US Environmental Protection Agency
Office of Pesticide Programs
Reregistration Eligibility Decision for
Formaldehyde and Paraformaldehyde
June 2008
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United States Prevention, Pesticides EPA 739-R-08-004
Environmental Protection and Toxic Substances June 2008
(7510P)
Reregistration Eligibility Decision for
Formaldehyde and Paraformaldehyde
(Case 0556)
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments
received related to the preliminary risk assessments for the antimicrobial formaldehyde and
paraformaldehyde. The enclosed Reregi strati on Eligibility Decision (RED) document was
approved on June 30, 2008.
Based on its review, EPA is now publishing its Reregi strati on Eligibility Decision (RED)
and risk management decision for formaldehyde and paraformaldehyde and their associated
human health and environmental risks. A Notice of Availability will be published in the Federal
Register announcing the publication of the RED.
The RED and supporting risk assessments for formaldehyde and paraformaldehyde are
available to the public on EPA's Pesticide Docket at: www.regulations.gov. The docket number
is EPA-HQ-OPP-2008-0121.
The formaldehyde and paraformaldehyde RED was developed through EPA's public
participation process, published in the Federal Register on September 10, 2004, which provides
opportunities for public involvement in the Agency's pesticide tolerance reassessment and
reregi strati on programs. Developed in partnership with USDA and with input from EPA's
advisory committees and others, the public participation process encourages robust public
involvement starting early and continuing throughout the pesticide risk assessment and risk
mitigation decision making process. The public participation process encompasses full,
modified, and streamlined versions that enable the Agency to tailor the level of review to the
level of refinement of the risk assessments, as well as to the amount of use, risk, public concern,
and complexity associated with each pesticide. Using the public participation process, EPA is
attaining its strong commitment to both involve the public and meet statutory deadlines.
Please note that the formaldehyde and paraformaldehyde risk assessment and the attached
RED document concern only these particular pesticides. This RED presents the Agency's
conclusions on the dietary, drinking water, occupational, residential and ecological risks posed
by exposure to formaldehyde and paraformaldehyde alone. This document also identifies both
generic and product-specific data that the Agency intends to require in Data Call-Ins (DCIs).
Note that DCIs, with all pertinent instructions, will be sent to registrants at a later date.
Additionally, for product-specific DCIs, the first set of required responses will be due 90 days
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from the receipt of the DCI letter. The second set of required responses will be due eight months
from the receipt of the DCI letter.
As part of the RED, the Agency has determined that formaldehyde and paraformaldehyde
will be eligible for reregistration provided that all the conditions identified in this document are
satisfied. Sections IV and V of this RED document describe the necessary labeling amendments
for end-use products and data requirements. Instructions for registrants on submitting the revised
labeling can be found in the set of instructions for product-specific data that will accompany the
DCI.
If you have questions on this document or the label changes relevant to this reregistration
decision, please contact the Chemical Review Manager, ShaRon Carlisle, at (703) 308-6427.
For questions about product reregistration and/or the Product DCI that will follow this document,
please contact Marshall Swindell at (703) 308-6341.
". Sanders
Director, Antimicrobials Division
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REREGISTRATION ELIGIBILITY
DECISION
for
Formaldehyde and Paraformaldehyde
Case 0556
Approved
T. Sanders
Director, Antimicrobials Division
June 30, 2008
Attachment
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Table of Contents
Formaldehyde and Paraformaldehyde Reregistration Team i
Glossary of Terms and Abbreviations ii
Abstract iv
I. Introduction 1
II. Chemical Overview
A. Regulatory History 3
B. Chemical Identification 3
C. Use Profile 6
III. Summary of Formaldehyde and Paraformaldehyde Risk Assessments
A. Human Health Risk Assessment 10
1. Toxicity of Formaldehyde and Paraformaldehyde 10
a. Acute Toxicity 10
b. Toxicological Endpoints 11
c. Carcinogenicity 14
2. FQPA Safety Factor 16
3. Dietary and Drinking Water Risk 16
4. Residential Exposure and Risk 16
a. Formaldehyde Residential Handler Risk 17
b. Formaldehyde Residential Post application Risk 18
c. Paraformaldehyde Residential Handler Risk 19
d. Paraformaldehyde Post Application Residential Risk ... 19
5. Aggregate Risk 19
6. Occupational Exposure and Risk 19
a. Occupational Handler Exposure and Risk 19
b. Occupational Post-Application Exposure and Risk 20
7. Human Incident Data 20
B. Environmental Risk Assessment 22
1. Environmental Fate and Transport 22
2. Ecological Hazard 23
3. Risk to Listed Species 23
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility 25
B. Public Comments and Responses 25
C. Regulatory Rationale 26
1. Human Health Risk Management 26
a. Residential Risk Mitigation for Formaldehyde 26
b. Occupational Risk Mitigation for Formaldehyde 26
c. Occupational and Residential Risk Mitigation for 27
Paraformaldehyde
2. Other Labeling Requirements 27
V. What Registrants Need to Do 28
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A. Manufacturing-Use Products 30
1. Additional Generic Data Requirements 30
2. Labeling for Technical and Manufacturing-Use Products 30
B. End-Use Products 30
1. Additional Product-Specific Data Requirements 30
2. Labeling for End-Use Products 30
a. Label Changes Summary Table 31
VI. Appendices 35
A. Table of Use Patterns Formaldehyde 36
A.I Table of Use Patterns ParaFormaldehyde 42
B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision 44
C. Technical Support Documents 48
D. Bibliography Citations 50
E. Generic Data Call-In 70
F. Product Specific Data Call-In 71
G. Batching of End-Use Products 72
H. List of All Registrants Sent the Data Call-In 73
I. List of Available Forms 74
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Formaldehyde and Paraformaldehyde Reregistration Team
Health Effects Risk Assessment
Timothy F. McMahon
Jonathan Chen
Srivivas Gowda
A. Najm Shamim
Timothy C. Dole
Timothy Leighton
Ecological Risk Assessment
Richard C. Petrie
Environmental Fate Risk Assessment
A. Najm Shamim
Registration Support
Marshall Swindell
Risk Management
ShaRon Carlisle
Diane Isbell
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
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
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected to cause
death in 50% of test animals, usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
ii
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MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
PDF USDA Pesticide Data Program
PF10 Protections factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Pre-harvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RPM Reasonable and Prudent Measures
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24C of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WP S Worker Protection Standard
ill
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Abstract
The Environmental Protection Agency (EPA or the Agency) has completed the human
health and environmental risk assessments for formaldehyde and paraformaldehyde and is
issuing its risk management decision. The risk assessments, which are summarized below, are
based on the review of the required target database supporting the use patterns of currently
registered products and additional information received through the public docket. After
considering the risks identified in the revised risk assessments, comments received, and
mitigation suggestions from interested parties, the Agency developed its risk management
decision for uses of formaldehyde and paraformaldehyde that pose risks of concern. As a result
of this review, EPA has determined that formaldehyde and paraformaldehyde containing
products are eligible for reregi strati on, provided that risk mitigation measures are adopted and
labels are amended accordingly. That decision is discussed fully in this document.
IV
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
in 1988 to accelerate the reregi strati on of products with active ingredients registered prior
to November 1, 1984 and amended again by the Pesticide Registration Improvement Act
of 2003 to set time frames for the issuance of Reregi strati on Eligibility Decisions. The
amended Act calls for the development and submission of data to support the
reregi strati on of an active ingredient, as well as a review of all submitted data by the U.S.
Environmental Protection Agency (EPA or the Agency). Reregi strati on involves a
thorough review of the scientific database 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 or not the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.
This document presents the Agency's revised human health and ecological risk
assessments and the Reregi strati on Eligibility Decision (RED) for formaldehyde and
paraformaldehyde. The formaldehyde and paraformaldehyde case consists of one PC
code each: 043001 (formaldehyde), 043002 (paraformaldehyde). The first product
containing formaldehyde was registered in 1967.
Formaldehyde as an antimicrobial pesticide is used as a fumigant in agricultural
premises such as poultry and swine farms and processing plants as well as in citrus and
mushroom houses. It is also used as a hard surface disinfectant in commercial premises,
industrial premises and veterinary clinics. Formaldehyde containing products are also
used in oil drilling wells for preservation of processing waters. Formaldehyde is also
registered as a materials preservative for consumer products such as laundry detergents,
general purpose cleaners and wall paper adhesives. Paraformaldehyde is used for in-
drawer fumigation of hair cutting equipment and as a mildewcide in closets and
unoccupied vacation homes. The currently registered formaldehyde products are
formulated as liquid concentrates or liquid ready to use solutions with formaldehyde
concentrations that range from 2.28% to 54%. The paraformaldehyde products are
formulated as solids with paraformaldehyde concentrations of 62.3% and 91%.This
suggests there are only 2 formulations. Just want to ensure this is not a range.
The Agency has determined that analysis of the potential need for a special
hazard-based safety factor under the FQPA is not needed at this time. The Agency does
not anticipate dietary or drinking water exposures based on the registered use patterns
and there are no tolerances or tolerance exemptions for the use of formaldehyde and
paraformaldehyde as an active ingredient. Therefore, a FQPA hazard analysis is not
necessary at this time.
This document presents the Agency's decision regarding the reregi strati on
eligibility of the registered uses of formaldehyde and paraformaldehyde. In an effort to
simplify the RED, the information presented herein is summarized from more detailed
information which can be found in the technical supporting documents for formaldehyde
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and paraformaldehyde referenced in this RED. The revised risk assessments and related
addenda are not included in this document, but are available in the Public Docket at
www.regulations.gov (Docket ID #EPA-HQ-OPP-2008-0121).
This document consists of six sections. Section I is the Introduction. Section II
provides a chemical overview, a profile of the use and usage of formaldehyde and
paraformaldehyde and its regulatory history. Section III, Summary of Formaldehyde and
Paraformaldehyde Risk Assessments, gives an overview of the human health and
environmental assessments, based on the data available to the Agency. Section IV, Risk
Management and Reregi strati on, presents the reregi strati on eligibility and risk
management decisions. Section V, What Registrants Need to Do, summarizes the
necessary label changes based on the risk mitigation measures outlined in Section IV.
Finally, the Appendices list all use patterns eligible for reregi strati on, bibliographic
information, related documents and how to access them, and Data Call-In (DCI)
information.
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II. Chemical Overview
A. Regulatory History
Formaldehyde
The first product containing formaldehyde was registered in the United States on
January 25, 1967, for use as a fumigant. Currently there are 6 active products under PC Code
043001. There are no inert ingredient uses for this chemical. Formaldehyde is used primarily
as a fumigant in agricultural premises such as poultry and swine farms and processing plants
as well as in citrus packing and mushroom houses. It is used as a hard surface disinfectant in
commercial premises, industrial premises and veterinary clinics. Formaldehyde is also
registered as a materials preservative for consumer products such as laundry detergents,
general purpose cleaners and wall paper adhesives.
Paraformaldehyde
Paraformaldehyde is a white crystalline solid formed by polymerization of
formaldehyde. In 1964, paraformaldehyde was registered as a sanitizer and fungicide for use
on barber and beauty shop equipment. Currently there are 2 active products under PC Code
043002. Steri-DriFumigant (Registration #397-6) is used as bacteriostat, fungicide, and
sanitizer in hair/beauty salons and barber shops, and Sun Pac(Registration #4972-43) is used
primarily as mildewcide in closets and unoccupied vacation homes. There are no inert
ingredient uses for this chemical. EPA issued a Registration Standard for paraformaldehyde
in May 31, 1988.
B. Chemical Identification
Formaldehyde Molecular Structures:
O
Figure 1. Formaldehyde (Gas)
QH
i
-OH
Figure 2. Formaldehyde (In Water)
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Common Name:
Chemical Name:
Formaldehyde (Gas)
Aqueous Formaldehyde solution (in water)
Formaldehyde (Gas)
Formaldehyde monohydrate (Aqueous solution)
Other Names:
OPP Chemical Codes:
CAS Registry No.:
Case Number:
Empirical Formula:
Molecular Weight:
Manufacturers:
Highest Percent of
Active Ingredient:
Formaldehyde
Formalin
043001
50-00-0
0556
CH O (Gas or anhydrous form)
H C(OH) or C H O (Formaldehyde
monohydrate)
30.03 (Gas)
48.03 (Aqueous solution)
Champion Technologies,
Hess & Clark, Inc.,
Baker Petrolite Corporation,
54%
Formulation Types Registered:
Technical Grade (TGAI):
Manufacturing Use Products (MP):
End Use Products (EP):
None.
Soluble Concentrate
Soluble Concentrate, ready to use solution
Chemical Properties:
Formaldehyde gas is colorless with a pungent, suffocating
odor; it is readily soluble in water. It has a boiling point
of-19.5°C, melting point of-92°C, a density of 0.815 g/mL
at 20°C with a vapor pressure of 3,890 mm Hg @ 25°C.
Formaldehyde is gas at room temperature and, therefore,
has no pH. Formaldehyde gas is unstable and can
polymerize quite easily. It is corrosive to metals and has a
flashpoint of 60°C.
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Commercially formaldehyde is sold as formalin, a 37% to
55% by weight aqueous solution in water, usually with
0.5% to 15% methyl alcohol added to prevent
polymerization to a solid crystalline form. In water, it
exists as formaldehyde monohydrate and its chemical
formula is H C(OH)
2 V J2.
A 37% Formaldehyde solution is a colorless liquid with a
pungent odor. It is 100% miscible in water and has a
boiling point of 101°C. It has a density of 8.75 Ibs/gal and
sp gr. of 1.08 at 20°C. It is soluble in organic solvents such
as ether, alcohol, acetone and benzene. It has a vapor
pressure of 1.3 mm Hg at 68°F, and 67- 88 mm Hg at 98°F.
Paraformaldehyde Molecular Structures:
-co-
Figure 1. Paraformaldehyde
HLJ LJj LJ
ji riQ r~1.o
^o"" ""o'" ^o^ ^o
Paraformaldehyde
Figure 2. Paraformaldehyde
Common Name:
Chemical Name:
OPP Chemical Codes:
CAS Registry No.:
Case Number:
Paraformaldehyde
Paraformaldehyde
043002
30525-89-4
0556
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Empirical Formula: HO(CH O) H (n = 6 - 100 )
2 n
Molecular Weight: (30.03)n g/mole
Manufacturers: Protexall Products Inc
Noble Pine Products Co.,
Highest Percent of
Active Ingredient: 95%
Formulation Types Registered:
Technical Grade (TGAI): None
Manufacturing Use Products (MP): None
End Use Products (EP): Crystalline
Chemical Properties: Paraformaldehyde is a white crystalline solid with an irritating
odor. It is the polymerized form of formaldehyde. It has a
melting point of 120 to 170°C, density of 1.46 g/ml at 15°C,
bulk density of 750 to 850 kg/m3, and sp gr. of 1.4. Solubility
in water is partial and is dependent on pH, temperature and
molecular weight. It is insoluble in most organic solvents and
very soluble in dilute alkali and acids. It has a vapor pressure
of 1.45 mm Hg at 25°C and 1 mm Hg at 30°C. It has a pH of
3.5-4.5 and is moderately corrosive
C. Use Profile
The following information is a description of the currently registered uses of
formaldehyde and paraformaldehyde products, and an overview of use sites and
application methods. A detailed table of the uses for formaldehyde and paraformaldehyde
that are eligible for reregi strati on can be found in Appendix A.
Formaldehyde
Type of Pesticide: Disinfectant (Bactedocide/ Germicide), Sanitizer, Microbicide/
Microbistat, Fungicide
Use Sites:
Agricultural premises and equipment
Chicken and Turkey farms
Swine operations
Dairy farms
Cattle farms
Veal farms
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Emu and ostrich farms
Federally inspected meat and poultry establishments except where meat and food
products are handled.
Poultry and swine premises and confinement areas
Hatching egg washing/fumigating treatment
Citrus packing houses
Iris and daffodil bulbs in bulb farms
Mushroom houses, equipment and premises
Commercial, institutional and industrial premises and equipment
Hard non-porous surfaces
Rooms and Railway cars
Residential and public access premises
Zoos
Veterinary clinics, kennels
Pet shops
Industrial processes and water systems
Oil recovery injection water systems
Drilling muds, work over fluids and water based packer fluids
Formulation Types: soluble concentrate and ready to use
Methods and Rates of Application:
A summary of the formaldehyde registered uses is given in Table 1 and a more
detailed listing is included in Appendix A. Formaldehyde application sites include
agricultural premises and equipment, railroad car fumigation and oil production.
Formaldehyde is also registered as an in can preservative for use in consumer products.
Formaldehyde is not registered for use in paints.
Table 1: Formaldehyde Use Site and Application Rates
In Container Preservative
Poultry and Livestock Bldgs
and Equipment. Vet Clinics
and Kennels
Poultry and swine premises
and confinement areas
Egg Hatcher/Incubator
8133-32
134-65
8133-32
8133-32
Use range = 0. 1 to 1000 ppm in final
product.
Spray all surfaces to saturation using 1-3 oz
product/gallon.
Wet mist using an automatic wet fogger and
1 Vi - 2 !/2 oz product/gallon.
Use 20-60 oz. product/1000 ft3.
Sprinkler application: Use a 1 : 1 1 dilution
Spray Sled: Use a 1 :4 dilution
Use a maximum of 1 fl. oz./30 ft3. Place in
an open container and allow to evaporate.
After the 19th day of incubation, use Vz fl.
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Use Site
Citrus packing houses
Mushroom houses, equipment
and premises
Rooms and Railway cars
Oil recovery injection water
systems
Drilling muds, work over
fluids and water based packer
fluids
Label #
8133-32
8133-32
8133-32
8133-28
10707-43
Application Rates and Instructions
oz/30ff.
Use 16 fl. oz product/ 1000 ft ' Apply using a
stationary mounted spray manifold and
suitable air operated foggers. Premises may
be treated up to twice a year.
Non Producing areas: Inj ect solution into
steam (1 gallon per 5,500 - 6650 ft3)
For each 1000 ft3, use 16 2/3 oz potassium
permanganate and 20 oz of product.
Inject 25-5000 ppm active ingredient for
continuous treatment or slug application.
Inject 100-500 ppm active ingredient for
continuous treatment or slug application
Paraformaldehyde
Type of Pesticide: Disinfectant, bacteriocide, algaecide, fungicide
Use Sites:
Residential and Public Access Premises
Bathroom premises (cabinets, drawers and closets)
Kitchen premises (cabinets, drawers and closets)
Human bedding
Barber shops and beauty salons (cabinets and drawers)
Formulation Types: crystalline
Methods and Rates of Application:
A summary of the paraformaldehyde registered uses is given in Table 2 and a more
detailed listing is included in Appendix A.
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Table 2: Paraformaldehyde Use Site and Application Rates
Closets
(Clothing and
Linen)
Vacation Homes
Hair/Beauty
Salons and Barber
Shops
4972-43
4972-43
397-6
Hang cloth bag in closet or lay on shelf or in drawer.
Contents of this bag will treat up to 700 cubic feet.
For musty odor in bedding, place one bag Sun Pac along
with mattress, quilts, blankets, sheets in sealed closet space
no greater than 100 cubic feet. Leave articles 24 hours.
When closing home for vacation or season, place one bag
Sun Pac for each 700 cubic feet of space. Use only in
unoccupied rooms. Rooms must be ventilated thoroughly
before reentry.
Remove cap, place Steri-dri in sanitizer cabinets, implement
drawers, roller trays, student implement kits, covers or doors
which are to be kept tightly closed.
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III. Summary of Formaldehyde and Paraformaldehyde Risk Assessments
The purpose of this summary is to assist the reader by identifying the key features
and findings of these risk assessments and to help the reader better understand the
conclusions reached in the assessments. The human health and ecological risk
assessment documents and supporting information listed in Appendix C were used to
formulate the safety finding and regulatory decision for formaldehyde and
paraformaldehyde. While the risk assessments and related addenda are not included in
this document, they are available from the Federal Government Public Docket at
www.regulations.gov. The docket identification number is EPA-HQ-OPP-2008-0121.
Hard copies of these documents may be found in the OPP public docket which is located
in Room S-4400, One Potomac Yard, 2777 South Crystal Drive, Arlington, VA, and is
open Monday through Friday, excluding Federal holidays, from 8:30 a.m.to 4:00 p.m.
The Agency's use of human studies in the formaldehyde and paraformaldehyde
risk assessment is in accordance with the Agency's Final Rule promulgated on January
26, 2006, related to Protections for Subjects in Human Research, which is codified in 40
CFR Part 26.
A. Human Health Risk Assessment
1. Toxicity of Formaldehyde and Paraformaldehyde
A brief overview of the toxicity studies used for determining endpoints in the risk
assessments are outlined below in Table 3. Further details on the toxicity of
formaldehyde and paraformaldehyde can be found in the Formaldehyde: Toxicology
Disciplinary Chapter for the Reregistration Eligibility Decision (RED) Document, dated
3/31/2008; and Formaldehyde: Risk Assessments for the Reregistration Eligibility
Decision (RED) Document, dated 4/7/2008. These documents are available on the U.S.
Federal Government Public Docket website at www.regolations.gov (Docket ID #EPA-
HQ-OPP-2008-0121).
The Agency has reviewed all toxicity studies submitted to support guideline
requirements for formaldehyde and paraformaldehyde and determined that the
toxicological database is sufficient for reregi strati on. Major features of the toxicology
profile are presented below.
a. Acute Toxicity
The acute toxicity database for formaldehyde is considered complete. Technical
grade formaldehyde (37% a.i.) has a moderate order of acute toxicity in experimental
animals via the oral and dermal routes (Toxicity Categories II and III). Inhalation toxicity
studies on formaldehyde are extensive and include both acute exposures and longer term
exposures. Toxicity from acute exposures is characterized by pathology of the respiratory
epithelium and has been observed in rats exposed for 4 hours to a concentration of 10
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ppm (Bhalla, 1991), while longer term exposures of rats (3 ppm for 6 hours/day for 5
days) also results in respiratory tract lesions (Buckley et al., 1984). Table 3 gives a
summary of the acute toxicity data.
870.1100
(§81-1)
870.1200
(§81-2)
870.1200
(§81-2)
870.1200
(§81-2)
870.1300
(§81-3)
870.2400
(§81-4)
870.2500
(§81-5)
870.2600
(§81-6)
Acute Oral - Guinea Pig
Purity 37.3% - Formaldehyde
Acute Dermal - Rat
Purity 37.3% - Formaldehyde
Acute Dermal - Rabbit
Purity 37.3% - Formaldehyde
Acute Dermal - Dog
Purity 37.3% - Formaldehyde
Acute Inhalation - Mouse and Rat
Primary Eye Irritation -
Purity 37.3% - Formaldehyde
Primary Dermal Irritation
Purity 37.3% - Formaldehyde
Dermal Sensitization - Guinea pigs
Purity 40.0% - Formaldehyde
00058054
00058054
00058054
00058054
LD50 = 260 mg/kg
LD50 = 300 mg/kg
LD50 = 240 mg/kg
LD50 = 550 mg/kg
II
II
II
II
See Open Literature studies in Toxicity Profile for
Formaldehyde
00058054
00058054
40161103
Severe eye irritant
Formation of vesicles
with superficial necrosis
or nodules.
Extreme Sensitizer
I
I
NA
b. Toxicological Endpoints
On June 12, 2008, members of the Antimicrobials Division's Toxicity
endpoint Selection Committee (ADTC) met to discuss the non-cancer inhalation toxicity
endpoint for formaldehyde that had been previously selected by the committee for use in
conducting inhalation toxicity risk assessments for the formaldehyde reregi strati on
eligibility decision (RED) document.
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The original endpoint of 100 ppb was selected from the published report of
Horvath et. al., [JAMA 259, no. 5: 701-707, 1988], who reported nasal and respiratory
effects in 109 workers occupationally exposed to formaldehyde. The value of 100 ppb
was selected as a NOAEL for use in occupational risk assessments, while for the general
population; a value of 10 ppb was selected. This value was derived by application of a
10-fold uncertainty factor to the NOAEL value of 100 ppb to account for intraspecies
variation in response in accordance with Agency policy.
During the public comment phase of the formaldehyde risk assessment, the
Formaldehyde Council responded to the selection of the 100 ppb endpoint. They stated
that the Agency should consider the results of a 2007 publication by Noisel et al.
(Regulatory Toxicology and Pharmacology 48: 118-127), which reviewed some of the
available scientific literature. This study, in the Council's opinion, "is based on human
exposure rather than controlled human chamber studies and can be used for deriving a
No-Observed-Adverse-Effect-Level (NOAEL) for the non-cancer endpoint for
formaldehyde."
The ADTC noted both observational human exposure data as well as data
compiled from exposure of human subjects under controlled conditions in the Noisel et.
al., publication. Notwithstanding the need for intentional exposure data to be presented
to the Agency's Human Studies Review Board, the ADTC noted that irritant effects of
formaldehyde have been reported in other studies below the 0.75 ppm concentration
recommended by Noisel et. al., as a safe level. Further, this recommendation is for
worker populations only.
The irritant effects of formaldehyde, including both eye and nasal irritation as
well as respiratory symptoms (irritation, changes in pulmonary function), can be
considered from a toxicological perspective to be composed of both physiological and
adverse responses. Based on the available data, the ADTC was not compelled to select a
value higher than that already proposed. With respect to the 10-fold uncertainty factor
used for risk assessment to the general population, the ADTC concluded that a reduction
in this factor is not warranted at this time. Contrary to the Formaldehyde Council's
statement that "the nature of the health effect does not suggest that there are particularly
susceptible subpopulations which would warrant application of the lOx intraspecies UF,"
the 1999 ATSDR Toxicological Review of formaldehyde (ATSDR, 1999) noted two
studies "...providing suggestive evidence that children may be more sensitive to the
irritant effects of formaldehyde." These studies were not intentional exposure studies. It
is also noted in the ATSDR review that "additional research is necessary to confirm or
discard the hypothesis that children may be more susceptible than adults to the irritant
effects of formaldehyde..."
The ADTC concluded that, based on the available data, it is appropriate to remain
with the NOAEL value selected from the 1988 Horvath et. al., publication and with the
10-fold uncertainty factor for risk assessments to the general population. The ADTC is
also aware, however, of ongoing efforts by ORD/NCEA to develop an inhalation
reference concentration, or RfC for formaldehyde. OPP will continue to coordinate its
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efforts with ORD and other program offices to refine the non-cancer inhalation
assessment as necessary. The toxicological endpoints selected for various exposure
scenarios are summarized below in Table 4.
Table 4. Toxicology Endpoint Selection for Formaldehyde
Exposure
Scenario
Dose Used in Risk Target MOE, UF,
Assessment Special FQPA SF*
(mg/kg/day) for Risk Assessment
Study and Toxicological
Effects
Dietary Risk Assessments
Acute Dietary
(general
population
including infants
and children)
Chronic Dietary
(all populations)
An acute dietary assessment is not needed for the registered antimicrobial uses of
formaldehyde.
A chronic dietary assessment is not needed for the registered antimicrobial uses of
formaldehyde.
Non-Dietary Risk Assessments
Incidental Oral
Dermal (all
durations)
Inhalation
(all durations)
Cancer
An incidental oral risk assessment is not required for the registered antimicrobial uses of
formaldehyde.
A dermal risk assessment is not required for the registered antimicrobial uses of
formaldehyde.
NOAEL (human) =
0.1 ppm
Occupational UF = 1
Residential UF = 10 (lOx
intraspecies)
ACGIH 2001 publication on
formaldehyde
Horvath, E.P. et. al., (1986):
JAMA 259(5): 701-707. Based on
complaints of eye, nose, and throat
irritation in particle board workers
at concentrations of formaldehyde
from 0.4 - 1.0 ppm.
Redden, J. (2005): Section 18
Emergency Exemption for the use
of Paraformaldehyde: U.S. Army
Medical Research Institute of
Infectious Diseases.
Formaldehyde is currently classified as a Bl (probable human carcinogen) in EPA's IRIS
assessment. IARC has classified formaldehyde as "carcinogenic to humans." The Agency
has decided to present the formaldehyde cancer risks for the pesticidal uses using both the
existing 1991 IRIS cancer unit risk of 1 .3 E-5 per ((ig/m3) and the CUT BBDR model until
any new cancer estimates are fully peer reviewed.
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c. Carcinogenicity
The Agency is currently reevaluating the carcinogenic potential of formaldehyde.
The historical and ongoing development of an inhalation unit risk value to assess the
carcinogenic potential of formaldehyde is briefly summarized below. Contributors to this
summary included scientists from several EPA program offices (Office of Pesticide
Programs [OPP], Office of Pollution, Prevention, and Toxics [OPPT], Office of Research
and Development /National Center for Environmental Assessment [ORD/NCEA], Office
of Research and Development/National Health Effects Exposure Research Laboratory
[ORD/NHEERL], and Office of Air and Radiation [OAR]).
In 1991 IRIS published a weight-of-evidence characterization for carcinogenicity
of formaldehyde, classifying formaldehyde as a Bl probable human carcinogen
with a potency factor of 1.3 E-5 per (ug/m3)) on the basis of squamous cell nasal
tumors observed in a two-year study in rats (Kerns et al., 1983).
In 1999 the Chemical Industry Institute of Toxicology (CUT) developed a health
risk assessment for formaldehyde based upon the animal toxicology data (CUT,
1999). This document presented the dose-response modeling of these data in two
distinct parts: 1) based upon a biologically-based dose response (BBDR) model,
and 2) benchmark dose models that were based upon point of departures at
various response levels of the tumor and precursor data. Both these approaches
made extensive use of the available time-to-tumor and mechanistic information.
The 1999 assessment was subsequently published in various articles in peer-
reviewed journals (2001, 2002, 2003, and 2004).
In 1999, the U.S. EPA's Office of Air and Radiation and Office of Research and
Development, in conjunction with Health Canada, conducted an external peer
review workshop for the CUT BDDR model as well as an external written peer
review and public comment period for their assessments. While the review was
largely positive on the overall approach in the assessment, reviewers also pointed
to the potential for significant uncertainty due to model mis-specification and
uncertainties in key parameters involved in the BBDR model.
Based on the peer review of the CUT model, OAR determined in 2004 that the
CUT model was the most appropriate tool for risk assessment for formaldehyde.
OAR has subsequently used the formaldehyde cancer potency derived using the
CUT model for a number of risk assessments involving formaldehyde emissions
to the atmosphere such as the Plywood and Composite Wood Products National
Emission Standard for Hazardous Air Pollutants (final rule 2004, reconsidered
final rule 2006, remanded to EPA by court 2007); Control of Hazardous Air
Pollutants from Mobile Sources (Final Rule 2007); and Proposed Rule for
National Emission Standard for Combustion Turbines (2004). Health Canada,
Australia, the World Health Organization, and the German Maximale
Arbeitsplatzkonzentrationen (MAK) Commission have also used the CUT model.
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Model strengths include consideration of the mode of action data for
formaldehyde and a conservative approach to account for potential direct DNA
interaction and mutation induction. Model uncertainties include variability for
some of the parameters of the model (e.g., cell proliferation) which can affect
predictions of risk (Subramanian et. al., 2007; 2008 [in press]).
In 2004, NCEA convened a panel of experts, including scientists from CUT, to
provide advice on these and other critical biological and statistical uncertainties.
The strength of the CUT model is its consideration of mode of action and
extensive mechanistic information.
Although current OAR assessments still use the CUT model, these assessments
now acknowledge previously unknown uncertainties with the CUT model when
characterizing the risk results.
In 2004, the International Agency for Research on Cancer (IARC) characterized
formaldehyde as a human carcinogen based on their review of the current
literature (IARC, 2004), including data in humans on nasopharyngeal cancer,
cancer of the nasal cavity and paranasal sinuses, and leukemia. It should be noted
that some epidemiology studies did not find a reported association between
formaldehyde exposure and carcinogenicity. For example, Coggon et. al., 2003
studied over 14,000 workers exposed to formaldehyde in industrial workplaces
and reported no excesses of either leukemia or nasal and nasopharyngeal cancer.
In 2005, the Scientific Review Panel (SRP) of the California Office of
Environmental Health Hazard Assessment responded to the CA Air Resources
Board request to reevaluate the carcinogenic potential of formaldehyde. The
Panel noted in this 2005 review that California's Office of Environmental Health
(OEHHA)'s November 2002 evaluation of a petition had included the 1999 report
on the CUT model and other information, and that OEHHA had concluded that
"the evidence... (1) did not change the determination that formaldehyde is a
carcinogen; (2) presented information that considered the possibility of non-
linear dose response relationships, but presented no clear grounds to review the
original "no threshold" determination; and (3) did not provide any new
epidemiology or bioassays supporting a change in potency. In addition, there
was insufficient information to fully evaluate the CUT model; issues such as
model uncertainty were not adequately addressed...." The Scientific Review
Panel's overall conclusion in 2005 was, "The Panel concluded that there was not
sufficient new data to support the petition to review the [OEHHA 's earlier 1992]
formaldehyde risk assessment. In addition, the newly published studies
represented relevant new information, but they did not allow determination of a
causal relationship between formaldehyde exposure and leukemia. These studies
deserve further evaluation over time given their potential importance. " (Froines,
2005).
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EPA is currently completing a new IRIS assessment and unit risk value for
formaldehyde; the reassessment is scheduled to start internal peer review in May
2008 and begin independent external peer review in January 2009
(http://cfpub.epa.gov/ncea/iri strac/index.cfm?fuseaction=viewChemical.showChe
mical&sw_id=1031). EPA anticipates that the peer review of the formaldehyde
assessment will be a longer process then that of EPA's reregi strati on process
scheduled to conclude in September 2008.
Based on the on going development of the science to predict carcinogenic
potential of formaldehyde, OPP has decided to present the formaldehyde cancer risks for
the pesticidal uses using both the existing 1991 IRIS cancer unit risk of 1.3 E-5 per
(|ig/m3) and the CUT BBDR model until any new cancer estimates are fully peer
reviewed. OPP also acknowledges the wide range in cancer risks using these approaches
and will coordinate with other offices in EPA on the outcome of the upcoming peer
review process on the carcinogenicity of formaldehyde. Because formaldehyde air
concentrations approach those associated with ocular and respiratory tract irritation, the
risk mitigation measures to be implemented in the meantime for the pesticidal uses will
be based on mitigating the non-cancer effects at a limit of 0.01 ppm. It is believed that
this level will reduce exposures sufficiently such that the cancer risks would not be of
concern. The EPA process of regulating pesticides allows for reevaluation at any time if
new information from the peer review process of the carcinogenic potential of
formaldehyde warrants.
2. FQPA Safety Factor
There are no tolerances for formaldehyde or paraformaldehyde and the use
patterns considered for the reregi strati on eligibility decision do not involve dietary
exposure. As a result, an FQPA safety finding is not applicable.
3. Dietary and Drinking Water Risk
Formaldehyde is used to treat mushroom houses, equipment and premises and
citrus facilities as a disinfectant treatment when food is not present. The Agency believes
that the dietary exposure from citrus packing and mushroom houses will be negligible. In
addition, formaldehyde is used as a materials preservative in dishwashing detergent.
Formaldehyde is a gas at room temperature and it is dissolved in water. However,
formaldehyde is not stable in water and has a tendency to escape from solution. Half
lives in air and water are short, so it is unlikely formaldehyde persists on pots, pans, and
dishes. In addition, it is not expected to contaminate ground water. Therefore, there are
no dietary or drinking water concerns from the antimicrobial uses of formaldehyde.
4. Residential Exposure and Risk
The residential exposure assessment considers all potential pesticide exposure,
other than exposure due to residues in food or in drinking water. Each route of exposure
(oral, dermal, inhalation) is assessed, where appropriate, and risk is expressed as an MOE
(Margin of Exposure) which is the ratio of estimated exposure to an appropriate NOAEL
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(No Observed Adverse Effect Level). Estimated MOEs are then compared to the Target
MOE, which represents the dose selected for risk assessment and uncertainty factors (UF)
applied to that dose. The standard UF is lOOx, which includes lOx for interspecies
extrapolation (to account for differences between laboratory animals and humans) and
lOx for intraspecies variation (to account for differences within the same species).
There is one product containing formaldehyde that is labeled for use as in can
preservative of consumer products such as laundry detergents, general purpose cleaners
and wall paper adhesives. Use of these products can result in residential handler
exposure. In addition, there is one paraformaldehyde mildewcide product that is labeled
for treatment of closets and vacation homes. Use of this product could result in
residential postapplication exposure to paraformaldehyde. The exposure scenarios for
residential exposure are provided in Table 5. Additional information on the residential
exposures to formaldehyde and paraformaldehyde can be found in the Formaldehyde:
Revised Occupational and Residential Exposure Assessment for the Reregistration
Eligibility Decision (RED) Document., dated 4/15/2008; and Formaldehyde: Risk
Assessments for the Reregistration Eligibility Decision (RED) Document., dated 4/7/2008.
These documents are available on the Federal Government Public Docket website at
www.regulations.gov (Docket ID #EPA-HQ-OPP-2008-0121). No updated risk
assessments to reference?
Table 5. Exposure Scenarios for Formaldehyde and Paraformaldehyde
Residential Handler Inhalation Exposures from Formaldehyde Uses
Material Preservation of
Laundry Detergent
Material Preservation of
Floor and Furniture Polish
and Detergent Products
Material Preservation of Wall
Paper Adhesive
Handler Exposure While Using Treated
Laundry Detergent
Handler Exposure While Using Treated
General Purpose Cleaners
Handler Exposure While Using Treated
Wallpaper Adhesive
1000 ppm product
1 50 ppm product
100 ppm product
Residential Postapplication Inhalation Exposures from Paraformaldehyde Uses
Mildewcide for clothing and
linen in closets
Mildewcide for Vacation
Homes
Material Preservation of Wall
Paper Adhesive
Post Application Exposure
Post Application Exposure
Post Application Exposure from Wallpaper
Adhesive
4 ounce of product per 750 ft
4 ounce of product per 750 ft
100 ppm product
a. Formaldehyde Residential Handler Risk
Residential handler inhalation exposures were assessed for handlers of
formaldehyde treated laundry detergent, general purpose cleaners and wall paper
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adhesives. The EPA's Consumer Exposure Module (CEM) was used to estimate air
concentrations resulting from the use of laundry detergent and general purpose cleaner
preserved with formaldehyde. The EPA's Wall Paint Exposure Model (WPEM) was
used to estimate handler inhalation as well as post application exposures resulting from
the use of wall paper adhesive preserved with formaldehyde.
A summary of the residential risks for formaldehyde is included in Table 6. The
non-cancer risks are of concern for three of the scenarios because the MOEs are less than
the target MOE of 10. The non-cancer risk estimates are based upon EPA exposure
models which are generally believed to be conservative. The fact that the vapor pressure
of 1.0 mm Hg, which is based on formaldehyde as formalin, was used in these models
rather than the vapor pressure of pure formaldehyde, which exists only as gas, is a source
of uncertainty. There are also uncertainties regarding the use of the WPEM model
because it is based on test data for paint solvents that have different physical/chemical
properties than formaldehyde.
The estimated cancer risks range from <3 x 10"9 when using the CUT model to 8 x
10"6 when using the IRIS unit risk. The IRIS cancer risk estimates provide an upper-
bound on risk. Based on the on going reevaluationf the potential cancer and non-cancer
risks of formaldehyde through the ORD Integrated Risk Information System (IRIS)
program, a reevaluation may need to be done at a later date. The EPA process of
regulating pesticides allows for reevaluation at any time if new information from the peer
review process of the carcinogenic potential of formaldehyde warrants.
Table 6 - Residential Risk Summary for Biocidal Uses of Formaldehyde
Laundry Detergent
Handler
General Purpose
Cleaner Handler
Wall Paper Adhesive
Handler
Wall Paper Adhesive
Post Application
240 ppb
21ppb
15 ppb
4.9 ppb
0.4
4.8
6.7
20
0.5 ppb
0.12 ppb
0.044
ppb
0.038
ppb
8 x 10 6
2 x 10 6
7xlO'7
6xlO'7
<3 x 10'9
<3 x 10'9
<3 x 10'9
<3 x 10'9
b. Formaldehyde Residential Post Application Risk
The EPA's Wall Paint Exposure Model (WPEM) was used to estimate post
application exposures resulting from the use of wall paper adhesive preserved with
formaldehyde. The MOE for peak exposure is 20 and is not of concern. The estimated
cancer risk ranges from <3 x 10"9 when using the CUT model to 6 x 10"7 when using the
IRIS unit risk.
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c. Paraformaldehyde Handler Residential Risk
Based on current use patterns, there are no residential handler exposures
anticipated from the use of paraformaldehyde.
d. Paraformaldehyde Post Application Residential Risk
The EPA's Consumer Exposure Module (CEM) was used to estimate post
application inhalation exposures resulting from the use of paraformaldehyde mildewcide
in closets of occupied homes. The MOE for the mildewcide use is less than 0.1, which is
below the target MOE of alO and is of concern. The estimated cancer risk ranges from
<8 x 10"7 when using the CUT model to 3 x 10"3 when using the IRIS unit risk.
Conversations with the registrant of this product have indicated that it is primarily
intended to be used in unoccupied homes. Although these products are used in
unoccupied homes, the risks for the closet scenario are of concern because of potential
difficulty providing thourough ventilation before reentry. For this reason, use in closets
and other confined spaces present risk concerns.
5. Aggregate Risk
The Food Quality Protection Act amendments to the Federal Food, Drug, and
Cosmetic Act (FFDCA, Section 408(b)(2)(A)(ii)) require "that there is reasonable
certainty that no harm will result from aggregate exposure to pesticide chemical residue,
including all anticipated dietary exposures and other exposures for which there are
reliable information." Aggregate exposure is the total exposure to a single chemical (or
its residues) that may occur from dietary (i.e., food and drinking water), residential, and
other non-occupational sources, and from all known or plausible exposure routes (oral,
dermal, and inhalation). Acute and chronic dietary aggregate assessments were not
conducted for formaldehyde because there are no uses for formaldehyde attributable to
the dietary route of exposure.
6. Occupational Exposure and Risk
a. Occupational Handler Exposure and Risk
Workers can be exposed to formaldehyde through mixing, loading, applying a
pesticide or re-entering treated sites. Formaldehyde is used as a fumigant for agricultural
premises, in preservation, in production, and in wall paper adhesive. The Agency has
very little information concerning exposure from biocidal uses for formaldehyde.
Because formaldehyde has a high vapor pressure (1.0 mm Hg in formalin), the inhalation
unit surrogate exposure data that are often used to estimate risks associated with pesticide
use are generally not applicable. Although there are many studies of formaldehyde
occupational exposures reported in the literature, these studies involved the non-biocidal
uses. Therefore, it was not possible to quantitatively assess the formaldehyde exposures
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that result from biocide uses; a qualitative assessment was completed based upon work
practices listed on the labels.
In general, it was determined for the biocide application scenarios that if the label
requirements such as closed system loading, remote application and adequate ventilation
are followed, exposures would be reduced to levels that are not of concern. There are
several occupational handler exposure scenarios that involve formaldehyde products.
These scenarios are listed below:
Mechanical Fumigation
Evaporative Fumigation
Catalyzed Evaporative Fumigation
Hard Surface Disinfection of Animal Housing Areas and Equipment
Material Preservation
Oil Production
Wall Paper Adhesive Application
The wall paper adhesive application was assessed using the WPEM model. The
MOE for non-cancer risk is 1.6 which is above the target MOE of 1 and is thus not of
concern. The estimated cancer risk ranges from <1 x 10"8 when using the CUT model to
6 x 10"5 when using the IRIS unit risk. For additional information, please see the
Formaldehyde: Revised Occupational and Residential Exposure Assessment for the
Reregistration Eligibility Decision (RED) Document., dated 4/15/2008; located on the
Federal Government Public Docket website at www.regolations.gov (Docket ID #EPA-
HQ-OPP-2008-0121).
b. Occupational Post Application Exposure and Risk
Formaldehyde is used for fumigating poultry and swine containment buildings
and post application exposure can occur when the workers re-enter the fumigated areas.
These exposures were assessed using the single chamber decay formula from the Multi-
Chamber Concentration and Exposure Model (MCCEM) and a ventilation rate of 4 air
changes per hour. This assessment was based upon the application parameters listed in
the Champion Technologies Formaldehyde Solution 37 Label (EPA Reg #8133-32). The
ventilation rate is based upon poultry and animal housing design criteria; given these
conditions, the formaldehyde air concentration declines to a level that is not of concern
after 3 hours. For additional information, please see the Formaldehyde: Revised
Occupational and Residential Exposure Assessment for the Reregistration Eligibility
Decision (RED) Document, dated 4/15/2008; located on the Federal Government Public
Docket website at www.regolations.gov (Docket ID #EPA-HQ-OPP-2008-0121).
7. Human Incident Data
There are many reported incidents associated with formaldehyde exposure, but
only a limited few are associated with its use as an antimicrobial agent (biocide).
Formaldehyde is a dermal irritant and a dermal sensitizer. The primary dermal effects
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that have been reported are rash, burning sensation, itching, dry scaling irritation,
cracking and thickened skin, itching, and blisters and rash on hands. Symptoms
associated with eyes are the primary reported illness in all associated incidents. Nausea,
dizziness, headache, and sore throat are the primary systemic effects that have been
reported. Allergic reactions and asthma-like symptoms also have been reported
following occupational exposures. Only limited acute cases with oral exposure to
formaldehyde have been published in scientific literature. For additional information on
the reported incidents, refer to the Incidents Report Associated with Formaldehyde., dated
1/30/2008; located on the Federal Government Public Docket website at
www^eguiations^ovfDocket ID #EPA-HQ-OPP-2008-0121).
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B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below.
The following risk characterization is intended to describe the magnitude of the estimated
ecological hazards and environmental risks for formaldehyde and paraformaldehyde.
Based on the registered antimicrobial use patterns, formaldehyde and paraformaldehyde
have low potential for terrestrial or aquatic environmental exposure. Therefore, a
quanitatiave risk assessment was not conducted.
For detailed discussions of all aspects of the environmental risk assessment, see
the Environmental Fate Assessment of Formaldehyde for the Issuance of the
Reregistration Eligibility Decision Document, dated January 23, 2008, and the Ecological
Hazard and Environmental Risk Assessment of Formaldehyde and Paraformaldehyde for
the Reregistration Eligibility Decision (RED) Document, dated January 29, 2008.
1. Environmental Fate and Transport
The Agency has no environmental fate and transport data for formaldehyde or
paraformaldehyde and relied on open literature for fate and transport studies. Available
literature indicates that there are multiple degradation pathways for formaldehyde.
Paraformaldehyde off-gasses as formaldehyde from a formaldehyde/paraformaldehyde
solution; therefore, the Agency has assumed that paraformaldehyde will have fate and
transport behavior similar to formaldehyde.
a. Water
The half-life of formaldehyde has been reported between 24-168 hours (1-7 days)
in surface water and 48-336 hours (2- 14 days) in groundwater, based on estimated
aqueous aerobic biodegradation half lives. Formaldehyde, therefore, is not likely to
persist in natural waters. The Agency for Toxic Substances and Disease Registry
(ATSDR) notes that when formaldehyde is released into water it biodegrades to low
levels in a few days.
b. Soil
A Koc value of 1.567 was estimated for formaldehyde based on open literature
(ATDSR, 19991) therefore, it is not expected to adsorb to soils and is likely to be mobile
in soils. Compounds with a Koc value of less than <100 are considered to be moderately
mobile in soils and may contaminate groundwater. Octanol/Water partition is low (log
Kow = 0.65). Therefore formaldehyde is not likely bioaccumulate in aquatic organisms.
1 ATSDR (Agency for Toxic Substances and Disease Registry). Toxicological Profile for Formaldehyde.
U.S. Department of Health and Human Services. 1999.
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c. Air
The half life of formaldehyde in air has been found to depend on intensity of
natural light, temperature, and location. Based on its reaction with hydroxy radical using
hydroxyl radical rate constant, the half life of formaldehyde in air varies between 7 to 70
hours. One study even estimated the air half life to vary between 0.3 to 250 hours. This
study, however, assumed there was hydroxyl or hydroperoxyl radicals present. It is not
likely to persistent in air. Degradation products from this interaction likely are: water,
formic acid, carbon monoxide and an intermediate adduct likely
hydroperoxyl/formaldehyde. Air photolytic half life of formaldehyde has been estimated
between 1.6 to 6 hours.
2. Ecological Hazard
Formaldehyde and paraformaldehyde labeled uses including oil field uses such as
treatments of drilling muds and water-floods are considered by the Agency to pose little
adverse risk to non-target organisms or listed species. Antimicrobial pesticides used in oil
fields are typically minor use chemicals, diluted and greatly reduced before discharge
into water, and are often regulated by other Federal or EPA offices (OW, Office of Solid
Waste, OPPTS, state NPDES permits). In the case of oil fields, the US Department of the
Interior, Minerals Management Service (MMS) had jurisdiction over the environmental
impacts of synthetic drilling fluids in terrestrial and aquatic areas.
Terrestrial oil fields typically use berms and catch basins to prevent surface runoff
of oil drilling muds and wastes from oil drilling areas. Estuarine and marine aquatic
organisms may be temporarily exposed during marine drilling; however, impacts are
limited to a defined area around the oil well (Neff, 2000). If the pesticide is to be used in
estuarine or marine environments, three additional acute estuarine/marine toxicity studies
are required. The ecological hazard assessment has determined that formaldehyde
product labels must state: "This product is toxic to oysters."
3. Risk to Listed Species
Section 7 of the Endangered Species Act (ESA), 16 U.S.C. Section 1536(a)(2),
requires that federal agencies consult with the National Marine Fisheries Service (NMFS)
for marine and andronomus listed species, or with the United States Fish and Wildlife
Services (FWS) for listed wildlife and freshwater organisms, if proposing an "action" that
may affect listed species or their designated habitat. Each federal agency is required
under the Act to insure that any action they authorize, fund, or carry out is not likely to
jeopardize the continued existence of a listed species or result in the destruction or
adverse modification of designated critical habitat. To jeopardize the continued existence
of a listed species is to "to engage in an action that reasonably would be expected,
directly or indirectly, to reduce appreciably the likelihood of both the survival and
recovery of a listed species in the wild by reducing the reproduction, numbers, or
distribution of the species." 50 C.F.R. §402.02.
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To comply with subsection (a)(2) of the ESA, EPA's Office of Pesticide
Programs has established procedures to evaluate whether a proposed registration action
may directly or indirectly appreciably reduce the likelihood of both the survival and
recovery of a listed species in the wild by reducing the reproduction, numbers, or
distribution of any listed species (U.S. EPA 2004). If any of the Listed Species LOG
Criteria are exceeded for either direct or indirect effects in the Agency's screening-level
risk assessment, the Agency identifies any listed or candidate species that may occur
spatially and temporally in the footprint of the proposed use. Further biological
assessment is undertaken to refine the risk. The extent to which any species may be at
risk determines the need to develop a more comprehensive consultation package as
required by the ESA.
For certain use categories, including all current formaldehyde and
paraformaldehyde uses, the Agency assumes there will be minimal environmental
exposure, and only a minimal toxicity data set is required (Overview of the Ecological
Risk Assessment Process in the Office of Pesticide Programs U.S. Environmental
Protection Agency - Endangered and Threatened Species Effects Determinations,
1/23/04, Appendix A, Section IIB, p 81). Uses in these categories do not undergo a full
screening-level risk assessment and are considered to generally fall under a "no effect"
determination, however, an endangered species effect determination will not be made at
this time.
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether or not products containing the
active ingredient are eligible for reregi strati on. The Agency has previously identified and
required the submission of the generic (i.e., active ingredient-specific) data required to
support reregi strati on of products containing formaldehyde and paraformaldehyde as an
active ingredient. The Agency has completed its review of these generic data and has
determined that the data are sufficient to support reregi strati on of virtually all supported
products containing formaldehyde and paraformaldehyde.
The Agency has completed its assessment of the residential, occupational and
ecological risks associated with the use of pesticide products containing the active
ingredient formaldehyde and paraformaldehyde. The Agency has determined that
virtually all formaldehyde and paraformaldehyde containing products are eligible for
reregi strati on provided that: 1) all risk mitigation measures are implemented; 2) current
data gaps and confirmatory data needs are addressed; and 3) label amendments are made
as described in Section V. Use in confined spaces such as closets is not eligible for
registration because of the difficulty associated with ventilation of these spaces.
Appendix A summarizes the uses of formaldehyde and paraformaldehyde that are eligible
for reregistration. Appendix B identifies the generic data requirements that the Agency
reviewed as part of its determination of reregistration eligibility of formaldehyde and
paraformaldehyde and lists the submitted studies that the Agency found acceptable. Data
gaps are identified as generic data requirements that have not been satisfied with
acceptable data.
Based on its evaluation of formaldehyde and paraformaldehyde, the Agency has
determined that formaldehyde and paraformaldehyde products, unless labeled and used as
specified in this document, would present risks inconsistent with FIFRA. Accordingly,
should a registrant fail to implement the risk mitigation measures, submit confirmatory
data as well as make the label changes identified in this document, the Agency may take
regulatory action to address the risk concerns from the use of formaldehyde and
paraformaldehyde. If all changes outlined in this document are fully complied with, then
no risks of concern exist for the registered uses of formaldehyde and paraformaldehyde
and the purposes of this determination. Once an endangered species assessment is
completed, further changes to these registrations may be necessary as explained in
Section III of this document.
B. Public Comments and Responses
Through the Agency's public participation process, EPA worked with
stakeholders and the public to reach the regulatory decision for formaldehyde and
paraformaldehyde. EPA released its preliminary risk assessment for formaldehyde and
paraformaldehyde for public comment on April 23, 2008. The Agency received a
comment from the registrant, as well as the Formaldeyde Council, during the 60-day
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public comment period, which closed on March 23, 2008. The comments included
suggestions to refine the endpoint selection.
C. Regulatory Rationale
The Agency has determined that formaldehyde and paraformaldehyde are eligible
for reregi strati on provided that risk mitigation measures are implemented as outlined in
this document, additional required data confirm this decision and label changes are made
accordingly. Where labeling revisions are warranted, specific language is set forth in the
summary tables of Section V of this document.
1. Human Health Risk Management
a. Residential Risk Mitigation for Formaldehyde
In order to address the risks of concern identified for the laundry detergent,
general purpose cleaner and wall paper adhesive uses, maximum allowable application
rates need to be reduced. The non-cancer risks (i.e., MOEs) would require product rate
reductions to 40 ppm, 72 ppm and 67 ppm for the laundry detergent, general purpose
cleaner and wall paper adhesive handler scenarios, respectively to achieve the target
MOE of 10. However, the registrant has requested voluntary cancellation of the laundry
detergent use. The non-cancer risk for the wall paper post application scenario does not
require a product rate reduction. In terms of potential cancer risks, the Agency believes
that the mitigation required for the non-cancer risks will adequately address these risks as
well regardless of which of the current cancer approaches are used.
b. Occupational Risk Mitigation for Formaldehyde
In order to reduce potential occupational handler exposures the following mitigation is
required:
For industrial uses of formaldehyde closed systems with dry couplers (or
equivilant) are required
Structures that may be fumigated are limited to animal premises such as poultry
houses and swine houses, mushroom houses, citrus packing houses, egg facilities
and rail cars (not in-transit).
All fumugiated uses must be done in such a way that the operator is outside the
structure undergoing fumigation when applying the fog.
The labels must be updated to eliminate cloth or mop applications of
formaldehyde.
Manual spray applications of formaldehyde solutions require the use of a full face
respirator.
After fumigating poultry/swine containment buildings, re-entry by unprotected
persons should be allowed only after a total 12 air changes, (e.g., 3 hours of
ventilation at a rate of 4 air changes per hour (ACH))
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e. Occupational and Residential Risk Mitigation for
Paraformaldehyde
To mitigate the occupational risks from paraformaldehyde use in beauty salons
and barber shops, it is necessary that these areas have general ventilation that meets the
American Society of Heating, Refrigerating and Air-conditioning Engineers (ASHRAE)
recommendations and/or local exhaust ventilation that meets ACGIH recommendations.
To mitigate the residential risks from paraformaldehyde use in vacation homes,
use must be limited to unoccupied structure that can be thoroughly ventilated six (6)
hours prior to re-occupancy.
2. Other Labeling Requirements
In order to be eligible for reregi strati on, various use and safety information will be
included in the labeling of all end-use products containing formaldehyde and
paraformaldehyde. For the specific labeling statements and a list of outstanding data,
refer to Section V of this RED document.
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V. What Registrants Need to Do
The Agency has determined that formaldehyde and paraformaldehyde are eligible
for reregistration provided that: (i) additional data that the Agency intends to require
confirm this decision; (ii) the risk mitigation measures outlined in this document are
adopted; and (iii) label amendments are made to reflect these measures. To implement
the risk mitigation measures, the registrants must amend their product labeling to
incorporate the label statements set forth in the Label Changes Summary Table in Section
B below (Table 8). The additional data requirements that the Agency intends to obtain
will include, among other things, submission of the following:
For formaldehyde and paraformaldehyde technical grade active ingredient
products, the registrant needs to submit the following items:
Within 90 days from receipt of the generic data call-in (DCI):
1. Completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
2. Submit any time extension and/or waiver requests with a full written
justification.
Within the time limit specified in the generic DCI:
1. Cite any existing generic data which address data requirements or submit new
generic data responding to the DCI.
Please contact ShaRon Carlisle at (703) 308-6427 with questions regarding generic
reregistration.
By US mail:
Document Processing Desk
ShaRon Carlisle
Office of Pesticide Programs
(751OP)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
By express or courier service:
Document Processing Desk
ShaRon Carlisle
Office of Pesticide Programs
(751OP)
U.S. Environmental Protection Agency
One Potomac Yard, Room S-4900
2777 South Crystal Drive
Arlington, VA 22202
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For end-use products containing the active ingredient formaldehyde and
paraformaldehyde, the registrant needs to submit the following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
1. Completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant's response form); and
2. Submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
1. Two copies of the confidential statement of formula (EPA Form 8570-4);
2. A completed original application for reregi strati on (EPA Form 8570-1).
Indicate on the form that it is an "application for reregi strati on";
3. Five copies of the draft label incorporating all label amendments outlined in
Table 26 of this document;
4. A completed form certifying compliance with data compensation requirements
(EPA Form 8570-34);
5. If applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
6. The product-specific data responding to the PDCI.
Please contact Marshall Swindell at (703) 308-6341 with questions regarding
product reregi strati on and/or the PDCI. All materials submitted in response to the PDCI
should be addressed as follows:
By US mail:
Document Processing Desk
Marshall Swindell
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
By express or courier service:
Document Processing Desk
Marshall Swindell
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
Room S-4900, One Potomac Yard
2777 South Crystal Drive
Arlington, VA 22202
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A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregi strati on of formaldehyde and
paraformaldehyde has been reviewed and determined to be substantially complete.
However, the following additional data requirements have been identified by the Agency
as confirmatory data requirements and are included in the generic data-call-in (DCI) for
this RED. Table 8 provides an outline of the requested confirmatory data for
formaldehyde and paraformaldehyde.
Table 8. Confirmatory and Conditional Data for Formaldeyde and Paraformaldehyde
90-Day Dermal Toxicity
Developmental Toxicity in Non-Rodents
870.3250
870.3700
Acute Daphnia magna using TGAI formaldehyde
850.1010
2. Labeling for Manufacturing Use Products
To ensure compliance with FIFRA, technical and manufacturing-use product
(MP) labeling should be revised to comply with all current EPA regulations, PR Notices
and applicable policies. The Technical and MP labeling should bear the labeling
contained in Table 9, Label Changes Summary Table.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-
specific data regarding the pesticide after a determination of eligibility has been made.
The Registrant must review previous data submissions to ensure that they meet current
EPA acceptance criteria and if not, commit to conduct new studies. If a registrant
believes that previously submitted data meet current testing standards, then the study
MRID numbers should be cited according to the instructions in the Requirement Status
and Registrants Response Form provided for each product. A product-specific data call-in
will be issued at a later date.
2. Labeling for Technical and End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV
above. Specific language to incorporate these changes is specified in Table 9 Label
Changes Summary Table.
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this Reregi strati on Eligibility Decision
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document. Persons other than the registrant may generally distribute or sell such
products for 52 months from the approval of labels reflecting the mitigation described in
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.
a. Label Changes Summary Table
In order to be eligible for reregi strati on, all product labels must be amended to
incorporate the risk mitigation measure outlined in Section IV of the formaldehyde and
paraformaldehyde RED. The following table describes how language on the labels
should be amended.
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Table 9 Labeling Changes Summary Table
Environmental Hazards
Statements Required by the
RED and Agency Label Policies
"This pesticide is toxic to oysters. 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 (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."
Precautionary
Statements
End Use Products Intended for
Poultry/ Swine Containment
Buildings
End Use Products Intended for
Occupational Disinfectant use
End Use Products Intended for
Laundry Detergent
End Use Products Intended for
General Purpose Cleaner
End Use Products Intended for
Wall Paper Adhesive
"A minimum re-entry time of 3 hours into the fumigated area is required"
ALL Labels must be updated to eliminate mop and cloth
or sponge applications
This use has been voluntarily cancelled
Product application rate MUST be reduced to 72 ppm
Product application rate MUST be reduced to 67 ppm
Directions for Use
Directions for Use
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FORMALDEHYDE
Description
End Use Products Intended for
Occupational use
Amended Labeling Language
In order to reduce potential occupational handler exposures the following
mitigation is required:
For industrial uses of formaldehyde close systems with dry couplers (or
equivilant) are required
Structures that may be fumigated are limited to animal premises such as
poultry houses and swine houses, mushroom houses, citrus packing
houses, egg facilities and rail cars (not in-transit).
All fumugiated uses must be done in such a way that the operator is
outside the structure undergoing fumigation when applying the fog.
The labels must be updated to eliminate cloth or mop applications of
formaldehyde.
Manual spray applications of formaldehyde solutions require the use of
a full face respirator.
After fumigation poultry/swine containment building, re-entry by
unprotected persons should be allowed only after a total 12 air changes.
(e.g. 3 hours of ventilation at a rate of 4 air changes per hour ( ACH))
Placement on Label
Directions for Use
End-Use Products for Vacation
Homes
ALL labels must limit the use to an UNOCCUPIED structure that can be
thoroughly ventilated six (6) hours prior to re-occupancy.
Directions for Use
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FORMALDEHYDE
Description
End-Use Products for Beauty
Salons and Barber Shops
Amended Labeling Language
This product must be used in areas with general ventilation that meets
ASHRAE recommendations and/or local exhaust ventilation that meets ACGIH
recommendations.
Placement on Label
Directions for Use
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VI. APPENDICES
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Appendix A: Use Patterns Eligible for Reregistration for Formaldehyde (Case 0556)
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Agricultural premises and equipment
Poultry and Turkey
farms, Swine operations,
Dairy farms, Cattle
farms, Veal farms, Emu
and ostrich farms
Soluble
concentrate:
Reg: 134-65
Reg: 8133-33
Spray or soak
or fog
1 - 3 oz of product per
gallon of water. ONLY
FOUND directions using
3 oz for canine and feline
(not those listed to the left
under use site) Preclean
all surfaces. Spray all
surfaces to saturation. 10
minute contact time.
1 1A - 2 l/2 oz of product
per gallon of water. Wet
mist until the area is moist
using an approved
automatic wet fogger.
Ventilate closed spaces. Do not house
livestock until treatment has absorbed
or dried and all surfaces have been
scrubbed with soap or detergent and
rinsed with potable water.
Reentry restrictions: Entry into treated
areas by other than correctly equipped
handler is prohibited until the air
concentration level of formaldehyde is
LESS than 0.75 ppm.
Federally inspected meat
and poultry
establishments except
where meat and food
products are handled.
Soluble
concentrate:
Reg: 134-65
Reg: 8133-33
Spray or soak
or fog
1 - 3 oz of product per
gallon of water. ONLY
FOUND directions using
3 oz for canine and feline
(not those listed to the left
under use site) Preclean
all surfaces. Spray all
surfaces to saturation. 10
minute contact time.
Ventilate closed spaces. Do not house
livestock until treatment has absorbed
or dried and all surfaces have been
scrubbed with soap or detergent and
rinsed with potable water.
Reentry restrictions: Entry into treated
areas by other than correctly equipped
handler is prohibited until the air
concentration level of formaldehyde is
LESS than 0.75 ppm.
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
1 1A - 2 l/2 oz of product
per gallon of water. Wet
mist until the area is moist
using an approved
automatic wet fogger.
Poultry and swine
premises and
confinement areas
Soluble
concentrate:
Reg: 8133-32
Reg: 8133-33
Mechanical
sprayer or
sprinkler
Remove all animals.
Preclean and sanitize the
premises. Use 20-60 oz.
of product for each 1000
ft3 of building volume.
Sprinkler application:
Use a 1:11 dilution in an
approved sprinkler
system. Follow approved
application methods.
Spray Sled: Use a 1:4
dilution in an approved
portable spray sled.
Follow approved
application methods.
For effectiveness, relative humidity
should be at least 70% and ambient
temperature at least 70F or higher.
Reentry restrictions: Treated buildings
must be left closed, locked and secured
against unauthorized entry for a
minimum of 24 hours.
Entry into treated areas by other than
correctly equipped handler is prohibited
until the air concentration level of
formaldehyde is LESS than 0.75 ppm.
Hatching egg
washing/fumigating
treatment
Ready to
Use: Reg:
8133-32
Reg: 8133-33
Fog,
fumigation
Maximum of 2 fl. oz. per
1,000 eggs in a 24-hour
period. Product is to be
place in an open container
and allowed to evaporate
or in a slight vacuum. Do
not use potassium
permanganate as a
catalyst. Repeated at a
Incubators must be vented directly
("directly" has been removed from the
label) to outside air. Fumigation may be
performed on both empty incubators
and incubators containing eggs. Eggs
to be fumigated should be held on clean
racks or egg flats which permit air
circulation. Egg fumigation should
NOT be done between 24 hours and
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
maximum rate of 2 fl. oz.
of Formaldehyde Solution
37 per 1,000 eggs in a 24-
hour period.
five days incubation because embryo
damage may occur. Last treatment
should be added at least 12 hours
before chicks are pulled. Reentry
restrictions: Entry into treated areas by
other than correctly equipped handler is
prohibited until the air concentration
level of formaldehyde is LESS than
0.75 ppm.
Citrus packing houses
Soluble
concentrate:
Reg: 8133-32
Reg: 8133-33
Fog,
fumigation
Use 16 fl. Oz. of product
per 1000 ft3 of space to be
treated. Product may be
diluted at a rate of up to
one part solution to 10
parts water. Room to be
treated should be tightly
closed and humidity
introduced for at least 24
hours. Do not wet down
with hose. Apply using an
approved stationary
mounted spray manifold
and suitable air operated
foggers. Premises may be
treated up to twice a year.
Worker buffer zone: Establish a
worker buffer zone of 25 feet and a
residential buffer zone surrounding the
treated building during treatment and
aeration. See buffer zone tables from
distributor. Buffer zones should be
maintained for 24 hours.
Reentry restrictions: Treated buildings
must be left closed, locked and secured
against unauthorized entry for a
minimum of 24 hours.
Entry into treated areas by other than
correctly equipped handler is prohibited
until the air concentration level of
formaldehyde is LESS than 0.75 ppm.
Formaldehyde is phytotoxic to citrus.
Remove all fruit from spaces to be
treated. Allow formaldehyde residue to
dissipate from storage boxes before
filling with fruit.
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Use Site
Iris and daffodil bulbs in
bulb farms
Mushroom houses,
equipment and premises
Formulation
Soluble
concentrate:
Reg: 8133-33
Ready to
Use: Reg:
8133-32
Reg: 8133-33
Method of
Application
None listed
on label
Fog,
fumigation
Application Rate/ No. of
applications
None listed on label
Non Producing areas:
Empty mushroom house
of all growing media.
Broom clean. Wet out
growing boards. Close
and seal up area to be
treated. Inject steam into
house until interior
temperature reads 140-
150F. Inject solution into
steam (4 gallons for
houses up to 26,600 ft3, 5
gallons in houses up to
33,300 ft3 and 8 gallons
for houses up to 44,400
ft3) and continue steaming
for 12 hours. Turn on
exhaust fan for 12 hours,
then ventilate for 24
hours.
Use Limitations
None
Reentry restrictions: Entry into treated
areas by other than correctly equipped
handler is prohibited until the air
concentration level of formaldehyde is
LESS than 0.75 ppm.
Reentry restrictions: Treated buildings
must be left closed, locked and secured
against unauthorized entry for a
minimum of 24 hours.
Entry into treated areas by other than
correctly equipped handler is prohibited
until the air concentration level of
formaldehyde is LESS than 0.75 ppm.
Commercial, institutional and industrial premises and equipment
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Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Hard non-porous surfaces
Soluble
concentrate:
Reg: 134-65
Reg: 8133-33
Spray or soak
or fog
1 - 3 oz of product per
gallon of water. Preclean
all surfaces. Spray all
surfaces to saturation. 10
minute contact time.
1 1A - 2 l/2 oz of product
per gallon of water. Wet
mist until the area is moist
using an approved
automatic wet fogger.
Ventilate closed spaces. Do not house
livestock until treatment has absorbed
or dried and all surfaces have been
scrubbed with soap or detergent and
rinsed with potable water.
Reentry restrictions: Entry into treated
areas by other than correctly equipped
handler is prohibited until the air
concentration level of formaldehyde is
LESS than 0.75 ppm.
Rooms and Railway cars
Ready to
Use: Reg:
8133-32
Reg: 8133-33
Fog,
fumigation
For each 1000 cubic feet
of space, use 16 2/3 oz
potassium permanganate
and 20 oz of product.
Place large dishpan on
floor in which a smaller
pan is set. Put K-
permanganate in the
smaller pan and pour
product over it. Leave
room immediately. Close
all windows and doors.
Ventilate after 5 hours.
Reentry restrictions: Entry into treated
areas by other than correctly equipped
handler is prohibited until the air
concentration level of formaldehyde is
LESS than 0.75 ppm.
Residential and public access premises
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Use Site
Zoos
Veterinary clinics,
kennels
Pet shops
Formulation
Soluble
concentrate:
Reg: 134-65
Soluble
concentrate:
Reg: 134-65
Soluble
Method of
Application
Spray, soak,
mop or
sponge
Spray, soak,
mop or
sponge
Spray, soak,
Application Rate/ No. of
applications
1 oz of product per gallon
of water. Preclean all
surfaces. Spray all
surfaces to saturation. 10
minute contact time.
Use at 3 oz per gallon to
disinfect against canine
parvovirus and feline
panleukopenia.
1 oz of product per gallon
of water. Preclean all
surfaces. Spray all
surfaces to saturation. 10
minute contact time.
Use at 3 oz per gallon to
disinfect against canine
parvovirus and feline
panleukopenia.
1 oz of product per gallon
Use Limitations
Ventilate closed spaces. Do not house
livestock until treatment has absorbed
or dried and all surfaces have been
scrubbed with soap or detergent and
rinsed with potable water.
Reentry restrictions: Entry into treated
areas by other than correctly equipped
handler is prohibited until the air
concentration level of formaldehyde is
LESS than 0.75 ppm.
Ventilate closed spaces. Do not house
livestock until treatment has absorbed
or dried and all surfaces have been
scrubbed with soap or detergent and
rinsed with potable water.
Reentry restrictions: Entry into treated
areas by other than correctly equipped
handler is prohibited until the air
concentration level of formaldehyde is
LESS than 0.75 ppm.
Ventilate closed spaces. Do not house
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Use Site
Formulation
concentrate:
Reg: 134-65
Method of
Application
mop or
sponge
Application Rate/ No. of
applications
of water. Preclean all
surfaces. Spray all
surfaces to saturation. 10
minute contact time.
Use at 3 oz per gallon to
disinfect against canine
parvovirus and feline
panleukopenia
Use Limitations
livestock until treatment has absorbed
or dried and all surfaces have been
scrubbed with soap or detergent and
rinsed with potable water.
Reentry restrictions:
Entry into treated areas by other than
correctly equipped handler is prohibited
until the air concentration level of
formaldehyde is LESS than 0.75 ppm.
Industrial processes and water systems
Oil recovery injection
water systems
Drilling muds, work over
fluids and water based
packer fluids
Ready to
Use: Reg:
8133-28
Reg: 8133-30
Reg: 10707-
43
Ready to
Use:
Reg: 8133-
28
Reg: 8133-30
Reg: 10707-
43
Injection
Injection
Inject in either a
continuous treatment or
slug application to
produce between 25-5000
ppm of active ingredient.
Inject in either a
continuous treatment or
slug application to
produce between 100-500
ppm of active ingredient.
For use with closed delivery systems
only
For use with closed delivery systems
only
Materials preservative
Polishes for floors and
furniture, surfactants and
silicone emulsions
Ready to use:
8133-32
Incorporation
Use range = 0. 10 to 1000 Solution may not be used in products
ppm in final product coming in direct contact with food and
/ or drinking water
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Appendix A: Use Patterns Eligible for Reregistration
Paraformaldahyde case number: (0556)
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applications
Use Limitations
Residential and public access premises
Sanitizer
Hair/beauty salons, and barber
shops, sanitizer, cabinets,
implement drawers, roller trays,
student implement kits, covers or
doors of which are to be kept
tightly closed.
Ready to use
Reg 397-6
Fumigant
Remove cap place in sanitizer
cabinets
When fungicidal action is required
keep closed for 24 hours. For use in
hair, beauty salons and barber shops
None mentioned
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APPENDIX B: Formaldahyde / Paraformaldahyde (case 0556 )
Appendix B lists the generic (not product specific) data requirements which support the re-registration of Formaldahyde /
Paraformaldahyde. These requirements apply to Formaldahyde / Paraformaldahyde in all products, including data requirements for
which a technical grade active ingredient is the test substance.
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7200
830.7300
830.7840
830.7860
61-1
61-2a
61-2b
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-7
63-8
Product identity and composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
Melting point
Density or Specific Gravity
Solubility
43987201, 43983801
42724601, 43987201, 43983801
42724601, 43987201, 43983801
42724601, 43987201, 43983802,
43983801
42724601, 43987201
42724601, 43987201, 43983801
42724601, 43987201, 43983801,
57014, 57022, 57024, 7642
42724601, 43987201, 43983801,
57014,57022,76242
42724601, 43987201, 43983801,
57014,57022,7642
43987201, 43983801, 57014, 57024,
76242
43987201, 43983801, 124869, 57014,
57024, 76242
42724601, 57014, 57024, 76242
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DATA REQUIREMENT
830.7950
830.7370
830.7550
830.7000
830.6313
830.6315
830.6316
830.6315
830.7100
830.7100
830.6320
830.6321
830.6314
870.1100
870.1200
870.1300
870.2500
870.2600
870.3100
870-3150
63-9
63-10
63-11
63-12
63-13
63-15
63-16
63-17
63-18
63-19
63-20
63-21
63-14
81-1
81-2
81-3
81-5
81-6
82-la
82-1
Vapor pressure
Dissociation Constant
Oct/Water partition Coef
pH
Stability
Flammability
Explodability
Storage Stability
Viscosity
Miscibilty
Corrosion Characteristic
Dielectric Breakdown Voltage
Oxidation/Reduction: Chemical Incompatibility
Acute Oral - Rat
Acute Dermal - Rabbit
Acute Inhalation - Rat
Primary Dermal Irritation - Rabbit
Dermal Sensitization
90-Day Feeding-Rodent
90 Day oral toxicity in norodents
42724601, 43987201, 43983801,
124869, 57014, 57024, 76242
42930901, 43987201, 43983801
42930901, 43987201, 43983801
42930901, 43987201, 43983801
42930901, 43987201, 43983801,
57014, 57024, 124869
43987201, 43983801, 57022, 124869
43987201, 43983801
43987201, 43983801
43987201, 43983801
43987201, 43983801
43987201,43983801
43987201, 43983801
43987201, 43983801, 57022, 124869
00058054, 00065508
00058054, 00065508, 00159395
Open Literature, 43 17060 1
00058054, 00065514, 00159392
40161103, Open Literature
00124677, 00134114, Open Literature
Open Literature
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DATA REQUIREMENT
870.3250
870-3465
870.3465
870.3700
870.3700
870.3800
870.4100
870.4200
870.4200
870.4300
870.5100
870-5200
870-5275
870.5375
870.5380
870-5450
870.5550
870.5900
870.5915
870.6200
82-3
82-4
82-4
83-3a
83-3b
83-4
83-la
83 -2a
83-2b
83-5
84-2
84-2
84-2
84-2
84-2
84-2
84-2
84-2
82-7
90-Day Dermal Toxicity -Rodent
90 Day inhalation toxicity
6 week inhalation toxcity
Developmental Toxicity -Rat
Developmental Toxicity -Non rodent
Reproduction and fertility effects
Chronic Toxicity-Rat
Carcinogenicity-Rat
Carcinogenicity -Mouse
Combined chronic toxicity/ Carcinogenicity
Bacterial Reverse Mutation Assay
Mouse visible specific locus test
Sex- linked recessive lethal test in Dorosophlia melanogaster
In Vitro mammalian chromosome aberration test
Mammalian spermatogonial chromosome aberration test
Rodent dominant lethal assay
Unscheduled DNA synthesis in mammalian cell culture
In Vitro sister chromatid exchange assay
In Vitro sister chromatid exchange assay
Neurotoxicity screening battery
Data Gap
00082134. Open Literature
00149755
00082136, 00123770, 00123769,
00164652, Open Literature
Data Gap
00143291, Open Literature
Open Literature
00143288, Open Literature
Open Literature
00143289
00132156, 00138157, Open Literature
Open Literature
Open Literature
00132168, Open Literature
Open Literature
Open Literature
00132169
Open Literature
Open Literature
Open literature
46 of 87
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DATA REQUIREMENT
870.6500
870.7485
85-5
85-1
Schedule-controlled operant behavior
General metabolism
Open Literature
Open Literature
47 of 87
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Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP
docket, located in Room 119, Crystal Mall #2, 1801 Bell Street, Arlington, VA. It is open
Monday through Friday, excluding legal holidays, from 8:30 am to 4 pm.
OPP public docket is located in Room S-4400, One Potomac Yard (South Building),
2777 South Crystal Drive, Arlington, VA, 22202 and is open Monday through Friday,
excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
The docket initially contained the (date) preliminary risk assessment and the
related documents. EPA then considered comments on these risk assessments (which are
posted to the e-docket) and revised the risk assessments. The revised risk assessments
will be posted in the docket at the same time as the RED.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at www.regulations.gov
These documents include:
Formaldehyde Preliminary Risk Assessment; Notice of Availability, (date).
Formaldehyde Summary, (date).
Overview of the Formaldehyde Preliminary Risk Assessment, (date).
Preliminary Risk Assessment and Supporting Science Documents:
Formaldehyde: Preliminary Risk Assessment for the Reregi strati on Eligibility
Decision, PC Code 043001, Case 0556, Antimicrobials Division, 4/7/08,
Timothy F. McMahon, Ph.D., Jonathan Chen, Ph.D., Srivivas Gowda, Ph.D., A.
Najm Shamim, Ph.D., Richard C. Petrie, Agronomist, Timothy C. Dole, CIH,
Industrial Hygienist.
Product Chemistry Science Chapter on Formaldehyde. PC Code 043001, Case
0556, Antimicrobials Division, 1/24/08, Srivivas Gowda, Ph.D.
Product Chemistry Science Chapter on Paraformaldehyde. PC Code 043002, Case
0556,
Antimicrobials Division, 1/24/08, Srivivas Gowda, Ph.D.
Formaldehyde: Toxicology Disciplinary Chapter for the Reregi strati on Eligibility
Decision Document, PC Code 043001, Case 0556, Antimicrobials Division,
3/31/08, Timothy F. McMahon, Ph.D.
Formaldehyde Dietary Exposure Assessments for the Reregi strati on Eligibility
Decision. PC Code 043001, Case 0556, Antimicrobials Division, 1/29/08, A.
Najm Shamim, Ph.D.
Formaldehyde Occupational/Residential Exposure Assessment. PC Code 043001,
Case 0556, Antimicrobials Division, 4/15/08, Timothy C. Dole, CIH, Industrial
Hygienist.
Health Effects of Formaldehyde in Humans. PC Code 043001, Case 0556,
Antimicrobials Division, 1/30/08.
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Environmental Fate Assessment of Formaldehyde for the Reregi strati on
Eligibility Decision (RED). PC Code 043001, Case 0556, Antimicrobials
Division, 1/23/08, A. Najm Shamim, Ph.D.
Ecological Hazard and Environmental Risk Assessment: Formaldehyde. PC Code
043001, Case 0556, Antimicrobials Division, Richard C. Petrie, Agronomist.
Drinking Water Assessment for Formaldehyde Reregi strati on Eligibility Decision
(RED). PC Code 043001, Case 0556, Antimicrobials Division, 1/30/08 A. Najm
Shamim, Ph.D.
Formaldehyde/Paraformadehyde - Report of the Antimicrobials Division Toxicity
Endpoint Selection Committee (ADTC). PC Code 043001; 043002, Case 0556,
Antimicrobials Division, Timothy F. McMahon, Ph.D.
49 of 87
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Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography)
GUIDE TO APPENDIX D
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all
studies considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Chlorine Dioxide 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 (1999),
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.
51 of 87
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1. MRID Studies
MRID#
Citation
00065640 Birdsong, C. L. and J.W. Avalt, Jr. (1971). Toxicity of Certain Chemicals
to Juvenile Pompano. Progressive Fish Culturist.33:76-80.
00101857 Bentley, R.E. (1975). Acute Toxicity of Ten Baroid Compounds to Bluegill (Lepomis macrochirus)
and Rainbow Trout (Salmo gairdneri). Unpublished study. Conducted by Bionomics, EG&G for
Baroid, Division, N.L. Industries, Houston, TX.
00126394 Heitmuller, T. (1975). Acute Toxicity of Surflo-B17 to Larvae of the
Eastern Oyster ..., Pink Shrimp ..., and Fiddler Crabs (Uca pugilator).
Unpublished study. Conducted by Bionomics, EG&G for Baroid Division,
N. L. Industries, Houston, TX.
00126395 Heitmuller, T. (1975). Acute Toxicity of Aldacide to Larvae of the Eastern Oyster .., Pink Shrimp
..., and Fiddler Crabs (Uca pugilator). Unpublished study. Conducted by Bionomics, EG&G for
Baroid Division, N. L. Industries, Houston, TX.
00126396 Heitmuller, T. (1975). Acute Toxicity of Surflo-B 19 to Larvae of the Eastern Oyster ...,Pink
Shrimp ..., and Fiddler Crabs (Uca pugilator). Unpublished study. Conducted by Bionomics,
EG&G for Baroid Division, N. L. Industries, Houston, TX.
00128086 Heitmuller, T. (1975). Acute Toxicity of Surflo-B16 to Larvae of the Eastern Oyster ...,Pink
shrimp ..., and Fiddler Crabs (Uca pugilator). Unpublished study. Conducted by Bionomics,
EG&G for Baroid Division, N. L. Industries, Houston TX.
00132485 Bills, T.D., Marking, L.L., and J.H. Chandler. (1977). Formalin: Its Toxicity to Nontarget Aquatic
Organisms, Persistence, and Counteraction. U.S. Fish & Wildlife Service, Invest. Fish Control
73:1-7.
00134123 McCann, J. andF. Pitcher. (1973). Russell's Incubator Fumigant: Bluegill: Test No. 577.
Unpublished study. Prepared by Pesticides Regulation Division, Animal Biology Laboratory, U.S.
Environmental Protection Agency, Beltsville, MD.
00134124 McCann, I, andF. Pitcher. (1973). Russell's Incubator Fumigant: Rainbow Trout: Test No. 560.
Unpublished study. Prepared by Pesticides Regulation Division, Animal Biology Laboratory, U.S.
Environmental Protection Agency, Beltsville, MD.
00134126 McCann, J. andF. Pitcher. (1973). Parson's Formaldehyde: Bluegill: Test No. 594. Unpublished
study. Prepared by Pesticides Regulation Division, Animal Biology Laboratory, U.S.
Environmental Protection Agency, Beltsville MD.
00148770 Lemon, K.A. (1985). Acute Toxicological Evaluations of Estuarine
Organisms to Support Registration Action 44797-RL. Conducted by
EnviroSystems, Inc. for N.L. Treating Chemical Company, Houston, TX. .
00148772 Smith, E.H. (1985). Acute Toxicity of Formalin on Daphnia magna to
Support Registration Action 44797-RL. Unpublished study. Conducted by
ANATEC Laboratories, Inc. for N.L. Testing Chemicals, Houston TX.
52 of 87
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00148773 Fletcher, D.W. (1983). Report to NL Treating Chemicals/NL Industries,
Inc., Eight-day Dietary LCso Study with Surflo-B315 in Bobwhite Quail:
BLAL No.83 QC 39. Unpublished study. Conducted by Bio-Life
Associates Ltd. For NL Treating Chemicals/NL Industries, Inc.
00148774 Fletcher, D.W. (1983). Report to NL Treating Chemicals, NL Industries,
Inc., Acute Toxicity Study with Surflo-B315 in Bobwhite Quail: BLAL
No.83 QD 38. Unpublished study Conducted by Bio-Life Associates Ltd.
ForNL Treating Chemicals/NL Industries, Inc.
00148775 Fletcher, D.W. (1984). Report to NL Treating Chemicals, NL Industries,
Inc., Eight-day Dietary LC50 Study with Surflo-B315 in Mallard
Ducklings: BLAL No.83 DC 40. Unpublished study. Conducted by Bio-
Life Associates Ltd. ForNL Treating Chemicals/NL Industries, Inc.
00058054 Celanese Chemical Company (1976?) Toxicological Data and Health
Hazards: Formaldehyde. (Unpublished study received Nov 4, 1977 under
11558-8; CDL: 232282-K)
00065508 3T1522: Laboratory Nos. 5E-6921, 5E-6923, 5E-6924, 5E- 6922.
(Unpublished study received Jan 11, 1977 under 10000-4; submitted by
Hallemite Lehn & Fink, Montvale, N.J.; CDL: 229296-A)
00065514 St. Pierre, F.; Parke, G.S.E. (1976) Report on Primary Dermal Irritation
Study in Rabbits: Laboratory No. 6E-4231. (Unpublished study received
Jan 11, 1977 under 10000-4; prepared by Cannon Laboratories, Inc.,
submitted by Hallemite Lehn & Fink, Mont- vale, N.J.; CDL:229296-G)
00082134 Coon, R.A. et al. (1970) Animal Inhalation Studies on Ammonia, Ethylene
Glycol, Formaldehyde, Dimethylamine, and Ethanol. Toxicology and
Applied Pharmacology 16: 646-655.
00082136 Schnurer, L.B. (1963) Maternal and foetal responses to chronic stress in
pregnancy: A study in albino rats. Acta Endocrinologica, Supplement 80
?:3-96. (Also in unpublished submission received Oct 15, 1973 under
4G1438; submitted by Chevron Chemical Co., Richmond, Calif;
CDL:095383-A)
00123769 Ranstrom, S. and Schrurer, L. (1956) Stress and Pregnancy. Acta Pathol.
Microbiol. Scandinavia. Supplement III, 113-114.
00123770 Schnurer, L. (1963) Maternal and foetal responses to chronic stress in
pregnancy. Acta Endocrinologica (80):3-96. (Also In unpublished
submission received 1963 under 4G1438; submitted by Chevron Chemical
Co., Richmond, CA; CDL:093832-T)
53 of 87
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00124677 Driedger, A.; Walker, 1; Galloway, F. (1973) Letter sent to C. Smart
dated Oct 1, 1973: "Rat tolerance to Dietary Formaldehyde: Reference No.
AD-114-73, JRW-341-73." (Unpublished study; submitted by Celanese
Chemical Co., Dallas, TX; CDL:094622-H)
00132156 Jagannath, D. (1978) Mutagenicity Evaluation of Dantoin DMDMH-55
40-697 737543 in the Ames Salmonella/Microsome Plate Test: LBI
Project No. 20838. Final rept. (Unpublished study received May 9, 1983
under 38906-5; prepared by Litton Bionetics, Inc., sub- mitted by Glyco,
Inc., Greenwich, CT; CDL:250313-A)
00132157 Haworth, S.; Lawlor, T.; Burke, P.; et al. (1982). Salmonella/Mammalian-
microsome Preincubation Mutagenicity Assay (Ames Test): Test Article
447:34-3: Study No. T1804.502. (Unpublished study received May 9,
1983 under 38906-5; prepared by Microbiological Assoc., submitted by
Glyco, Inc., Greenwich, CT; CDL:250313-B).
00132168 Thilagar, A.; Kumaroo, P.; Pant, K. (1982) Cytogenicity Study: Chinese
Hamster Ovary (CHO) Cells in vitro: Test Article 447:34-1: Study No.
T1802.338. (Unpublished study received May 9, 1983 under 38906-5;
prepared by Microbiological Assoc., submitted by Glyco, Inc., Greenwich,
CT;CDL:250313-M)
00132169 Thilagar, A.; Pant, K. (1982) Unscheduled DNA Synthesis in Rat
Hepatocytes: Test Article 447:34-1: Study No. T1802.380002. (Un-
published study received May 9, 1983 under 38906-5; prepared by
Microbiological Assoc., submitted by Glyco, Inc., Greenwich, CT;
CDL:250313-N)
00134114 Viguera, C.; Kundzins, M. (1960) "28-Day Oral Administration-Rats:
U.F. Concentrate-851." (Unpublished study; prepared by Hazleton
Laboratories, Inc.; CDL: 105284-C)
00143288 Watanabe, F., et al. (1954) Study on the Carcinogenicity of
Aldehyde. 1st Report. Experimentally Produced Rat Sarcomas by
Repeated Injections of Aqueous Solution of Formaldehyde. Two
unpublished translations of Japanese article published in Gann 45(2-
3):451-452.
00143289 Kerns, W.D. et al. (1983) Carcinogenicity of Formaldehyde in Rats
and Mice after Long-Term Inhalation Exposure. Cancer Research 43:
4382-4392.
00143291 Hurni, H. and H. Odher (1972) Reproduction Study with Formaldehyde
and Hexamethylenetetr-amine in Beagle Dogs. Fd. Cosmet. Toxicol. 11:
459-462.
54 of 87
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00149755 Rusch, G.; Rinehart, W. (1980) A 26 Week Inhalation Toxicity Study of
Formaldehyde in Monkey, Rat, and Hamster: Project No. 79- 7259.
Unpublished study prepared by Bio/dynamics Inc. 184 p.
00159392 Liggett, M.; Wilson, J. (1980) Irritant Effects of Acticide BG on Rabbit
Skin: 79648D/THR 2. Unpublished study prepared by Huntingdon
Research Centre. 5 p.
00159393 Liggett, M.; Wilson, J. (1980) Irritant Effects of Acticide BG on
Rabbit Eye Mucosa: 8088D/THR3. Unpublished study prepared by
Huntingdon Research Centre. 5 p.
00159395 Kynoch, S.; Charnley, B.; Ginty, J. (1980) Acute Percutaneous Toxicity to
Rats of Acticide BG: 79625D/THR4. Unpublished study prepared by
Huntingdon Research Centre. 5 p.
00164652 Marks, Thomas A. et al. (1980) Influence of Formaldehyde and Sonacide
(Potentiated Acid Glutaraldehyde) on Embryo and Fetal Development in
Mice. Teratology 22: 51-58.
40161103 Spiers, J. (1987) Formaldehyde: Skin Sensitisation Study to the
Guinea Pig: (Positive Control): Laboratory Project ID: CTL/P/ 1211 A.
Unpublished study prepared by ICI Central Toxicology Laboratory. 28 p.
43167201 Burleigh- Flayer, H. D. and WJ. Kintigh (1992) Glutaraldehyde and
Formaldehyde: Vapor Pulmonary Hypersensitivity Study in Guinea Pigs.
Bushy Run Research Center (Export, PA), Union Carbide. Study ID
92U1123, dated February 28, 1992, Unpublished.
43170601 Werley et al. (1994). Glutardehyde and Formaldehyde: Sensory
Irritation Study in Swiss-Webster Mice. Union Carbide Lab Project No.
91U0123.
00146665 Celanese Chemical Co., Inc. (1985) [Product Chemistry: Formaldehyde
45%]. Unpublished compilation. 19 p.
41926001 Sibinovic, K. (1991) Reichold Formaldehyde/ Methanol: Product
Chemistry: Accelerated Storage Stability: Lab Project Number: C80- PC-
RI-1991. Unpublished study prepared by Shaldra, Inc. 38 p.
42596708 Stupp, S. (1992) Product Chemistries and 30-Day Storage Stability of
Methaform 55A: (Product renamed Formaldehyde Solution 54): Lab
Project Number: CHAMP-01A-92. Unpublished study prepared by A & S
Environmental Testing, Inc. 65 p.
55 of 87
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42656801 Petrolite Corp. (1993) Formaldehyde: Physical and Chemical
Characteristics. Unpublished study. 4 p.
42724601 Stupp, S. (1992) Product Chemistries and 30-Day Storage Stability of
Methaform 55A: (Product renamed Formaldehyde Solution 54): Lab
Project Number: CHAMP-01A-92. Unpublished study prepared by A & S
Environmental Testing, Inc. 65 p.
42859001 Stupp, S. (1991) Product Chemistry and 30-Day Storage Stability of
Bactron K-55W Microbiocide: Lab Project Number: C80-BACT55-PC-
1990: C80-ASST-PC-1991. Unpublished study prepared by A & S
Environmental Testing, Inc. 75 p.
42995401 Stupp, S. (1993) Product Chemistries and 30 Day Storage Stability of
Formaldehyde Solution 54: Lab Project Number: CHAMP-01A-92.
Unpublished study prepared by A&S Environmental Testing, Inc. 172 p.
42930901 Stupp, S. (1992) Product Chemistries and 30 Day Storage Stability of
Formaldehyde Solution 54: Lab Project Number: CHAMP-01A-92.
Unpublished study prepared by A & S Environmental Testing, Inc. 65 p.
43051601 Douglas, C. (1993) Formaldehyde-Product Identity Analysis and
Certification of Product Ingredients. Unpublished study prepared by
Borden Packaging and Industrial Products. 51 p.
43745001 Sibinovic, K.; Tenhaeff, S. (1995) Product Chemistry-Formaldehyde
Solution 37: Lab Project Number: BORDEN-FS97-95. Unpublished study
prepared by Shaldra, Inc. and Borden Chemical & Plastics. 35 p.
44952301 Sibinovic, K. (1999) Product Chemistry-Formaldehyde Solution 37F: Lab
Project Number: CTI-99-PC-01. Unpublished study prepared by Shaldra,
Inc. 31 p.
2.Open Literature
Citation
Neff, J.M., S. McKelvie and R.C. Ayers, Jr. (2000). "Environmental Impacts of Synthetic
Based Drilling Fluids. Report prepared for MMS by Robert Ayers & Associates,
Inc. August 2000. U.S. Department of the Interior, Minerals management Service,
Gulf of Mexico OCS Region, New Orleans, L.A. OCS Study MMS 2000-064.
118pp.
Chenier, R. (2003). An Ecological Risk Assessment of Formaldehyde. Human and
Ecological Risk Assessment. Vol. 9, No. 26 pgs.
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Canadian Environmental Protection Act (1999). Priority Substances List Assessment
Report. Formaldehyde. Health Canada. 102 pgs.
ATSDR (Agency for Toxic Substances and Disease Registry). Toxicological Profile for
Formaldehyde. U.S. Department of Health and Human Services. 1999.
Concise International Chemical Assessment Document 40 (CICADS) on Formaldehyde
Published Under IPCS (The International Programme on Chemical Safety,
Geneva, 2002. 116 pgs.
ACGIH (American Conference of Governmental Industrial Hygienists). (2001). Acrolein
in Documentation of the Threshold Limit Values and Biological Exposure Indices,
7th Ed. Cincinnati, OH: American Conference of Governmental Industrial
Hygienists.
Alexandersson, R. and Hedenstierna, G. (1988). Respiratory Hazards Associated with
Exposure to Formaldehyde and Solvents in Acid-Curing Paints. Arch. Env.
Health. 43:222-227.
Alexandersson, Rolf, M.D. and Hedenstierna, Goran, M.D. (1989). Pulmonary Function
in Wood Workers Exposed to Formaldehyde: A Prospective Study. Arch. Env.
Health. Vol. 44, No. 1. p. 5-11.
ATSDR (Agency for Toxic Substances and Disease Registry). (1999). Toxicological
Profile for Formaldehyde. U.S. Department of Health and Human Services, Public
Health Services, Agency for Toxic Substances and Disease Registry, Atlanta, GA.
July 1999.
BEST (The Board on Environmental Studies and Toxicology). (2007). Formaldehyde.
Emergency and Continuous Exposure Guidance Levels for Selected Submarine
Contaminants Vol. 1. Page 103-138. The National Academies Press.
Blair, A., R. Saracci, P.A. Stewart, R.B. Hayes, and C. Shy. (1990). Epidemiologic
evidence on the relationship between formaldehyde exposure and cancer. Scand.
J. Work Environ. Health 16(6):381-393.
Burkhart KK, Kulig KW, McMartin KE. (1990). Formate levels following a formalin
ingestion. Vet Hum Toxicol 32:135-137.
Collins, J.J., J.F. Acquavella, and N.A. Esmen. (1997). An updated meta-analysis of
formaldehyde exposure and upper respiratory tract cancers. J. Occup. Environ.
Med. 39(7):639-651.
Dally, K. A., Eckamnn, A. D., Hanrahan, L. P, Anderson, H.A., and Kanarek, M. S.
(1981). A follow-up study of indoor air quality in Wisconsin homes. International
Symposium on Indoor Air Pollution, Health and Energy Conservation, October
13-16,
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Dally, K. A., Hanrahan, L. P, Woodbury, M. A., and Kavarek, M. S. Formaldehyde
exposure in non-occupational environments. Arch. Environ. Health 36: 277-284
(1981).
Edling, C.; Odkvist, L.; Hellquist, H. (1985): Formaldehyde and the Nasal Mucosa. Br. J.
Ind. Med. 42: 570-571.
Eells JT, McMartin KE, Black K, et al. (1981). Formaldehyde poisoning: Rapid
metabolism to formic acid. JAMA, J Am Med Assoc 246:1237-1238.
Engel, H.O. and Calnan, C.D. (1966). Resin dermatitis in a Car Factory. Brit. J. Ind. Med.
23:62-66.
Feinman SE, editor. (1988). Formaldehyde sensitivity and toxicity. Boca Raton (FL):
CRC Press Inc;.
Fleischer, J.M. (1987). Medical student's exposure to formaldehyde in gross anatomy
laboratories, NY State J. Med., 87: 385-388.
Flyvholm, M.A.; Hall, B.M.; Agner, T.; Tiedemann, E.; Greenhill, P.; Vanderveken, W.;
Freeberg, F.E.; and Menne, T. (1997). Threshold for occluded formaldehyde
patch test in formaldehyde-sensitive patients: Relationship to repeated open
application test with a product containing formaldehyde releaser. Contact
Dermatitis 36:26-3 3.
Hanrahan, L. P, Anderson, H. A., Dally, K. A., Eckamnn, A. D., and Kanarek, M. S.
(1981). An investigation of the off gassing decay function in aging mobile homes
with climate corrected formaldehyde readings. International Symposium on
Indoor Air Pollution, Health and Energy Conservation, October 13-16 1981.
Hanrahan, LP; Dally, KA.; Anderson, HA.; Kanarek, MS. And Rankin, 1(1984).
Formaldehyde vapor in mobile homes: a cross sectional survey of concentrations
and irritant effects. Am J Public Health. 74: 1026-1027.
Hauptmann, M., J.H. Lubin, P.A. Stewart, R.B. Hayes, and A. Blair. (2003). Mortal- ity
from lymphohematopoietic malignancies among workers in formaldehyde
industries. J. Natl. Cancer Inst. 95(21): 1615-1623.
Hauptmann, M., J.H. Lubin, P.A. Stewart, R.B. Hayes, and A. Blair. (2004). Mortality
from solid cancers among workers in formaldehyde industries. Am. J. Epidemiol.
Holmstrom et al. (1989) Histological Changes in the Nasal Mucosa in Persons
Occupationally Exposed to Formaldehyde Alone and in Combination with Wood
Dust. Acta Otolaryngol (Stockh) 107:120-129.
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Horvath EP, Anderson H, Pierce WE, Hanrahan L, Wendlick J. (1985). The effects of
formaldehyde on the mucus membranes and lungs in an industrial population.
Submitted to US Department of Labor for proposed rulemaking for exposure to
formaldehyde (50 FR 50412, December 10, 1985).
Horvath Jr., E.P., H. Anderson Jr., W.E. Pierce, L. Hanrahan, and J.D. Wendlick. (1988).
Effects of formaldehyde on the mucous membranes and lungs: A study of an
industrial population. JAMA 259(5):701-707.
Horvath, E. P. Jr.et al. (1988). Effects of Formaldehyde on the Mucous Membranes and
Lungs: A Study of an Industrial Population. JAMA, Vol. 259, No.5. p. 701-707.
IARC (International Agency for Research on Cancer). (1995). Formaldehyde. Pp. 217-
362 in Wood Dust and Formaldehyde. IARC Monographs on the Evaluation of
Carcinogenic Risks to Humans, Vol. 62. Lyon, France: World Health
Organization, International Agency for Research on Cancer.
IARC (International Agency for Research on Cancer). (2004). Formaldehyde (Group 1).
IARC Monographs Programme on the Evaluation of Carcinogenic Risks to
Humans, Vol. 88. International Agency for Research on Cancer, World Health
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2. Website References
Citation
Assessments of the reproductive and developmental toxicity of formaldehyde
conducted by the Australian government (www.nicnas.gov.au) as well as the Agency
for Toxic Substances and Disease Registry (ATSDR, 1999)support this conclusion.
EPA is currently completing a new IRIS assessment that will include a cancer unit
risk value for formaldehyde; the reassessment is scheduled to start internal peer
review in May 2008 and begin independent external peer review in January 2009
=view
Chemical. showChemical&sw_id=103 1). EPA anticipates that the peer review of the
formaldehyde assessment will not be finished before EPA completes the
reregi strati on process for formaldehyde pesticidal uses, scheduled to conclude in
September 2008.
The EPA's Consumer Exposure Module (CEM) was used to estimate air
concentrations resulting from the use of laundry detergent preserved with
formaldehyde. Detailed information and the executable model can be downloaded
from http ://www. epa. gov/opptintr/exposure.
3. Other Supporting Documents
Citation
ASHRAE, 1989. Ventilation for Acceptable Indoor Air Quality, American Society of
Heating Refrigerating and Air Conditioning Engineers, 1989.
68 of 87
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ASRC, 2005. Formaldehyde Smart Meeting, August 9, 2005, Minutes Prepared by Eric
Brewer of ASRC Aerospace.
Jacobson, Larry. 2005. Professor and Extension Engineer at University of Minnesota.
Kline, 2000. Specialty Biocide North America 2000, Kline and Company, Inc.
NIOSH, 1990. Health Hazard Evaluation of Buckeye Hills Career Center (HETA 88-153-
2072), NIOSH, October 1990.
NIOSH, 1997. Pocket Guide to Chemical Hazards, DHHS (NIOSH Publication No. 97-
140)
Olcrest, 1999. Paraformaldehyde Sterilant Use in Vocational High School Program,
Robert Olcrest, Brujos Scientific Inc., Baltimore, Maryland. Published in Applied
Occupational and Environmental Hygiene, Volume 14: 391-396, 1999
USD A, 1999. Crop Profile for Poultry (Broilers) in California
USD A, 2000. Crop Profile for Eggs in California
USD A, 2002. Crop Profile for Poultry in Florida
US EPA, 1997'a. Exposure Factors Handbook. Volume I-II. Office of Research and
Development. Washington, D.C. EPA/600/P-95/002Fa.
US EPA, 1999. Evaluation of Chemical Manufacturers Association Antimicrobial
Exposure Assessment Study. Memorandum from Siroos Mostaghimi, Ph.D., US EPA, to
Julie Fairfax,
US EPA, 2008. Incident Reports Associated with Formaldehyde. Jonathen Chen Ph.D.,
US EPA, 2008. Formaldehyde - Report of the Antimicrobials Division Toxicity Endpoint
Selection Committee (ADTC),
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Appendix E. Generic Data Call-In
The Agency intends to issue a Generic Data Call-In at a later date. See the Formaldahyde
/ Paraformaldahyde RED for a list of studies that the Agency plans to require.
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Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In at a later date for:
Formaldahyde / Paraformaldahyde ( 0556 )
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Appendix G. Batching of Formaldahyde / ParaformaldahydeProducts for Meeting
Acute Toxicity Data Requirements for Reregistration
The Agency intends to complete a Batching Memo at a later date
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Appendix H. List of All Registrants Sent the Data Call-In
The Agency intends to issue a Data Call-In at a later date to the following registrants:
Baker Petrolite Corporation
12645 West Port Airport Blvd
Sugarland, Texas 77478
Champion Technologies, Inc.
3185 Madison Highway, PO Box 5126
Valdosta Georgia 316035126
Protexall Products, Inc.
402 Integrated Court
Debary, Florida 32713
Noble Pine Products Co.
FOB ox 41 CentuckStat
Yonkers, New York, 10710
Hess & Clark Inc.
110 Hopkins Drive
Randolph, Wisconsin 539561316
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Appendix I. List of Available Related Documents and Electronically Available
Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.cpa.gov/opprd001/fonns/
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 hardcopy in accord with the
existing policy.
3. Mail the forms, along with any additional documents necessary to comply with
EPA regulations covering your request, to the address below for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or
'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail at williams.nicolcfficpamail.cpa.gov.
The following Agency Pesticide Registration Forms are currently available via the
internet at the following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide Registration/Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of Distribution of
a Registered Pesticide Product
Application for an Experimental Use Permit
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data Gap Procedures
Pesticide Registration Maintenance Fee Filing
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
Certification with Respect to Citations of Data (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/opprdOO l/forms/8570-1 .pdf
http : //www . epa. aov/o pprdOO 1 /forms/8 5 70 -4 . 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 that contains
the following pertinent forms and information needed to register a pesticide product with
the U.S. Environmental Protection Agency's Office of Pesticide Programs (OPP):
1 . The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food
Quality Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program Storage and Disposal
Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy
Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation
Amendments
h. 98-1 Self Certification of Product Chemistry Data with
Attachments (This document is in PDF format and requires the
Acrobat reader.)
Other PR Notices can be found at htt://w^w;J^OYyoiiM^
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
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4. General Pesticide Information (Some of these forms are in PDF format
and will require the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and
Devices (PDF format)
f. 40 CFR Part 158,Data Requirements for Registration (PDF format)
g. 50 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
2. The booklet "General Information on Applying for Registration of
Pesticides in the United States", PB92-221811, available through the
National Technical Information Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. 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 (800) 858-7378 or
through their Web site:
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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
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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