http://www.fao.org/waicent/FaoInfo/Agricult/AGP/AGPP/Pesticid/PIC/pichome.htrn
The North American Free Trade Agreement (NAFTA). As a component of NAFTA and
efforts to harmonize pesticide product registration, lindane is undergoing a joint
reregistration review between the U.S. and Canada. Also, under the NAFTA
environmental side agreement, the US, Canada, and Mexico will develop a North
American Regional Action Plan (NARAP) on lindane beginning in 2002. Website:
http ://www.cec .org/programs_proj ects/pollutants_health/smoc/
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B. Chemical Identification
Common Name:
Structure:
Lindane
Chemical Name:
Chemical family:
Case number:
CAS registry number:
OPP chemical code:
Empirical formula:
Molecular weight:
Trade and other names:
Basic manufacturer:
Cl
gamma isomer of Hexachlorocyclohexane
Organochlorine
0315
58-89-9
009001
C6H6C16
290.9
Agrox Premiere®, Germate Plus®, Isotox F®, and
Kernel Guard®, DB Green®, Vitavax®, Enhance®,
Seed Shield®.
Inquinosa Internacional, SA
• Physical Chemical and Environmental Fate Properties:
Lindane is a white crystalline solid with a melting point of 1 12- 1 1 3°C, specific gravity of
1.85, octanol/water partition coefficient (Kow) of 3 135, and vapor, pressure of 9.4 x 10"6mmHgat
20°C. Lindane is slightly soluble in water (10 ppm at 20°C) and in most organic solvents,
including acetone and aromatic and chlorinated hydrocarbons. Lindane is only slightly soluble in
mineral oils. Lindane is stable to light, heat, air, and strong acids, but decomposes in alkali
solutions to trichlorobenzenes and HC1.
Fate studies show that lindane is both moderately mobile (mean K^. = 1368) and highly
persistent (soil half life of 2.6 years). It is resistant to photolysis and hydrolysis (except at high
pH), and degrades very slowly by microbial actions. Degradates are predominantly
pentachlorocyclohexane, 1 ,2,4,-trichlorobenzene, and 1,2,3-trichlorobenzene.
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C. Use Profile
The following information is based on the currently registered agricultural uses of
lindane:
Type of Pesticide: Insecticide
Summary of Use Sites:
Food/Feed: Seed treatment for barley, corn, oats, rye, sorghum, and wheat.
Non-Food
Agricultural: No other agricultural use sites.
Residential: None.
Pharmaceutical: Prescription lice and scabies treatments.
Other: None.
Use Classification: General use.
Target Pests: Wireworm; and less effective against flea beetles, seed corn maggots, seed
corn beetle and white grubs.
Formulation Types Registered: Dust (D), emulsifiable concentrate (EC), flowable
concentrate (FC), and liquid ready-to-use (RTU).
Method and Rates of Application:
Equipment: Liquid seed treater; planter/seed box; air seed treater; canister tube
applicator, and slurry-type seed treater.
Method: Applied to seeds on-farm at time of planting (> 90% of total Ibs
used), and applied to seeds in commercial seed treatment facilities.
Maximum Rate: Applied to seed at 0.03125 (oats) to 0.125 (corn) Ibs ai per 100 Ibs
of seed. When planted, 0.00425 (sorghum) to 0.0512 (wheat) Ibs
ai/acre (A) based on 6.76 Ibs seed/A for sorghum and 120 Ibs
seed/A for wheat. For the pending registration on canola, the rates
are 1.5 Ib ai/100 Ibs seed or 0.12 Ibs ai/A based on 8 Ibs seed/A.
Timing: Once in spring (or fall for whiter wheat) at time of planting.
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D. Estimated Usage of Pesticide
Table 1 summarizes the best estimates available for the pesticide uses of lindane, based
on available pesticide usage information for 1996 to 2001. A full listing of all uses of lindane
with the corresponding use and usage data for each site, has been completed and is in the
"Quantitative Use Assessment" document, which is available in the public docket and on the
internet at http://www.epa.gov/pesticides/reregistration/Iindane. The data, reported on an
aggregate and site (crop) basis, reflect annual fluctuations in use patterns as well as the variability
in using data from various information sources. Up to 233,000 Ibs ai of lindane are used
annually for seed treatment, which accounts for all of lindane used in the U.S., according to
Agency and registrant estimates. Seed treatment use of lindane has decreased over the years. In
1977, up to 937,000 Ibs ai were use, of which approximately 48% or 450,000 Ibs ai were used for
seed treatment.
Table 1. Lindane Estimated Usage for All Sites
Crop
Barley/wheat
Corn
Oats/rye
Sorghum
Totals
Acres Crop
Grown
68,373,000
79,545,000
5,812,000
9,195,000
Lbs. Active Ingredient Applied
Wt Avg.1
89,422
51,545
843
331
142,141
Likely Maximum
153,294
77,318
1,685
662
232,959
Percent Crop Treated
Wt. Avg.
7%
6%
1%
1%
Likely Maximum
12%
9%
2%
2%
' Weighted Average is based on data for 1996 - 2001; the most recent years and more reliable data are weighted more heavily.
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HI. Summary of Lindane Risk Assessments
Following is a summary of EPA's revised human health and ecological risk findings and
conclusions for the organochlorine pesticide lindane, as fully presented in the following
documents:
Human Health Risks
* Revised HED Risk Assessment for Lindane, dated July 31,2002
• Revised Assessment of Risk from Use of Lindane for Treatment of Lice and Scabies, dated
July 31,2002
Revised Estimates of the Number of Acres Treated per Day for Lindane Seed Treatment
Use of Field Corn, dated June 26, 2002
Environmental Fate and Effects
Revised EFED RED Chapter for Lindane, dated July 31, 2002
* Addition of corn and canola seeds treatment use to revised Lindane RED, dated June 17,
2002
Lindane Food Chain Bio-Accumulation, -Magnification and -Concentration, dated June
17,2002
* Qualitative Assessment of Long-range Transport and Atmospheric Deposition of Lindane
to Great Lakes, dated June 17, 2002
The listed documents may be found on the internet at
http://www.epa.gov/pesticides/reregistration/lindane and in the OPP public docket. The OPP
docket is located in Room 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA,
and is open Monday through Friday, excluding legal holidays from 8:30 am to 4:00 pm.
EPA issued its preliminary risk assessments for lindane in the public docket and on the
internet on August 29, 2001. In response to comments and studies submitted to the Agency, the
risk assessments were updated and refined. These risk assessments were made available to the
public a second tune on January 31, 2002, for comment on risk management for this pesticide.
There is a discussion of these comments in Section IV, later in this document. The risk
assessments presented here form the basis of the Agency's risk management decision for lindane.
A. Human Health Risk Assessment
The human health risk assessment for pesticides is conducted on exposures that may
result from food, drinking water and non-occupational use. A separate occupational risk
assessment is conducted for farmers and other professional pesticide handlers or applicators.
Although there are no residential (e.g., home gardens and lawns) or other non-occupational (e.g.,
golf course) pesticidal uses of lindane registered by EPA, lindane is approved by FDA for the
treatment of head lice and scabies on humans.
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EPA has also conducted an assessment of the risks resulting from exposure to lindane.
The risk assessment considered the exposure received by the general population and major
identifiable subpopulations, both from the use of lindane in registered pesticide products and
from use of lindane in pharmaceutical products. The use of lindane in registered pesticide
products comprise applications of lindane to seeds of various commodities for purposes of insect
control, and this use results in human exposure via residues in food and drinking water. The
approved pharmaceutical uses and products for control of head lice and scabies, which are
regulated by FDA, results in direct human exposure and via residues in drinking water. The
conclusions of the risk assessment are summarized below.
1. Dietary Risk from Food
a. Toxicity
The Agency has reviewed all toxicity studies submitted and has determined that the
toxicity database is essentially complete to support a reregistration eligibility determination for
all currently registered uses of lindane. 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 some evidence that lindane may act as an endocrine disrupter;
however, further investigation is necessary to ascertain the relevance and impact of such findings
on public health.
EPA has not received adequate data to determine if there are any lindane metabolites of
toxicological concern in plants. Historically only lindane per se has been analyzed; hence, none
of its metabolites have been considered when assessing exposure from eating treated crops. The
Agency has received some metabolism studies to determine the type of residues that may be
available from crops treated with lindane as a seed treatment, and feeding studies in which
livestock were orally dosed with lindane. However, additional metabolism data are needed to
determine whether there are metabolites of toxicological concern in plants. To account for the
undetermined, but potential toxic effects from lindane metabolites in plants, total radioactive
residues (TRRs) were used for risk assessment purposes, and all metabolites of lindane are
considered equally toxic to lindane, per se.
As noted previously, lindane has historically been classified as a B2/C carcinogen and the
Agency has regulated it as a class C carcinogen pending receipt of additional studies. In 2001,
the Agency reevaluated the carcinogenicity of lindane, in which all the available information/data
were considered including a newly submitted carcinogenicity study in CD-I mice. In accordance
with the EPA Draft Guidelines for Carcinogen Risk Assessment (July 1999), the Agency
classified lindane as "suggestive evidence of carcinogenicity, but not sufficient to assess human
carcinogenic potential." This classification was based on an increased incidence of benign lung
tumors in female mice only. Therefore, pursuant to the cancer guidelines, quantification of
cancer risk is not required.
-------
Further details of the toxicity of lindane can be found in the July 31, 2002 Revised BED
Risk Assessment for Lindane. A brief overview of the lexicological studies used for the dietary
risk assessment and other relevant information is outlined in Table 2.
b. Reference Dose and Uncertainty Factor
The acute Reference Dose (aRfD) or chronic RfD (cRfD) is the no-observed-adverse-
effect-level (NOAEL) divided by an uncertainty factor (UF), and is the dose at which an
individual could be exposed with no expected adverse health effects. The aRfD is applicable to
single day exposures, while the cRfD is applicable to lifetime exposures. The UF for lindane is
100X, based on 10X for interspecies extrapolation (from animals to humans) and 10X for
intraspecies variability (based on human variability).
c. FQPA Safety Factor
FQPA provides an additional tenfold (10X) special safety factor in assessing the risks to
infants and children to take into account the potential for pre- and postnatal toxicity, and the
completeness of the toxicity and exposure databases. This is referred to as the FQPA Safety
Factor (SF). The statute authorized EPA to reduce or remove this default 10X FQPA SF only if,
based on reliable data, the resulting margin would be safe for infants and children.
There was evidence of a qualitative increase in susceptibility in the rat multi-generation
reproduction study, and a quantitative increase in susceptibility demonstrated in the rat
developmental neurotoxicity study. The offspring effects seen in the developmental
neurotoxicity study were the same as those seen hi the two-generation reproduction study. No
additional functional or morphological hazards to the nervous system were noted. However, the
data provided no indication of quantitative or qualitative increased susceptibility/sensitivity in
rats following in utero exposure to lindane in the prenatal developmental toxicity studies in rats,
because the developmental effects were observed only at or above doses causing maternal
toxicity.
The Agency concluded that a reduced FQPA SF is required for lindane, since there is
evidence of increased susceptibility of the young demonstrated in both the developmental
neurotoxicity study (quantitative difference of approximately 3X) and the 2-generation
reproduction study in rats (qualitative). The FQPA SF was reduced to 3X, because: 1) the
toxicology data base is complete; 2) the available data provide no indication of quantitative or
qualitative increased susceptibility in rats from in utero exposure to lindane in the prenatal
developmental study; 3) the offspring effects seen hi the developmental neurotoxicity study were
the same as those seen in the two-generation reproduction study (no additional functional or
morphological hazards to the nervous system were noted); 4) adequate actual data, surrogate
data, and/or modeling outputs are available to satisfactorily assess food exposure and to provide a
screening-level drinking water exposure assessment; and 5) there are currently no residential uses
of lindane. The FQPA SF of 3X for lindane is applicable to all population subgroups for acute
and chronic dietary risk assessments.
10
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d. Population Adjusted Dose (PAD)
The Population Adjusted Dose (PAD) is a term that characterizes the dietary risk of a
chemical, and reflects the Reference Dose (RiD), either acute or chronic, that has been adjusted
to account for the FQPA SF (i.e., RiD - FQPA SF). In the case of lindane, the FQPA SF is 3X,
therefore the acute PAD (aPAD) and chronic PAD (cPAD) reflect the acute and chronic RfDs
divided by the FQPA SF of 3X. An exposure estimate that is less than 100% of the acute or
chronic PAD is not of concern to the Agency. Table 2 presents the PADs used to assess lindane
acute and chronic dietary exposure.
Table 2. lexicological Endpoints and Other Factors Used in the Human Dietary Risk
Assessment of Lindane
Assessment
Acute
Dietary
Chronic
Dietary
Dose
(mg/kg/day)
NOAEL= 6
NOAEL = 0.47
Endpoint
Increased grip strength,
decrease grooming
behavior and motor
activity at 20 mg/kg/day
(LOAEL).
Periacinar hepatocyte
hypertrophy, increased
liver/spleen weight,
decreased platelets at 4.81
mg/kg/day (LOAEL).
Study -
Rat Acute
Neurotoxicity
Feeding and
Carcinogenicity
UF&
FQPA SF
100 & 3
100 & 3
PAD
(mg/kg/day)
0.02
0.0016
NOAEL= No-observed-adverse-effect level
LOAEL= Lowest-observed-adverse-effect level
e. Exposure Assumptions
The dietary assessment evaluates the pre-plant seed treatment uses on barley, corn, oats,
rye, sorghum, and wheat, which are the only food/feed uses of lindane being supported for
reregistration. Additionally, this risk assessment also includes the pending new registration of
pre-plant seed treatment of lindane on canola for informational purposes. The decision on
whether or not to register canola as a new use is outside the scope of this RED and will be made
separately by the Agency.
U.S. General Population
The acute and chronic dietary exposure analyses for lindane were conducted with the
Dietary Exposure Evaluation Model (DEEM™). DEEM incorporates consumption data
generated in USDA's Continuing Surveys of Food Intakes by Individuals (CSFII), 1989-92. For
the acute dietary risk assessment, the entire distribution of single day food consumption events
was combined with a distribution of residues to create a distribution of exposure in mg/kg/day.
This is known as a probabilistic analysis. Risk is reported at the 99.9th percentile of exposure.
For the chronic dietary risk assessment, the three-day average of consumption for each sub-
11
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population is combined with residues in commodities to determine average exposure in
mg/kg/day.
Existing data from radiolabeled studies indicate uptake of residues from treated seeds into
the aerial portion of the growing plant. In the absence of acceptable metabolism studies, the
Agency concluded that the total radioactive residues (TRRs) should be used for risk assessment
purposes until adequate plant metabolism studies are submitted. For lindane, the acute and
chronic dietary analyses were conducted using anticipated residues for all commodities supported
for reregistration, and the pending new use on canola. These analyses included percent crop
treated information (listed in Table 1 for registered uses and 10% crop treated for canola use);
TRRs from seed treatment, poultry and ruminant metabolism studies; and a canola processing
study. The canola processing study found no detectable lindane residues in canola oil; therefore,
one-half the limit of quantitation (Yi LOQ) was used as the average residue.
Special Populations
Lindane does not occur naturally in the environment. Once released into the
environment, lindane can partition into all environmental media. Because of long-range
atmospheric transport, lindane has been detected in air, surface water, groundwater, sediment,
soil, ice, snowpack, fish, wildlife, and humans. The Arctic is considered a "sink" for persistent
organic pollutants, such as lindane, because they become less volatile in colder regions and are
deposited. Once in the Arctic, lindane bioconcentrates rapidly in microorganisms, invertebrates,
fish, birds and mammals, especially in fat tissue. However, although lindane may bioconcentrate
rapidly, most data suggest that biotransformation and elimination are relatively rapid once
exposure is discontinued.
The indigenous peoples of the Arctic region of the U.S. (Alaska) rely heavily on game as
a food source. Because lindane can concentrate in game, the Agency performed a supplementary
chronic dietary exposure and risk assessment for indigenous Alaskan people from subsistence
diets to determine the risk from the worldwide manufacture and use of Hndane. An acute dietary
exposure assessment is not possible at this time, because the Agency does not have the
information on a typical day's diet of indigenous Alaskan people.
The chronic dietary assessment was based on annual harvest rates of game obtained from
the Alaska Department of Fish and Game Division of Subsistence for 1990-2001. These annual
harvest rates were then divided by 365 to obtain daily harvest rates, which were conservatively
assumed to be equivalent to daily intake rates. In addition, the Agency used total hexachloro-
cyclohexane (HCH) residues in traditional foods, based on information provided by Dr. Laurie
Chan of McGill University in Canada, with adjustments to estimate lindane exposure because
lindane represents between 3 and 15% of total HCH residues in game. This assessment
evaluated the three highest exposed communities of approximately 180 Alaskan communities
with the highest harvest amounts of seal, whale, and walrus. For this assessment, the Agency's
evaluation only covers adult males, adult females, and children 1-6 and 7-12 years old, because
there are insufficient data to assess other age groups.
12
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f.
Food'Risk Assessment
The dietary (food) assessment was conducted using percent crop treated (%CT)
information and TRR from various metabolism studies. The acute dietary (food) exposure
analysis is a highly refined Tier 3 probabilistic assessment, and exposure was compared to the
aPAD. In the deterministic chronic dietary assessment, exposure was compared to the cPAD. As
noted previously, dietary risk estimates less than 100% of the aPAD or cPAD do not pose risks
of concern to the Agency. More information on the dietary (food) risk assessment for lindane is
available in the Revised HED Risk Assessment for Lindane, dated July 31, 2002.
U.S. General Population
For the U.S. population, the lindane acute dietary exposure estimates at the 99.9th
percentile are below 100% of the aPAD for all population subgroups. The subgroup with the
highest estimated exposure (infants <1 years) resulted in an estimated exposure of 17% of the
aPAD. The general U.S. population's acute dietary exposure is 7% of the aPAD.
Average chronic dietary exposure estimates are below 100% of the cPAD for all
populations subgroups usually considered. The subgroup with the highest estimated exposure
(children 1-6 years) resulted in an estimated average exposure of 11% of the cPAD. The general
U.S. population's average chronic dietary exposure is 3% of the cPAD. The acute and chronic
dietary exposures and risks are presented on Table 3.
Table 3. Estimated Acute and Chronic Dietary Exposures and Risks
Population Subgroup
U.S. Population
All infants (
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The chronic dietary risks based on consumption of traditional foods are generally not of
concern. For the most highly exposed subpopulation, children 1-6 years, the subsistence diet of
Alaskans results in lindane exposures that range from 13 - 65% of the cPAD, with the exception
of one scenario which was 138% of the cPAD. This exception was for one community where
EPA included a number of conservative assumptions discussed below, including that children ate
blubber for 365 days/year for six years. For the adult population, the subsistence diet is 3 - 44%
of the cPAD. The estimated chronic dietary exposure and risk estimates for the indigenous
people of Alaska are presented in Table 4.
Table 4. Assumed Total Dietary Intake of Lindane (gamma-HCH) and Estimated Chronic
Dietary Risk for Indigenous Peoples
Population Subgroup
Adult male
Adult female
Children (7- 12 years)
Children (1-6 years)
Body Weight (kg)
70
60
29
10
Lindane Exposure
(mg/kg/day)
0.000055 - 0.0006
0.000064 - 0.00071
0.00007-0.0008
0.0002-0.001,0.0022
%cPAD
3-38
4-44
4-48
13 - 65, 138
For the chronic dietary risk to indigenous populations in Alaska, the Agency believes this
assessment is conservative and probably overestimates dietary risk because:
(1) this assessment is based on the three communities with the highest dietary
exposure (highest harvest amounts of seal, whale, and walrus) of the
approximately 180 Alaskan communities surveyed;
(2) maximum detected residues in any game tissue were used to assess chronic
exposure;
(3) whale, walrus and seal blubber residues were used to assess all meat residues,
which are expected to have much lower lindane residues than blubber;
(4) it was assumed that harvest was equal to intake (i.e., adults consume up to 2.4 Ibs
and children up to 1.3 Ibs of meat per day); and
(5) children's consumption is based on data from the diet of 7 - 12 year-olds while the
risk assessment assumes the same amount is eaten for 1 - 6 year-olds.
2. Drinking Water Concentrations from Agricultural Uses
Drinking water exposure to pesticides can occur through ground water and surface water
contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks.
The Agency uses a tiered system of exposure modeling, and, if available, monitoring data to
estimate those risks. Each of the tiers are designed to screen out pesticides by requiring higher,
more complex levels of investigation for those that have not passed the next lower tier. For
lindane, Tier I drinking water models were used, which are considered to be preliminary
assessments and provide high-end estimates of exposure. Although monitoring data are available
14
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for lindane, this assessment relies on modeling estimates, because monitoring data were
randomly collected and not correlated with any particular use pattern. Additionally, information
on the site characteristics within the monitored basins would be necessary to understand the
relative vulnerability of the recipient surface waters. Moreover, the monitoring data collected
reflect many uses of lindane that have since been cancelled, and therefore, do not reflect the
current use pattern.
Lindane is persistent and moderately mobile, with an estimated aerobic soil half-life of
2.6 years. It is resistant to photolysis and hydrolysis (except at high pH), and degrades very
slowly by microbial action. Lindane degrades predominantly to isomers of benzene
hexachloride, pentachlorocyclohexane, 1,2,4-trichlorobenzene, and 1,2,3-trichlorobenzene at low
concentrations (less than 10% of the total residues); therefore, these degradates were not
quantified for use in the drinking water assessment.
Lindane is transported through the environment by both hydrologic and atmospheric
means. Lindane has often been detected in surface and ground water, and in areas of non-use
(e.g., the Arctic), indicating long-range atmospheric transport. Most of these detections have
likely resulted from a combination of lindane's past widespread use, long-range transport, and its
extreme persistence. Currently, U.S. agricultural uses of lindane are restricted to seed treatments,
and application rates are quite low. However, it is conceivable that a certain level of lindane may
continue to persist in non-use areas despite the limited use of lindane to treat seed. Additional
details of the physical-chemical properties of lindane are discussed in the Revised EFED RED
Chapter for Lindane, dated July 31, 2002.
a. Modeling Data
Exposure from Surface Water
Drinking water estimated concentrations (DWECs) from surface water sources were
derived from the FQPA Index Reservoir Screening Tool (FIRST) model, which is based upon the
linked Pesticide Root Zone Model (PRZM) and Exposure Analysis Modeling System (EXAMS)
models, and includes use of an Index Reservoir. FIRST is a Tier I screening-level model
designed to provide high-end estimates of potential pesticide exposure in surface water sources
of drinking water. The estimated peak (acute) and chronic (average) DWECs from surface water
sources are listed in Table 5 for the highest planted seed treatment rate for the supported uses
(wheat at 0.051 Ib ai/A), and for the proposed new use on canola (0.116 Ib ai/A).
Exposure from Ground Water
The Agency used the Screening Concentration in Ground Water (SCI-GROW) model,
which is a Tier I screening-level model to estimate concentrations of lindane in ground water.
The estimated DWEC from ground water sources is listed in Table 5 for the highest planted seed
treatment rate for the supported uses (wheat at 0.051 Ib ai/A), and for the proposed new use on
canola (0.116 Ib ai/A).
15
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Table 5. DWECs of Lindane in Prinking Water
Drinking Water
Source
Surface Water
Ground Water
Crop
wheat
canola
wheat
canola
Acute DWEC (ppb)
0.98
4.16
0.011
0.025
Chronic DWEC (ppb)
0.46
1.95
0.011
0.025
b. Monitoring Data
For ground water, the U.S. EPA STORET data base reported 720 detections of Undone
between the years 1968 and 1995, in nearly all regions of the country, with especially high
numbers of detections in the South and West. From these 720 detections, the median and mean
concentrations were 0.01 and 11 ppb, respectively. The maximum detected concentrations were
reported in two wells at a Superfund site in Alabama (5800 and 1000 ppb) in 1982 and 1984, and
appear to be outliers because subsequent sampling of these wells in 1985 showed much lower
lindane concentrations of 2.5 ppb. The next highest lindane concentration was 120 ppb hi 1982
from a well in Alabama. All other concentrations are less than 10 ppb. In the USGS NAWQA
ground water database, lindane was detected in 0.1 % of ground water samples (0.07% at levels
greater than 0.01 ppb, maximum concentration reported was 0.032 ppb).
For surface water, the U.S. EPA STORET data base reported 8775 detections of lindane
with median and mean concentrations of 0.005 and 0.18 ppb, respectively. STORET detections
were reported in nearly all regions of the contiguous U.S. 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 data have detected lindane in various water bodies,
the Agency determined that these data are not suitable for risk assessment purposes for the
reasons discussed earlier, and are presented here solely for informational purposes. Nevertheless,
the mean and median concentrations from monitoring data, as well as the maximum detected
concentrations are low and not of concern, with the exception of the two samples collected near a
Superfund site in Alabama in ground water nearly 20 years ago. Subsequent sampling of these
wells showed levels of 2.5 ppb, which would not pose levels of concern. As noted earlier, the
monitoring data collected include many uses of lindane uses that have since been cancelled, and
therefore, does not reflect the current supported seed treatment uses alone. However, even
though many uses of lindane have since been cancelled, modeling indicates that the seed
treatment uses of lindane can result in measurable concentrations of lindane in drinking water
sources.
16
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3. Risk from Pharmaceutical Uses
Lindane is also available, and regulated by FDA, for the treatment of scabies and head
lice. A 1 % lindane lotion is available for the treatment of scabies, and a 1 % lindane shampoo is
available for the treatment of head lice. The products are available by prescription only, with use
intended as a second line therapy for the treatment of patients who have either failed to respond
to, or are intolerant of, other approved therapies. It is currently supplied by the manufacturer in a
2-ounce patient size bottle, and a pharmacy-only size pint bottle, EPA's current understanding of
available data regarding the use of lindane pharmaceutical uses is present in the Revised
Assessment of Risk from Use of Lindane for Treatment of Lice and Scabies, dated July 25, 2002.
a. Scabies Treatment
The Agency performed two risk assessments for use of lindane to treat scabies uses. Data
were utilized from both animal and human studies, and a range of risk estimates is provided.
EPA conducted analyses using: 1) a Margin of Exposure (MOE) approach based on an animal
toxicity study; and 2) a comparison of lindane blood levels from one study which documents
cases of accidental lindane ingestion by toddlers in which blood levels were determined after
ingestion, and a second study which provides data on blood levels of lindane in children and
young adults following application of lindane to treat scabies. The first assessment (MOE
approach) followed conventional risk assessment methodologies and relied on animal data, and
the second assessment was performed using human blood levels.
MOE Approach
Risk Assessment
An estimated MOE is calculated based on a selected toxicological endpoint and compared
with the target MOE for short-term dermal exposure/risk to determine whether there is an
exposure of concern. The MOE is the ratio of the route appropriate NOAEL to estimated
exposure. For the short-term dermal endpoint for lindane, the Agency used a NOAEL of 6
mg/kg/day from an acute oral neurotoxicity study in rats. For non-occupational exposures,
uncertainty factors are used to determine target MOEs. The target MOE for non-occupational
exposures to lindane is 100, based on uncertainty factors (UF) used to account for differences
among humans (10X UF for intraspecies variability), and for differences between the test animals
and humans (10X for interspecies extrapolation).
Since the NOAEL is based on an oral toxicity study, dermal absorption data are required
to adjust the oral dose. Based on published articles, two different dermal absorption factors were
used to calculate estimated MOEs. One article reported data from a dermal absorption study
conducted on rhesus monkeys to determine if 1% lindane lotion applied for treatment of lice and
scabies is absorbed into the blood stream. Results from the study demonstrated that a weighted
average of 20% of the applied dose was absorbed following application to various regions of the
body. A second dermal absorption factor was taken from a study in which a lindane pesticide
17
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formulation was applied to human subjects to quantify dermal penetration. From this study,
lindane was shown to have a penetration factor of about 10%.
Results of the scabies MOE assessment for children and young adults using both monkey
and human dermal absorption data using conventional animal toxicity studies are provided in
Table 6. The analysis indicates MOEs of concern (MOE<100) from both high and low-end
treatment scenarios. The monkey assessment assumes that doses are applied at rates prescribed
on the label.
Table 6. Assessment of Scabies Use
Age Group
Applied
Bose (mg)
Daily Dermal Bose
(mg/kg/day)
Dermal
Absorption (%)
MOE*1'
Dermal Absorption Factor from Product Specific Monkey Study
Young Adult
Young Adult
Child (4-6 years)
Child (4-6 years)
Toddler (1-3 years)
Toddler (1-3 years)
600 high end
300 low end
300 high end
150 low end
300 high end
100 low end
10
5
11
7
15
8
20
20
20
20
20
20
3
6
3
4
2
4
Dermal Absorption Factor from Pesticide Exposure in Human Study
Young Adult
Young Adult
Child (4-6 years)
Child (4-6 years)
Toddler (1-3 years)
Toddler (1-3 years)
600 high end
300 low end
300 high end
150 low end
300 high end
100 low end
10
5
11
7
15
8
10
10
10
10
10
10
6
12
5
9
4
8
a Does not include an FQPA Safety Factor which, if applied, would increase the target MOE to 300 for infants and
children.
b Target MOE is 100
Uncertainties with MOE Risk Assessment
The toxicity endpoint used in the MOE assessment is based on an acute oral
neurotoxicity study where the test material was administered by gavage. An oral gavage dose
may be absorbed more rapidly than the dermal dose, thus use of a toxicity endpoint based on an
oral dose may overestimate toxicity from a dermal dose. Furthermore, since adult animals were
used in the acute oral study and children are more susceptible to exposure than adults, use of a
toxicity endpoint based on the acute study may underestimate risks to children who are exposed
to lindane.
18
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EPA calculated MOEs using different dermal absorption factors. The 20% absorption
value derived from the scabies lotion applied to monkeys may be an overestimate of dermal
absorption, because it was left on longer (24 hours) than label instructions (12 hours). In
addition, since there are no data to evaluate the relative absorption of the scabies lotion by
monkeys vs. humans or the relative absorption by humans of the pesticide vs. scabies lotion, it is
not possible to assess whether these dermal absorption factors tend to overstate or understate
potential risk. However, use of both studies provides a range of dermal absorption and probably
provides an adequate bounding of potential exposure.
EPA conducted its MOE assessment for scabies treatment to toddlers (1-3 years) and
children (years 4-6 years), in accordance with directions provided in the current label. According
to the FDA, the label for the 1% scabies treatment lotion will be revised to restrict use to
"patients who have attained adult stature, or approximately 60 kg" and to recommend only that a
thin layer of lotion be applied. Given anticipated label changes, use in accordance with the
revised label would eliminate risks to young children (less than 60 kg). Also, according to FDA,
pending label changes to the amount of lotion required should result in lower application rates
for both older children and adults.
Blood Level Comparison in Children
Risk Assessment
EPA also analyzed potential risk from lindane used as a scabies treatment based on data
on lindane blood levels provided in two published case reports. One study documents cases of
accidental lindane ingestion by toddlers in which blood levels were determined after ingestion.
The second study provides data on blood levels of lindane in children after application of 1%
lindane lotion to treat scabies. The blood level associated with acute accidental ingestion of the
contents of a bottle of Kwell (lindane) lotion, which resulted in short-term adverse effects
according to the accidental ingestion case study, is 0.32 ^ig/mL. Furthermore, the Physicians
Desk Reference (PDR) provides the following statement on clinical pharmacology regarding 1%
lindane cream, "Dale, et al reported a blood level of 290 ng/ml [0.29 |ag/mL] associated with
convulsions following the accidental ingestion of a lindane containing product."
EPA also has a published study on blood levels of lindane in infants and children who
had received scabies treatment with 1% lindane lotion. In this study, serum concentrations of
lindane were determined in infants and children with and without scabies infection following
application of 1% lindane lotion to the body surface area as prescribed by the label.. Studies were
performed on 20 infected and noninfected patients who averaged 33 to 64 months of age. The
current label for lindane lotion applied for scabies specifies that the lotion should not be left on
for more than 12 hours. Specimens of blood for determination of lindane concentrations were
obtained at 0, 2, 4, 6, 8, 12, 24, and 48 hours after topical application of 1% lotion. The highest
measured blood concentration from the clinical study was 0.064 [j,g/mL. Results are presented in
Table 7.
19
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Table 7. Blood Concentrations of Lindane After Scabies Treatment
Mean Concentrations of Lindane in Blood (jig/mL)
Time(hr)
2
4
6
8
12
24
36
48
Blood half-life
Infected
Avg
0.013
0.025
0.028
0.026
0.023
0.010
0.008
0.006
Range
0.005-0.038
0.007-0.048
0.013-0.039
0.010-0.037
0.002-0.043
0.003-0.019
0.002-0.012
0.001-0.021
J7.9hr
Noninfected
Avg
0.007
0.013
0.024
0.019
0.015
0.013
0.009
0.005
Range
0.001-0.017
0.008-0.027
0.007-0.064
0.009-0.040
0.002-0.033
0.006-0.024
0.004-0.018
0.002-0.008
2I.4hr
Uncertainties with Blood Level Analysis
It is uncertain whether the levels of 0.32 u.g/mL represent the maximum levels of lindane
in the subjects' blood. Given that the measured level of 0.32 ^ig/mL in the cited clinical study
was taken at least 4 hours after ingestion, it is likely that initial blood levels were higher. It is
also uncertain what blood level is associated with the effects observed in the case study patient,
thus to the extent that observed effects are attributable to higher or lower than measured lindane
blood levels, the assessment may tend to overestimate or underestimate risk, respectively. In
addition, the subjects in the clinical study received a bath with warm soapy water prior to
application of the lindane lotion. Wet skin tends to exhibit greater dermal absorption than dry
skin; hence, use of the blood levels from the study may overstate potential exposure for
individuals who have dry skin at the time of application.
hi the clinical study, the lindane lotion was left on for 24 hours after application. The
current label for scabies treatment specifies that the lotion should not be left on for more than 12
hours. Although this prolonged exposure may result in an overestimation of blood
concentrations seen after 12 hours, it should not effect the 6 hour peak level used in the risk
assessment. Additionally, the potential contribution of other lotion components to observed
effects is not known.
Based on the average age, the clinical scabies study included only infants and small
children (up to 8 yrs old). Average amounts of lindane applied in the study were 2-4 times less
that prescribed on the current label. However, the label for the 1% scabies lotion is to be revised
by FDA to prohibit use of the product for small children (i.e., children less than 60 kg), thus use
in accordance with the revised label would eliminate risks to young children (<60 kg). Also,
20
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according to FDA, pending label changes on the amount of lotion required should result in lower
application rates for both older children and adults. Although there is insufficient data to indicate
a correlation between amount applied dermally and corresponding blood levels, it is reasonable
to assume that use of a lower amount of product will produce lower lindane blood levels.
Finally, the new label will direct that lindane be applied to dry skin, which will reduce the
amount of lindane absorbed into the blood stream.
The blood level comparison analysis pertains and is applicable only to small children.
The Agency has no data on blood levels associated with adverse effects in adults or data on blood
levels associated with prescribed use of lindane to treat scabies in adults. Based on available
toxicity data, children are more sensitive than adults; therefore, adverse effects would occur at
higher blood levels in adults and older children than in young children. In addition, blood levels
associated with prescribed use (under both current and revised labels) would be lower in older
children and adults, due to differences in weight to body surface area ratios between young
children and adults/young adults.
Scabies Treatment Risk Conclusion
EPA's analysis using the animal data MOE approach indicates MOEs of concern from
both high and low-end treatment scenarios for all ages assessed using either monkey or human
dermal absorption data. For the blood concentration analysis, EPA compared adjusted blood
concentrations from the scabies study with blood concentration associated with short-term
adverse effects in children. Given variability of responses in humans, an uncertainty factor of 10
is considered reasonable for this risk assessment. There is a 4-5 fold difference between blood
levels in treated patients and allowable blood levels identified, based on evidence of adverse
effects. While this assessment considers mitigation efforts being taken by FDA, it is important to
note that it does not consider the medical benefits of scabies treatment.
b. Lice Treatment
The Agency's assessment of risk from use of lindane to treat head lice relies on data
provided in two published literature studies. One study documents cases of accidental lindane
ingestion by toddlers in which blood levels were determined after ingestion, and was discussed
above as part of the scabies treatment assessment. The second study provides data on blood
levels of lindane in children and young adults following application of Kwell (lindane) shampoo
to treat head lice.
In the head lice Kwell shampoo study, serum concentrations of lindane were determined
in children with pediculosis capititis following application of 1% Kwell shampoo. Studies were
performed in 9 patients who were from 3.5 to 18 years of age. After a pretreatment blood sample
was obtained, 1% lindane product was applied to dry hair using a sufficient amount of
medication to thoroughly saturate the hair and scalp. After 10 minutes, small quantities of water
were added until a lather formed. Shampooing was continued for an additional 4 minutes after
which the hair was rinsed and blown dry with a hair dryer. The current label for lindane
21
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shampoo specifies that the shampoo should remain in place on dry hair for 4 minutes only before
water is added to form lather. Consequently, the study may have resulted in higher absorption
than would occur following label directions. Four patients were retreated, because of persistence
of living lice after 5 days. Specimens of blood were obtained at 0, 2,4, 6, and 24 hours after
topical application of Kwell shampoo. The results are presented in Table 8.
Table 8. Blood Concentrations of Lindane After Lice Treatment
Mean Concentrations of Lindane in Blood Oig/mL)
Time (hr)
0
2
4
6
24
Initial Treatment
Avg
0
0.0014
0.00096
;. 0.00072
0.00041
Range
0.00043-0.00253
0.00038-0.00152
0.00029-0.00105
0.00026-0.00069
Retreatraent
Avg
0.00029
0.0036
0.0033
0.0021
0.0011
Range
0.00025-0.0003
0.00326-0.00388
0.00175-0.00613
0.00164-0.00264
0.00081-0.00133
Uncertainties with Blood Level Analysis
Likewise to uncertainties associated with the blood level analysis of scabies treatment, it
is uncertain whether the level of 0.32 u.g/mL represent the maximum levels of lindane in the
subjects' blood, and what blood level is associated with the effects observed in the case study
patient. Thus, to the extent that observed effects are attributable to higher or lower than
measured lindane blood levels, the assessment may tend to overestimate or underestimate risk,
respectively. Moreover, the current label for lindane shampoo specifies that the shampoo should
remain in place on dry hair for 4 minutes only before water is added to form lather. In the
clinical study, the shampoo was left in place for 10 minutes before water was added.
Consequently, the study may result in higher absorption than would occur following label
directions.
Lice Treatment Risk Conclusion
The highest measured blood concentration obtained following single and double
treatments of head lice at label rates, but at longer than label specified treatment durations, was
0.00613 |ig/mL. This is significantly lower than 0.32 u.g/mL, the blood level associated with
acute accidental ingestion, which resulted in short-term adverse effects according to the cited
case study article. Therefore, the Agency does not believe that lindane pharmaceutical products
used for treatment of lice pose acute human health risks of concern when used in accordance
with directions provided on the label.
22
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c. Drinking Water Concentrations from Pharmaceutical Uses
The Agency also assessed the risks associated with estimated concentrations of lindane in
surface water used as a source of drinking water from consumer use for both lice and scabies
treatments. The "down-the-drain" releases,assessment is based on an Agency exposure model,
Exposure and Fate Assessment Screening Tool (E-FAST). Surface water concentrations were
based on the reported lindane concentration of discharged effluent from the Publically Owned
Treatment Works (POTWs) of Sanitation Districts of Los Angeles County, California. The
reported median concentration of lindane ranged from 0.01 to 0.04 ppb. These concentrations
were averaged (0.03 ppb) and used in estimating surface water concentrations.
As part of this assessment, the Agency assumed that the reported concentration of lindane
from wastewater treatment was discharged and instantaneously diluted into surface water where
no further removal (e.g., degradation, absorption, volatilization) occurs. Also, different stream
dilution factors, which are the volume of receiving stream flow compared with the volume of
wastewater released from the POTW, were assumed to estimate acute and chronic DWECs from
surface water sources. Based on these data and assumptions for pharmaceutical use only of
lindane, the acute DWEC is 3.97 x 104 ppb and the chronic DWEC is 3.06 x 10'5 ppb. The
Agency believes that a conservative approach was used to estimate acute and chronic DWECs,
because of the instantaneous and upper-end stream dilution factors that were assumed in the
assessment.
d. Spontaneous Adverse Event Reports
Based on information provided by FDA, the most common adverse events from the
pharmaceutical uses of lindane (topical treatment) are skin irritation, and central nervous system
stimulation ranging from dizziness to seizures. The majority of adverse events occurred because
of misuse of the product, either ingestion or excessive topical application, but some have
occurred when the product was apparently used as recommended.
A postmarketing safety review conducted by FDA revealed 488 reports of adverse events
related to the'use of lindane in the Adverse Event Reporting System (AERS) database as of April
1, 2002. Spontaneously submitted reports are not considered incidence data since the total
number of patients treated with lindane is unknown, and the actual number of associated adverse
events is under reported. The AERS database reports included: outcome of death (15),
hospitalization (46), life threatening condition (7), and congenital anomaly (6). Only sixteen of
these cases occurred with lindane shampoo, and four of the sixteen were oral ingestion.
There were fifteen deaths, nine in adults and five in children, and one stillborn infant
possibly exposed during pregnancy. Of the cases whe're the route of administration could be
determined, thirteen of the patients were treated topically and one patient ingested lindane to
commit suicide. Two adult cases reported serious preexisting conditions, and four were elderly.
Three of the elderly patients died within 24 hours of treatment, one from pulmonary edema, one
from chronic obstructive pulmonary disease, and the third of the unreported condition. A fourth
23
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elderly patient suffered a seizure on the day of death, 41 days after treatment with lindane. Three
of the four elderly patients had contraindications to the use of lindane.
Three of the pediatric deaths were secondary to the other causes, including respiratory
syncytial virus infection, myelocytic leukemia, and lymphoma of the brain. The. fourth pediatric
case involved a fetus that may have been exposed in utero and was stillborn. The adverse event
report form stated that application occurred up to four times over four days. This would suggest
that the child received multiple treatments on consecutive days. FDA has concluded that in all
age groups, adverse events occurred mainly in patients who appeared to have misapplied or
ingested lindane.
One of the limitations of a voluntary system of reporting, such as for AERS, is the
substantial amount of under-reporting. The FDA estimates that 1-10% of all adverse events are
reported to the FDA. Other limitations include the variability in the quality and quantity of
information reported. In spite of known limitations, the spontaneous system has value. The
system is sensitive to rare, unexpected events, is simple to use, and is relatively inexpensive. In
addition, the AERS database does not include the total number of patients who have been treated,
with or without adverse events; therefore, it is not possible to quantify the percentage of patients
who have had adverse events. According to FDA, most of the serious adverse events in the
AERS database occurred in patients who had already labeled contraindications to the use of
lindane, who used lindane in excessive amounts, or who ingested lindane.
4. Risk from All Registered Pesticide Lindane Exposures
For lindane, a risk assessment was conducted for both acute and chronic durations that
considered combined food and drinking water exposures. Results of the risk assessment are
summarized here and are further explained in the July 31, 2002 Revised HED Risk Assessment
for Lindane.
To determine the maximum allowable contribution of lindane from water in the diet, the
Agency first looks at how much of the overall risk is contributed by food, residential and other
non-occupational sources, and then determines a drinking water level of comparison (DWLOC)
to determine whether modeled or monitored water concentrations exceed this value. The Agency
uses the DWLOC as a surrogate measure of risk associated with exposure from pesticides in
drinking water. The DWLOC is the maximum concentration in drinking water which, when
considered together with other sources of ambient exposure, does not exceed a level of concern.
The DWLOC is then compared with the DWEC to determine whether there is a potential concern
for combined exposure and risk. When the DWEC is less than the DWLOC, the Agency can
make a determination of safety for combined exposures. When the DWEC is greater than the
DWLOC, the Agency may not be able to make a determination of safety or may require
additional data concerning potential water contamination.
24
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Acute Risk (Food + Drinking Water)
The acute risk estimates for lindane address exposure from food and drinking water
sources only, because there are no residential or other non-occupational uses of lindane that
would result in acute exposure. Acute exposure is considered to occur in a one-day time frame.
Acute dietary risks less than 100% of the aPAD are not of concern to the Agency. As indicated
in Table 9, the highest DWEC for the currently registered uses of lindane (wheat), resulted in
0.98 ppb for surface water and 0.011 ppb for groundwater. These DWECs are less than the acute
DWLOC of 170 ppb for the most sensitive population subgroup, infants less than 1 year old.
Therefore, acute risks associated with food and drinking water exposures to lindane are not of
concern to the Agency.
Chronic Risk (Food + Drinking Water)
A chronic assessment estimates risk from long-term exposure to food and drinking water
sources only, because there are no residential or other non-occupational uses of lindane that
would result in chronic exposure. Chronic dietary risks less than 100% of the cPAD are not of
concern to the Agency. As indicated in Table 9, the highest DWEC for the currently registered
uses of lindane (wheat), resulted in 0.46 ppb for surface water and 0.011 ppb for ground water
sources. These DWECs are less than the chronic DWLOC of 14 ppb for the most sensitive
population subgroup, children 1-6 years old. Therefore, chronic risks associated with food and
drinking water exposures to lindane are not of concern to the Agency.
Table 9. Summary of Food and Drinking Water Risks for Acute and Chronic Dietary
Exposure
Population Subgroup
US Population
Children (1 -6 yrs)
Infants (<1 yr)
DWLOCs (ppb)
Acute
665
180
170
Chronic
54
14
15
DWECs (ppb)
Surface Water
Acute
0.98 (wheat)
4.16(canola)
Chronic
0.46 (wheat)
1 .95 (canola)
Ground
Water
0.011 (wheat)
0.025 (canola)
Special Populations (Food+Drinking Water)
For the indigenous people of the Arctic region of the U.S. (Alaska), the Agency has
insufficient information on lindane concentrations in Alaskan drinking water sources to
determine if exposure to lindane in food and water is of concern to the Agency. The calculated
DWECs are not appropriate for assessing potential exposures in Alaska, because they are specific
to seed treatment uses, and are not representative of background environmental levels of lindane
in Alaska from the long-range transport of the compound. However, it is expected that the
background environmental levels of lindane in Alaska are much less than the calculated chronic
25
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DWEC (0.46 ppb) for surface water sources, which represents the average concentration of
lindane in a drinking water reservoir where 87% of the watershed was planted with seed treated
with lindane. Drinking water monitoring data for Alaska are not available. Nevertheless, the
chronic DWEC of 0.46 ppb, which is based on seed treatment use, is significantly less than the
calculated chronic DWLOC of 6 ppb for children and 31 ppb for adults. The chronic DWLOC
calculations are derived from the conservative subsistence dietary food exposure estimates for all
but the one Alaskan community, which resulted in 138% of the cPAD being consumed by the
children (1-6 years) subpopulation. For the reasons discussed previously, the Agency believes
this assessment is conservative and probably overestimates dietary risk; therefore, a chronic
dietary risk in special populations does not pose a risk concern to the Agency,
As noted previously, an acute dietary assessment for indigenous people is not possible at
this time, because the Agency does not have the information on a typical day's diet.
Nevertheless, based on limited residue data, the Agency believes acute dietary risks are unlikely
to be of concern, because of the significantly large amount of game indigenous people would
have to consume in a single day to pose a risk of concern.
5. Occupational Risk
Occupational workers can be exposed to a pesticide through mixing, loading, and/or
applying a pesticide, or re-entering treated sites. Occupational exposure to lindane occurs either
on-farm or at commercial seed treatment facilities to farmers or workers who mix, load and/or
apply lindane as a seed treatment, and persons who handle or plant treated seed. Risk for these
potentially exposed populations is measured by a Margin of Exposure (MOE) which determines
how close the occupational exposure comes to a NOAEL after taking into account an uncertainty
factor of 100X. The uncertainty factor of 100X is based on a 1 OX for interspecies extrapolation
and a 10X for intraspecies variability. In the case of lindane, MOEs greater than 100 for dermal
and inhalation exposures are not of concern to the Agency. More information on the lindane
occupational risk assessment is available in the Revised HED Risk Assessment for Lindane, dated
July 31, 2002, and the Revised Estimates of the Number of Acres Treated per Day for Lindane
Seed Treatment Use of Field Corn, dated June 26, 2002.
a. Toxicity
The toxicity of lindane is integral to assessing the occupational risk. All risk calculations
are based on the most current toxicity information available for lindane. The lexicological
endpoints, and other factors used in the occupational risk assessment for lindane are listed below
in Table 10.
26
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Table 10. Summary of Toxicological Information Used in the Occupational Assessment
Assessment
Short-and
Intermediate-Term
Dermal a
Short-Term
Inhalation
Intermediate-Term
Inhalation
Dose
(mg/kg/day)
NOAEL= 1.2
NOAEL=0.13
(0.5 mg/m3)
Endpoint
Reduced pup survival, decreased body weights and
body weight gains during lactation, increased motor
activity, and decreased motor activity habituation at
5.6mg/kg/day(LOAEL).
Clinical signs (diarrhea, piloerection) on day 14 and
continuing for 20 days at 1.3 mg/kg/day (LOAEL).
Increased kidney weights of females and bone
marrow effects at 1 .3 mg/kg/day (LOAEL).
Study
Developmental
Neurotoxicity (Oral)
Study in Rats
90-Day Inhalation
Study in Rats
A 10% dermal absorption factor (relative to oral absorption) was used for risk assessment.
Because an oral study was selected as the dermal toxicological endpoint for lindane, a
dermal absorption factor of 10% (relative to oral absorption) was used for route-to-route
extrapolation. This factor is based on a study that tested 12 pesticides, including lindane, to
quantify dermal penetration. Also, the Agency believes that the offspring effects from the
developmental neurotoxicity study selected to assess occupational dermal exposure are protective
of all populations. Furthermore, because of the different toxicological endpoints of concern, it is
not appropriate to combine the dermal and inhalation exposures as part of the occupational risk
assessment.
Information in Table 11 indicates that lindane is moderately toxic following acute oral
and dermal exposures, and has been placed in Acute Toxicity category II. It is not an eye or
dermal irritant, or dermal sensitizer.
Table 11. Acute Toxicity of Lindane
Study Type
81-1 Acute oral-rat
81-2 Acute dermal-rabbit
81-3 Acute inhalation-rat
81-4 Eye irritation-rabbit
81-5 Dermal irritation-rabbit
81-6 Dermal sensitization-g. pig
MR®
00049330
00109141
Ace. 263946
Ace. 263946
Ace. 262946
Ace. 262946
Category
II
n
in
in
IV
NA
Result
LD50 88 mg/kg - males
91 mg/kg - females
LD50 1000 mg/kg - males
900 mg/kg - females
LCSO 1 .56 mg/L both sexes
no corneal involvement
irritation cleared after 24 hours
not an, irritant
not a sensitizer
b. Exposure
There are potential exposures to mixers, loaders, applicators and other handlers
associated with seed treatment uses of lindane. Based on the use patterns, the Agency evaluated
six major worker exposure scenarios. Workers can be exposed to lindane through:
(1) on-farm seed treatment (mixing/loading/planting) with the dust formulation;
27
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(2) on-farm seed treatment (mixing/loading/planting) with the liquid formulation using a
closed transfer system;
(3) mixing/loading and applying the liquid formulation with commercial seed-treatment
equipment;
(4a) seed handlers at a commercial seed treatment facility (bagger/sewer/stacker);
(4b) seed handlers at a commercial seed treatment facility (forklift operator);
(5) seed handlers at a commercial seed treatment facility (cleaner); and
(6) loading and planting treated seed.
The Agency assumed that on-farm workers could be exposed to lindane for short-term (1-
30 days) durations, while commercial workers could be exposed for both short- and interrnediate-
term (1-6 months) durations. Several chemical-specific and surrogate chemical exposure studies
were available and considered to assess worker risks; therefore, the limited data on seed
treatment uses from the Pesticide Handlers Exposure Database (PHED) were not used.
On-farm seed treatment exposures with the dust formulation (scenario 1) were based on a
study that monitored four workers treating wheat seed in South Dakota with a dust formulation
containing 18.75% lindane (Fenske study, MRID 44405802). This study is considered to be
representative of manual seed treatments in the Midwest and was used as a surrogate to assess
other seed treatment as well. Dermal and respiratory exposures were measured during seed
treatment activities, during which workers wore the label-required long sleeve shirt, long pants,
chemical-resistant gloves, and a pesticide respirator (i.e., a half-mask, dual cartridge respirator
equipped with an organic vapor cartridge and dust filter).
To assess the exposures from on-farm treatment of the liquid formulation with a closed
transfer system (scenario 2) and commercial seed treatment activities with lindane (scenarios 3,
4a, 4b, and 5), the Agency considered all relevant data, including a study which was conducted at
three seed-treatment plants in Alberta, Canada. This seed treatment study met guideline
requirements, and was useful information because lindane was one of the active ingredients
being monitored (MRID 44731501). To refine this assessment, the Agency also used surrogate
data from a commercial seed treatment facility (Helix study, MRID 45200002), from which
median unit dermal and inhalation exposure measurements were available to assess risks to
various commercial seed treatment workers, including baggers, sewers, stackers, forklift
operators, and cleaners. Because the equipment used for on-farm treatment with the liquid
formulation has similar performance to the equipment used in the commercial facility, exposure
data from the Helix study was also used to refine the assessment for workers treating seeds for
this scenario (scenario 2). hi addition, the Agency used surrogate exposure data (Isophenfos
study, MRID 42251901) to assess loading and planting treated seeds (scenario 6).
Anticipated use patterns and application methods, and range of application rates were
derived from current product labeling. For lindane, the Agency based its assessment on the
amount of seeds that need to be treated to plant a certain number of acres in an 8 hour work day.
28
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Because of the amount of ai applied/100 Ib seed compared with the amount of seed
planted/A, wheat was assessed as a representative crop for barley, oats, and rye. Similarly, corn
was assessed as a representative crop for on-farm treatment of sorghum seed with lindane.
However, for occupational risks associated with commercial seed treatment practices, only wheat
was assessed to represent the supported seed treatment uses, and canola was assessed for
informational purposes because of the pending new use registration.
Occupational handler exposure assessments are conducted by the Agency using different
levels of personal protection. The Agency typically evaluates all exposures with minimal
baseline protection, and then adds additional protective measures using a tiered approach to
obtain an appropriate MOE (i.e., going from minimum to maximum levels of protection). For
this assessment, worker exposures are based on the personal protective equipment (PPE) used in
the chemical-specific studies and relevant commercial seed treatment studies, which are specified
in Table 12.
Due to the method of seed treatment with lindane, EPA has determined that when the
seeds are planted (soil incorporated), post-application agricultural exposure is considered to be
negligible, as long as the soil is not directly contacted. Therefore, a post-application
occupational risk assessment was not conducted.
c. Occupational Handler Risk Summary
Table 12 below summarizes the MOE values for both the short and/or intermediate-term
exposure durations for the six major worker exposure scenarios, including the PPE and/or
engineering controls used in the assessment. For the currently registered seed treatment uses
(i.e., excluding canofa), only one scenario (scenario 1; on-farm application of the dust
formulation) is below the target MOE of 100 and is of concern to the Agency. Because of the
rate of seeds planted per acre, the risk associated with lindane use on wheat seeds (dermal MOEs
9-17), which is representative of barley, oats, and rye, is much higher than the risk for lindane use
on corn seeds (dermal MOEs 26-92), which is representative of sorghum. All other scenarios for
currently registered uses result in MOEs that are greater than 100 and are not of concern.
For the on-farm worker scenario, dermal exposure rather than inhalation exposure
contributes relatively more exposure, and is considered the "risk driver" for this type of work
activity. Dermal and inhalation exposures were not combined in this assessment for the short
and intermediate-term MOEs because of different toxicological endpoints of concern. However,
even if dermal and inhalation exposures were combined, the overall results of the occupational
risks assessment will not change.
Note that different acres treated per day assumption were used to assess risks to on-farm
workers treating seeds with the dust formulation. These assumptions were based on the size of
the planter being used and the amount of seed that can be planted in a day. The 180 A/day
planting rate is an upper-bound estimate, based on use by some growers of 20-row corn planter.
The 100 A/day planting rate is based on use of a typical 8-row to 12-row planter used by most
growers.
29
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Table 12. MOEs for Workers Treating and Planting of Seeds
Exposure
Scenario (No.)
Data
Source
Crop
Application Rate
(Ibai/lOOlbseed)
Amount Handled/
Day (Ibs at)
[Acres Planted]
PPE
Short-Term MOEs
Dermal
Inhalation
On-Farm Seed Treatment
Mixing/loading/
planting dry
formulation (1)
Mixing/loading/
planting liquid
formulation-closed
transfer system (2)
Fensky
study
Helix
study
wheat3
cornb
wheat
canola
0.043
0.056
0.125
0.043
1.5
0.75
5 [100 A]
10 [200 A]
0.84 [100 A]
1.5 [180 A]
1.9 [100 A]
3.4 [180 A]
13
30
15
single-layer clothing,
gloves, and pesticide
respirator
coveralls, long-sleeved
shirt, long pants,
gloves, no respirator
•
17
9
92
60
48
26
67,000
29,000
57,000
1,100
550
6,500
3,700
3,000
1,700
5,900
2,500
5,000
Short- & Interra.-Term
MOEs
Commercial Seed Treatment
Mixing/loading/
application of
liquid formulation-
treater closed
system (3)
Seed Handler
bagger/sewer/
stacker (4a)
Helix
study
Helix
study
wheat
canola
wheat
canola
0.043
1.5
0.75
0.043
1.5
0.75
76
2640
1320
76
2640
1320
coveralls, long-sleeved
shirt, long pants,
chemical-resistant
gloves, no respirator
11,000
330
660
37,000
1,000
2,100
1,000
30
60
2,000
60
120
30
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Exposure
Scenario (No.)
Seed Handler-
forklift operator
(4b)
Seed Handler-
cleaner (5)
Data
Source
Helix
study
Helix
study
Crop
wheat
canola
N/A
Application Rate
(11) ai/100 Ib seed)
0.043
1.5
0.75
N/A
Amount Handled/
Day (Ibs ai)
[Acres Planted]
76
2640
1320
N/A
PPE
coveralls, long-sleeved
shirt, long pants,
chemical-resistant
gloves, no respirator
coveralls, long-sleeved
shirt, long pants,
chemical-resistant
gloves, no respirator
Short-Term MOEs
Dermal
119,000
3,400
6,800
1,800
Inhalation
16,000
450
900
110
Planting Treated Seed
Loading and
planting treated
seed (6)
Isophenfos
study
wheat
canola
0.043 [250]
1.5 [250]
0.75 [250]
13
30
15
single-layer clothing,
gloves, no respirator j
i
920
400
800
1,200
500
1,000
" Scenarios based on wheat also represent risks from use on barley, oats, and rye
b Scenarios based on corn also represent risks from use on sorghum
31
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d. Occupational Incident Reports
The Agency has conducted a review of reported poisoning incidents associated with
human exposure from occupational uses of lindane. The Agency has consulted the following
data bases for the poisoning incident data on the active ingredient lindane: Office of Pesticide
Programs (OPP) Incident Data System; Poison Control Center Data - 1993 through 1998;
California Data -1982 through 1998; and the National Pesticide Telecommunications Network.
The review only included lindane-containing products currently registered for use as a
seed treatment. Incidents due to all other types of lindane products were excluded. The OPP
Incident Data System includes incidents reported since 1992 from various sources, including
registrants, other Federal and state health and environmental agencies and individual consumers.
However, no incidents were reported in this system related to seed treatment use of lindane.
None of the cases reported to Poison Control Centers from 1993 through 1998 concerned
products identified as being used for seed treatment. However, it should be noted that nearly
one-third of the exposures involving lindane did not identify a specific product, but rather just
exposure to lindane.
Detailed descriptions of eight cases submitted to the California Pesticide Illness
Surveillance Program (1982-1998) were reviewed, hi three of these cases, lindane was deemed
the primary cause of the illness. All three incidents occurred in 1984 and involved driving and
filling planter hoppers with treated cotton seed. Two of the cases, apparently involving the same
operation, were both treated in a hospital and off work for 7 days. The third case was not treated
in a hospital, but was off work for 2 days. Specific symptoms were not reported for any of these
three cases. Although these incidents pertain to seed treatment activities for lindane use on
cotton, which is not a registered, there is insufficient information to draw any conclusions as to
whether these incidents were caused by applications in accordance with approved label
instructions or by misuse of the product.
The National Pesticide Telecommunications Network did not report on incidents
specifically related to lindane use for seed treatment. Relatively few incidents of illness have
been reported due to lindane used for seed treatment in California.
32
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B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. For
detailed discussions of all aspects of the environmental risk assessment, see Revised EFED RED
Chapter for Lindane dated July 31, 2002; Addition of corn andcanola seeds treatment use to
revised Lindane RED dated June 17, 2002; Lindane Food Chain Bio-Accumulation, -
Magnification and -Concentration dated June 17, 2002; and Qualitative Assessment of Long-
range Transport and Atmospheric Deposition of Lindane to Great Lakes dated June 17, 2002,
which are available in the public docket and on the internet at
http://www.epa.gov/pesticides/reregistration/lindane.
The lindane ecological risk assessment integrates the results of the exposure and
ecotoxicity data to evaluate the potential for adverse ecological effects. The method divides
exposure estimates, which are based on maximum application rates (worst case), by ecotoxicity
data to derive risk quotients (RQs) for acute and chronic effects. These RQ values are then
compared to the Agency's levels of concern (LOCs), which indicate whether a chemical, when
used as directed, has the potential to cause adverse effects on nontarget organisms. When the RQ
exceeds the LOG for a particular category, the Agency presumes a potential risk of concern to
that category. The LOCs and the corresponding risk presumptions are presented in Table 13.
Table 13. LOCs and Associated Ecological Risk Presumptions
IF...
THEN the Agency presumes...
Mammals and Birds
The acute RQ > LOG of 0.5,
The acute RQ >LOC of 0.2,
The acute RQ > LOG of 0.1,
The chronic RQ > LOC of 1
Acute risk
Risk that may be mitigated through restricted use
Acute effects may occur in endangered species
Chronic risk and
Chronic effects may occur in endangered species
Fish and Aquatic Invertebrates
The acute RQ > LOC of 0.5
The acute RQ > LOC of 0.1
The acute RQ >LOC of 0.05
The chronic RQ > LOC of 1
Acute risk
Risk that may be mitigated through restricted use
Acute effects may occur in endangered species
Chronic risk and
Chronic effects may occur in endangered species
Ecological effects data requirements and assessments for seed treatment pesticides are
normally based on the granular risk assessment methods. The seed treatment assessment process
is designed to assess lexicological endpoints according to application rates, application method,
and soil incorporation depth. Granules (seeds) are assumed to be consumed by terrestrial
wildlife, and exposure may be limited by type of application method.
33
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1. Environmental Fate and Transport
Lindane is persistent and moderately mobile. It has an estimated soil half-life of 2.6 years
and a mean K^. of 1368 mL/g. It is resistant to photolysis and hydrolysis (except at high pH), and
degrades very slowly by microbial actions. Because lindane is a relatively volatile, persistent and
lipophilic organochlorine pesticide, it can migrate over a long distance through various
environmental media such as air, water and sediment. Volatilization from soil and surface waters
is a major dissipation route for lindane. To a lesser degree, lindane can also enter the air as
adsorbed phase into suspended particulate matter. Lindane has often been detected hi ambient
air, precipitation, and surface water throughout North America, and 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 past widespread use in the U.S. and other countries, its extreme persistence, and to a lesser
extent, current seed treatment use which has been declining in recent years, and the
pharmaceutical use of lindane.
The Great Lakes Binational Toxics Strategy, which provides a framework for actions to
reduce or eliminate persistent toxic substances, especially those which bioaccumulate, from the
Great Lakes Basin, was developed jointly by Canada and the United States and signed April 7,
1997. For chemicals, such as lindane, that are designated as a Level II substance under the
Binational Strategy, pollution prevention activities are encouraged to reduce levels in the
environment.
The presence of lindane in atmosphere, natural water bodies, soils, and sediments of the
Great Lakes regions implies redeposition of lindane from secondary emissions (i.e.,
remobilization of lindane into the atmosphere from water bodies or ground surfaces) and long-
range transport of lindane from agricultural and Industrial sites. There is very limited
information available to link lindane loading from global, regional, or local sources to the Great
Lakes; however, reported concentrations in water samples from the channels of the Great Lakes
are very similar throughout the Great Lakes, which suggest that the atmosphere is the
predominant source of lindane. Some data indicate that lindane deposition from precipitation has
not changed since 1990. Moreover, the Integrated Atmospheric Deposition Network (LADN)
was established in 1990 by the United States and Canada to conduct air and precipitation
monitoring in the Great Lakes Basin to determine the magnitude and trends of atmospheric
loadings of toxic contaminants. LADN monitoring data from 1992 to 1998 indicate that the total
deposition of alpha-HCH, the use which was discontinued in the U.S. in 1977 and in Canada in
1978, has significantly decreased across the Great Lakes basin, and the deposition of lindane
(gamma-HCH) has also initially decreased but has remained relatively stable since 1995.
Considerable progress has been made hi monitoring and assessing the loading of lindane
and many other toxic contaminants for the Great Lakes regions. Nevertheless, there is limited
information available to understand the importance of long-range transport and atmospheric
deposition of toxic contaminants into the Great Lakes and their effects on the chronic exposure
of human, terrestrial, and aquatic organisms.
34
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2. Risk to Terrestrial Species
a. Toxicity (Hazard) Assessment
Lindane is classified as moderately toxic to birds and mammals following acute
exposures. Chronic effects to birds and mammals measured by reproduction studies show
adverse reproductive effects at low levels, with some effects indicative of endocrine disruption.
For birds, chronic reproductive effects include significant reductions in egg production, growth
and survival parameters, eggshell thinning and estradiol (a hormone associated with avian
reproduction) insufficiency in female birds, which may cause a drastic reduction in the number of
eggs produced. A statistically significant decrease in the number of viable embryos, live 3-week
embryos and normal hatchlings was observed when mallard duck mated pairs were fed diets
containing 45 ppm or more of lindane. Chronic reproductive effects in mammals include
disruption in male reproductive behavior and functioning, decreased viability in both generations
of offspring, and delayed maturation of second generation pups. In addition, lindane is a
lipophilic compound and has been found in milk from exposed lactating females. The acute and
chronic toxicity endpoints to assess terrestrial risks from lindane use are presented in Tables 14
and 15.
b. Exposure and Risk
Terrestrial wildlife can be exposed to lindane via ingestion of treated seeds, incidental
ingestion of soil while feeding or preening, ingestion of residues on soil-dwelling invertebrates
and plants, dermal contact, and inhalation. The assessment below bases acute exposure on the
quantity of seeds that a bird could ingest in one day and assumes the bird eats only lindane-
treated seeds. This terrestrial exposure assessment differs with other assessments that are based
on a Ib ai/A application rate, such as risks to aquatic species and even workers handling lindane
products. For instance, commodities such as corn that have a relatively lower Ib ai/A application
rate (0.0078 Ib ai/A) that result in low aquatic and occupational risks, but have a high rate of Ib
ai/100 Ib seed (0.125 Ib ai/100 Ib seed treatment rate), will result in relatively higher RQs to
terrestrial species, because there is more ai on any given seed.
Birds
For avian species, acute and chronic LOCs are exceeded for all seed-treatment uses of
lindane at current application rates. RQs range from 0.21-5.48 for acute risks, and 3.9-83.3 for
chronic risks for currently registered crops (i.e., excluding use on canola seeds). As noted
previously, RQs are calculated by dividing exposure estimates by ecotoxicity values, both acute
and chronic, for various wildlife species. The risk quotients are presented in Table 14 for avian
risk due to ingestion of lindane-treated seeds.
Although there is acute risk to songbirds and other similar seed eating avian species,
some studies have shown that birds, when given a choice of seeds, will preferentially eat seeds
not treated with lindane. Waterfowl and upland gamebirds are at a reduced acute risk from seed
treatment. Small birds, which consume proportionally larger quantities of food with respect to
35
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their body weight, are at greater risk than larger birds. Chronic risk to avian species may be
greater during breeding season due to high seed consumption over time and the persistence of the
compound in soil.
In addition, the results from two 14-day free choice avian dietary (aversion) toxicity
studies suggest that bobwhite quail and red-winged blackbirds are repelled by treated seeds.
These studies clearly suggested that birds avoided lindane treated food when given a choice, and
even in a no-choice situation, birds did not readily eat and were emaciated at study termination.
This conclusion is supported by a field study where lindane was substituted for heptaclor for
treatment of seed. The results of this field study are that lindane did not produce adverse effects
in birds, and residues were not detected in either their eggs or brains. This conclusion is further
supported by the fact that a lindane pesticide product was once register for use as a repellent to
pheasants (EPA Reg. No. 10182-31).
Table 14. Avian Acute/Chronic RQs for Lindane
Crop
barley
canola
corn
oats
rye
sorghum
wheat
Seed
concentration
(Ibai/
100 Ib seed)
.0375
1.456
0.72
0.125
0.0558
0.0313
0.0328
0.0628
0.0426
Acute RQs
Sparrow
M=75iBg*g)
1.10
42.6
21.0
3.67
1.64
0.92
0.96
1.84
1.25
{LDM=122
mg/kg)
0.25
9.9
4.9
0.85
0.38
0.21
0.22
0.43
0.29
Chronic RQs
Mallard
(NOAEC=
15 mg/kg)
25.0
970.7
480.0
83.3
37.2
20.8
21.9
41.9
28.4
Quail
(NOAEC=
SO mg/kg)
4.7
182.0
90.0
15.6
6.9
3.9
4.1
7.9
5.3
Mammals
For mammals, acute and chronic LOCs are exceeded for all seed treatment uses at current
application rates. The acute and chronic RQs are based solely on dietary exposure via ingestion
of lindane-treated seed. Since lindane is moderately to highly toxic to terrestrial vertebrates, low
level exposures by dermal, inhalation or oral routes considered singularly or in combination, can
result in significant impairment or death of exposed organisms. Furthermore, organisms which
survive acute exposure and predation may still experience reproductive impairment. Smaller
mammals are more vulnerable than larger mammals, especially those with high metabolic rates
that dig and cache seeds. Chronic risk to mammalian species may be greater during breeding
season due to high seed consumption over time and the persistence of the compound in soil.
Table 15 presents the calculated risk quotients for the mammalian risk due to lindane exposures.
36
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Table 15. Mammalian Acute/Chronic RQs for Lindane
Crop
barley
canola
corn
oats
rye
sorghum
wheat
Seed
concentration
(Ib ai/100 Ib
seedXv,
0.0375
1.456
0.72
0.125
0.0558
0.0313
0.0328
0.0628
0.0426
Acute RQs
(LD^SS rag/kg)
0.015 kg
mammal
0.62
24
12
2.1
0.92
0.51
0.54
1.0
0.70
0.035kg :
mammal
0.53
21
10
1.8
0.79
0.44
0.46
0.89
0.60
Ifcg
mammal
0.29
11
6
0.98
0.44
0.24
0.26
0.49
0.33
Chronic RQs
f NO AFP —
20mg/kg)
19
728
360
63
28
16
16
31
21
3. Risk to Aquatic Species
a. Toxicity (Hazard) Assessment
The available acute toxicity data on lindane indicate that it is very highly toxic to both
freshwater and estuarine species. Lindane-treated seeds planted in the ground may reach surface
water bodies through runoff from the site. Because of the high toxicity of lindane, small
quantities reaching surface water may kill aquatic organisms. Chronic data for freshwater
organisms show that reduced growth and reproduction were the most sensitive endpoints to
lindane testing. Also, no chronic toxicity data are available to assess estuarine and marine
organisms. Table 16 presents the toxicity endpoints that were used to assess risk to aquatic
species.
b. Exposure and Risk
Estimated environmental concentrations (EECs) used to assess potential surface water
exposure to aquatic species resulting from lindane use as a seed treatment were predicted with
the Tier I-Generic Estimated Environmental Concentrations (GENEEC) model. The peak EEC
from the model is 0.67 ppb, and the average EEC is 0.48 ppb. At current application rates used
for the seed treatment uses supported for reregistration, acute high risk and restricted use LOCs
are exceeded for both freshwater and estuarine/marine organisms. The acute RQs for aquatic risk
range from 0.04 to 12.2. The acute, restricted use, and endangered species LOCs are exceeded
for freshwater fish (RQ= 0.55) and freshwater invertebrates (RQ= 0.94). Although the acute,
restricted use, and endangered species LOCs were exceeded for estuarine/marine invertebrates
(RQ= 12.2), no estuarine/marine invertebrates are currently listed as endangered. No chronic
LOCs are exceeded for freshwater fish and invertebrates, although chronic risk to
estuarine/marine fish could not be assessed due to a lack of toxicity data. The acute and chronic
RQs are provided in Table 16. Note that lindane use on wheat seeds, which has the highest
application rate in terms of Ibs ai/A, was used as a surrogate to assess all seed treatment uses.
37
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Aquatic risk estimates are conservative, because they are based on the assumption that
100% of the lindane will disassociate from the treated seed and be available to migrate to surface
water after planting. However, some lindane from seed treatment may be expected to remain
with the seed/plant, or in the soil or volatilize. This assessment could be refined with a seed
leaching study and use of the more refined Tier IIPRZM/EXAMS surface water runoff model.
Table 16. Acute/Chronic RQs for Aquatic Species for Lindane
Crop
Wheat
Canola
Freshwater
Acute RQ
Fish
&&&=
1.7 ppb)
0.55
1.51
Invert
XtlCJjQ/ljC.JQ
=10.0 ppb)
0.94
2.57
Chronic RQ
Fish
(NOAEC
=2.9 ppb)
0.30
0.81
Invert
(NOAEC
=54 ppb)
0.02
0.05
Estaarrae/Marrae
Acute RQ
Fish
(LCM=
23 ppb)
0.04
0.11
Invert
{LCVECs.
=6.«77ppb)
12.2
33.40
Chronic RQ
Fish
Invert
Not evaluated
The Agency also assessed the risks associated with estimated concentrations of lindane in
surface water used as a source of drinking water from consumer use for both lice and scabies
treatments. As described earlier, this "down-the-drain" releases assessment, which is based on
the reported lindane concentration of discharged effluent from the Publically Owned Treatment
Works (POTWs) of Sanitation Districts of Los Angeles County, California, resulted in a peak
lindane surface water concentration of 3.97 x 10"4 ppb and average concentration of 3.06 x 10"5
ppb. These estimated concentrations of lindane are significantly lower than the EECs generated
by the GENEEC to assess aquatic risk; therefore, use of the lindane pharmaceutical products
would not result in higher aquatic RQs than those listed in Table 16.
4. Risk to Insects
Currently, EPA does not assess risk to nontarget insects; however, results of acceptable
studies are used for recommending appropriate label precautions. Although lindane is highly
toxic (0.2 to 0.56 fag/bee) to honeybees, risks should be low, because lindane is only used as a
seed treatment application (sub-soil). However beneficial soil dwelling insects may be at risk.
5.
Risk to Plants
There are no risks to plants of concern and no plant toxicity data are required. This
conclusion is based upon the current use pattern, low application rate, lack of incident data on
plants, and no available literature suggesting phytotoxicity.
6. Risk to Endangered Species
The Agency has developed the Endangered Species Protection Program to identify
pesticides whose use may cause adverse impacts on endangered and threatened species, and to
implement mitigation measures that address these impacts. The Endangered Species Act requires
Federal agencies to ensure that their actions are not likely to jeopardize listed species or
adversely modify designated critical habitat. To analyze the potential of registered pesticide uses
38
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to affect any particular species, EPA puts basic toxicity and exposure data developed for REDs
into context for individual listed species and their locations by evaluating important ecological
parameters, pesticide use information, the geographic relationship between specific pesticide
uses and species locations, and biological requirements and behavioral aspects of the particular
species. This analysis will take into consideration any regulatory changes recommended in this
RED that are being implemented at this time. A determination that there is a likelihood of
potential impact to a listed species may result in limitations on use of the pesticide, other
measures to mitigate any potential impact, or consultations with the U.S. Fish and Wildlife
Service (FWS) and/or the National Marine Fisheries Service (NMFS) as necessary.
The Agency's assessment suggests that endangered birds and especially small mammals
that eat a large daily proportion of seeds may be at risk from the current seed treatment uses.
Endangered freshwater fish and invertebrates may also be at acute risk. Also, exposed endangered
birds, mammals and possibly fish may be at risk due to the endocrine disrupting properties of
lindane combined with already limited population sizes and/or losses in critical habitat.
The endangered mammals that are potentially at risk from seeds treated with lindane are
the seed-eating rodents. They inhabit beaches and arid areas and are unlikely to forage in fields
with lindane-treated seeds. The risks to endangered seed-eating birds are mitigated by the fact
that they are not found in the vicinity of the grain crops that are treated with lindane, and also by
the results of the laboratory and field studies for lindane. These data showed that birds avoided
eating seeds treated with lindane under laboratory conditions and did not show signs of
intoxication through tissue residues or changes in reproductive success in field trials. Therefore,
there is a "no effect" determination for endangered birds and mammals from the seed treatment
use of lindane.
As discussed earlier, the model used to determine aquatic residues is conservative (it
assumes that 100% of the chemical leaves the seeds and runs off into the pond) and
overestimates the residues entering aquatic habitats. Therefore, the Agency does not have risk
concerns to endangered aquatic species, and is requiring seed leaching data as part of this RED to
confirm this determination. Once the aquatic exposure assessment is refined, the risks to
endangered aquatic species will be reassessed.
The endocrine-disrupting properties of lindane require future testing under the Endocrine
Disruptor Screening Program. Once these data are developed, the risk assessment for
endangered species can be further refined.
In 1983, the Agency requested a "case-by-case" opinion for a Section 18 (emergency use
exemption) for an at-planting, in-furrow treatment of sugarcane use in Florida. Jeopardy to the
snail kite, bald eagle and Florida panther was found from potential lindane use. The Agency
agreed with the jeopardy to the snail kite due to reductions to its food source (apple snails) from
the sugarcane use. However, this use is no longer registered.
The Reasonable and Prudent Alternatives in the 1983 Opinion pertain to a use no longer
registered and to type of exposure no longer applicable. Therefore, when the regulatory changes
39
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stipulated in this RED document are implemented, and the ecological effects and environmental
fate data are submitted and accepted by the Agency, a consultation on the uses specified in this
RED document may need to be initiated.
7. Ecological Incident Reports
Incident reports submitted to EPA involving lindane have been tracked by Incident Data
System (IDS) and entered into a second database, the Ecological Incident Information System
(EIIS). Since 1971, only four incidents which involve fish kills have been reported that are
related to lindane use. However, no aquatic incidents have been reported as having occurred
from treating seeds with lindane.
8. Bio-Accumulation Risks
Due to extensive use over the past 50 years, lindane is present in most environmental
media and biological compartments, and is present in terrestrial and aquatic food chains.
However, evidence suggests that concentrations have been gradually decreasing. The behavior of
HCH isomers in the environment is complex, because they are multimedia chemicals, existing
and exchanging among different compartments of the environment such as the atmosphere,
surface water, soil and sediment. The most common isomers found in the environment are
lindane (gamma-), alpha-, and beta-HCHs. The physical and chemical properties of these HCH
isomers are quite different from one another, which likely reflect some of the differences seen in
HCH isomer persistence and variability in bio-magnification, -concentration and -accumulation
in the various biological compartments. Differences in accumulation are also likely due to
different modes of uptake, metabolism and sources of contamination.
Bio-concentration factors (BCF) for lindane were 780x in fillet, 2500x in viscera, and
1400x in whole fish, which is partly due to high lipid solubility. Lindane can become enriched in
lipid-containing biological compartments. However, although lindane may bioconcentrate
rapidly, most data suggest bio-transformation, depuration, and elimination are relatively rapid
once exposure is eliminated. After a 28-day exposure and 14 days of depuration, levels were
reduced by 96%, 95%, and 85% in fillet, viscera, and in whole fish, respectively.
Bio-accumulation/food chain data from Russia and from Central/Western Canada suggest
that lindane seems to be the least likely of the HCH isomers to bio-accumulate/bio-magnify.
Other data indicate that upper trophic level mammals may be able to efficiently eliminate
lindane. Even though concentrations of HCH isomers were detected in surface waters of the
Arctic, bio-accumulation in the aquatic food chains was significantly less than the other
organochlorine compounds analyzed.
Overall, lindane seems to accumulate in the environment, but generally to a lesser extent
than either the alpha, and especially, the beta isomers. Generally, lindane tends to bio-magnify in
lower trophic levels where bio-transformation was minimal; however, because upper trophic
levels are able to depurate and eliminate the compound, lindane does not appear to readily work
its way up the food chain.
40
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IV. Risk Management and Reregistration Decision
A. Determination of Registration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active ingredient
are eligible for reregistration, which is set forth in the reregistration eligibility decision (RED).
The Agency has previously identified and required the submission of the generic (i.e., an active
ingredient specific) data required to support reregistration of products containing lindane active
ingredients. — . ;
The Agency has completed its assessment of the dietary, occupational, and ecological
risks associated with the use of currently registered pesticide products containing the active ,
ingredient lindane. Based on a review of these data and public comments on the Agency's
assessments for the active ingredient lindane, EPA has sufficient information on the human
health and ecological effects of lindane to make decisions as part of the tolerance reassessment
process under FFDCA and reregistration under FIFRA, as amended by FQPA.
EPA has determined that all existing tolerances for lindane should be revoked.
Consistent with longstanding EPA policy, the-reason for revoking these tolerances is that they are
no longer necessary because all lindane products for which the tolerances were originally
established have been canceled. In reaching this conclusion, the Agency does not need to make
any determination whether the exposures permitted under these tolerances would meet the
FFDCA safety standard.
EPA has determined that a number of changes to the terms and conditions of registration
of the seed treatment products are necessary to prevent "unreasonable adverse effects on the
environment." These changes are specified in section IV ,F of this document. In addition, EPA
has determined that the use of lindane for seed treatment is likely to result in residues in raw
agricultural commodities derived from plants grown from seeds treated with lindane. Therefore,
new tolerances are required before the currently registered lindane products may be reregistered.
EPA has identified additional data needed to characterize lindane metabolites in order to
complete its assessment of potential dietary risks. In summary, EPA finds that the currently
registered lindane seed treatment products would be eligible for reregistration if the registrants
make the changes to the terms and conditions specified in this document and provide the required
data, and EPA is able to establish all required tolerances for residues of lindane in food.
EPA notes that the establishment of new tolerances for the seed treatment uses of lindane
is conditioned on: 1) the receipt and review of additional data to characterize lindane
metabolites; and 2) EPA's ability to make a determination that establishing the new tolerances
meets the safety standard in FFDCA. Because EPA does not know what the data will indicate
about lindane metabolites, and for other reasons explained more fully below, EPA is unable to
determine whether it will be able to make a determination that new tolerances for lindane would
be safe.
41
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FFDCA § 408(b)(2)(A)(i) provides that EPA may establish a new tolerance "only if...
the tolerance is safe." The statute defines "safe" to mean "that there is a reasonable certainty that
no harm will result from aggregate exposure .. .." "Aggregate exposure" includes both exposure
to residues in food "and exposure from other non-occupational sources." See § 408(b)(2)(D)(vi).
In light of these statutory provisions, EPA is considering whether the statute requires the
Agency to include in its safety assessment those exposures resulting from the use of lindane in
pharmaceutical products. Lindane is currently approved by the Food and Drug Administration
for use in pharmaceutical products intended to control head lice and scabies. EPA and FDA have
worked together to examine the available data to assess the potential of lindane Pharmaceuticals
to cause adverse effects, sharing our assessments and commenting on the other agency's
assessments. As discussed more fully later in this document, although the information for
assessing risks is limited, the exposure and risk assessment indicates that the use of lindane for
head lice control does not pose risks of concern. The limited information available on the
scabies product, however, suggests that there is some possibility a portion of the patient
population using lindane for scabies control may experience adverse effects. FDA has taken
steps - including stronger warnings, clearer use directions, and other measures - to limit such
potential adverse effects. Based on these additional steps, FDA has concluded that the
therapeutic benefits of the lindane pharmaceutical products outweigh the limited potential to
cause adverse effects in the patient population. Therefore, FDA regards these products as safe
and effective for the purposes for which they were approved.
The existence of pharmaceutical sources of exposure to lindane raise questions of public
policy and statutory interpretation that have not been resolved. These questions include: whether
"aggregate exposure" encompasses exposures resulting from the use of lindane hi pharmaceutical
products; and if so, whether there is any reasonable statutory interpretation that could avoid
apparently questionable public policy results. EPA is particularly concerned that the statute be
interpreted and applied in a manner that yields results that are protective of public health and
consistent with common sense. If § 408 were interpreted to cover exposure from pharmaceutical
uses, then EPA might never be able to establish new tolerances, or to leave existing tolerances in
effect, for a substance that is used both as a pesticide and a pharmaceutical product, if the
pharmaceutical product caused adverse effects in humans. This result could occur regardless of
the level of risk posed by the exposures permitted under the tolerance(s) and their associated
pesticide registrations, and even though the pharmaceutical product has been deemed "safe and
effective." In other words, EPA would be concerned about relying on an interpretation of
FFDCA § 408 that could compel regulatory actions which would have no impact on the major
source of exposure, and where the source of such exposure is fully regulated and approved under
a public health standard.
EPA is interested in additional information and views that would help it determine how to
approach the issues discussed above. First, because there are many uncertainties about the extent
of risk from the use of lindane for scabies control, EPA encourages the development of
additional information that might support a more certain assessment of the potential risks of the
lindane scabies product. EPA is also continuing to pursue a dialogue with FDA to refine aspects
42
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of the analysis. Second, EPA invites'public comment on the regulatory and public policy
questions raised by the use of chemicals, such as lindane, both as pesticides and Pharmaceuticals.
There will be a 60-day public comment period for this document, commencing on the day the
Notice of Availability publishes in the Federal Register.
Finally, EPA notes that, in addition to the reviews of lindane described above, the
governments of Canada, Mexico and the United States are also considering joint actions to
reduce the risks associated with lindane. Specifically, the three countries, working through the
Commission for Environmental Cooperation (CEC), established by the North American
Agreement for Environmental Cooperation, have agreed to develop a North American Regional
Action Plan (NARAP) on lindane (CEC Council Resolution 02-07). The purpose of the NARAP
is to reduce environmental and health risks from lindane on a regional basis. The Agency is also
aware that internationally, other countries are taking significant actions to reduce and eliminate
risks from lindane.
B. Summary of Phase 5 Comments
The Agency considered all public comments received during Phase 5 of the Public
Participation Process. Comments related to new information in the risk assessment which
consisted (almost exclusively) of the Agency's revised cancer assessment were also solicited. A
brief summary of the comments is provided below. All of the submitted comments in their
entirety are available in the public docket, and the Agency's response to the comments
documents are also available in the docket and on the internet at
http ://www. epa. gov/pesticides/reregi stration/lindane.
Comments were received by the Natural Resources Defense Council (NRDC); Beyond
Pesticides; World Wildlife Fund; Alaska Department of Environmental Conservation; Farm
Workers Justice Fund, Inc.; National Pediculosis Association; Alaska Community Action on
Toxics; Pesticide Action Network North America; the Attorney General of the State of New
York; CA Regional Water Quality Control Board; Los Angeles County, CA Sanitation District;
Thompson Family Farms Ltd.; Technology Sciences Group; Uniroyal Chemical Company, and a
number of individuals.
Most of the comments received pertained to the Agency's methodologies and subsequent
conclusions in assessing risks associated with the use of lindane for seed treatment. For instance,
some commentors disagreed with the Agency's rationale for reducing the FQPA SF; disagreed
also with the Agency's cancer classification for lindane; expressed concern regarding endocrine
disruption from lindane, and the Agency not including breast milk exposure in the risk
assessment; recommended that risk to workers from dermal and inhalation exposure to lindane
should be combined; and noted that assessed surface water concentrations of lindane exceed
current EPA Water Quality Standards. Information on modern seed treatment technology was
also provided that helped refine occupational risks associated with commercial seed treatment.
43
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The Agency also received comments regarding the pharmaceutical uses (i.e., lice and
scabies treatments) of lindane. Comments were received that stressed the need for the Agency to
assess and consider as part of the lindane RED the direct exposure from human application of
these treatments, and the environmental and human health risk that result from the disposal of
this compound to waste water treatment facilities following the lice and/or scabies treatment. In
response, the Agency assessed, in cooperation with FDA, the risk associated with the direct
application to humans of lindane pharmaceutical products for the treatment of lice and scabies.
In addition, the Agency calculated the estimated concentrations of lindane in surface water used
as a source of drinking water which might result from consumer use of lindane for both lice and
scabies treatments. More detailed responses to these and other comments are available in the
public docket and on the internet.
C. Regulatory Position
1. FQPA Assessment
a. "Risk Cup" Determination
EPA assessed the risks associated with both the pesticide and pharmaceutical uses of
lindane. EPA has determined that risk from exposure to lindane from agricultural uses only is
within its own "risk cup" for pesticidal uses of lindane registered by EPA. In reaching this
determination, EPA has considered the available information on the special sensitivity of infants
and children, acute and chronic food and drinking water exposure, and the potential exposure to
indigenous populations in Alaska from subsistence diets. This assessment indicates that the
human health risks from these combined exposures are considered to be within acceptable levels,
and that the combined risks from all exposures to lindane from agricultural uses only "fit" within
the individual risk cup.
The Agency also evaluated exposures and risks associated with the pharmaceutical (i.e.,
lice and scabies treatment) uses of lindane. As noted previously, exposures associated with the
pharmaceutical use of lindane to treat lice do not pose risks of concern; however, the scabies
pharmaceutical use alone exceeds the Agency's level of concern.
b. Tolerance Summary
Tolerances for residues of lindane in/on raw agricultural and animal commodities are
established under 40 CFR §180.133 and expressed in terms of residues of lindane per se (gamma
isomer of benzene hexachloride). The residue definition for lindane should be amended as
follows to harmonize with International Union of Pure and Applied Chemistry (IUPAC)
nomenclature: gamma isomer of 1,2,3,4,5,6-hexachlorocyclohexane. Plant commodity
tolerances for lindane were originally established based on certain registered uses. Animal
commodity tolerances were established based on uses which included direct livestock animal
treatment as well as animal premise treatment. All of these uses have been cancelled and
associated tolerances should be revoked.
44
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The Agency considers lindane seed treatment as a food use requiring tolerances, based on
existing data from radiolabeled studies which indicate uptake of lindane residues from the treated
seeds into the aerial portion of the growing crop; therefore, tolerances need to be established for
the existing seed treatment uses.
While the nature of the residue in livestock is adequately understood, the nature of the
residue in plants is not adequately understood. Therefore, a new plant metabolism study starting
from seed treatment is required for a cereal grain. The EPA concluded that the total radioactive
residues (TRRs) should be used for risk assessment purposes and calculation of dietary burdens,
pending receipt of additional metabolism data.
The listing of lindane tolerances under 40 CFR §180.133 should be subdivided into parts
(a), (b), (c), and (d). Part (a) should be reserved for commodities with permanent tolerances, part
(b) for Section 18 emergency exemptions, part (c) for tolerances with regional registrations, and
part (d) for indirect or inadvertent residues.
Tolerances Listed Under 40 CFR §180.133
The established tolerances for the following commodities should be revoked: apples;
apricots; asparagus; avocados; broccoli; Brussels sprouts; cabbage; cauliflower; celery; cherry;
collards; cucumbers; eggplants; fat of meat from cattle, goats, horses, and sheep; fat of meat from
hogs; grapes; guavas; kale; kohlrabi; lettuce; mangoes; melons; mushrooms; mustard greens;
nectarines; okra; onions (dry bulb only); peaches; pears; pecans; peppers; pineapple; plums (fresh
prunes); pumpkins; quinces; spinach; squash; strawberries; summer squash; Swiss chard; and
tomatoes. The tolerances for these commodities are to be revoked, because the registrants do not
support these uses for reregistration, and have requested that these uses be deleted from the label.
These requests for use deletions have been published in the Federal Register on August 26, 1998
(Volume 63, Number 165, Page 45481-45483); September 30, 1998 (Volume 63, Number 189,
Pages 52257-52260); January 27, 1999 (Volume 64, Number 17, Pages 4096-4097); August 18,
2000 (Volume 65, Number 161, Page 50524-50526); June 13, 2002 (Volume 67, Number 67,
Page 40730-40732); and July 17, 2002 (Volume 67, Number 137, Page 46976-46978).
Additional notices announcing these use deletions from lindane labels are to be issued soon.
Tolerances To Be Proposed Under 40 CFR §180.133
Radiolabeled studies showed uptake of lindane from seed treatment into the aerial portion
of the plant; therefore, tolerances for lindane residues should be established for the treatment of
wheat, barley, oats, rye, corn, and sorghum seeds with lindane. Following resolutions of residue
chemistry data deficiencies, a statement in 40 CFR §180.133 should be added to specify that the
established tolerances result from seed treatment only. If EPA grants the pending application for
lindane use on canola seeds, a tolerance for this use is also required.
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Tolerance Reassessment Summary
The Agency's tolerance reassessment summary is provided in Table 17. This table lists
tolerances associated with uses that are no longer registered, as announced in several FIFRA
6(f)(l) Notices of Receipt of Requests from the registrant for cancellation and/or use deletions,
which EPA approved. Therefore, the tolerances for these commodities should be revoked.
Table 17. Tolerance Reassessment Summary for Lin dan e
Commodity
Tolerance Listed
Under 40 CFR (ppm)
Reassessed
Tolerance (ppm)
Comment
[Correct Commodity Definition]
Tolerance Listed trader 40 CFR §180.133
Apples
Apricots
Asparagus
Avocados
Broccoli
Brussels sprouts
Cabbage
Cauliflower
Lettuce
Spinach
Celery
Collards
Kale
Kohlrabi
Mustard greens
Swiss chard
Cherry
Cucumbers
Eggplants
Fat of meat from cattle,
goats, horses, and sheep
Fat of meat from hogs
Grapes
Guavas
Mangoes
Melons
Mushrooms
Nectarines
Okra
Onions (dry bulb only)
Peaches
Pears
1
I
1
1
1
1
1
1
3
1
1
1
1
1
1
1
1
3
1
7
4
1
1
1
3
3
1
1
. 1
1
1
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Uses have been deleted from the labels;
therefore, tolerances should be
revoked.
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Commodity
Pecans
Peppers
Pineapple
Plums (fresh prunes)
Pumpkins
Quinces
Squash
Strawberries
Summer squash
Tomatoes
Tolerance Listed
Under 40 CFR (ppm)
0.01
1
1
1
3
1
3
1
3
^
Reassessed
Tolerance (ppm)
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Revoke
Comment
[Correct Commodity Definition/
Codex Harmonization
The Codex Alimentarius Commission has established several maximum residue limits
(MRLs) for lindane in/on various plant and animal commodities. The Codex MRLs are
expressed in terms of gamma HCH (fat-soluble). With respect to tolerance expression, the
Codex MRL and U.S. tolerance for lindane are presently in harmony. However, the nature of the
residue in plants is currently not adequately understood. Pending the results of required
metabolism data, the Agency may determine that additional lindane metabolites should be
included in the U.S. tolerance expression.
A numerical comparison of the Codex MRLs and the corresponding reassessed U.S.
tolerances resulting from seed treatment is presented in Table 18. The established Codex MRL
and the recommended U.S. tolerances for cereal grains are not in harmony presumably because of
differences in good agricultural practices. Attempts to harmonize residue limits in animal
commodities cannot be made at this time because of several residue chemistry data gaps.
Table 18. Codex MRLs and Applicable U.S. Tolerances for Lindane
Codex
Commodity
(As Defined)
Apple
Beans (dry)
Brussels sprouts
Cabbage, Savoy
Cabbages, Head
Cacao beans
Carrot
Cauliflower
Cereal grains
MRL in mg/kg
(Step)
0.5 (CXL)2
. 1 (CXL) 3
0.5 (CXL)
0.5 (CXL)
0.5 (CXL)
l(CXL)
0.2 (CXL)
0.5 (CXL)
0.5 (CXL) 3
Reassessed U.S.
Tolerance, ppm '
Revoke
None established
Revoke
Revoke
Revoke
None established
None established
Revoke
To be determined (TBD)
for the grains of barley,
oats, rye, and wheat
Comments
Use deleted from the label
Not a registered use
Use deleted from the label
Use deleted from the label
Use deleted from the label
Not a registered use
Not a registered use
Use deleted from the label
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Codex
Commodity
(As Defined)
Cereal grains
Cherries
Cocoa butter
Cocoa mass
Cranberry
Currant, Red, White
Eggs
Endive
Grapes
Kohlrabi
Lettuce, Head
Meat of cattle, pigs,
and sheep
Milks
Pear
Peas (pods and
succulent = immature
seeds)
Plums (including
prunes)
Potato
Poultry meat
Radish
Rape seed
Spinach
Strawberry
Sugar beet
Sugar beet leaves or
tops
Tomato
MRL in mg/kg
(Step)
0.5 (CXL) 3
0.5 (CXL)
1 (CXL)
I (CXL)
3 (CXL)
0.5 (CXL)
0.1 (CXL)
2 (CXL)
0.5 (CXL)
l(CXL)
2 (CXL)
2 (CXL)
0.1 (CXL)
0.5 (CXL)
0.1 (CXL)
0.5 (CXL)
0.05 (CXL)
0.7 (CXL)
1 (CXL)
0.05 (CXL)
2 (CXL)
3 (CXL)
0.1 (CXL)
0.1 (CXL)
2 (CXL)
Reassessed U.S.
Tolerance, ppm *
To be determined (TBD)
for the grains of barley,
oats, rye, and wheat
Revoke
None established
None established
None established
None established
None established
None established
Revoke
Revoke
Revoke
None established
None established
Revoke
None established
Revoke
None established
None established
None established
None established
Revoke
Revoke
None established
None established
Revoke
Comments
Use deleted from the label
Not a registered use
Not a registered use
Not a registered use
Not a registered use
Not a registered use
Use deleted from the label
Use deleted from the label
Use deleted from the label
Use deleted from the label
Not a registered use
Use deleted from the label
Not a registered use
Not a registered use
Not a registered use
Use deleted from the label
Use deleted from the label
Not a registered use
Not a registered use
Use deleted from the label
Reassessed U.S. tolerances pending compliance by the registrants with the recommendations specified in
"GLN 860.1200: Directions for Use" section of the Agency's December 11,2001 Revised Product and
Residue Chemistry Chapters for the Lindane Registration Eligibility Document (RED).
CXL indicates that the Codex Alimentarius Commission accepted this as the final MRL for this commodity
Postharvest treatment of the commodity.
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c. Residue Analytical Methods
Adequate methods are available for determination of residues of lindaneper se in/on
plant and animal commodities. The Pesticide Analytical Manual (PAM) Vol. II lists Methods I
and II for the analysis of mixed isomers of 1,2,3,4,5,6-hexachlorocyclohexane in/on plant and
animal commodities. Method I is a multiresidue method (see "GLN 860.1360: Multiresidue
Methods: section) for the chlorinated compounds. Method II is based upon the official final
AOAC method (1990, 15th edition of AOAC) and is suitable for determining residues of lindane
in/on AOAC Group I nonfatty foods (vegetables and fruits), dairy products, fish, and eggs. The
stated limit of detection of Method II is 0.05 ppm for most commodities.
!U i.
The nature of the residue in plants resulting from seed treatment uses has not been
adequately delineated; therefore, the adequacy of the available analytical methods cannot be
determined. Radiovalidation of enforcement method(s) is a reregistration requirement; therefore,
representative samples from the ruminant metabolism study and the required plant metabolism
study should be used for radiovalidation and analyzed by the existing or proposed enforcement
method(s) to determine whether total toxic residues are extracted from weathered samples (i.e.,
residues that were present when the crop was growing).
Based on the results of the livestock metabolism study and the required nature of the
residue in plants study that is to be submitted, if the Agency determines that residues of concern
include metabolites in addition to lindane per se, then additional crop field trial data, magnitude
of the residue in poultry and cattle, and processing studies would be required. In addition, an
adequate residue analytical method and storage stability data would also be required.
2. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other such endocrine effects as the Administrator may designate."
Following the recommendations of its Endocrine Disrupter Screening and Testing Advisory
Committee (EDSTAC), EPA determined that there were scientific bases for including, as part of
the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that
effects in wildlife may help determine whether a substance may have an effect in humans,
FFDCA authority to require the wildlife evaluations. As the science develops and resources
allow, screening of additional hormone systems may be added to the Endocrine Disrupter
Screening Program (EDSP).
When the appropriate screening and/or testing protocols being considered under the
Agency's EDSP have been developed, lindane may be subjected to additional screening and/or
testing to better characterize effects related to endocrine disruption.
49
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D. Regulatory Rationale
Provided the following risk mitigation measures are incorporated in their entirety into
labels for lindane-containing products, the Agency finds that certain currently registered
agricultural (seed treatment) products would be eligible for reregistration if the registrants make
the changes to the terms and conditions specified in this document and provide the required data,
and EPA is able to establish all required tolerances for residues of lindane in food. The
regulatory rationale for each of the mitigation measures is discussed below. Where labeling
revisions are warranted, specific language is set forth in Table 19.
1. Human Health Risk Mitigation
a. Dietary Risk
Acute (Food)
The acute dietary (food) risk estimate for lindane is less than 100% of the aPAD for the
general population and all population subgroups. Infants (< 1 year), the most highly exposed
population group, are estimated to be exposed to lindane at a level of 17% of the aPAD at the
99.9th exposure percentile.
An acute dietary assessment of indigenous people in Alaska is not possible at this time,
because the Agency does not have the information on a typical day's diet of indigenous people.
Nevertheless, based on limited residue data, the Agency believes acute dietary (food) risks are
unlikely to be of concern because indigenous adults and children would have to consume more
than 50 Ibs and 10 Ibs, respectively, of game in a single day containing the maximum detected
lindane residues to exceed the aPAD. Hence, the acute dietary (food) risk estimate is not of
concern, and no additional mitigation measures are necessary to reduce these risks.
Chronic (Food)
The chronic dietary (food) risk estimate for lindane is less than 100% of the cPAD for the
general population and all population subgroups usually considered. Children (1-6 years), the
most highly exposed population group, are exposed to lindane at a level of 11% of the cPAD.
The chronic dietary (food) risks for indigenous people based on traditional foods are
generally not of concern. For the most highly exposed population group (children 1 -6 years), the
subsistence diet results in lindane exposure estimates that range from 13-65 % of the cPAD, with
the exception of a scenario which was 138% of the cPAD. This exception was for one
community where EPA included a number of conservative assumptions discussed below. For the
adult population the subsistence diet is 3-44% of the cPAD. For the risk to indigenous
50
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populations in Alaska, the Agency believes this assessment is conservative and probably over
estimates dietary risk because:
1. this assessment is based on the three communities with the highest dietary
exposure (highest harvest amounts of seal, whale^ and walrus) of approximately
180 Alaskan communities surveyed;
2. maximum detected residues in any game tissue were used to assess chronic
exposure;
3. whale, walrus and seal blubber residues were used to assess all meat residues,
even though meat is expected to have much lower lindane residues than blubber;
4. it was assumed that harvest was equal to intake (i.e., adults consume up to 2.4 Ibs
and children up to 1.3 Ibs of meat per day); and
5. children's consumption is based on data from the diet of 7-12 year-olds while the
risk assessment assumes the same amount is eaten for 1-6 year-olds.
Hence, the chronic dietary (food) risk estimate is not of concern, and no additional
mitigation measures are necessary to reduce these risks.
Drinking Water - Surface
Drinking water estimated concentrations (DWECs) from surface water sources were
derived from the FIRST model, which is a Tier I screening-level model designed to provide high-
end estimates of potential pesticide exposure in surface water sources of drinking water. Based
on the highest seed treatment/planting rate for the supported uses (wheat at 0.051 Ib ai/A), the
peak (acute) DWEC is 0.98 ppb and the and chronic (average) DWEC is 0.46 ppb.
Drinking Water - Ground
The Agency used the Tier I SCI-GROW screening-level model to estimate concentrations
of lindane in ground water. Based on the highest planted seed treatment rate for the supported
uses (wheat at 0.051 Ib ai/A), both the peak (acute) and chronic (average) DWEC is 0.011 ppb.
b.
Scabies Treatment
Pharmaceutical Risk
Lindane is also available, and regulated by FDA, for the treatment of scabies and head
lice. The Agency's assessment of risk from use of lindane to treat scabies uses data from both
animal and human blood levels, and provides a range of risk estimates. EPA's analysis using the
MOE approach indicates MOEs of concern from both high and low-end treatment scenarios and
using either monkey or human dermal absorption data. For the blood concentration analysis,
EPA compared adjusted blood concentrations from the scabies study with blood concentration
associated with short-term adverse effects in children. Based on the results of these analyses,
which also factors in some of the proposed mitigation efforts to be imposed by FDA, EPA is
51
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concerned that there is an inadequate margin of safety between blood levels associated with
scabies treatment and the blood levels known to produce short-term effects in children. Note,
however, that this assessment does not consider any of the medical benefits of scabies treatment.
As discussed previously in this chapter, the Agency is concerned that applying risk
mitigation measures to EPA regulated pesticides uses to address risks resulting from a FDA
regulated use does not represent sound public policy. This is underscored by the fact that
cancellation of all EPA registered pesticide uses would not be able to reduce exposures to a level
that does not exceed the Agency's level of concern.
In determining whether to approve drug for use, FDA considers the benefits associated
with its use. FDA conducted a risk/benefit analysis of use of lindane as a prescription medication
for scabies and concluded, based on that analysis, that lindane is safe and effective for treatment
of scabies when used as labeled. The safely and potential risks from use of lindane
Pharmaceuticals based on safety information from the AERS database current literature were also
assessed by FDA. FDA recognizes that all drugs have associated risks. Therefore, FDA must
determine if the risk is acceptable when compared to non-treatment of the condition (i.e., do the
potential risks or adverse side effects associated with a drug treatment outweigh the overall
health benefit of treating the condition). FDA has determined that there are other therapies for
the treatment of scabies that may have less risk associated with them, and thus, the label states
that lindane should be reserved for patients, 6twho have either failed to respond to adequate doses,
or are intolerant of, other approved therapies." These patients would have documented failed
prior treatment with other approved products, or documented reactions, either local or systemic,
to those products or drugs that would be expected to cross-react with those products. For the
indication of scabies, alternative therapies are limited.
Resistance to products is also considered when evaluating drugs. At this time, there is
documented resistance to lindane, which has been available since 1947. It should be noted that
there is no resistance to permethrin noted in the literature to date, but with increased usage, there
is a likely possibility that this will occur.
Based on this information, FDA has determined that lindane is safe and effective when
used as labeled, specifically when it is used as a second-line therapy, and when it is applied in the
manner and for the duration that appears in the label. Although there are other therapies
available for first-line use in the treatment of scabies and lice, it is in the best interest of the
public health to have several alternatives available because of existing and/or potential resistance
and because of potential patient intolerance.
According to FDA, the following measures are to be implemented to reduce over-usage
and increase the safe use of lindane for the treatment of scabies and pediculosis:
The manufacturer is to make available only single-dose units of the shampoo, lotion, and
cream (1-ounce packages) to reduce unnecessary, repeat applications.
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• New labeling for the scabies use will exclude the volume to be described and will
describe application as a thin layer.
The current label is to be revised to indicate that lindane is for use only for patients who
have attained adult stature (approximately 60 kilograms), to emphasizes that it should not
be used in young pediatric patients, and that patients should be post-pubescent.
The labeling is to be modified to more effectively communicate the appropriate use of the
products (lotion and shampoo). Using the product and not following current labeled
instructions has resulted in most of the adverse events.
The labeling for lindane 1% is to include a Medication Guide, available in Spanish as
well as English, that explains appropriate use and risks to the patient.
• A public information alert is to be issued to inform prescribers and the public about the
correct use of lindane <\ % products.
Furthermore, in accordance with Section 3 of the Best Pharmaceuticals for Children Act
of 2001, provides for a research fund for the study of drugs that lack patent or exclusivity. The
National Institutes of Health (NIH), in consultation with the FDA, has developed a list of drugs
that would be studied. The studies would be structured by the NIH and FDA to answer questions
that the FDA believes are necessary for labeling. The study request would first be issued to all
holders of the drug (in lindane's case it would be the generic drug companies), who then have 39
days to say whether or not they will conduct the studies. If they decline to conduct the study, the
NIH puts out a request for a proposal. If there is someone who is interested in doing the studies,
they would receive the grant, and then the results of the study would become public information
that can be incorporated into labeling. Lindane was recommended for placement on the list of
drugs that no longer have patent and that need additional studies. Although not yet been
specifically designed, FDA intends to request for general dosage and duration studies.
Lice Treatment
The Agency's assessment of risk from use of lindane to treat head lice relies on blood
level data provided in two published literature studies. The highest measured blood
concentration obtained following single and double treatments of head lice at label rates was
significantly lower than the blood level associated with acute accidental ingestion, which resulted
in short-term adverse effects according to the cited case study article. Therefore, the Agency
does not believe that lindane pharmaceutical products used for treatment of lice pose human
health risks of concern when used in accordance with directions provided on the label. In
addition, there are documented cases of resistance to all treatments that are currently indicated
for the treatment of head lice.
The current label and package volume for lindane shampoo is being changed consistent
with changes being made for the lindane lotion and include the same warnings and information.
The only difference will be the condition being treated and the instructions for use.
53
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Drinking Water Risks from Pharmaceutical Uses
The Agency used an exposure model to assess, the risks associated with estimated
concentrations of lindane in surface water from consumer use for both lice and scabies
treatments. Surface water concentrations were based on the average of reported lindane
concentrations in discharged effluent (0.03 ppb) from the Publically Owned Treatment Works
(POTWs) of Sanitation Districts of Los Angeles County, California.
As part of this assessment, the Agency assumed that the reported concentration of lindane
from wastewater treatment was discharged and instantaneously diluted into surface water where
no further removal (e.g., degradation, absorption, volatilization) occurs. Also, different stream
dilution factors, which are the volume of receiving stream flow compared with the volume of
wastewater released from the POTW, were assumed to estimate acute and chronic DWECs from
surface water sources. Based this information, the acute DWEC is 3.97 x 1Q'4 ppb and the
chronic DWEC is 3.06 x 10'5 ppb for the pharmaceutical use only of lindane. The Agency
believes that a conservative approach was used to estimate acute and chronic DWECs, because of
the instantaneous and upper-end stream dilution factors that were assumed in the assessment.
Therefore, because the DWECs are extremely low, and are considered upper-end values due to
the conservative assumptions used in the assessment, the Agency does not have risk concerns for
concentrations of lindane in surface water used as a source of drinking water from consumer use
for both lice and scabies treatments.
c. Risk for All Registered Pesticide Lindane Exposures
For lindane, risk assessments were conducted that included the combined risk from food
and drinking water exposures only. For acute and chronic exposure, the Agency uses the
DWLOC as a surrogate measure of risk associated with exposure from pesticides in drinking
water. The DWLOC is then compared with the DWEC to determine whether there is a potential
concern for exposure and risk.
Acute Risk
Based on the registered uses of lindane, the highest surface water acute DWEC of 0.98
ppb and ground water acute DWEC of 0.011 ppb resulted from lindane use on wheat seeds. As
indicated in Table 5, these DWECs are less than the acute DWLOC of 170 ppb for the most
sensitive population subgroup (infants < 1 year); therefore, acute risks associated with food and
drinking water exposures to lindane are not of concern to the Agency, and no further mitigation
measures are necessary.
Chronic Risk
Based on the registered uses of lindane, the highest surface water chronic DWEC of 0.46
ppb and ground water chronic DWEC of 0.011 ppb resulted from lindane use on wheat seeds.
54
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As indicated in Table 5, these DWECs are less than the chronic DWLOC of 14 ppb for the most
sensitive population subgroup (children 1-6 years); therefore, chronic risks associated with food
and drinking water exposures to lindane are not of concern to the Agency, and no further
mitigation measures are necessary.
Special Populations
For the indigenous people of the Arctic region of the U.S. (Alaska), the Agency has
insufficient quantitative information on lindane concentrations in Alaskan drinking water sources
to estimate chronic exposure to lindane in food and drinking water is of concern to the Agency.
However, it is expected that the background environmental levels of lindane in Alaska are much
less than the calculated chronic DWEC (0.46 ppb) for surface water sources from seed treatment
uses of lindane. Nevertheless, the chronic DWEC of 0.46 ppb, which is based on seed treatment
use, is significantly less than the calculated chronic DWLOC of 6 ppb for children and 31 ppb for
adults. The chronic DWLOC calculations are derived from the conservative subsistence dietary
food exposure estimates for all but the one Alaskan community which resulted in 138% of the
cPAD being consumed by the children (\-.6 years) subpopulation. For the reasons discussed
previously, the Agency believes this assessment is conservative and probably overestimates
dietary risk; therefore, and chronic dietary risk does not pose a risk concern to the Agency and
not further measures are necessary to mitigate these risks.
d. Occupational Risk
On-Farm Seed Treatment
Dust Formulation
As indicated in Table 12, for the currently registered seed treatment uses (excluding
canola), on-farm treatment with the dust formulation (scenario 1) is below the target MOE of 100
and is of concern to the Agency. Because of the rate of seeds planted per acre, the risk associated
with the use of the dust formulation on wheat seeds (dermal MOEs 9-17), which is representative
of barley, oats, and rye, is much higher than the risk for lindane use on corn seeds (dermal MOEs
26-92), which is representative of sorghum. In response to these risk concerns, the registrant has
voluntarily agreed to discontinue on-farm treatment with the dust formulation for wheat, barley,
oats, and rye, and reduce the maximum application rate for corn from 0.125 Ib ai/100 Ib seed to
0.0558 Ib ai/100 Ib seed. As a result of this rate reduction, the corresponding dermal MOEs for
on-farm treatment of corn and sorghums seeds with the dust formulation are 60 and 92,
depending upon the size of the planter and the amount of seed planted in a day. Inhalation MOEs
are 3,700 and 6,500 respectively, and are not of risk concern. However, wheat, barley, oats, and
rye seeds may still be treated with the liquid formulation on-farm with the use of a closed transfer
system, or at a commercial treatment facility (see below).
Thus, the remaining uses that are available for on-farm treatment with the dust
formulation are corn and sorghum seeds. Based on the proposed lower seed treatment rate and
55
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the seeding rate of 15 Ibs seed/A for corn, the estimate amount of Undone applied to the field is
0.00837 Ib ai/A. Although the maximum application rate for lindane use on sorghum is slightly
higher (0.0628 Ib ai/100 Ib seed) than for com, the typical seeding rate is much lower (6.76 Ibs
seed/A), resulting in a rate of 0.00425 Ib ai/A of lindane being applied to the field when planting
sorghum seeds. As a result, the total amount of lindane being handled by workers and the
associated risk to treat and/or plant 180 acres of sorghum in a day will be about 2X less than the
amount of lindane and risks to treat and/or plant corn. Hence, risks associated with on-farm
treatment of corn seeds are protective of the risks for treating sorghum seeds with lindane.
As stated previously, the assessed risks to workers treating com and sorghum seeds with
the dust formulation were based on the size of the planter and the amount of seed planted in a
day. MOEs were calculated for the amount of seeds that need to be treated to plant 180 A/day
and 100 A/day. The 180 A/day is an upper-bound estimate, based on use by some growers of a
20-row corn planter. However, the Agency recognizes that the typical sized planter used by corn
growers is 8-row to 12-row. It is estimated that a grower using a 8-row or 12-row planter will
only be able to plant about 100 A in a work day, when including the amount of time needed to
treat the seed with the dust formulation. As indicated in Table 12, the risks associated with
treating corn with the dust formulation at the proposed lower application rate, and assuming the
grower is using a typical 8-row or 12-row planter, result in an MOE of 92, which is slightly
below the target MOE of 100 and not of concern to the Agency.
As noted in Table 12, the PPE utilized in the chemical-specific exposure study was
single-layer clothing, gloves, and a respirator, which resulted in dermal MOEs for on-farm
treatment of corn and sorghum seeds with the dust formulation are less than the target MOE. To
mitigate the dermal risk concern, especially for the MOE of 60 at a planting rate of 180 A/day,
double-layer clothing (coveralls over single-layer clothing) needs to be employed. The Agency
believes that this added PPE is adequately protective to reduce dermal exposure below the level
of concern. Moreover, the calculated inhalation MOEs, which are based on the use of a half-
mask, dual cartridge respirator equipped with an organic vapor cartridge and dust filter, are
significantly greater than the target MOE. Because of this substantial MOE exceedance, it is
appropriate to reduce the level of inhalation PPE for workers treating com and sorghum seeds
on-farm with the dust formulation to a dust/mist respirator for products that contain lindane only
as the active ingredient. The Agency acknowledges that there are some end-use products that
contain other active ingredients in addition to lindane, and that the use of more protective PPE
may be necessary, because of the inclusion of these other active ingredients in the product
formulation. The Agency believes that this reduction on inhalation PPE is protective and will not
result in exposures of concern. Therefore, to mitigate on-farm treatment of corn and sorghum
seeds with the dust formulation, the following mitigation measures needs to be implemented:
workers must wear double layer clothing (coveralls over long-sleeved shirt and long
pants, chemical-resistant footwear), chemical-resistant gloves, and a dust/mist respirator;
and
• reduce the maximum application rate for com to 0.0558 Ib ai/100 Ib seed.
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Furthermore, the exposure study for lindane treatment of wheat seeds from which the risk
estimates for scenario 1 were derived involved workers scooping pesticide from open 10 Ib bags
of product and mixing the pesticide in the seed hopper with a stick. It is likely that some of the
exposure to these workers occurred during the removal of lindane from the bag with a hand-held
scoop. Current packaging for some end-use products of the dust formulation is much smaller
(1.5 oz) and pre-measured for ease of use (one packet per seed hopper). In addition, some end-
use products are also packaged in a small cylindrical container that is inserted into a tube
applicator, which applies the product to the seed while the tube is inserted into the seed, thus
minimizing potential exposure to the dust formulation. The tube is also used as a device to mix
the product with the seed. Although not all registered products of the dust formulation are
packaged in small pre-measured packets or cylindrical containers to be used with a tube
applicator/mixing device, that Agency acknowledges that these efforts help further reduce
exposure to workers. However, the Agency does not believe that these specific packaging and
application device measures are necessary to be imposed for all end-use product labels.
Liquid Formulation
The other scenario of on-farm treatment of seeds with the liquid formulation using a
closed transfer system resulted in MOEs significantly greater than the target MOE of 100 and are
not of concern. Therefore, for the on-farm treatment of seeds with the liquid formulation in a
closed transfer system for currently registered uses (scenario 2), no further measures are
necessary to mitigate these risks. Because the calculated dermal MOEs are significantly greater
than the target MOE, and current practices specified by the Worker Protection Standard allow a
reduction of PPE when engineering controls are used, it is appropriate to reduce the level of PPE
utilized during the surrogate exposure study. Workers treating seeds on-farm with the liquid
formulation using a closed transfer system are to use single-layer clothing (long-sleeved shirt,
long pants, shoes and socks), gloves, and a chemical-resistant apron. The Agency believes that
these PPE reductions are protective and will not result in exposures of concern.
Commercial Seed Treatment
As indicated in Table 12, the MOEs associated with the work activities in treating seeds
with lindane in a commercial facility are above the target MOE of 100 and are not of concern to
the Agency, except for two scenarios that involve treatment of canola seeds (scenarios 3 and 4a).
Therefore, for the treatment of seeds currently registered, no farther measures are necessary to
mitigate these risks, provided the PPE utilized during the surrogate exposure study are employed
(i.e., double-layer clothing and gloves). However, because the calculated dermal MOEs are
significantly greater than the target MOE, and the Agency traditionally allows handlers to reduce
their PPE when using engineering controls, it is appropriate to reduce the level of PPE for
workers in commercial seed treatment facilities to single-layer clothing (long-sleeved shirt, long
pants, shoes and socks) and gloves, and a chemical-resistant apron. The Agency believes that
these PPE reductions are protective and will not result in exposures of concern.
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Planting Treated Seed
The scenario of loading and planting treated seed (including canola), whether treated on-
farm or received from a commercial facility, resulted in MOEs greater than the target MOE of
100 and are not of concern. Therefore, no further measures beyond the PPE utilized in the
surrogate study are necessary to mitigate these risks (scenario 5), which includes single layer
clothing (long-sleeved shirt, long pants, shoes and socks) and gloves.
Post-Application Risk
Because lindane is used in agriculture only as a seed treatment, EPA has determined that
post-application exposure to agricultural workers is unlikely as long as workers are not
performing tasks that involve contact with or disruption of the soil subsurface where treated seed
has recently been planted. In accordance with the Worker Protection Standard (WPS), the
restricted-entry interval (REI), based on the acute toxicity of technical lindane (Table 11), is 24
hours. Note, however, that under the "No Contact" early entry exception in the WPS, workers
may reenter treated areas during the REI once the application is finished as long as they will not
contact anything that has been treated with the pesticide. Therefore, the Agency has no risk
concerns for post-application exposures to agricultural workers, and no risk mitigation measures
are necessary beyond the 24 hour REI. Also, provided the soil is not disturbed and there is no
contact with the treated seeds, workers may enter the planted field during the 24-hour REI.
2. Environmental Risk Mitigation
The Agency's assessment suggests that the use of lindane can result in adverse acute and
chronic effects to terrestrial organisms, and adverse acute effects to aquatic organisms. Lindane
is a potential endocrine disrupter in birds, mammals, and possibly fish.
Birds
The Agency has acute and chronic risks of concern for birds that may be exposed to
lindane. For the currently registered uses of lindane, the RQs for acute exposure range from 0.21
to 5.48, and the RQs for chronic exposure range from 3.9 to 83.3. The highest RQs for acute
and chronic risks are based on lindane use on corn seeds. To help mitigate occupational risks
associated with on-farm treatment of corn seeds, the registrant has agreed to reduce the
maximum application rate from 0.125 to 0.0558 Ib ai/100 Ib seed; thereby reducing the highest
acute RQ for from 5.48 to 2.75, and the highest chronic RQ from 83.3 to 41.9. Currently, almost
all corn seed treatment occurs on-farm, however, the corresponding rate for commercial seed
treatment will also be lowered to 0.0558 Ib ai/100 Ib seed. With the reduction of the corn
application rate, the maximum application rates for all of the registered uses of lindane are
comparable (within a factor of about 2X or less), which results in the corresponding avian RQs
also being in the same range.
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In addition, the results of two avian dietary aversion toxicity studies suggest that birds are
repelled by treated seeds. These studies clearly suggested that birds avoided Hndane treated food
when given a choice, and even in a no-choice situation, birds did not readily eat and were
emaciated at study termination. In fact, lindane was once register for use as a repellent to
pheasants. This conclusion is also supported by a field study where lindane was substituted for
heptaclor for treatment of seed. It was determined from this study that lindane did not produce
adverse effects in birds and residues were not detected in either their eggs or brains. Hence, the
Agency believes that the risk to birds by treating certain seeds with lindane are lower than the
current risk assessment suggests and not of concern; therefore, no further measures are necessary
to mitigate these risks.
Mammals
Similar to birds, the Agency has acute and chronic risks of concern for mammals,
particularly small mammals that eat and cache seeds. For the currently registered uses of lindane,
the RQs for acute exposure range from 0.24 to 2.1, and the RQs from chronic exposure range
from 16 to 63 with the highest RQ based on corn use as well. To help mitigate occupational risks
associated with the on-farm treatment of corn seeds, the registrant has agreed to reduce the
maximum application rate from 0.125 to 0.0558 Ib ai/100 Ib seed. Reducing the maximum
application rate will also reduce the highest acute RQs from 2.1 to 1.0, and the chronic RQ from
63 to 31. Likewise with the avian risk assessment, this measure results in the maximum
application rates and corresponding mammalian RQs for all of the registered uses of lindane to
be comparable (within a factor of about 2X or less).
It is important to note that because mammals hold territories, the peak RQs discussed in
this section only apply to local populations of mammals that dig and feed on seeds, and where
lindane treated seeds are planted. On average, approximately 6% of the corn and 1% of the
sorghum that is planted in the U.S. is treated with lindane. The Agency believes that the local
population of mammals that may be exposed to lindane treated seed is low. Moreover, although
there are no data available to demonstrate that mammals avoid consuming lindane treated seeds
as do birds, mammals may be similarly adverse to eating seeds treated with lindane. Therefore,
actual exposure to mammals could be lower. For these reasons, the Agency believes that no
further measures are necessary to mitigate these risks.
A quatic Species
. The Agency has acute risks of concern for freshwater fish and invertebrates, and estuarine
marine invertebrates, with RQs that range from 0.55 to 12.2. The chronic risk RQs for
freshwater fish and invertebrates are less than 1.0 and are not of concern to the Agency. EPA has
not received any chronic aquatic toxicity data for estuarine and marine fish or invertebrates.
Aquatic risks are based on a Tier I surface water runoff model (GENEEC), and the
assumption that 100% of the compound will disassociate from the seed surface, which has likely
produced conservative estimates that overestimate the environmental concentrations and
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resulting risks to aquatic species. Actual aquatic risks are expected to be lower; therefore, the
Agency does not have risk concerns to aquatic species, and is requiring seed leaching data as part
of this RED to confirm this determination.
Endangered Species Statetnen t
The Agency is currently engaged in a Proactive Conservation Review with the U.S. Fish
and Wildlife Service (FWS) and the National Marine Fisheries Service under section 7(a)(l) of
the Endangered Species Act. The objective of this review is to clarify and develop consistent
processes for endangered species risk assessments and consultations. Subsequent to the
completion of this process, the Agency will reassess the potential effects of lindane use to
Federally listed threatened and endangered species. At that time, the Agency will also consider
any regulatory changes recommended in the RED document that are being implemented. Until
such time as this analysis is completed, the overall environmental effects mitigation strategy
articulated in this document will serve as interim protection measures to reduce the likelihood
that endangered and threatened species may be exposed to lindane at levels of concern.
The Endangered Species Protection Program as described in a Federal Register notice (54
FR 27984-28008, July 3, 1989) is currently being implemented on an interim basis. As part of
the interim program, the Agency has developed County Specific Pamphlets that articulate many
of the specific measures outlined in the Biological Opinions issued to date. The Pamphlets are
available for voluntary use by pesticide applicators on EPA's website at www.epa.gov/espp. A
final Endangered Species Protection Program, which may be altered from the interim program,
will soon be proposed for public comment in the Federal Register in 2002.
E. Labeling Statements
Other use and safety information needs to be placed on the labeling of all end-use
products containing lindane. For the specific labeling statements, refer to Section V of this
document
For manufacturing-use products, the following statement needs to be added on the label:
"This pesticide is toxic to fish, birds, and other wildlife. Do not discharge effluent containing
this product into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance
with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit
and the permitting authority has been notified in writing prior to discharge. Do not discharge
effluent containing this product into sewer systems without previously notifying the sewage
treatment plant authority. For guidance contact your State Water Board or Regional Office of the
US EPA."
For end-use products, the following statement needs to be added on the label: "This
product is toxic to fish, birds, and other wildlife. Exposed treated seeds may be hazardous to
birds and other wildlife. Dispose of all excess treated seeds by burial away from bodies of water.
Do not contaminate water by disposing of equipment washwaters. Apply this product only as
specified on the label."
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F. Lindane Risk Mitigation Summary
The following is a summary of the risk mitigation measures that are necessary to be
incorporated in their entirety into labels for lindane-containing products. Specific language for
these revisions is set forth in Table 19 of this document. Likewise, the data required to be
provided to the Agency to confirm these regulatory decisions are also listed in Section V.
Prohibit on-farm treatment of wheat, barley, oats, and rye with the lindane dust
formulation.
Reduce maximum application rate for corn to 0.0558 Ib ai/100 Ib seed.
• Workers must wear double layer clothing (coveralls over long-sleeved shirt and
long pants, chemical-resistant footwear), chemical-resistant gloves, and a
dust/mist respirator for on-farm treatment of corn and sorghum seeds only with
the dust formulation.
• A 24 hour REI for all seed treatment uses.
• All lindane end-use product labels need to specify a 30-day plantback interval for
leafy vegetables and a 12-month plantback interval for all other unregistered
crops. The registrant has the option to conduct a confined accumulation of
rotational crops (OPPTS 860.1850) study to potentially reduce these plantback
intervals.
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V. What Registrants Need to Do
EPA finds that the currently registered lindane seed treatment products would be eligible
for reregistration if the registrants make the changes to the terms and conditions specified in this
document and provide the required data, and EPA is able to establish all required tolerances for
residues of lindane in food. To implement the risk mitigation measures, the registrants must
amend their product labeling to incorporate the label statements set forth in the Label Summary
Table in Section V.jD below. The additional data requirements that the Agency intends to obtain
will include, among other things, submission of the following:
A. For lindane technical grade active ingredient products, registrants need to submit
the following items.
Within 90 days from receipt of the generic data call-in (DCI):
(1) completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
(2) submit any time extension and/or waiver requests with a full written
justification.
Within the time limit specified in the generic DCI:
(1) cite any existing generic data which address data requirements or submit new
generic data responding to the DCI.
Please contact Mark Howard at (703) 308-8172 with questions regarding generic
reregistration and/or the DCI. All materials submitted in response to the generic DCI should be
addressed:
Bv US mail:
Document Processing Desk (DCVSRRD)
Mark Howard
US EPA (7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
Bv express or courier service:
Document Processing Desk (DCI/SRRD)
Mark Howard
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
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B. For products containing the active ingredient lindane, registrants need to submit
the following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
(1) completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and
(2) submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
(1) two copies of the confidential statement of formula (EPA Form 8570-4);
(2) a completed original application for reregistration (EPA Form 8570-1).
Indicate on the form that it is an "application for reregistration";
(3) five copies of the draft label incorporating all label amendments outlined in
Table 19 of this document;
(4) a completed form certifying compliance with data compensation requirements
(EPA Form 8570-34);
(5) if applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
(6) the product-specific data responding to the PDCI.
Please contact Karen Jones at (703) 308-8047 with questions regarding product
reregistration and/or the PDCI. All materials submitted in response to the PDCI should be
addressed:
By US mail:
Document Processing Desk (PDCI/PRB)
Karen Jones
US EPA (7508C)
1200 Pennsylvania Ave., NW
Washington, DC 20460
By express or courier service only:
Document Processing Desk (PDCI/PRB)
Karen Jones
Office of Pesticide Programs (7508C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Highway
Arlington, VA 22202
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A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration determination of Hndane for the above
uses has been reviewed and determined to be substantially complete. However, the following
data requirements are necessary to confirm the reregistration decision documented in this RED:
Product and Residue Chemistry
OPPTS 830.1550, Product identity and description
• OPPTS 830.1620, Description of the production process
OPPTS 830.6314, Oxidation/reduction: chemical incompatibility
OPPTS 830.6316, Explodability
OPPTS 830.6317, Storage stability
OPPTS 830.6320, Corrosive characteristic
OPPTS 830.7050, UV/Visible light absorption
The Agency acknowledges that data in response to these and other product and residue
chemistry study requirements (i.e., OPPTS 830.1600, 830.1700, 830.1750) included in the 1985
Registration Standard DCI for lindane have been submitted to the Agency and are being
reviewed. Even though data have been submitted, the data requirements listed above are
included in the generic DCI accompanying this lindane RED document.
* OPPTS 860.1300, Nature of residue (plant metabolism study). A new nature of
the residue study is required for application of lindane as a seed treatment to a
cereal grain. This data requirement is included in the 1985 Registration Standard
DCI for lindane and remains outstanding. Because this data requirement is listed
in the 1985 DCI, it is not being repeated in the DCI accompanying this lindane
RED document.
Environmental Fate
Seed leaching (Special Study, OPPTS guideline number not yet established)
If, after submission of an acceptable cereal grain seed treatment metabolism study, the
Agency determines the residues of concern to include metabolites in addition to lindane per se,
the following additional data will be required, and are listed in the DCI accompanying this RED
document as reserved:
OPPTS 860.1500, Crop field trials for wheat and corn (Reserved)
OPPTS 860.1480, Magnitude of the residue in poultry and cattle (Reserved)
OPPTS 860.1520, Processed food/feed (Reserved)
OPPTS 860.1340, Residue analytical method (Reserved)
OPPTS 860.1380, Storage stability (Reserved)
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2. Labeling for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing-use product (MP) labeling should
be revised to comply with all current EPA regulations, PR Notices and applicable policies. The
MP labeling should bear the labeling contained in Table 19 at the end of this section.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination regarding eligibility has been made.
Registrants must review previous data submissions to ensure that they meet current EPA
acceptance criteria and if not, commit to conduct new studies. If a registrant believes that
previously submitted data meet current testing standards, then the study MRID numbers should
be cited according to the instructions in the Requirement Status and Registrants Response Form
provided for each product. A PDCI, outlining specific data requirements, accompanies this RED.
2. Labeling for End-Use Products
Labeling changes are necessary to implement the mitigation measures outlined in Section
IV above. Specific language to incorporate these changes is specified in the Table 19 at the end
of this section.
C. Existing Stocks
Existing stocks time frames are established case-by-case, depending on the number of
products involved, the number of label changes, and other factors. Refer to "Existing Stocks of
Pesticide Products; Statement of Policy;" Federal Register, Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell lindane products bearing old
labels/labeling for 26 months from the date of issuance of this RED. Persons other than the
registrant may distribute or sell such products for 50 months from the date of the issuance of this
RED. Registrants and persons other than the registrant remain obligated to meet pre-existing
label requirements and existing stocks requirements applicable to products they sell or distribute.
D. Labeling Changes Summary Table
Table 19 describes how language on the labels should be amended to incorporate the risk
mitigation measures outlined in Section IV.
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Table 19: Summary of Labeling Changes for Lindane
Description
Labeling
Placement on Label
Formulation Instructions
Required on All MUPs
"Only for formulation into an insecticide for the following use(s)" [fill blank only with those uses that are
being supported by MP registrant}.
"Dust formulations made from this MUP are for on-farm treatment of corn and sorghum seeds only."
"Liquid formulations made from this MLJP are for commercial or on-farm seed treatment for barley,
wheat, corn, oats, rye, and sorghum with a closed transfer system only."
Directions for Use
One of these statements may
be added to a label to allow
reformulation of the product
for a specific use or all
additional uses supported by
a formulator or user group
"This product may be used to formulate products for specific use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S. EPA submission requirements regarding
support of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S. EPA submission requirements regarding
support of such use(s)."
Directions for Use
Environmental Hazards
Statements Required by the
RED and Agency Label
Policies
"Environmental Hazards"
"This pesticide is toxic to fish, birds, and other wildlife. Do not discharge effluent containing this product
into lakes, streams, ponds, estuaries, oceans, or other waters unless in accordance with the requirements of
a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been
notified in writing prior to discharge. Do not discharge effluent containing this product into sewer
systems without previously notifying the sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the US EPA."
Precautionary Statements
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Description
Labeling
Placement on Label
Handler PPE Guidelines (al!
formulations)
Note the following information when preparing labeling for all end use products:
For sole-active-ingredient end-use products that contain Lindane, the product label must be revised to
adopt the handler personal protective equipment (PPE)/engineering control requirements set forth in this
section. Any conflicting PPE requirements on the current label must be removed.
For multiple-active-ingredient end-use products that contain Lindane, the handler PPE/engineering
control requirements set forth in this section must be compared with the requirements on the current label,
and the more protective language must be retained. For guidance on which requirements are considered
to be more protective, see PR Notice 93-7.
PPE that will be established on the basis of Acute Toxicity testing on end-use products undergoing
product reregistration must be compared with the active ingredient PPE specified below by the RED. The
more protective PPE must be placed in the product labeling. For guidance on which PPE is considered
more protective, see PR Notice 93-7.
Handler PPE Statements
PPE Established by the RED
for Dust Formulations.
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are (registrant inserts correct chemical-
resistant material), "If you want more options, follow the instructions for category" [registrant inserts
A,B,C,D,E,F,G,or H] "on an EPA chemical-resistance category selection chart."
"Mixers, loaders, applicators and other handlers, including persons handling or planting treated seeds,
must wear:
- Coveralls over long-sleeved shirt and long pants
- Chemical-resistant footwear plus socks
- Chemical-resistant gloves
- A NIOSH-approved dust/mist filtering respirator with MSHA/NIOSH approval number prefix TC-21C
or a NIOSH-approved respirator with any N, R, P, or HE filter."
Note to Registrant: If the product contains oil or bears instructions that will allow application with an
oil-containing material, the "N" filter designation must be dropped from the above respirator statement.
Precautionary Statements:
Immediately
following/below Hazards
to Humans and Domestic
Animals
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Description
Labeling
Placement on Label
PPE Established by the RED
for Liquid Formulations.
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are" (registrant inserts correct chemical-
resistant material). "If you want more options, follow the instructions for category [registrant inserts
A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection chart."
"Handlers using closed systems and handlers planting or otherwise handling treated seed must wear:
- Long-sleeved shirt and long pants,
- Shoes plus socks,
- Chemical-resistant gloves,
- Chemical-resistant apron when mixing, loading or treating seeds on farm."
"Handlers exposed to the concentrate while performing tasks such as equipment or spill clean-up, for
which engineering controls are not feasible must wear:
- Coveralls over long-sleeved shirt and long pants,
- Chemical-resistant footwear plus socks,
- Chemical-resistant gloves,
- Chemical-resistant apron."
"See engineering controls for additional requirements."
Precautionary Statements:
Immediately
following/below Hazards
to Humans and Domestic
Animals
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables
exist, use detergent and hot water. Keep and wash PPE separately from other laundry."
"Discard clothing and other absorbent materials that have been drenched or heavily contaminated with
this product's concentrate. Do not reuse them."
Precautionary Statements:
Immediately following
the PPE requirements
Engineering Controls
for Dust Formulations
"When handlers use enclosed cabs in a manner that meets the requirements listed in the Worker
Protection Standard (WPS) for agricultural pesticides (40 CFR 170.240(d)(4-6)t the handler PPE
requirements may be reduced or modified as specified in the WPS."
Precautionary Statements;
Immediately following
the User Safety
Requirements _
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Description
Labeling
Placement on Label
Engineering Controls
for Liquid Formulations
(only products marketed in
closed system compatible
packages will be eligible for
Reregistration for on-farm
seed treatment)
"Engineering Controls"
"Seeds must be treated using a closed system that meets the requirements listed in the Worker Protection
Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(4)] for dermal protection, and must:
~ wear the personal protective equipment required above handlers using a closed system,
- wear protective eyewear if the system operates under pressure, and
-- be provided and have immediately available for use in an emergency, such as a broken
package, spill, or equipment breakdown the PPE specified for handlers exposed to the
concentrate that are performing tasks for which engineering controls are not feasible."
Precautionary Statements:
Immediately following
the User Safety
Requirements
User Safety
Recommendations
"User Safety Recommendations"
"Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet."
"Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put
on clean clothing."
"Users should remove PPE immediately after handling this product. Wash the outside of gloves before
removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary Statements:
Immediately following
Engineering Controls) •
Must be placed in a box
Environmental Hazards
"Environmental Hazards"
"This product is toxic to fish, birds, and other wildlife. Exposed treated seeds may be hazardous to birds
and other wildlife. Dispose of all excess treated seeds by burial away from bodies of water. Do not
contaminate water by disposing of equipment washwaters. Apply this product only as specified on the
label." !
Precautionary Statements:
Immediately following
the User Safety
Recommendations
69
-------
Description
Labeling
Placement on Label
Restricted Entry Interval
(REI),
"Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 24
hours:"
"Exception: if the product is soil-injected or soil-incorporated, the Worker Protection Standard, under
certain circumstances, allows workers to enter the treated areas without restriction if there will be no
contact with anything that has been treated."
Agricultural Use
Requirements Box.
Early Entry PPE
PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and
that involves contact with anything that has been treated, such as plants, soil, or water, is:
* coveralls worn over short-sleeve shirt and short pants,
* chemical-resistant gloves made of any waterproof material, and
* chemical-resistant footwear plus socks."
Agricultural Use
Requirements Box.
General Application
Restrictions
"Do not apply this product in a way that will contact workers or other persons, either directly or through
drift. Only protected handlers may be in the area during application."
Place in the Directions for
Use
70
-------
Description
Labeling
Placement on Label
Other Risk Mitigation
Restrictions
All Formulations:
Labels must be amended to reflect a reduced application rate for corn of 0.0558 Ibs of a.i. per 100 Ib seed.
Labels must reflect the following maximum application rates for wheat: 0.0426 Ibs of a.i. per 100 Ib seed;
barley: 0.0375 Ibs of a.i. per 100 Ib seed; oats: 0.03125 Ibs of a.i. per 100 Ib seed; rye: 0.0328 Ibs of a.i.
per 100 Ib seed; sorghum: 0.0628 Ibs of a.i. per 100 Ib seed.
A plant-back interval of 30 days for leafy vegetables and 12 months for all unregistered crops must be
placed on the label.
Dust Formulations:
"This product may only be used as an on-farm seed treatment for corn and sorghum.".
(All other crop sites must be removed from the label)
Liquid Formulations:
"This product may only be used as a commercial or on-farm seed treatment for barley, wheat, corn, oats,
rye, and sorghum."
(All other crop sites must be removed from the label)
"Labels attached to the treated seed must read:
i
Persons handling treated seed must wear long-sleeved shirt and long pants plus chemical-resistant gloves
made out of any waterproof material. Treated seed must not be used or mixed with food or animal feed or
processed for oil. Exposed treated seeds may be hazardous to birds and other wildlife. Dispose of all
excess treated seed and seed packaging by burial away from bodies of water.
Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 24 hours.
Exception: if the product is soil-injected or soil-incorporated, the Worker Protection Standard, under
certain circumstances, allows workers to enter the treated areas without restriction if there will be no
contact with anything that has been treated."
Directions for Use
71
-------
72
-------
APPENDICES
73
-------
APPENDIX A: Lindane Use Patterns Reflecting Label Changes
Crop
Corn
Sorghum
Barley
Formulation and % ai
8.6% RTU
18.75% Dust
25% Dust
99.5% Powder (Technical Product)
18.75% RTU
16.6% Dust
99.5% Powder (Technical Product)
25% Dust
16.6% Dust
18.75% Dust
40% EC
8.6% RTU
99.5% Powder (Technical Product)
30% FC
25% RTU
8% RTU
18.75% RTU
30% EC
25% EC
EPA Reg. No.
554-140
554-142,7501-37,34704-737,42056-15
1381-165, 7501-38, 7501-1 12, 34704-674, 42056-1 1,66330-19
655-28, 5481-225, 19713-61,19713-91,40083-1
7501-152
42056-14
655-28,5481-225, 19713-61, 19713-191,40083-1
7501-38
42056-14
42056-15
400-490, 544-144
554-140
655-28, 5481-225, 19713-61, 19713-191
7501-34, 19713-387
7501-78
7501-141
7501-152 :
19713-401
34704-674
Maximum Seed
Treatment Rate
(Ibs ai/CTW
seed)
0.0558
i
0.0628
0.0375
Maximum
Planting
Rate
(Ibs seed/A)
14
9
96
74
-------
Crop
Oats
Rye
Wheat
Formulation and % ai
40% EC
8.6% RTU
99.5% Powder (Technical Product)
30% FC
8% RTU
18.75% RTU
30% EC
25% EC
6.5% RTU
40.0% EC
8.6% RTU
99.5% Powder (Technical Product)
30% FC
30% EC
25% EC
6.5% RTU
40% RTU
8.6% RTU
40% EC
99.5% Powder (Technical Product)
30% FC
30% EC
25% RTU
25% EC
6.5% RTU
EPA Reg. No.
400-490,554-144
54-140
655-28,5481-225, 19713-61, 19713-191,40083-1
7501-34, 19713-387
7501-141
7501-152
19713-401
34704-674
42056-16
400-490, 554-144
554-140
655-28,5481-225, 19713-61, 19713-191,40083-1
19713-387
19173-401
34704-674
42056-16
400-490
554-140
554-144
655-28, 5481-225, 19713-61, 19713-191, 40083-1
7501-34, 19713-387
19713-401
7501-78
34704-674
42056-160
Maximum Seed
Treatment Rate
(Ibs ai/CTW
seed)
0.03125
0.0328
0.0426
Maximum
Planting
Rate
(Ibs seed/A)
80
84
120
75
-------
APPENDIX B: Data Supporting Guideline Requirements for the Reregistration of Lindane
GUIDELINE REQUIREMENT
Sew Guideline
Number
Old
Guideline
Number
Study Title
USE
PATTERN
CITATION(S)
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1670
830.1700
830,1750
830.1800
830.6302
830.6303
830.6304
830.7050
830-7200
830.7300
830.7840
830.7860
830.7950
830.7550
830.6313
830.6314
830.6316
830.6317
830.6320
61-1
61-2A
6 1-2 A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
None
63-5
63-7
63-8
63-9
63-11
63-13
63-14
63-16
63-17
63-20
deduct Identity and Composition
Start. Mat. & Mnfg. Process
Description of production process
rormation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
UV/Visible Absorption
Melting Point
Density
Solubility (Shake Flask Method)
Vapor Pressure
Octanol/Water Partition
Coefficient
Stability
Oxidizing/Reducing Action
Explodability
Storage Stability
Corrosion characteristics
All
All
AH
AH
All
All
All
All
All
All
All
All
AH
AH
All
All
Confidential Statement of Formula
45426601
45426601
45426601
45426602, 45426603, 45426604,
45426605
Acceptable*
45426606
00072468
00118743
00102995
Data Gap
00118743
00072468
00118712
00118743
00160130
00072468
45426607, Data Gap (Sept.1985
DCI)
45436608
45426609, Data Gap (Sept.1985
DCI)
45426610
76
-------
GUIDELINE REQUIREMENT
New Guideline
Number
Old
Guideline
Number
Study Title
USE
PATTERN
CITATION(S)
d ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
850.2400
850.2300
850.2300
850.2500
850.1075
850.1075
850.1010
850.1010
850.1075
850.1055
None
850.1400
None
850.1450
850.1850
850.3020
71-1
7 1-2 A
71-2B
71-3
71-4A
71-4B
71-5(b)
72-1 A
72- 1C
72-2A
72-2B
72-3A
72-3B
72-3C
72-4A
72-4B
72-4D
72-6
141-1
Avian Acute Oral Toxicity
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Wild Mammal Toxicity
Avian Reproduction - Quail
Avian Reproduction - Duck
Terrestrial Wildlife Field Test
Fish Toxicity Biuegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Invertebrate Toxicity - TEP
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
Fish- Early Life Stage-Freshwater
Estuarine/Marine Invertebrate Life
Cycle
Freshwater Invertebrate Life-
Cycle
Aquatic Food Chain Transfer
Honey Bee Acute Contact
ABN
ABN
AB
AB
AB
AB
AB
AB
ABN
ABN
AB
AB
AB
AB
AB
AB
AB
00161629, 00020560, 00160000
0002293, 40056103, 40056104
44867101
Reserved
44812201
44867101
Waived
40094602, 40098001
40098001,40094602
40094602
40094602, 40098001
40098001
44355501, 00161764, 40098001
40094602,40098001
44405401,40056105
44405402,40056106
44405402,40056106
40056102
00036935,05001991
77
-------
GUIDELINE REQUIREMENT
New Guideline
Number
Old
Guideline
Number
Study Title
USE
PATTERN
CITATION(S)
TOXICOLOGY
870. U 00
870.1200
870.1300
870.2400
870.2500
870.2600
870.6200
870.3100
870.3150
870.3200
870.3250
870.3465
870.3800
870.6200
870.4100
870.4100
870.4200
870.4200
870.4300
870.3700
870.3700
870.3800
870.5140
870.5300
870.6200
870.6200
870.6300
870.7600
81-1
81-2
81-3
81-4
81-5
81-6
81-8
82-1 A
82- IB
82-2
82-3
82^1
82-5b
83-1A
83- IB
83-2A
83-2B
83-5
83-3A
83-3B
83-4
84-2A
84-2
81-8A
81-8B
83-6
85-2
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-Rabbit/Rat
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
Acute Neurotoxicity Screen
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21 -Day Dermal - Rabbit/Rat
90-day Subchronic Dermal
Toxicity Test, Rat
90-Day Inhalation-Rat
Reproductive & Fertility Effects
90-day neurotoxicity - mammal
Chronic Feeding Toxicity -
Rodent
Chronic Feeding Toxicity -
Non-Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Combined chronic toxicity/
Oncogenicity feeding - Rat
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
Gene Mutation in Mammalian
Cells
Acute Neurotoxicity Screening
Battery- Rat
Subchronic Neurotoxicity
Screening Battery- Rat
Developmental Neurotoxicity- Rat
Dermal Penetration
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
ABN
00049330
00109141
00161631
00161632
00161633
00161634
44769201
Satisfied under 870.4300
Satisfied under 870.4300
41427601
41427601
00145073,40873501
42246101
44781101
Satisfied under 870.4300
Satisfied under 870.4300
Satisfied under 870.4300
45291402
41094101,41853701,42891201
00062656, 42808001
00062658, 42808002 (both studies
supplemental when considered
together)
00049330,42246101
00142715
00144500
44769201
44781101
45073501
40056107,40056108
78
-------
GUIDELINE REQUIREMENT
New Guideline
Number
Old
Guideline
Number
Study Title
USE
PATTERN
CITATION(S)
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2400
875.2500
None
None
133-3
133-4
231
232
Dermal Passive Dosimetry
Exposure
Inhalation Passive Dosimetry
Exposure
Estimation of Dermal Exposure at
Outdoor Sites
Estimation of Inhalation Exposure
at Outdoor Sites
ABN
ABH
AB
AB
45200002, 44405802, 42251901,
44731501
45200002, 44405802, 42251901,
44731501
45200002, 44405802, 42251901,
44731501
45200002, 44405802, 42251901,
44731501
79
-------
GUIDELINE REQUIREMENT
New Guideline
Number
Old
Guideline
Number
Study Title
USE
PATTERN
CITATION(S)
ENVIRONMENTAL FATE
None
835.2120
835.2240
835.2410
835.2370
835.4100
835.4200
835.1240
835.1410
835.6100
835.6300
None
850.1730
None
835.SS01
160-5
161-1
161-2
161-3
161-4
162-1
162-2
163-1
163-2
164-1
164-3
165-3
165-4
165-5
None
Chemical Identity
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Photodegradation - Air
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Leaching/ Adsorption/Desorption
Laboratory Volatilization (from
Soil) Study
Terrestrial Field Dissipation
Forestry Field Dissipation
Accumulation in irrigated crops
Bioaccumulation in Fish
Bio-accumulation, non target
Seed Leaching Study
ABN
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
Acceptable*
00161630
00164545, 00164547, 44793101
44440605
Waived
40622501
Data gap (Sept. 1 985 DCI)
00164346, 00164538, 40067301
Waived
40622502, 44867103
Waived
Waived
40056101,40056102
Reserved (Sept. 1985 DCI)
Data Gap
80
-------
GUIDELINE REQUIREMENT
New Guideline
Number
Old
Guideline
Number
Study Title
USE
PATTERN
CITATION(S)
RESIDUE CHEMISTRY
860.1100
860.1300
860.1300
860.1340
860.1340
860.1380
860.1380
860.1480
860.1500
860.1500
860.1520
860.1520
860.1850
860.1900
171-2
171-4A
171-4B
171-4C
171-4D
171-4E
171-4E
171-4J
171-4K
171-4K
171-4L
171-4L
165-1
165-2
Chemical Identity
Nature of Residue - Plants
Nature of Residue - Livestock
animals
Residue Analytical Method -
Plants
Residue Analytical Method -
Animals
Storage Stability-Plants
Storage Stability-Animals
Magnitude of Residues -
Meat/Milk/Poultry/Egg
Crop Field Trials - Corn
Crop Field Trials - Wheat
Process Food/Feed - Corn
Process Food/Feed - Wheat
Confined Rotational Crop study
Field Rotational Crop Study
ABN
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
Acceptable*
1985 Lindane Reregistration
Standard*, 00025707, 00060143,
00060150, 00105413, 44383001,
44383002, 44405403, Data Gap
(Sept. 1985 DCI)
1985 Lindane Reregistration
Standard*, 4027 1301, 4027 1 302,
44405404, 44867 1 04, 45224 101,
45224102, 45277201, 40271301
1985 Lindane Reregistration
Standard*, 050063 1 2, 4043 1 202,
40431206 , 44383003 , 44383004,
44909901, Reserved
1985 Lindane Reregistration
Standard*, 00025690, ,00032233,
00099909, 05002348, 05003005,
40431208, 44440601, 44867105,
Reserved
40431203, 40431205, 41699701,
44440602,44909901
Data Gap (Sept. 1985 DCI)
40660502, 44440603, 44867106,
Reserved (Sept. 1985 DCI)
1985 Lindane Reregistration
Standard*, 00025685, 00045126,
00075989, 00088048, 00088165,
00089592, 00101478, 00104441,
00118722, 00118723, 00118724,
00118725, 001 18739, 40660503,
40660504, 40660505, 40660501,
44440604, Reserved
Reserved
Reserved
Reserved
Reserved
Waived
Reserved
No MRID assigned.
81
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APPENDIX C: EPA's Technical Support Documents for Lindane
All technical support documents for the Hndane RED may be viewed either on paper at the
OPP Public Docket or via the Internet. The paper documentation in support of this RED is
maintained in the OPP docket: Room 119, Crystal Mall #2,1921 Jefferson Davis Highway,
Arlington, VA. It is open Monday through Friday, excluding Federal holidays, from 8:30 am to 4
pm. Electronic copies of these documents are maintained at the following sites:
www.epa.gov/pesticides/reregistration/status.htm (the OPP website) or
http://cascade.epa.gov/RightSite/dk _public home.htm. under docket number OPP-2002-0202
(EPA's e-dockets site).
These documents include the following:
Human Health Risk Assessment Documents
1. Rebecca Daiss (USEPA/OPPTS/OPP/HED). Revised RED Risk Assessment for Lindane.
July 31,2002.
2. Rebecca Daiss (USEPA/OPPTS/OPP/HED). Revised Assessment of Risk from Use of Lindane
for Treatment of Lice and Scabies. July 30, 2002.
3. Thurston Morton (USEPA/OPPTS/OPP/HED). Revised Anticipated Residues and Dietary Risk
Analysis. December 13, 2001.
4. Thurston Morton (USEPA/OPPTS/OPP/HED). Revised (Product and Residue) Chemistry
Chapter. December 11, 2001.
5. Thurston Morton (USEPA/OPPTS/OPP/HED). Revised Dietary Risk and Exposure Estimate
for Lindane Through Subsistence Diets for Indigenous People of Alaska. April 17, 2002.
6. Suhair Shallal. (USEPA/OPPTS/OPP/HED). Toxicology Chapter. September 28, 2000.
7. Brenda Tarplee (USEPA/OPPTS/OPP/HED). FQPA Safety Factor Report. August 2, 2002.
8. Suhair Shallal. (USEPA/OPPTS/OPP/HED). Lindane - A Second Report of the Hazard
Identification Assessment Review Committee. June 18,2001.
9. Suhair Shallal and Sanjivani Diwan. (USEPA/OPPTS/OPP/HED/CARC). Cancer Assessment
Document: Evaluation of Carcinogenic Potential of Lindane. November 29, 2001.
10. David Jaquith. (USEPA/OPPTS/OPP/HED). Lindane: Revision of Exposure Assessment for
Commercial Seed Treatment Plant Worker. April 23,2002.
11. David Jaquith. (USEPA/OPPTS/OPP/HED). Revision of Exposure Assessment for Planting of
Seed Treated with Lindane. April 24,2002.
12. David Jaquith. (USEPA/OPPTS/OPP/HED). Revision of Exposure Assessment of Workers for
On Farm Seed Treatment with Lindane Using Open and Closed Systems and Planting Treated
Seed. June 4,2002.
82
-------
Environmental Fate and Ecological Effects Documents
13. Nick Federoff (USEPA/OPPTS/OPP/EFED). Revised EFED RED Chapter for Lindane.
July 31, 2002.
14. Nick Federoff (USEPA/OPPTS/OPP/EFED). Addition of Corn and Canola Seed Treatment
Use to Revised Lindane RED. June 17, 2002.
15. Faruque A. Khan (USEPA/OPPTS/OPP/EFED). Qualitative Assessment of Long-Range
Transport and Atmospheric Deposition of Lindane to [the] Great Lakes. June 17, 2002.
16. Faruque A. Khan (USEPA/OPPTS/OPP/EFED). Correction in Qualitative Assessment of
Long-Range Transport and Atmospheric Deposition of Lindane to Great Lakes. July 31, 2002.
17. Nick Federoff (USEPA/OPPTS/OPP/EFED). Lindane Food Chain Bio-Accumulation,
Magnification, and Concentration. June 17, 2002.
18. Faruque A. Khan (USEPA/OPPTS/OPP/EFED). Estimated Concentrations of Lindane in
Surface Water Used as a Source of Drinking Water From Use and Disposal of Shampoo and
Lotions Into Household Wastewater. April 25,2002.
Use, Usage, and Benefits Documents
19. Istanbul Yusuf (USEPA/OPPTS/OPP/BEAD). Quantitative Usage Analysis of Lindane.
February 27, 2002.
20. David Brassard (USEPA/OPPTS/OPP/BEAD). BEAD'S Impact Analysis of the Seed
Treatment Use of Lindane on Wheat, Barley, Oats, Rye, Corn, Sorghum, and Canola.
February 5,2002.
21. David Brassard (USEPA/OPPTS/OPP/BEAD). BEAD Review of Korpalski Handler
Exposure Assessment for Lindane Use as a Seed Treatment in the US. May 15, 2002.
22. David Brassard (USEPA/OPPTS/OPP/BEAD). Revised Number of Acres Treated per Day for
Lindane Seed Treatment Use on Field Corn. June 26,2002.
83
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APPENDIX D: MRID Bibliography for Lindane
GUIDE TO APPENDIX D.
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the
Reregistration Eligibility Document. Primary sources for studies in this bibliography have
been the body of data submitted to EPA and its predecessor agencies in support of past
regulatory decisions. Selections from other sources including the published literature, in those
instances where they have been considered,'are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger volumes in which they were submitted. The
resulting "studies" generally have a distinct title (or at least a single subject), can stand alone
for purposes of review and can be described with a conventional bibliographic citation. The
Agency has also attempted to unite basic documents and commentaries upon them, treating
them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID" number. This number is unique to the citation, and
should be used whenever a specific reference is required. It is not related to the six-digit
"Accession Number" which has been used to identify volumes of submitted studies (see
paragraph 4(d)(4) below for further explanation), hi a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier.
These entries are listed after all MRID entries. This temporary identifying number is also to be
used whenever specific reference is needed.
4. FORM OF ENTRY, hi addition to the Master Record Identifier (MRID), each entry consists of
a citation containing standard elements followed, in the case of material submitted to EPA, by a
description of the earliest known submission. Bibliographic conventions used reflect the
standard of the American National Standards Institute (ANSI), expanded to provide for certain
special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to
show a personal author. When no individual was identified, the Agency has shown an
identifiable laboratory or testing facility as the author. When no author or laboratory could
be identified, the Agency has shown the first submitter as the author.
84
-------
contained in the document. When the date appears as (1999), the Agency was unable to
determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears immediately
following the word "received."
(2) Administrative number. The next element immediately following the word "under" is
the registration number, experimental use permit number, petition number, or other
administrative number associated with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the original
submission of the study appears. The six-digit accession number follows the symbol
"CDL," which stands for "Company Data Library." This accession number is in turn
followed by an alphabetic suffix which shows the relative position of the study within
the volume.
85
-------
MRID
Citation
0006455 Dill, R.; Mobley, J.E. (1976) Evaluation of CGA-43089 as a Safener on Grain
Sorghum Where Dual Is Applied Preemergence: Test No. SE OH 318 76.
(Unpublished study received Dec 14,1976 under 100- EX-54; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL: 229063-D)
00016457 Gagnon, S.A. (1976) Evaluate CGA-43089 Seed Treatment for Protection of
Sorghum Treated with CGA-24705 Herbicide Treatments: Test No. OW OH 534
76. (Unpublished study received Dec 14,1976 under 100-EX-54; submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:229063-F)
00020560 Schafer, E.W. (1972). The acute oral toxicity of 369 pesticidal, pharmaceutical and
other chemicals to wild birds. Toxicology and Applied Pharmacology
21(?):315-330. (Also in unpublished submission received Apr 25,1978 under
476-2180; submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:233577-C)
00022923 Hill, E. F.; Heath, R. G.; Spann, J. W.; et al. (1975) Lethal Dietary Toxicities of
Environmental Pollutants to Birds: Special Scientific Report—Wildlife No. 191.
(U.S. Dept. of the Interior, Fish and Wildlife Service, Patuxent Wildlife Research
Center; unpublished report)
00024504 Monsanto Company (19??). Reasonable Grounds in Support of the Re-quest.
(Unpublished study received Jan 16,1978 under 524-285; CDL:232680-C)
00025685 Williams, S.; Mills, P.A.; McDowell, R.E. (1964) Residues in milk of cows fed
rations containing low concentrations of five Chlorinated hydrocarbon pesticides.
Journal of the Association of Official Analytical Chemists 47(6):1124-1128. (Also
In unpublished submission received Nov 5, 1970 under 1F1060; submitted by
Velsicol Chemical Corp., Chicago, 111.; CDL:099195-AK)
00025690 Cummings, J.G.; Eidelman, M.; Turner, V.; et al. (1967) Residues in poultry tissues
from low level feeding of five Chlorinated hydrocarbon insecticides to hens.
Journal of the Association of Official Analytical Chemists 50(2):418-425. (Also In
unpublished submission received Nov 5, 1970 under 1F1060; submitted by Velsicol
Chemical Corp., Chicago, HI; CDL:099195-AQ
00025707 Hill, K.R. (1970) Pesticide residues: IUPAC commission on terminal residues.
Journal of the Association of Official Analytical Chemists 53(5):987-1003. (Also
In unpublished submission received Nov 5, 1970 under 1F1060; submitted by
Velsicol Chemical Corp., Chicago, 111.; CDL:099195-BH)
86
-------
MRID
Citation
00032233 Dionne, E.; Gary, G.A.; Sleight, B.H., III (1980) Analytical Procedure for the
Determination of Pesticides and PCB in Brine Shrimp Tissue. (Unpublished study
received Feb 19, 1980 under 677-313; prepared by EG&G, Bionomics, submitted
by Diamond Shamrock Agricultural Chemicals, Cleveland, Ohio; CDL:099247-K)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of Pesticides and
Other Agricultural Chemicals to Honey Bees: Laboratory Studies. By University of
California, Dept. of Entomology. UC, Cooperative Extension. (Leaflet 2287;
published study.)
00045126 Claborn, H.V.; Radeleff, R.D.; Bushland, R.C. (1960) Pesticide Residues in Meat
and Milk: A Research Report. (U.S., Agricultural Research Service, Entomology
Research Div. and Animal Disease and Parasite Research Div., unpublished study;
CDL:093429-S)
00049330 Gaines, T.B. (1969) Acute toxicity of pesticides. Toxicology and Applied
Pharmacology 14:515-534. (Report no. 25529; also in unpublished submission
received Jul 15, 1976 -under 3125-EX-135; submitted by Mobay Chemical Corp.,
Kansas City, Mo.; CDL: 226487-E)
00060143 Sana, J.G. (1969) Letter sent to P.E. Porter dated Mar 10, 1969. Metabolism of
Lindane-14C by wheat plants. (Canada, Dept. of Agriculture, Research Branch,
unpublished study; CDL:091355-S)
00060150 Lichtenstein, E.P.; Fuhremann, T.W.; Scopes, N.E.A.; et al. (1967)Translocation of
insecticides from soils into pea plants: Effects of the detergent LAS on translocation
and plant growth. Journal of Agricultural and Food Chemistry 15(5):864-869.
(Also In unpublished submission received Apr 5, 1969 under 9F0785; submitted by
Shell Chemical Co., Washington, D.C.; CDL:091355-Z)
00062656 Reno, F.E. (1976) Teratology Study in Rats: Lindane (gamma Benzene
hexachloride, USP): Project No. 405-104. Final rept. (Unpublished study received
Mar 3, 1978 under 9160-1; prepared by Hazleton Laboratories America, Inc.,
submitted by Reed & Carnrick Pharmaceuticals, Kenilworth, N.J.; CDL:232994-E)
00062657 Reno, F.E. (1976) Final Report: Dominant Lethal Study in Rats: Project No.
405-107. (Unpublished study received Mar 3, 1978 under 9160-1; prepared by
87
-------
MRID
Citation
Hazleton Laboratories America, Inc., submitted by Reed & Camrick
Pharmaceuticals, Kenilworth, N.J.; CDL:232994-F)
00062658 Reno, F.E. (1976) Teratology Study in Rabbits: Lindane (gamma Benzene
hexachloride, U.S.P.): Project No. 405-103. Final rept. (Unpublished study
received Mar 3, 1978 under 9160-1; prepared by Hazleton Laboratories America,
Inc., submitted by Reed & Camrick Pharmaceuticals, Kenilworth, N.J.;
CDL:232994-G)
00072468 Hooker Chemical & Plastics Corporation (19??) Product Chemistry Data: Lindane
HGI. (Unpublished study received May 7,1981 under 935-17; CDL:245029-A)
00075989 Chevron Chemical Company (1949) Milk Contamination Studies. (Unpublished
study received Jul 24,1952 under 239-399; CDL: 231161-B)
00088048 Gyrisco, G.G.; Muka, A.A. comps. (1951) Report on a Preliminary Study on the
Effects of Feeding Insecticide Treated Alfalfa Hay to Dairy Cattle. (Unpublished
study received Feb 21,1955 under PP0007; prepared by G.L.F. Soil Building
Service and Cornell Univ., Depts. of Entomology, Animal Husbandry and Dairy
Industry, submitted by Shell Chemical Corp., New York, N.Y.; CDL: 090081-U)
00088165 National Agricultural Chemicals Association (1955) Supplementary Petition for
Lindane Residue Tolerance. (Unpublished study received Jan 25, 1956 under
PP0058; CDL:090056-A)
00089592 California Spray Chemical Corporation (1959) Residues of Lindane on Raw
Agricultural Commodities. (Compilation; unpublished study received Apr 27, 1959
under PP0190; CDL:090218-B)
00099909 Shell Development Co. (1964) Determination of Chlorinated Pesticide Residues in
Water, Soils, Crops and Animal Products: GLC-Electron Capture Method:
Analytical Method MMS-43/64. (Unpublished study received Nov 9,1964 under
unknown admin, no.; CDL: 129668-A)
00101478 Radeleff, R. (1951) Effects of various levels of lindane in the feed of beef cattle.
Veterinary Medicine XLVI(3):105-106,119. (Also hi unpublished submission
received Sep 14, 1955 under PP0045; submitted by National Agricultural Chemicals
Assn., Falls Church, VA; CDL:090042-F)
88
-------
MRID
Citation
00102995 Zoecon Corp. (1981). Study of the Chemical Lindane. (Compilation; unpublished
study received Sep 15, 1981 under 20954-107; CDL: 246026-A)
00104441 . Hornstein, L; McGregor, W.; Sullivan, W. (1956) Lowering the volatility of lindane
cattle sprays by addition of film-forming material. Agricultural and Food Chemistry
4(2):148-149. (Also In unpublished submission received May 14, 1970 under
OH2545; submitted by Hazleton Laboratories, Inc., Falls Church, VA for Paper
Products, Inc.; CDL:221691-C)
00105413 Caro, J. (1969) Accumulation by plants of organochlorine insecticides from the soil.
Phytopathology 59(9):1191-1197. (Also In unpublished submission received Nov
1,1970 under unknown admin, no.; submitted by Hercules, Inc., Agricultural
Chemicals, Wilmington, DE; CDL:005105-AM
00109141 Midwest American Aerovap, Inc. (1951) Lindane: Animal Toxicity: Biological
Analysis. (Compilation; unpublished study received on unknown date under
unknown admin, no.; CDL:102026-C)
00118712 Commerce Industrial Chemicals, Inc. (1969). Laboratory Report: Lindane: Lab No.
Cl 1,131, Supplement #1. (Unpublished study received May 12,1969 under
10531-1; submitted by Petland Products, Inc., Chicago, IL; CDL:026276-A)
00118722 National Agricultural Chemicals Assoc. (1955) Residues of Lindane in Agricultural
and Cow Products]. (Compilation; unpublished study received Jan 24, 1956 under
PP0058; CDL:092338-A)
00118723 California Spray-Chemical Corp. (1959) Lindane Residues in Milk and Meatj.
(Compilation; unpublished study received on unknown date under PPO190;
CDL:092466-A)
00118724 Collett, J.; Harrison, D. (1968) Lindane residues on pasture and in the fat of sheep
grazing pasture treated with lindane prills. N.Z. Jl Agric. Res. 11:589-600. (Also In
unpublished submission received May 12, 1969 under 9E0833; submitted by Office
of the Commissioner, Washington, DC; CDL:093535-A)
00118725 National Agricultural Chemicals Assoc. (1955) The Results of Tests on the Amount
of Residue Remaining, Including a Description of the Analytical Method Used:
Lindane. (Compilation; unpublished study received on unknown date under
PP0058; CDL: 098733-A)
89
-------
MRID
Citation
00118739 Chevron Chemical Co. (1949) BHC: Residues in Milk. (Compilation; unpublished
study received on unknown date under 239-229; CDL: 224548-A)
00118743 Makhteshim Beer-Sheva Chemical Works, Ltd. (1976). Chemistry of Lindane.
(Compilation; unpublished study received Jul 11, 1978 under 11678-16;
CDL:234441-A)
00142715 Glatt,H. (1984). Mammalian Cell (V79) Mutagenicity Test on Lindane: Report
No. 540-VT21. Unpublished study prepared by the University of Mainz, Institute of
Toxicology, lip.
00144500 Glatt, H. (1985) Mammalian Cell (V79) Mutagenicity Test under Anaerobic
Conditions for Lindane: Preliminary Report: Project No. SP 540-VT21-b.
Unpublished study prepared by University of Mainz. 14 p.
00145073 Hertel, R. (1983) 90-Day Inhalation Study with Lindane: Project No.104264.
Unpublished study by prepared Frauenhofer Institut Fuer Toxikologie und
Aerosolforschung. 544 p.
00160000 Hudson, R.; Tucker, R.; Haegele, M. (1984). Handbook of toxicity of pesticides to
wildlife: Second edition. US Fish and Wildlife Service: Resource Publication 153.
91 p.
00160127 Inquinosa (19??). Synthesis of Lindane. Unpublished study. 4 p.
00160129 Buys, M. (1986) Lindane.. .Product Identity and Composition. Discussion of the
Formation of Impurities: Report AG/CRLD/AN/MB/ ID/15274.86. Unpublished
study prepared by Rhone-Poulenc Agrochimie. 10 p.
00160130 Mirfakhrae, K.; Norris, F. (1986) Determination of the Octanol/Water Partition
Coefficient of Lindane: Ref. No. 86/BHL/191/AG: ASD No. 86/187. Unpublished
study prepared by Rhone-Poulenc Inc. 26 p.
00160863 Rexroat, M. (1985) The Effect of Benefm (EL-110, Compound 54521)on the
Induction of Reverse Mutations in Salmonella typhimurium Using the Ames Test:
Studies 850624AMS2598 and 850708AMS2598. Unpublished study prepared by
Lilly Research Laboratories. 36 p.
90
-------
MRID
Citation
00160865 Hill, L. (1985) The Effect of Benefit! (EL-110, Compound 54521) onthe Induction
of DNA Repair Synthesis in Primary Cultures of Adult Rat Hepatocytes: Studies
850716UDS2598 and 850723UDS2598. Unpublished study prepared by Lilly
Research Laboratories. 29 p.
00160866 Bewsey, B. (1985) The Effect of Benefm (EL-110, Compound 54521) on the
Induction of Forward Mutation at the Thymidine Kinase Locus of L5178Y Mouse
Lymphoma Cells: Studies 850612MLA2598 and 850724MLA2598. Unpublished
study prepared by Lilly Research Laboratories. 42 p.
00161629 Fletcher, D. (1986) Acute Oral Toxicity Study with Lindane Technical in Bobwhite
Quail: BLAL No. 85 QD 65. Unpublished study prepared by Bio-Life Associates,
Ltd. 30 p.
00161630 Mirfakhrae, M. (1986) The Hydrolysis of Lindane at pH Levels of 5, 7, and 9: Ref.
No.: 86/BHL/405/AG; ASD No.: 86/204. Unpublished study prepared by
Rhone-Poulenc, Inc. 71 p.
00161631 Ullmann, L. (1986) 4-Hour Acute Inhalation Toxicity Study with Lindane in Rats:
Project 061637. Unpublished study prepared by Research & Consulting Co. AG. 52
P-
00161632 Ullmann, L. (1986) Primary Eye Irritation Study with Lindane in Rabbits: Project
061672. Unpublished study prepared by Research & Consulting Co. AG. 28 p
00161633 Ullmann, L. (1986) Primary Skin Irritation Study with Lindane in Rabbits: (4-Hour
Occlusive Application):Project 061661. Unpublished study prepared by Research
& Consulting Co. AG. 30 p.
00161634 Ullmann, L. (1986) Test for Delayed Contact Hypersensitivity in the Albino Guinea
Pig with Lindane: Maximization Test. Project 061650. Unpublished study prepared
by Research & Consulting Co. AG. 41 p.
00161764 Ward, G.; Winslow, M. (1986) Acute Toxicity of Lindane to Embryos and Larvae of
the Eastern Oyster (Crassostrea virginica): ESE No. 86-310-0100-2130. Unpublished
study prepared by Environmental Science and Engineering, Inc. 15 p.
91
-------
MRID
Citation
00162724 Noel, P.; Rivett, K.; Sortwell, R,; et al. (1971) Lindane: Toxicity Studies in Beagle
Dogs: Dietary Intake (200 ppm) for Thirty-two Weeks: No. 3720/70/532.
Unpublished study prepared by Huntingdon Research Centre. 54 p.
00164346 Hobbs, D.; Godward, P.; England, D.; et al. (1986) Insecticides: Lindane-carbon 14:
Adsorption/Desorption on Four Soils. Unpublished study prepared by May & Baker
Ltd. 100 p.
00164538 American Cyanamid Co. (1986) Arsenal Herbicide Railroad Applications
Concentrate: Product Chemistry. Unpublished compilation. 75 p.
00164545 Norris, F. (1986) Lindane-carbon-14-Photodegradation in Aqueous Solution by
Natural Sunlight Using Acetone as a Photosensitizer A Supplemental Study: Report
No. ASD 86/215. Unpublished study prepared by Rhone-Poulenc Inc. 67 p.
00164547 Norris, F. (1986) Lindane-carbon-14 - Photodegradation in Aqueous Solution by
Natural Sunlight: Report No. ASD 86/212. Unpublished study prepared by
Rhone-Poulenc, Inc. 74 p.
00164782 Viziere, G. (1986) Lindane: Analysis and Certification of Product Ingredients:
AG/CRLD/AN/MB/ID/15871.86. Unpublished study prepared by Rhone-Poulenc
Agrochimie. 57 p.
00164783 Buys, M. (1986) Lindane: Analytical Data for the Technical Grade Lindane
Produced by Inquinosa: Report AG/CRLD/AN/MB/ID/158874. 86. Unpublished
study prepared by Rhone-Poulenc Agrochimie. 9 p.
00118739 Chevron Chemical Co. (1949) BHC: Residues in Milkj. (Compilation; unpublished
study received on unknown date under 239-229; CDL: 224548-A)
05001991 Stevenson, J.H. (1978) The acute toxicity of unformulated pesticides to worker
honey bees (Apis mellifera L). Plant Pathology 27(1):38-40.
05002348 Burke, J.; Johnson, L. (1962) Investigations in the use of the micro-coulometric gas
chromatograph for pesticide residue analysis. Journal of the Association of Official
Agricultural Chemists 45(2):348-354.
92
-------
MRID
Citation
05003005 Kovacs, M.F.. Jr. (1966) Rapid detection of chlorinated pesticide residues by an
improved TLC technique: 3 1/4 X 4" micro slides. Journal of the Association of
Official Analytical Chemists 49(2):365-370.
05006312 Osadchuk, M.; Romach, M; McCully, K.A. (1971) Cleanup and separation
procedures for multi-pesticide residue analysis in monitoring and regulatory
laboratories. Pages 357-381, In Pesticide Chemistry: Proceedings of the
International IUPAC Congress of Pesticide Chemistry, 2nd; Feb 22-26, 1971,
Tel-Aviv, Israel. Vol. 4: Methods in Residue Analysis. Edited by A.S. Tahori. New
York: Gordon and Breach.
05006312 Osadchuk, M.; Romach, M.; McCully, K.A. (1971) Cleanup and separation
procedures for multi-pesticide residue analysis in monitoring and regulatory
laboratories. Pages 357-381, In Pesticide Chemistry: Proceedings of the
International IUPAC Congress of Pesticide Chemistry, 2nd; Feb 22-26, 1971,
Tel-Aviv, Israel. Vol. 4: Methods in Residue Analysis. Edited by A.S. Tahori. New
York: Gordon and Breach.
40056101 Forbis, A. (1986) Uptake, Depuration and Bioconcentration of Carbon 14-Lindane
by Bluegill Sunfish (Lepomis macrochirus): ABC Final Report #34324.
Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 311 p.
40056102 Forbis, L.; Teeter, D. (1986) Metabolite Characterization of Carbon 14-Lindane in
Bluegill Sunfish (Lepomis macrochirus): Final Report #34325. Unpublished study
prepared by Analytical Bio-Chemistry Laboratories, Inc. 393 p.
40056103 Fletcher, D. (1986) 14-Day Free-choice Dietary Toxicity Study with Lindane
Formulated Product in Bobwhite Quail: Laboratory Project No. BLAL No. 86 QF 2.
Unpublished study prepared by Bio-Life Associates, Ltd. in cooperation with
Hazleton Laboratories America, Inc. 60 p.
40056104 Fletcher, D. (1986) 14-Day Free-choice Dietary Toxicity Study with Lindane
Formulated Product in Red-winged Blackbirds: Laboratory Project No. BLAL No.
86 RWB 2. Unpublished study prepared by Bio-Life Associates, Ltd. in
cooperation with Hazleton Laboratories America, Inc. 60 p.
40056105 Surprenant, D. (1986) The Toxicity of Lindane to Rainbow Trout (Salmo gairdneri)
Embryos and Larvae: Report #BW-86-12-2223: Study #10566.0286.6104.121.
Unpublished study prepared by Springborn Bionomics, Inc. 42 p.
93
-------
MRID
Citation
40056106 Surprenant, D. (1986) The Chronic Toxicity of Lindane to Daphnia magna under
Flow-through Conditions: Report #BW-86-l 1-2231: Study #10566-0286-6104-130.
Unpublished study prepared by Springborn Bionomics, Inc. 41 p.
40056107 Bosch, A. (1986) Dermal Absorption of Carbon 14-Lindane in Male Rats: Final
Report: HLA Study No. 6188-103. Unpublished study prepared by Hazleton
Laboratories America, Inc. 70 p.
40056108 Bosch, A. (1986) Dermal Absorption of Carbon 14-Lindane in Male Rabbits: Final
Report: HLA Study No. 6188-104. Unpublished study prepared by Hazleton
Laboratories America, Inc. 70 p.
40067301 Reeves, G.; Savage, E. (1986) Insecticides: Lindane-carbon 14: Leaching Study
with Two Soils. Unpublished study prepared by May & Baker Limited. 85 p.
40094602 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of Chemicals to Fish
and Aquatic Invertebrates: Resource Publication 137. US Fish and Wildlife Service,
Washington, D.C. 106 p.
40098001 Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Interpretation and Data
Base for 410 Chemicals and 66 Species of Freshwater Animals. US Fish &
Wildlife Service, Resource Publication 160. 579 p.
40271301 Merricks, D. (1987) Determining the Metabolic Fate of Radiolabeled Fed to Laying
Hens: Laboratory Project No. 1503. Unpublished compilation prepared by
Agrisearch Inc. 47 p.
40271302 Wilkes, L.; Mulkey, N.; Hallenbeck, S.; et al. (1987) Metabolism Study of [Carbon
14]-Lindane Fed of Topically Applied to Lactating Goats: Laboratory Project No.
ADC 957. Unpublished study prepared by Analytical Development Corp., in
cooperation with Rhone-Poulenc Inc. 304 p
40410902 Gemma, A. (1987) Metabolism of Carbon 14-Lindane in/on Apple Leaves and Fruit
after Treatment with Carbon 14-Lindane 25% EC: Project No.: 799R14: File No.:
40152. Unpublished study prepared by Rhone-Poulenc Inc. 89 p.
94
-------
MRID
Citation
40431201 England, D. (1987) Insecticides: Lmdane: Metabolism in Spinach Plants Following
Post-emergence Application: Laboratory Project ID: D. Ag. 571. Unpublished
study prepared by May & Baker Ltd. 62 p.
40431202 Godward, P. (1987) Insecticides: Lindane: Analytical Procedure for the
Determination of Residues in Spinach: Laboratory Project ID: D. Ag. 573.
Unpublished study prepared by May & Baker Ltd. 41 p.
40431203 Godward, P. (1987) Insecticides: Lindane: Storage Stability Study on Fortified
Spinach Samples: Laboratory Project ID: D. Ag 572. Unpublished study prepared
by May & Baker Ltd. 20 p.
40431204 England, D. (1987) Insecticides: Lindane: Metabolism in Cucumber Plants
Following Post-emergency Application: Laboratory Project ID: D. Ag. 570.
Unpublished study prepared by May & Baker Ltd. 96 p.
40431205 England, P. (1987) Insecticides: Lindane; Storage Stability Study on Fortified
Cucumber Samples: Laboratory Project ID: D. Ag 569. Unpublished study
prepared by May & Baker Ltd. 20 p.
40431206 Godward, P. (1987) Insecticides: Lindane: Analytical Procedure for the
Determination of Residues in Cucumber: Laboratory Project ID: D. Ag. 568.
Unpublished study prepared by May & Baker Ltd. 41 p.
40431207 Piznik, M. (1987) The Uptake and Translocation of Radioactive Residues in Plants
Grown from Seeds Treated with a Carbon 14 Radiolabeled Lindane Emulsifiable
Concentrate (EC) Formulation: ASD No. 87/243. Unpublished study prepared by
Rhone-Poulenc Inc. 107 p.
40431208 Piznik, M. (1987) An Analytical Method for the Determination of Lindane in
Animal Tissues, Eggs and Milk: Laboratory Project ID: ASD No. 87/241.
Unpublished study prepared by Rhone-Poulenc Inc. 36 p.
40622501 Jordan, E. (1988) Lindane Insecticide: Metabolism of Lindane in Soil under
Aerobic and Anaerobic Conditions: File No. 40223: Protocol No. AD-286-120.
Unpublished study prepared by Rhone-Poulenc Ag. Co. 101 p.
95
-------
MRID
Citation
40622502 White, S. (1988) Field Dissipation Study on Lindane for Terrestrial Uses on
Peaches in Donalsonville, Georgia: ADC Project #975. Unpublished study prepared
by Analytical Development Corp. 298 p.
40660501 Merricks, D. (1988) Lindane Tissue and Egg Residue Study in Poultry: Final
Report: Agrisearch Project No. 1507. Unpublished study prepared by Agrisearch,
Inc. 96 p.
40660502 Piznik, M; Ziegelbein, J.; Margitics, I.; et al. (1988) Freezer Storage Stability of
Lindane in Animal Tissues, Eggs, and Milk: Project No. 799R14. Unpublished
study prepared by Rhone-Poulenc Ag Co. 38 p.
40660503 Billings, T. (1988) Tissue Residue Study in Sheep Using Lindane: Laboratory
Project No. 8705o. Unpublished study prepared by Southwest Bio-Labs, Inc. 285 p.
40660504 Billings, T. (1988) Tissue Residue Study in Swine Using Lindane: Laboratory
Project No. 8704s. Unpublished study prepared by Southwest Bio-Labs, Inc. 259 p.
40660505 Merricks, D. (1987) Lindane Tissue and Milk Residue Study in Dairy Cows:
Agrisearch Project NO. 1508. Unpublished study prepared by Agrisearch, Inc. 117
P-
40693201 Berard, D. (1988) Characterization and Identification of Radioactivity in Urine and
Feces of Rats Dosed with Carbon 14-Benefin: Project ID. ABC-0389. Unpublished
study prepared by Lilly Research Laboratories. 48 p.
40693202 Koenig, G.; Pohland, R. (1988) Excretion of Radiocarbon in the Expired Air of
Fischer 344 Rats Given a Single Oral Dose of Carbon 14-Benefin: Project ID.
R06087. Unpublished study prepared by Lilly Research Laboratories. 27 p
40693203 Koenig, G.; Byrd, T.; Pohland, R. (1988) Radiocarbon Dispositionin Fischer 344
Rats Given Single Oral Doses of Carbon 14-Benefin: Pharmacokinetics, Excretion,
and Residual Tissue Levels: Project ID. R16687. Unpublished study prepared by
Lilly Research Laboratories. 121 p.
40693204 Koenig, G.; Byrd, T.; Pohland, R. (1988) Biliary Excretion of Radioactivity by
Fischer 344 Rats Given Single Oral Doses of Carbon 14-Benefin: Project ID.
96
-------
MRID
Citation
R09887 and R23887. Unpublished study prepared Lilly Research Laboratories.
35 p.
40693205 Koenig, G.; Byrd, T.; Pohland, R. (1988) Tissue Distribution of Radioactivity in
Fischer 344 Rats Given Single Oral Doses of Carbon 14-Benefm: Project ID.
R09987. Unpublished study prepared by Lilly Research Laboratories. 131 p.
40873501 Klonne, D.; Kintigh, W. (1988) Lindane Technical: Fourteen-week Dust Aerosol
Inhalation Study on Mice: BRRC #51-524: MetPath #14014. Unpublished study
prepared by Union Carbide Bushy Run Research Center in cooperation with
MetPath Mid Atlantic Regional Laboratory. 680 p.
41094101 Amyes, S. (1989) Lindane: Combined Oncogenicity and Toxicity Study by Dietary
Administration to Wistar Rats for 104 Weeks: Interim Report Weeks 0-26:
Laboratory Report No. 88/CIL002/816. Unpublished study prepared by Life
Science Research, Ltd. 929 p.
41289401 Landis Asscociates, Inc. (1988) Lindane 25% WP: Raw Agricultural Commodity
Field Residue Protocol on Apples in California, Michigan, New York,
Pennsylvania, North Carolina, and Washington: Lab Project Number:
HLA/6237/116A. Unpublished study prepared by Hazleton Laboratories America,
Inc. 386 p.
41289402 Landis Associates, Inc. (1989) Lindane 25% WP: Processed Commodity Field
Residue Protocol on Apples in California, Michigan, North Carolina, and
Washington: Lab Project Number: HLA/6237/116PA. Unpublished study prepared
by Hazleton Laboratories, America. 588 p.
41289403 Landis Associates, Inc. (1989) Lindane 25% WP & 40% F: Raw Agricultural
Commodity Field Residue Protocol on Cabbage in California, New York, Florida,
Georgia, Texas, and Wisconsin: Lab Project Number: HLA/6237/116CA. 417 p.
41289404 Landis Associates, Inc. (1989) Lindane 25% WP & Lindane 40% F: Raw
Agricultural Commodity Field Residue Protocol on Cucumbers in California, Ohio,
and Michigan: Lab Project Number: HLA/6237/116CU. Unpublished study
prepared by Hazleton Laboratories, America 438 p.
41289405 Landis Associates, Inc. (1988) Lindane 20% EC: Raw Agricultural Commodity
Field Residue Protocol on Grapes in California, Michigan, New York, and
97
-------
MRID
Citation
Washington: Lab Project Number: HLA/6237/116G. Unpublished study prepared
by Hazleton Laboratories America, Inc. 333 p.
41289406 Landis Associates, Inc. (1988) Lindane 20% EC: Processed Commodity Field
Residue Protocol on Grapes in California, New York, and Washington: Lab Project
Number: HLA/6237/116PG. Unpublished study prepared by Hazleton Laboratories
America, Inc. 367 p.
41289407 Landis Associates, Inc. (1989) Lindane 25% WP and 40% F: Raw Agricultural
Commodity Field Residue Protocol on Lettuce in California, Texas, New York, and
New Jersey: Lab Project Number HLA/6237/116L. Unpublished study prepared by
Hazleton Laboratories America, Inc. 471 p.
41289408 Landis Associates, Inc. (1989) Lindane 25% WP: Raw Agricultural Commodity
Field Residue Protocol on Peaches in California, Michigan, Washington,
Pennsylvania, and Georgia: Lab Project Number: HLA/6237/116P. Unpublished
study prepared by Hazleton Laboratories America, Inc. 345 p.
41289409 Landis Associates, Inc. (1989) Lindane 20% EC: Raw Agricultural Commodity
Field Residue Protocol on Tobacco in Virginia and Georgia: Lab. Project No.
HLA/6237/116P. Unpublished study prepared by Hazleton Laboratories America,
Inc. 237 p.
41289601 Landis Associates, Inc. (1989) Lindane 20% EC: Raw Agricultural Commodity
Field Residue Protocol on Pecans in Louisiana, Texas, and Oklahoma: Lab Project
Number: 6237/116. Unpublished study prepared by Hazleton Laboratories
America, Inc. 257 p.
41421001 Walker, K. (1990) Lindane 20 Percent EC: Raw Agricultural Commodity Field
Residue Protocol on Pecans in Louisiana: Lab Project Number: 6237-116 PC.
Unpublished study prepared by Hazleton Laboratories America, Inc. 153 p.
41427601 Brown, D. (1990) Lindane: 13 Week Dermal Toxicity Study (With Interim Kill and
Recovery Period) in the Rabbit: Final Report: Lab Project Number: 6164-580/6.
Unpublished study prepared by Hazleton UK. 1261 p.
41699701 Landis International, Inc. (1990) Lindane 25% WP: Raw Agricultural Commodity
Field Residue on Tomatoes in Florida, Pennsylvania, California, New Jersey,
Indiana, Michigan, and South Carolina: Lab Project Number: HLA 6237-116PT:
98
-------
MRID
Citation
W714-89-44-04-15B-02. Unpublished study prepared by Hazleton Laboratories
America, Inc. 568 p.
41853701 Amyes, S. (1989) Lindane: Combined Oncogenicity and Toxicity Study by Dietary
Administration to Wistar Rats for 104 Weeks: Final Report: Lab Project Number:
90/CIL002/0839: CIL/002/LIN. Unpublished study prepared by Life Science
Research Ltd. 3451 p.
41861201 Landis International, Inc. (1990) Lindane 25(percent) WP and Lindane 40% F:
Processed Commodity Field Residue Protocol on Tomatoes in California, New
Jersey Pennsylvania, and Michigan: Lab Project Number: 6237-116PT:
1717-89-44-04-15B-08: 1714-89-44-04-15B- 04. Unpublished study prepared by
Hazleton Laboratories America, Inc. 742 p.
41861202 Hattermann, D. (1991) Lindane 20% EC: Processed Commodity Residue
Evaluation Study on Tomatoes in California: Lab Project Number:
714-90-44-01-15B-01: 6237-130. Unpublished study prepared by Hazleton
Wisconsin, Inc. 65 p.
41967301 Hurshman, B.; Xiao (1991) Confined Accumulation Studies on Rotational Crops fo
Lindane: Lab Project Number: 36976: EF-88-41. Unpublished study prepared by
ABC Labs and Pan-Agricultural Labs., Inc. 120 p.
42246101 King, V. (1991) Lindane: Reproductive Performance Study in Rats Treated
Continuously Through Two Successive Generations: Final Report: (Addendum to
MRID 422210):Lab Project Number: 91/0948: 91-CIL004-0948: CIL-004-LIND.
Unpublished study prepared by Life Science Research, Ltd. 833 p.
42251901 Dean, V. (1989) Exposures of Workers to Isofenphos during Planting of
Oftanol-treated Canola Seed: Lab Project Number: 99799. Unpublished study
prepared by Mobay Corp. 252 p.
42808001 Palmer, A.; Lovell, M. (1971) Effect of Lindane on Pregnancy the Rat: Lab Project
Number: 4307/71/463: 742. Unpublished study prepared by Huntingdon Research
Centre. 32 p.
42808002 Palmer, A.; Neuff, A. (1971) Effect of Lindane on Pregnancy of the New Zealand
White Rabbit: Lab Project Number: 4308/71/464: 744: 111AA-451-002.
Unpublished study prepared by Huntingdon Research Centre. 50 p.
99
-------
MRID
Citation
42853701 Schofield, C. (1993) Magnitude of Residue for Dichlorvos in Nonperishable Raw
Agricultural Commodities and Processed Foods: Warehouse Storage on Packaged
and Bagged Commodities: Final Report: Lab Project Number: SARS-92-16A.
Unpublished study prepared by Stewart Agricultural Research Services, Inc.,
Horizon Labs, Inc., and Analytical Bio-Chemistry Labs, Inc. 493 p.
42891201 Zorbas, M. (1993) Dermal Sensitization Study with Technical Grade Trebufos
(DEF) in Guinea Pigs: Lab Project Number: 90-324-GK: 100268-1. Unpublished
study prepared by Miles, Inc. 9 p.
42891401 Robinson, J.; Downs, P. (1992) Sultan Germicide: Product Performance Data:
Confirmatory Use-Dilution Testing: Supplemental Data: Lab Project Number:
G-66136:GR729: 1087. Unpublished study prepared by Gibraltar Biological
Laboratories, Inc. 17 p.
43498201 Brookman, D.; Curry, K. (1994) The Product Chemistry of Kanoria Lindane
(Product Identity and Disclosure of Ingredients). Unpublished study prepared by
Technology Sciences Group, Inc. 35 p.
43498202 Brookman, D.; Curry, K. (1994) The Product Chemistry of Kanoria Lindane
(Analysis and Certification of Product Ingredients). Unpublished study prepared by
Technology Sciences Group, Inc. 49 p.
43498203 Brookman, D.; Curry, K. (1994) The Product Chemistry of Kanoria Lindane
(Physical and Chemical Characteristics). Unpublished study prepared by
Technology Sciences Group, Inc. 18 p.
44355501 Technology Sciences Group, Inc. (1997) Acute Toxicity of Lindane to Embryos and
Larvae of the Eastern Oyster (Crassostrea virginica): Supplement to MRID No.
00161764: Lab Project Number: 86-310-0100-2130. Unpublished study. 6 p.
44383001 Curry, K.; Brookman, D. (1997) Metabolism of (carbonl4)-Lindane in/on Apple
Leaves and Fruit After Treatment With (carbon 14)-Lindane 25% EC: Supplement:
Lab Project Number: 799R14: 40152. Unpublished study prepared by
Rhone-Poulenc Inc. 40 p. (OPPTS 862.1300}
44383002 Curry, K.; Brookman, D. (1997) Insecticides: Lindane-(carbonl4)-Metabolism in
Cucumber Plants Following Post-Emergence Application: Supplement: Lab Project
100
-------
MRID
Citation
Number: 5738: 5812: EC/86/004/01. Unpublished study prepared by May & Baker
Ltd. 68 p. {OPPTS 862.1300}
44383003 Curry, K.; Brookman, D. (1997) Insecticides: Lindane: Analytical Procedure for the
Determination of Residues in Cucumber: Supplement: Lab Project Number: D. AG
568. Unpublished study prepared by May & Baker Ltd. lip. {OPPTS 862.1300}
44383004 Curry, K.; Brookman, D. (1997) Insecticides: Lindane: Analytical Procedure for the
Determination of Residues in Spinach: Supplement: Lab Project Number: D. AG
573. Unpublished study prepared by Mary & Baker Ltd. 11 p. {OPPTS 862.1300}
44405401 Hamburger, S. (1997) The Toxicity of Lindane to Rainbow Trout (Salmo gairdneri)
Embryos and Larvae: Supplement Report: Lab Project Number: BW-86-12-2223.
Unpublished study prepared by Technology Sciences Group Inc. 671 p.
44405402 Hamburger, S- (1997) The Chronic Toxicity of Lindane to Daphnia magna:
Supplement Report: Lab Project Number: BW-86-11-2231. Unpublished study
prepared by Technology Sciences Group Inc. 483 p.
44405403 Curry, K.; Brookman, D. (1997) Insecticides: Lindane-(carbonl4) Metabolism in
Spinach Plants Following Post-Emergence Application: Supplement Report: Lab
Project Number: 5739: STUD Y/EC/86/001/01: STUDY/EC/86/001/02.
Unpublished study prepared by Technology Sciences Group Inc. 53 p.
44405404 Curry, K.; Brookman, D. (1997) Determining the Metabolic Fate of Radiolabeled
Lindane Fed to Laying Hens: Supplement Report: Lab Project Number: 1503.
Unpublished study prepared by Technology Sciences Group Inc. 308 p.
44405802 Fenske, R. (1986) Worker Exposure to Lindane During Manual Seed Treatment:
Lab Project Number: 475-005: 111FX-471-022. Unpublished study prepared by
Rutgers University and Rhone-Poulenc Inc. 149 p.
44445301 Brookman, D.; Curry, K. (1997) Soil Surface Volatility Study for Lindane
Formulated as Lindafor: Lab Project Number: 96-150: R&D/CRLD/AN/9415506.
Unpublished study prepared by Rhone-Poulenc Secteur Agro, Centre de Recherche
de laDargoire. 81 p.
101
-------
MRID
Citation
44440601 Curry, K.; Brookrnan, D. (1997) Insecticides: Lindane: Analytical Procedure for the
Determination of Residues in Poultry Tissues and Eggs. Unpublished study Centre
International d'Etudes du Lindane. 42 p. {OPPTS 830.1340}
44440602 Curry, K.; Brookman, D.(1997) Insecticides: Lindane: Freezer Storage Stability
Study on Fortified Spinach and Cucumber Samples: Supplement: Lab Project
Number: 572:569 unpublished study prepared by Technology Sciences Group, Inc.
21 p. {OPPTS 860.1380}
44440603 Curry, K.; Brookman, D. (1997) Insecticides: Lindane: Freezer Storage Stability
Study on Fortified Spinach and Cucumber Samples: Supplement: Lab Project
Number: 572:569. Unpublished study prepared by Technology Sciences Group,
Inc. 21 p. {OPPTS 860.1380}
44440604 Curry, K.; Brookman, D.; Burin, G. (1997) Lindane Tissue and Egg Residue Study
in Poultry: Supplement: Lab Project Number: 1507. Unpublished study prepared by
Technology Sciences Group, Inc. 74 p. {OPPTS 860.1480}
44440605 Das, Y. (1990) Photodegradation of of(sic) (u-(carbon 14)) Lindane on Soil Under
Artificial Sunlight: Lab Project Number: 89161: EC-89-076: 925-002. Unpublished
study prepared by Innovative Scientific Services, Inc. 76 p.
44405802 Fenske, R. (1986) Worker Exposure to Lindane During Manual Seed Treatment:
Lab Project Number: 475-005: 111FX-471-022. Unpublished study prepared by
Rutgers University and Rhone-Poulenc Inc. 149 p.
44440602 Curry, K.; Brookman, D. (1997) Insecticides: Lindane: Freezer Storage Stability
Study on Fortified Spinach and Cucumber Samples: Supplement: Lab Project
Number: 572:569. Unpublished study prepared by Technology Sciences Group,
Inc. 21 p. {OPPTS 860.1380}
44445301 Brookman, D.; Curry, K. (1997) Soil Surface Volatility Study for Lindane
Formulated as Lindafor: Lab Project Number: 96-150: R&D/CRLD/AN/9415506.
Unpublished study prepared by Rhone-Poulenc Secteur Agro, Centre de Recherche
de la Dargoire. 81 p.
44731501 Bird, R.; Avakian, M. (1992) Assessment of Worker Exposure to a Commercial
Seed Treatment in Seed-Treating Plants: Final Study Report: Lab Project Number:
102
-------
MRID
Citation
ETI911022: CPR-91001: 91-P1104. Unpublished study prepared by Environmental
Technologies Institute, Inc. and Enviro-Test Laboratories (ETL). 272 p.
44769201 Hughes, E. (1999) Undone: Neurotoxicity Study by a Single Oral Gavage
Administration to CD Rats Followed by,a 14-Day Observation Period: Lab Project
Number: CIL/011: CIL 011/983402. Unpublished study prepared by Huntingdon
Life Sciences Ltd. 308 p. {OPPTS 870.6200}
44781101 Hughes, E. (1999) Lindane: 13 Week Neurotoxicity Study in Rats by Dietary
Administration: Lab Project Number: CIL/012: CIL/984959. Unpublished study
prepared by Huntingdon Life Sciences, Ltd. 309 p. {OPPTS 870.6200}
44793101 Williams, H. (1999) Photodegradation of Lindane in Water: Lab Project Number:
105-027A: 212783. Unpublished study prepared by NotoxB.V. 86 p.
44812201 Van Dreumel, I.; Heijink, E. (1999) Reproduction Study in Bobwhite Quail with
Lindane (By Dietary Admixture): Lab Project Number: 212726: 71901: 445-003.
Unpublished study prepared by NOTOXB.V. 391 p. {OPPTS 850.2300}
44864401 Willard, T. (1999) Magnitude of the Residue of Lindane in Canola Raw and
Processed Agricultural Commodities Following Seed Treatment with Premiere
Plus: Lab Project Number: AA980775: AA980775.MN1: AA980775.ND 1.
Unpublished study prepared by American Agricultural Services, Inc. 134 p.
{OPPTS 860.1500, 860.1520}
44867101 Dreumel, L; Heijink, E. (1999) Reproduction Study in Mallard Duck with Lindane
(By Dietary Admixture): Lab Project Number:222132: 71901. Unpublished study
prepared by Notox BV. 465 p.
44867102 Willems, H. (1999) Anaerobic Soil Metabolism of Lindane: Lab Project Number:
212772: 105-027C. Unpublished study prepared by Notox BV. 99 p.
44867103 Willard, T. (1999) Field Soil Dissipation of Lindane in Bare Ground in California:
Final Report: Lab Project Number: AA980601: METH-77. Unpublished study
prepared by American Agricultural Services, Inc. 108 p.
103
-------
MRID
Citation
44867104 Willems, H.; Pluijmen, M. (1999) Fate of Orally Administered (carbon-14) Lindane
in the Lactating Goat: Lab Project Number: 212761: 76104. Unpublished study
prepared by Notox BV. 211 p.
44867105 Curry, K.; Hemingway, R.; Brookman, D. (1999) Lindane: Analytical Method for
Determination of Residues in Animal Tissues and Milk: Supplement—Response to
DER: Lab Project Number: CIEL6/993. Unpublished study prepared by
Technology Sciences Group, Inc. 48 p. {OPPTS 860.1340
44867106 Curry, K.; Hemingway, R.; Brookman, D. (1999) Freezer Storage Stability of
Lindane in Animal Tissues, Eggs and Milk Response to DER and Proposal for
Study Upgrade: Supplement to MRID 406605-02: Lab Project Number: CIEL6/99
2. Unpublished study prepared by Technology Sciences Group, Inc. 18 p.
44867107 Curry, K.; Brookman, D. (1999) Lindane—Anaerobic Degradation to Carbon
Dioxide and Methane Supplement to Anaerobic Soil Metabolism of Lindane
Concurrent Submission: Lab Project Number: CIEL6/99 4. Unpublished study
prepared by Technology Sciences Group, Inc. 81 p.
44877501 Hemingway, R.; Curry, K.; Brookman, D. (1999) Lindane: Tissue and Milk Residue
Study in Dairy Cows Response to DER and Proposal for Study Upgrade,
Supplement to MRID 406605-5: Lab Project Number: CIEL 6/99 1. Unpublished
study prepared by Technology Sciences Group Inc. 40 p. {OPPTS. 860.1480}
44909901 Willard, T. (1999) Magnitude of the Residue of Lindane in Wheat Raw Agricultural
Commodities Following Seed Treatment: Lab Project Number: AA980775:
AA970775: AA970775.IA1. Unpublished study prepared by American Agricultural
Services, Inc. 247 p. {OPPTS 860.1500}
45073501 Myers, D. (2000) Lindane Developmental Neurotoxicity Study in the Han Wistar
Rat by Dietary Administration: Lab Project Number: CIL/022: 993378.
Unpublished study prepared by Huntingdon Life Sciences, Ltd. 561 p. {OPPTS
870.6300}
45200002 Purdy, J.; Houghton, D. (2000) Commercial Seed Treatment Plant Worker
Exposure Study with Helix 289FS Seed Treatment on Canola: Final Report: Lab
Project Number: CER 03220/99: 1145-00. Unpublished study prepared by Novartis
Crop Protection Canada Inc. 213 p. {OPPTS 875.1000, 875.1100, 875.1300}
104
-------
MRID
Citation
45224101 Pluijmen, M.; Willems, H. (2000) Fate of Orally Administered (carbon 14)-Lindane
in the Lactating Goat: Lab Project Number: 212761. Unpublished study prepared
byNOTOXB.V. 14p. {OPPTS 860.1300}
45224102 Steward, R. (2000) Fate of Orally Administered (carbon 14)-Lindane in the
Lactating Goat; Investigations into the Identity of a Radioactive Metabolite;
Detected in the Liver of Huntingdon Life Sciences. 10 p. {OPPTS 860.1300}
45277201 Aikens, P. (2000) Investigations into the Identity of a Radioactive Metabolite
Detected in the Liver of a Goat Dosed with (carbon-14)-Lindane: Lab Project
Number: SCI/056: SCI 056/004020. Unpublished study prepared by Huntingdon
Life Sciences, Ltd. 36 p. {860.1300}
45291402 Chase, K. (2000) Lindane: Carcinogenicity Study by Dietary Administration to
CD-I Mice for 78 Weeks: Final Report: Lab Project Number: 00 3512: CIL
021/003512. Unpublished study prepared by Huntingdon Life Sciences Ltd. 1234 p.
{OPPTS 870.4200}
45310501 Willard, T. (2000) Magnitude of the Residue of Lindane in Canola Raw and
Processed Agricultural Commodities Following Seed Treatment with Premiere
Plus: Lab Project Number: AA980775. Unpublished study prepared by American
Agricultural Services, Inc. 151 p. {OPPTS 860.1500, 860.1500}
45330301 Willard, T. (2001) Magnitude of the Residue of Lindane in Wheat Raw Agricultural-
Commodities Following Seed Treatment: Study Report Amendment to MRID
499099-01: Lab Project Number: AA970775. Unpublished study prepared by
Technology Sciences Group, Inc. 58 p. {OPPTS 860.1500}
45426600 Inquinosa Internacional, S. A. (2001) Submission of Product Chemistry and
Residue Data in Support of the Reregistration of Lindane. Transmittal of 11
Studies.
45426601 Galvan, V.; Brookman, D.; Curry, K. (2001) Lindane Technical: Product Properties.
Unpublished study prepared by Technology Sciences Group Inc. 64 p. {OPPTS
830.1550 and 830.1900}
45426602 Flack, I. (2000) Analytical Profile of Five Batches of Lindane Technical: Amended
Final Report: Lab Project Number: CIL 009/994614. Unpublished study prepared
by Huntingdon Life Sciences Ltd. 76 p.
105
-------
MRID
Citation
45426603 Flack, I. (2000) Method Validation for the Quantification of Five Organic
Impurities which may occur in Lindane Technical: Amended Final Report: Lab
Project Number: CIL 008/994611. Unpublished study prepared by Huntingdon Life
Sciences Ltd. 70 p.
45426604 Flack, I. (2000) Water Content of Five Batches of Lindane Technical: Lab Project
Number: CIL 025/002145. Unpublished study prepared by Huntingdon Life
Sciences Ltd. 32 p.
45426605 Rivera, J, (1996) Lindane Technical Report on the Determination of Tetra, Penta,
Hexa, Hepta, and Octachlorodibenzo-p-dioxins (Dioxins and Dibenzofurans
(Furans) on a Lindane Sample Supplied by Inquinosa. Unpublished study prepared
by Laboratori D'Espectrometria de Masses. 20 p. {OPPTS 830.1700}
45426606 Flack, I. (1999) Method Validation for the Quantitation of the Active Ingredient in
Lindane Technical: Lab Project Number: CIL 007/994578. Unpublished study
prepared by Huntingdon Life Sciences Ltd. 34 p.
45426607 Nunez, J. (2000) Lindane Technical: Determination of Oxidizing Properties of
Lindane: Lab Project Number: 00200. Unpublished study prepared by Cartera
Ambiental. 60 p. {OPPTS 830.6314}
45426608 Nunez, J. (2000) Lindane Technical: Determination of Explosive Properties of
Lindane: Lab Project Number: 00400. Unpublished study prepared by Cartera
Ambiental. 65 p. {OPPTS 830.6316}
45426609 Nunez, J. (2000) Lindane Technical: Determination of Stability After Storage of
Lindane: Lab Project Number: 03100. Unpublished study prepared by Cartera
Ambiental. 58 p. {OPPTS 830.6317}
45426610 Curry, K. (2001) Lindane Technical: Product Properties-Part B. Unpublished study
prepared by Inquinosa Internacional, S.A. 4 p. {OPPTS 830.6320}
45426611 Jendrzejczak, N.; Maestracci, M.; Ott, M. et al. (1994) Lindane-NMR, IR, MS and
UV-Visible Spectra: Lab Project Number: 1 94-73: R&D/CRLD/AN/9416350.
Unpublished study prepared by Rhone-Poulenc Secteur Agro. 27 p. {OPPTS
830.7050}
106
-------
MRID
Citation
45470601 Chase, K. (2001) Lindane Additional Pathology Investigations to An Oncogenicity
Study by Dietary Administration to CD-I Mice for 78 Weeks: Final Report: Lab
Project Number: 01 3302: CIL/027. Unpublished study prepared by Huntingdon
Life Sciences Ltd. 23 p.
107
-------
CITATIONS FROM PUBLISHED LITERATURE
Agency for Toxic Substances and Disease Registry (ATSDR). 1997. Toxicological profile for
Alpha-, Beta-, Gamma-, and Delta-Hexachlorocyclohexane. U.S. Department of Health and
Human Services, Public Health Service, Agency for Toxic Substances and Disease Registry.
September 1997.
Aks, S.E., Krantz A., Hryhorczuk, D.O., Wagner, S., and Mock, J. Ann EmergMed. 26: 647-651,
1995
Barrie L.A., D. Gregor, B. Hargrave, R. Lake, D. Muir, R. Shearer, B. Tracey and T. Bidleman.
1991. Arctic contaminants: sources, occurrence and pathways. The Science of the Total
Environment 122:1-74.
Belfroid A., J. Meiling, D. Sijm, W. Hermens, K. van Gestel. 1994. Uptake of hydrophobic
halogenated aromatic compounds from food by earthworms (Eisenia andrei). Archives of
Environmental Contaminants and Toxicology 27:260-265.
Beyer, W.N., E.E. Conner and S. Gerould. 1994. Estimates of soil ingestion by wildlife. J. Wild.
Management 58(2):375-382.
Blockwell, S.J., D. Pascoe , and S.J. Maund. 1999. Effects of the organochlorine insecticide
lindane on the population responses of the freshwater amphipod Hyalella azteca. Environmental
Toxicology and Chemistry 18(6): 1264-1269.
Blockwell SJ, D. Pascoe, E.J. Taylor. 1996. Effects of lindane on the growth of the freshwater
amphipod Gammaruspulex (L.). Chemosphere 32:1795-1803.
Blus, L.J., C.J. Henny, and A.J. Krynitsky. 1985. The effects of heptachlor and lindane on birds,
Columbia Basin, Oregon and Washington, 1976-1981. Science of the Total Environment 46:73-81.
Blus, L.J., C.J. Henny, DJ. Lenhart, and T.E. Kaiser. 1984, Effects of heptachlor and lindane
treated seed on Canada geese. Journal of Wildlife Management 48(4): 1097-1 111.
Boehringer C. H. Sohn Ingelheim am Rhein.; (Testing of the substance Lindane for carcinogenic
effects in mice using oral administration-duration 80 weeks). Translated from German (1975).
Brubaker, W.W., and R.A. Kites Jr. 1998. OH reaction kinetics of gas-phase a- and g-
hexachlorocyclohexane and hexachlorobenzene. Environ Sci TechnoL 32:766-769.
108
-------
CITATIONS FROM PUBLISHED LITERATURE
Chakravarty, S. and P. Lahiri. 1986. Effect of lindane on eggshell characteristics and calcium
level in the domestic duck. Toxicology 42:245-258.
Chakravarty, S., A. Mandal, and P. Lahiri. 1986. Effect of lindane on clutch size and level of egg
yolk protein in domestic duck. Toxicology 39:93-103.
Chowdhury, A.R. and A.K. Gautam. 1994. Steroidogenic impairment after lindane treatment in
male rats. Sangyo-Ika-Daigaku-Zasshi 16:145-152.
Chowdhury, A.R., H. Venkatakrishna-Bhatt, and A.K. Gautam. 1987. Testicular changes of rats
under lindane treatment. Bulletin of Environmental Contamination and Toxicology 38:154-156.
Cleemann, M, Poulsen M.E., and G. Hilbert. 1995. Deposition of lindane in Danmark.
Chemosphere 30:2039-2049.
Clench, M.H. and R.C. Leberman. 1978. Weights of 151 species of Pennsylvanian birds analyzed
by month, age and sex. Bulletin of the Carnegie Museum of Natural History:5; Tomlinson, R.E.
1975. Weights and wing lengths of wild Sonoran Masked bobwhites during fall and winter.
Wilson Bulletin 87:180-18
Cooper, R.L., R.W. Chadwick, G.L. Goldman, K.C. Booth, J.F. Hein, and W.K. McElroy. 1989.
Effect of lindane on hormonal control of reproductive function in the female rat. Toxicology and
Applied Pharmacology 99:384-394.
Dalsenter, P.R., A.S. Faqi, J. Webb, H-J. Merker and I. Chahoud. 1997. Reproductive toxicity and
toxicokenetics of lindane in the male offspring of rats exposed during lactation. Human and
Experimental Toxicology 16:146-153.
Dalsenter, P.R., A.S. Faqi, J. Webb, H-J. Merker and I. Chahoud. 1996. Reproductive toxicity and
tissue concentrations of lindane in adult male rats. Human and Experimental Toxicology 15:406-
410.
Dalsenter, P.R., A.S. Faqi, and I. Chahoud. 1997. Serum testosterone and sexual behavior in rats
after prenatal exposure to lindane. Bulletin of Environmental Contamination and Toxicology
59:360-366.
109
-------
CITATIONS FROM PUBLISHED LITERATURE
Dewitt, J.B. and J.L. George. 1957. Pesticide wildlife review. U.S. Fish and Wildlife Service,
USDI, Washington, D.C.
Donald, D.B., H. Block and J. Wood. 1997. Role of groundwater on lindane detections in surface
water in western Canada. Environmental Toxicology and Chemistry 16(9): 1867-1872.
Elliot, J.E., D.G. Noble and R.J. Norstrom. 1989. Organochlorine contaminants in seabird eggs
from the Pacific coast of Canada, 1971-1986. Environmental Monitoring and Assessment 12:67-
82.
Feldman, RJ. and Maibach, H.I., Toxicol and Applied Pharmacology 28, 126-132, 1974
Feldmann, RJ and HI Maibach. Percutaneous penetration of some pesticides and herbicides in man.
Toxicology and Applied Pharmacology, 28:126-132 (1974).
Fenske, R.A., A.M. Blacker, S.J. Hamburger, and G.S. Simon (1990) Worker
Exposure and Protective Clothing Performance During Manual Seed Treatment
with Lindane. Arch. Environ. Contam. Toxicol. 19, 190-196.
Fenske, R. A. Reregistration of Lindane Technical Case No. 0315, Chemical No. 9001.
Worker Exposure to Lindane During Manual Seed Treatment.
Fitzhugh, O.G.; Nelson, A.A.; and Frawley, J.P.; The chronic toxicities of technical benzene
hexachloride and its alpha, beta and gamma isomers. J. Pharmacol Expt. Therapeutics. 100: 59
(1950).
Ginsburg, C.M. and Lowry, W., Pediatric Dermatology Vol 1. No. 1 74-76, 1983
Glogoza, P.A., R. Zollinger, and M. McMullen. 2001. Assessment of Insecticide Use for Field
Crops in North Dakota for 2000. North Dakota State University, Fargo, ND.
Goto, M.; Hattori, M.; Miyagawa, T.; and Enomoto, M..; Contributions to ecological chemistry II.
Hepatoma development in mice after administration of HCH isomers in high dosage. Chemosphere
1(6): 279-282 (1972).
110
-------
CITATIONS FROM PUBLISHED LITERATURE
Gustafson, 2002. Technical Specifications for the Gustafson Continuous Batch Coater, Model
CBT50, http://www.gustafson.com/gustafson_equipment/id69.htm
Harner T. 1997. Organochlorine contamination of the Canadian Arctic, and speculation on further
trends. Int. J. Environ. And Poll. 8:51-73.
Harner, T, T.F. Bidleman, L.M.M Jantunen, and D. Mackay. 2001. Soil-air exchange model of
pesticides in the United States cotton belt. Environ Toxi Chem 20:1612-1621.
Harner, T., H. Kylin, T.F. Bidleman, and W.M.J. Strachan. 1999. Removal of (-and (-
hexachlorocyclohexane and enentiomers of (-hexachlocyclohexane in the eastern Arctic ocean.
Environ Sci Technol 33:1157-1164.
Heller, C., 1966. Meat Consumption at Three Northern Eskimo Villages. Environment of the
Cape Thompson Region, Alaska. Wilimovsky, Norman, & Wolfe, John, Editors. United States
Atomic Energy Commission, pp. 1109-1111.
Hoffman, D.J. and W.C. Eastin. 1982. Effects of lindane, paraquat, toxaphene, and
2,4,5-trichlorophenoxyacetic acid on mallard embryo development. Archives of Environmental
Contamination and Toxicology \ 1 (2):79-86.
Hulth, L., R. Larsson, R. Carlsson, and J.E. Kihlstron. 1976. Convulsive action of small single
oral doses of the insecticide lindane. Bulletin of Environmental Contamination and Toxicology
16:133-137.
Hanada, M.; Yutani, C.; and Miya, T.; Induction of hepatoma in mice with benzene hydrochloride
GANN 64:511-513 (1973).
International Programme on Chemical Safety (IPCS), Environmental Health Criteria 124, Lindane,
WHO, Geneva, 1991
Ito, N.; Nagasaki, H.; Arai, M.; Sugihara, S.; and Makiura, S.; Pathologic and ultrastructural
studies in the hepatocarcinogenicity of benzene hexachlooride in mice J. NCI 51:817-826 (1973).
Ito, N.; Nagasaki, H.; et al.; Brief communication: development of hepatocellular carcinomas in
rats treated with benzene hexachloride J. NCI 54:801-805 (1975).
Ill
-------
CITATIONS FROM PUBLISHED LITERATURE
Iwata, H., S. Tanabe, N. Sakai and R. Tatsukawa. 1993. Distribution of persistent organochlorines
in the oceanic air and surface seawater and the role of ocean on their global transport and fate.
Environmental Science and Technology 27:1080-1098.
Joy, R.M. 1982. Mode of action of lindane, dieldrin and related insecticides in the central nervous
system. Neurobehavioral Toxicology and Teratology 4:813-823.
Kelly, B. and F. Gobas. 2001. Bioaccumulation of POPs in lichen-caribou-wolf food chains of
Canada's Central and Western Arctic. Environmental Science and Technology 35(2):325-334.
Korpalski, S.J. 2002. Handler Exposure Assessment for Lindane Use as a Seed Treatment in the
United States. Exposure study submitted to EPA by Uniroyal Chemical Company, Bethany, CT
06524,13 pp.
KSU. 1999. Kansas Agricultural Chemical Usage: 1998 Wheat and Sorghum Pesticide Usage
Summary. Kansas State University, Manhattan KS
Lane, D.A., N.D. Johnson, M.J. Hanley, Schroeder W.H., and D.T. Ord . 1992. Gas and particle
phase concentrations a-hexachlorocyclohexane and g-hexachlorocyclohexane and
hexachlorobenzene hi Ontario air. Environ Sci Technol. 26:126-133.
Lindane, Environmental Health Criteria 124, IPCS, WHO, Geneva, Switzerland (1991).
Li, Y.F., T.F. Bidleman, L.A. Barrie, and L.L. McConnell. 1998. Global hexachlorocyclohexane
use trends and their impact on the arctic atmospheric environment. Geophys Res Lett. 25:39-41.
Macek K.J., K.S. Buxton, S.K. Derr, J.W. Dean, and S. Sauter. 1976. Chronic toxicity of lindane
to selected aquatic invertebrates and fishes. EPA-60013-76-047. U.S. Environmental Protection
Agency, Washington, DC.
Mackey, D. 1991. Multimedia environmental models. The fugacity approach. Lewis Publication,
Boca Raton, FL.
Mackey, D., W.Y. Shiu, K.C. Ma. 1992-1997. Illustrated handbook of physical-chemical
properties and environmental fate for organic chemicals. Vol. I to V. Lewis Publication, Chelsea,
MI
112
-------
CITATIONS FROM PUBLISHED LITERATURE
McCann, J.A., W. Teeters, D.J. Urban, and N. Cook. 1981. A short-term dietary toxicity test on
small mammals. In: Avian and Mammalian Wildlife Toxicology: Second Conference, ASTM STP,
pp. 132-142.
Moisey, J., A. Fisk, K. Hobson and R. Norstrom. 2001. Hexachlorocyclohexane (HCH) isomers
and chiral signatures of alpha-HCH in Arctic marine food web of the Northwater Polynya.
Environmental Science and Technology 35(10):1920-1927.
Moody, R.P., and Ritter, L. J. Toxicol. Env. Health 28:161-169, 1989
Muggeridge, J.M. 1997. Up to 400 acres a day. Farm & Country Magazine, February 1997 issue,
Agricultural Publishing Company Ltd., Ottawa, Ontario, Canada.
Nagasaki, H.; Tonrii, S.; et al.; Carcinogenicity of Benzene Hexachloride (BHC) Proc. of 2nd
Intern Symp of Princess Tokamatsu Cancer Center Res. Fund in Topics in Chem. Carcinogenesis.
1972
Nagy, K.A. 1987. Field metabolic rate and food requirement scaling in mammals and birds.
Ecology Monographs 57:111-128.
NCI; NTP Combined Chronic Toxicity/Carcinogenicity Study with Lindane in Rats. National
Cancer Institute, Carcinogenesis Program, DHEW Pub # (NIH) 77-814 (1977).
Niklas, 2002. Technical Specifications for the Niklas liquid seed treaters type W.N. 36 S.
http://www.niklas-beizgeraete.de/English/Conti_Units/Tech-Data/tech-data.html
Norstrom, R.J., and D.C.G. Muir, 1994. Chlorinated hydrocarbon contaminants in arctic marine
mammals. Sci Total Environ. 154:107-128.
Ockenden, W.A., E. Steinnes, C. Parker, and K.C. Jones. 1998. Observations on persistent
organic pollutants in plants: implications of their use as passive air samplers and POP cycling,
Environ Sci Technol. 33:3482-3488.
Oehme, M., J.-E. Haugen and M. Schlabach. 1995. Ambient levels of POPs in spring 1992 at
Spitzbergan and the Norwegian mainland: comparison with 1984 results and quality control
measures. Sci Total Environment 160/161:139-152.
Ortega, P.; Hayes, W.J.; and Durham, W.F.; Pathologic changes in the liver of rats after feeding
low levels of various insecticides A.M.A. Archives of Pathology 64:614, (1957).
113
-------
CITATIONS FROM PUBLISHED LITERATURE
Parsons, J. 1998. Efficacy ReviewrHelix Seed Treatment for Canola. Canada Pest Management
Regulatory Agency. 10pp.
Petkus, 2002. Technical Specifications for the Petkus CTD. Seed Treater.
http://www.petkus.net/treater.htm#THE CTD-SERIES
Petit, F., P. Le Goff, J.P. Cravedi, Y. Valotaire, and F. Pakdel. 1997. Two complementary
bioassays for screening the estrogenic potency of xenobiotics: recombinant yeast for trout estrogen
receptor and trout hepatocyte cultures. Journal of Molecular Endocrinology 19(3):321-335.
Poissant, L. and J.F. Koprivnjak. 1996. Fate and atmospheric concentrations of a- and g-
hexachlorocyclohexane in Quebec, Canada. Environ Sci Technol 30:845-851.
Pompa, G., L. Fadini, F. Di-Lauro, and F. Caloni. 1994. Transfer of lindane and
pentachlorobenzene from mother to newborn rabbits. Pharmacology and Toxicology 74:28-34.
Raizada, R.B., P. Misra, I. Saxena, K.K. Datta, and T.S. Dikshitt. 1980. Weak estrogenic activity
of lindane in rats. Journal of Toxicology and Environmental Health 6:483-492.
SRC, 2000. Estimation Program Interface, Version 3.10. Prepared for: U.S. Environmental
Protection Agency, Office of Pollution Prevention and Toxics, Exposure Assessment Branch.
William Meyland and Philip Howard, Syracuse Research Corporation, Syracuse, NY.
Strachan, W.M.J. 1985. Organic substances in the rainfall of Lake Superior: 1983. J. Environ.
Toxicol Chem. 4:677-683.
Taylor E.J., S.J. Blockwell, S.J. Maund, and D. Pascoe. 1993. Effects of lindane on the life-cycle
of a freshwater macroinvertebrate Chironomous riparius Meigen (Insecta:Diptera). Archives of
Environmental Contaminants and Toxicology 24:145-150.
Thorpe and Walker; The toxicology of dieldrin (HEOD). II. Comparitive long-term oral toxicity
studies in mice with dieldrin, DDT, phenobarbitone, beta-BHC and gamma-BHC Fd. Cosmet.
Toxicol 11:433-442 (1973).
Ulman, E. 1972. Monograph of an insecticide. Schillinger Verlag, Federal Republic of Germany.
Uphouse, L. 1987. Decreased rodent sexual receptivity after lindane. Toxicology Letters 39:4-14.
114
-------
CITATIONS FROM PUBLISHED LITERATURE
USDA. 1997a. 1997 United States Census of Agriculture-State Data: Table 26 Grains-Corn,
Sorghum, Wheat, and Other Small Grains: 1997 and 1992. USDA/NASS,
USDA. 1997b. 1997 United States Census of Agriculture-United States Data: Table 42. Specified
Crops by Acres Harvested: 1997, USDA/NASS - ......
http://www.nass.usda.gov/census/census97/volumel/us-5 lAisl_42.pdf
USDA 2001. Agricultural Statistics 2001.
USDA. 1999-2001. Crop Profiles for Wheat, Barley, Oats, Corn, Sorghum, and Canola. Office of
Pest Management Policy, USDA, http://pestdata.ncsu.edu/cropprofiies/
U.S. EPA. 1993. Wildlife exposure factors handbook (Volume I). EPA/600/R-93/187a.
U.S. EPA. 1998. Atmospheric deposition of toxic substances to the Great Lakes: IADN Results
through 1998. Environment Canada and the United States Environmental Protection Agency
(www.epa.gov/glnpo/iadn/).
U.S. EPA. 1985. Guidance for Reregistration of Pesticide Products Containing Lindane as the
Active Ingredient. EPA RS-85-027. September 1985.
Versar, Inc. 1999. Exposure and Fate Assessment Screening Tool (E-FAST), Beta Version,
Documentation Manual, December 31, 1999. Prepared for: U.S. Environmental Protection
Agency, Office of Pollution Prevention and Toxics, Exposure Assessment Branch. Versar, Inc.
Springfield Va. Contract No. 68-W-99-041.
Waite, D., N.P. Gurprasad and T. Thompson. 1998. Atmospheric studies of Hexachlorobenzene
(HCB) and y-Hexachlorocyclohexane (lindane or y-HCH) in the prairies. BAD Seminar 10/22/98.
Waite, D., N.P. Gurprasad, J.F. Sproull, D.V. Quiring and M.W. Kotylak. (2001). Atmospheric
movements of lindane from canola fields planted with treated seed. Journal of Environmental
Quality 30:768-775.
Walker, K., D.A. Vallero and R.G. Lewis. 1999. Factors influencing the distribution of lindane
and other hexachlorocyclohexanes in the environment. Environ Sci Technol 33, pp. 4373-4378.
115
-------
CITATIONS FROM PUBLISHED LITERATURE
Wania, F. and Mackay, D. 2000. A comparison of overall persistence values and atmospheric
travel distances calculated by various multimedia fate models. WECC Report2/2000. WECC
Wania Environmental Chemists Corp. Toronto, Canada.
Wania, F. and Mackay, D. 1999. The evolution of mass balance models of persistent organic
pollutant fate in the environment. Environ. Poll. 100:223-240.
Wania, F. and Mackay, D. 1996. Tracking the distribution of persistent organic pollutants.
Environ Sci Technol. 30:390A-396A.
Whitehead, C.C., A.G. Downing, and R.J. Pettigrew. 1972. The effects of lindane on laying hens.
Br. Poultry Science 13:293
Willet, K., E.M. Ulrich and R.A. Hites. 1998. Differential toxicity and environmental fates of
hexachlorocyclohexane isomers. Environmental Science and Technology 32 (15): 2197-2207.
Williams, D.J., K.W. Kuntz, S. L'ltalien, and V. Recardson. 1998. Lake Ontario surveillance
program: spatial and temporal trends of selected parameters with emphasis on 1992-93 results.
Environment Canada, Ecosystem Health Division Report 98-01/1.
Whitmore, R.W., F.W. Immerman, D.E. Camann, A.E. Bond, R.G. Lewis and J.L. Schaum. 1994.
Non-occupational exposures to pesticides for residents of two US cities. Archives of
Environmental Contaminants and Toxicology 26:47-59.
Wolff, G.L., Roberts, D.W., Monissey, R.L., Greenman, D.L., Allen, R.R., Campbell, W.L.,
Bergman, H.,Nesnow, S., and Firth, C.H. 1987. Tumorigenic responses to lindane in mice:
potentiation by a dominant mutation. Carcinogenesis 8:1889-1897(1987). National Center for
Toxicological Research, Jefferson, AK.
World Health Organization (WHO). 1991. Lindane (Environmental Health Criteria 124). 208pp.
Zollinger et al., 1996. Pesticide Use and Pest Management Practices for Major Crops in North
Dakota 1996. Table 4: On Farm Seed Treatment. North Dakota State Univ., Fargo, ND,
http://www.ag.ndsu.nod^.edu/aginfo/entomology/ndpiap/Major_Crops_GS/01table_of_contents.
htm.
116
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APPENDIX E: Generic Data Call In (0CI)
See the following table for a list of generic data requirements for lindane. Please note that a
complete Data Call In (DCI) with detailed instructions for completing the DCI will be sent to
registrants under separate cover.
117
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DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-010?
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print In ink. Please read carefully the attached Instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address 2. Case* and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0315 Lindane DD-MMM-YYYY
NO STREET ADDRESS Chemical # and Name 009001 GENERIC
NOdTY.XX 00000 Lindane |D# GDC,009001.NNNNN
4. EPA
Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. 1 am claiming a Generic
Data Exemption because 1
obtain the active Ingredient
from the source EPA regis-
tration number listed below,
6b. 1 agree to satisfy Generic
Data requirements as Indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7, Product Specific Data
7a. My product is an MUP and
1 agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
NA
7b. My product is an EUP and
1 agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
NA
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any g rjate
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
1 0. Name of Company - - .-In nhaafcthariMfc^^^^^^^^^^a^^^a^^^
-------
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.6314
830.6317
830.7050
835.SS01
5. Study Title
2. Case # and Name 3. Date and Type of DCI and Number
0315 Lindane DD-MMM-YYYY
Chemical # and Name 009001 GENERIC
Lindane ID# GDCI-009001-NNNNN
Product Chemistrv Data Reaulrements (Conventional
Chemical)
Oxidizing or reducing action
Storage stability of product
UVA/isible absorption
Seed Leaching Study
(D
(2)
P
R
0
T
0
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A,B
A.B
A.B
A, B
7. Test
Substance
MP/EP
MP/EP
TGAI/PAI
TEP
10. Certification I certify that the statements made on this form and att attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
12. Name of Company •
8. Time
Frame
(Months)
6
8
8
12
9. Registrant
Response
•
11. Date
13; Phone Number
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0315 Lindane
DCI Number: GDCI-009001 -NNNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TEP = Typical End Use Product [TEP]; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop
B - Terrestrial feed crop
Footnotes; [The following notes are referenced In column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 Required if the product contains an oxidizing or reducing agent
2 This a special study to determine whether lindane can leach from treated seeds. The registrant should follow EPA's guidance document titled "Standard Method of Determining the Leachability
of Pesticides from Treated Seeds," dated June 2000, which is available in the lindane docket. A study protocol must be submitted to and approved by EPA prior to study initiation.
-------
APPENDIX F: Product Specific Data Call-in
See the following table for a list of product-specific data requirements for lindane. Please note
that a complete product specific Data Call-In (PDCI) with detailed instructions for completing the
DCI will be sent to registrants under separate cover.
121
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0315 Lindane DD-MMM-YYYY
NO STREET ADDRESS Chemical # and Name 009001 PRODUCT SPECIFIC
NO CITY, XX 00000 Lindane |D# pDC,0(J9001.NNNN
4. EPA
Product
Registration
NNNNNN-NNNNN
5. 1 wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. 1 am claiming a Generic
Data Exemption because 1
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. 1 agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N,A:
7. Product Specific Data
7a. My product is an MUP and
1 agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
1 agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any g pa(e
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company — ^_^^mmi^^^^^^^^^^^^^^^m^^^^m^^^^^
-------
DRAFT COP
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
5. Study Title
2. Case # and Name 3. Date and Type of DCl and Number
0315 Lindane DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-009001-NNNN
EPA Reg. No. NNNNNN-NNNNN
Product Chemistry Data Retirements (Conventional
Chemical)
Product Identity and composition
0)
Description of materials used to produce the product (3)
Description of production process
Description of formulation process
Discussion of formation of impurities
Preliminary analysis
Certified limits
Enforcement analytical method
Color
Physical state
Odor
(2)
(5)
(6)
- (4,7,8)
(9 ,35)
(10)
(11)
(12)
(13)
P
R
n
V
T
0
C
0
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, 0
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, 0
A, B.C.D.E.F.G. H.I,
J.K.L.M.N.O
A.B.C.D.E, F.G.H.I,
J.K, L, M, N,0
A. B, C, D, E, F, G, H, I,
J.K, L.M.N. 0
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, 0
A, B.C.D, E, F, G, H.l,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J; K, L, M, N, 0
A, B, C. D, E, F, G, H, I,
J, K, L, M, N, 0
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, 0
A.B.C.D.E, F.G.HJ.
J, K, L, M, N, 0
7. Test
.Substance
EP; MP; TGAI
EP: MP: TGAI
TGAI
MP.EP
EP; MP; TGAI
TGAI
EP; MP; TGAI
EP; MP; TGAI
EP; MP; TGAI
EP; MP; TGAI
EP; MP; TGAI
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
12. Name of Company
8. Time
Frame
(Months)
8
B
3
8
8
8
B
8
8
8
8
9. Registrant
Response
11. Date
13. Phone Number
-------
DRAFT COPY
Page 2 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0 107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form,
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.6314
830.6315
830.6316
830.6317
630.6319
830.6320
830.6321
830.7000
830.7050
830.7100
830.7300
5. Study Title
Oxidizing or reducing action
Flammability
Explodability
Storage stability of product
Miscibitity
Corrosion characteristics
Dielectric breakdown voltage
pH of water solutions or suspensions
UV/Visible absorption
Viscosity
2. Case # and Name 3. Date and Type of DCI and Number
0315 Lindane DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-009001-NNNN
EPA Reg. No. NNNNNN-NNNNN
(14)
,05)
[
(16)
(36)
(18)
(37)
(17)
(19,20)
(21)
Density/relative density (22 ,23)
Toxicoloav Data Reaulrementa (Conventional Chemical)
P
R
0
T
0
C
0
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B.C.D, E,F, G, H,l,
J, K,L, M, N,0
A, B, C, D,E, F,G, H.l,
J, K, L, M, N, 0
A.B.C.D, E,F, G,H, I,
J, K, L, M, N, 0
A, B, C.D.E, F,G, H,l,
J, K, L, M, N, 0
A,B, C, D.E.F.G, H.I,
J, K, L, M, N, 0
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, 0
A, B, C, D, E, F,G, H, I,
J, K,L, M, N.O
A, B.C, D.E, F.O.H. I,
J.K, L, M, N,0
A, B, C, D, E, F, G, H, I.
J, K, L, M, N, 0
A, B, C, D, E, F,G,H, I,
J, K, L, M, N.O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N,0
Initial to indicate certification as to information on this page
(full text of certification is on page one), _^ ^-^^^— ^^•^•^^^^^^^^^^•^^^^^^••^^^•^^^a
7. Test
Substance
MP.EP
MP.EP
MP, EP
MP.EP
MP.EP
MP, EP
MP, EP
EP; MP; TGAI
TGAI/PAI
MP, EP
EP; MP; TGAI
8, Time
Frame
(Months)
B
8
B
8
B
8
B
8
8
8
8
9. Registrant
Response
Date
i^H^B^H^H^H
-------
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0315 Lindane DD-MMM-YYYY
NO STREET ADDRESS PRODUCT SPECIFIC
NO CITY, XX 00000 ID# PDCI-009001-NNNN
EPA Reg. No. NNNNNN-NNNNN
4. Guideline
Requirement
Number
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
5. Study Title
Acute Oral Toxicity (33 ,34)
Acute dermal toxicity (24 ,25 ,26)
Acute inhalation toxicity (27)
Acute eye irritation (28)
Acute dermal irritation (29 ,30)
Skin sensitization (31 ,32)
P
R
0
T
0
C
o
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G, H. I,
J, K, L, M, N, 0
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, 0
A, B, C, D, E, F, G, H, I,
J, K, L, M. N, O
A, B, C, D, E, F, G. H, I,
J, K. L, M, N, 0
A.B.C, D, E, F,G, H.l,
J, K, L, M, N, O
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
EP; MP; TGAI
EP; MP; TGAI
EP; MP; TGAI
EP; MP; TGAI
EP; MP; TGAI
EP; MP; TGAI
8. Time
Frame
(Months)
3
B
B
8
8
8
i
9. Registrant
Response
Date
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DRAFT COPY Page 1 of3
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0315 Lindane
DCI Number: PDCI-009001-NNNN
Key; EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP, EP = Manufacturing Use Product, End Use Product; TGAI = Technical Grade Active
Ingredient [TGAI]; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M- Indoor nonfood use
B - Terrestrial feed crop E - Aquatic nonfood outdoor use H - Greenhouse food crop K - Residential N - Indoor medical use
C- Terrestrial nonfood crop F- Aquatic nonfood industrial use I- Greenhouse nonfood crop L- Indoor food use O- Residential Indoor use
Footnotes: Phe following notes are referenced In column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 Data must be provided in accordance with the "Product Composition" Section.(158.155)
2 Data must be provided in accordance with the "Description of Production Process" Section.(158.162)
3 Data must be provided in accordance with the "Description of Materials used to Produce the Product" Section,(158.160)
4 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient Is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
5 Data must be provided in accordance with the "Description of Formulation Process" Section.(158.165)
6 Data must be provided in accordance with the "Description of Formation of Impurities" Section(158.167)
7 Required for TGAIs and products produced by an integrated system.
8 Data must be provided in accordance with the "Preliminary Analysis" Section.(158.170)
g Data must be provided in accordance with the "Certified Limits" Section(158.175)
10 Data must be provided in accordance with the "Enforcement Analytical Method" Section.(158,180)
11 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed In acid equivalent or active equivalent).
12 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated Into salts or esters,
the concentration of the active Ingredient in these products must be expressed in acid equivalent or active equivalent).
13 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
14 Required if the product contains an oxidizing or reducing agent
15 Required when the product contains combustible liquids.
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United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0315 Lindane
DCI Number: PDCI-009001-NNNN
Key: EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP, EP = Manufacturing Use Product, End Use Product; TGAI = Technical Grade Active
Ingredient [TGAI]; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop D -
B - Terrestrial feed crop E -
C - Terrestrial nonfood crop F -
Aquatic food crop G -
Aquatic nonfood outdoor use H -
Aquatic nonfood industrial use I -
Aquatic non-food residential J - Forestry use
Greenhouse food crop K - Residential
Greenhouse nonfood crop L - Indoor food use
M - Indoor nonfood use
N - Indoor medical use
O - Residential Indoor use
Footnotes: Fhe following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
16 Required when the product is potentially explosive.
17 Required if the end-use product is a liquid and is to be used around electrical equipment.
18 Required if the product is an emulsiftable liquid and is to be diluted with petroleum solvents.
19 Required if the product is dispersible with water.
20 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
21 Required if the product is a liquid.
22 True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.
23 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI {i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
24 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
25 Not required if test material is a gas or a highly volatile liquid.
26 Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under Section 152.170(0) or special review
consideration under Section 154.7(a)(1).
27 Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or participate).
28 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
29 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
30 Not required if test material is a gas or a highly volatile liquid.
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DRAFT COPY
Page 3 of 3
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0315 Lindane
DCI Number: PDCI-009001-NNNN
Key: EP; MP; TGAI = End Use Product; Manufacturing Use Product; Technical Grade Active Ingredient; MP, EP = Manufacturing Use Product, End Use Product; TGAI = Technical Grade Active
Ingredient [TGAI]; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop D -
B - Terrestrial feed crop E -
C - Terrestrial nonfood crop F -
Aquatic food crop G -
Aquatic nonfood outdoor use H -
Aquatic nonfood industrial use I -
Aquatic non-food residential J - Forestry use
Greenhouse food crop K - Residential
Greenhouse nonfood crop L - Indoor food use
M - Indoor nonfood use
N - Indoor medical use
0 - Residential Indoor use
Footnotes: (The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
31 Required if repeated dermal exposure is likely to occur under conditions of use.
32 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
33 Not required if test material is a gas or a highly volatile liquid.
34 Diluted EP testing is required to support the end product registration if results using the EP meet the criteria for restricted use classification under Section 152.170(b) or special review
consideration under Section 154.7(a)(1).
35 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
36 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Data Call-Ins issued under the Re registration Eligibility Decision (RED)/lnterim Re registration Eligibility Decision (IRED) Documents."
37 Please see attached "Additional Information and Requirements Pertaining to Storage Stability {OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Data Call-ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
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APPENDIX G: EPA'S Batching of Lindane Products for Meeting Acute Toxicity Data
Requirements for Reregistration
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of products containing lindane as the active ingredient,
the Agency has batched products which can be considered similar for purposes of acute toxicity.
Factors considered in the sorting process include each product's active and inert ingredients
(identity, percent composition and biological activity), type of formulation (e.g., emulsifiable
concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use
classification, precautionary labeling, etc.). Note that the Agency is not describing batched
products as "substantially similar" since some products within a batch may not be considered
chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single battery of six acute toxicological studies to represent all the products within that batch. It is
the registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute
toxicological studies for each of their own products. If a registrant chooses to generate the data for
a batch, he/she must use one of the products within the batch as the test material. If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the
data base is complete and valid by today's standards (see acceptance criteria attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has
not been significantly altered since submission and acceptance of the acute toxicity data.
Regardless of whether new data is generated or existing data is referenced, registrants must clearly
identify the test material by EPA Registration Number. If more than one confidential statement of
formula (CSF) exists for a product, the registrant must indicate the formulation actually tested by
identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-in Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency within
90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet
the data requirements for each product. The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each product, including the standard six
acute toxicity tests. A registrant who wishes to participate in a batch must decide whether he/she
will provide the data or depend on someone else to do so. If a registrant supplies the data to
support a batch of products, he/she must select one of the following options: Developing Data
(Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or
Citing an Existing Study (Option 6). If a registrant depends on another's data, he/she must choose
129
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among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study
(Option 6). If a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or
6. However, a registrant should know that choosing not to participate in a batch does not preclude
other registrants in the batch from citing his/her studies and offering to cost share (Option 3) those
studies.
Thirty-one products were found which contain lindane as the active ingredient. These products
have been placed into five batches and a "No Batch" category in accordance with the active and
inert ingredients and type of formulation. Furthermore, the following bridging strategies are
deemed acceptable for this chemical:
• Batch 5: EPA Reg. No. 34704-653 and 66330-19 may not rely on the acute inhalation (81-3)
data conducted on EPA Reg. No. 7501-38.
• No Batch: Each product in this Batch should generate their own data.
NOTE: The technical acute toxicity values included in this document are for informational
purposes only. The data supporting these values may or may not meet the current acceptance
criteria.
Batch I
EPA Reg. No.
655-28
5481-225
19713-61
19713-191
40083-1
% Active Ingredient
99.5
99.5
99.5
99.5
99.5
Batch 2
EPA Reg. No.
7501-34
19713-387
% Active Ingredient
30.0
30.0
Batch 3
EPA Reg. No.
19713-262
34704-674
% Active Ingredient
25.0
25.0
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Batch 4
EPA Reg. No.
% Active Ingredient
7501-37
7501-152
Lindane: 18.75
Carboxin: 20.00
Maneb: 35.00
Lindane: 18.75
Carboxin: 20.00
Maneb: 35.00
Batch 5
EPA Reg. No.
7501-38
34704-653
66330-19
% Active Ingredient
Lindane: 25.00
Captan: 12.24
Lindane: 25.00
Captan: 12.50
Lindane: 25.00
Captan: 12.50
No Batch
EPA Reg. No.
400-490
554-140
554-142
554-144
1381-165
7501-78
7501-112
7501-141
% Active Ingredient
40.00
Lindane: 8.60
Maneb: 25.60
Lindane: 18.75
Maneb: 50.00
40.00
Lindane: 25.00
Captan: 15.00
Diazinon: 15.52
Metalaxyl: 1.00
Lindane: 10.53
PCNB: 17.68
Lindane: 25.00
Carboxin: 14.00
Diazinon: 15.00
Lindane: 8.00
Carboxin: 14.00
Thiram: 12.00
131
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No Batch
EPA Reg. No.
19713-401
34704-658
34704-737
42056-11
42056-14
42056-15
42056-16
% Active Ingredient
30.00
25.00
Lindane: 18.75
Maneb: 50.00
Lindane: 25.00
Captan: 14.67
Diazinon: 15.00
Lindane: 16.60
Captan: 32.75
Lindane: 18.75
Mancozeb: 50.00
Lindane: 6.50
Mancozeb: 20.00
132
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APPENDIX H: List of Registrants Sent DCIs
133
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United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Co. Nr.
400
554
655
1381
5481
7501
19713
34704
40083
42056
66330
Case # and Name: 0315,Lindane
Company Name Agent For
CROMPTON MANUFACTURING
COMPANY, INC.
AGSCO INC
PRENTISS INC
AGRILIANCE, LLC
AMVAC CHEMICAL CORP
GUSTAFSON LLC
DREXEL CHEMICAL CO
LOVELAND PRODUCTS, INC.
INQUINOSA INTERNACIONAL, S.A. JLM INDUSTRIES, INC
TRACE CHEMICALS LLC
ARVESTA CORPORATION
Address
74 AMITY RD
PO Box 13458
C.B. 2000
PO Box 64089
4695 MACARTHUR COURT, SUITE 1250
PO Box 660065
PO Box 13327 1700 CHANNEL AVENUE
PO Box 1286
8675 HIDDEN RIVER PARKWAY
2320 LAKECREST DRIVE
100 FIRST STREET, SUITE 1700
City & State
BETHANY
GRAND FORKS
FLORAL PARK
ST. PAUL
NEWPORT BEACH
DALLAS
MEMPHIS
GREELEY
TAMPA
PEKIN
SAN FRANCISCO
Zip
CT 065243402
ND 582083458
NY 110012000
MN 551640089
CA 926601706
TX 75266
TN 381130327
CO 806321 286
FL 33637
IL 615546637
CA 94105
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APPENDIX I: List of Electronically Available Forms
Pesticide Registration Forms are available (in PDF format and require the Acrobat reader) at the
EPA internet site: hnp://www.epa.gov/opprd001/forms/ .
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on
your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information1 or 'Sensitive
Information.' If you have any problems accessing these forms, please contact Nicole Williams at
(703) 308-5551 or by e-mail at williams.nicole@epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution
of a Registered Pesticide Product,
Application for an Experimental Use Permit
Application for/Notification of State Registration of
a Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap
Procedures
Pesticide Registration Maintenance Fee Filing.
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (PR
Notice 98-5)
Data Matrix (PR Notice 98-5)
Summary of the Physical/Chemical Properties (PR
Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (PRNotice98-l)
http://www.epa.aov/opprd001/fonns/8570-l.pdf
http://www.epa.aov/ODDrd001/forms/8570-4.pdf
httD://www.eDa.eov/ODDrd001/forms/8570-5.pdf
htto://www.epa.aov/opprdOOI/forrns/8570-l 7.pdf
http://www.epa.eov/opprd001/forms/8570-25.Ddf
http://www.epa.aov/opprd001/forms/8570-27.pdf
htto://www.epa.aov/opDrd001/forms/8570-28.Ddf
httD://www.eDa.sov/oDDrd001/forms/8570-30.Ddf
http://www.epa.aov/opDrd001/forms/8570-32.pdf
httD://www.epa.aov/opDpmsdl/PR Notices/pr9 8-5.pdf
http://www.epa.eov/opppmsdl/PR Notices7pr98-5.pdf
http://www.epa.aov/opppmsdl/PR Notices/or98-l .odf
http://www.epa.aov/opDpmsdl/PR Notices/or98-l.Ddf
135
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Pesticide Registration Kit www. epa.gov/pestici des/registrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental
Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug
and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices:
a. 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is in
PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will
require the Acrobat reader).
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are hi PDF format and will require the
Acrobat reader).
a. Registration Division Personnel Contact List
B. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 FR 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF
format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g.. 50 FR 48833, Disclosure of Reviews of Pesticide Data (November 27,1985)
136
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Before submitting your application for registration, you may wish to consult some additional sources
of information. These include:
1. The Office of Pesticide Programs' website.
2. The booklet "General Information on Applying for Registration of Pesticides in the United
States", PB92-221811, available through the National Technical Information Service (NTIS)
at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center
for Environmental and Regulatory Information Systems. This service does charge a fee for
subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614
or through their website.
4. The National Pesticide Information Center (NPIC) can provide information on active
ingredients, uses, toxicology, and chemistry of pesticides (website: http://pnic.orst.edu ). You
can contact NPIC by telephone at (800) 858-7378 or by e-mail at
npicfgiace.orst.edu/info/extoxne/.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner
encloses with his submission a stamped, self-addressed postcard. The postcard must contain
the following entries to be completed by OPP:
• Date of receipt;
• EPA identifying number; and
• Product Manager assignment.
Other identifying information may be included by the applicant to link the acknowledgment of
receipt to the specific application submitted. EPA will stamp the date of receipt and provide
the EPA identifying file symbol or petition number for the new submission. The identifying
number should be used whenever you contact the Agency concerning an application for
registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded
and assigned to your company, please include a list of all synonyms, common and trade
names, company experimental codes, and other names which identify the chemical (including
"blind" codes used when a sample was submitted for testing by commercial or academic
facilities). Please provide a chemical abstract system (CAS) number if one has been assigned.
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