United States Prevention, Pesticides EPA738-R-99-001
Environmental Protection And Toxic Substances February 1999
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Chlorine Gas
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5 vxr^y I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
%'^^wl^^^ ?
\imo^ WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide chemical case Chlorine Gas. The
enclosed Reregi strati on Eligibility Decision (RED), which was approved on December 5, 1995
contains the Agency's evaluation of the data base of this chemical, its conclusions on the potential
human health and environmental risks of the current product uses, and its decisions and conditions
under which these uses and products will be eligible for reregistration. The RED includes the data
and labeling requirements for products for reregistration. It also includes requirements for
additional generic data on chlorinated disinfection byproducts to confirm the risk assessments.
To assist you with a proper response, please read the enclosed document entitled
"Summary of Instructions for Responding to the RED". This summary also refers to other
enclosed documents which include further instructions. You must follow all instructions and
submit complete and timely responses The first set of required responses are due 90 days
from the date of this letter. The second set of required responses are due 8 months from
the date of this letter. Complete and timely responses are necessary to avoid the potential
initiation of suspension action against your product registrations.
Please note that this RED was finalized and signed prior to August 3, 1996. On that date,
the Food Quality Protection Act of 1996 (FQPA) became effective, amending portions of both the
pesticide law (FIFRA) and the food and drug law (FFDCA). This RED does not address any
issues raised by FQPA. Since there are no tolerances associated with chlorine gas, the changes in
tolerance reassessment required with FQPA do not affect this RED.
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If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Antimicrobial Division representative Wanda Mitchell at (703) 308-
6345. Address any questions on required generic data to the Special Review and Reregi strati on
Division representative Patrick Dobak at (703) 308-8180.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregi strati on Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, another DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific letter will be
enclosed describing such data. Complete the two response forms provided with each DCI letter
(or four forms for the combined) by following the instructions provided. You must submit the
response forms for each product and for each DCI within 90 days of the date of this letter
(RED issuance date); otherwise, your product may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response, but
certainly no later than the 8-month response date. All data waiver and time extension requests
must be accompanied by a full justification. All waivers and time extensions must be granted by
EPA in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original application
form. Mark it "Application for Reregistration." Send your Application for Reregistration (along
with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses which
the RED says are ineligible for reregistration. For further labeling guidance, refer to the labeling
section of the EPA publication "General Information on Applying for Registration in the U.S.,
Second Edition, August 1992" (available from the National Technical Information Service,
publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data Submit all data in a format which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRID) numbers. Before citing these studies, you must make sure that they meet the
Agency's acceptance criteria (attached to the DCI).
d Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
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You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
ง158.175) or (2) provide certified limits that are supported by the analysis of five batches. If you
choose the second option, you must submit or cite the data for the five batches along with a
certification statement as described in 40 CFR ง158.175(e). A copy of the CSF is enclosed;
follow the instructions on its back.
e Certification With Respect to Data Compensation Requirements Complete and
sign EPA form 8570-31 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-AD-RMB)
Office of Pesticide Programs (75 IOC)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-AD-RMB)
Office of Pesticide Programs (75 IOC)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWSEPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data waiver
and time extension requests within 60 days. EPA will also try to respond to all 8-month
submissions with a final reregi strati on determination within 14 months after the RED has been
issued.
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REREGISTRATION ELIGIBILITY DECISION
Chlorine Gas
LISTD
CASE 4022
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
CHLORINE GAS REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 1
A. Chemical Overview 1
B. Use Profile 2
C. Data Requirements 6
D. Regulatory History 6
III. SCIENCE ASSESSMENT 6
A. Physical Chemistry Assessment 6
B. Human Health Assessment 7
1. Toxicology Assessment 7
a. Human Toxicology 7
b. Human Toxicology 9
(1) Acute Toxicity 9
(2) Subchronic Toxicity 9
(3) Chronic Toxicity 10
(4) Carcinogenicity 11
(5) Developmental Toxicity 11
(6) Reproductive Toxicity 12
(7) Mutagenicity 12
(8) Metabolism 12
(9) Other Toxic Endpoints 13
2. Exposure Assessment 14
a. Dietary Exposure 14
b. Regulatory Levels for Chlorine 15
c. Occupational and Residential 18
3. Risk Assessment 19
a. Dietary 19
b. Occupational and Residential 21
C. Environmental Assessment 22
1. Environmental Fate 22
a. Environmental Chemistry, Fate and Transport 22
b. Environmental Fate Assessment 24
2. Ecological Effects 24
a. Ecological Effects Data 24
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(1) Terrestrial Data 24
(2) Aquatic Data 25
(3) Non-Target Insects Data 25
(4) Non-Target Plants Data 25
b. Ecological Effects Risk Assessment 26
(1) Non-Endangered Species 26
(2) Endangered Species 26
(3) Non-Target Aquatic Species Risk 26
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 29
A. Determination of Eligibility 29
1. Eligibility Decision 29
2. Eligible and Ineligible Uses 30
B. Regulatory Position 30
1. Tolerance Reassessment 30
2. Restricted Use Classification 30
3. General Use Classification 32
4. Improved Product Labeling 33
5. Endangered Species Statement 33
V. ACTIONS REQUIRED BY REGISTRANTS 33
A. Additional Data Requirements 34
1. Additional Generic Data Requirements 34
2. Additional Product-Specific Data Requirements 34
B. Labeling Requirements 35
1. Labeling Requirements for Manufacturing-Use Products 35
2. Labeling Requirements for End-Use Products 35
a. Use Directions 35
b. Guidance for Specific Directions for Use 37
c. Effluent Discharge Labeling Statements 37
C. Existing Stocks 51
VI. APPENDICES 53
A. Table of Use Patterns Subject to Reregistration 54
B. Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision 60
C. Citations Considered to be Part of the Data Base Supporting the Reregistration
Decision 63
D. Generic Data Call-In 73
1. Generic Data Call-In Chemical Status Sheet 91
2. Generic DCI Response Forms Inserts (Insert A) plus Instructions . 93
3. Requirements Status and Registrants' Response Forms (Insert B) plus
Instructions 97
E. Product Specific Data Call-In 105
1. Product Specific Chemical Status Sheets 118
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2. Data Call-in Response Form for the Product Specific Data (Form A
inserts) Plus Instructions 120
3. Product Specific Requirement Status and Registrant's Response Forms
(Form B inserts) and Instructions 122
4. EPA Batching of End-Use Products for Meeting Data Requirements for
Reregistration 129
5. List of All Registrants Sent This Data Call-in (insert) Notice .... 131
F. List of Available Related Documents and Electronically Available Forms
134
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CHLORINE GAS REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Assessment
Alan Goozner
Rafael Prieto
Phyllis Johnson
Michele Cottrill
Environmental Fate and Effects Assessment
Tom Bailey
Silvia Termes
Sharlene Matten
Health Effects Assessment
John Redden
Irving Mauer
Winston Dang
Bonnie Cropp-Kohlligian
Registration Assessment
JoAnne Hayes
Wallace Powell
Risk Management Assessment
Tom Myers
Patrick Dobak
Kathleen Depukat
Jay Ellenberger
Stakeholder Input Communications
John MacDonald
Deborah Hartman
Ronald Jackson
Economic Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Science Analysis and Coordination Staff
Chemical Coordination Branch
Toxicology Branch I
Occupational and Residential Exposure Branch
Reregi strati on Support Chemistry Branch
Registration Support Branch
Antimicrobial Division
Accelerated Reregi strati on Branch
Reregi strati on Branch I
Accelerated Reregi strati on Branch
Accelerated Reregi strati on Branch
Field Operations Division
Policy and Special Projects Staff
Field and External Affairs Division
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Office of Enforcement and Compliance:
Rose Lew
Office of General Counsel:
Robert Perils
Office of Drinking Water:
Mary Manibusan
Jennifer McLain
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (D WEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA) The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
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). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
ug/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No effect concentration
NPDES National Pollutant Discharge Elimination System
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 ฉ of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
The Environmental Protection Agency has completed an assessment of the potential human
health and environmental risks associated with the pesticidal uses of chlorine gas. The Agency has
determined that the pesticidal uses of chlorine gas will not pose unreasonable risks to humans or the
environment when products are labeled and used as specified in this Reregistration Eligibility Decision
document. Therefore, all chlorine gas pesticide products are eligible for reregistration. Furthermore,
the risks associated with this acutely toxic gas are considered reasonable in light of the health benefits
provided by its use.
However, to reduce the risks of poisonings to workers from this chemical's high acute
toxicity, the Agency is requiring that use associated with industrial and agricultural food settings, non-
residential swimming pools, recirculating cooling water towers, and pulp and paper mill water process
systems be restricted to certified pesticide applicators or to those under their direct supervision. The
Agency is not imposing this limitation for applications to drinking water, sewage, or wastewater
because applicators for these uses already receive formal training on the handling of hazardous
chemicals. Although the Agency has concerns for the use of chlorine gas in residential pools, there
currently are few reported incidents that would support requiring restricted use. In addition, all
product labels will be upgraded with improved use directions, precautions, and instructions for the
use of personal protective equipment.
Chlorine gas is used in water treatment to disinfect drinking water, sewage and wastewater,
swimming pools, and other types of water reservoirs. Chlorine gas is also used as a
microbistat/microbicide, disinfectant, and algicide for food and water processing systems, and pulp
and paper mill systems. During washing operations, chlorine gas is used to control microorganisms
that cause decay of meat, produce, and seeds.
The Agency concludes from a review of available data that chlorine gas is a highly acute
toxicant by all routes of exposure. Also, the Agency classifies chlorine as a Group D carcinogen (not
classifiable as to human carcinogenicity) and concludes that available studies report no adverse
reproductive or developmental effects in test animals. Dietary exposures from food contact surface
sanitizer uses are regulated by FDA and, under a separate action the Agency has established a
Maximum Residual Disinfectant Level of 4 mg/L for chlorine in drinking water. For occupational
exposures to chlorine gas there are various reports of poisonings to workers and to others near
treatment areas. Many of these incidents resulted from chlorine transfer and chlorinator system
maintenance operations and equipment failure.
While the consumption of chlorinated drinking water is considered safe by the Agency, there
is a need to more adequately characterize the toxicity of three chlorinated organic byproducts.
Bromodichloromethane, dichloroacetic acid, and dibromoacetic acid have been identified as having
health effects in laboratory studies. Because these compounds occur at relatively high concentrations
and have been shown to cause adverse effects in laboratory animals, there is a need for additional
testing on these compounds to improve the Agency's ability to assess chronic risks from drinking
water exposure. Two two-generation reproduction and three developmental toxicity studies are being
requested from registrants that support the drinking water use.
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While chorine is highly toxic to aquatic organisms, uses which result in effluent discharges are
regulated under NPDES permits to reduce the impact on aquatic environments. For other chlorine
gas uses, such as residential swimming pools, the Agency believes there are minimal environmental
exposures due to the minimal and intermittent discharges. Further, chlorine byproducts are highly
reactive with organic matter which reduces the availability of residual chlorine to aquatic organisms.
Before reregistering the products containing chlorine gas, the Agency is requiring that product
specific data, revised Confidential Statements of Formula (CSF), and revised labeling be submitted
within eight months of the issuance of this document for every product containing chlorine gas as an
active ingredient. These data include product chemistry testing for each registration. After reviewing
these data and any revised labels and finding them acceptable in accordance with the requirements
listed in this document and Section 3(c)(5) of FIFRA, the Agency will reregister products. Those
products which contain other active ingredients will be eligible for reregi strati on only when the other
active ingredients are determined to be eligible for reregi strati on.
VI
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregi strati on of products with active ingredients registered prior to November 1,1984.
The amended Act provides a schedule for the reregi strati on process to be completed in nine years.
There are five phases to the reregi strati on process. The first four phases of the process focus on
identification of data requirements to support the reregi strati on of an active ingredient and the
generation and submission of data to fulfill the requirements. The fifth phase is a review by the U.S.
Environmental Protection Agency (referred to as "the Agency") of all data submitted to support
reregi strati on.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for registration" before calling in data on
products and either reregistering products or taking "other appropriate regulatory action." Thus,
reregi strati on involves a thorough review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to reassess the potential hazards arising from the
currently registered uses of the pesticide; to determine the need for additional data on health and
environmental effects; and to determine whether the pesticide continues to meet the "no unreasonable
adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregi strati on eligibility of the
registered uses of chlorine gas, hereafter also referred to as "chlorine". The document consists of six
sections. Section I is the introduction. Section II describes chlorine, its uses, data requirements and
regulatory history. Section III discusses the human health and environmental assessment based on the
data available to the Agency. Section IV presents the reregi strati on decision for chlorine. Section V
discusses the reregi strati on requirements for chlorine. Finally, Section VI is the Appendices which
support this Reregi strati on Eligibility Decision. Additional details concerning the Agency's review
of applicable data are available on request.
II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregi strati on Eligibility Document:
! Common Name: Chlorine Gas
! Chemical Name: Chlorine Gas
! Chemical Family: Halogen
! CAS Registry Number: 7782-50-5
1
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OPP Chemical Code: 020501
Empirical Formula: C12
B.
Use Profile
The following is information on the current registered uses with an overview of use
sites and application methods. A detailed table of the currently registered uses of chlorine is
in Appendix A.
For Chlorine Gas:
Type of Pesticide:
Use Sites:
disinfectant, sanitizer (for food and nonfood contact sites),
microbicide/microbistat (slime-forming algae, bacteria and
fungi) and algicide
AQUATIC NON-FOOD INDUSTRIAL:
Pulp/Paper Mill Water Systems
Commercial/Industrial Recirculating Water Cooling Systems
Sewage Systems
Lakes/Ponds/Reservoirs (Without Human and Wildlife
Use)
AQUATIC NON-FOOD RESIDENTIAL:
Swimming Pool Water Systems
Ornamental Ponds/Aquaria
INDOOR FOOD:
Human Drinking Water Systems
Food Processing Water Systems
Egg Handling Equipment (Commercial)
Food Processing Plant Equipment (Food Contact)
Meat Processing Plant Equipment (Food Contact)
Poultry Processing Plant Equipment (Food Contact)
Fish/Seafood Processing Plant Equipment (Food Contact)
Food Processing Plant Premises (Nonfood Contact)
Meat Processing Plant Premises (Nonfood Contact)
Poultry Processing Plant Premises (Nonfood Contact)
Fish/Seafood Processing Plant Premises (Nonfood Contact)
INDOOR NON-FOOD:
Pasteurizer/Warmer/Cannery Cooling Water Systems
Egg Plants/Hatcheries/Brooder Rooms/Shoe Baths
(Hatching)
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Target Pests:
Formulation Types
Registered:
Method and Rates
of Application:
slime-forming bacteria, fungi and algae; organisms causing
decay of raw agricultural commodities
Type: end use and manufacturing use
Form: pressurized gas
Types of Treatment -gas diffusion through a chlorinator into
the appropriate water system
spray, dip, wash water treatment for raw agricultural
commodities and meats (including poultry, meat,
seafood, and egg shells). Spray is also the treatment
type for food handling premises and equipment
Equipment - dip tank, sprayer, flume, dump tank,
hydrocooler, tank, cooler, brush washer spray,
rinser, drencher
cylinder-mounted chlorinators which are
designed to convey chlorine under vacuum
from the vacuum regulator to the injector
check-valve assembly into the appropriate
water system.
Timing - post harvest for food commodities
continuous for water systems; see also below
under Rates and Application
Rates of Application: Some of the following rates of
application are not on the labels. They were obtained from a
variety of sources and are presented here for informational
purposes on the usage of chlorine gas.
AQUATIC NON-FOOD INDUSTRIAL:
Pulp/Paper Mill Water Systems - A typical treatment is to
feed 1 to 3 ppm available chlorine into the system in order to
achieve a minimum of 0.2 ppm residual chlorine
(microbicide/microbistat)*. (Source: Nalco Chemical
Company, Naperville, Illinois)
Commercial/Industrial Water Cooling Systems
Recirculating water cooling systems are treated with a residual
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chlorine level of 0.2 to 1.0 ppm for one hour. Once-through
water cooling systems are treated with a residual chlorine level
of 0.3 to 0.8 ppm for two hours (microbicide/microbistat)*.
(Source: Betz Laboratories, Inc. 1980. Betz Handbook of
Industrial Water Conditioning. 8th Edition, p. 187.
Sewage Systems - A typical treatment is to feed 1 to 5 ppm
available chlorine into the system in order to achieve 1 ppm
for 30 minutes (disinfectant/algaecide)*. (Source: Water
Environment Federation)
Lakes/Ponds/Reservoirs (Without Human and Wildlife
Use) - 3 to 5 ppm available chlorine (microbicide/
microbistat).
AQUATIC NON-FOOD RESIDENTIAL:
Swimming Pool Water Systems - A level of 0.6 to 1.0 ppm
residual chlorine (1 to 2 ppm residual chlorine for pools
containing cyanuric acid) should be maintained
(disinfectant/algaecide)*. (Source: American Water Works
Association; Seymour S. Block, ed. 1991. Disinfection.
Sterilization, and Preservation. 4th Edition, p. 146.
Ornamental Ponds/Aquaria - 3 to 5 ppm available chlorine
(microbicide/microbistat).
INDOOR FOOD:
Human Drinking Water Systems - A typical treatment is to
feed 5 to 6 ppm available chlorine into the system in order to
achieve a 0.2 ppm residual chlorine level
(disinfectant/algaecide)*. (Source: American Water Works
Association)
Food Processing Water Systems - 1 to 400 ppm available
chlorine (for control of organisms causing decay of raw
agricultural commodities, poultry, meat, and seafood; for
sanitizing egg shells).
Food Processing Plant Equipment (Food Contact) - 15
(porous surfaces) to 200 (hard surfaces) ppm available
chlorine (sanitizer/microbicide/microbistat).
Food Processing Plant Premises (Nonfood Contact) - 50 to
200 ppm available chlorine (sanitizer).
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INDOOR NON-FOOD:
Pasteurizer /Warmer/Cannery Cooling Water Systems -10
to 15 ppm available chlorine (microbicide/microbistat).
Egg Plant Premises - 50 ppm available chlorine (sanitizer).
'Rates of application for this use site were not given on the product label
and were obtained from the indicated source to include information
concerning the usage of chlorine gas. These rates of application are not
meant to be guidance regarding use directions and do not represent actual
label usage information.
Current Use Practice Limitations:
Below, are use practice limitations that appear on various product labels for
different uses. Through this document the Agency is revising these limitations for
clarity, consistency, and to further reduce the risks of accidents and adverse effects.
The revisions are described in Section V.
"For use by 'experienced personnel' only. For use by 'trained personnel' for
dispensing from large stationary containers such as tank cars, tank trucks, 1-ton and
150-pound cylinders. For use by "trained and qualified servicemen," under the control
and supervision of the registrant of this pesticide, and in accordance with state or
municipal regulatory requirements. Only specifically designed dispensing equipment
should be used in accordance with the manufacturer's instructions and with the
Chlorine Institute recommendations. Only specifically designed dispensing equipment
should be used in accordance with the manufacturer's instructions and according to
state regulatory agency recommendations for dosages or residual chlorine levels
which should be maintained for each specific site of application."
"Dosages of residual chlorine levels which should be maintained for each
specific site of application must be consistent with recommended practice and state
and municipal recommendations. Use only valves, gauges, regulators, fittings, piping,
etc., recommended for chlorine service. Proper ventilation required. Keep away from
intense heat or open sunlight. Corrosive to most metals in the presence of moisture.
Do not heat cylinder. Segregate from other compressed gasses. Keep away from
intense heat, open sunlight, and combustible materials. Reacts dangerously with many
other chemicals. Do not vent chlorine containers, lines or valves. Do not use heat or
hot water to increase discharge rate. Proper ventilation is required. There are
NPDES license restrictions. Water is not to be contaminated by cleaning or disposal
of wastes and, food or animal feed are not to be contaminated by product storage or
disposal."
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C. Data Requirements
In addition to data requirements imposed to obtain the original registration of this
active ingredient, the Agency required generic data in the reregi strati on Phase IV Data Call-In
issued on November 9, 1993. Appendix B includes all generic data requirements identified
by the Agency for currently registered uses needed to support reregi strati on. These data
include studies on chlorine's physical chemistry and toxicology. The Agency has also relied
on available published information.
D. Regulatory History
Chlorine gas was registered as a pesticide in the United States as early as 1948. Six
chlorine products were registered that year, to six companies. One of those products was a
manufacturing-use product. The other five were all registered as disinfectants against algae
and pathogenic bacteria in general, for use in swimming pools, human drinking water, cooling
towers, and sewage systems. After 1949 there were no further chlorine product registrations
until 1964. In 1976, chlorine gas was classified for general use based on the premise that the
industrial users of this chemical were already adequately trained in its use.
Currently there are 94 products registered to 94 companies. In addition, there are
three 24(C) State Registrations. Chlorine products are currently registered for use against
pathogenic bacteria, in general, and against the algae, fungi, and bacteria that cause slime and
decay. Current use sites include various water applications, sewage treatment, food
processing applications, and wash water for about 40 fruits and vegetables and meats, poultry,
and seafood. The labeling of registered chlorine products is generally in accordance with the
standard labeling that was agreed upon by EPA and the Chlorine Institute. However, changes
are necessary, which are described in Section V of this RED document.
Chlorine gas is exempt from the requirement of a tolerance when used pre-harvest or
post-harvest in solution on all raw agricultural commodities. Both the Proposed Rule and the
Final Rule for this exemption were announced in the Federal Register in 1991, and the
exemption has since been promulgated in 40 CFR ง180.1095.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Chlorine, at normal pressures and temperatures, exists as a diatomic gas. Chlorine
hydrolyzes in water to form hypochlorous acid and hypochlorite ion. Hypochlorous acid is
an oxidizing agent and thus, chemicals that generate hypochlorous acid in water (such as
chlorine gas, hypochlorite salts and chlorinated isocyanurates) are used in water treatment to
disinfect drinking water, sewage and wastewater, swimming pools and other types of water
reservoirs.
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The physical and chemical properties* of chlorine are given in Table 1.
Table 1: Physical and Chemical Properties of Chlorine Gas
Property
Molecular Formula
Molecular weight
Physical form (25 ฐC)
Boiling point
Melting point:
Density, as liquid (20ฐC/6.864 atm)
Density, as liquid (-35ฐC/0.9949 atm)
Specific gravity
Water solubility
Color
Odor threshold
Conversion factors
Residue level (water):
Description
C12
70.906
gas
-34.05ฐC
-101ฐC
1.4085 g/mL
1.5649 g/mL
2.482 (0ฐC)
7.3 g/L (20 ฐC), 14.6 g/L (0ฐC)
greenish-yellow
0.002 mg/L water, 0.31 ppm air
1 ppm=2.9 mg/m3 1 mg/m3=0.344 ppm
0.2-1.5 mg/L
* This information is from the U.S. EPA, 1994, Drinking Water Criteria Document for Chlorine, Hypochlorous Acid
and Hypochlorite Ion.
Chlorine exists as a greenish-yellow gas under standard conditions (25ฐC and 1
atmosphere) or as a high-density amber liquid when compressed. The chlorine TGAI is
packaged as a liquefied gas in pressurized containers. Chlorine gas is stable under pressure,
and has a characteristic pungent bleach odor. Chlorine is slightly soluble in water, 8.3 kg/m3
at 15.6ฐC and 1 atmosphere; however, in pure water, chlorine forms a mixture of hydrochloric
and hypochlorous acids. Hypochlorous acid acts as an oxidant toward organic and inorganic
contaminants.
B.
Human Health Assessment
1. Toxicology Assessment
The toxicological data base for chlorine is adequate and will support
reregi strati on eligibility. In addition to submitted studies, the Agency is also relying
on information contained in the U.S. EPA, 1994, Drinking Water Criteria Document
for Chlorine, Hypochlorous Acid and Hypochlorite Ion as noted above.
a. Human Toxicology
The list of reported adverse health effects associated with chlorine gas
exposure ranges from bronchitis, asthma and pulmonary edema to headaches,
meningitis and heart disease (NRC, 1976; WHO, 1982). In addition, acute
7
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exposure to chlorine gas has resulted in adverse health effects which include
pulmonary congestion, respiratory failure, pulmonary edema and
bronchopneumonia (WHO, 1982). Table 2 indicates the threshold levels of
the effects produced by inhaling chlorine gas. The authors of the (WHO,
1982) report also stated that there were no indications of permanent
respiratory damage in persons surviving acute exposures to chlorine gas. In
cases of acute, low-level exposure to chlorine gas, complete and rapid
recovery occurred with symptomatic treatment.
Table 2: Threshold Levels for Chlorine Gas Inhalation Effects*
Effect
Odor perception/irritation
Perceivable sensory irritation
Intolerable sensory irritation
Chronaxie/visual adaptation changes
Pronounced dyspnea, anxiety, vomiting, cyanosis, pulmonary edema
C12 Threshold
Levels - mg/m3
0.06-5.8
2.9
11.6
1.5
87.0-116.0
C12 Threshold
Levels - ppm
0.02-2.0
1.0
4.0
0.52
30.0-40.0
*Source: WHO, 1982
Episodes of dermatitis have been linked to exposure to chlorine and
hypochlorite ion (U.S. EPA, 1981). Sodium hypochlorite disinfectants, in
particular, have been determined to be the causal agent in the development of
occupational allergic reaction or irritation of the skin.
Individuals who are allergic to chlorine products or who are asthmatic
may be at high risk for adverse reactions after inhalation or ingestion of even
low levels of chlorine compounds. Asthmatic attacks have been reported after
consumption of municipal drinking water that contained 0.2-0.4 ppm chlorine
(Sheldon and Lovell, 1949). Studies by (Lubbers et al., 1983, 1984) have
indicated that individuals with an A-variant form of G6-PD deficiency may
also be at higher risk due to oxidant stress. Newborns, especially those with
enzymatic deficiencies, are also a group which may be at increased risk from
oxidant-stress agents (Jones and McCance, 1949; Ross, 1963).
Acute exposure to chlorine has also occurred through the ingestion of
household bleach usually consisting of 3-6% solutions of sodium hypochlorite
in water with pH values averaging -11.0. The typical amount of bleach
ingested by a child has been estimated to be -4-5 ml. Intake of this small
amount of bleach generally results in irritation of the oropharynx and
esophagus, a burning sensation in the mouth and throat, spontaneous emesis,
and in rare instances, permanent injury to the esophagus with perforation or
stricture formation dependent upon the pH of the solution (Mack, 1983).
-------
Ingestion of a few teaspoons of bleach proved fatal for an 18-month-
old girl (Done, 1961). The bleach solution was apparently aspirated into the
trachea where it caused acute tracheobronchitis. Strange et al., 1951,
reported a case in which a 49-year-old male ingested a quart of liquid bleach
containing roughly 5% free available chlorine in the form of sodium
hypochlorite (-6557 mg/kg). Injury to the stomach eventually necessitated
a total gastrectomy. The individual's esophagus appeared to be healthy.
There is further discussion of reported effects from accidental exposure to
chlorine's uses as a pesticide in Subsection 3 .b., Occupational and Residential
Risk Assessment, below.
b. Human Toxicology
(1) Acute Toxicity
Table 3: Acute Toxicity
Test
Oral LD50 - Rat
Dermal LD50 - Rabbit
Inhalation LC50 - Rat
Eye Irritation - Rabbit*
Dermal Irritation - Rabbit*
Dermal sensitization - Guinea Pig*
Results
Waived
Waived
Waived
Waived
Waived
Waived
Category
I
I
I
I
I
positive
Note: Data pertaining to acute eye irritation, dermal irritation, and dermal sensitization
are not required to support the reregistration of the TGAI. These data are presented for
informational purposes.
Technical (99%) chlorine (gas and/or liquid) and its reactive
byproducts, hypochlorous acid and hypochlorite ions, are highly toxic
and corrosive substances, and are thus classified as Toxicity Category
I for acute oral and dermal effects (GDLN 81-1, -2). Due to its
corrosivity, the Agency has not required studies for acute inhalation
(GDLN 81-3), primary eye irritation (GDLN 81-4), primary dermal
irritation (GDLN 81-5), and dermal sensitization (GDLN 81-6).
Accordingly, chlorine and its byproducts have also been assigned
Toxicity Category I for these effects.
(2) Subchronic Toxicity
The Agency has not received any subchronic toxicity studies
(GDLN 82-1 through 7) with chlorine or its byproducts from any of
the registrants. Due to its acknowledged corrosivity (see above), the
registrants have been granted a waiver for submission of data from a
90-day dermal study (GDLN 82-3). The data from a 90-day
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inhalation study (GDLN 82-4) will be discussed together with the
Final Report of a chronic rat inhalation study conducted at the
Chemical Industries Institute of Toxicology (CUT).
Daniel et al., 1991, reported that chlorinated drinking water
over a three-month period was without adverse effects to rats at up to
250 mg/L available chlorine (intakes up to 16.7 mg/kg/day males; 24.9
mg/kg/day females), and occasioned only decreased water
consumption in mice at comparable concentrations (intakes up to 34.4
mg/kg/day, males; up to 39.2 mg/kg/day, females) (Daniel et al.,
1991).
(3) Chronic Toxicity
The Agency is relying on published studies for its assessment
of chlorine's chronic toxicity. Because of the sufficiency of these
studies, which are presented below, the Agency has not required
registrants to generate and submit the standard chronic toxicology
studies normally required for registration or reregi strati on (GDLN 83-
1; oncogenicity, GDLN 83-2; developmental toxicity, GDLN 83-3 and
reproduction, GDLN 83-4). Additionally, a 2-year inhalation study
with chlorine was conducted at CUT. Chlorine gas was administered
at 0,0.4, 1.0 and 2.5 ppm to both mice and rats. Dose-dependent
lesions in the upper respiratory tracts were present at all dose levels
including the LDT (0.4 ppm, equivalent to 0.001 mg/L), however no
neoplasms were present at any dose level. The HOT, 2.5 ppm
(equivalent to 0.007 mg/L) was considered a MTD, since it caused a
10-12% reduction in body weight. The results of this study indicate
that chlorine gas is negative for oncogenic potential and were
consistent with the findings in the previous studies.
Diverse results have been reported for chronic exposure to
chlorine in drinking water. National Toxicology Program (NTP)
studies reported no treatment-related clinical adverse effects other
than decreased water consumption in F-344 rats drinking water
containing up to 275 ppm (13.3 mg/kg/day, males; 14.4 mg/kg/day,
females) (NTP, 1990). In contrast, an earlier study recorded
significant decreases in body and liver weights in both sexes,
coincident with decreased brain and heart weights in male rats and
salivary gland and kidney weights in female rats, administered 0.1 to
1.0% sodium hypochlorite in drinking water (5.5 to 21.9 mg/kg/day,
males; 15.5 to 54.7 mg/kg/day, females) (Hasegawa et al., 1986).
10
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(4) Carcinogenicity
The Agency has classified chlorine in Group D, that is, not
classifiable as to human carcinogenicity. This classification stems
from the findings of the NTP (1990) study indicating equivocal
evidence in female rats (increased mononuclear call leukemia) and no
evidence in male rats or in male and female mice, discussed below.
The International Agency for Research on Cancer (IARC, 1991) also
evaluated chlorinated drinking water and hypochlorite for potential
human carcinogenicity. IARC determined that there was inadequate
evidence for carcinogenicity of drinking water and hypochlorite salts
in humans and animals. IARC concluded that chlorinated drinking
water and hypochlorite salts were not classifiable as to their
carcinogenicity to humans and thus assigned these chemicals to IARC
Group 3. This category is similar to the Agency's cancer classification
Group D.
In the NTP study, Fischer 344/N rats and B6C3F1 mice
(70/sex/group) were administered chlorinated drinking water
containing 0, 70, 140 or 275 ppm available chlorine for up to 104
weeks (corresponding to intake levels of 4.2/4.2, 7.3/7.8 and
13.6/14.4 mg/kg/day for male/female rats; 7.4/7.6, 14.0/14.2 and
24.0/24.2 mg/kg/day for male/female mice). Due to lack of
palatability, 275 ppm was considered the maximum dose animals
would drink, as evidenced by significantly decreased water
consumption.
Epidemiologic studies have also been inadequate to develop
any conclusions as to the carcinogenicity of chlorine or its byproducts,
hypochlorous acid and/or the hypochlorite ion (U.S. EPA, 1994,
Drinking Water Criteria Document for Chlorine, Hypochlorous Acid
and Hypochlorite Ion).
(5) Developmental Toxicity
Published sources recorded no adverse clinical, reproductive
or developmental effects in mouse dams or fetuses from chlorinated
water administration during pregnancy (Chernoff et al., 1979 and
Staples et al., 1979). These studies were not designed to assess the
toxicity associated with chlorinated organic byproducts of water
treatment.
11
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(6) Reproductive Toxicity
In a single published study, no adverse clinical, reproductive
or developmental effects were reported in BD-II rats receiving highly
chlorinated water (100 mg/L residual chlorine equivalent to intake of
10 mg/kg/day) for seven consecutive generations (Druckrey, 1968).
This study was also not designed to assess the toxicity associated with
chlorinated organic byproducts of water treatment.
(7) Mutagenicity
Acceptable data (unpublished) from the primary battery of
mutagenicity studies submitted under Guideline 84-2 recorded
negative results for gene mutation in bacteria (Salmonella-Ames Test)
and mammalian cells (L5178Y mouse lymphoma), as well as for
chromosome aberrations in vivo (mouse micronucleus) at doses up to
cytotoxic or maximum toleratedlevels(MRIDs42002801,42002802,
and 42002803).
Table 4: Mutagenicity
Study
Ames Test
Mouse Micronucleus
Mammalian cell (L5178Y)
gene mutation
Reported Results
Negative for reversions in Salmonella strains, exposed up
to 0.5-0.7 ppm, non-toxic doses.
Negative for micronuclei in bone marrow cells of mice
exposed up to toxic doses (80 ppm).
Negative for forward mutation in mouse lymphoma cells
exposed up to cytotoxic doses.
MRID
42002801
42002802
42002803
The results of other studies are confounded by the reactive
nature of chlorine and its reaction products which generated positive
results at low doses (50 |ig/ml in bacterial assays (Rosenkranz et al.,
1973; Sweeny et al., 1985; Walton et al., 1976; Wlodkowski, 1975),
but only at severe cytotoxic levels in mammalian cell cultures (Mickey,
1971), with essentially negative results in vivo (Meier et al., 1985 and
Gumming, 1978).
(8) Metabolism
Radiolabelled (36C1) chlorine-containing compounds orally
administered to rats are rapidly absorbed into blood, peaking in 2-4
hours, with a half life of 2.2 hours (Abdel-Rahman et al., 1983; Suh
et al., 1983). After 72-96 hours, the label was highest in plasma,
followed by bone marrow, kidney, testes, lungs, skin and liver; lowest
12
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concentrations remained in ileum and adipose tissue (Abdel-Rahman
et al., 1983 and Abdel-Rahman et al., 1982). As the gas or base liquid
(C12) or as byproducts (OC1"; HOC1), chlorine is a potent oxidizing
agent, readily reacting in biological systems with proteins and
nucleotides to produce a wide variety of chlorinated organic
compounds (Abdel-Rahman et al., 1983; Abdel-Rahman et al., 1982;
Baker, 1947; Cumming, 1978; Dennis et al., 1978; Hoyano et al.,
1973; Mink et al., 1983; Patton et al., 1972; Pereira, 1973). Chlorine
is eliminated primarily in urine and feces, mainly (81% of ingested
label) as the chloride ion (Abdel-Rahman et al., 1983 and Suh et al.,
1983).
These published sources contribute limited understanding to
the toxicokinetics of chlorine and its byproducts in biological systems,
due to their high reactivity with other molecules, generating short-
lived chlorinated products (Seegert et al., 1980). Because of its high
reactivity, additional data to fulfill the Agency's standard metabolism
requirement (GDLN 85-1) are not required at this time.
(9) Other Toxic Endpoints
Cardiovascular effects have been reported in some published
subchronic studies. Increased hydroxyproline levels were found in
heart tissue of New Zealand white rabbits drinking water containing
15 mg/L chlorine (1.6 mg/kg/day) (Revis, 1985). Sprague-Dawley
rats administered 100 mg/L (14/mg/kg/day) chlorinated water
registered transient but significant decreases in erythrocyte counts and
hematocrit, as well as increased osmotic fragility early in a 12-month
treatment schedule, all of which reversed by six months of the
treatment (Abdel-Rahman et al., 1984).
(10) Toxicological Endpoints of Concern
The risk assessment for noncancer health effects is
characterized by a Reference Dose (RfD). The RfD is an Agency-
wide number used to estimate, with uncertainty spanning perhaps an
order of magnitude, the daily exposure to the human population,
including sensitive subgroups, that is likely to be without an
appreciable risk of deleterious health effects during a lifetime. Other
toxicological endpoints used for regulatory purposes for drinking
water are discussed below in the dietary exposure subsection of the
exposure assessment.
13
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The RfD for chlorine in drinking water can be estimated as
follows:
RfD = 14.4 mg/kg/dav
100
= 0.144 mg/kg/day (rounded off to 0.1 mg/kg/day)
where: 14.4 mg/kg/day is the NOAEL based upon absence of
adverse effects in female rats exposed to chlorinated
water for two years (NTP, 1992);
and: 100 is the uncertainty factor (10 for
interspecies and 10 for intraspecies variation).
No toxicological endpoint for cancer was selected because
chlorine is classified as a Group D carcinogen (i.e., not classifiable
based on lack of data or inadequate evidence of carcinogen!city from
animal data). Further, no definitive carcinogenic effects have been
detected for hypochlorous acid or hypochlorite ion. Therefore, no
quantification of potential cancer effects is appropriate.
2. Exposure Assessment
a. Dietary Exposure
Chlorine gas is exempt from the requirement of a tolerance when used
preharvest and postharvest in solution on all raw agricultural commodities [40
CFR ง180.1095]. Although chlorine residues of concern may remain in/on
raw agricultural commodities resulting from currently registered postharvest
uses of chlorine gas, there is no reasonable expectation that finite residues or
residues significantly above naturally occurring background levels would be
incurred. Therefore, residue data are not required to support the
reregi strati on of chlorine for use in food processing water systems to control
decay in or on raw agricultural commodities.
The Agency has considered the possibility that livestock might ingest
chlorine-treated water and has determined that in the unlikely event that
livestock did ingest chlorine-treated water that there is no reasonable
expectation that finite residues of chlorine or residues significantly above
naturally occurring background levels would be incurred in meat, milk, or
eggs as a result [40 งCFR 180.6(c)]. Therefore, animal metabolism, storage
stability and magnitude of the residue data are not required to support the
reregi strati on of chlorine for use in drinking water.
14
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A full risk assessment for the use of aqueous chlorine gas solutions as
a food contact surface sanitizer in or on food, meat, and/or poultry processing
premises and/or equipment was not performed because these issues are under
FDA purview. The Agency defers to FDA on this subject, and they have
concluded that chlorine gas solutions may be safely used for these
applications. For this RED, the Agency is relying on drinking water risk
assessments performed under the Safe Drinking Water Act (SOW A). Current
risk assessments continue to support the conclusion that chlorine gas can be
safely used in public water systems. However, because most of the U.S.
population is exposed to chlorinated drinking water, it is necessary to better
characterize the chronic risks associated with exposure to chlorinated
byproducts that may be present.
In summary, the regulation of chlorine gas when used in solution as a
food contact surface sanitizer in or on food, meat, and/or poultry processing
premises and/or equipment falls under FDA jurisdiction. The regulation of
chlorine gas when used in potable water systems falls under the jurisdiction
of the Agency's Office of Drinking Water. It has the responsibility to
determine the nature and magnitude of the residues of chlorine gas in potable
water resulting from the maximum permitted uses of chlorine gas. Regulatory
endpoints for chlorine in potable water are described below.
b. Regulatory Levels for Chlorine
In addition to developing the previously discussed RfD, which is used
for risk assessment, the Agency has developed several health-related
thresholds for chlorine gas. The Drinking Water Equivalent Level (DWEL),
Maximum Residual DisinfectantLevel Goal (MRDLG) and Health Advisories
(HA) represent the EPA Office of Water's efforts in assessing potential
adverse effects. Each of these endpoints is described as follows.
Drinking Water Equivalent Level (DWEL)
The DWEL represents a medium specific (i.e., drinking water) lifetime
exposure at which adverse, non-carcinogenic health effects are not anticipated
to occur. The DWEL provides the non-carcinogenic health effects basis for
establishing a drinking water standard. A DWEL can be calculated as follows:
DWEL=
2L/day
where: 0. 1 mg/kg/day is the RfD;
70 kg = assumed human adult body weight;
2 Liter/day = assumed adult water consumption.
15
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Maximum Residual Disinfectant Level Goal (MRDLG)
The Agency regulates contaminants in drinking water under the Safe
Drinking Water Act (SDWA). In general, the Agency regulates contaminants
that may have an adverse health effect and are known or anticipated to occur
in public water systems. In addition to the standards that are designed to
protect against certain microorganisms (54 FR 27486), the Agency has
recently established a MRDLG of 4 mg/L for chlorine. MRDLGs are like the
Maximum Contaminant Level Goal and are established at the level at which
no known or anticipated adverse effects on the health of persons occur and
which allows an adequate margin or safety. MRDLGs are nonenforceable
health goals based on health effects.
Health Advisories (HAs)
In addition to the RfD and the DWEL, Health Advisories for
exposures of shorter duration (1-day, 10-day and longer-term) are
determined. The HA values are used as informal guidance to municipalities
and other organizations when emergency spills or contamination situations
occur. HAs can be calculated for 1 or 10 days or longer periods of time and
for a child or adult. Below are the equations for these calculations. The
NOAEL and LOAEL are identified from acute or subchronic studies.
_(NOAELVWAEL)xbw _
HA_
1-day HA: In the absence of suitable data to derive a 1-day HA, the
Agency recommends that the 10-day HA of 2.5 mg/1 be used as a
conservative estimate of the 1-day HA.
10-day HA: The 10-day HA for a 10 kg child is calculated as follows:
Q A=25mgkg/dcy>
-------
100 = uncertainty factor chosen in accordance with U.S. EPA (1988)
guidelines for use of a NOAEL from an animal study.
Longer-term HA for a child: The longer-term HA for a 10 kg child is
calculated as follows:
IL/dayxWO
where:
16.7 mg/kg/day = NOAEL based on the absence of adverse gross
effects in male rats exposed to chlorinated drinking water for 90 days
(Daniel et al., 1990) (Blabaum and Nichols, 1956)
10 kg = assumed weight of a child
1 liter/day = assumed water consumption by a child
100 = uncertainty factor chosen in accordance with U.S. EPA (1988)
guidelines for use of a NOAEL from an animal study.
Longer-term HA for an adult: The longer-term HA for a 70 kg adult is
calculated as follows:
IL/dayxWO
where:
16.7 mg/kg/day = NOAEL based on the absence of adverse gross
effects in male rats exposed to chlorinated drinking water for 90 days
(Daniel et al., 1990) (Blabaum and Nichols, 1956)
70 kg = assumed weight of an adult
2 Liter/day = assumed water consumption by a adult
100 = uncertainty factor chosen in accordance with U.S. EPA (1988)
guidelines for use of a NOAEL from an animal study.
17
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c. Occupational and Residential Exposure
Chlorine gas is metered into water through closed systems in
manufacturing processes or from large stationary containers such as tank cars,
tank trucks, 20 and 150-pound and 1-ton cylinders. Given the current use
patterns of chlorine gas, there is potential for dermal and inhalation exposure
to the applicators and to other people who are exposed to the chlorinated
water, including swimmers, bystanders, and workers in food processing plants
and in water/sewage treatment plants.
The Agency believes post-application exposure to chlorine during
swimming in treated water is not significant provided if proper application
methods are followed. No post-application exposure studies are required.
There are a number of occupational exposure guidelines that are
established from different sources, including ACGIH, the U.S. Occupational
Safety and Health Administration (OSHA), and foreign government agencies.
These guideline values are listed in Table 5.
Table 5: Existing Guidelines on Human Exposure to Chlorine"
Source
American Conference of Government
Industrial Hygienists
OSHA
U.S. Mine Safety and Health Administration
ACGIH Criteria Document
West Germany, Switzerland, former Yugoslavia
(former USSR, most eastern European countries
most other countries
Type of Guideline
TLV-air TWA
STEL-air
Standard in air
Standard-air TWA
Occupational exposure to
chlorine in air
TLV
TLV
TLV
Exposure Level (ppm)
1
o
3
i
i
0.5 for 15 minutes
0.5
0.3
1
TLV= Threshold limit value
*Source: ACGIH, 1986
STEL= short-term exposure limit TWA= Time Weighted Average
California is the only State with a system designed specifically to track
pesticide illnesses. Case reports received by the California Pesticide Illness
Surveillance Program in which health effects were attributed to the use of
chlorine gas as a pesticide in 1991 demonstrated that there were
approximately 62 events involving about 100 people. A majority of the
accidents occurred at swimming pools and food processing plants. Many of
the incidents at food processing plants involved workers who reported dermal,
ocular, and/or respiratory irritation from exposure to chlorinated wash water.
Pool incidents involve applicator error in switching cylinders that resulted in
the release of chlorine gas.
18
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The 1992-1993 California Case Reports included 64 incidents
specifically involving chlorine gas as a source. Of these incidents, 22 occurred
at food processing facilities. There were 10 incidents each at commercial
swimming pools and water/wastewater treatment plants. There were 3
incidents involving repackaging to small cylinders, and 2 involving residential
swimming pool treatment. Some of these use incidents were not attributable
to specific use patterns. In general, the majority of these incidents involved
tank changing, maintenance operations or equipment failure of in-place gas
chlorinator systems. A significant number of these incidents involved
untrained personnel or resulted from precautions not taken.
Between 1982 and 1986, 81 cases of chlorine gas poisoning were
reported by the California Department of Food and Agricultural averaging 16
per year. About 50% of the cases (41) involved agricultural uses, 25% (20)
involved sewage treatment facilities, and 20% (16) involved swimming pools.
The 1986 report of the American Association of Poison Control
Centers reported 3,174 cases of chlorine exposure. Of these cases 1,231 were
treated in a health care facility. The number of cases related to chlorine gas
could not be distinguished from other sources of chlorine such as sodium and
calcium hypochlorite and chlorinated isocyanurates.
The Chlorine Institute, an industry association, reported approximately
200 accidents involving non-residential swimming pools over the 5-year
period prior to 1988. Annually, on average, one person was admitted to a
hospital and seven persons were treated. A significant number of accidents
which involved leaks in chlorine cylinders were reportedly the result of
application error.
In the past few years there have been four deaths related to the use of
chlorine gas in Florida. In all of these cases it appears that applicator error
was the cause of death. In two cases, the applicators apparently were
asthmatics which may have contributed to their death. These cases both
occurred at water treatment plants.
3. Risk Assessment
a. Dietary
Adverse risk to the general population from consumption of food or
potable water treated with chlorine as a pesticide is not expected. Chlorine
residues may remain in or on raw agricultural commodities resulting from
currently registered postharvest uses of chlorine gas. However, because of
19
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a lack of toxicological concerns, the current exemption from the requirements
for a tolerance is adequate for chlorine residues resulting from preharvest or
postharvest uses on all raw agricultural commodities [40 CFR ง180.1095].
The Agency has considered the possibility that livestock might ingest
chlorine-treated water and has determined that in the unlikely event that
livestock did ingest chlorine-treated water that there is no reasonable
expectation that finite residues or residues significantly above naturally
occurring background levels would be incurred in meat, milk, or eggs as a
result [40 CFR ง180.6(c)].
The regulation of chlorine gas when used in solution as a food contact
surface sanitizer in or on food, meat, and/or poultry processing premises
and/or equipment falls under FDA jurisdiction.
The Agency regulates contaminants in drinking water under the Safe
Drinking Water Act (SDWA). Through this authority, the Agency regulates
contaminants that may have adverse health effects and are known or
anticipated to occur in public water systems. The Office of Drinking Water
has recently established a Maximum Residual Disinfectant Level (MRDL) of
4 mg/L for chlorine. This is an enforceable Federal standard.
Because FIFRA has the authority to require the submission of testing
relevant to the use pattern of each pesticide, the adequacy of the database for
all uses, especially those under the Agency's authority was considered. While
the proper use of chlorine gas for drinking water treatment continues to be
considered safe, advances in the understanding of the significance of
chlorinated hydrocarbons as drinking water byproducts have resulted in a
greater level of uncertainty regarding the long-term health effects of drinking
water exposure. The Office of Ground Water and Drinking Water identified
three byproducts which occur at relatively high concentrations where
additional testing would reduce the uncertainty in the understanding of the
health effects from these three byproducts. The most commonly occuring
byproduct, chloroform, is already adequately characterized.
Bromodichloromethane is a key brominated trihalomethane. This
byproduct has been associated with early term miscarriages in a recent
epidemiologic study conducted in California (Waller et al., 1998). Thus, it is
important to better characterize its developmental risk. BDCM has been
shown to alter male reproductive function in F344 rats (Klinefelter et al.,
1995). A dose-response increase in sternebra aberrations (50, 100, and 200
mg/kg bw/day)were observed in a developmental study in Sprague-Dawley
rats (Ruddick et al., 1983), and a recent study in F344 rats found that BDCM
induced full litter resorptions at 50 and 75 mg/kg/bw/day (Narotssky et al.,
1997).
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Dichloroacetic acid (DCA) is a major byproduct in the haloacetic acid
family. It is generally the highest occurring of the haloacetic acids. Damage
and atrophy to sexual organs has been reported in male rats and dogs exposed
to level from 50 mg/kg BW/day to 2000 mg/kg BW/day for up to 3 months.
DCA has been shown cause to heart defects in fetal rats at a dose of 140
mg/kg BW/day during 9-11 day of gestation (Smith, et al., 1992). Exposure
of rats during days 12-15 of gestation to 1900 mg/kg BW/day produces the
same heart defects (Epstein et al., 1992). Developmental toxicity testing is
considered adequate in the rat.
Dibromoacetic acid (DBA) is another haloacetic acid that will occur
in higher levels in waters high in bromine. DBA has been shown to cause
histopathologic chages in the tests and alter spematogenesis (e.g., marked
effects on epidiymal sperm counts and morpholgy) in rats (Linder et al., 1994;
1996; 1997). DBA has been shown to cause developmental defects in a
mouse developmental assay (Narotsky et al, 1996; Teratogly abstract). The
developmental toxicity data on DBA has been adequately characterized since
it has been tested in both rats and mice already.
b. Occupational and Residential
As stated above, chlorine gas is highly acutely toxic by inhalation.
Under the Agency's scheme of categorizing acute toxicity, it is the highest
category, Category I. A level of 3.5 ppm it produces a detectable odor, 15
ppm causes immediate irritation of the throat, 50 ppm is life threatening for
even short exposures, and 1,000 ppm may be fatal. The occupational
permissible exposure limit (PEL) for chlorine in air has been set at 0.5 ppm/15
minutes.
The Agency has significant concerns with applicator and post-
application exposure because chlorine gas is highly toxic for all routes of
exposure. The greatest risk is from uses that could expose many people in the
vicinity of chlorine's storage and use. This includes applicators and bystanders
in the vicinity of accidental releases of chlorine gas in swimming pools and to
applicators and workers in the industrial food use settings. While there are
reported chlorine gas releases from its use in drinking water and sewage
treatment plants, these facilities are subject to operator certification
requirements and have standard operating procedures to minimize accidents.
Applicators and other people in the vicinity of the chlorine gas tanks
can be exposed to gas released when metering equipment fails or there is
human error in working with the tank and equipment. Exposure can be to the
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skin, eyes, and respiratory tract. Secondary exposure can also occur to
workers in food processing plants and swimmers who are exposed to the
chlorinated water. Routes of exposure are the same as for the gas.
The Agency has summarized the reported poisoning incidents above
in the Occupational and Residential Exposure discussion. While pesticide
incidents are typically under-reported, the Agency believes the available
reports are sufficient to strongly suggest that the use of chlorine gas in certain
situations presents a significant risk of acute toxicity to applicators, other
workers, and bystanders. Reported hazards include fatalities, hospitalizations,
and acute transient irritations to the skin, eyes, and respiratory tract.
C. Environmental Assessment
1. Environmental Fate
The Agency is relying on data available in the scientific literature to assess the
environmental chemistry, fate, and transport of chlorine used as a pesticidal
compound. The environmental fate of chlorine in aqueous media is essentially that
of hypochlorous acid. Hypochlorous acid is also formed when hypochlorite salts
(sodium, potassium, lithium and calcium) and chlorinated isocyanurates react with
water.
a. Environmental Chemistry, Fate and Transport
Chlorine (C12), a greenish yellow gas at room temperature, is usually
transported as a liquefied gas in pressurized containers. Chlorine reacts readily
with water to form solvated chlorine, C12 (aqueous). The solvated chlorine
molecule disproportionates very rapidly (in the order of milliseconds) to
hypochlorous acid and hydrochloric acid (Greenwood et al., 1984; Cotton et
al., 1988; Tchobanoglous et al., 1985; Snoeyink et al., 1980). Chlorine
(aqueous) is not a predominant species at pHs above 2.
Hydrochloric acid (a strong acid) is completely dissociated (to chloride
anions and hydronium ions) under usual dilute aqueous solution conditions
(Snoeyink et al., 1980). The formation of hydrochloric acid by addition of
chlorine gas to water causes a lowering of pH in the aqueous medium, which
affects the subsequent chemical properties of the water (Snoeyink et al.,
1980).
Molecular chlorine can be considered primarily as a precursor to
hypochlorous acid, which is known and registered for its pesticidal activity.
The pesticidal activity of hypochlorous acid arises from its oxidizing effect on
organic and inorganic contaminant sources (Wojtowicz, 1978). Hypochlorous
acid is a weak acid, with a pKa of 7.4 at 25ฐ C (Adam et al., 1992). In the
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acidic pH media, the predominant species is undissociated hypochlorous acid;
in the neutral range, small amounts of hypochlorite ions are present together
with hypochlorous acid. Only at very alkaline pHs does the acid completely
dissociate into hypochlorite anions and hydronium ions.
The mechanisms and rates of decomposition of hypochlorous acid and
hypochlorite anions are dependent on a number of factors including pH,
chemical concentration, sunlight, and temperature (Greenwood et al., 1984;
Cotton et al., 1988; Adam et al., 1992). Sunlight increases the rate of
decomposition of hypochlorous acid/hypochlorite anions; these species absorb
energy in the 292 to 380 nm region (Adam et al., 1992). The concentration
and nature of organic and inorganic matter present in the aqueous medium
(waters receiving treatment; natural waters) have an important effect in the
decomposition of hypochlorous acid. The decomposition of hypochlorous
acid/hypochlorite anions by organic and inorganic matter involves redox
reactions that are pH-dependent (Greenwood et al., 1984; Cotton et al., 1988;
Tchobanoglous et al., 1985; Snoeyink et al., 1980). The maximum
decomposition rate of hypochlorous acid occurs at pH 6.89 (Adam et al.,
1992).
The sanitizing properties or oxidizing effects of chlorinating agents
such as chlorine, can be either associated with hypochlorous acid or with the
hypochlorite anion. However, it is rare that both species are involved
simultaneously in the same reaction (Greenwood et al., 1984). The most
common redox reactions are: (a) oxidation of reduced inorganic matter, such
as iron(II), manganese(II), nitrite, and sulfide; (b) reactions with ammonia and
organic nitrogen (formation of chloroamines); (c) reactions with phenols; (d)
reactions with an acetyl group to form chloroform; (e) addition to double
bonds (Snoeyink et al., 1980).
In disinfection by chlorination operations, the use of the expression
free residual chlorine is used to define the sum of the concentrations of
hypochlorous acid and hypochlorite anions. Free residual chlorine is often
used as a measure of the effectiveness of chlorination, which in turn is also a
measurement of the available chlorine in solution (Wojtowicz, 1978). There
are many chlorine by-products that are formed as a result of chlorination of
organic compounds. Chloroamines, for example, are formed as a result of
chlorination of amines in the effluent stream or receiving body of water. Each
of the chloroamines (monochloroamine, dichloroamine and trichloroamine)
contribute to the total (or combined) chlorine residual in water.
The amount of chlorine that must be added to water receiving
treatment before a stable free chlorine residual can be obtained is known as
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the "breakpoint dosage". When sufficient chlorine is added to completely
oxidize and destroy chloroamines, the residual remaining consists almost
entirely of free residual chlorine. Possible end products of the oxidation of
ammonia are hydrazine, hydroxylamine, nitrogen, oxides of nitrogen, nitrite
and nitrate, depending on the dosage of chlorine used.
Chlorine can react with organic chemicals containing an acetyl group
(of which a major source appears to be the humic substances). This reaction
can lead to the formation of chloroform. Formation of chloroform during
water treatment is undesirable and of concern because chloroform is a
suspected carcinogen (Snoeyink et al., 1980).
b. Environmental Fate Assessment
Treated effluents (which contain a free residual chlorine) released into
receiving waters appear to dissipate rapidly, reducing the residence time at the
point of discharge. Processes involved in the dissipation of free residual
chlorine are dilution, phototransformation, volatilization and redox chemical
reactions (Jolley, 1983; Heinimman et al., 1983; Osborne, 1985; Abel-Gawad
et al., 1988). Temperature of the aqueous media influences the rate of
dissipation (Heinimman et al., 1983). A half-life of free residual chlorine in
natural freshwater systems has been estimated as 1.3 to 5 hours (Jolley, 1983).
There is no evidence at this point that active chlorine accumulates in
sediments. This is attributed to the presence of reducing inorganic materials
and of organic material capable of reacting with chlorine (Haas, 1990).
The ultimate fate of chlorine containing effluents released into
receiving waters is site-specific and depends on such factors as the chemical
constituents of the receiving waters, their temperature, dilution ratio and the
intensity of sunlight.
2. Ecological Effects
Studies for lithium hypochlorite, used as an industrial biocide, were deemed
appropriate for satisfying all ecological effects data requirements for chlorine when
it is used as an industrial microbicide. Both lithium hypochlorite and chlorine form
hypochlorous acid when dissolved in water.
a. Ecological Effects Data
(1) Terrestrial Data
Lithium hypochlorite (data acceptable for chlorine) was
practically non-toxic to birds on a sub-acute dietary basis. An LD50
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of 567 mg/kg was determined for lithium hypochlorite (data
acceptable for chlorine) in an acute avian oral toxicity test with the
Bobwhite quail and was shown to be slightly toxic on an oral basis
(Piccavillo, 1977; MRID 94673). The LD50s for both the mallard
duck (Piccavillo, 1977) and the Bobwhite quail (Piccavillo, 1977,
MRID 104674) were >5000 ppm which indicated that lithium
hypochlorite was practically non-toxic on a sub-acute dietary basis.
(2) Aquatic Data
Chlorine is very highly toxic to fish. In acute freshwater fish
toxicity tests, anLC50 of 0.20 mg/L (Buccafusco, 1978, MRID 94672)
was determined for the rainbow trout (cold water) and an LC50 of 0.28
mg/L (Buccafusco, 1978) was determined for the bluegill (warm
water). Lithium hypochlorite was highly toxic to freshwater fish.
EPA (Ambient Water Quality Criteria for Chlorine, 1984, EPA 440/5-
84-030) reported that the toxicity of chlorine to 21 species (16
genera) offish ranged from 0.045 mg/L (channel catfish) to 0.710
mg/L (Stickleback).
Chlorine was very highly to highly toxic to freshwater
invertebrates. LeBlanc (MRID 94674) reported in 1978 that lithium
hypochlorite (data acceptable for chlorine) was very highly toxic to
freshwater invertebrates with an LC50 of 0.037 mg/L for Daphnia
magna. Additionally, data was reported for chlorine by EPA
(Ambient Water Quality Criteria for Chlorine, 1984, EPA 440/5-84-
030) on 12 species of freshwater invertebrates in 12 genera with LC50s
ranging from 0.017 mg/L (D. magna) to 0.673 mg/L (crayfish). EPA
(Ambient Water Quality Criteria for Chlorine 1984, EPA 440/5-84-
030) reported data on 24 species of saltwater organisms in 21 genera.
Fish and invertebrates had similar sensitivities to chlorine and LC50s
ranged from 0.026 mg/L (eastern oyster) to 1.42 mg/L (shore crab).
(3) Non-Target Insects Data
There are no non-target insect data requirements for industrial
microbicide pesticides.
(4) Non-Target Plants Data
There are no non-target plant data requirements for industrial
microbicide pesticides.
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b. Ecological Effects Risk Assessment
(1) Non-Endangered Species
The acute risk for the use of this pesticide is based on the
residue levels in water receiving effluent from a facility using the
pesticide. If residues should exceed one-half of the EC50 to aquatic
invertebrates [D. magna 1A EC50 (0.017 ppm) = 0.009 ppm] and/or
freshwater fish [channel catfish /^ LC50 (0.045 ppm) = 0.023 ppm]
these organisms are potentially at risk. If residues should exceed one-
half of the EC50 to estuarine invertebrates [eastern oyster /^ LC50
(0.026 ppm) = 0.013 ppm] estuarine organisms are at risk. If these
acute levels of concern are exceeded, a significant risk to aquatic
organisms can be anticipated.
(2) Endangered Species
The acute risk to endangered species for the use of this
pesticide is based on the residue levels in the receiving stream from a
facility using the pesticide. If residues should exceed one-twentieth
of the EC50 to aquatic invertebrates [D. magna 1/20 EC50 (0.017 ppm)
= 0.85 ppb] and/or freshwater fish [channel catfish 1/20 LC50 (0.045
ppm) = 2.3 ppb] these organisms are potentially at risk. If residues
should exceed one-twentieth of the EC50 to estuarine invertebrates
[eastern oyster 1/20 LC50 (0.026 ppm) =1.3 ppb] estuarine organisms
are at risk. If these acute levels of concern are exceeded, a significant
risk to endangered aquatic organisms can be anticipated.
(3) Non-Target Aquatic Species Risk
Initial maximum exposure levels required for efficacious use
were based on label information and are expressed in terms of residual
chlorine ppm and are as follows: sewage systems (0.02 ppm effluent),
pulp and paper mills (0.2 ppm), water cooling systems (0.3-0.8 ppm),
swimming pool water (0.6-2 ppm), lakes/pond/reservoirs/aquaria (no
human, fish, wildlife use) (3-5 ppm), human drinking water systems
(0.2 ppm), food water processing systems (50-200 ppm),
food/meat/poultry processing (food contact/non-contact) (3-5
ppm/10-25 ppm). These values are assumed to be equal to the
estimated environmental concentration discharged because there is a
lack of actual data and no degradation of residual chlorine.
The chlorine uses may be categorized into two divisions,
NPDES regulated and non-NPDES regulated.
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Non-NPDES Regulated Uses
For reregi strati on purposes, all aquatic non-food residential
and indoor uses are considered to be non-NPDES regulated e.g.,
swimming pool, aquaria, and the indoor use patterns consisting of
agricultural (fruit and vegetable rinse) and food processing. The
concentration of any discharges from these uses should be minimal
and intermittent resulting in minimal environmental exposures.
There are no acceptable exposure data to support any risk
assessment conclusions for these use patterns. However, there are
mitigating factors that support the conclusion that the aquatic
organism exposure resulting from swimming pool, ornamental pool or
other indoor use drainage is minimal. First, pools are not routinely
emptied and refilled. For example, swimming pools may be emptied
at the end of the swimming season or for maintenance. These
drainings should be very infrequent, at most, twice per year. Second,
owners/operators would be unlikely to treat a swimming pool with
chlorine and then immediately discharge the water into a lake or
stream. Third, direct discharge of swimming pool water into a lake or
stream is probably not typical. Pools are most often drained either
directly onto the area immediately surrounding the pool, including
onto a nearby street, or into municipal sewage systems. In either case,
the high reactivity of hypochlorous and hypochlorite ions with organic
matter greatly reduces the levels of residual chlorine available to
aquatic organisms.
NPDES Regulated Uses
Aquatic non-food industrial use patterns are included under
the NPDES permitting system administered by the Office of Water
e.g., water-cooling towers, sewage treatments plants, and pulp and
paper mills.
Processes involved in the dissipation of free residual chlorine
are dilution, phototransformation, temperature, volatilization and
redox chemical reactions. A half-life of free residual chlorine in
natural freshwater systems has been estimated as 1.3 to 5 hours.
There is no available evidence that active chlorine accumulates
in sediments. The lack of accumulation is attributed to the presence of
reducing inorganic materials and of organic material capable of
reacting with chlorine. The type and relative amounts of organic
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chemicals already present in the effluent and receiving water into
which the chlorine is being discharged will determine the formation of
chlorinated organic compounds.
Acceptable chlorine levels on a national level (at the end of
mixing) have been described in the Water Quality Criteria document
for Chlorine (50 FR 30788). These values are as follows: fresh
water acute (19 ppb), estuarine acute (13 ppb), fresh water chronic
(11 ppb), and estuarine chronic (7.5 ppb). Effluent discharges
containing chlorine are regulated under NPDES permits to reduce the
impact on water bodies. The maximum concentration of chlorine in
the effluent stream established by the NPDES permit is done on a site-
specific and use-specific basis in order to achieve the lowest possible
concentrations of chlorine in the receiving stream. The chlorine
concentration at the site of discharge is dependent on the location of
the site (lake, river or ocean), the flow of the current, the duration of
the discharge, the frequency of the discharge, and the length of time
before discharge occurs.
The acute aquatic risk level of concern for non-endangered
aquatic species calculated by the Agency's Office of Pesticide
Programs is !/2 the LC50. Based on this approach, the levels of
concern for chlorine are as follows: freshwater fish (23 ppb);
miscellaneous invertebrates including Daphnia (9 ppb); and
miscellaneous estuarine/marine invertebrates (13 ppb). The calculated
acute aquatic risk level of concern for endangered aquatic species is
1/20 LC50: freshwater fish (2.3 ppb), miscellaneous invertebrates
including Daphnia (0.85 ppb), and estuarine/marine invertebrates (1.3
ppb).
The values cited in the Water Quality Criteria document for
Chlorine are not directly comparable to the levels of concern
calculated by the Office Of Pesticide Programs because the
methodologies used to calculate these values are significantly
different. However, because chlorine discharge is regulated by the
Agency (Office of Water) and the Water Quality Criteria are adequate,
no significant adverse effects to aquatic organisms are anticipated
from the discharge of chlorine under the NPDES permitting system.
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of 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. The Agency has previously identified and required
the submission of the generic (i.e. active ingredient specific) data required to support
reregistration of products containing chlorine as the active ingredient. The Agency has
completed its review of these generic data, and has determined that the data are sufficient to
support reregistration of all products containing chlorine as the sole active ingredient.
Appendix B identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of chlorine, and lists the submitted studies that the
Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of chlorine and to determine that chlorine can be used without resulting in
unreasonable adverse effects to humans and the environment. The Agency therefore finds
that all products containing chlorine as the active ingredients are eligible for reregistration.
The reregistration of particular products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies to
generate such data, published scientific literature, available incident information, and the data
identified in Appendix B. Although the Agency has found that all uses of chlorine are eligible
for reregistration, it should be understood that the Agency may take appropriate regulatory
action, and/or require the submission of additional data to support the registration of products
containing chlorine, if new information comes to the Agency's attention or if the data
requirements for registration (or the guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient chlorine, the
Agency has sufficient information on the health effects of chlorine and on its potential
for causing adverse effects in fish and wildlife and the environment. The Agency has
determined that chlorine products, labeled and used as specified in this Reregistration
Eligibility Decision, will not pose unreasonable risks or adverse effects to humans or
the environment if products are labeled and applied according to the requirements
specified in Section V. Therefore, the Agency concludes that products containing
chlorine for all uses are eligible for reregistration. Those products which contain
other active ingredients will be eligible for reregistration only when the other active
ingredients are determined to be eligible for reregistration.
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2. Eligible and Ineligible Uses
The Agency has determined that all uses of chlorine, labeled and used as
specified in the RED, are eligible for reregi strati on.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for chlorine.
Where labeling revisions are imposed, specific language is set forth in Section V of this
document.
1. Tolerance Reassessment
Chlorine gas is exempt from the requirements for a tolerance when used
preharvest or postharvest in solution on all raw agricultural commodities [40 CFR
ง180.1095]. Because of the exemption, plant metabolism, storage stability, and
magnitude of the residue data are not required. The Agency believes this exemption
is appropriate and no change is needed.
2. Restricted Use Classification
Because of its high toxicity and occurrence of poisoning incidents, the
Agency is requiring restricted use status for the non-residential swimming pool use,
the industrial food use settings, cooling water towers, and for pulp and paper mill
process water systems. Under the provisions of restricted use, only certified
applicators or other persons under direct supervision of a certified applicator (40 CFR
ง171.6) would be able to apply chlorine gas and only for these uses covered by the
Certified Applicators certification. This level of restricted use is appropriate because
of the rapid, acute action of released chlorine. For automated systems which monitor
water and add chlorine as needed, direct supervision is required only when the
chlorine tanks are changed and allowed to operate without supervision between tank
changes.
The Agency is using the authority of FIFRA section 3(d)(2) to reclassify these
uses of chlorine gas from "General Use" to "Restricted Use". Chlorine gas meets the
criteria for restricted use by certified applicators for human hazard as stated in CFR
152.170 because of acute inhalation toxicity, dermal toxicity and corrosivity to the
eyes and to the skin, and because of the occurrence of poisoning incidents.
The Agency has determined that the chlorine gas uses consisting of non-
residential swimming pools, pulp and paper mill processes, and industrial food
processing plants should be reclassified from General Use to Restricted Use. In 1976
the Agency classified all pesticidal uses of chlorine gas as General Use. It assumed
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that training programs and oversight by various State and Federal agencies would
provide sufficient guidance and assurance that risks from the use of chlorine gas
would be held to a minimum. The reports of incidents suggest this assumption was
not correct. Based chiefly on California incident reports, the Agency believes that
many applicators of chlorine gas for these uses lack adequate training. This has
significantly contributed to the potential for accidents. This regulatory action is
required to improve the application practices and to reduce the risks of accidents and
injury to applicators and other people in the vicinity of applications.
The Agency believes the Restricted-Use classification is appropriate for the
uses of chlorine gas in food processing, public/ commercial pools, and commercial and
industrial water treatment systems. These uses involve in-place chlorinator systems,
and the majority of reported chlorine gas incidents involve chlorinator system
maintenance operations, particularly changing tanks. These are sites at which many
people can be in the vicinity of a chlorine gas release and exposed to toxic levels.
Incidents involving lifeguards and other untrained maintenance workers are common
among those reported. Because of the high acute toxicity of chlorine gas and the
potential for exposures to untrained workers, these uses will be limited to certified
applicators. Labeling changes alone could not be expected to adequately address risks
to untrained workers.
When the Agency classifies a use of a pesticide as Restricted, the pesticide can
only be used by or under the direct supervision of an applicator who is certified in the
appropriate category for that use. State Lead Agencies for pesticide programs carry
out their certification programs under cooperative agreement with the Agency. The
Agency has approved the certification program plan for each state that conducts such
a program. Within those plans, the states identify categories of certification that must
be met to become certified in each category and standards of competency. The
Agency will work with industry groups and any interested parties in the development
of training materials for use by State Lead Agencies and Extension Service. These
processes are likely to take 12 to 18 months to accomplish.
As required under FIFRA ง 3(d)(2), the Agency will publish a notice of this
proposed change in classification from General to Restricted Use in the Federal
Register. Registrants will need to amend their registrations and product labels to
incorporate the Restricted Use Statement, and the other required language in this
RED, to coincide with the certification program.
The Agency must coordinate the timing of the distribution and sale of
products with restricted use labeling with the 12 to 18 months it will take states to
develop and implement new certification training programs. To accomplish this, the
Agency will follow the normal course for label amendments for product reregi strati on.
That is, eight months for registrants to submit revised labels and another six months
for Agency review. Additionally, the Agency is requiring that restricted use labeling
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cannot be on products sold or distributed by registrants prior to October 1, 2000
(approximately 20 months after the issuance date of this document), and that by April
1, 2001 (approximately 26 months after the issuance date), all products subject to the
restricted use labeling must have that labeling for distribution or sale to any person.
3. General Use Classification
Chlorine gas was previously classified as a general use pesticide. In order
harmonize chlorine labeling with Label Review Manual directions, the remaining non-
restricted uses of chlorine will be considered unclassified.
The Agency does not, at this time, support the need to restrict the use of
chlorine gas for the industrial uses of drinking water, sewage, and wastewater
treatment. These uses are year round, so there are no seasonal applicators/ workers
that are not familiar with application techniques of chlorine gas. Fewer workers are
likely to be in the vicinity of chlorine tanks and dispensing equipment. Pesticide
handler's training would be of marginal benefit since it is geared toward agricultural
uses, and would add a regulatory burden without providing additional protection to
workers. Additionally, these applicators/ workers receive formal training on proper
use of chlorine gas through State Operator Certification Programs. Improvements
in labeling are considered to be more an effective approach to reducing chlorine gas
exposure risks to water/wastewater treatment workers. Since access to these facilities
is controlled, bystander risks are not significant.
For the residential swimming pool use, the Agency also does not support the
need to restrict the use of chlorine gas to trained applicators at this time. Currently,
the incident information on residential pool use is not sufficient to support adding this
additional regulatory burden; however the Agency recognizes that incidents at these
sites may fall outside the normal incident reporting mechanisms. Treatment of
residential swimming pools does not rely on the in-place chlorinator systems, so the
risks associated with the in-place systems are not applicable. Improvements in
labeling will facilitate the states' ability to enforce proper application procedure.
Currently, most of the states where residential pool use is common place have
implemented programs that require training of applicators which may meet the
purpose and intent of certification. Even though there is little documented evidence
of accidents associated with the treatment of smaller residential swimming pools, the
applicator and residents with residential swimming pools can be at risk to the same
type of injuries as other chlorine gas uses. While the Agency is not, at present,
reclassifying the residential swimming pool use site as restricted use, this change could
be made in the future, as an independent action, if new information becomes available
to the Agency. The Agency will attempt to gather information on incidents related
to residential use and evaluate the effectiveness of existing training programs to
ensure the same level of protection to applicators and bystanders at residential
swimming pools.
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Pursuant to FIFRA ง6(a)(2), the Agency has the authority to reclassify or
otherwise regulate the use of pesticides based on the review of lexicological,
environmental fate, incident reports, or in general any information indicating adverse
effects. This issue is particularly important with regard to residential pool use because
of the Agency's regulatory position and because of the likelihood of unreported
incidents. PR Notice 92-1 specifically includes incident reports as part of the ง6(a)(2)
reporting requirements, and informs the public of the Agency's intention to
aggressively enforce the failure to report such information.
4. Improved Product Labeling
To promote more consistent and appropriate use of chlorine gas products, the
Agency through this document is requiring significant revisions to product labeling.
Currently, product labels refer users to consult printed materials published by the
Chlorine Institute for additional directions for use. However, labels and this
supplemental information do not contain sufficient specific use information. This
major deficiency is being corrected through this RED. Also, any supplemental printed
information will be brought under FIFRA labeling requirements and will be made part
of the official accepted labeling of products. Use directions and precautions will be
provided for all uses and clearly presented.
Labeling improvements are necessary since the current label language is not
specific enough to support enforcement actions. States and EPA Regions have had
difficulty citing specific procedural failures because of these ambiguities. These
changes are intended to bring chlorine gas labeling up to parity with that associated
with other acutely hazardous substances.
5. Endangered Species Statement
When the Endangered Species Protection Program becomes final, limitations
in the use of chlorine gas may be required to protect endangered and threatened
species, but these limitations have not been defined and may be formulation specific.
The Agency anticipates that a consultation with the Fish and Wildlife Service may be
conducted in accordance with the species-based priority approach described in the
Program. After completion of consultation, registrants will be informed if any
required label modifications are necessary. Such modifications would most likely
consist of the generic label statement referring pesticide users to use limitations
contained in county Bulletins.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregi strati on of
both manufacturing-use and end-use products.
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A. Additional Data Requirements
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of chlorine for the above
eligible uses has been reviewed and determined to be substantially complete to
characterize acute risks. For the majority of exposure scenarios, enough data exists
to adequately characterize chronic risks, also. Regarding the drinking water treatment
use, although the quality of data is sufficient to reregister this public health use, there
is some uncertainty regarding the health effects of halogenated byproducts.
The Agency has concluded that there is a need to better characterize the
reproductive and developmental risks associated with drinking water consumption in
order to assure that children, infants and fetuses do not face unreasonable risk from
chronic exposure to drinking water byproducts. Because of the high levels of
exposure, both in terms of population (greater than 200,000,000) and individual
consumption of chlorinated drinking water, it is necessary to assess the associated
risks with greater certainty.
Three disinfection byproducts in particular have been identified for which the
health effects need to be better characterized. Bromodichloromethane, dichloroacetic
acid, and dibromoacetic acid have been identified as having health effects in laboratory
studies. Because these compounds occur at relatively high concentrations and have
been shown to cause adverse effects in laboratory animals, there is a need for
additional testing on these compounds to improve the Agency's ability to assess
chronic risks from drinking water exposure.
The following confirmatory tests on particular halogenated hydrocarbons will
be required:
Bromodichloromethane (BDCM): Rodent and non-rodent developmental
test (40 CFR ง870.3700); and a two-generation reproductive test (40 CFR
ง870.3800).
Dichloroacetic acid (DCA): Non-rodent developmental test (40 CFR
ง870.3700)
Dibromoacetic acid (DBA): Two-generation reproductive test (40 CFR
ง870.3800)
2. 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 of eligibility has
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been made. The product specific data requirements are listed in Appendix E, the
Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix E; Attachment 3) and if not, commit to
conduct new studies. If a registrant believes that previously submitted data meet
current testing standards, then study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for
each product.
B. Labeling Requirements
1. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current EPA regulations, PR Notices and
applicable policies. The MP labeling must bear the statements specified in Table 6.
Because of space limitations on labels and the complexity of the precautions
necessary to use chlorine gas safely, the Agency is requiring registrants to submit an
applicator's manual which provides the necessary details for the safe use of chlorine
gas. The manual should provide, but need not be limited to, information on chemical
and physical properties, equipment operation, care and use of personal protective
equipment, first aid and medical management of exposures, leak detection, emergency
response, storage and handling of containers, and instructions to comply with all local
regulations and ordinances. The manual is to be submitted concurrently with
submittal of the product label. The label should contain a statement referring the user
to the manual for instructions on the required product use and safety procedures.
2. Labeling Requirements for End-Use Products
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR ง156.10. Additionally, the
Agency intends to work with the Chlorine Institute to bring its published materials on
the use of chlorine gas for pesticidal uses under FIFRA labeling requirements. These
materials will be considered supplemental labeling. All EUP labeling must bear the
statements specified in Table 6.
a. Use Directions
The end-use label must indicate the specific intended uses. Each use
must have specific directions. Products must be labeled for only restricted-use
sites or unclassified use sites, not both, as stipulated in Section 156.10(j).
This may require label revision and application for new product registrations
if a registrant wishes to have products intended for both types of uses.
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In this document, several revisions are being made to the standard
label text required for chlorine products:
1. The standard Precautionary Statements and the First Aid Statement/
Statement of Practical Treatment have been re-worded based on
current policy and recent data review.
2. In accordance with Agency policy, a product may not be labeled for
both end-use and manufacturing-use under the same EPA Registration
Number.
3. For end-use products, specific directions must be provided for each
use, either on the main label or in collateral labeling referenced by the
main label. Any supplemental labeling thus referenced must be
submitted as part of the product labeling for EPA acceptance.
A product registration may include either restricted or non-restricted
(unclassified) uses, but not both. Therefore, if a product is currently
registered for any of the uses now being classified as restricted and the
registrant wishes to retain that use for its product registration, all non-
restricted uses must be deleted from that registration. The non-restricted uses
may then be registered separately under a new registration number.
In this RED document, all the uses of chlorine gas except for
treatment of drinking water and sewage and wastewater and commercial
applications to residential swimming pools serviced by professional
applicators are being declared Restricted. The uses now classified as
restricted are treatment of non-residential swimming pool water, treatment of
wash-water for raw agricultural commodities and certain other food
commodities, treatment of food-contact and non-food contact surfaces in the
food processing plants, and treatment of cooling tower water and cooling
water for pulp and paper mill process water systems.
For products being reregistered under this RED document with a use
being declared restricted, a restricted use legend must appear at the top of the
front panel of the label, as shown in the standard labeling below. No other
wording or symbols may appear above the legend. It must begin with the
heading "RESTRICTED USE PESTICIDE," followed by a brief statement of
the reason for the restricted use classification (i.e., "DUE TO HIGH ACUTE
TOXICITY"). Following this, the terms of the restriction must be stated as,
"For retail sale to and use only by Certified Applicators or persons under their
direct supervision and only for those uses covered by the Certified
Applicator's certification."
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Until recently, one of two standard labels would be selected based on
whether stationary storage containers were to be used, or smaller portable
cylinders. Now, however, because of the similarity of the two standard labels
and for the sake of complete labeling, they are being merged into one standard
label, with the provision that the appropriate general usage paragraph (above
the ingredients statement) should be selected based on the type of container
and use.
Following the standard labeling depicted below, various comments and
examples are provided as guidance in developing specific directions for use.
Because of space limitations on labels and the complexity of the
precautions necessary to use chlorine gas safely, the Agency is requiring
registrants to submit an applicator's manual which provides the necessary
details for the safe use of chlorine gas. The manual should provide, but need
not be limited to, information on chemical and physical properties, equipment
operation, care and use of personal protective equipment, first aid and medical
management of exposures, leak detection, emergency response, storage and
handling of containers, and instructions to comply with all local regulations
and ordinances. The manual is to be submitted concurrently with submittal
of the product label. The label should contain a statement referring the user
to the manual for instructions on the required product use and safety
procedures.
b. Guidance for Specific Directions for Use
The labels of all chlorine products must bear directions for each
recommended use. The directions for use should include statements similar
to the following sample directions. Those statements which are actually
required are indicated as such. Additional instructions may be necessary for
some product uses to ensure safe and effective use of a product. Such
additional instructions may be recommended by the applicant, or required by
the Agency, as determined on a case by case basis.
c. Effluent Discharge Labeling Statements
Refer to subsection V.A.2 or V.B.2.b., above for labeling
requirements for effluent discharge.
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Table 6: Summary of Required Labeling Changes for Chlorine Gas
Description
Required Labeling
Placement on Label
Manufacturing Use Products (MUPs)
Front Panel Labeling
(all MUPs)
[Place brand name here if desired]
"CHLORINE LIQUEFIED GAS UNDER PRESSURE
ACTIVE INGREDIENT: Chlorine....
INERT INGREDIENTS:
KEEP OUT OF REACH OF CHILDREN
DANGER
[Place skull-and-
crossbones close
to the word
POISON.]
POISON" ["POISON" must be in
red, on a background
of distinctly
contrasting color.]
"FATAL IF INHALED.
LIQUID CAUSES SEVERE BURNS
EPA Reg. No.
EPA Est. No."
Company name and address:
"NET CONTENTS:
Front panel
Heading: Precautionary Statement
(all MUPs)
"PRECAUTIONARY STATEMENTS''
Place directly below "Net
Contents: " Note: If
some precautionary
statements appear on
other panels, the heading
Precautionary
Statements" must also be
placed above those
statements.
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Description
Required Labeling
Placement on Label
First Aid or Statement of Practical
Treatment or (either heading is
acceptable)
(all MUPs)
" FIRST AID:" or " STATEMENT OF PRACTICAL TREATMENT"
"IF INHALED: Remove victim to fresh air. If not breathing, give artificial respiration, preferably mouth-to-
mouth. Get medical attention.
IF IN EYES: Hold eyelids open and flush with a steady, gentle stream of water for 15 minutes. Get medical
attention.
IF ON SKIN: Wash with plenty of soap and water while removing contaminated clothing and shoes. Get
medical attention."
[If remaining precautionary statements (Hazards to Humans & Domestic Animals, Personal Protective
Equipment, Environmental Hazards, and Chemical & Physical Hazards) are not placed on front panel,
the following statement is also required.]
"See back panel for additional precautions."
Front Panel below the
heading "Precautionary
Statements"
Hazards to Humans and Domestic
Animals
(all MUPs)
"HAZARDS TO HUMANS AND DOMESTIC ANIMALS:
DANGER. Fatal if inhaled or absorbed through skin. Corrosive. Causes irreversible eye damage and skin
burns. Do not breathe vapors or get in eyes, on skin or clothing. Wear goggles, protective clothing and rubber
gloves as discussed below. Wash hands thoroughly with soap and water after handling and before eating,
drinking, or using tobacco. Remove contaminated clothing and wash clothing before reuse. Prolonged or
frequently repeated skin contact may cause allergic reactions in some individuals."
Front panel directly
below the First Aid
Statements or on other
panels of the label.
PPE Requirements
(all MUPs)
"PERSONAL PROTECTIVE EQUIPMENT:
Handlers must wear long-sleeved shirts, long pants, shoes, and socks.
In Case of Spill or Leakage:
Under normal use-conditions, no protective eyewear, respirator, or gloves are required. However, in case of a
spill or leak, handlers must wear chemical-resistant gloves (such as nitrile or butyl) and a full-face canister-
style (gas mask) respirator with a canister approved for chlorine (MSHA/NIOSH approval number prefix TC-
14G) OR a self-contained breathing apparatus (SCBA) (MSHA/NIOSH approval number prefix TC-13F).
Since there is always the possibility of a spill or leak, gloves and a respirator of a type specified above must be
available and are required for anyone entering into an affected area in the event of a leak or spill."
Directly below the
Hazards to Humans and
Domestic Animals
Statement
Environmental Hazards
(all MUPs)
"ENVIRONMENTAL HAZARDS: This pesticide is toxic or highly toxic to fish and aquatic invertebrates.
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 to sewer systems without previously notifying the local sewage treatment plant
authority. For guidance contact your State Water Board or Regional Office of the EPA.
Directly below/after the
Personal Protective
Equipment Statement
Physical and Chemical Hazards
(all MUPs)
"PHYSICAL & CHEMICAL HAZARDS: Chlorine is a non-flammable gas, liquefied, under pressure. Do not
drop container. Do not heat container. Keep away from intense heat or open sunlight. Corrosive to most
metals in the presence of moisture."
Directly below/after the
Environmental Hazard
Statement
39
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Description
Required Labeling
Placement on Label
Directions for use
(all MUPs)
"DIRECTIONS FOR USE
It is a violation of Federal law to use this product in a manner inconsistent with its labeling. Refer to [state the
name of the manual being used] for instructions on the required product use and safety procedures. Before
working with this product, handlers must be trained how to appropriately use respirators that conform to
OSHA requirements (described in 29 CFR Part 1910.134) and how to appropriately handle and use chlorine.
This product, including dispensing equipment, must be handled and used in accordance with the practices
specified by all applicable product labeling and the [state the name of the manual being used]." Use only in
well ventilated areas.
Only for formulation into an" [fill blank with Sanitizer, Disinfectant, or the applicable term which
describes the type of pesticide uses(s)] "for the following uses(s):" [fill blank only with those uses
that are being supported by MP registrant].
[ Additional optional statement may be placed here as specified above under "Labeling Requirements
for Manufacturing-Use Products." ]
[ Note that directions for specific uses are not permitted on MP labels. A product must be labeled as EP
or MP, not both. ]
Directly below the
PRECAUTIONARY
STATEMENTS section.
Storage & Disposal
(all MUPs)
"STORAGE & DISPOSAL
STORAGE: Store cylinders and ton containers in a dry area away from sources of heat and protected from
direct sunlight and precipitation. Do not store in excessive heat. Segregate chlorine containers from other
compressed gases, and never store near hydrocarbons, finely divided metals, turpentine, ether, anhydrous
ammonia, or other flammable materials. All storage containers and cylinders must have a weather resistant
label and must not be accessible to the general public. Do not drop container. If container is damaged or
leaking, refer to procedures in the [state the name of the manual being used] and/or notify supplier
immediately. Do not contaminate water, food, or feed by storage or disposal. Pesticide wastes are acutely
hazardous. Improper disposal of excess pesticide, spray mixture, or rinsate is a violation of Federal Law."
40
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Description
Storage & Disposal (Continued)
(all MUPs)
Required Labeling
"LEAK PROCEDURES: Make daily inspections for leaks. Stop a leak at once, since it will become worse
with time.
In case of a leak, evacuate everyone from the immediate area. For entry into the affected area to correct
problem, wear personal protective equipment (including prescribed respirators) specified in the Hazards to
Humans section of this labeling. When possible, move leaking or damaged cylinders outdoors or to an isolated
location. Observe strict safety precautions. Work upwind, if possible. Allow any liquid chlorine to evaporate.
Only correctly trained and Personal Protective Equipment (PPE)-equipped handlers are permitted to perform
such cleanup. Do not permit entry into the leak area by any other person until the chlorine has completely
dispersed.
DISPOSAL OF CONTAINER: Container is returnable and must be properly identified with return tag and
returned as promptly as possible to supplier according to prescribed instructions and practices in the" [state
the name of the manual being used]. "All valves must be closed tight and closures or caps secured. It is
illegal to ship a leaking chlorine container."
Placement on Label
Place in Storage &
Disposal box with
Storage statement
End Use Products Intended for Occupational/Commercial Use
Restricted Use Pesticide (RUP)
Statement [required on all RUP
products (products used on non-
residential swimming pools, industrial
food use settings, cooling water
towers, and pulp and paper mill
process water systems)]
User Statement [required for non-RUP
products only (water and sewage
treatment, and residential swimming
pools)]
Brand Name and Chlorine
Identification Statement (required for
all End Use Products)
Usage Statement (required for all bulk
containers such as tank cars, tank
trucks, and 1-ton and 150-pound
cylinders)
"RESTRICTED USE PESTICIDE
DUE TO HIGH ACUTE TOXICITY
For retail sale to and use only by Certified Applicators or persons under their direct supervision and only for
those uses covered by the Certified Applicator's certification."
"For Use Only By Trained Commercial Applicators"
[Place brand name here if desired]
"CHLORINE LIQUEFIED GAS UNDER PRESSURE"
"For use as a" [indicate whichever kind(s) of antimicrobial activity and specific uses(s) your product is
registered for, e.g., disinfectant in swimming pools, or as a sanitizer for wash water treatment of food
handling premises and equipment (fruit, vegetable, meat, poultry or seafood), or as an algicide and
slimicide for use in recirculating cooling towers and pulp and papermill process water systems. ] "The
registrant is solely responsible for the safety of the servicing equipment used with this pesticide, and for the
repackaging of this gas from larger containers into portable cylinders. Each repackager must obtain his own
EPA Registration Number for this pesticide for this use, and his own EPA Establishment Number from the
EPA. Repackers may only dispense this product to portable containers that are appropriately labeled."
Top of Front Panel and
Beginning of Directions
for Use
Top of Front Panel
Below/after the RUP or
Trained Applicator
Statement
Directly below/after the
"Chlorine Identification
Statement"
41
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Description
Required Labeling
Placement on Label
Usage Statement for portable
containers used by service companies
in treating swimming pools or wash
water for raw agricultural
commodities
"For use as a" [ indicate whichever use(s) your product is registered for: disinfectant and algicide ] "in"
[indicate use, either "servicing swimming pools" or "wash water for raw agricultural commodities"].
Directly below/after the
"Chlorine Identification
Statement"
Front Panel Labeling (required on all
End Use Products)
"ACTIVE INGREDIENT: Chlorine.... %
INERT INGREDIENTS: %
KEEP OUT OF REACH OF CHILDREN
DANGER
[Place skull-and- POISON" ["POISON" must be in red, on
crossbones close a background of distinctly
to the word POISON.] contrasting color.]
"FATAL IF INHALED.
LIQUID CAUSES SEVERE BURNS
EPA Reg. No.
EPA Est. No.
Company name and address: ]
"NET CONTENTS:
Front Panel directly
below/after Usage
Statement
Precautionary Statements Heading
required on all End Use Products
"PRECAUTIONARY STATEMENTS"
Front Panel directly
below "Net Contents:_
"Place directly below
"Net Contents: "
Note: If some
precautionary statements
appear on other panels,
the heading
Precautionary
Statements" must also be
placed above those
statements.
42
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Description
Required Labeling
Placement on Label
First Aid Heading and Statements
(required on all End Use Products)
"FIRST AID:"
"IF INHALED: Remove victim to fresh air. If not breathing, give artificial respiration, preferably mouth-to-
mouth. Get medical attention.
IF IN EYES: Hold eyelids open and flush with a steady, gentle stream of water for 15 minutes. Get medical
attention.
IF ON SKIN: Wash with plenty of soap and water while removing contaminated clothing and shoes. Get
medical attention."
[If remaining precautionary statements (Hazard to Humans & Domestic Animals, Personal Protective
Equipment, Environmental Hazards, and Chemical & Physical Hazards) are not placed on front panel,
the following statement is also required.]
"See back panel for additional precautions."
Place directly below the
heading
"PRECAUTIONARY
STATEMENTS" on
Front Panel.
Precautionary Statements (required on
all End Use Products)
"Precautionary Statement" [and signal word] "Danger"
"HAZARDS TO HUMANS AND DOMESTIC ANIMALS:
DANGER. Fatal if inhaled or absorbed through skin. Corrosive. Causes irreversible eye damage and skin
burns. Do not breathe vapors or get in eyes, on skin or clothing. Wear goggles, protective clothing and rubber
gloves as discussed below. Wash hands thoroughly with soap and water after handling and before eating,
drinking, or using tobacco. Remove contaminated clothing and wash clothing before reuse. Prolonged or
frequently repeated skin contact may cause allergic reactions in some individuals."
May appear on front
panel (below the First
Aid Statements) or other
panels of the label.
PPE Requirements (required on all
End Use Products)
"Personal Protective Equipment:
Applicators and other handlers must wear long-sleeved shirts, long pants, shoes, and socks".
Directly below the
Hazards to Humans and
Domestic Animals
Statement.
Leakage Personal Protective
Equipment (required for bulk
containers)
"IN CASE OF LEAKAGE
Under normal use-conditions, no protective eyewear, respirator, or gloves are required. However, in case of a
leak, handlers must wear chemical-resistant gloves (such as nitrile or butyl) and a full-face canister-style (gas
mask) respirator with a canister approved for chlorine (MSHA/NIOSH approval number prefix TC-14G) OR a
self-contained breathing apparatus (SCBA) (MSHA/NIOSH approval number prefix TC-13F). Since there is
always the possibility of a leak, gloves and a respirator of a type specified above must be available. Gloves and
a respirator are required for anyone entering into an affected area in the event of a leak."
Directly below the
PERSONAL
PROTECTIVE
EQUIPMENT Statement.
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Description
Required Labeling
Placement on Label
Leakage Personal Protective
Equipment (required for portable
cylinders or containers)
'In Case of Leakage:
Under normal use-conditions, no protective eyewear, respirator, or gloves are required. However, in case of a
leak, handlers must wear chemical-resistant gloves (such as any waterproof material) and a full-face canister-
style (gas mask) respirator with a canister approved for chlorine (MSHA/NIOSH approval number prefix TC-
14G). Since there is always the possibility of a leak, gloves and a respirator of a type specified above must be
available. Gloves and a respirator are required for anyone entering into an affected area in the event of a
leak."
Directly below/following
Personal Protective
Equipment Statement.
Environmental Hazards
"ENVIRONMENTAL HAZARDS: This pesticide is toxic or highly toxic to fish and aquatic invertebrates.
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 to sewer systems without previously notifying the local sewage treatment plant
authority. For guidance contact your State Water Board or Regional Office of the EPA."
Directly below/following
Spillage Personal
Protective Equipment
Statement.
Physical & Chemical Hazards
"PHYSICAL & CHEMICAL HAZARDS: Chlorine is a non-flammable gas, liquefied, under pressure. Do not
drop container. Do not heat container. Keep away from intense heat or open sunlight. Corrosive to most
metals in the presence of moisture."
Directly below/following
Environmental Hazards
statement.
General Directions for Use (required
for all End Use Products)
"DIRECTIONS FOR USE
It is a violation of Federal law to use this product in a manner inconsistent with its labeling. Refer to [state the
name of the manual being used] for instructions on the required product use and safety procedures. Before
using this product, handlers must be trained how to appropriately use respirators that conform to OSHA
requirements (described in 29 CFR Part 1910.134) and how to appropriately handle and use chlorine. This
product, including dispensing equipment, must be handled and used in accordance with the practices specified
by all applicable product labeling and the [state the name of the manual being used]." Use only in well
ventilated areas."
Directly below/following
the PRECAUTIONARY
STATEMENTS section.
Specific Directions for Use.
supplemental labeling.
The following information must appear on the label or be referred to in
Specific Directions for Use (required
for all End Use Products)
An instruction to test the chlorinated water with a test kit to ensure adequate concentration (ppm) of
available chlorine or chlorine residual.
Identification of the type of water, object, or surface to be treated, and the type of area or
establishment in which the product is to be used.
For surface treatments, an instruction for thorough pre-cleaning should be included.
The recommended concentration (ppm) available chlorine or chlorine residual, and how to prepare it.
Directly below/following
the General Directions
for Use statement or
attached as supplemental
labeling
44
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Description
Required Labeling
Placement on Label
Specific Directions for Use (required
for all End Use Products)
(continued)
The method of application (e.g., wipe, rinse, immerse, spray), if not already understood (as in water
treatment applications). For surface treatments, the reader must understand that all surfaces must be
thoroughly wetted.
The contact time necessary for effectiveness. For surfaces, also indicate any necessary information on
a final rinse, and if and how the product should be removed from the surface after the recommended
contact time.
For some water treatment applications, a follow-up dosage(s) should be indicated.
For surface treatments, an instruction regarding limitations on re-use of the solution (e.g., whether it
may be re-used if it has not become diluted or soiled, and for how many batches or how many days).
Additional instructions or information may be appropriate, or required on a case-by-case basis.
Directly below/following
the General Directions
for Use statement or
attached as supplemental
labeling
Specific Directions for Use (required
for all products registered for
swimming pool water treatment)
(a) The proper range in the concentration (ppm) of chlorine or residual (e.g., available chlorine) and pH to be
maintained at all times. The directions should advise users to test the water with test kits to maintain pH and
the proper concentration of principle active ingredient or residual.
(b) The frequency of treatment required for the maintenance of the desired concentration of chlorine is
dependent on bather load, and the concentration should be checked frequently with a test kit.
(c) How the product is to be added to the pool (e.g., automatic metering device).
(d) The maximum concentration of chlorine or residual allowable in the pool water, following application of
the product, before swimmers are allowed to re-enter the pool.
(e) Any water quality conditions essential to effective use of the product as a disinfectant (e.g., alkalinity).
(f) Treatment procedure(s) for newly filled pools.
Directly below/following
the General Directions
for Use statement or
attached as supplemental
labeling
Specific Directions for Use (required
for all products registered for
Industrial Water Treatment
Systems)
(a) General. This section provides labeling guidance for chlorine products intended for control of algal,
bacterial, and/or fungal slime in industrial cooling water systems, pulp and paper mills and similar water
treatment systems.
(b) Label Claims. Broad label claims such as "microbicide", "microbistat", "slimicide" and "microorganism
control" should not be used unless they are modified by:
! The names of the types of organisms (algae, bacteria, fungi) for which control is intended. Terms
such as "biocide" or "biostat" are generally not acceptable when only microorganism control is
intended.
Directly below/following
the General Directions
for Use statement or
attached as supplemental
labeling
45
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Description
Required Labeling
Placement on Label
Specific Directions for Use (required
for all products registered for
Industrial Water Treatment
Systems)
(continued)
An identification of the industrial or commercial recirculating water cooling systems (e.g., industrial
and/or commercial recirculating cooling water towers, air washers, and/or evaporative condensers) in
which the product is intended for use.
An accurate description of the level of activity claimed for each use stated on the label. An acceptable
statement for a microbicide would be: "Microbicide for use in industrial recirculating cooling water
towers to reduce the number of living algae, bacteria and fungi." An acceptable statement for a
"microbistat" would be: "A microbistat (microorganism control) for use in industrial recirculating
cooling towers to control the growth of algae, bacteria, and fungi."
(c) Special Directions for Use. Directions for general microbial control must include, but are not limited to,
the following:
Site of Use. Directions should state where in the system the product is to be applied (e.g., at a point
in the system where the product will be uniformly mixed).
Time of Use. Directions should specify when the product should be applied (e.g., when the system is
in danger of becoming impaired or after cleaning a system whose efficiency is already impaired).
Dosage. The dosage rate or amout should be specified as volume or weight of chlorine per unit
volume of water. The product weight per gallon must be shown on the label, whether the dosage is
given as volume or weight.
Method of Application. The method of application or pattern of use must appear on the label and
should conform to the instructions provided below for the intermittent or "slug method", the modified
intermittent method, or the continuous feed method.
Intermittent or Slug Method. The directions should state an initial dosage range of relatively
high product concentration to obtain control of obvious microbial contamination. When microbial
control is evident, a subsequent dosage regimen of relatively lower product concentration should be
stated. The label should state the usual time interval between doses, or include the phrase "as needed
to maintain control", or both. The label should not claim maintenance of any particular pesticide
concentration. The following is an example of acceptable directions or use:
Initial Dose. When the system is noticeably fouled, apply to (volume or unit weight)
of (product name or active ingredient) per (unit volume) of water in the system. Repeat
until control is achieved. Badly fouled systems must be cleaned before initial treatment.
Directly below/following
the General Directions
for Use statement or
attached as supplemental
labeling
46
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Description
Required Labeling
Placement on Label
Subsequent Dose. When microbial control is evident, add
weight) of (product name or active ingredient) per
to (volume or unit
(unit volume) of water in the
Specific Directions for Use (required
for all products registered for
Industrial Water Treatment
Systems)
(continued)
system every days (weekly), or as needed to maintain control.
Modified Intermittent Method. This method is similar to the intermittent, or slug method,
except that the interval between treatments is based on the time for a stated fraction of the system
water to be lost by blowdown. This method of application may be accompanied by label claims for
the maintenance of the pesticide concentration within a stated maximal and minimal limit. The
following is an example of acceptable directions for use:
Initial Dose. When the system is noticeably fouled, apply to (volume or unit weight)
of (product name or active ingredient) per (unit volume) of water in the system.
Apply half (or 1/3, 1/4, or 1/5) of this initial dose when half (or 1/3, 1/4, or 1/5) of the water
in the system has been lost by blowdown. Badly fouled systems must be cleaned before
initial treatment.
Subsequent Dose. When control of microbial growth is evident, apply to (volume or
unit weight) of (product name or active ingredient) per (unit volume of water) in the
system. Apply half (or 1/3, 1/4, 1/5) of this initial dose when half (or 1/3, 1/4, 1/5) of the
water in the system has been lost by blowdown.
Continuous Feed Method. The label should specify an initial dose, based on the volume of
water in the cooling system, to establish an initial product concentration. For volatile products,
continuous feed is based on total makeup water. For non-volatile products, continuous feed is
expressed as amount of product to be applied per stated volume of water lost by blowdown. The claim
to maintain a pesticide concentration in the system may be made for this method of application. The
following is an example of acceptable directions for use:
Initial Dose. When the system is noticeably fouled, apply (volume or unit weight) of
(product name or active ingredient) per (unit volume) of water in the system. Badly
Directly below/following
the General Directions
for Use statement or
attached as supplemental
labeling
fouled systems must be cleaned before initial treatment.
(volume
Subsequent Dose. Maintain this treatment level by starting a continuous feed of
or unit weight) of (product name or active ingredient) per (unit volume) of water
lost by blowdown.
47
-------
Description
Required Labeling
Placement on Label
Specific Directions for Use (required
for products registered for Hard
Surface Disinfectants)
General or broad spectrum disinfectants may bear label claims as hard, food-contact surface
disinfectants. Use directions must indicate that following the specified contact period, the product should be
removed from the treated surfaces with a final sanitizing rinse which may be worded as follows:
"CLEANING AND DISINFECTING FOOD PREPARATION AND PROCESSING FACILITIES AND
EQUIPMENT: Cover or remove all food and packaging materials. Remove all gross soils. Saturate all
surfaces with the use-solution. Scrub to loosen all soils. Allow to soak for (contact time) in a 600 ppm
available chlorine solution. Thoroughly rinse all wetted and cleaned surfaces with a final sanitizing rinse
solution of 200 ppm available chlorine."
Directly below/following
the General Directions
for Use statement or
attached as supplemental
labeling
Specific Directions for Use (required
for products registered for Hard Non-
Food Contact Surfaces Sanitizers)
A product intended for use on non-food contact surfaces which does not eliminate but significantly
reduces the numbers of target microorganisms should be represented and qualified in labeling as being
effective at the sanitizing level only. Examples of acceptable label claims are: "Sanitizes", "Significantly
reduces", or "Reduces the number of bacteria by 99.9%." Products recommended for use in critical hospital or
medical environments that are not effective at the sterilizing or disinfecting level should bear a label
disclaimer statement such as: "This product is not a disinfectant or sterilizer."
Directly below/following
the General Directions
for Use statement or
attached as supplemental
labeling
Specific Directions for Use (required
for products registered for Circulate-
In-Place (CIP) Applications)
Label claims for CIP applications as "germicidal" or "disinfecting" are not generally acceptable
because these methods have not been shown to be an effective means of disinfecting surfaces in these systems.
Representations for CIP applications to sanitize the surfaces of the systems are acceptable.
Directly below/following
the General Directions
for Use statement or
attached as supplemental
labeling
Specific Directions for Use (required
for products registered for Hard Food
Contact Surface Sanitizers)
(a) The major area(s) in which the product is recommended for use (e.g., restaurants, dairies, food processing
plants).
(b) The identification of the types of hard surfaces, or objects, intended for treatment.
(c) The necessity for removal of gross food particles and soil by a pre-flush, or pre-scrape and, when
necessary, pre-soak treatment. In addition, instructions must be provided for a thorough washing of the
surfaces or objects with a good detergent or compatible cleaner, followed by a potable water rinse prior to
application of the sanitizing solution.
(d) The recommended use solution and instructions for preparing it. The units of measure (e.g., volume or
weight per unit volume of water) to be employed in diluting the product must be given, and must be
understandable to the user. The concentration (in parts per million) of available chlorine provided by the
recommended use solution should also be given.
(e) The method of application (e.g., immersion, flooding, spraying) to wet all surfaces thoroughly. Additional
instructions for in-place sanitizing may be required (e.g., filling piping with the sanitizing solution).
(f) A contact time of a least 1 minute.
Directly below/following
the General Directions
for Use statement or
attached as supplemental
labeling
48
-------
Description
Required Labeling
Placement on Label
Specific Directions for Use (required
for products registered for Hard Food
Contact Surface Sanitizers)
(continued)
(g) The directions should also indicate if, and how, the product is to be removed from the surfaces after the
recommended contact time. Instructions to drain the use solution from the surface and allow to air dry are
appropriate for products cleared for use on food contact surfaces under the Federal Food, Drug and Cosmetic
Act. However, the recommendation of a potable water rinse after food-contact surfaces have been treated with
a sanitizing rinse is not acceptable for products intended for use as a terminal sanitizing rinse.
(h) For mechanical operations, the limitation that the prepared use solution may not be re-used for sanitizing
but may be re-used for other purposes (e.g., cleaning floors, etc.). For manual operations the label should
include a recommendation that a fresh sanitizing solution should be prepared at least daily or more often if the
solution becomes diluted or soiled.
(i) Additional instructions may be necessary for certain use patterns and/or categories of products to ensure
safe and effective use of a product. Such additional instructions may be recommended by the applicant, or
required by the Agency, as determined on a case-by-case basis.
Directly below/following
the General Directions
for Use statement or
attached as supplemental
labeling
Specific Directions for Use (required
for all products registered for Human
Drinking Water Treatment)
(a) Public Water Supplies. Municipal drinking water must meet the requirements of the Safe Drinking Water
Act (42 U.S.C. 300f). Label claims and directions, as well as testing and performance requirements, must be
acceptable to the Office of Drinking Water of the EPA, and appropriate documentation of such acceptance
must be submitted.
(b) Emergency Water Supplies. This section applies to emergency purification of small quantities of drinking
water of questionable potability by the general public in the absence of bacteriological monitoring facilities.
The special directions for use of a product intended for field or emergency disinfection of small quantities of
drinking water must include the following information:
I
The effective dosage.
Directly below/following
the General Directions
for Use statement or
attached as supplemental
labeling
! The water source to be treated (e.g., lake, pond, stream) and its characteristics (e.g., clear, muddy,
brackish).
! The exposure time.
Specific Directions for Use (required
for all products registered for
disinfectants for treatment of
sewage and wastewater effluent)
The amount of chlorine delivered to treat sewage and wastewater effluent will depend on the flow rate of
the water being treated, the number and placement of feed tubes and the outlet weir size opening.
Specific use directions must be provided on the label or in collateral literature to enable the user to
determine the amount of chlorine to satisfy treatment demands and the appropriate residue levels required for
disinfection.
Directly below/following
the General Directions
for Use statement or
attached as supplemental
labeling
49
-------
Description
Required Labeling
Placement on Label
Specific Directions for Use (required
for products registered for Sanitizing
Use for Fruit and Vegetable Wash
Water Treatment must include the
following information:
Specific use directions must be provided on the label or in collateral literature to enable the user to determine
the amount of chlorine to satisfy treatment demands and the appropriate residual levels required for
sanitization.
Directly below/following
the General Directions
for Use statement or
attached as supplemental
labeling
Storage & Disposal Heading and
Statements (required for all End Use
Products)
"STORAGE & DISPOSAL
STORAGE: Store cylinders and ton containers in a dry area away from sources of heat and protected from
direct sunlight and precipitation. Do not store in excessive heat. Segregate chlorine containers from other
compressed gases, and never store near hydrocarbons, finely divided metals such as filings or granules,
turpentine, ether, anhydrous ammonia, or other flammable materials. All storage containers and cylinders
must have a weather resistant label and must not be accessible to the general public. Do not drop container. If
container is damaged or leaking, refer to procedures in the [state the name of the manual being used] and/or
notify supplier immediately. Do not contaminate water, food, or feed by storage or disposal. Pesticide wastes
are acutely hazardous. Improper disposal of excess pesticide, spray mixture, or rinsate is a violation of Federal
Law."
"LEAK PROCEDURES: Make daily inspections for leaks. Stop a leak at once, since it will become worse
with time.
In case of a leak, evacuate everyone from the immediate area. For entry into the affected area to correct
problem, wear personal protective equipment (including prescribed respirators) specified in the Hazards to
Humans section of this labeling. When possible, move leaking or damaged cylinders outdoors or to an isolated
location. Observe strict safety precautions. Work upwind, if possible. Allow any liquid chlorine to evaporate.
Only correctly trained and PPE-equipped handlers are permitted to perform such cleanup. Do not permit entry
into the leak area by any other person until the chlorine has completely dispersed.
DISPOSAL OF CONTAINER: Container is returnable and must be properly identified with return tag and
returned as promptly as possible to supplier according to prescribed instructions and practices in the" [state
the name of the manual being used] ". All valves must be closed tight and closures or caps secured. It is
illegal to ship a leaking chlorine container."
Directly below/following
DIRECTIONS FOR USE
statements.
50
-------
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for
26 months from the date of the issuance of this RED. Persons other than the registrant may
generally distribute or sell such products for 50 months from the date of the issuance of this
RED. However, existing stocks time frames will be 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 chlorine gas
products bearing old labels/labeling until April 1, 2001, which is approximately 26 months
from the date of issuance of this RED. Persons other than the registrant may distribute or sell
such products for an additional year or until April 1, 2001, which is approximately 38 months
from the date of issuance of this RED. After then, or April 1, 2001, products must bear new
labels. These actions on these dates will coincide with implementation of State certification
programs as discussed above. Registrants and persons other than registrants remain obligated
to meet pre-existing Agency imposed label changes and existing stocks requirements
applicable to products they sell or distribute.
51
-------
52
-------
VI. APPENDICES
53
-------
APPENDIX A ) Case Number 4022, Chlorine Gas, (Chemical Number: 020501)
Application Type, Application Timing,
Application Equipment ) Surface Type
& Efficacy Influencing Factor
Min. Interval
ed
Entry
Interval
Disallow
Use Pattern Limitations
USES EVALUATED FOR REREGISTRATION
FOOD/FEED
EGG HANDLING EQUIPMENT
FISH/SEAFOOD PROCESSING PLANT EQUIPMENT (FOOD CONTACT)
FISH/SEAFOOD PROCESSING PLANT PREMISES (NONFOOD CONTACT)
FOOD PROCESSING PLANT EQUIPMENT (FOOD CONTACT)
50
Preclean claim.
Not on label, Not on label, Not on
label
Porous, Not applicable for this use
Not on label, Not on label, Not on
label
Porous, Not applicable for this use
FOOD PROCESSING PLANT PREMISES (NONFOOD CONTACT)
Not on label, Not on label, Not on
label
Hard, Not applicable for this use
Wash water treatment, Postharvest,
Dump tank
Not applicable, Not applicable for
this use
Wash water treatment, Postharvest,
Dump tank
Not applicable, Not applicable for
this use
Wash water treatment, Postharvest,
Dump tank
Not applicable, Not applicable for
this use
54
-------
Application Type, Application Timing,
Application Equipment ) Surface Type
& Efficacy Influencing Factor
Min. Interval
Between Apps.
@ Max. Rate
ed
Entry
Interval
Use Pattern Limitations
USES EVALUATED FOR REREGISTRATION
Wash water treatment, Postharvest,
Dump tank
Not applicable, Not applicable for
this use
Wash water treatment, Postharvest,
Dump tank
Not applicable, Not applicable for
this use
Wash water treatment, Postharvest,
Flume
Not applicable, Not applicable for
this use
Wash water treatment, Postharvest,
Flume
Not applicable, Not applicable for
this use
Wash water treatment, Postharvest,
Flume Not applicable, Not applicable
for this use
Wash water treatment, Postharvest,
Sprayer
Not applicable, Not applicable for
this use
Wash water treatment, Not on label,
Sprayer Not applicable, Not
applicable for this use
Wash water treatment, Not on label,
Sprayer
Not applicable, Not applicable for
this use
Wash water treatment, Not on label,
prayer
Not applicable, Not applicable for
this use
20
Wash water treatment, Not on label,
Sprayer
Not applicable, Not applicable for
this use
Wash water treatment, Not on label,
prayer
Not applicable, Not applicable for
this use
Wash water treatment, Not on label,
Cooler
Not applicable, Not applicable for
this use
Wash water treatment, Not on label,
Cooler
Not applicable, Not applicable for
this use
55
-------
Application Type, Application Timing,
Application Equipment ) Surface Type
& Efficacy Influencing Factor
Min. Interval
Between Apps.
@ Max. Rate
ed
Entry
Interval
Use Pattern Limitations
USES EVALUATED FOR REREGISTRATION
Wash water treatment, Postharvest,
Hydrocooler
Not applicable, Not applicable for
this use
Wash water treatment, Postharvest,
Tank
Not applicable, Not applicable for
this use
Wash water treatment, Postharvest,
Tank
Not applicable, Not applicable for
this use
50
Wash water treatment, Postharvest,
Tank
Not applicable, Not applicable for
this use
Wash water treatment, Postharvest,
Drencher
Not applicable, Not applicable for
this use
Wash water treatment, Postharvest,
Wash tanks
Not applicable, Not applicable for
this use
Wash water treatment, Postharvest,
Brush washer spray
Not applicable, Not applicable for
this use
50
Wash water treatment, Postharvest,
Flume
Not applicable, Not applicable for
this use
Wash water treatment, Postharvest,
Rinser
Not applicable, Not applicable for
this use
50
Wash water treatment, Postharvest,
Cooler
Not applicable, Not applicable for
this use
Not on label, Postharvest, Drencher
Not applicable, Not applicable for
this use
Not on label, Postharvest,
Hydrocooler
Not applicable, Not applicable for
this use
56
-------
Application Type, Application Timing,
Application Equipment ) Surface Type
& Efficacy Influencing Factor
Min. Interval
Between Apps.
@ Max. Rate
ed
Entry
Use Pattern Limitations
USES EVALUATED FOR REREGISTRATION
Not on label, Postharvest, Not on
label
Not applicable, Not applicable for
this use
20
Wash water treatment, Postharvest,
Not on label
Not applicable, Not applicable for
this use
Dip treatment, Postharvest, Dip Tank
Not applicable, Not applicable for
this use
HUMAN DRINKING WATER SYSTEMS
Not on label, Not on label, Not on
label
Not applicable, Not applicable for
this use
s, streams, ponds; Do
disposal of wastes;
this pesticide into
entilation required.
blic waters, unless in
e effluent containing
Do not discharge
ams, ponds, estuaries,
the requirements of a
ermit and the
prior to discharge.
Spray, Not on label, Sprayer
Hard, Not applicable for this use
Not on label, Not on label, Not on
label
Hard, Not applicable for this use
MEAT PROCESSING PLANT PREMISES (NONFOOD CONTACT)
Not on label, Not on label, Not on
label
Hard, Not applicable for this use
POULTRY PROCESSING PLANT EQUIPMENT (FOOD CONTACT)
57
-------
Application Type, Application Timing,
Application Equipment ) Surface Type
& Efficacy Influencing Factor
Min. Interval
ed
Entry
Use Pattern Limitations
USES EVALUATED FOR REREGISTRATION
50
Not on label, Not on label, Not on
label
Hard, Not applicable for this use
POULTRY PROCESSING PLANT PREMISES (NONFOOD CONTACT)
Spray, Not on label, Sprayer
Hard, Not applicable for this use
50 NOL
Not on label, Not on label, Not on
label
Hard, Not applicable for this use
NON-FOOD/NON-FEED
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
Not on label, Not on label, Not on
label
Not applicable, Not applicable for
this use
Proper ventilation required. Do not discharge into lakes, streams,
ponds or public waters, unless in accordance with an NPDES permit. Do
not discharge effluent containing this product to sewage treatment plant
authority. 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 Pollution Discharge
Elimination System permit and the permitting authority has been notified
in writing prior to discharge.
EGG PLANT/HATCHERIES/BROODER ROOMS/SHOE BATHS (HATCHING)
50
LAKES/PONDS/RESERVOIRS (WITHOUT HUMAN AND WILDLIFE USE)
Not on label, Not on label, Not on
label
Not applicable, Not applicable for
this use
Use Group: AQUATIC NON-FOOD RESIDENTIAL
Not on label, Not on label, Not on
label
Not applicable, Not applicable for
this use
PASTEURIZER/WARMER/CANNERY COOLING WATER SYSTEMS
Not on label, Not on label, Not on
label
Not applicable, Not applicable for
this use
58
-------
APPENDIX A ) Case Number 4022, Chlorine Gas, (Chemical Number: 020501)
Application Type, Application Timing,
Application Equipment ) Surface Type
& Efficacy Influencing Factor
Form
( *)
Min . Interval
Between Apps.
( *)
Minimum
Appl.
Rate
(ppm)
(*)
Maximum
Appl.
Rate
(ppm)
(*)
Restrict
ed
Entry
Interval
(*)
Geograph
ic
Allowed
(*)
Geograph
ic
Disallow
(*)
Use Pattern Limitations
( *)
USES EVALUATED FOR REREGISTRATION
Not on label, Not on label, Not on
label
Not applicable, Not applicable for
this use
PrG
NOL
10
15
NOL
CA
Do not discharge into lakes, streams, ponds or public waters, unless in
accordance with an NPDES permit.
PULP/PAPER MILL WATER SYSTEMS USE Group: AQUATIC NON-FOOD INDUSTRIAL
Not on label, Not on label, Not on
label
Not applicable, Not applicable for
this use
PrG
NOL
NOL
NOL
NOL
Proper ventilation required. Do not discharge into lakes, streams,
ponds or public waters, unless in accordance with an NPDES permit. Do
not discharge effluent containing this product to sewage treatment plant
authority. 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 Pollution Discharge
Elimination System permit and the permitting authority has been notified
in writing prior to discharge.
SEWAGE SYSTEMS Use Group: AQUATIC NON-FOOD INDUSTRIAL
Not on label, Not on label, Not on
label
Not applicable, Not applicable for
this use
PrG
NOL
NOL
NOL
NOL
Proper ventilation required. This pesticide is toxic to fish, keep out
of lakes, streams, ponds; Do not contaminate water by cleaning of
equipment or disposal of wastes; Permits may be required for discharges
containing this pesticide into lakes, streams, ponds or public waters .
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 Pollution Discharge Elimination System permit
and the permitting authority has been notified in writing prior to
discharge. Do not discharge effluent containing this product to sewage
treatment plant authority.
SWIMMING POOL WATER SYSTEMS Use Group: AQUATIC NON-FOOD RESIDENTIAL
Not on label, Not on label, Not on
label
Not applicable, Not applicable for
PrG
NOL
NOL
NOL
NOL
Proper ventilation required. This pesticide is toxic to fish, keep out
of lakes, streams, ponds; Do not contaminate water by cleaning of
equipment or disposal of wastes; Permits may be required for discharges
containing this pesticide into lakes, streams, ponds or public waters .
Do not discharge into lakes, streams, ponds or public waters, unless in
accordance with an NPDES permit . Do not discharge effluent containing
this product to sewage treatment plant authority. 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 Pollution Discharge Elimination System permit and the
permitting authority has been notified in writing prior to discharge.
UNSPECIFIED SITE Use Group: UNSPECIFIED
label
Not specified, Not specified
PrG
NOL
NOL
NOL
NOL
Proper ventilation required. Do not discharge into lakes, streams,
ponds or public waters, unless in accordance with an NPDES permit. This
pesticide is toxic to fish, keep out of lakes, streams, ponds; Do not
contaminate water by cleaning of equipment or disposal of wastes;
Permits may be required for discharges containing this pesticide into
lakes, streams, ponds or public waters.
Header: ppm a.i. = parts per million of active ingredient; Max. # Apps. = maximum number of applications
Max. # Apps. @ Max. Rate = maximum number of applications at maximum rate
Min. Interval Between Apps. @ Max. Rate (Days) = minimum interval between applications at maximum rate (in days)
Geographic: CA = California; FL = Florida
Form: PrG = Pressurized gas
Rate: ppm = parts per million
In general: NOL = not on the label
59
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active
ingredients within the case 4022 covered by this Reregi strati on Eligibility Decision Document. It
contains generic data requirements that apply to 4022 in all products, including data requirements for
which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test protocols
set in the Pesticide Assessment Guidelines, which are available from the National Technical
Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record Identification
(MRID) number, but may be a "GS" number if no MRID number has been assigned. Refer to the
Bibliography appendix for a complete citation of the study.
60
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of
Chlorine Gas
REQUIREMENT
PRODUCT CHEMISTRY
61-1 Chemical Identity
6 1-2 A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
ECOLOGICAL EFFECTS
7 1-1 A Acute Avian Oral - Quail/Duck
7 1-2 A Avian Dietary - Quail
7 1 -2B Avian Dietary - Duck
72-1 A Fish Toxicity Bluegill
72- 1C Fish Toxicity Rainbow Trout
72-2A Invertebrate Toxicity
72-3 A Estuarine/Marine Toxicity - Fish
72-3B Estuarine/Marine Toxicity - Mollusk
72-3 C Estuarine/Marine Toxicity - Shrimp
72-4 A Early Life Stage Fish
USE
PATTERN
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
CITATION(S)
41767301
41767301
41767301
41767302
41767302
41767302
41767303
41767303
41767303
41767303
41767303
41767303
41767303
41767303
41767303
41767303
94673
104674
unknown
unknown
94672
94672
EPA 440/5-84-030
EPA 440/5-84-030
EPA 440/5-84-030
EPA 440/5-84-030
61
-------
Data Supporting Guideline Requirements for the Reregistration of
Chlorine Gas
REQUIREMENT
72-5 Life Cycle Fish
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
8 1 -2 Acute Dermal Toxicity - Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation - Rabbit
81-6 Dermal Sensitization - Guinea Pig
82-1 A 90-Day Feeding - Rodent
82- IB 90-Day Feeding - Non-rodent
82-3 90-Day Dermal - Rodent
82-4 90-Day Inhalation - Rat
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal Aberration
84-4 Other Genotoxic Effects
ENVIRONMENTAL FATE
161-1 Hydrolysis
161-2 Photodegradati on - Water
162-3 Anaerobic Aquatic Metabolism
162-4 Aerobic Aquatic Metabolism
163-1 Leaching/ Adsorption/Desorpti on
164-2 Aquatic Field Dissipation
165-3 Accumulation - Irrigated Crop
165-4 Bioaccumulation in Fish
165-5 Bioaccumulation - Aquatic NonTarget
USE
PATTERN
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
FGLM
CITATION(S)
EPA 440/5-84-030
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
43170101
42002801
42002802
42002803
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
62
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GUIDE TO APPENDIX C
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). In 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. In 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.
b. Document date. The date of the study is taken directly from the document. When the
date is followed by a question mark, the bibliographer has deduced the date from the
evidence contained in the document. When the date appears as (19??), the Agency
was unable to determine or estimate the date of the document.
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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.
64
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BIBLIOGRAPHY
MRID
CITATION
00094671 Buccafusco, RJ. (1978) Acute Toxicity of Lithcoa Lithium Hypochlorite to Bluegill
(Lepomismacrochirus: Report #BW-78-2-030. (Unpublished study received Apr 25,
1978 under 7675-4; prepared by EG & G Bionomics, submitted by Lithium Corp. of
America, Gastonia, N.C.; CDL:246732-A)
00094672 Buccafusco, R. J. (1978) Acute Toxicity of Lithcoa Lithium Hypochlorite to Rainbow
Trout (Salmo gairdneri): Report #BW-78-2-031. (Unpublished study received Apr
25, 1978 under 7675-4; prepared by EG & G Bionomics, submitted by Lithium Corp.
of America, Gastonia, N.C.; CDL:246732-C)
00094673 Piccirillo, V.J. (1977) Final Report: Acute Oral LD50 Study in Mallard Ducks: Project
No. 668-107. (Unpublished study received Apr 25, 1978 under 7675-4; prepared by
Hazleton Laboratories America, Inc. and Truslow Farms, Inc., submitted by Lithium
Corp. of America, Gastonia, N.C.; CDL:246732-D)
00094674 LeBlanc, G.A. (1978) Acute Toxicity of Lithcoa Lithium Hypochlorite to the Water
Flea (Daphnia magna): Report #BW-78-2-032. (Unpublished study received Apr 25,
1978 under 7675-4; prepared by EG & G Bionomics, submitted by Lithium Corp. of
America, Gastonia, N.C.; CDL:246732-E)
00094675 Piccirillo, V.J. (1977) Final Report: Subacute Dietary LC50 Study in Mallard Ducks:
Project No. 668-108. (Unpublished study received Apr 25, 1978 under 7675-4;
prepared by Hazleton Laboratories America, Inc. and Truslow Farms, Inc., submitted
by Lithium Corp. of America, Gastonia, N.C.; CDL:246732-F)
00104674 Piccirillo, V.J. (1977) Final Report: Subacute Dietary LC50 Study in Bobwhite Quail:
Project No. 668-109. (Unpublished study received Apr 25, 1978 under 7675-4;
prepared by Hazleton Laboratories America, Inc. and Truslow Farms, Inc., submitted
by Lithium Corp. of America, Gastonia, N.C.; CDL:246732-B)
41767301 Damico, J.; Doyle, J. (1991) Chlorine: Product Identity and Composition.
Unpublished study prepared by SRA International, Inc. 3 p.
41767302 Damico, J. (1991) Chlorine: Analysis and Certification of Product Ingredients.
Unpublished study prepared by SRA International, Inc. lip.
41767303 Damico, J. (1991) Chlorine: Physical and Chemical Characteristics. Unpublished
study prepared by SRA International, Inc. 8 p.
65
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BIBLIOGRAPHY
MRID
CITATION
42002801 Xu, J. (1991) Evaluation of Chlorine Gas in the Salmonella typhimurium Plate
Incorporation Mutagenesis Assay in the Presence and Absence of Aroclor-Induced
Rat Liver S-9: Lab Project Number: 0166/2120. Unpublished study prepared by
SITEK Research Labs. 45 p.
42002802 Gudi, R. (1991) Evaluation of Chlorine Gas in the in vivo Test for Chemical Induction
of Micronucleated Polychromatic Erythrocyte in Mouse Bone Marrow Cells: Lab
Project Number 0166M521. Unpublished study prepared by SITEK Research Labs.
40 p.
42002803 Kirby, P. (1991) Evaluation of Chlorine Gas in the L5178Y TK +/- Mouse
Lymphoma Mutagenesis Assay with Colony Size Evaluation in the Presence and
Absence of Aroclor-Induced Rat Liver S-9: Lab Project Number: 0166-2400.
Unpublished study prepared by SITEK Research Labs. 52 p.
43170101 Barrow, C., Popp, J. A., and Wong, K. L. (1993), A Chronic Inhalation Toxicity Stud
of Chlorine in Female and Male B6C3F1 mice and Fischer 344 Rats. Unpublished
study by Chemical Industry Institute of Toxicology, RTP(NC).
Abdel-Gawad, S.T. and Bewtra, J.K., "Decay of Chlorine in Diluted Municipal Effluents",
Canadian Journal of Civil Engineering. 1988, vol.15, pp.948-954.
Abdel-Rahman, M.S., D. Couri and RJ. Bull. 1982. Metabolism and pharmacokinetics of
alternate drinking water disinfectants. Environ. Health Perspect. 46: 19-23.
Abdel-Rahman, M.S., D.M. Waldron and RJ. Bull. 1983. A comparative kinetics study of
monochloramine and hypochlorous acid in rats. J. Appl. Toxicol. 3_: 175-179.
Abdel-Rahman, M.S., D.H. Suh and RJ. Bull. 1984. Pharmacodynamics and toxicity of
chlorine in drinking water in the rat. J. Appl. Toxicol. 4: 82-86.
Adam, L.C., Fabian, L, Suzuki, K. and Gordon, G. "Hypochlorous Acid Decomposition in
the pH 5-8 Region", Inorganic Chemistry. 1992, vol.31, pp. 3534-3541.
Baker, R.W. 1947. Studies on the reaction between sodium hypochlorite and proteins: I.
Physicochemical study of the course of the reaction. Biochemistry 41: 337-341.
66
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BIBLIOGRAPHY
MRID CITATION
Blabaum, DJ. and M.S. Nichols. 1956. Effect of highly chlorinated water on white mice. J.
Am. Waterworks Assoc. 4: 1503-1506.
California Department of Pesticide Regulation, "Case Reports Received by the California
Pesticide Illness Surveillance Program in Which Health Effects were Attributed to Exposure
to Chlorine 1992-1993".
Chernoff, N., E. Rogers, B. Canover, B. Kavlock and E. Gray. 1979. The fetotoxic potential
of municipal drinking water in the mouse. Teratology 19: 165-169.
Chlorine: FIFRA - 88/PHASE-4 REVIEW (MEMO: Mauer to Brisco/Compton, 11/04/92).
Cotton, F.A. and Wilkinson, G. Advanced Inorganic Chemistry. Fifth Edition, 1988, John
Wiley and Sons, New York.
Cumming, R. 1978. The potential for increased mutagenic risk to the human population due
to the products of water chlorination. In: Water Chlorination: Environmental Impact and
Health Effects. Vol. 1, R.L. Jolley, Ed. Ann Arbor Science Publishers, Inc., Ann Arbor, MI.
p. 229-241.
Daniel, F., L. Condie, M. Robinson et al. 1990. Comparative subchronic toxicity studies of
three disinfectants. J. Am. Water Works Assoc. 82: 61-69.
Daniel, B.F., H. Ringhand, M. Robinson, J. Stober, G. Olson and N. Page. 1991.
Comparative subchronic toxicity of chlorine and monochloramine in B6C3F1 mice. J. Am.
Water Works Assoc. 83.: 68-75.
Dennis, W.H., V.P. Olivieri and C.W. Kruse. 1978. Reaction of uracil with hypochlorous
acid. Biochem. Biophys. Res. Comm. 83: 168-171.
Done, A.K. 1961. Bulletin of Supplementary Material. Clinical Toxicology of Commercial
Products. 5: 13-14.
DRAFT-Addendum Report, ARB/SRRD, dated 09/10/92.
Druckrey, H. 1968. Chlorinated drinking water toxicity tests involving seven generations of
rats. Food Cosmet. Toxicol. 6: 147-154.
67
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BIBLIOGRAPHY
MRID CITATION
Greenwood, N.N. and Earnshaw, A. The Chemistry of the Elements. 1984, Pergamon Press.
Oxford, UK.
Haas, C.N. Review of Chlorine Decay in Freshwater. Prepared for The Chlorine Institute,
September 1990. Submitted as part of reregi strati on package for CHLORINE.
Hasegawa, R., M. Takahashi, T. Kokubo et al. 1986. Carcinogenicity study of sodium
hypochlorite in F344 rats. Food Chem. Toxicol. 24: 1295-1302.
Hayatsu, R., H. Hoshimo and Y. Kawazoe. 1971. Potential co-carcinogenicity of sodium
hypochlorite. Nature 23: 495.
Heinimman, T.J., et al. "Summary of Studies of Modeling Persistence of Domestic
Wastewater Chlorine in Colorado Front Range Rivers" in Water Chlorination: Environmental
Impact and Health Effects. 1983, vol. 4, pp. 97-112.
Hoyano, Y., V. Bacon, R.E. Summons, W.E. Pereira, B. Halpeen and A.M. Duffield. 1973.
Chlorination studies. IV. The reaction of aqueous hypochlorous acid with pyrimidine and
pyrine bases. Biochem. Biophys. Res. Comm. 53: 1195-1199.
Jolley, R.L. "A Review of the Chemistry and Environmental Fate of Reactive Oxidant Species
in Chlorinated Water" in Water Chlorination: Environmental Impact and Health Effects. 1983,
vol. 4, pp. 3-47.
Jones, P.E. and R.A. McCance. 1949. Enzyme activities in the blood of infants and adult.
Biochem. J. 45: 464-467.
Lubbers, J.R., J.R. Bianchine andRJ. Bull. 1983. Safety of oral chlorine dioxide, chlorite and
chlorate ingestion in man. In: Water Chlorination: Environmental Impact and Health Effects.
Vol. 4, Book 2, R.L. Jolley, W.A. Brungs, J.A. Cotruvo, R.B. Cumming, J.S. Mattice and
V.A. Jacobs, Ed. Ann Arbor Science Publishers, Inc., Ann Arbor, MI. p. 1335-1341.
Lubbers, J.R., S. Chauhan, J.K. Miller and J.R. Bianchine. 1984. The effects of chronic
administration of chlorite to glucose-6-phosphate dehydrogenase deficient healthy adult male
volunteers. J. Environ Pathol.
Mack, R.B. 1983. Some non-caustic remarks about bleach. NC Med. J. 44: 221.
68
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BIBLIOGRAPHY
MRID CITATION
Meier, J., R. Bull, J. Stober and M. Cimino. 1985. Evaluation of chemicals used for drinking
water disinfection for production of chromosomal damage and spermhead abnormalities in
mice. Environ. Mutat. 7: 201-211.
Mickey, G. and H. Holden Jr. 1971. Chromosomal effects of chlorine on mammalian cells in
vitro. EMS Newslett. 4: 39-41.
Mink, F.L., W.E. Coleman, J.W. Munch, W.H. Kaylor and H.P. Ringhand. 1983. In vivo
formation of halogenated reaction products following peroral sodium hypochlorite. Bull
Environ. Contam. Toxicol. 30: 394-399.
NRC (National Research Council). 1976. Chlorine and Hydrogen Chloride. Committee on
Medical and Biologic Effects of Environmental Pollutants. Washington, D.C. p. 282.
National Toxicology Program 1990. toxicology and carcinogenesis studies of chlorinated and
chloraminated water in F344/N rats and B6C3F1 mice. NTP TR 392.
National Toxicology Program 1992. Toxicology and Carcinogenesis studies of Chlorinated
and Chloraminated water (CAS Nos. 7782-50-5, 7681-52-9 and 10599-90-3) in F344 Rats
and B6C3F1 Mice (drinking water studies). NTP-TR 392.
Osborne, L.L. "Response of Sheep River, Alberta, Macroinvertebrate Communities to
Discharge of Chlorinated Municipal Sewage Effluent" in Water Chlorination: Environmental
Impact and Health Effects. 1985, vol. 5, pp.481-492.
Patton, W., V. Bacon, A.M. Duffield et. al. 1972. Chlorination studies. I. The reaction of
aqueous hypochlorous acid with cytocine. Biochem. Biophys. Res. Comm. 48: 880-884.
Pereira, W.E., Y. Hoyano, R., T. Summons, V.A. Bacon and A.M. Duffield. 1973.
Chlorination studies. II. The reaction of aqueous hypochlorous acid with a-amino acids and
dipeptites. Biochem. Biophys. Acta 313: 170-180.
Pfeiffer, E. 1978. Health aspects of water chorination with special consideration to the
carcinogencity of chlorine. II. Communication: On the co-carcinogenicity. Zbl. Bakt. Hyg.
166: 185-211.
Revis, N.W., T.R. Osborne, G. Holdworth and P. McCauley. Effect of chlorinated drinking
water on myocardial structure and functions in pigeons and rabbits. In: Water Chlorination:
Chemistry, Environmental Impact, and Health Effects, vol. 5, R.L. Jolley et. al., Ed. p. 365-
371.
69
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BIBLIOGRAPHY
MRID CITATION
Robinson, M., R. Bull, M. Schammer and R. Long. 1986. Epidermal hyperplasia in mouse
skin following treatment with alternative drinking water disinfectants. Environ. Health
Perspect. 69: 293-300.
Rosenkranz, H. 1973. Sodium hypochlorite and sodium perborate: Preferential inhibitors of
DNA polymerase-deficient bacteria. Mutat. Res. 21: 171-174.
Ross, J.D. 1963. Deficient activity of DPNH-dependent methemoglobin diaphoease in coral
blood erythrocytes. Blood. 21: 51-62.
Seegert, G.L. and R.B. Bogardus. 1980. Ecological and environmental factors to be
considered in developing chlorine criteria. In: Water Chlorination: Environmental Impact and
Health Effects. Vol. 3, R.L. Jolley, W.A. Brungs and R.B. Gumming, Ed. Ann Arbor Science
Publishers, Inc., Ann Arbor, MI. p. 961-971.
Sheldon, J.M. and R.G. Lovell. 1949. Asthma due to halogens. Am. Pract. 4: 43-44.
Snoeyink, V.L. and Jenkins, D. Water Chemistry. 1980, John Wiley and Sons, New York.
Staples, R.E., W.C. Worthy and T.A. Marks. 1979. Influence of drinking water-tap versus
purified on embryo development in mice. Teratology 19: 237-244.
Strange, D.C., J.C. Finneran, H.B. Schmacker, Jr. andD.E. Bowman. 1951. Corrosive injury
of stomach. Report of a case caused by ingestion of Clorox and experimental study of
injurious effects. Arch. Surg. 62: 350-357.
Suh, D.H. and M.S. Abdel-Rahman. 1983. Kinetics study of chlorine in rat. J. Toxicol.
Environ. Health 12: 467-473.
Sweeny, A. and A. Chen. 1985. Production of mutagenic artifacts by the action of residual
chlorine on XAD-4 resin. J. Chromat. 325: 95-102.
Tchobanoglous, C. and Schroeder, E.D. Water Quality- Characteristics: Modeling:
Modification. 1985, Addison-Wesley, Reading, MA
U.S..EPA. 1981. Ambient Water Quality Criterion for the Protection of Human Health:
Chlorine. Prepared by the Environmental Criteria and Assessment Office, Cincinnati, OH for
the Office of Water Regulations and Standards, Washington, DC.
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U.S. EPA. 1984. Ambient Water Quality Criteria for Chlorine - 1984. U.S. EPA, Office of
Water Regulations and Standards, Criteria and Standards Division, 401 M St. SW,
Washington, DC. 20460. EPA 440/5-84-030. 57pp.
U.S. EPA. 1994. Drinking Water Criteria Document for Chlorine, Hypochlorous Acid and
Hypochlorite Ion (External Review Draft). Prepared by the Environmental Criteria and
Assessment Office, Cincinnati, OH for the Office of Drinking Water, Washington, DC.
(ECAO/OHEA-CIN-D004).
U.S. EPA. 1987. Chlorine Poisoning Summary. Prepared by Exposure Assessment Branch,
Office of Pesticide Programs, Washington, DC. 18 pp.
Walton, M. andR. Gumming. 1976. 5-Halogenateduracil base analogue mutagenesis. Mutat.
Res. 38: 371.
WHO (World Health Organization). 1982. Environmental Health Criteria, Chlorine and
Hydrogen Chloride. Geneva, p. 1-95.
Wlodkowski, T. and H. Rosenkranz. 1975. Mutagencity of sodium hypochlorite for
Salmonella typhimurium. Mutat. Res. 31: 39-43.
Wojtowicz, J.A., "Chlorine Monoxide, Hypochlorous Acid and the Hypochlorites" in Kirk-
Othmer Encyclopedia of Chemical Technology. Third Edition, Vol. 5, Wiley-Interscience,
New York, pp. 580-611.
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72
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\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your product(s)
containing this active ingredient(s). Within 90 days after you receive this Notice you must
respond as set forth in Section III below. Your response must state:
1. how you will comply with the requirements set forth in this Notice and its Attachments 1
through 4; or,
2. why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section III-B);
or,
3. why you believe EPA should not require your submission of data in the manner specified
by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with
its requirements or should be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a list
of all registrants who were sent this Notice (Attachment 4).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 3-31-99).
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This Notice is divided into six sections and five Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment 1 - Data Call-In Chemical Status Sheet
Attachment 2 - Data Call-In Response Form (Insert A)
Attachment 3 - Requirements Status And Registrant's Response Form (Insert B)
Attachment 4 - List Of All Registrants Sent This Data Call-In Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This reevaluation
identified additional data necessary to assess the health and safety of the continued use of products
containing this active ingredient(s). You have been sent this Notice because you have product(s)
containing the subject active ingredient(s).
SECTION II. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and
Registrant's Response Form (Insert B). Depending on the results of the studies required in
this Notice, additional testing may be required.
B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in Attachment 3, Requirements Status and Registrant's Response Form (Insert B),
within the time frames provided.
C. TESTING PROTOCOL
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All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information
Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-
487-4650).
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD-recommended test standards
conform to those specified in the Pesticide Data Requirements regulation (40 CFR ง
158.70). When using the OECD protocols, they should be modified as appropriate so that
the data generated by the study will satisfy the requirements of 40 CFR ง 158. Normally,
the Agency will not extend deadlines for complying with data requirements when the
studies were not conducted in accordance with acceptable standards. The OECD protocols
are available from 2001 L Street, N.W., Washington, D.C. 20036 (Telephone number 202-
785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(cฅ2ฅB) NOTICES
IS SUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or
change the requirements of any previous Data Call-In(sX or any other agreements entered
into with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected
products.
SECTION HI. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice must be submitted to
the Agency within 90 days after your receipt of this Notice. Failure to adequately respond
to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent to
Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to
failure to comply with this Notice are presented in Section IV-A and IV-B.
B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2) delete
use(s), (3) claim generic data exemption, (4) agree to satisfy the data requirements imposed
by this Notice or (5) request a data waiver(s).
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A discussion of how to respond if you chose the Voluntary Cancellation option, the
Delete Use(s) option or the Generic Data Exemption option is presented below. A
discussion of the various options available for satisfying the data requirements of this
Notice is contained in Section III-C. A discussion of options relating to requests for data
waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the
Data-Call-in Response Form (Insert A) and the Requirements Status and Registrant's
Response Form (Insert B). The Data Call-In Response Form (Insert A) must be submitted
as part of every response to this Notice. Please note that the company's authorized
representative is required to sign the first page of the Data Call-In Response Form (Insert
A) and Requirements Status and Registrant's Response Form (Insert B) and initial any
subsequent pages. The forms contain separate detailed instructions on the response
options. Do not alter the printed material. If you have questions or need assistance in
preparing your response, call or write the contact person identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by
requesting voluntary cancellation of your product(s) containing the active
ingredient(s) that is the subject of this Notice. If you wish to voluntarily cancel
your product, you must submit a completed Data Call-In Response Form (Insert A),
indicating your election of this option. Voluntary cancellation is item number 5 on
the Data Call-In Response Form (Insert A). If you choose this option, this is the
only form that you are required to complete.
If you choose to voluntarily cancel your product, further sale and
distribution of your product after the effective date of cancellation must be in
accordance with the Existing Stocks provisions of this Notice which are contained
in Section IV-C.
2. Use Deletion - You may avoid the requirements of this Notice by
eliminating the uses of your product to which the requirements apply. If you wish
to amend your registration to delete uses, you must submit the Requirements Status
and Registrant's Response Form (Insert B), a completed application for amendment,
a copy of your proposed amended labeling, and all other information required for
processing the application. Use deletion is option number 7 on the Requirements
Status and Registrant's Response Form (Insert B). You must also complete a Data
Call-In Response Form (Insert A) by signing the certification, item number 8.
Application forms for amending registrations may be obtained from the
Registration Support and Emergency Response Branch, Registration Division,
(703) 308-8358.
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If you choose to delete the use(s) subject to this Notice or uses subject to
specific data requirements, further sale, distribution, or use of your product after
one year from the due date of your 90 day response, must bear an amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an applicant
for registration of a product is exempt from the requirement to submit or cite
generic data concerning an active ingredient(s) if the active ingredient(s) in the
product is derived exclusively from purchased, registered pesticide products
containing the active ingredient(s). EPA has concluded, as an exercise of its
discretion, that it normally will not suspend the registration of a product which
would qualify and continue to qualify for the generic data exemption in section
3(c)(2)(D) of FIFRA. To qualify, all of the following requirements must be met:
a. The active ingredient(s) in your registered product must be present
solely because of incorporation of another registered product which
contains the subject active ingredient(s) and is purchased from a source not
connected with you; and,
b. every registrant who is the ultimate source of the active
ingredient(s) in your product subject to this DCI must be in compliance
with the requirements of this Notice and must remain in compliance; and
c. you must have provided to EPA an accurate and current
"Confidential Statement of Formula" for each of your products to which this
Notice applies.
To apply for the Generic Data Exemption you must submit a completed
Data Call-In Response Form (Insert A), and all supporting documentation. The
Generic Data Exemption is item number 6a on the Data Call-In Response Form
(Insert A). If you claim a generic data exemption you are not required to complete
the Requirements Status and Registrant's Response Form (Insert B). Generic Data
Exemption cannot be selected as an option for product specific data.
If you are granted a Generic Data Exemption, you rely on the efforts of
other persons to provide the Agency with the required data. If the registrant(s) who
have committed to generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance with this Data Call-
in Notice, the Agency will consider that both they and you are not in compliance
and will normally initiate proceedings to suspend the registrations of both your and
their product(s), unless you commit to submit and do submit the required data
within the specified time. In such cases the Agency generally will not grant a time
extension for submitting the data.
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4. Satisfying the Data Requirements of this Notice - There are various options
available to satisfy the data requirements of this Notice. These options are
discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form (Insert B) and option 6b and
7 on the Data Call-In Response Formdnsert A). If you choose option 6b or 7, you
must submit both forms as well as any other information/data pertaining to the
option chosen to address the data requirement.
5. Request for Data Waivers. Data waivers are discussed in Section III-D of
this Notice and are covered by options 8 and 9 on the Requirements Status and
Registrant's Response Form (Insert B). If you choose one of these options, you
must submit both forms as well as any other information/data pertaining to the
option chosen to address the data requirement.
C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form (Insert A) that you agree to
satisfy the data requirements (i.e. you select option 6b and/or 7), then you must select one
of the six options on the Requirements Status and Registrant's Response Form (Insert A)
related to data production for each data requirement. Your option selection should be
entered under item number 9, "Registrant Response." The six options related to data
production are the first six options discussed under item 9 in the instructions for
completing the Requirements Status and Registrant's Response Form (Insert B). These six
options are listed immediately below with information in parentheses to guide registrants
to additional instructions provided in this Section. The options are:
1. I will generate and submit data within the specified time frame (Developing
Data),
2. I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing),
3. I have made offers to cost-share (Offers to Cost Share),
4. I am submitting an existing study that has not been submitted previously to
the Agency by anyone (Submitting an Existing Study),
5. I am submitting or citing data to upgrade a study classified by EPA as
partially acceptable and upgradeable (Upgrading a Study),
6. I am citing an existing study that EPA has classified as acceptable or an
existing study that has been submitted but not reviewed by the Agency
(Citing an Existing Study).
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Option 1. Developing Data
If you choose to develop the required data it must be in conformance with
Agency deadlines and with other Agency requirements as referenced herein and in
the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the
Pesticide Assessment Guidelines (PAG), and be in conformance with the
requirements of PR Notice 86-5. In addition, certain studies require Agency
approval of test protocols in advance of study initiation. Those studies for which a
protocol must be submitted have been identified in the Requirements Status and
Registrant's Response Form (Insert B) and/or footnotes to the form. If you wish to
use a protocol which differs from the options discussed in Section II-C of this
Notice, you must submit a detailed description of the proposed protocol and your
reason for wishing to use it. The Agency may choose to reject a protocol not
specified in Section II-C. If the Agency rejects your protocol you will be notified
in writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from the
date you are required to commit to generate or undertake some other means to
address that study requirement, such as making an offer to cost-share or agreeing to
share in the cost of developing that study. A 90-day progress report must be
submitted for all studies. This 90-day progress report must include the date the
study was or will be initiated and, for studies to be started within 12 months of
commitment, the name and address of the laboratory(ies) or individuals who are or
will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1
year, interim reports must be submitted at 12 month intervals from the date you are
required to commit to generate or otherwise address the requirement for the study.
In addition to the other information specified in the preceding paragraph, at a
minimum, a brief description of current activity on and the status of the study must
be included as well as a full description of any problems encountered since the last
progress report.
The time frames in the Requirements Status and Registrant's Response
Form (Insert B) are the time frames that the Agency is allowing for the submission
of completed study reports or protocols. The noted deadlines run from the date of
the receipt of this Notice by the registrant. If the data are not submitted by the
deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by
this Notice and intend to seek additional time to meet the requirement(s), you must
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submit a request to the Agency which includes: (1) a detailed description of the
expected difficulty and (2) a proposed schedule including alternative dates for
meeting such requirements on a step-by-step basis. You must explain any technical
or laboratory difficulties and provide documentation from the laboratory
performing the testing. While EPA is considering your request, the original
deadline remains. The Agency will respond to your request in writing. If EPA
does not grant your request, the original deadline remains. Normally, extensions
can be requested only in cases of extraordinary testing problems beyond the
expectation or control of the registrant. Extensions will not be given in submitting
the 90-day responses. Extensions will not be considered if the request for
extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data ~
If you choose to enter into an agreement to share in the cost of producing
the required data but will not be submitting the data yourself, you must provide the
name of the registrant who will be submitting the data. You must also provide EPA
with documentary evidence that an agreement has been formed. Such evidence
may be your letter offering to join in an agreement and the other registrant's
acceptance of your offer, or a written statement by the parties that an agreement
exists. The agreement to produce the data need not specify all of the terms of the
final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the
agreement they may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into an agreement or
amend an existing agreement to meet the requirements of this Notice and have been
unsuccessful, you may request EPA (by selecting this option) to exercise its
discretion not to suspend your registration(s), although you do not comply with the
data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a
product of a registrant who has in good faith sought and continues to seek to enter
into a joint data development/cost sharing program, but the other registrant(s)
developing the data has refused to accept your offer. To qualify for this option, you
must submit documentation to the Agency proving that you have made an offer to
another registrant (who has an obligation to submit data) to share in the burden of
developing that data. You must also submit to the Agency a completed EPA Form
8570-32, Certification of Offer to Cost Share in the Development of Data. In
addition, you must demonstrate that the other registrant to whom the offer was
made has not accepted your offer to enter into a cost sharing agreement by
including a copy of your offer and proof of the other registrant's receipt of that offer
(such as a certified mail receipt). Your offer must, in addition to anything else,
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offer to share in the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section
3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the data required by
this Notice by submitting a Data Call-In Response Form (Insert A) and a
Requirements Status and Registrant's Response Form (Insert B) committing to
develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not
withdraw your offer to share in the burdens of developing the data. In addition, the
other registrant must fulfill its commitment to develop and submit the data as
required by this Notice. If the other registrant fails to develop the data or for some
other reason is subject to suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame.
In such cases, the Agency generally will not grant a time extension for submitting
the data.
Option 4. Submitting an Existing Study
If you choose to submit an existing study in response to this Notice, you
must determine that the study satisfies the requirements imposed by this Notice.
You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance
of this Notice. Do not use this option if you are submitting data to upgrade a study.
(See Option 5).
You should be aware that if the Agency determines that the study is not
acceptable, the Agency will require you to comply with this Notice, normally
without an extension of the required date of submission. The Agency may
determine at any time that a study is not valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing
study, all of the following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that
the raw data and specimens from the study are available for audit and
review and you must identify where they are available. This must be done
in accordance with the requirements of the Good Laboratory Practice (GLP)
regulation, 40 CFRPart 160. As stated in 40 CFR 160.3(7)" raw data
means any laboratory worksheets, records, memoranda, notes, or exact
copies thereof, that are the result of original observations and activities of a
study and are necessary for the reconstruction and evaluation of the report
of that study. In the event that exact transcripts of raw data have been
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prepared (e.g., tapes which have been transcribed verbatim, dated, and
verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. Raw data may include
photographs, microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from automated
instruments." The term "specimens", according to 40 CFR 160.3(7), means
"any material derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-required quality assurance and quality control information,
pursuant to the requirements of 40 CFR Part 160. Registrants must also
certify at the time of submitting the existing study that such GLP
information is available for post-May 1984 studies by including an
appropriate statement on or attached to the study signed by an authorized
official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for
the Guideline relevant to the study provided in the FIFRA Accelerated
Reregistration Phase 3 Technical Guidance and that the study has been
conducted according to the Pesticide Assessment Guidelines (PAG) or
meets the purpose of the PAG (both available from NTIS). A study not
conducted according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which
states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of the
PAG are met by the study, clearly articulate the rationale why you believe
the study meets the purpose of the PAG, including copies of any supporting
information or data. It has been the Agency's experience that studies
completed prior to January 1970 rarely satisfied the purpose of the PAG and
that necessary raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study
meets all requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are
submitting, you must identify any action taken by the Agency on the
protocol and must indicate, as part of your certification, the manner in
which all Agency comments, concerns, or issues were addressed in the final
protocol and study.
If you know of a study pertaining to any requirement in this Notice
which does not meet the criteria outlined above but does contain factual
information regarding unreasonable adverse effects, you must notify the
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Agency of such a study. If such a study is in the Agency's files, you need
only cite it along with the notification. If not in the Agency's files, you must
submit a summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study
If a study has been classified as partially acceptable and upgradeable, you
may submit data to upgrade that study. The Agency will review the data submitted
and determine if the requirement is satisfied. If the Agency decides the
requirement is not satisfied, you may still be required to submit new data normally
without any time extension. Deficient, but upgradeable studies will normally be
classified as supplemental. However, it is important to note that not all studies
classified as supplemental are upgradeable. If you have questions regarding the
classification of a study or whether a study may be upgraded, call or write the
contact person listed in Attachment 1. If you submit data to upgrade an existing
study you must satisfy or supply information to correct all deficiencies in the study
identified by EPA. You must provide a clearly articulated rationale of how the
deficiencies have been remedied or corrected and why the study should be rated as
acceptable to EPA. Your submission must also specify the MRID number(s) of the
study which you are attempting to upgrade and must be in conformance with PR
Notice 86-5.
Do not submit additional data for the purpose of upgrading a study
classified as unacceptable and determined by the Agency as not capable of being
upgraded.
This option should also be used to cite data that has been previously
submitted to upgrade a study, but has not yet been reviewed by the Agency. You
must provide the MRID number of the data submission as well as the MRID
number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above,
apply to all data submissions intended to upgrade studies. Additionally your
submission of data intended to upgrade studies must be accompanied by a
certification that you comply with each of those criteria as well as a certification
regarding protocol compliance with Agency requirements.
Option 6. Citing Existing Studies
If you choose to cite a study that has been previously submitted to EPA, that
study must have been previously classified by EPA as acceptable or it must be a
study which has not yet been reviewed by the Agency. Acceptable toxicology
studies generally will have been classified as "core-guideline" or "core minimum."
For ecological effects studies, the classification generally would be a rating of
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"core." For all other disciplines the classification would be "acceptable." With
respect to any studies for which you wish to select this option you must provide the
MRID number of the study you are citing and, if the study has been reviewed by the
Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter,
you must submit a completed copy of Certification with Respect to Citations of
Data (in PR Notice 98-5) EPA Form 8570-34 .
D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request
for a low volume/minor use waiver and the second is a waiver request based on your belief
that the data requirement(s) are inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver Option 8 on the Requirements Status
and Registrant's Response Form (Insert B). Section 3(c)(2)(A) of FIFRA requires
EPA to consider the appropriateness of requiring data for low volume, minor use
pesticides. In implementing this provision EPA considers as low volume pesticides
only those active ingredient(s) whose total production volume for all pesticide
registrants is small. In determining whether to grant a low volume, minor use
waiver the Agency will consider the extent, pattern and volume of use, the
economic incentive to conduct the testing, the importance of the pesticide, and the
exposure and risk from use of the pesticide. If an active ingredient(s) is used for
both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient(s) are low volume and the combined
volumes for all uses are also low, then an exemption may be granted, depending on
review of other information outlined below. An exemption will not be granted if
any registrant of the active ingredient(s) elects to conduct the testing. Any
registrant receiving a low volume minor use waiver must remain within the sales
figures in their forecast supporting the waiver request in order to remain qualified
for such waiver. If granted a waiver, a registrant will be required, as a condition of
the waiver, to submit annual sales reports. The Agency will respond to requests for
waivers in writing.
To apply for a low volume, minor use waiver, you must submit the
following information, as applicable to your product(s), as part of your 90-day
response to this Notice:
a. Total company sales (pounds and dollars) of all registered
product(s) containing the active ingredient(s). If applicable to the active
ingredient(s), include foreign sales for those products that are not registered
in this country but are applied to sugar (cane or beet), coffee, bananas,
cocoa, and other such crops. Present the above information by year for each
of the past five years.
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b. Provide an estimate of the sales (pounds and dollars) of the active
ingredient(s) for each major use site. Present the above information by year
for each of the past five years.
c. Total direct production cost of product(s) containing the active
ingredient(s) by year for the past five years. Include information on raw
material cost, direct labor cost, advertising, sales and marketing, and any
other significant costs listed separately.
d. Total indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to product(s) containing the active ingredient(s) by
year for the past five years. Exclude all non-recurring costs that were
directly related to the active ingredient(s), such as costs of initial
registration and any data development.
e. A list of each data requirement for which you seek a waiver. Indicate
the type of waiver sought and the estimated cost to you (listed separately for
each data requirement and associated test) of conducting the testing needed
to fulfill each of these data requirements.
f A list of each data requirement for which you are not seeking any
waiver and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill
each of these data requirements.
g. For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient(s), direct production
costs of product(s) containing the active ingredient(s) (following the
parameters in item c above), indirect production costs of product(s)
containing the active ingredient(s) (following the parameters in item d
above), and costs of data development pertaining to the active ingredient(s).
h. A description of the importance and unique benefits of the active
ingredient(s) to users. Discuss the use patterns and the effectiveness of the
active ingredient(s) relative to registered alternative chemicals and
non-chemical control strategies. Focus on benefits unique to the active
ingredient(s), providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates, then
present the reasoning used to derive your estimates. To assist the Agency in
determining the degree of importance of the active ingredient(s) in terms of
its benefits, you should provide information on any of the following factors,
as applicable to your product(s):
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(1) documentation of the usefulness of the active ingredient(s)
in Integrated Pest Management, (b) description of the beneficial impacts on
the environment of use of the active ingredient(s), as opposed to its
registered alternatives, (c) information on the breakdown of the active
ingredient(s) after use and on its persistence in the environment, and (d)
description of its usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume minor use waiver will result in denial of the request
for a waiver.
2. Request for Waiver of Data Option 9 on the Requirements Status and
Registrant's Response Form (Insert B). This option may be used if you believe that
a particular data requirement should not apply because the corresponding use is no
longer registered or the requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply. You must also
submit the current label(s) of your product(s) and, if a current copy of your
Confidential Statement of Formula is not already on file you must submit a current
copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice do not apply to your
product(s), you will not be required to supply the data pursuant to section
3(c)(2)(B). If EPA determines that the data are required for your product(sX you
must choose a method of meeting the requirements of this Notice within the time
frame provided by this Notice. Within 30 days of your receipt of the Agency's
written decision, you must submit a revised Requirements Status and Registrant's
Response Form (Insert B) indicating the option chosen.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
A. NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice
due to failure by a registrant to comply with the requirements of this Data Call-In Notice,
pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a
Notice of Intent to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt
of this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
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3. Failure to submit on the required schedule an adequate progress report on a
study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by
this Notice.
5. Failure to take a required action or submit adequate information pertaining
to any option chosen to address the data requirements (e.g., any required
action or information pertaining to submission or citation of existing studies
or offers, arrangements, or arbitration on the sharing of costs or the
formation of Task Forces, failure to comply with the terms of an agreement
or arbitration concerning joint data development or failure to comply with
any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of
submitted studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the
cost of developing data and provided proof of the registrant's receipt of such
offer, or failure of a registrant on whom you rely for a generic data
exemption either to:
a. inform EPA of intent to develop and submit the data required by
this Notice on a Data Call-In Response Form (Insert A) and a Requirements
Status and Registrant's Response Form (Insert B); or,
b. fulfill the commitment to develop and submit the data as required
by this Notice; or,
c. otherwise take appropriate steps to meet the requirements stated in
this Notice, unless you commit to submit and do submit the required data in
the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at
any time following the issuance of this Notice.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required
time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend.
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The grounds for suspension include, but are not limited to, failure to meet any of the
following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test
Guidelines) regarding the design, conduct, and reporting of required studies. Such
requirements include, but are not limited to, those relating to test material, test
procedures, selection of species, number of animals, sex and distribution of
animals, dose and effect levels to be tested or attained, duration of test, and, as
applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of
reporting, the completeness of results, and the adequacy of any required supporting
(or raw) data, including, but not limited to, requirements referenced or included in
this Notice or contained in PR 86-5. All studies must be submitted in the form of a
final report; a preliminary report will not be considered to fulfill the submission
requirement.
C. EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of
existing stocks of a pesticide product which has been suspended or canceled if doing so
would be consistent with the purposes of the Federal Insecticide, Fungicide, and
Rodenticide Act.
The Agency has determined that such disposition by registrants of existing stocks
for a suspended registration when a section 3(c)(2)(B) data request is outstanding would
generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates
granting registrants permission to sell, distribute, or use existing stocks of suspended
product(s) only in exceptional circumstances. If you believe such disposition of existing
stocks of your product(s) which may be suspended for failure to comply with this Notice
should be permitted, you have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. You must also explain why an "existing
stocks" provision is necessary, including a statement of the quantity of existing stocks and
your estimate of the time required for their sale, distribution, and use. Unless you meet this
burden the Agency will not consider any request pertaining to the continued sale,
distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this
Notice and your product is in full compliance with all Agency requirements, you will have,
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under most circumstances, one year from the date your 90 day response to this Notice is
due, to sell, distribute, or use existing stocks. Normally, the Agency will allow persons
other than the registrant such as independent distributors, retailers and end users to sell,
distribute or use such existing stocks until the stocks are exhausted. Any sale, distribution
or use of stocks of voluntarily canceled products containing an active ingredient(s) for
which the Agency has particular risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period
required by this Notice will not result in the Agency granting any additional time to sell,
distribute, or use existing stocks beyond a year from the date the 90 day response was due
unless you demonstrate to the Agency that you are in full compliance with all Agency
requirements, including the requirements of this Notice. For example, if you decide to
voluntarily cancel your registration six months before a 3 year study is scheduled to be
submitted, all progress reports and other information necessary to establish that you have
been conducting the study in an acceptable and good faith manner must have been
submitted to the Agency, before EPA will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person listed in Attachment 1, the Data Call-In Chemical Status Sheet.
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All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form (Insert A) and a
completed Requirements Status and Registrant's Response Form (Insert B) and any other
documents required by this Notice, and should be submitted to the contact person identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only the
Data Call-In Response Form (Insert A) need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance
(OECA), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
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CHLORINE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing chlorine.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregistration of chlorine. This
attachment is to be used in conjunction with (1) the Generic Data Call-In Notice, (2) the Generic
Data Call-In Response Form (Attachment 2), (3) the Requirements Status and Registrant's Form
(Attachment 2), (4) a list of registrants receiving this DCI (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), and (6) the Cost Share and Data Compensation Forms in
replying to this chlorine Generic Data Callln (Attachment F). Instructions and guidance
accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for chlorine are
contained in the Requirements Status and Registrant's Response. Attachment C. The Agency has
concluded that additional product chemistry data on chlorine are needed. These data are needed
to fully complete the reregistration of all eligible chlorine products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Patrick Dobak at (703) 308-8180.
All responses to this Notice for the generic data requirements should be submitted to:
Patrick Dobak, Chemical Review Manager
Reregistration Branch I
Special Review and Registration Division (H7508C)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Chlorine, Case 4022
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM
(INSERT A)
This Form is designed to be used to respond to call-ins for generic and product specific
data for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and
Rodenticide Act. Fill out this form each time you are responding to a data call-in for which EPA
has sent you the form entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form Items 5 through 7 must be completed by
the registrant as appropriate Items 8 through 11 must be completed by the registrant
before submitting a response to the Agency.
Public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggesting for reducing this burden, to Chief, Information Policy
Branch, PM-223, U S Environmental Protection Agency, 401 M St, S W , Washington, D C
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, DC 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number and address.
Item 2. This item identifies the ease number, ease name, EPA chemical number and
chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations relevant to the data
call-in. Please note that you are also responsible for informing the Agency
of your response regarding any product that you believe may be covered by
this data call-in but that is not listed by the Agency in Item 4. You must
bring any such apparent omission to the Agency's attention within the
period required for submission of this response form.
Item 5. Cheek this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate in Item 5 the date of
that request. You do not need to complete any item on the Requirements
Status and Registrant's Response Form for any product that is voluntarily
canceled.
Item 6a. Check this item if this data call-in is for generic data as indicated in Item 3
and if you are eligible for a Generic Data Exemption for the chemical listed
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in Item 2 and used in the subject product. By electing this exemption, you
agree to the terms and conditions of a Generic Data Exemption as
explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that
you use in your product.
Typically, if you purchase an EPA-registered product from one or more
other producers (who, with respect to the incorporated product, are in
compliance with this and-any other outstanding Data Call-In Notice), and
incorporate that product into all your products, you may complete this item
for all products listed on this form If, however, you produce the active
ingredient yourself, or use any unregistered product (regardless of the fact
that some of your sources are registered), you may not claim a Generic
Data Exemption and you may not select this item.
Item 6b. Check this Item if the data call-in is a generic data call-in as indicated in
Item 3 and if you are agreeing to satisfy the generic data requirements of
this data call-in. Attach the Requirements Status and Registrant's
Response Form (Insert A) that indicates how you will satisfy those
requirements.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing
use product for which you agree to supply product-specific data. Attach
the Requirements Status and Registrants' Response Form (Insert A) that
indicates how you will satisfy those requirements.
Item 7b. Check this item if this call-in is a data call-in for an end use product (EUP)
as indicated in Item 3 and if your product is an end use product for which
you agree to supply product-specific data. Attach the Requirements Status
and Registrant's Response Form (Insert A) that indicates how you will
satisfy those requirements.
Item 8. This certification statement must be signed by an authorized representative
of your company and the person signing must include his/her title.
Additional pages used in your response must be initialed and dated in the
space provided for the certification.
Item 9. Enter the date of signature.
Item 10. Enter the name of the person EPA should contact with questions regarding
your response.
Item 11. Enter the phone number of your company contact.
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DRAFT COPY
Page 1 of I
United States Environmental Protection Agency
Washington, D.C, 20460
DATA CALL -IN RESPONSE
Form Approved
OMB NO, 2070-0107
2070-0057
Approval Expires 03/31/99
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet (si if necessary
1 . Company name and Address 2 , Case tt and Name
4022 Chlorine
Chemical tt and Name 020501
Chlorine
4. IPA Product
Registration
S, I wish to
cancel this
product regis-
tration volun-
tarily
6 . Generic Data
6s. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source SPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant * s Response . "
3. Date and Type of DCI
GENERIC
7. Product Specific Data
7a. My product is an HUP and
I agree to satisfy the MUP
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 Knowingly false or misleading statement njay be punishable by fine, imprisonment
or both under applicable law,
Signature and Title of Company's authorized Representative
10. Name of Company Contact
7b. My product IB an BOP and
I agree to satisfy the BOP
requirements on the attached
form entitled "Requirementa
Status and Registrant's
Response, "
*
9. Date
11.
Phone Number
-------
96
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS
AND REGISTRANTS RESPONSE FORM (INSERTS)
Generic Data
This form is designed to be used for registrants to respond to call-in- for generic and
product-specific data as part of EPA's reregi strati on program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for both product specific and
generic data, instructions for completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (1) deletion of uses or (2) request for
a low volume/minor use waiver. These instructions are for completion of generic data
requirements.
EPA has developed this form individually for each data call-in addressed to each registrant, and
has preprinted this form with a number of items. DO NOT use this form for any other active
ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all other
items on this form by typing or printing legibly.
Public reporting burden for this collection of information is estimated to average 30 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of this collection of information,
including suggesting for reducing this burden, to Chief, Information Policy Branch, PM-223, U.S.
Environmental Protection Agency, 401 M St., SW., Washington, D.C. 20460; and to the Office of
Management and Budget, Paperwork Reduction Project 2070-0107, Washington, D.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2. This item identifies the case number, case name, EPA chemical number and
chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of studies required to support
the product(s) being reregistered. These guidelines, in addition to requirements
specified in the Data Call-In Notice, govern the conduct of the required studies.
Item 5. This item identifies the study title associated with the guideline reference number
and whether protocols and 1, 2, or 3-year progress reports are required to be
submitted in connection with the study. As noted in Section III of the Data Call-In
Notice, 90-day progress reports are required for all studies.
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If an asterisk appears in Item 5, EPA has attached information relevant to
this guideline reference number to the Requirements Status and Registrant's
Response Form (Insert B).
Item 6. This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G. Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food crop
J. Forestry
K. Residential
L. Indoor food
M. Indoor non-food
N. Indoor medical
O. Indoor residential
Item 7. This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows.
EP End-Use Product
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical Grade
Active Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAIRA Pure Active Ingredient or Pure Active Ingredient
Radiolabelled
PAIRA Pure Active Ingredient Radiolabelled
PAIRA/M Pure Active Ingredient Radiolabelled and
Metabolites
PAIRA/PM Pure Active Ingredient Radiolabelled and Plant
Metabolites
TEP Typical End-Use Product
TEP _ * Typical End-Use Product, Percent Active Ingredient
Specified
TEP/MET Typical End-Use Product and Metabolites
TEP/PAI/M Typical End-Use Product or Pure Active Ingredient
and Metabolites
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TGAI/PAIRA Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
TGAI Technical Grade Active Ingredient
TGAI/TEP Technical Grade Active Ingredient or Typical
End-Use Product
TGAI/PAI Technical Grade Active Ingredient or Pure Active
Ingredient
MET Metabolites
IMP Impurities
DEGR Degradates
*See: guideline comment
Item 8. This item identifies the time frame allowed for submission of the study or protocol
identified in item 2. The time frame runs from the date of your receipt of the Data
Call-In Notice.
Item 9. Enter the appropriate Response Code or Codes to show how you intend to comply
with each data requirement. Brief descriptions of each code follow. The Data Call-
in Notice contains a fuller description of each of these options.
1. (Developing Data) I will conduct a new study and submit it within the time
frames specified in item 8 above. By indicating that I have chosen this
option, I certify that I will comply with all the requirements pertaining to
the conditions for submittal of this study as outlined in the Data Call-In
Notice and that I will provide the protocol and progress reports required in
item 5 above.
2. (Agreement to Cost Share) I have entered into an agreement with one or
more registrants to develop data jointly. By indicating that I have chosen
this option, I certify that I will comply with all the requirements pertaining
to sharing in the cost of developing data as outlined in the Data Call-In
Notice.
3. (Offer to Cost Share) I have made an offer to enter into an agreement with
one or more registrants to develop data jointly. I am submitting a copy of
the form "Certification of Offer to Cost Share in the Development of Data"
that describes this offer/agreement. By indicating that I have chosen this
option, I certify that I will comply with all the requirements pertaining to
making an offer to share in the cost of developing data as outlined in the
Data Call-In Notice.
4. (Submitting Existing Data) I am submitting an existing study that has never
before been submitted to EPA. By indicating that I have chosen this option,
I certify that this study meets all the requirements pertaining to the
conditions for submittal of existing data outlined in the Data Call-In Notice
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and I have attached the needed supporting information along with this
response.
5. (Upgrading a Study) I am submitting or citing data to upgrade a study that
EPA has classified as partially acceptable and potentially upgradeable. By
indicating that I have chosen this option, I certify that I have met all the
requirements pertaining to the conditions for submitting or citing existing
data to upgrade a study described in the Data Call-In Notice. I am
indicating on attached correspondence the Master Record Identification
Number (MRID) that EPA has assigned to the data that I am citing as well
as the MRID of the study I am attempting to upgrade.
6. (Citing a Study) I am citing an existing study that has been previously
classified by EPA as acceptable, core, core minimum, or a study that has
not yet been reviewed by the Agency. I am providing the Agency's
classification of the study.
7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In Notice
and I request a low-volume minor use waiver of the data requirement. I
am attaching a detailed justification to support this waiver request
including, among other things, all information required to support the
request. I understand that, unless modified by the Agency in writing, the
data requirement as stated in the Notice governs.
9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than low volume minor-use data waivers in the Data Call-In
Notice and I request a waiver of the data requirement. I am attaching an
identification of the basis for this waiver and a detailed justification to
support this waiver request. The justification includes, among other things,
all information required to support the request. I understand that, unless
modified by the Agency in writing, the data requirement as stated in the
Notice governs.
Item 10. This item must be signed by an authorized representative of your company. The
person signing must include his/her title, and must initial and date all other pages of
this form.
Item 11. Enter the date of signature.
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Item 12. Enter the name of the person EPA should contact with questions regarding your
response.
Item 13. Enter the phone number of your company contact.
101
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102
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DRAFT COPY
Paqe 1 of 1
United States Environmental Protection Agency
Washington, B.C. 20460
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully Che attached instructions and supply the information requested
Dse additional sheet (s) if necessary
1. Company name and Address
4 , Guideline
Requirement
Number
83-3(a) *
83-3 (b) *
83-4 *
5. Study Title
Teratogenicity - rat
Protocol
Teratogenicity - rabbit
Protocol
2-generation repjro.-rat
Protocol
p
R
O
T
O
O
L
sr
f
if
2. Case i and Name
4022 Chlorine
Chemical ff and Name 020501
Chlorine
Progress
Reports
1
Y
Y
Y
2
Y
3
Y
6. Use
Pattern
LM
LM
LM
7. Test
Substance
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 Contact
Form Approved
OMB No. 2070-0107
207Q-QQ5T
Approval Expires 03/31/99
on this form.
3. Date and Type of DCI
GENERIC
8 . Time
Frame
24
6
24
6
48
6
mos .
tnos.
mos.
mos.
mos .
mos.
9. Registrant
Response
11. Date
13 . Phone Number
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D,C. 20460
* COMMENTS FOE GUIDELINE REQUIREMENTS
Case # and Name
4022 Chlorine
Chemica1 tf and Name
020501 Chlorine :
GUIDELINE COMMENT ' :
83-3(a) This requirement applies only to drinking water treatment use. The test substance is the
water treatment byproduct Bromodichlordmethane. The preferred dosing is by water.
83-3(b) This requirement applies only to the drinking water treatment use. The test substances
are; Bromodichloromethane and Dichloroacetic acid. The preferred dosing is by water.
83-4 This requirement applies only to the drinking water treatment use. The test substances
are: Bromodichloromethane and Dibromoacetic acid. The preferred dosing is by water.
-------
\
I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
f
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you must
respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 5; or
2. Why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section
III-B); or
3. Why you believe EPA should not require your submission of product specific data
in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with
its requirements or should be exempt or excused from doing so, then the registration of your
105
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product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a list
of all registrants who were sent this Notice (Attachment 5).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 03-31-99).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VT - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form (Insert A)
3 - Requirements Status and Registrant's Response Form (Insert B)
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
SECTIONI. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional generic
data requirements are being imposed. You have been sent this Notice because you have product(s)
containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form (Insert B). Depending on the results of the
studies required in this Notice, additional testing may be required.
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II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Insert B, Requirements Status and Registrant's Response Form (Insert BX within the time frames
provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information
Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-
487-4650).
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD-recommended test standards
conform to those specified in the Pesticide Data Requirements regulation (40 CFR ง
158.70). When using the OECD protocols, they should be modified as appropriate so that
the data generated by the study will satisfy the requirements of 40 CFR ง 158. Normally,
the Agency will not extend deadlines for complying with data requirements when the
studies were not conducted in accordance with acceptable standards. The OECD protocols
are available from OECD, 2001 L Street, N.W., Washington, D.C. 20036 (Telephone
number 202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or
change the requirements of any previous Data Call-In(sX or any other agreements entered
into with the Agency pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent to Suspend their affected
products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data
must be submitted to the Agency within 90 days after your receipt of this Notice. Failure
to adequately respond to this Notice within 90 days of your receipt will be a basis for
issuing a Notice of Intent to Suspend (NOIS) affecting your products. This and other bases
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for issuance of NOIS due to failure to comply with this Notice are presented in Section IV-
A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a)
voluntary cancellation, (b) agree to satisfy the product specific data requirements imposed
by this notice or (c) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section III-C. A discussion of
options relating to requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the
Data-Call-in Response Form (Insert A), and the Requirements Status and Registrant's
Response Form (Insert B). The Data Call-In Response Form must be submitted as part of
every response to this Notice. In addition, one copy of the Requirements Status and
Registrant's Response Form (Insert B) must be submitted for each product listed on the
Data Call-In Response Form (Insert A) unless the voluntary cancellation option is selected
or unless the product is identical to another (refer to the instructions for completing the
Data Call-In Response Form(Insert A). Please note that the company's authorized
representative is required to sign the first page of the Data Call-In Response Form (Insert
A) and Requirements Status and Registrant's Response Form (Insert B), initial any
subsequent pages. The forms contain separate detailed instructions on the response
options. Do not alter the printed material. If you have questions or need assistance in
preparing your response, call or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by
requesting voluntary cancellation of your product(s) containing the active ingredient that is
the subject of this Notice. If you wish to voluntarily cancel your product, you must submit
a completed Data Call-In Response Form (Insert AX indicating your election of this option.
Voluntary cancellation is item number 5 on the Data Call-In Response Form (Insert B). If
you choose this option, this is the only form that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing
Stocks provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are
various options available to satisfy the product specific data requirements of this Notice.
These options are discussed in Section III-C of this Notice and comprise options 1 through
5 on the Requirements Status and Registrant's Response Formdnsert A) and item numbers
7a and 7b on the Data Call-In Response Formdnsert B). Deletion of a use(s) and the low
volume/minor use option are not valid options for fulfilling product specific data
requirements.
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3. Request for Product Specific Data Waivers. Waivers for product specific data
are discussed in Section III-D of this Notice and are covered by option 7 on the
Requirements Status and Registrant's Response Form (Insert B). If you choose one of
these options, you must submit both forms as well as any other information/data pertaining
to the option chosen to address the data requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form (Insert A) that you agree to
satisfy the product specific data requirements (i.e. you select item number 7a or 7b), then
you must select one of the six options on the Requirements Status and Registrant's
Response Form (Insert A) related to data production for each data requirement. Your
option selection should be entered under item number 9, "Registrant Response." The six
options related to data production are the first six options discussed under item 9 in the
instructions for completing the Requirements Status and Registrant's Response Formdnsert
A). These six options are listed immediately below with information in parentheses to
guide registrants to additional instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1, Developing Data ~ If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced
here in and in the attachments. All data generated and submitted must comply with the
Good Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the
Pesticide Assessment Guidelines(PAG), and be in conformance with the requirements of
PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form (Insert
A) are the time frames that the Agency is allowing for the submission of completed study
reports. The noted deadlines run from the date of the receipt of this Notice by the
registrant. If the data are not submitted by the deadline, each registrant is subject to receipt
of a Notice of Intent to Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this
Notice and intend to seek additional time to meet the requirements(s), you must submit a
request to the Agency which includes: (1) a detailed description of the expected difficulty
109
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and (2) a proposed schedule including alternative dates for meeting such requirements on a
step-by-step basis. You must explain any technical or laboratory difficulties and provide
documentation from the laboratory performing the testing. While EPA is considering your
request, the original deadline remains. The Agency will respond to your request in writing.
If EPA does not grant your request, the original deadline remains. Normally, extensions
can be requested only in cases of extraordinary testing problems beyond the expectation or
control of the registrant. Extensions will not be given in submitting the 90-day responses.
Extensions will not be considered if the request for extension is not made in a timely
fashion; in no event shall an extension request be considered if it is submitted at or after
the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data ~ Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in
the attached data tables that your product and at least one other product are similar for
purposes of depending on the same data. If this is the case, data may be generated for just
one of the products in the group. The registration number of the product for which data
will be submitted must be noted in the agreement to cost share by the registrant selecting
this option. If you choose to enter into an agreement to share in the cost of producing the
required data but will not be submitting the data yourself, you must provide the name of
the registrant who will be submitting the data. You must also provide EPA with
documentary evidence that an agreement has been formed. Such evidence may be your
letter offering to join in an agreement and the other registrant's acceptance of your offer, or
a written statement by the parties that an agreement exists. The agreement to produce the
data need not specify all of the terms of the final arrangement between the parties or the
mechanism to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot
resolve the terms of the agreement they may resolve their differences through binding
arbitration.
Option 3, Offer to Share in the Cost of Data Development This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an
offer to pay in an attempt to enter into an agreement or amend an existing agreement to
meet the requirements of this Notice and have been unsuccessful, you may request EPA
(by selecting this option) to exercise its discretion not to suspend your registration(s),
although you do not comply with the data submission requirements of this Notice. EPA
has determined that as a general policy, absent other relevant considerations, it will not
suspend the registration of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost sharing program, but the other
registrant(s) developing the data has refused to accept your offer. To qualify for this
option, you must submit documentation to the Agency proving that you have made an offer
to another registrant (who has an obligation to submit data) to share in the burden of
developing that data. You must also submit to the Agency a completed EPA Form 8570-
32, Certification of Offer to Cost Share in the Development of Data, Attachment 7. In
addition, you must demonstrate that the other registrant to whom the offer was made has
not accepted your offer to enter into a cost sharing agreement by including a copy of your
offer and proof of the other registrant's receipt of that offer (such as a certified mail
receipt). Your offer must, in addition to anything else, offer to share in the burden of
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producing the data upon terms to be agreed or failing agreement to be bound by binding
arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this offer.
The other registrant must also inform EPA of its election of an option to develop and
submit the data required by this Notice by submitting a Data Call-In Response Form (Insert
A) and a Requirements Status and Registrant's Response Form (Insert B) committing to
develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your
offer to share in the burdens of developing the data. In addition, the other registrant must
fulfill its commitment to develop and submit the data as required by this Notice. If the
other registrant fails to develop the data or for some other reason is subject to suspension,
your registration as well as that of the other registrant will normally be subject to initiation
of suspension proceedings, unless you commit to submit, and do submit the required data
in the specified time frame. In such cases, the Agency generally will not grant a time
extension for submitting the data.
Option 4, Submitting an Existing Study ~ If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements
imposed by this Notice. You may only submit a study that has not been previously
submitted to the Agency or previously cited by anyone. Existing studies are studies which
predate issuance of this Notice. Do not use this option if you are submitting data to
upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable,
the Agency will require you to comply with this Notice, normally without an extension of
the required date of submission. The Agency may determine at any time that a study is not
valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of
the following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFRPart 160.
As stated in 40 CFR 160.3(j)" 'raw data' means any laboratory worksheets, records,
memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been transcribed verbatim, dated, and
verified accurate by signature), the exact copy or exact transcript may be substituted
for the original source as raw data. 'Raw data' may include photographs, microfilm
or microfiche copies, computer printouts, magnetic media, including dictated
observations, and recorded data from automated instruments." The term
"specimens", according to 40 CFR 160.3(k), means "any material derived from a
test system for examination or analysis."
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b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158.70
which states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you believe the study
meets the purpose of the PAG, including copies of any supporting information or
data. It has been the Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary raw data are usually
not available for such studies.
If you submit an existing study, you must certify that the study meets all
requirements of the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding
unreasonable adverse effects, you must notify the Agency of such a study. If such study is
in the Agency's files, you need only cite it along with the notification. If not in the Agency's
files, you must submit a summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study ~ If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the
requirement is not satisfied, you may still be required to submit new data normally without
any time extension. Deficient, but upgradeable studies will normally be classified as
supplemental. However, it is important to note that not all studies classified as
supplemental are upgradeable. If you have questions regarding the classification of a study
or whether a study may be upgraded, call or write the contact person listed in Attachment
1. If you submit data to upgrade an existing study you must satisfy or supply information
to correct all deficiencies in the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or corrected and why the
study should be rated as acceptable to EPA. Your submission must also specify the MRID
number(s) of the study which you are attempting to upgrade and must be in conformance
with PR Notice 86-5.
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Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the
MRID number of the data submission as well as the MRID number of the study being
upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply
to all data submissions intended to upgrade studies. Additionally your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with
each of those criteria as well as a certification regarding protocol compliance with Agency
requirements.
Option 6, Citing Existing Studies ~ If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or
it must be a study which has not yet been reviewed by the Agency. Acceptable toxicology
studies generally will have been classified as "core-guideline" or "core minimum." For all
other disciplines the classification would be "acceptable." With respect to any studies for
which you wish to select this option you must provide the MRID number of the study you
are citing and, if the study has been reviewed by the Agency, you must provide the
Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-34, Certification with Respect to Citations of
Data (in PR Notice 98-51.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form (Insert A) and
the Requirements Status and Registrant's Response Form (Insert B), as appropriate.
III-D. REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will
be the only opportunity to state the reasons or provide information in support of your
request. If the Agency approves your waiver request, you will not be required to supply the
data pursuant to section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request,
you must choose an option for meeting the data requirements of this Notice within 30 days
of the receipt of the Agency's decision. You must indicate and submit the option chosen
on the Requirements Status and Registrant's Response Form. Product specific data
requirements for product chemistry, acute toxicity and efficacy (where appropriate) are
required for all products and the Agency would grant a waiver only under extraordinary
circumstances. You should also be aware that submitting a waiver request will not
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automatically extend the due date for the study in question. Waiver requests submitted
without adequate supporting rationale will be denied and the original due date will remain
in force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice
due to failure by a registrant to comply with the requirements of this Data Call-In Notice,
pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a
Notice of Intent to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint
data development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure
of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-In Response Formdnsert A) and a Requirements Status and
Registrant's Response Formdnsert B):
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b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required
time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend.
The grounds for suspension include, but are not limited to, failure to meet any of the
following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
to, those relating to test material, test procedures, selection of species, number of animals,
sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of
existing stocks of a pesticide product which has been suspended or canceled if doing so
would be consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks
for a suspended registration when a section 3(c)(2)(B) data request is outstanding would
generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates
granting registrants permission to sell, distribute, or use existing stocks of suspended
product(s) only in exceptional circumstances. If you believe such disposition of existing
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stocks of your product(s) which may be suspended for failure to comply with this Notice
should be permitted, you have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. You must also explain why an "existing
stocks" provision is necessary, including a statement of the quantity of existing stocks and
your estimate of the time required for their sale, distribution, and use. Unless you meet this
burden the Agency will not consider any request pertaining to the continued sale,
distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this
Notice and your product is in full compliance with all Agency requirements, you will have,
under most circumstances, one year from the date your 90 day response to this Notice is
due, to sell, distribute, or use existing stocks. Normally, the Agency will allow persons
other than the registrant such as independent distributors, retailers and end users to sell,
distribute or use such existing stocks until the stocks are exhausted. Any sale, distribution
or use of stocks of voluntarily canceled products containing an active ingredient for which
the Agency has particular risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period
required by this Notice will not result in the Agency granting any additional time to sell,
distribute, or use existing stocks beyond a year from the date the 90 day response was due
unless you demonstrate to the Agency that you are in full compliance with all Agency
requirements, including the requirements of this Notice. For example, if you decide to
voluntarily cancel your registration six months before a 3 year study is scheduled to be
submitted, all progress reports and other information necessary to establish that you have
been conducting the study in an acceptable and good faith manner must have been
submitted to the Agency, before EPA will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT
POSSIBLEUNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical
Status Sheet.
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All responses to this Notice (other than voluntary cancellation requests and generic
data exemption claims) must include a completed Data Call-In Response Form (Insert A)
and a completed Requirements Status and Registrant's Response Form (Insert B) for
product specific data) and any other documents required by this Notice, and should be
submitted to the contact person(s) identified in Attachment 1. If the voluntary cancellation
or generic data exemption option is chosen, only the Data Call-In Response Form (Insert
A) need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachments
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form (Insert A)
3 - Requirements Status and Registrant's Response Form (Insert B)
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
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CHLORINE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing chlorine .
This Product Specific Data Call-In Chemical Status Sheet contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregi strati on of chlorine.
This attachment is to be used in conjunction with (1) the Product Specific Data Call-In Notice, (2)
the Product Specific Data Call-In Response Form (Attachment 2), (3) the Requirements Status and
Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirement (Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), (6)
a list of registrants receiving this DCI (Attachment 6) and (7) the Cost Share and Data Compensation
Forms in replying to this chlorine Product Specific Data Call-In (Attachment 7). Instructions and
guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for chlorine are contained
in the Requirements Status and Registrant's Response. Attachment 3. The Agency has concluded that
additional data on chlorine are needed for specific products. These data are required to be submitted
to the Agency within the time frame listed. These data are needed to fully complete the reregistration
of all eligible chlorine products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of chlorine, please contact Patrick
Dobak at (703) 308-8074.
If you have any questions regarding the product specific data requirements and procedures
established by this Notice, please contact Wanda Mitchell at (703) 308-6345.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Wanda Mitchell,
Regulatory Management Branch
Antimicrobial Division 75IOC
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Chlorine; Case 4022
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the
Existing Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." If you are requesting
a data waiver, answer "yes" here; in addition, on the "Requirements Status and
Registrant's Response" form under Item 9, you must respond with Option 7 (Waiver
Request) for each study for which you are requesting a waiver. See Item 6 with
regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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DRAFT COPY
Page 1 of 1
United States Environmental Protection Agency Form Approved
Washington, D. C. 20460
J OMB Ho. 2070-0107
DATA CALL-IN RESPONSE 2070-0057
Approval Expires 03-31-99
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 S and Name 3. Date and Type of DCI
SAMPLE COMPANY 4022 Chlorine PRODUCT SPECIFIC
NO STREET ADDRESS
NO CITY, XX 00000
4. EPA Product
Registration
IMNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily.
6 . Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A,
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached forin entitled
"Requirements Status and
Registrant ' s Response . "
N.A.
7. Product Specific Data
7a. My product is a HUP and
I agree to satisfy the MOP
requirements on the attached
forfti entitled "Requirements
Status and Registrant ' s
Response . "
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response . "
8, Certification 9. Date
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
10. Name of Company Contact 11. Phone Number
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the requirements
specified in the Notice, govern the conduct of the required studies. Note that series
61 and 62 in product chemistry are now listed under 40 CFR 158.155 through
158.180, SubpartC.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to
show how you intend to comply with the data requirements listed in this table.
Fuller descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification with Respect to Citations of Data (in PR Notice 98-5)" form
(EPA Form 8570-34) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4)
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Notice that my product is similar enough to another
product to qualify for this option. I certify that another party in the agreement is
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committing to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension. By the specified due
date, I will also submit: (1) a completed "Certification with Respect to Citations
of Data (in PR Notice 98-5)" form (EPA Form 8570-34) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-In Notice that my
product is similar enough to another product to qualify for this option. I am
submitting evidence that I have made an offer to another registrant (who has an
obligation to submit data) to share in the cost of that data. I am also submitting a
completed "Certification of Attempt to Enter into an Agreement with other
Restraints for Development of Data " (EPA Form 8570-32) I am including a
copy of my offer and proof of the other registrant's receipt of that offer. I am
identifying the party which is committing to submit or provide the required data; if the
required study is not submitted on time, my product may be subject to suspension.
I understand that other terms under Option 3 in the Data Call-In Notice (Section III-
C.l.) apply as well. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-34) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4)
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Study). I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-In Notice (Section III-C.l.) and will meet the attached
acceptance criteria (for acute toxicity and product chemistry data). I will attach the
needed supporting information along with this response. I also certify that I have
determined that this study will fill the data requirement for which I have indicated this
choice. By the specified due date, I will also submit a completed "Certification
With Respect To Data Compensation Requirements" form (EPA Form 8570-34)
to show what data compensation option I have chosen. By the specified due date, I
will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-34) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this option
outlined Option 5 in the Data Call-In Notice (Section III-C. 1.) apply. By the specified
due date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-34) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
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6. By the specified due date, I will cite an existing study that the Agency has classified
as acceptable or an existing study that has been submitted but not reviewed by the
Agency (Citing an Existing Study). If I am citing another registrant's study, I
understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number(s) for the cited
data on a "Product Specific Data Report" form or in a similar format. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-34) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA
Form 8570-4)
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the format required by P.R. Notice
86-5]. I understand that this is my only opportunity to state the reasons or provide
information in support of my request. If the Agency approves my waiver request, I
will not be required to supply the data pursuant to Section 3(c)(2)(B) of FIFRA. If
the Agency denies my waiver request, I must choose a method of meeting the data
requirements of this Notice by the due date stated by this Notice. In this case, I must,
within 30 days of my receipt of the Agency's written decision, submit a revised
"Requirements Status and Registrant's Response" Form indicating the option chosen.
I also understand that the deadline for submission of data as specified by the original
data call-in notice will not change. By the specified due date, I will also submit: (1)
a completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-34) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4)
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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DRAFT COPY
Page 1 of
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Form Approved
OMB No, 2070-0107
2070-0057
Approval Expires 03-31-99
INSTRUCTIONS : Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet is) if necessary.
1 , Company name and Address 2 . Case # and Name 3 . Date and Type of DCI
SAMPLE COMPANY 4022 Chlorine PRODUCT SPECIFIC
NO STREET ADDRESS ID# NNNNNN-RD-NNNN
NO CITY, XX 00000 EPA Reg. No. NNNNNN-NNNNN
4 . Guide 1 ine
Requirement
Number
830.1550
830, .6:302 - /-."
830.6303
830.6304 : - '.'.
830.7300
830.6314
830.6315
830.6316
830.6317
830.6320
885.1100
5, Study Title
Prod Chera - Reqular Chenical
Product identity & composition (1)
Color ' ' ;..; : ,;-: :-.:'..: : ' '.. ''". : '''.' .'''''' ' '""
Physical state
'Odor'- '.: :: . ..:.:".....-.. .. ; v -: ;'-.:. ;
Density
Oxidation/reduction:- chemical .(ID)'-'.
incompat ability
Flammability (11) '
Explodability (12)
Storage stability .
Corrosion characteristics
Prod Chem - Microbial
Product identity
F
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Progress
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1
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AB CDEFGH I JKLMNO
7. Test
Substance
MP/EP
MP/EP:.and :TGAI:
MP/EP and TGAI
MP/EP. and TGAt
MP/EP and TGAI
MP/EP ;
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
8. Time
Frame
8 mos .
:8 .mos.
8 mos .
8 mos .
8 mos .
8 mos .
8 mos .
8 mos .
8 mos .
8 mos .
8 mos .
9, Registrant
Response
10. Certification 11. Date
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 Contact 13. Phone Number
-------
DRAFT COPY
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS : Please type or print in ink. Please read carefully
Use additional sheet (s) if necessary.
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4 . Guideline
Requirement
Number
88-5.1200. : ..-'..
885,1300
885.1400
885.-15QO ,'.'.'
5 . Study Title
the attached instructions and supply the information requested
2 . Case # and Name
4022 Chlorine
EPA Reg. No, NNNNNN-NNNNN
X Manufacfcttring process '. .'''. '.'"':W "':.'.'''.' '-.':
Discussion of formation of (2}
'.' unintentional' ingredients- . ...':.... ::.:;...... . -.
Analysis of samples (3)
. . Certification 'bf limits -.." ': '::: ::: :'.: . ; ';::; '.'; ':/'['' . :
0
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1
2
3
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ABCDE F.GHI JKLMNO
ABCDEFGHI JKLMNO
ABCDEFGHIJKLMNO
ABCDE FGH t JKLMNO
Initial to indicate certification as to information on this page
(full text of certification is on page one) .
Form Approved
OMB No. 2070-0107
2070-0057
Approval Expires -03-31-99
on this fortru
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
7 . Test
Substance
MP/EP :..' :
MP/EP
MP/EP
MP/EP'.;: : :.: .'
8 . Time
Frame
8' mos .'
8 mos .
8 mos .
' 8-;. mos...
9. Registrant
Response
Date
-------
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128
-------
EPA'S DECISION ON BATCHING PRODUCTS CONTAINING CHLORINE FOR
PURPOSES OF 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 reregi strati on of products containing the active ingredient chlorine the
Agency considered batching products. This process involves grouping similar products 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. Acute toxicity data on individual products has frequently been found to be
incomplete. 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 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 cited, the registrant must clearly identify the material tested by its 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 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.
129
-------
Table 1 below lists a single batch of the currently registered products containing 99.5 - 100%
chlorine as liquified gas.
Table 1: Chlorine Batch 1
148-707
168-372
266-35
335-178
464-99
550-177
748-31
813-10
935-8
1258-779
1744-10
1803-25
2686-3
2792-61
5382-38
6785-1
7870-2
8176-9
8996-6
9488-1
9768-21
10464-2
33458-1
33593-1
33981-2
34277-1
34910-2
35317-2
35934-1
37982-2
37982-34
41209-4
41211-3
43407-1
43843-3
45085-1
45851-1
45869-1
45880-1
46266-1
47075-1
48867-1
49256-1
49405-1
49720-1
49721-1
49723-1
49756-1
50221-1
50397-1
50400-1
50956-6
51551-1
52374-12
54135-1
56410-1
56652-1
57101-1
57135-1
57476-1
57966-1
58415-1
58618-1
58687-1
59301-2
59597-1
59732-1
61219-2
61602-1
61616-1
61667-1
63015-1
63802-1
64454-1
65560-1
65782-1
65862-1
66534-1
66760-1
67209-1
67544-1
67553-1
67624-1
67649-5
67714-1
67770-1
67799-1
67985-1
69413-1
70264-1
70529-1
70598-1
71207-1
71413-1
CA89005000
HI98000900
LA95000100
Since all currently registered products are batched together in Table 1, there is no table of
non-batched products.
130
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List of All Registrants Sent This Data Call-in Notice
Case f and Name
4022 Chlorine
Chemical 8 and Name
020501 Chlorine
Company Number Company Name
Additional Name
Address
City & State
Zip
000148
000158
000266
000335
000464
OOOS50
000748
000813
000935
001258
001744
001803
002686
002792
00S382
006785
007151
007870
008176
008996
009488
009768
010464
033458
033S93
033981
034277
034910
03S317
035934
037982
HAKCROS CHEMICALS INC.
GREAT WESTERN CHEMICAL COMPANY
HILL BROTHERS CHEMICAL CO.
ELF ATGCHEM N.A. INC
DOW CHEMICAL CO, THE
VAN WATERS & ROGERS, INC
PPO INDUSTRIES, INC
DPC INDUSTRIES, INC.
OCCIDENTAL CHEMICAL CORPORATION
OLIN CORP
TONES CHEMICALS, INC.
CONTINENTAL CHEMICAL COMPANY INC
HYDRITE CHEMICAL CO.
ELF ATOCHEM N.A. INC
VULCAN MATERIAL CO CHEMICAL DIVIS
P B & S CHEMICAL CO INC
ALEXANDER CHEMICAL CORP
HAWKINS CHEM INC
HVC
SURRA CHEMICAL CO
DELTA CHEMICAL CORPORATION
THATCHER CO
WBYERHAEUSER CO
ALLIED UNIVERSAL CORP.
MARZAHL CHEMICAL COMPANY
K A STEEL CHEMICALS INC
PRILLAMAN CHEMICAL CORPORATION
ULRICH CHEMICAL INC
KUEHNB CHEMICAL COMPANY, INC
B+B (US) ISC
ALL PURE CHEMICAL
ATTO: GREGORY BRADLEY
PRODUCT SAFETY
DECCO DIVISION
ATTH: FRED NICHOLS
CHEMICALS DIVISION
BOX 2930
808 S.W, 1STH AVB.
1675 N. MAIN STREET
2000 MARKET ST
2030 DOW CENTER
BOX 34325
ONE PPQ PLACE - 36 WEST
300 0ACKSON HILL
TECHNICAL CENTER, V-81 SOX 344
350 KNOTTER DR
100 SUNSY SOL BLVD. BOX 115
4660 SPRING GROVE AVENUE
300 N PATRICK BLVD
1713 S CALIFORNIA AVE
BOX 385015
BOX 20
BOX 1747
3100 E HBNNEPIN AVE
4600 DUES DR
2302 LARKIN CIRCLE
2601 CANNERY AVE
BOX 27407
BOX 188
8350 N.W. 93 STREET
HACKENSACK AVE & 3RD ST
15185 MAIN ST
201 SUBURBAN DRIVE BOX 1606
3111 NORTH POST ROAD
86 HACKENSACK AVS.
700 GALLERIA PKWY STE 350
2185 N. CALIFORNIA BLVD, SUITE 500
KANSAS CITY KS
PORTLAND OR
ORANGE CA
PHILADELPHIA PA
MIDLAND MI
SEATTLE WA
PITTSBURGH PA
HOUSTON TX
NIAGARA FALLS NY
CHESHIRE CT
CALEDONIA NY
CINCINNATI OH
BROORFIELD HI
MONROVIA CA
BIRMINGHAM AL
HENDERSON KY
LAPORTE IN
MINNEAPOLIS MN
CINCINNATI OH
SPARKS NV
BALTIMORE MD
SALT LAKE CITY OT
LONGVIEW WA
MIAMI PL
SO KEARNY SJ
LEMONT IL
SUFFOLK VA
INDIANAPOLIS IN
SOUTH KEARNY HJ
ATLANTA QA
WALNUT CRBEK CA
66110
97205
92667
19103
48674
98124
15272
77007
14302
06410
14423
45232
53045
91017
35253
42420
46352
55413
4S246
89431
21226
84127
98632
33166
07032
60439
23434
46226
07032
30339
94596
-------
List of All Registrants Sent This Data Call-In Notice
Case f and Name
4022 Chlorine
Chemical # and Name
020501 Chlorine
Company Number Company Name
Additional Name
Address
City & State
Zip
041209
041211
043407
043843
04S851
045869
045880
046266
047075
048867
049256
049405
049720
049731
049723
049756
050221
050397
OS0400
050956
OS1SS1
052374
OS413S
056410
056652
051101
OS7135
057476
057966
058415
058618
SOUTH TEXAS CHLORINE INC
DX VENTURES, LIMITED PARTNERSHIP
CALIFORNIA IHT'L CHEMICAL CO, INC
OREGON METALLURGICAL, COR?
POOL CHLOR OF NEVADA, INC.
SOUTH BAY POOL CHLOR
TRI-county POOL SERVICE INC.
BMD ENTERPRISES INC.
AQUA CLEAJR POOLS INC
AGRICULTURAL INSTALLATIONS INC
PURE WATER POOL SERVICE
J.C. & SONS INC
SCC CHEMICAL CORP
PROGRESSIVE HALOGENS INC
PENINSULA CHEMICAL CO
SACRAMENTO CHEMICAL CORP
PACIFIC CHEMICAL CO
METRO POOL CHEMICAL
S0NRAY POOL SERVICE CO
GEORGE DYCHCMA
A DIAMOND POOL INC
SUMMIT INDUSTRIES
SWIM CON POOL CO. INC.
RIVEROAKS CHEMICAL COMPANY
POOLMAS
RAINBOW POOL SERVICE & REPAIR
CLIARWATER CHEMICAL COMPANY INC.
CHEMPURA POOLS, LTD,
KING'S POOL WORLD, INC
NORTHEAST FLORIDA CHEMICAL CORP
SUN COAST POOL CHEMICAL
DBA DX SYSTEMS COMPANY
DBA CENTRAL VALLEY CHEMICAL
AGENT FOR: STERLING PULP CHSMCALS
DIVISION OP ADVANCE CHEMICAL DISTR
BOX 430
BOX 130410
3450-C REGIONAL PARKWAY
530 34TH AVENUE SW BOX 580
5560 PROCYON AVENUE
330 PH1LAN AVE
P.O. BOX 1068
4959 EAST DAKOTA AVE.
9100 INDEPENDENCE AVE
1310 SIMPSON MAY
13704 THERMAL DRIVE
4444 AUBURN BLVD
BOX 2021
BOX 442
110 EAST TWENTIETH AVE
BOX 27i081
4083 RAFFEE DR
BOX 92547
11919 RAIL DRIVE #2
68 SHIRLEY LN
1341 EAST RUTH AVI
5702 E, CHANNEL ROAD
2373 E. WASHINGTON BLVD.
714 HERSICK COURT
1444 N. 26TH AVE
4320 ARMOUR AVE
205 E. ARROW HWY. BOX 308
586 BENJAMIN'S HAY BOX 56
220 LOCUST STREET
BOX 24080
16880 GATOR RD SUITE 109
HARLINOEH TX
HOUSTON TX
SANTA ROSA CA
ALBANY OR
LAS VEGAS NV
SAN JOSE CA
SALIDA CA
FRESNO CA
CHATSMORTH CA
ESCONDIDO CA
AUSTIN TX
SACRAMENTO CA
REDLANDS CA
LODI CA
SAN MATED CA
SACRAMENTO CA
SAN DIEGO CA
SOUTHLAKE TX
SAN ANTONIO TX
NQRRISTOWN PA
PHOENIX AZ
CATOOSA OK
PASADENA CA
KATY TX
PHOENIX AZ
BAKERSFIELD CA
SAN DIMAS CA
LEHISVILLE TX
GADS DEN AL
JACKSONVILLE FL
FT. MEYERS FL
78551
77219
95403
97321
89118
95112
95368
93727
91311
92026
78728
95841
92373
95241
94403
95827
92117
76092
78233
19403
85020
74015
91104
774SO
85009
93308
91773
7S067
35901
32241
33912
-------
List of All Registrants Sent This Data Call-in Notice
Case # and Name
4022 Chlorine
Chemical tf and Name
020501 Chlorine
Company Number Company Hame
Additional Name
Address
City 6 State
Zip
058687
059301
059597
059732
061219
061602
061616
061661
063015
063 8 02
0644S4
065560
065782
065862
066534
066760
067209
067544
067S53
067624
067649
067770
067799
067985
069413
069798
070264
070529
070598
071207
071413
GEORGIA GULF CORPORATION
FRESHWATER POOL CHEMICAL SERVICE
NIACHLQR
NORTH BAY WATER SERVICES INC
HOLTRACHBM MANUFACTURING CO, L.L.C
LAROCHE INDUSTRIES IHC
CCC POOL SERVICES INC
PIONEER CHLOR ALKALI COMPANY, INC.
SPARKLE POOL SERVICE CO., INC.
MAGNESIUM CORPORATION OP AMERICA !
OCR POOL CHEMICAL COMPANY
MORTH CH1MICAL CORP
SPARKLE POOL SERVICE AND SUPPLY OP
BAY AREA POOLS AND SPAS IHC
KATO AMD HANKS INC
HAMILTON POOLS INC
VICKSBURG CHEMICAL CO
LAIRD'S REGULATORY CONSULTANTS, IN
BLUE BAYOU CHEMICALS INC
FLORIDA POOL CHEMICAL INC
RQWSLL CHEMICAL CORP
LONESTAR POOL CHEMICALS
SEACO TECHNOLOGIES, INC
BLUEWATER POOL CHEMICALS
DELTA ANALYTICAL CORP
LAIRD'S REGULATORY CONSULTANT'S IH
COASTAL PRODUCTS t CHEMICALS
CHEMICAL FORMUIATORS INC
GEORGIA PACIFIC BEST IHC
PCI CHEMICALS CANADA INC
DELTA ANALYTICAL CORP.
ATTN: DAMA OLIVER
DBA/FOOTHIIjL-ORANGE COAST CHEMICAL
DBA/POOL CARE
AGENT FOR: SPARKLE POOL SERVICE, L
AGB8T FORs CXY CHEMICALS CANADA LI
AGENT FOR: DALLAS/FT WORTH POOL CH
AGENT FORi PCI CHEMICALS CANADA IN
AGENT FORi CANADIAN MIRACL1AN PROD
HIGHWAY 405 BOX 629
BOX 2648
BUFFALO AVENUE & HYDE PARK BQUL1VA
6180 EGRET COURT, ONIT A
209 BEST CENTRAL'STREET, SUITE 104
BOX 5500
120-8 H. LAS POSAS ROAD
BOX 23
BOX 14205
238 N, 2200 W.
BOX 2751
BOX 20725
BOX 36443
501S WEST MATERS AVE
1269 S. SEVENTH STREET
305 I.H. 10 SOUTH
BOX 821003
501 S. LINCOLN AVENUE
2040 N CAUSEWAY 8LVD
12594 SW 128TH ST
15 SALT CREEK LN - STE 205
BOX 5126
BOX 60205
BOX 34961
7910 WOODMONT AVE - STS 1000
501 S LINCOLN AVE
1100 LOUISIANA - STE 3160
5215 WEST TYSON AVSHUB
900 S.M. FIFTH AVB
700 LOUISIANA - STE 4200
7910 WOODMONT AVE., SUITE 1000
PLAQUEMINE LA
RANCHO CORDOVA CA
NIAGARA FALLS NY
BENICIA CA
NATICK MA
GRAMERCY LA
SAN MARCOS CA
ST. GABRIEL LA
BATON ROUGE LA
SALT LAKE CITY DT
SPRING TX
GREENSBORO NC
INDIANAPOLIS IN
TAMPA PL
UPLAND CA
BEAUMONT TX
VICKSBUHG MS
STERLING VA
MANDEVILLE LA
MIAMI FL
HINSDALE XL
KATY TX
BAKBRSFIELD CA
SAN ANTONIO TX
BETHESDA MD
STERLING VA
HOUSTON TX
TAMPA FL
PORTLAND OR
HOUSTON TX
BETHESDA MD
7076S
95741
14302
94510
01760
70052
92069
70776
70898
84116
77383
27420
46236
33634
91786
77702
39182
20164
70448
33186
60521
77491
93380
78265
20814
20164
77002
33611
97204
77002
20814
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Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO I/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
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 hard copy 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 Information'
or 'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551
or by e-mail atwilliams.nicole@epamail.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 Restraints for
Development of Data
Certification with Respect to Citations of Data
(in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties
(in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice
98-1)
http://www.epa.gov/opprd001/forms/8570-l.pdf.
http://www.epa.gov/opprd001/forms/8570-4.pdf.
http://www.epa.gov/opprd001/forms/8570-5.pdf.
http://www.epa. gov/opprdOO l/forms/8570- 1 7.pdf.
http://www.epa.gov/opprd001/forms/8570-25.pdf.
http://www.epa.gov/opprd001/forms/8570-27.pdf.
http://www.epa.gov/opprd001/forms/8570-28.pdf.
http://www.epa.gov/opprd001/forms/8570-30.pdf.
http://www.epa.gov/opprd001/forms/8570-32.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf.
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Pesticide Registration Kit www.epa.gov/pesticides/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 ProgramStorage 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 in PDF format and will require the
Acrobat reader.)
a. Registration Division Personnel Contact List
Biopesticides and Pollution Prevention Division (BPPD) Contacts
Antimicrobials Division Organizational Structure/Contact List
c. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF
format)
d. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
e. 40 CFR Part 158, Data Requirements for Registration (PDF format)
f. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional sources
of information.
These include:
1. The Office of Pesticide Programs' Web Site
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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)
the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 487-4650. Please note that EPA is currently in the
process of updating this booklet to reflect the changes in the registration program resulting from the
passage of the FQPA and the reorganization of the Office of Pesticide Programs. We anticipate that this
publication will become available during the Fall of 1998.
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 Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide information on active
ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone
at 1-800-858-7378 or through their Web site.
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
the 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 CAS number
if one has been assigned.
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Documents Associated with this RED
The following documents are part of the Administrative Record for this RED document and may
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not
available electronically, but may be obtained by contacting the person listed on the respective Chemical
Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
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